Companion

Diagnostics
Market- A Global
and Regional
Analysis

Global Companion Diagnostics Market

Focus on Application, End User,
Technology, and Region
Analysis and Forecast: 2023-2033

March 2024

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Global Companion Diagnostics Market

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Table of Content 1.8.3.1 Progress in Companion Diagnostics Driven by Continuous Development
and Technological Advancements ...................................................... 45
Executive Summary .............................................................. 12 1.8.3.2 Introduction of Epigenomics-Based Companion Diagnostics ............. 46
Scope and Definition............................................................. 22 2. Application ................................................................... 47
1. Markets ......................................................................... 26 2.1 Application Segmentation.............................................................................. 48
1.1 Trends: Current and Future Impact Assessment ........................................ 27
2.1.1 Application Summary ............................................................................... 49
1.1.1 Companion Diagnostics Market Trend Analysis .................................... 27
2.1.2 End User Summary ................................................................................... 50
1.1.2 Implementation of Liquid Biopsy-Based Companion Diagnostics ...... 28
2.2 Global Companion Diagnostics Market (by Application) ............................ 51
1.1.3 Combining Artificial Intelligence and Companion Diagnostics ............ 29
2.2.1 Lung Cancer .............................................................................................. 52
1.2 Supply Chain Overview .................................................................................. 30
2.2.2 Breast Cancer ............................................................................................ 52
1.2.1 Value Chain Analysis ............................................................................... 31
2.2.3 Colorectal Cancer ..................................................................................... 52
1.3 Research and Development Review ............................................................. 32
2.2.4 Leukemia ................................................................................................... 52
1.3.1 Patent Filing Trend (by Country, Year) ................................................... 32
2.2.5 Stomach Cancer ........................................................................................ 53
1.4 Regulatory Landscape ................................................................................... 33
2.2.6 Melanoma .................................................................................................. 53
1.4.1 Legal Requirements and Framework by the FDA .................................. 34
2.2.7 Others ........................................................................................................ 53
1.4.2 Legal Requirements and Framework by the EMA .................................. 34
2.3 Global Companion Diagnostics Market (by End User) ................................ 54
1.4.3 Legal Requirements and Framework by the MHLW .............................. 35
2.3.1 Pharmaceutical and Biotechnology Companies .................................... 55
1.5 CDx from a Historical Perspective ................................................................ 36
2.3.2 Reference Laboratories ............................................................................ 55
1.6 Constituents for Companion Diagnostics (CDx) Development .................. 37
2.3.3 Others ........................................................................................................ 55
1.7 Companion Diagnostics (CDx): Future Potential......................................... 38
3. Products ....................................................................... 56

Global Companion Diagnostics Market

1.8 Market Dynamics Overview ........................................................................... 39
3.1 Product Segmentation.................................................................................... 57
1.8.1 Market Drivers ........................................................................................... 40
3.2 Product Summary ........................................................................................... 58
1.8.1.1 Rising Prevalence of Cancer Cases ................................................... 40
3.3 Global Companion Diagnostics Market (by Technology)............................ 59
1.8.1.2 Increasing Product Approvals in the Field of Companion Diagnostics 41
3.3.1 Polymerase Chain Reaction (PCR) .......................................................... 60
1.8.1.3 Advancing Biomedical Imaging as the Driving Force for Precision
3.3.2 Immunohistochemistry (IHC) ................................................................... 60
Medicine's Companion Diagnostics.................................................... 42
3.3.3 In-Situ Hybridization (ISH) ........................................................................ 60
1.8.2 Market Restraints ...................................................................................... 43
3.3.4 Next-Generation Sequencing ................................................................... 60
1.8.2.1 Uncertain Reimbursement Scenario................................................... 43
4. Regions ........................................................................ 61
1.8.2.2 Stringent Regulatory Approval Processes .......................................... 44
4.1 Regional Summary ......................................................................................... 62
1.8.3 Market Opportunities ................................................................................ 45
4.2 Drivers and Restraints.................................................................................... 63

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 4.3 North America ................................................................................................. 64 4.4.18 Italy ............................................................................................................. 88
4.3.1 Regional Overview .................................................................................... 64 4.4.19 Application ................................................................................................ 89
4.3.2 Driving Factors for Market Growth .......................................................... 64 4.4.20 Product ...................................................................................................... 90
4.3.3 Factors Challenging the Market .............................................................. 64 4.4.21 Rest-of-Europe .......................................................................................... 91
4.3.4 Application ................................................................................................ 65 4.4.22 Application ................................................................................................ 92
4.3.5 Product ...................................................................................................... 66 4.4.23 Product ...................................................................................................... 93
4.3.6 U.S. ............................................................................................................. 67 4.5 Asia-Pacific ..................................................................................................... 94
4.3.7 Application ................................................................................................ 68 4.5.1 Regional Overview .................................................................................... 94
4.3.8 Product ...................................................................................................... 69 4.5.2 Driving Factors for Market Growth .......................................................... 94
4.3.9 Canada ....................................................................................................... 70 4.5.3 Factors Challenging the Market ............................................................... 94
4.3.10 Application ................................................................................................ 71 4.5.4 Application ................................................................................................ 95
4.3.11 Product ...................................................................................................... 72 4.5.5 Product ...................................................................................................... 96
4.4 Europe ............................................................................................................. 73 4.5.6 China .......................................................................................................... 97
4.4.1 Regional Overview .................................................................................... 73 4.5.7 Application ................................................................................................ 98
4.4.2 Driving Factors for Market Growth .......................................................... 73 4.5.8 Product ...................................................................................................... 99
4.4.3 Factors Challenging the Market .............................................................. 73 4.5.9 India.......................................................................................................... 100
4.4.4 Application ................................................................................................ 74 4.5.10 Application .............................................................................................. 101
4.4.5 Product ...................................................................................................... 75 4.5.11 Product .................................................................................................... 102
4.4.6 France ........................................................................................................ 76 4.5.12 Australia ................................................................................................... 103
4.4.7 Application ................................................................................................ 77 4.5.13 Application .............................................................................................. 104

Global Companion Diagnostics Market

4.4.8 Product ...................................................................................................... 78 4.5.14 Product .................................................................................................... 105
4.4.9 Germany .................................................................................................... 79 4.5.15 Japan........................................................................................................ 106
4.4.10 Application ................................................................................................ 80 4.5.16 Application .............................................................................................. 107
4.4.11 Product ...................................................................................................... 81 4.5.17 Product .................................................................................................... 108
4.4.12 U.K. ............................................................................................................ 82 4.5.18 South Korea ............................................................................................. 109
4.4.13 Application ................................................................................................ 83 4.5.19 Application .............................................................................................. 110
4.4.14 Product ...................................................................................................... 84 4.5.20 Product .................................................................................................... 111
4.4.15 Spain .......................................................................................................... 85 4.5.21 Rest-of-Asia-Pacific ................................................................................ 112
4.4.16 Application ................................................................................................ 86 4.5.22 Application .............................................................................................. 113
4.4.17 Product ...................................................................................................... 87 4.5.23 Product .................................................................................................... 114

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 4.6 Latin America ................................................................................................ 115 5. Markets - Competitive Benchmarking & Company Profiles
4.6.1 Regional Overview .................................................................................. 115 ................................................................................... 139
4.6.2 Driving Factors for Market Growth ........................................................ 115 5.1 Next Frontiers….. .......................................................................................... 140

4.6.3 Factors Challenging the Market ............................................................ 115 5.2 Geographic Assessment .............................................................................. 141

4.6.4 Application .............................................................................................. 116 5.2.1 Abbott Laboratories ................................................................................ 142

4.6.5 Product .................................................................................................... 117 5.2.1.1 Overview........................................................................................... 142

4.6.6 Brazil ........................................................................................................ 118 5.2.1.2 Top Products/Product Portfolio ......................................................... 142

4.6.7 Application .............................................................................................. 119 5.2.1.3 Top Competitors ............................................................................... 142

4.6.8 Product .................................................................................................... 120 5.2.1.4 Target Customers ............................................................................. 142

4.6.9 Mexico ..................................................................................................... 121 5.2.1.5 Key Personnel .................................................................................. 142

4.6.10 Application .............................................................................................. 122 5.2.1.6 Analyst View ..................................................................................... 142

4.6.11 Product .................................................................................................... 123 5.2.2 Agilent Technologies, Inc. ...................................................................... 143

4.6.12 Rest-of-Latin America ............................................................................ 124 5.2.2.1 Overview........................................................................................... 143

4.6.13 Application .............................................................................................. 125 5.2.2.2 Top Products/Product Portfolio ......................................................... 143

4.6.14 Product .................................................................................................... 126 5.2.2.3 Top Competitors ............................................................................... 143

4.7 Middle East and Africa ................................................................................. 127 5.2.2.4 Target Customers ............................................................................. 143

4.7.1 Regional Overview .................................................................................. 127 5.2.2.5 Key Personnel .................................................................................. 143

4.7.2 Driving Factors for Market Growth ........................................................ 127 5.2.2.6 Analyst View ..................................................................................... 143

4.7.3 Factors Challenging the Market ............................................................ 127 5.2.3 Amoy Diagnostics Co., Ltd. ................................................................... 144

4.7.4 Application .............................................................................................. 128 5.2.3.1 Overview........................................................................................... 144

Global Companion Diagnostics Market

4.7.5 Product .................................................................................................... 129 5.2.3.2 Top Products/Product Portfolio ......................................................... 144

4.7.1 U.A.E. ....................................................................................................... 130 5.2.3.3 Top Competitors ............................................................................... 144

4.7.2 Application .............................................................................................. 131 5.2.3.4 Target Customers ............................................................................. 144

4.7.3 Product .................................................................................................... 132 5.2.3.5 Key Personnel .................................................................................. 144

4.7.4 South Africa ............................................................................................ 133 5.2.3.6 Analyst View ..................................................................................... 144

4.7.5 Application .............................................................................................. 134 5.2.4 bioMérieux ............................................................................................... 145

4.7.6 Product .................................................................................................... 135 5.2.4.1 Overview........................................................................................... 145

4.7.7 Rest-of-Middle East and Africa .............................................................. 136 5.2.4.2 Top Products .................................................................................... 145

4.7.8 Application .............................................................................................. 137 5.2.4.3 Top Competitors ............................................................................... 145

4.7.9 Product .................................................................................................... 138 5.2.4.4 Target Customers ............................................................................. 145

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 5.2.4.5 Key Personnel .................................................................................. 145 5.2.9 Illumina, Inc. ............................................................................................ 150
5.2.4.6 Analyst View ..................................................................................... 145 5.2.9.1 Overview........................................................................................... 150
5.2.5 Danaher Corporation .............................................................................. 146 5.2.9.2 Top Products/Product Portfolio ......................................................... 150
5.2.5.1 Overview .......................................................................................... 146 5.2.9.3 Top Competitors ............................................................................... 150
5.2.5.2 Top Products/Product Portfolio ........................................................ 146 5.2.9.4 Target Customers ............................................................................. 150
5.2.5.3 Top Competitors ............................................................................... 146 5.2.9.5 Key Personnel .................................................................................. 150
5.2.5.4 Target Customers............................................................................. 146 5.2.9.6 Analyst View ..................................................................................... 150
5.2.5.5 Key Personnel .................................................................................. 146 5.2.10 Invivoscribe Technologies, Inc. ............................................................. 151
5.2.5.6 Analyst View ..................................................................................... 146 5.2.10.1 Overview........................................................................................... 151
5.2.6 DiaCarta ................................................................................................... 147 5.2.10.2 Top Products/Product Portfolio ......................................................... 151
5.2.6.1 Overview .......................................................................................... 147 5.2.10.3 Top Competitors ............................................................................... 151
5.2.6.2 Top Products/Product Portfolio ........................................................ 147 5.2.10.4 Target Customers ............................................................................. 151
5.2.6.3 Top Competitors ............................................................................... 147 5.2.10.5 Key Personnel .................................................................................. 151
5.2.6.4 Target Customers............................................................................. 147 5.2.10.6 Analyst View ..................................................................................... 151
5.2.6.5 Key Personnel .................................................................................. 147 5.2.11 Myriad Genetics, Inc. .............................................................................. 152
5.2.6.6 Analyst View ..................................................................................... 147 5.2.11.1 Overview........................................................................................... 152
5.2.7 F. Hoffmann-La Roche Ltd ..................................................................... 148 5.2.11.2 Top Products/Product Portfolio ......................................................... 152
5.2.7.1 Overview .......................................................................................... 148 5.2.11.3 Top Competitors ............................................................................... 152
5.2.7.2 Top Products/Product Portfolio ........................................................ 148 5.2.11.4 Target Customers ............................................................................. 152
5.2.7.3 Top Competitors ............................................................................... 148 5.2.11.5 Key Personnel .................................................................................. 152

Global Companion Diagnostics Market

5.2.7.4 Target Customers............................................................................. 148 5.2.11.6 Analyst View ..................................................................................... 152
5.2.7.5 Key Personnel .................................................................................. 148 5.2.12 Novogene Co, Ltd. ................................................................................. 153
5.2.7.6 Analyst View ..................................................................................... 148 5.2.12.1 Overview........................................................................................... 153
5.2.8 ICON plc................................................................................................... 149 5.2.12.2 Top Products/Product Portfolio ......................................................... 153
5.2.8.1 Overview .......................................................................................... 149 5.2.12.3 Top Competitors ............................................................................... 153
5.2.8.2 Top Products/Product Portfolio ........................................................ 149 5.2.12.4 Target Customers ............................................................................. 153
5.2.8.3 Top Competitors ............................................................................... 149 5.2.12.5 Key Personnel .................................................................................. 153
5.2.8.4 Target Customers............................................................................. 149 5.2.12.6 Analyst View ..................................................................................... 153
5.2.8.5 Key Personnel .................................................................................. 149 5.2.13 QIAGEN N.V. ............................................................................................ 154
5.2.8.6 Analyst View ..................................................................................... 149 5.2.13.1 Overview........................................................................................... 154

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 5.2.13.2 Top Products/Product Portfolio ........................................................ 154
5.2.13.3 Top Competitors ............................................................................... 154
5.2.13.4 Target Customers............................................................................. 154
5.2.13.5 Key Personnel .................................................................................. 154
5.2.13.6 Analyst View ..................................................................................... 154
5.2.14 Sysmex Corporation ............................................................................... 155
5.2.14.1 Overview .......................................................................................... 155
5.2.14.2 Top Products/Product Portfolio ........................................................ 155
5.2.14.3 Top Competitors ............................................................................... 155
5.2.14.4 Target Customers............................................................................. 155
5.2.14.5 Key Personnel .................................................................................. 155
5.2.14.6 Analyst View ..................................................................................... 155
5.2.15 Thermo Fisher Scientific Inc. ................................................................. 156
5.2.15.1 Overview .......................................................................................... 156
5.2.15.2 Top Products/Product Portfolio ........................................................ 156
5.2.15.3 Top Competitors ............................................................................... 156
5.2.15.4 Target Customers............................................................................. 156
5.2.15.5 Key Personnel .................................................................................. 156
5.2.15.6 Analyst View ..................................................................................... 156
6. Research Methodology................................................ 157

Global Companion Diagnostics Market

6.1 Data Sources ................................................................................................ 157
6.1.1 Primary Data Sources ............................................................................ 157
6.1.2 Secondary Data Sources........................................................................ 157
6.1.3 Data Triangulation .................................................................................. 157
6.2 Market Estimation and Forecast ................................................................. 159

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List of Figures Figure 24: France Companion Diagnostics Market, $Million, 2022-2033
Figure 25: Germany Companion Diagnostics Market, $Million, 2022-2033
Figure 26: U.K. Companion Diagnostics Market, $Million, 2022-2033
Figure 1: Global Companion Diagnostics Market, $Million, 2023, 2026, and 2033
Figure 27: Spain Companion Diagnostics Market, $Million, 2022-2033
Figure 2: Global Companion Diagnostics Market (by Region), $Million, 2022, 2026, and
2033 Figure 28: Italy Companion Diagnostics Market, $Million, 2022-2033

Figure 3: Global Companion Diagnostics Market (by Application), $Million, 2022, 2026, Figure 29: Rest-of-Europe Companion Diagnostics Market, $Million, 2022-2033

and 2033 Figure 30: Asia-Pacific Companion Diagnostics Market, $Million, 2022-2033

Figure 4: Global Companion Diagnostics Market (by Technology), $Million, 2022, 2026, Figure 31: China Companion Diagnostics Market, $Million, 2022-2033
and 2033 Figure 32: India Companion Diagnostics Market, $Million, 2022-2033
Figure 5: Global Companion Diagnostics Market (by End User), $Million, 2022, 2026, Figure 33: Australia Companion Diagnostics Market, $Million, 2022-2033
and 2033
Figure 34: Japan Companion Diagnostics Market, $Million, 2022-2033
Figure 6: Key Players in the Companion Diagnostics Industry
Figure 35: South Korea Companion Diagnostics Market, $Million, 2022-2033
Figure 7: Key Industrial Developments in Global Companion Diagnostics Market, 2023
Figure 36: Rest-of-Asia-Pacific Companion Diagnostics Market, $Million, 2022-2033
Figure 8: Key Aspects Related to Liquid Biopsy-Based Companion Diagnostics
Figure 37: Latin America Companion Diagnostics Market, $Million, 2022-2033
Figure 9: Applications of Digital Diagnostics
Figure 38: Brazil Companion Diagnostics Market, $Million, 2022-2033
Figure 10: Supply Chain and Risks within the Supply Chain
Figure 39: Mexico Companion Diagnostics Market, $Million, 2022-2033
Figure 11: Global Companion Diagnostics Market (by Country), January 2021-December
Figure 40: Rest-of-Latin America Companion Diagnostics Market, $Million, 2022-2033
2023
Figure 41: Middle East and Africa Companion Diagnostics Market, $Million, 2022-2033
Figure 12: Global Companion Diagnostics (by Year), January 2021-December 2023
Figure 42: U.A.E. Companion Diagnostics Market, $Million, 2022-2033
Figure 13: Evolution of Companion Diagnostics
Figure 43: South Africa Companion Diagnostics Market, $Million, 2022-2033

Global Companion Diagnostics Market

Figure 14: Components Required to Develop Companion Diagnostics
Figure 44: Rest-of-Middle East and Africa Companion Diagnostics Market, $Million,
Figure 15: Future Prospects of CDx
2022-2033
Figure 16: Impact Analysis of Market Navigating Factors, 2023-2033
Figure 45: Strategic Initiatives, 2021-2023
Figure 17: Factors Impacting Reimbursement Scenario
Figure 46: Share of Strategic Initiatives, 2021-2023
Figure 18: Advancements in Companion Diagnostics
Figure 47: Data Triangulation
Figure 19: Future Outlook of Epigenomics
Figure 48: Top-Down and Bottom-Up Approach
Figure 20: North America Companion Diagnostics Market, $Million, 2022-2033
Figure 49: Assumptions and Limitations
Figure 21: U.S. Companion Diagnostics Market, $Million, 2022-2033
Figure 22: Canada Companion Diagnostics Market, $Million, 2022-2033
Figure 23: Europe Companion Diagnostics Market, $Million, 2022-2033

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List of Tables Table 25: Germany Companion Diagnostics Market (by Technology), $Million, 2022-
2033
Table 26: U.K. Companion Diagnostics Market (by Application), $Million, 2022-2033
Table 1: Market Snapshot
Table 27: U.K. Companion Diagnostics Market (by End User), $Million, 2022-2033
Table 2: Global Companion Diagnostics Market, Opportunities
Table 28: U.K. Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 3: Some of FDA Approved Liquid Biopsy CDx Tests
Table 29: Spain Companion Diagnostics Market (by Application), $Million, 2022-2033
Table 4: Cancer Cases Expected between 2020 and 2040
Table 30: Spain Companion Diagnostics Market (by End User), $Million, 2022-2033
Table 5: Product Approvals in the Field of Companion Diagnostics
Table 31: Spain Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 6: Global Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 32: Italy Companion Diagnostics Market (by Application), $Million, 2022-2033
Table 7: Companion Diagnostics Preparation (by Region), $Million, 2022-2033
Table 33: Italy Companion Diagnostics Market (by End User), $Million, 2022-2033
Table 8: North America Companion Diagnostics Market (by Application), $Million,
Table 34: Italy Companion Diagnostics Market (by Technology), $Million, 2022-2033
2022-2033
Table 35: Rest-of-Europe Companion Diagnostics Market (by Application), $Million,
Table 9: North America Companion Diagnostics Market (by End User), $Million, 2022-
2022-2033
2033
Table 36: Rest-of-Europe Companion Diagnostics Market (by End User), $Million, 2022-
Table 10: North America Companion Diagnostics Market (by Technology), $Million,
2033
2022-2033
Table 37: Rest-of-Europe Companion Diagnostics Market (by Technology), $Million,
Table 11: U.S. Companion Diagnostics Market (by Application), $Million, 2022-2033
2022-2033
Table 12: U.S. Companion Diagnostics Market (by End User), $Million, 2022-2033
Table 38: Asia-Pacific Companion Diagnostics Market (by Application), $Million, 2022-
Table 13: U.S. Companion Diagnostics Market (by Technology), $Million, 2022-2033 2033
Table 14: Canada Companion Diagnostics Market (by Application), $Million, 2022-2033 Table 39: Asia-Pacific Companion Diagnostics Market (by End User), $Million, 2022-
Table 15: Canada Companion Diagnostics Market (by End User), $Million, 2022-2033 2033

Global Companion Diagnostics Market

Table 16: Canada Companion Diagnostics Market (by Technology), $Million, 2022-2033 Table 40: Asia-Pacific Companion Diagnostics Market (by Technology), $Million, 2022-
Table 17: Europe Companion Diagnostics Market (by Application), $Million, 2022-2033 2033

Table 18: Europe Companion Diagnostics Market (by End User), $Million, 2022-2033 Table 41: China Companion Diagnostics Market (by Application), $Million, 2022-2033

Table 19: Europe Companion Diagnostics Market (by Technology), $Million, 2022-2033 Table 42: China Companion Diagnostics Market (by End User), $Million, 2022-2033

Table 20: France Companion Diagnostics Market (by Application), $Million, 2022-2033 Table 43: China Companion Diagnostics Market (by Technology), $Million, 2022-2033

Table 21: France Companion Diagnostics Market (by End User), $Million, 2022-2033 Table 44: India Companion Diagnostics Market (by Application), $Million, 2022-2033

Table 22: France Companion Diagnostics Market (by Technology), $Million, 2022-2033 Table 45: India Companion Diagnostics Market (by End User), $Million, 2022-2033

Table 23: Germany Companion Diagnostics Market (by Application), $Million, 2022- Table 46: India Companion Diagnostics Market (by Technology), $Million, 2022-2033
2033 Table 47: Australia Companion Diagnostics Market (by Application), $Million, 2022-2033
Table 24: Germany Companion Diagnostics Market (by End User), $Million, 2022-2033 Table 48: Australia Companion Diagnostics Market (by End User), $Million, 2022-2033

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Table 49: Australia Companion Diagnostics Market (by Technology), $Million, 2022- Table 69: Rest-of-Latin America Companion Diagnostics Market (by End User), $Million,
2033 2022-2033
Table 50: Japan Companion Diagnostics Market (by Application), $Million, 2022-2033 Table 70: Rest-of-Latin America Companion Diagnostics Market (by Technology),
Table 51: Japan Companion Diagnostics Market (by End User), $Million, 2022-2033 $Million, 2022-2033

Table 52: Japan Companion Diagnostics Market (by Technology), $Million, 2022-2033 Table 71: Middle East and Africa Companion Diagnostics Market (by Application),
$Million, 2022-2033
Table 53: South Korea Companion Diagnostics Market (by Application), $Million, 2022-
2033 Table 72: Middle East and Africa Companion Diagnostics Market (by End User),
$Million, 2022-2033
Table 54: South Korea Companion Diagnostics Market (by End User), $Million, 2022-
2033 Table 73: Middle East and Africa Companion Diagnostics Market (by Technology),
$Million, 2022-2033
Table 55: South Korea Companion Diagnostics Market (by Technology), $Million, 2022-
2033 Table 74: U.A.E. Companion Diagnostics Market (by Application), $Million, 2022-2033

Table 56: Rest-of-Asia-Pacific Companion Diagnostics Market (by Application), $Million, Table 75: U.A.E. Companion Diagnostics Market (by End User), $Million, 2022-2033
2022-2033 Table 76: U.A.E. Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 57: Rest-of-Asia-Pacific Companion Diagnostics Market (by End User), $Million, Table 77: South Africa Companion Diagnostics Market (by Application), $Million, 2022-
2022-2033 2033
Table 58: Rest-of-Asia-Pacific Companion Diagnostics Market (by Technology), $Million, Table 78: South Africa Companion Diagnostics Market (by End User), $Million, 2022-
2022-2033 2033
Table 59: Latin America Companion Diagnostics Market (by Application), $Million, 2022- Table 79: South Africa Companion Diagnostics Market (by Technology), $Million, 2022-
2033 2033
Table 60: Latin America Companion Diagnostics Market (by End User), $Million, 2022- Table 80: Rest-of-Middle East and Africa Companion Diagnostics Market (by
2033 Application), $Million, 2022-2033

Global Companion Diagnostics Market

Table 61: Latin America Companion Diagnostics Market (by Technology), $Million, Table 81: Rest-of-Middle East and Africa Companion Diagnostics Market (by End User),
2022-2033 $Million, 2022-2033
Table 62: Brazil Companion Diagnostics Market (by Application), $Million, 2022-2033 Table 82: Rest-of-Middle East and Africa Companion Diagnostics Market (by
Table 63: Brazil Companion Diagnostics Market (by End User), $Million, 2022-2033 Technology), $Million, 2022-2033

Table 64: Brazil Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 65: Mexico Companion Diagnostics Market (by Application), $Million, 2022-2033
Table 66: Mexico Companion Diagnostics Market (by End User), $Million, 2022-2033
Table 67: Mexico Companion Diagnostics Market (by Technology), $Million, 2022-2033
Table 68: Rest-of-Latin America Companion Diagnostics Market (by Application),
$Million, 2022-2033

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List of Acronyms
Acronym Description

AI Artificial Intelligence
CDx Companion Diagnostics
CML Chronic Myeloid Leukemia
CROs Contract Research Organizations
CTCs Circulating Tumor Cells
ctDNA Circulating Tumor DNA
EMA European Medicines Agency
ER Estrogen Receptor
EU European Union
FDA Food and Drug Administration
GMP Good Manufacturing Practice
GSPR General Safety And Performance Requirements
HER2 Human Epidermal Growth Factor Receptor 2
ICI Immune Checkpoint Inhibitor
IHC Immunohistochemistry
ISH In-Situ Hybridization

Global Companion Diagnostics Market

IVD In-Vitro Diagnostics
MHLW Ministry of Health, Labour and Welfare
MHRA Medicines and Healthcare Products Regulatory Agency
MRI Magnetic Resonance Imaging
NMPA National Medical Products Administration
PCR Polymerase Chain Reaction
PET Positron Emission Tomography
PMDA Pharmaceuticals and Medical Devices
PR Progesterone Receptor
NGS Next-Generation Sequencing

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 Executive Summary

Global Companion Diagnostics Market

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Mega and Macro Trends
Ta ble 1 : Mar ke t S na ps ho t

Scenario Market Size (2023) Market Size (2033) CAGR (%) Scenario Parameter
Assuming that there is no significant impact of restraints and driving factors
Optimistic $3,854.6 million $15,068.5 million 14.61%
continue fueling the market
Assuming that the restraining factors are impacting the growth rate of the
Pessimistic $3,663.0 million $9,788.0 million 9.30%
market
A balance being observed between driving factors and restraining factors,
Realistic $3,762.0 million $12,498.7 million 12.76%
along with upcoming technologies invading the market

Fi g ure 1 : G lobal Com pa nio n Dia g nos tic s Ma rke t , $Milli o n,

2 023 , 202 6, and 203 3

15,068.4
7,119.9
12,498.7
6,224.8
3,300.0 9,788.0
3,300.00
5,498.4
3,300.0

2023 2027 2033

Global Companion Diagnostics Market

Optimistic Pessimistic Realistic
Source: BIS Research Analysis

The inception of companion diagnostics (CDx) in 1998 marked the origin of the drug-diagnostic co-development model, a transformative approach that has since witnessed consistent and substantial
adoption. Initially, companion diagnostics advancement was slow, with approximately 20 new approvals between 1998 and 2012, whereas from 2015 to 2023, this number rose to 134. About 50%
of all new molecular entity (NME) approvals in oncology have an associated CDx or biomarker included in the label required for safe and effective use (based on FDA approvals from 2021 and
2022 of NME in oncology). By the end of August 2023, the FDA approved 56 CDx assays. The global companion diagnostics market is primarily driven by increased demand for precision medicine,
growing sales of CDx complementary therapeutic drugs, regulatory tailwinds, widespread adoption of next-generation sequencing (NGS) enabling multiple biomarker screening simultaneously in
clinical trials, and the emergence of targeted gene panels, comprehensive genome profiling (CGP), and whole exome sequencing (WES) which have further streamlined the development of multi-
biomarker-driven CDx. These companion diagnostics assays are associated with different oncological and hematological drugs, which would lose their value without an accurate and reliable CDx
assay.

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Furthermore, significant technological advancements in recent years, such as the evolution of liquid biopsy-based companion diagnostic tests, continuous expansion label expansion for marketed
CDx, and growing use in therapeutic areas beyond oncology, are fueling the market growth. In 2023, the FDA approved several liquid biopsy tests as companion diagnostics, such as FoundationOne
CDx and FoundationOne Liquid CDx, Braftovi, and Mektovi, to identify metastatic non-small cell lung cancer patients. For instance, in 2022, Agilent Technologies, Inc. received the Europe CE-IVD
mark for PD-L1 IHC 22C3 pharmDx for use in cervical cancer.

Despite the historical trend toward oncology, applications in metabolic syndrome and rare diseases are gaining traction, empowering CDx to become an integral part of precision medicine clinical
trials across many indications. Most NGS-based CDx follow the single-site regulatory pathway today, limiting sample analysis capacity, increasing turnaround times, and reducing patient access.
Moreover, advancements in precision medicine are focused on addressing these limitations through decentralized testing and an easy-to-implement workflow and analysis model.

Global Companion Diagnostics Market

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North America Region to Lead the Global Companion Diagnostics
Market (by Region)
Fi g ure 2 : G lobal Com pa nio n Dia g nos tic s Ma rke t (by Regi o n) ,
$Mil lio n, 20 22 , 2 026 , a nd 2 033

5,336.9

3,562.1

2,849.7
2,371.6

1,614.1
1,428.9

1,125.1
983.4

633.6

400.0
350.0
219.8
174.4
141.9
112.2

2022 2026 2033

North America Europe Asia-Pacific Middle East and Africa Latin America
Source: BIS Research Analysis

The global companion diagnostics market (by region) has been dominated by North America, which held a 43.30% market share in 2022, and it is anticipated to retain its position in the market
during the forecast period. The region is at the forefront of the market due to the increased adoption of precision medicine, the presence of key industry leaders and strategic collaborations, a

Global Companion Diagnostics Market

favorable regulatory environment, rapid development, and accessibility to targeted therapies. Correspondingly, the shift in the cancer treatment paradigm toward immunotherapy and targeted
therapy is fueling the adoption of CDx in developing countries such as China, South Korea, Japan, Australia, Taiwan, and others. Besides accounting for about a quarter of the newly diagnosed
cancer cases globally, China has broadened access to targeted therapy for the most prevalent cancer indications, which is driving the demand for immunohistochemistry testing. In 2022, the South
Korean Ministry of Food and Drug Safety (MFDS) approved PD-L1 IHC 22C3 pharmDx, developed by Agilent Technologies, Inc., as a CDx to identify patients with non-small cell lung cancer
(NSCLC) who are suitable for the first-line monotherapy with Keytruda on the Dako Omnis platform. In another example, Guardant Health received Ministry of Health, Labour and Welfare in Japan
(MHLW) regulatory approval for Guardant360 CDx for identifying patients with NSCLC who benefited from Lumakras in 2021 and in patients with advanced solid tumors in 2022.

Furthermore, in February 2022, the company received CAP accreditation to process in-vitro diagnostics (IVD) samples in a laboratory in Japan and reimbursement approval. The company also
launched a new laboratory in China. The growing interest of key industry leaders in developing countries and the increasing prevalence of cancer are fueling the market growth. The Asia-Pacific
region has been expanding alongside the U.S. and Europe and is projected to grow faster, with 14.53% CAGR during the forecast period 2023-2033.

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Opportunities across Regions
Ta ble 2 : G lobal Com pa nio n Dia g nos tic s Ma rke t , Op p or tuni ties

Parameter Description
Collaborating with payers to establish coverage policies and reimbursement structures for diagnostic tests.
Developing solutions to integrate companion diagnostics into healthcare systems, such as molecular and genetic testing, into routine healthcare practices.
Developing a genomic database that aids in biomarker discovery and validation.
Developing liquid biopsy-based companion diagnostics
For instance, critical companies such as F. Hoffmann-La Roche, Illumina, Inc., and others contributing liquid biopsy solutions for identifying cancer biomarkers and
Market enhancing personalized treatment options.
Opportunities Developing comprehensive genomic profiling-based companion diagnostics
Collaborating with biopharmaceutical companies in the development of new drugs
Emerging mutations with high unmet needs, such as ESR1, an urgent mutation that evolves after breast cancer treatment and patients expressing ESR1 can be
put on a new class of targeted therapy.
There are growth opportunities in emerging countries, including China, India, South Korea, Japan, and others. For instance, China offers a point of differentiation
and potential for biopharma strategic partnerships.
Source: BIS Research Analysis

Global Companion Diagnostics Market

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Oncology to Lead the Global Companion Diagnostics Market (by
Application)
Fi g ure 3 : G lobal Com pa nio n Dia g nos tic s Ma rke t (by
Applic at ion) , $Million, 2 022 , 20 26 , a nd 20 33

4,988.4

2,956.8

2,296.7
2,107.6

1,369.1
1,234.0

1,001.7

958.1
844.3

676.1
597.2

432.8

421.3
327.2
258.8
206.9

201.3
164.1

102.5
91.9

66.8

2022 2026 2033

Lung Cancer Breast Cancer Colorectal Cancer Leukemia Stomach Cancer Melanoma Others
Source: BIS Research Analysis

The global companion diagnostics market (by application) has been dominated by lung cancer, which held 37.39% of the market share in 2022. The dominance could be attributed to the rise of

Global Companion Diagnostics Market

precision medicine in oncology, which heavily relies on CDx to identify patients who will benefit from specific therapies, high cancer burden and mortality rate, and rapid advancement in cancer
research leading to the discovery of new cancer-specific biomarkers and streamlined regulatory process encouraging co-development and approval of CDx alongside oncology drugs. While CDx
has become intrinsic tools for the implementation of personalized medicine in oncology, growing use beyond oncology spheres to other therapeutic areas, including women's health, rare and
orphan diseases, and neurodegenerative diseases such as Alzheimer's disease., has impacted on dealmaking, clinical practice, and the R&D pipeline. For instance, in 2023, the FDA approved
AAV5 DetectCDx, the first CDx immunoassay for a gene therapy developed by ARUP Laboratories, to identify adult patients eligible for treatment with Roctavian.

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Polymerase Chain Reaction (PCR) to Lead the Global Companion Diagnostics Market (by Technology)
Fi g ure 4 : G lobal Com pa nio n Dia g nos tic s Ma rke t (by
Tec hnol ogy ), $Mill ion, 2 022 , 20 26 , a nd 20 33

4,579.6

2,979.9
2,847.2
1,950.5

1,766.0
1,373.7
1,147.0

1,102.4

887.8
845.4
614.0

574.2

326.0
190.6
119.3

2022 2026 2033

PCR NGS IHC ISH Others

Source: BIS Research Analysis

The global companion diagnostics market (by technology) was dominated by PCR, representing 34.76% market share in 2022. The significant contribution could primarily be attributed to diverse

Global Companion Diagnostics Market

applications, ease of use, better results, faster turnaround time, and cost-effective solutions. Of the 56 CDx assays approved by the FDA, most were powdered by polymerase chain reaction (PCR)
followed by immunohistochemistry (IHC) and NGS, respectively. Furthermore, as PCR is preferred as a validation strategy for NGS-based companion diagnostics, the technology continues to be
in demand in the market. Since NGS-based companion diagnostics are also experiencing increased exposure due to their larger sample size and result accuracy, PCR will continue to dominate
the global companion diagnostics market for its corroborative characteristics. While immunohistochemistry (IHC) has historical significance and maintains a role, PCR currently leads the market,
with NGS gaining traction and potentially holding the key to future advancements. For instance, in 2022, Illumina Inc. collaborated with Boehringer Ingelheim to develop companion diagnostics
(CDx) for several programs in Boehringer Ingelheim's oncology pipeline. The partnership added CDx claims to an in-vitro diagnostic (IVD) test that Illumina Inc. developed based on TruSight
Oncology 500 (TSO 500) content. Similarly, in 2021, ThermoFisher Scientific Inc. and AstraZeneca plc entered a strategic partnership to co-develop next-generation sequencing (NGS)-based
companion diagnostics (CDx) supporting AstraZeneca Plc clinical pipeline, which is 90% composed of targeted precision medicine therapies across oncology, cardiovascular and renal to metabolic
and respiratory disease.

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Reference Laboratories and Hospitals to Lead the Global
Companion Diagnostics Market (by End User)
Fi g ure 5 : G lobal Com pa ni o n Dia g nos tic s Ma rke t (by E nd User ) ,
$Mil lio n, 20 22 , 2 026 , a nd 2 03 3

6,063.2
4,587.0
2,472.9
2,101.6

1,848.4
1,418.9
1,288.5

930.6
592.6

2022 2026 2033

Pharmaceutical and Biotechnology Companies Reference Laboratories and Hospitals Others
Source: BIS Research Analysis

The global companion diagnostics market (by the end user) has been segmented into pharmaceutical and biotechnological companies, reference laboratories and hospitals, and others. Reference

Global Companion Diagnostics Market

laboratories and hospital segment dominated the market with 43.00% market share in 2022, as they increasingly utilize CDx in clinical decision-making. The growing number of approved CDx
across various disease areas and the expansion of healthcare infrastructure enhancing the capacity of healthcare providers is fueling the segment growth. While the dominance of pharmaceutical
and biotechnological companies has decreased, the end user remains relevant by co-developing companion diagnostics alongside new drugs.

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Competitive Landscape
The global companion diagnostics market is rapidly evolving and growing. A few major companies, such as F. Hoffmann-La Roche Ltd, Abbott Laboratories, Agilent Technologies, Inc., and others,
dominate the market, offering a wide range of companion diagnostics across various disease areas. The market has been witnessing increased collaborations between industry-leading players to
develop and commercialize CDx, further underpinning their position in the market. For instance, in 2021, Illumnia, Inc. collaborated with Myriad Genetics to integrate TruSight Oncology 500 assay
with myChoice CDx to offer more comprehensive tumor profiling capabilities for homologous recombination deficiency (HRD) detection testing. Agilent Technologies, Inc. is one of the leading
market players with a history of success in companion diagnostics dating back to HercepTest's launch in 1998. Recently, in 2023, the company collaborated with Quest Diagnostics to provide ctDx
FIRST, the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients
who may benefit from treatment with Krazati. The company exhibits expertise across different modalities, which offers significant capacity for growth and support of future companion diagnostics
partnerships. Additionally, Agilent Technologies, Inc. has built a strong relationship with Merck KGaA to bring a drug and a companion diagnostic product to the market.

Fi g ure 6 : Key Pla yers in t he Com pa nio n Dia g nos tic s I ndus tr y

Big Players Small to Medium Size Players Emerging

• F. Hoffmann-La Roche Ltd • Myriad Genetics • Tempus

• Quest Diagnostics • Abnova • OncXerna
• Abbott Laboratories • Promega Corporation • Niramai
• Qiagen N.V. • Predicine
• ARUP
• Illumnia
• Agilent Technologies, Inc.

Global Companion Diagnostics Market

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Companion Diagnostics Industry Overview in the Next Decade
The future outlook of companion diagnostics appears promising, with ongoing evolution, transition into clinical settings, and technological advancements. Advancing CDx is expected to become
an integral component of precision medicine, enabling healthcare providers to tailor treatments based on individual patient characteristics. The increasing integration of artificial intelligence is further
expected to elevate the accuracy and efficiency of diagnostic tests in companion diagnostics. For instance, Agilent and Visiopharm have collaborated since 2020 and are developing an integrated
solution comprising Visiopharm’s portfolio of leading artificial intelligence (AI)-driven precision pathology software and Agilent Technologies, Inc. automated pathology staining solutions. Despite
limitations, CDx is anticipated to expand, especially in oncology, demonstrating the promise of future therapies that are not only more rational but also cost-effective. The sustainable growth of the
companion diagnostic industry hinges on the collaborative efforts of key stakeholders, fostering comprehensive diagnostic portfolios and ensuring continued adoption in clinical settings.

Fi g ure 7 : Key Ind ustri al Develop me nts i n G lob al Com pa nio n

D iagnosti cs M arke t , 2 023

Foundation Medicine, Inc. Recieves FDA Approval for FoundationOne CDx as a Use for Selpercatinib
(Retevmo)

•The FDA, in October 2023, approved FoundationOne CDx for use with selpercatinib (Retevmo) for the treatment of tumors with a RET gene
fusion.

Agilent Technologies, Inc. Collaborates with Incyte to Develop Advanced Companion Diagnostics in
Hematology and Oncology

•In January 2024, Agilent Technologies, Inc. collaborated with Incyte to develop advanced companion diagnostics in hematology and oncology.
This would enables Agilent Technologies, Inc. to continue to expand its CDx portfolio with novel biomarkers and allow Incyte to leverage the
company's expertise in IVD assay development, global regulatory approvals, and commercialization.

Global Companion Diagnostics Market

Guardant Health Receives Coverage from UnitedHealthcare for Guardant360 CDx

•As of May 2023, UnitedHealthcare (UHC) would now cover the Guardant360 CDx liquid biopsy test for patients enrolled in its commercial policies
for all FDA-approved companion diagnostic indications. The test is used by oncologists as a CDx to assess if patients are eligible for targeted
therapy for advanced or metastatic breast or non-small-cell lung cancer (NSCLC).
Source: BIS Research Analysis

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Scope and Definition

Scope and Definition

Global Companion Diagnostics Market

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Market Definition
Companion diagnostics refer to medical tests or assays that are used in conjunction with a specific therapeutic product, typically a targeted drug or therapy. These tests help identify patients who
are most likely to benefit from the treatment or those who may be at a higher risk of adverse reactions. In other words, companion diagnostics are designed to personalize and optimize the use of
a particular drug by tailoring the treatment to the individual patient's characteristics.

Inclusion and Exclusion Criteria

The products considered in the study include kits and assays that are used to assess a patient’s disease profile and segregate them according to the specific drugs that will treat the disease. The
study excludes any companion diagnostic-recommended drug for treatment.

Global Companion Diagnostics Market

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Key Questions Answered
• What are the key trends influencing the global companion diagnostics market, and what is their potential for impacting the market?

• What does the patent landscape of the global companion diagnostics market look like? Which year and country witnessed the maximum patent filings?

• What are the key regulations that impact the growth of the global companion diagnostics market?

• What are the key drivers, restraints, and opportunities for the global companion diagnostics market, and what will be their impact on the market in short-, mid-, and long-term duration?

• What is the estimated global market size for the companion diagnostics market?

• What are the different types of products available in the market?

• Which segment holds the largest market share of the companion diagnostics market, and which one of these segments is projected to be the fastest-growing segment during the forecast
period 2023-2033?

• Which region holds the largest market share of the companion diagnostics market, and which one of these regions is expected to be the fastest-growing segment during the forecast period
2023-2033?

• Which country holds the largest market share of the companion diagnostics market, and which one of these countries is expected to be the fastest-growing segment during the forecast
period 2023-2033.?

• Who are the key players in the global companion diagnostics market, and what are their product offerings in the market?

Global Companion Diagnostics Market

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Analysis and Forecast Note

Year Considered (2022-2033)

• The base year considered for the calculation of the market size is 2022. The historical year analysis has been done from FY2020 to FY2021, and the market
size has been calculated for FY2022 and projected for 2023-2033.

Data Availability and Proxies

• Data for different automated products

• Factors driving and restraining the market growth
• Secondary sources for market estimation

Assumptions and Limitations

• The geographical distribution of the market revenue has been estimated to be the same as the company’s net revenue distribution. All the numbers have
been adjusted off to two digits after decimal for report presentation reasons. However, the real figures have been utilized for compound annual growth rate
(CAGR) estimation. CAGR has been calculated from 2023 to 2033.

Global Companion Diagnostics Market

• In the study, the primary respondent’s verification has been considered to finalize the estimated market for the companion diagnostics.
• The latest annual reports of each market player have been taken into consideration for market revenue calculation.
• Market strategies and developments of key players have been considered for the calculation of sub-segment split.
• The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations,
• considering the average conversion rate for that particular year. The currency conversion rate has been taken from the historical exchange rate of the Oanda
website or from the annual reports of the respective company, if stated.

Source: BIS Research Analysis

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1. Markets

1. Market: Industry Outlook

Global Companion Diagnostics Market

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1.1 Trends: Current and Future Impact Assessment
1.1.1 Companion Diagnostics Market Trend Analysis

Future Impact Scenario

Trend Current Impact Developments
Best Case Realistic Case

In January 2023, Agilent Technologies, Inc. entered into an agreement

with Quest Diagnostics, a provider of diagnostic information services.
Implementation of Liquid Biopsy-Based
Medium High High This collaboration would allow healthcare providers and patients across
Companion Diagnostics
the U.S. to utilize the Agilent Resolution ctDx FIRST liquid biopsy next-
generation sequencing (NGS) test.
In June 2023, Tempus, a company that uses smart technology for
precise medical care, collaborated with TScan Therapeutics, a company
working on creating special T cells to treat cancer patients. Together,
they plan to make a companion diagnostic (CDx) test. This test may help
Combining Artificial Intelligence and
Low Medium Medium TScan Therapeutics in its Phase 1 solid tumor clinical trial. The goal is
Companion Diagnostics
to provide patients with personalized combinations of T cells, depending
on the presence of certain substances in their tumors and how their cells
express specific proteins. This collaboration would support TScan's
screening process for the clinical trial.
Source: BIS Research Analysis

Global Companion Diagnostics Market

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1.1.2 Implementation of Liquid Biopsy-Based Fi g ure 8 : Key As pects Rela te d t o Li qui d B iopsy -B ase d
Companion Diagnostics C om pa nion Dia gnos ti cs

The implementation of liquid biopsy-based companion diagnostics represents a •Liquid biopsy can be used for the early detection of
transformative approach in oncology, offering a non-invasive and dynamic method for cancer, potentially identifying genetic alterations
assessing tumor characteristics. This innovative diagnostic strategy involves the analysis of before the manifestation of clinical symptoms.
Application Furthermore, it provides a dynamic assessment of
circulating biomarkers, such as circulating tumor DNA (ctDNA) and circulating tumor cells treatment response and allows for the detection of
(CTCs), in bodily fluids such as blood. minimal residual disease (MRD) or disease
recurrence.
For instance, according to a research paper published by PubMed Central in October 2022,
titled “Clinical utility of liquid biopsy-based companion diagnostics in the non-small-cell lung •Liquid biopsy-based companion diagnostics are
cancer treatment,” tests that analyze multiple genes in liquid biopsy have been given the green specifically designed to identify actionable genetic or
molecular alterations that can guide the selection of
light as companion diagnostics and are used in regular clinical situations. One way that liquid Companion
targeted therapies. These diagnostics are crucial for
biopsy can help is by checking the number of mutations in the blood tumor (bTMB). This can Diagnostics
personalized medicine, ensuring that patients receive
be useful in predicting how well immune checkpoint inhibitor (ICI) treatments might work. treatments that are most likely to be effective based
on their individual tumor profile.

Ta ble 3 : S ome o f FD A Ap pr o ve d Li quid B iop sy CDx Tes ts

•Identification and validation of specific biomarkers are
Biomarkers critical for the success of liquid biopsy-based
Name of Test Technology companion diagnostics.

ArcherMET NGS
Gurdant 360 CDx NGS panel (61 genes) •Liquid biopsy has demonstrated clinical utility in
multiple cancer types, including lung, breast,
FoundationOne Liquid CDx NGS panel (318 genes) colorectal, and prostate cancer. It enables real-time
Clinical Utility
Source: PubMed Central, Clinical Utility of Liquid Biopsy-Based Companion Diagnostics in the Non-Small-Cell monitoring of treatment response, helps in the
Lung Cancer Treatment, October 2022 identification of resistance mechanisms, and assists in

Global Companion Diagnostics Market

adapting treatment strategies.
Source: BIS Research Analysis

Analyst View
As liquid biopsy technology continues to evolve, it holds immense promise for guiding
personalized cancer treatment by identifying actionable genetic alterations. The successful
implementation of liquid biopsy-based companion diagnostics requires collaboration among
researchers, clinicians, regulatory authorities, and industry partners, ultimately contributing to
a paradigm shift toward precision medicine in cancer care.

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1.1.3 Combining Artificial Intelligence and Companion Fi g ure 9 : A pplic ation s of D igi tal Di agnostics
Diagnostics
AI technologies, such as machine learning and deep learning algorithms, are applied to
Fast and
analyze complex datasets generated by companion diagnostic tests. This dynamic pairing Efficient
enables faster and more precise interpretation of results, leading to improved diagnostic Diagnoses

accuracy and the ability to identify subtle patterns or correlations that may be challenging for
traditional methods.

For instance, in September 2022, Neuron23 Inc., a company working on creating precise Subtype
Tumor
Identificati
medicines for specific brain and immune system diseases, teamed up with QIAGEN N.V. to Grading
on
make a special test. This test, called a companion diagnostic, could help determine if Digital
Neuron23's LRRK2 inhibitor medicine is a good fit for people with Parkinson's disease. The Diagnostics
collaboration would assist in the final stages of testing Neuron23's potential drug, which is
currently being studied before clinical trials. If the drug continues to show promise in these
trials, the partnership also includes the possibility of creating more tests in the future to go
along with other potential medicines.
Integration
with Quality
Furthermore, in February 2024, F. Hoffmann-La Roche Ltd and PathAI joined forces to use Clinical Assurance
artificial intelligence (AI) in creating computer programs, known as algorithms, for companion Data
diagnostics. This collaboration would enhance the use of AI in developing tests that can help
identify the right patients for specific treatments. Companion diagnostics can play a crucial Source: BIS Research Analysis

role in tailoring medical interventions to individual patients, and AI can contribute to the
efficiency and accuracy of such diagnostic processes. Analyst View
The integration of artificial intelligence (AI) with companion diagnostics represents a

Global Companion Diagnostics Market

groundbreaking synergy in the field of healthcare. This combination harnesses the power of
advanced computing to enhance the efficiency, accuracy, and overall capabilities of diagnostic
processes.

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1.2 Supply Chain Overview
Fi g ure 10 : S upply C hai n a nd Ris ks wi thin t he S uppl y C hai n

Regulatory
Raw Material Compliance
Procurement Risk Assessment

Raw material
procurement and
assay development
and production are
the key concerns.

Assay
Supplier Evaluation Technology
Development
and Data
and Production
Integration

Global Companion Diagnostics Market

Source: BIS Research Analysis

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1.2.1 Value Chain Analysis

Assay
Biomarker Development Healthcare
Manufacturing Quality Commercialization
Discovery and Integration
Regulatory Check
Approval

Upstream Activities Primary Activities

Marketing
Sales
andDistribution
Downstream Activities

Global Companion Diagnostics Market

Post-Market Documentation Customer
Surveillance and Support
Reporting

Source: BIS Research Analysis

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1.3 Research and Development Review
1.3.1 Patent Filing Trend (by Country, Year)
Companion Diagnostics Patent Analysis
Fi g ure 12 : G lobal Com pa nio n Dia gnos tic s ( by Year) , Ja nua ry
Fi g ure 11 : G lobal Com pa nio n Dia g nos tic s Ma rke t (by Co untr y ), 2 021 -Decem ber 202 3
J a nuar y 20 2 1 -De cem ber 202 3

23
Japan 2 22

Number of Patents Filed

European Patent Office 5

China 2

Canada 8
6
U.S. 9

Australia 3

Others 22 2021 2022 2023

Source: BIS Research Analysis

Source: BIS Research Analysis

Global Companion Diagnostics Market

The highest number of patents filed was recorded in 2022, followed by 2021. However, from
Based on country, the U.S. recorded the highest number of patents during the period of 2021 to 2023, 2023 recorded the lowest number of patents filed for the companion diagnostics
January 2021-December 2023, followed by Canada. market.

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1.4 Regulatory Landscape
From a Policy Perspective, the U.S. and European Countries are
Leading Geographies with a Seemingly Favorable Environment.

U.S. Canada U.K. Germany China

Regulatory Approvals

Guidelines

Quality Testing Assurance

High Medium Low

Source: BIS Research Analysis

Global Companion Diagnostics Market

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1.4.1 Legal Requirements and Framework by the FDA 1.4.2 Legal Requirements and Framework by the EMA
Drug discovery and development efforts toward targeted therapies, particularly in oncology, The European Union has been overhauling its rules on in-vitro diagnostics (IVD) to bring them
have spurred the emergence of companion diagnostics (CDx). CDx and their corresponding more in line with the internationally agreed standards. This has been particularly focused upon
therapeutics are most often co-developed or parallelly developed, to ensure the safe and companion diagnostics. However, despite the changes, there is still the retention of a
effective use of the products. The regulatory framework for companion diagnostics has regulatory system that keeps the approval of IVDs separate from those for pharmaceuticals.
gradually evolved, owing to the essential role of diagnostic tests to identify the intended Different regulatory pathways will be followed for the authorization of medicines and
population for a corresponding treatment. diagnostics even though the use of companion diagnostics (CDx) is considered to be crucial
for the performance of the drug.

According to the approved FDA guidelines, a companion diagnostic is “a medical device, often
an in vitro device, which provides information that is essential for the safe and effective use of The splitting of regulatory responsibilities could hamper prospects for the co-development of
a corresponding drug or biological product.” The test helps a healthcare professional a medicine and consequently, its CDx, causing the drug and the diagnostic to reach the market
determine whether a particular therapeutic product’s benefits to patients will outweigh any at the different timeframe. The co-development of drugs with assays for pharmacogenomic
potential serious side effects or risks. biomarkers necessary for patient selection will be an important component for the shift to
precision or personalized medicines from traditional treatment. Gaps in controls could be
maintained by the division of responsibilities. This gap control could be beneficial for the
The FDA has laid down two draft guidance documents for the regulatory approval of quality of specimens with respect to their storage and transportation, pre-analytical phases of
companion diagnostics. These are as follows: biomarker testing, and in the monitoring of the reproducibility of tests.

▪ In July 2014, the FDA issued "Guidance for Industry: In Vitro Companion Diagnostic
Devices". This guidance was issued to help companies identify the need for Replacing legislations dates back to the early 1990s, two new legislations have been
companion diagnostics at an earlier stage in the drug development process and simultaneously approved in 2017. IVD Regulation 2017/746 will come into full force in 2022
accordingly plan for co-development of the drug and companion diagnostic test. The and EU Regulation 2017/745, Medical Devices will come into full force in 2020. The new rules
guidance ultimately aimed to stimulate early collaborations that would result in faster are more consistent with those developed at the international level for medical devices

Global Companion Diagnostics Market

access to promising new treatments for patients living with serious and life- including IVDs, in particular with the guidance from the Global Harmonization Task Force
(GHTF) and the International Medical Devices Regulators Forum (IMDRF).
threatening diseases.

▪ In July 2016, the FDA released the draft guidance, "Principles for Co-development
of an In Vitro Companion Diagnostic Device with a Therapeutic Product." This According to the EU’s new IVD legislation, health institutes, including hospitals, should
continue to have the freedom “of manufacturing, modifying, and using devices in-house”
guidance document was intended to be a practical guide to assist therapeutic product
outside the regulation. However, national quality rules may still apply to them. The EU’s
sponsors and IVD sponsors in developing a therapeutic product and an
existing regulatory system has largely been retained, under which self-certification of the
accompanying IVD companion diagnostic. quality and safety of their diagnostic kits can still be done by the IVD manufacturers.

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1.4.3 Legal Requirements and Framework by the MHLW
An official notification was issued in July 2013 by the Ministry of Health, Labour and Welfare (MHLW), Japan, regarding the co-development of companion diagnostics (CDx) with a drug. The
notification stated that any exclusive diagnostic test or medical device was required to predict efficacy or adverse reactions to the drug. The core contents in the MHLW’s notification were highly
similar to the summaries in the final guidance issued by the US Food and Drug Administration’s (FDA) Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic
Devices, [August 2014]). The guidelines recommended the respective industries to develop, study, and submit CDx as well as their corresponding drug contemporaneously as much as possible.

In December 2013, Following the MHLW’s notification, the Pharmaceutical and Medical Device Agency (PMDA) notified the regulatory requirements for a clinical trial of the CDx and drug as well
as the necessary analytical validity of CDx for the trials. These official notifications from the Ministry and the Agency were useful for pharmaceutical and diagnostics manufacturers in comprehending
ways to co-develop and validate CDx for clinical trials and consequently, regulatory submission. However, since the highly anticipated technologies, such as the next-generation sequencing (NGS),
are exceedingly complex for adoption and medically risky, the existing regulatory system which focuses only on IVD-manufacturer made diagnostic reagents and devices, may not be suitable for
the characteristics of CDx for the future.

In November 2013, the FDA cleared 510 K for NGS and its universal kit due to a substantial increment of clinical needs for multiple biomarkers assays by DNA sequencing. Additionally, in October
2014, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory
Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and
Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) to oversee laboratory developed tests (LDTs) associated with medium or high medical risks. These strategic decisions
and new regulatory frameworks would further allow the clinical laboratories to develop and perform NGS-based CDx easily under the certification of Clinical Laboratory Improvement Amendments
(CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. Effective regulatory changes and reimbursement policies still await Japan’s companion
diagnostics co-development regime.

Global Companion Diagnostics Market

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1.5 CDx from a Historical Perspective
The evolution of companion diagnostics represents a transformative journey in the field of personalized medicine. Initially emerging as a tool to identify specific genetic markers associated with
diseases, companion diagnostics have evolved into sophisticated and integral components of patient care. Advancements in molecular biology, genomics, and technology have played a pivotal
role in enhancing the precision and capabilities of these diagnostics. From early applications in oncology to the exploration of biomarkers in various therapeutic areas, companion diagnostics have
expanded their scope, contributing to more targeted and effective treatments. The integration of next-generation sequencing (NGS) technologies, immunohistochemistry, and in-situ hybridization
has further propelled the evolution of companion diagnostics, allowing for comprehensive genomic profiling and spatial analysis of biomarkers. As the understanding of disease biology continues
to deepen, companion diagnostics are expected to play an increasingly critical role in tailoring therapies to individual patient profiles, shaping the future of precision medicine.

Fi g ure 13 : Evol utio n of C omp a nio n Dia g nos tics

Global Companion Diagnostics Market

Source:https://cdn.amegroups.cn/journals/amepc/files/journals/12/articles/118835/public/118835-PB1-2618-
R1.pdf
Note: IHC: Immunohistochemistry, FISH: Fluorescence In-Situ Hybridization, RT-PCR: Real-Time Polymerase
Chain Reaction, NGS: Next-Generation Sequencing, ECLIA: Electrochemiluminescence Immunoassay

The figure shows the timeline for the introduction of various companion diagnostics platforms.

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1.6 Constituents for Companion Diagnostics (CDx)
Development
Ideally, when creating a specific treatment and its matching CDx solution, they should be developed together. This involves checking the CDx's importance and how well it works by using the data
and information gathered during the clinical development of the treatment. Even though various CDx solutions might face different challenges and have specific needs in their testing, the basic
principles for checking if they work well in real-world situations should be the same.

The decisions in developing CDx are usually guided by the goal of maximizing the exposure of patients who would benefit from a drug while minimizing exposure for those for whom the drug may
not work or could pose risks. Deciding how to evaluate patients who test negative for the diagnostic is crucial. Analyzing the performance of the diagnostic assay should be done before using it in
clinical trials. Identifying key data elements necessary for analytical validation is essential early in development. Therefore, it is vital to bring together researchers, clinicians, sponsors, and regulators
to discuss challenges and opportunities in co-developing drugs and diagnostics. This collaboration is crucial for advancing breakthrough precision diagnostics and targeted therapies.

Fi g ure 14 : Com po ne nt s Re quired to Develo p Com panio n

D iagnosti cs

• DNA
R&D Laboratories (Biomarker • RNA
Identification) • Proteins
• Metabolite Targets

• Screening Assay
• Predictive Marker Screen
Diagnostic Companies (Development
• Final Marker Selection
and Optimizing Assay)
• Assay and Platform Selection
• Final Kit Design

Global Companion Diagnostics Market

Clinical Laboratories (Deployment into
• Multi-Center Prospective Meta-Analysis
Clinical Laboratories)

Regulatory Consultants (Submission for

• File Appropriate Regulatory Documents
Regulatory Approvals)

Contract Manufacturing • Good Manufacturing Practice

Source: BIS Research Analysis

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1.7 Companion Diagnostics (CDx): Future Potential
The future potential of CDx holds immense promise, with ongoing advancements poised to revolutionize the landscape of personalized medicine. Until now, personalized medicine, which tailors
treatments based on individual characteristics, has mostly been used in cancer care. It started with a few specific drugs and tests for cancer, but now it has been expanding to cover more kinds of
illnesses. A better understanding of how our bodies work on a molecular level, owing to advances in molecular testing, is helping in areas like metabolic disorders (such as diabetes), neurological
conditions (such as Alzheimer's), and heart problems. However, more research is needed to find clear signs (biomarkers) for these diseases. One also needs to create tests (companion diagnostics)
for diseases other than cancer to use personalized medicine more widely. To make this happen, everyone involved, i.e., government agencies, insurance companies, and drug and test makers,
needs to work closely together and build strong partnerships for successful development in areas beyond cancer. Several key areas highlight the prospective developments and impacts:

Fi g ure 15 : F uture P ros pec ts o f C Dx

Expanding
Therapeutic
Areas

Integration of
Integration with
Multi-Omics
Immunotherapy
Data

Future Potential

Global Companion Diagnostics Market

Patient
Empowerment
and Informed Liquid Biopsies
Decision-
Making

Artificial
Intelligence (AI)
and Data
Analytics

Source: BIS Research Analysis

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1.8 Market Dynamics Overview
The market dynamics section of the report examines the diverse factors that govern the manufacturing, distribution, and usage of companion diagnostic products. This analysis provides an in-
depth understanding of the present and future directions in which the market is headed and the impact of various factors on the same. This section covers the major market dynamics, namely,
drivers, challenges, and opportunities, analyzing several factors that may positively and negatively affect the companion diagnostics market.

Fi g ure 16 : Im pac t A nal ysis of Ma rke t N avig a ti ng Fact or s , 202 3 -

2 033

Market Driver 1-4 Years 5-10 Years

Rising Prevalence of Cancer Cases High High
Increasing Product Approvals in the Field of Companion Diagnostics Medium High
Advancing Biomedical Imaging as the Driving Force for Precision Medicine's Companion Diagnostics Medium High

Market Restraint 1-4 Years 5-10 Years

Uncertain Reimbursement Scenario Medium Medium
Stringent Regulatory Approval Processes Medium High

Market Opportunity 1-4 Years 5-10 Years

Progress in Companion Diagnostics Driving Continuous Developments and Technological Advancements Medium High

Global Companion Diagnostics Market

Introduction of Epigenomics-Based Companion Diagnostics High Medium

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1.8.1 Market Drivers
1.8.1.1 Rising Prevalence of Cancer Cases
The rising prevalence of chronic diseases, particularly cancer, is a pivotal driver propelling the growth of the companion diagnostics market.

Ta ble 4 : Ca ncer Cases Ex pec te d bet ween 2020 a nd 204 0

19.3 M 30.2 M

Source: Cancer Tomorrow, IARC, 2024

As chronic diseases become more prevalent globally, there has been an increasing need for advanced diagnostic tools that can provide personalized insights into patients' conditions. Companion
diagnostics play a crucial role in this landscape by identifying specific biomarkers or genetic mutations associated with diseases, notably cancer.

The diagnostic tests enable healthcare professionals to tailor treatment strategies based on the individual characteristics of patients, ensuring a more targeted and effective approach to therapy.
As the incidence of cancer continues to climb, the demand for companion diagnostics is expected to rise, facilitating the development of precision medicine and contributing to improved patient
outcomes in the field of oncology.

While companion diagnostics are applicable across various therapeutic areas, oncology remains a dominant field due to the complex genetic nature of cancers and the need for targeted therapies.

Global Companion Diagnostics Market

According to a paper published by PubMed Central titled “Companion Diagnostics: State of the Art and New Regulations,” in October 2021, 44 tests were approved by the FDA to help diagnose
cancer diseases. Out of these, 19 (43%) were approved from 1998 to 2015, and the remaining 25 (57%) were approved in the last five years.

Analyst View
As the understanding of the molecular basis of diseases continues to advance, companion diagnostics are expected to play an increasingly crucial role in shaping the future of medicine. The market
is likely to see continued growth with ongoing research, technological innovations, and increased collaboration between diagnostic and pharmaceutical companies.

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1.8.1.2 Increasing Product Approvals in the Field of Laboratories, Drug
Companion Diagnostics Inc. Administration
Source: BIS Research Analysis
The field of companion diagnostics is experiencing a noteworthy surge in product approvals,
.
reflecting a dynamic and rapidly evolving landscape. The increasing number of product
approvals in companion diagnostics underscores the growing significance of these tests in Analyst View
personalized medicine. Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA), are actively evaluating and approving companion
diagnostic products, providing a regulatory framework that facilitates their integration into
Ta ble 5 : P ro duc t Ap p rovals in t he Fiel d of Com panio n
clinical practice. These approvals are a testament to the advancements in genomic
D iagnosti cs
technologies, molecular biology, and the understanding of disease at the molecular level. The
expanding repertoire of companion diagnostics signifies the critical role they play in guiding
Company Product Date Regulatory Body
treatment decisions, especially in the context of oncology, where targeted therapies are
Agilent becoming more prevalent.
PD-L1 IHC
Technologies, August 2023 CE-IVD
22C3 pharmDx As the range of approved companion diagnostic products widens, healthcare providers gain
Inc.
access to more sophisticated tools that enable precise patient stratification, ultimately
AmoyDx
National Medical contributing to improved therapeutic outcomes and the realization of the promise of
Microsatellite
Amoy November 2023 Products personalized medicine.
Instability (MSI)
Diagnostics Administration
Detection Kit
Co.,
Ltd. AmoyDx Pan Japanese Ministry
Lung Cancer March 2023 of Health, Labour
PCR Panel and Welfare
PATHWAY U.S. Food and
F. Hoffmann-La

Global Companion Diagnostics Market

anti-HER2/neu October 2022 Drug
Roche Ltd
(4B5) Administration

Invivoscribe LeukoStrat CDx U.S. Food and

Technologies, FLT3 Mutation July 2023 Drug
Inc. Assay Administration
U.S. Food and
therascreen PDGFRA
QIAGEN N.V. August 2023 Drug
RGQ PCR kit
Administration
U.S. Food and
Thermo Fisher Oncomine Dx Target
September 2022 Drug
Scientific Inc. Test
Administration
Myriad Genetic BRACAnalysis CDx March 2022 U.S. Food and

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1.8.1.3 Advancing Biomedical Imaging as the Driving Force
for Precision Medicine's Companion Diagnostics
The rapid progression of biomedical imaging stands at the forefront of driving precision medicine's companion diagnostics to new heights. As advanced technologies evolve, such as magnetic
resonance imaging (MRI), positron emission tomography (PET), and advanced microscopy techniques, they empower healthcare professionals with unprecedented insights into the molecular and
cellular landscapes of diseases.

These advancements not only facilitate the identification of specific biomarkers crucial for companion diagnostics but also enable a more nuanced understanding of individual patient characteristics.
By harnessing the power of precise and detailed biomedical imaging, the field of precision medicine is poised to revolutionize diagnostics, tailoring treatments to the unique profiles of patients for
improved therapeutic outcomes.

Analyst View
For instance, according to a research paper published by PubMed Central in July 2023, titled “Emerging Biomedical Imaging-Based Companion Diagnostics for Precision Medicine,” a new type of
diagnostic tool that uses molecular imaging has been developed to quickly diagnose tumors and monitor how well treatments are working in precision medicine. Presently, the only imaging-based
companion diagnostic tool approved by the FDA is FerriScan, which uses MRI to check iron levels in the livers of people with certain types of thalassemia. Furthermore, with the progress in
molecular imaging, there are more ways to measure the differences in tumors and see how they respond to treatment. This includes methods such as nuclear medicine, ultrasound, MRI, CT scans,
and optical imaging to predict how well a treatment might work.

Global Companion Diagnostics Market

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1.8.2 Market Restraints Analyst View
1.8.2.1 Uncertain Reimbursement Scenario Diagnostic companies investing substantially in the development of these innovative tools may
find their enthusiasm dampened by the unpredictability surrounding reimbursement policies.
The companion diagnostics market faces a notable impediment in the form of an uncertain
Moreover, the lack of clarity in reimbursement can trickle down to patients, resulting in
reimbursement scenario, casting a shadow over its potential growth and adoption. This
increased out-of-pocket costs and potentially limiting their access to these advanced
uncertainty introduces financial challenges for healthcare providers, who heavily depend on
diagnostic solutions.
reimbursements to offset the costs associated with integrating companion diagnostics into
their clinical practices. According to a paper published by Inside Precision Medicine titled “CDx Reimbursement and
Funding Challenges and Potential Solutions” in June 2022, sometimes, a medicine might get
its reimbursement approved in a specific market, but the companion diagnostic that goes with
Fi g ure 17 : Fa ctors Imp ac ti ng Reim b urseme nt S cenario it might face delays in getting reimbursed. This is because the evaluations for diagnostic
reimbursement often don't have strict timelines set by law. For instance, in Belgium, Xalkori
got its reimbursement approval in 2013, but the decision to reimburse the companion
• The uncertainty surrounding reimbursement creates diagnostic (used to identify the ALK fusion gene) only happened in 2019.
Financial Strain financial challenges for healthcare providers. These
on Healthcare providers heavily rely on reimbursements to offset the costs To overcome these challenges, concerted efforts are needed to advocate for transparent and
Providers associated with implementing and offering companion
diagnostics. fair reimbursement policies, ensuring that the clinical and economic benefits of companion
diagnostics are recognized and supported in the healthcare ecosystem.

Patient • The financial burden on patients can act as a barrier to

accessing companion diagnostics, as individuals may be
Affordability less inclined to opt for these advanced tests if affordability
Concerns becomes a concern.

Global Companion Diagnostics Market

• Healthcare providers may exhibit reluctance in incorporating
Slow Adoption companion diagnostics into their standard practice when
faced with uncertain reimbursement. This hesitation can
Rates lead to slower adoption rates, impeding the integration of
companion diagnostics into routine clinical workflows.

Source: BIS Research Analysis

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1.8.2.2 Stringent Regulatory Approval Processes
Companion diagnostics play a critical role in tailoring medical treatments to individual patients, and to uphold their reliability and effectiveness, there are stringent regulations in place. These
regulations are designed to ensure the safety and accuracy of companion diagnostics, particularly in their correlation with specific therapeutic interventions.

According to a paper published by PubMed Central, titled “Companion Diagnostics: State of the Art and New Regulations,” in October 2021, companion diagnostics (CDx) show potential in
improving drug development and precision medicine, however they face challenges in clinical development and regulation. CDx is considered high-risk because it plays a crucial role in treatment
decisions, and its sensitivity and specificity can complicate matters. The European Union (EU) has been working on implementing the In-Vitro Diagnostic Medical Devices Regulation (IVDR), which
brings in strict requirements for scientific validity, analytical and clinical performance, and ongoing monitoring for in-vitro diagnostics (IVD) throughout their lifetime.

Adhering to General Safety and Performance Requirements (GSPRs) follows a risk-based approach, similar to the new classification system. This evolving regulatory framework affects everyone
in the in-vitro diagnostics (IVD) industry, such as authorized representatives, distributors, importers, notified bodies, and reference laboratories. It is anticipated to notably influence the creation of
new companion diagnostics (CDx).

Analyst View
The regulatory framework for companion diagnostics involves rigorous scrutiny of their development, validation, and clinical utility. This process aims to confirm that these diagnostics accurately
identify biomarkers or genetic variations, providing essential information for determining the most suitable treatment for an individual patient.

Global Companion Diagnostics Market

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1.8.3 Market Opportunities Analyst View
1.8.3.1 Progress in Companion Diagnostics Driven by The integration of advanced technologies, such as next-generation sequencing, liquid biopsy,
Continuous Development and Technological and advanced imaging techniques, has significantly enhanced the sensitivity and specificity
Advancements of companion diagnostics. These technological strides not only enable more accurate disease
diagnosis but also play a pivotal role in patient stratification for personalized treatment plans.
The landscape of companion diagnostics is continually being shaped by ongoing
The evolution of companion diagnostics is a dynamic process marked by continuous
developments and technological evolutions. Advancements in genetic and molecular research
innovation and the exploration of novel biomarkers and diagnostic modalities.
have paved the way for a deeper understanding of disease mechanisms at the molecular
level. This progress has led to the identification and validation of a plethora of biomarkers, For instance, in August 2022, the FDA gave approval for the first next-generation sequencing
allowing for more precise and targeted diagnostic approaches. (NGS)-based companion diagnostics. This diagnostic tool assists in identifying patients with
non-small cell lung cancer who have specific HER2 (ERBB2) activating mutations (SNVs &
Exon 20 Insertions). The purpose of this diagnostic is to help healthcare professionals in
Fi g ure 18 : Adv anceme nts i n Com pa nio n Dia g nos tic s selecting appropriate patients for treatment with ENHERTU.

As these technologies mature, the companion diagnostics field is expected to make even
Next-Generation Sequencing
greater contributions to personalized medicine, ultimately improving patient outcomes by
•A significant leap forward in companion diagnostics involves the application of ensuring that treatments are tailored to individual genetic profiles and disease characteristics.
next-generation sequencing (NGS) technology. NGS is a robust tool that
enables the quick and simultaneous examination of several genes, facilitating
the identification of genetic mutations linked to specific diseases. The ability to
analyze multiple genes rapidly through NGS has substantially contributed to
the precision and efficiency of diagnostic processes, ushering in a new era in
personalized medicine.
Liquid Biopsy
•Another notable technological evolution in companion diagnostics is the
adoption of liquid biopsy. This method represents a non-invasive approach

Global Companion Diagnostics Market

utilizing a straightforward blood test to identify cancer cells or other
biomarkers circulating in the bloodstream. Its non-invasive nature makes it a
more patient-friendly alternative to traditional biopsy methods. As this
technology continues to advance, it is anticipated to play an increasingly
crucial role in the future of diagnostics, offering valuable insights into cancer
detection and monitoring.
Artificial Intelligence
•The use of artificial intelligence (AI) and machine learning in companion
diagnostics is increasing. AI-powered programs can study a lot of data, find
patterns, and make predictions. This helps make diagnostic tests more
accurate and efficient.
Source: Healthcareradius, Companion diagnostics: Everything you wanted to know, January 2023

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1.8.3.2 Introduction of Epigenomics-Based Companion
Diagnostics
The emergence of epigenomics-based companion diagnostics presents a compelling opportunity for the companion diagnostics market. By delving into the intricate realm of epigenetic modifications,
these diagnostics offer a nuanced understanding of individualized molecular profiles, revolutionizing the landscape of precision medicine.

This level of granularity facilitates a more tailored and effective approach to treatment, potentially leading to improved patient outcomes. The versatility of epigenomics spans across various disease
areas, allowing for the discovery of novel biomarkers and expanding the applications of companion diagnostics. Moreover, the dynamic nature of epigenetic changes enables longitudinal monitoring,
providing valuable insights into disease progression and treatment response over time.

Fi g ure 19 : F uture Outlo ok of E pig en omics

Enhanced Precision in Treatment

•Epigenomics-based companion diagnostics offer a more detailed understanding of a patient's molecular profile, enabling healthcare providers to tailor treatments with
greater precision.

Expanded Biomarker Discovery

•Epigenomics-related studies can contribute to the discovery of novel biomarkers associated with various diseases. This expands the repertoire of diagnostic tools,
allowing for the identification of unique epigenetic signatures that may serve as indicators for treatment response or disease progression.

Advancement in Personalized Medicine

•Epigenomics enhances the capabilities of personalized medicine by incorporating information about epigenetic modifications alongside genetic data.

Integration with Technological Advancements

Global Companion Diagnostics Market

•Advances in epigenomic technologies, such as high-throughput sequencing and advanced analytical methods, contribute to the robustness and accuracy of
companion diagnostics.
Source: Future Medicine, Epigenetics and Companion Diagnostics: Opportunities and Challenges, September
2023

Analyst View
As technological advancements in epigenomic tools continue to evolve, there is expected to be a significant potential for market growth and collaboration opportunities within the healthcare sector.
Epigenomics-based companion diagnostics not only enhance diagnostic precision but also contribute to the strategic expansion of the companion diagnostics market, thereby positioning it at the
forefront of personalized medicine innovations.

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2. Application

Application

Global Companion Diagnostics Market

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2.1 Application Segmentation

Application Segmentation

Global Companion Diagnostics Market

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2.1.1 Application Summary
Application

Lung Cancer Breast Cancer Colorectal Cancer Leukemia Stomach Cancer Melanoma Others

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 1,234.0 1,415.1 1,619.3 1,849.3 2,107.6 2,397.3 2,721.5 3,083.6 3,487.3 3,936.4 4,435.3 4,988.4 13.43%

Breast Cancer 844.3 955.7 1,079.6 1,217.0 1,369.1 1,537.2 1,722.4 1,926.3 2,150.1 2,395.5 2,663.8 2,956.8 11.96%

Colorectal Cancer 597.2 681.8 776.6 882.9 1,001.7 1,134.2 1,281.8 1,445.7 1,627.6 1,828.9 2,051.4 2,296.7 12.91%

Leukemia 206.9 232.8 261.3 292.7 327.2 365.0 406.4 451.6 501.0 554.6 612.9 676.1 11.25%

Stomach Cancer 91.9 106.6 123.3 142.4 164.1 188.8 216.8 248.5 284.3 324.7 370.2 421.3 14.74%

Melanoma 66.8 74.6 83.1 92.4 102.5 113.5 125.5 138.4 152.4 167.5 183.8 201.3 10.44%

Others 258.8 295.6 336.6 382.2 432.8 488.7 550.4 618.2 692.5 773.7 862.1 958.1 12.48%

Total 3,300.0 3,762.0 4,279.8 4,858.8 5,505.0 6,224.8 7,024.8 7,912.4 8,895.2 9,981.4 11,179.5 12,498.7 12.76%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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2.1.2 End User Summary
End User
Pharmaceutical and Biotechnology Companies Reference Laboratories and Hospitals Others

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-33)

Pharmaceutical and Biotechnology

1,288.5 1,460.7 1,652.3 1,865.3 2,101.6 2,363.0 2,651.7 2,970.0 3,320.2 3,704.7 4,126.1 4,587.0 12.12%
Companies
Reference Laboratories and
1,418.9 1,635.3 1,880.9 2,158.8 2,472.9 2,827.0 3,225.5 3,673.2 4,175.0 4,736.6 5,363.8 6,063.2 14.00%
Hospitals
Others 592.6 666.0 746.6 834.6 930.6 1,034.8 1,147.6 1,269.2 1,400.0 1,540.1 1,689.6 1,848.4 10.75%

Total 3,300.0 3,762.0 4,279.8 4,858.8 5,505.0 6,224.8 7,024.8 7,912.4 8,895.2 9,981.4 11,179.5 12,498.7 12.76%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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2.2 Global Companion Diagnostics Market (by
Application)

Global Companion Diagnostics Market

(by Application)

Global Companion Diagnostics Market

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2.2.1 Lung Cancer
Companion diagnostics in lung cancer have transformed the landscape of treatment by customizing therapeutic approaches based on the specific genetic characteristics of individual tumors. These
diagnostics play a pivotal role in identifying biomarkers such as EGFR mutations, ALK rearrangements, and ROS1 alterations, guiding the selection of targeted therapies. For instance, patients
with EGFR mutations may benefit from EGFR tyrosine kinase inhibitors, while those with ALK rearrangements may respond to ALK inhibitors.

PD-L1 expression testing assists in determining eligibility for immune checkpoint inhibitors. Furthermore, companion diagnostics not only aid in precise patient stratification but also enable ongoing
monitoring of treatment response. As a result, these tools have significantly improved treatment outcomes in lung cancer patients, offering a paradigm shift toward personalized and more effective
therapies.

2.2.2 Breast Cancer

Companion diagnostics in breast cancer have emerged as vital tools for tailoring treatment strategies to the unique characteristics of individual tumors. By identifying specific biomarkers such as
Human Epidermal Growth Factor Receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR), these diagnostics guide the selection of targeted therapies. For instance, HER2-
positive breast cancers may benefit from HER2-targeted therapies such as trastuzumab. Hormone receptor-positive tumors, characterized by the presence of ER and/or PR, may be treated with
endocrine therapies.

2.2.3 Colorectal Cancer

In the colorectal cancer landscape, companion diagnostics has assumed a pivotal role, guiding personalized treatment strategies based on the unique molecular profiles of tumors. Biomarkers
such as RAS and BRAF mutations serve as crucial indicators, allowing for the selection of targeted therapies tailored to individual patient needs. Companion diagnostics play a key role in identifying
patients who may benefit from anti-EGFR therapies, particularly in cases with RAS wild-type tumors.

This approach optimizes treatment efficacy while minimizing potential side effects in patients who are unlikely to respond to certain therapies. The integration of companion diagnostics in colorectal
cancer not only enhances the precision of therapeutic interventions but also represents a significant stride toward more effective and individualized patient care in the evolving landscape of precision

Global Companion Diagnostics Market

medicine.

2.2.4 Leukemia
In the field of leukemia, the companion diagnostics market has emerged in tailoring treatment strategies to the specific genetic and molecular characteristics of individual patients. The identification
of biomarkers, such as specific genetic mutations or chromosomal abnormalities, is pivotal for guiding targeted therapies. For instance, companion diagnostics are instrumental in identifying patients
with chronic myeloid leukemia (CML) who harbor the BCR-ABL fusion gene, guiding the use of tyrosine kinase inhibitors such as imatinib.

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2.2.5 Stomach Cancer
In stomach cancer, the companion diagnostics market has become an essential component in guiding tailored treatment approaches based on the distinct molecular characteristics of tumors.
Biomarkers such as HER2 amplification are crucial in identifying patients who may benefit from targeted therapies such as trastuzumab. Companion diagnostics play a pivotal role in determining
the eligibility of patients for specific treatments, optimizing therapeutic outcomes, and avoiding unnecessary side effects. The integration of these diagnostics into stomach cancer care underscores
the importance of personalized medicine, allowing for more precise and effective treatment strategies tailored to individual patient profiles.

2.2.6 Melanoma
Melanoma is a big health problem, causing most skin cancer-related deaths. Even though it makes up only 1% of diagnosed skin cancers, it's expected to be the main reason for skin cancer-
related deaths. The integration of companion diagnostics in melanoma care addresses the unmet needs in oncology, offering personalized approaches to enhance patient outcomes. As the
incidence of melanoma and other common cancer types continues to rise, companion diagnostics for melanoma become increasingly crucial in advancing precision oncology and optimizing patient
care.

2.2.7 Others
Researchers are working on creating drugs and companion diagnostics for common and aggressive cancers worldwide. They are also looking into less common types, such as ovarian cancer,
urothelial cancer, and squamous cell carcinoma of the head and neck. Some important companies making these companion diagnostics are Myriad Genetics, Inc., F. Hoffmann-La Roche Ltd, and
Agilent Technologies, Inc. The other applications include disease such as infectious diseases, cardiac diseases, and neurological diseases:

Companion diagnostics play a crucial role in identifying specific markers or genetic characteristics related to infectious agents, aiding in the diagnosis and treatment of infections. As the field of
infectious diseases evolves, companion diagnostics contribute to precision medicine by guiding the selection of appropriate antimicrobial therapies and helping to manage the growing concern of
antimicrobial resistance. The integration of companion diagnostics in infectious disease management represents a valuable advancement in healthcare, offering a more personalized and efficient
approach to addressing microbial infections.

Global Companion Diagnostics Market

Further, in the study of brain-related illnesses, the use of companion diagnostics is becoming more crucial for personalized medicine. These diagnostics help find specific signs and genetic clues
linked to brain conditions, making it easier for doctors to diagnose and choose treatments. By using companion diagnostics, healthcare professionals can create personalized plans for each patient,
selecting treatments that work better for them. This precise approach improves how brain diseases such as Alzheimer's and Parkinson's are handled. Including companion diagnostics in brain
disease care is a big step forward, as it could offer better-tailored treatments and provide better results for patients with challenging brain issues.

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2.3 Global Companion Diagnostics Market (by End
User)

Global Companion Diagnostics Market

(by End User)

Global Companion Diagnostics Market

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2.3.1 Pharmaceutical and Biotechnology Companies
Companion diagnostics play a pivotal role in the pharmaceutical and biotechnology industries by aligning treatments with individual patient characteristics. These diagnostics are integral to drug
development, allowing pharmaceutical companies to identify specific patient populations that may benefit the most from their therapies. Through biomarker identification and validation, companion
diagnostics enable the selection of responsive patient groups, increasing the likelihood of successful clinical trials and regulatory approvals.

The integration of companion diagnostics into pharmaceutical and biotechnology strategies is part of a broader shift toward precision medicine. It facilitates the development of more targeted and
efficient therapeutic interventions, reducing potential side effects and improving patient adherence. As the pharmaceutical and biotechnology sectors continue to advance, companion diagnostics
play a vital role in shaping the future of individualized and optimized healthcare.

2.3.2 Reference Laboratories

Reference laboratories play a crucial role in the adoption and utilization of companion diagnostics, providing specialized testing services to support personalized medicine. Companion diagnostics
are often complex molecular or genetic tests designed to identify specific markers that guide treatment decisions. Furthermore, reference laboratories, equipped with advanced technologies and
expertise, are well-positioned to conduct these intricate diagnostic tests.

In reference laboratories, companion diagnostics serve as tools for refining treatment strategies based on individual patient profiles. These labs contribute to the integration of personalized medicine
into routine clinical practice by offering reliable and accurate testing services. This is particularly relevant in the context of oncology, where companion diagnostics help identify patients who are
most likely to respond to targeted therapies.

2.3.3 Others
Companion diagnostics are essential tools that help tailor medical treatments to individual patients based on their unique genetic or molecular characteristics. CROs contribute to this process by
offering a range of services related to the development and validation of companion diagnostics.

Global Companion Diagnostics Market

CROs are often involved in clinical trials, where companion diagnostics are crucial for patient stratification, ensuring that participants have the specific genetic or molecular markers that the
investigational therapy targets. CROs work closely with pharmaceutical and diagnostic companies to design and implement clinical trials that integrate companion diagnostics seamlessly.

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3. Products

Product

Global Companion Diagnostics Market

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3.1 Product Segmentation

Product Segmentation

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3.2 Product Summary

Technology

Polymerase Chain Reaction (PCR) Next-Generation Sequencing (NGS) Immunohistochemistry (IHC) In-Situ Hybridization (ISH) Others

Ta ble 6 : G lobal Com pa nio n Dia g nos tic s Ma rke t (by

Tec hnol ogy ), $Mill ion, 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-33)

PCR 1,147.0 1,313.9 1,501.9 1,713.3 1,950.5 2,216.2 2,513.0 2,844.1 3,212.8 3,622.4 4,076.7 4,579.6 13.30%

NGS 614.0 713.0 826.1 955.3 1,102.4 1,269.6 1,459.4 1,674.4 1,917.3 2,191.4 2,500.1 2,847.2 14.85%

IHC 845.4 957.5 1,082.1 1,220.4 1,373.7 1,543.1 1,730.1 1,936.0 2,162.4 2,410.7 2,682.6 2,979.9 12.02%

ISH 574.2 642.3 716.9 798.6 887.8 985.1 1,090.8 1,205.7 1,330.1 1,464.6 1,609.7 1,766.0 10.64%

Others 119.3 135.4 152.8 171.2 190.6 210.8 231.4 252.2 272.7 292.3 310.3 326.0 9.18%

Total 3,300.0 3,762.0 4,279.8 4,858.8 5,505.0 6,224.8 7,024.8 7,912.4 8,895.2 9,981.4 11,179.5 12,498.7 12.76%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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3.3 Global Companion Diagnostics Market (by
Technology)

Global Companion Diagnostics Market

(by Technology)

Global Companion Diagnostics Market

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3.3.1 Polymerase Chain Reaction (PCR)
Polymerase chain reaction (PCR) is a fundamental and widely used technique in companion diagnostics, contributing significantly to the identification of specific genetic or molecular markers
associated with various diseases. PCR amplifies and detects nucleic acid sequences, allowing for the accurate and sensitive detection of genetic variations, mutations, or biomarkers that are
essential in guiding personalized treatment decisions.

In companion diagnostics, PCR is applied to amplify and analyze specific DNA or RNA regions linked to the targeted disease or condition. This is particularly valuable in oncology, where identifying
mutations or alterations in genes can help determine the most appropriate therapeutic interventions. For instance, in cancer companion diagnostics, PCR may be used to detect mutations such as
those in the EGFR gene for lung cancer or the BRAF gene for melanoma.

3.3.2 Immunohistochemistry (IHC)

The use of IHC in companion diagnostics offers several advantages, including its ability to provide spatial information about protein expression within the context of tissue architecture. This
information is critical in understanding the biological characteristics of the tumor and tailoring treatment strategies accordingly.

Companion diagnostics incorporating IHC techniques contribute to the advancement of personalized medicine by helping clinicians identify patient subgroups that are more likely to respond to
specific therapies. The results of IHC tests are often integrated into the overall diagnostic and treatment decision-making process, facilitating a more targeted and individualized approach to patient
care.

3.3.3 In-Situ Hybridization (ISH)

In-situ hybridization (ISH) is a powerful molecular technique employed in companion diagnostics, particularly in the field of pathology and cancer management. ISH enables the visualization and
localization of specific nucleic acid sequences within tissue samples, providing valuable information about the presence of genetic alterations or molecular markers associated with diseases.

In the context of companion diagnostics, ISH is often used to detect and analyze specific RNA or DNA sequences, including gene amplifications, translocations, or mutations. This information is

Global Companion Diagnostics Market

critical for identifying patients who may benefit from targeted therapies tailored to their molecular profiles.

3.3.4 Next-Generation Sequencing

Next-generation sequencing (NGS) has revolutionized companion diagnostics by enabling comprehensive and high-throughput analysis of genomic information. NGS technology allows for the
simultaneous sequencing of multiple genes or entire genomes, providing a detailed understanding of an individual's genetic makeup. In the context of companion diagnostics, NGS plays a pivotal
role in identifying specific genetic alterations or mutations that can guide personalized treatment decisions.

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4. Regions

Region

Global Companion Diagnostics Market

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4.1 Regional Summary
Ta ble 7 : Com pa nion Dia g nos ti cs P rep ara tio n (b y Re gio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Region 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

North America 1,428.9 1,626.9 1,848.4 2,095.9 2,371.6 2,678.3 3,018.7 3,395.8 3,812.7 4,272.9 4,779.7 5,336.9 12.61%

Europe 983.4 1,116.5 1,265.1 1,430.4 1,614.1 1,817.7 2,043.1 2,291.9 2,566.2 2,867.9 3,199.1 3,562.1 12.30%

Asia-Pacific 633.6 733.7 847.8 977.6 1,125.1 1,292.3 1,481.3 1,694.7 1,935.3 2,205.7 2,509.4 2,849.7 14.53%

Latin America 141.9 159.2 178.0 198.2 219.8 242.7 266.9 292.2 318.5 345.4 372.7 400.0 9.65%

Middle East and

112.2 125.7 140.5 156.7 174.4 193.8 214.8 237.8 262.6 289.5 318.6 350.0 10.78%
Africa
Total 3,300.0 3,762.0 4,279.8 4,858.8 5,505.0 6,224.8 7,024.8 7,912.4 8,895.2 9,981.4 11,179.5 12,498.7 12.76%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.2 Drivers and Restraints
Key drivers across geographies pertain to growing adoption and
advancements to accelerate companion diagnostics development, while
barriers include a complex and slow regulatory environments:

Higher Readiness Key Drivers Potential Restraints

• The stringent regulatory environment acts as a catalyst for continuous
• The rising prevalence of cancer cases globally is a significant driver for the
improvement in companion diagnostics, encouraging companies to invest in
U.S. growth of the companion diagnostics market, as these tests play a crucial
research and development to meet evolving regulatory requirements and
role in personalized treatment strategies
industry standards

• Increasing product approvals in the field of companion diagnostics • The uncertain reimbursement scenario poses a challenge to the companion
contribute to market expansion, fostering the development of targeted diagnostics market, impacting the adoption of these tests as healthcare
U.K. therapies and enhancing patient outcomes providers seek clarity on reimbursement policies
• Growing awareness among healthcare professionals about the benefits of • Market players respond to reimbursement uncertainties by conducting health
Germany companion diagnostics in tailoring treatments based on individual patient economic studies, providing evidence of the value proposition of companion
profiles propels market demand diagnostics, and enhancing market acceptance
• Advancements in biomedical imaging techniques serve as a driving force • Challenges associated with an uncertain reimbursement landscape drive
China for precision medicine's companion diagnostics, enabling more accurate industry stakeholders to work collaboratively to establish clear
diagnosis and treatment planning reimbursement pathways for companion diagnostics

• Government initiatives for precision medicine initiatives fuel the companion • Stringent regulatory approval processes contribute to the credibility and
Japan diagnostics market, creating a favorable environment for research and trustworthiness of companion diagnostics, assuring healthcare professionals
development and patients of the tests' reliability and efficacy

• Technological advancements in molecular diagnostics and genomics • Navigating complex reimbursement scenarios encourages companion
South Africa contribute to the evolution of companion diagnostics, enabling more precise diagnostics developers to demonstrate the clinical utility and cost-
identification of biomarkers for various diseases, including cancer effectiveness of their tests, driving innovation in the field.

Lower Readiness

Global Companion Diagnostics Market

Source: BIS Research Analysis

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4.3 North America Fi g ure 20 : N or th Ameri ca Com pa ni on Di agnos tics Mar ke t,
$Mil lio n, 20 22 -2 033

5,336.9
4,779.7
4,272.9
3,812.7
3,395.8
3,018.7
2,678.3
2,371.6
2,095.9
1,848.4
1,626.9
1,428.9
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
4.3.1 Regional Overview
Source: BIS Research Analysis
The North America region, including the U.S. and Canada, is a significant market in the
companion diagnostics market because the region allocates substantial resources to
healthcare, fostering a robust market for advanced diagnostics. Furthermore, the U.S. FDA Analyst View
and Health Canada provide clear regulatory pathways, instilling confidence in developers and In 2022, North America accounted for a share of 43.30% of the companion diagnostics market.
facilitating market growth. The region is expected to reach $5,336.9 million in 2033 from $1,428.9 million in 2022, at a

Global Companion Diagnostics Market

CAGR of 12.61% during the forecast period 2023-2033.

4.3.2 Driving Factors for Market Growth The aging population in North America increases the demand for precise diagnostics to cater
to age-related health concerns, supporting the companion diagnostics market. Furthermore,
• Increasing number of product approvals
the region witnesses widespread adoption of advanced technologies such as next-generation
• Rapid growth in biomarker discovery sequencing, driving companion diagnostics market growth.

Moreover, the region's prominence in conducting clinical trials encourages the integration of
4.3.3 Factors Challenging the Market companion diagnostics in trial design.

• Stringent regulatory scenario

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4.3.4 Application
Ta ble 8 : N or th Ameri ca Com pa ni on Di agnos tics Mar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 533.3 610.2 696.6 793.7 902.5 1,024.2 1,160.0 1,311.3 1,479.6 1,666.4 1,873.2 2,102.0 13.17%

Breast Cancer 360.9 408.5 461.5 520.2 585.3 657.2 736.4 823.7 919.5 1,024.5 1,139.4 1,264.9 11.97%

Colorectal Cancer 263.8 300.8 342.3 388.7 440.5 498.3 562.5 633.7 712.6 799.8 896.0 1,001.9 12.79%

Leukemia 92.1 103.6 116.2 130.2 145.5 162.2 180.6 200.6 222.5 246.2 272.0 300.0 11.22%

Stomach 42.5 48.9 56.3 64.5 73.9 84.4 96.3 109.6 124.5 141.2 159.8 180.6 13.95%

Melanoma 28.4 31.8 35.6 39.7 44.2 49.2 54.5 60.4 66.7 73.6 81.0 89.0 10.84%

Others 108.0 123.1 140.0 158.8 179.7 202.8 228.4 256.5 287.4 321.2 358.2 398.6 12.47%

Total 1,428.9 1,626.9 1,848.4 2,095.9 2,371.6 2,678.3 3,018.7 3,395.8 3,812.7 4,272.9 4,779.7 5,336.9 12.61%
Source: BIS Research Analysis

Ta ble 9 : N or th Ameri ca Com pa ni on Di agnos tics Mar ke t ( by End

User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
560.6 633.3 714.1 803.5 902.2 1,011.2 1,131.1 1,262.8 1,407.2 1,565.1 1,737.7 1,925.8 11.76%
Biotechnology Companies
Reference Laboratories
615.1 709.2 816.0 937.0 1,073.7 1,227.9 1,401.4 1,596.3 1,814.9 2,059.4 2,332.5 2,637.1 14.03%
and Hospitals
Others 253.3 284.3 318.3 355.4 395.6 439.2 486.2 536.7 590.7 648.3 709.5 774.1 10.53%

Total 1,428.9 1,626.9 1,848.4 2,095.9 2,371.6 2,678.3 3,018.7 3,395.8 3,812.7 4,272.9 4,779.7 5,336.9 12.61%
Source: BIS Research Analysis

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4.3.5 Product
Ta ble 1 0 : N or th Ameri ca Com pa ni on Di agnos tics Mar ke t ( by
Tec hnol ogy ), $Mill ion, 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 486.4 556.9 636.4 725.6 825.7 937.6 1,062.7 1,202.1 1,357.1 1,529.2 1,720.0 1,931.0 13.24%

NGS 270.1 313.6 363.2 419.8 484.3 557.5 640.5 734.5 840.7 960.3 1,095.0 1,246.2 14.80%

IHC 358.4 405.2 457.2 514.8 578.5 648.9 726.3 811.5 904.9 1,007.2 1,119.0 1,241.1 11.84%

ISH 257.0 286.6 318.9 354.2 392.6 434.3 479.6 528.7 581.7 638.9 700.5 766.7 10.34%

Others 57.0 64.6 72.8 81.5 90.6 100.0 109.5 119.1 128.4 137.2 145.2 152.0 8.93%

Total 1,428.9 1,626.9 1,848.4 2,095.9 2,371.6 2,678.3 3,018.7 3,395.8 3,812.7 4,272.9 4,779.7 5,336.9 12.61%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.3.6 U.S. Fi g ure 21 : U.S . Com pa ni on Di agnos tics Mar ke t , $Millio n, 202 2 -
2 033

4,488.4
4,030.0
3,611.9
3,231.2
2,885.2
2,571.4
2,287.3
2,030.6
1,799.1
1,590.7
1,403.7
1,236.0
Country Overview
The companion diagnostics market in the U.S. has been experiencing significant growth,
primarily driven by advancements in personalized medicine and the increasing focus on 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
targeted therapies. As the understanding of the genetic and molecular basis of diseases has
expanded, companion diagnostics have become crucial in tailoring treatments to individual Source: BIS Research Analysis

patients.

The regulatory landscape for companion diagnostics is overseen by the U.S. Food and Drug Analyst View
Administration (FDA). The FDA has been actively involved in streamlining the approval The U.S. companion diagnostics market was valued at $1,236.0 million in 2022 and is

Global Companion Diagnostics Market

process for these diagnostics to ensure timely access to targeted therapies for patients. expected to reach $4,488.4 million by 2033, growing at a CAGR of 12.33% during the forecast
period 2023-2033.

Advances in technologies such as next-generation sequencing (NGS) and other molecular

diagnostic techniques have played a crucial role in the development of more sophisticated
companion diagnostics in the country. These technologies enable a deeper understanding of
the genetic and molecular characteristics of diseases.

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4.3.7 Application
Ta ble 1 1 : U.S . Com pa ni on Di agnos tics Mar ke t ( by Ap pl ica tio n ),
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 460.4 525.2 597.8 679.1 769.8 871.0 983.5 1,108.4 1,246.8 1,399.9 1,568.8 1,754.9 12.82%

Breast Cancer 311.5 351.8 396.4 445.8 500.4 560.5 626.7 699.2 778.7 865.6 960.5 1,063.7 11.70%

Colorectal Cancer 228.7 260.2 295.4 334.8 378.6 427.3 481.3 541.1 607.1 680.0 760.2 848.3 12.55%

Leukemia 80.3 90.2 101.0 112.8 125.8 140.1 155.6 172.5 190.9 210.9 232.5 255.8 10.99%

Stomach 37.1 42.6 48.8 55.8 63.8 72.6 82.6 93.7 106.2 120.0 135.5 152.6 13.61%

Melanoma 24.7 27.7 30.9 34.4 38.3 42.5 47.1 52.0 57.4 63.2 69.5 76.3 10.68%

Others 93.3 106.1 120.4 136.3 153.9 173.3 194.7 218.2 244.0 272.3 303.1 336.6 12.23%

Total 1,236.0 1,403.7 1,590.7 1,799.1 2,030.6 2,287.3 2,571.4 2,885.2 3,231.2 3,611.9 4,030.0 4,488.4 12.33%
Source: BIS Research Analysis

Ta ble 1 2 : U.S . Com pa ni on Di agnos tics Mar ke t ( by End Use r) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
Biotechnology 488.2 549.9 618.1 693.4 776.2 867.3 967.0 1,076.2 1,195.5 1,325.4 1,466.8 1,620.3 11.41%
Companies
Reference Laboratories
532.7 613.2 704.4 807.4 923.7 1,054.7 1,201.8 1,366.8 1,551.5 1,757.8 1,988.0 2,244.2 13.85%
and Hospitals
Others 215.1 240.5 268.2 298.2 330.6 365.4 402.6 442.2 484.3 528.7 575.2 623.9 10.00%

Total 1,236.0 1,403.7 1,590.7 1,799.1 2,030.6 2,287.3 2,571.4 2,885.2 3,231.2 3,611.9 4,030.0 4,488.4 12.33%
Source: BIS Research Analysis

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4.3.8 Product
Ta ble 1 3 : U.S . Com pa ni on Di agnos tics Mar ke t ( by Tec hno log y) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 420.2 480.3 547.9 623.6 708.4 803.2 908.8 1,026.3 1,156.8 1,301.5 1,461.5 1,638.2 13.05%

NGS 234.8 272.1 314.6 363.1 418.1 480.5 551.2 631.0 721.0 822.3 936.1 1,063.7 14.61%

IHC 309.0 348.3 391.7 439.7 492.5 550.6 614.3 684.0 760.3 843.4 934.0 1,032.3 11.48%

ISH 222.5 247.0 273.5 302.4 333.6 367.3 403.6 442.6 484.5 529.3 577.2 628.4 9.79%

Others 49.4 56.0 63.0 70.3 78.0 85.8 93.6 101.3 108.7 115.4 121.2 125.7 8.42%

Total 1,236.0 1,403.7 1,590.7 1,799.1 2,030.6 2,287.3 2,571.4 2,885.2 3,231.2 3,611.9 4,030.0 4,488.4 12.33%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.3.9 Canada Fi g ure 22 : C a na da Com pa nio n Dia gnos tic s Ma rke t, $ Milli o n,
2 022 -2033

848.6
749.7
661.0
581.5
510.6
447.3
391.0
341.0
296.8
257.7
223.2
192.9
Country Overview
Canada stands as a significant hub for pharmaceutical and biotechnology research and
development (R&D), showcasing a robust presence in the global landscape. Health Canada 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
manages the regulatory oversight for companion diagnostics in Canada. Regulatory
Source: BIS Research Analysis
processes and approvals are in place to ensure the safety, efficacy, and quality of these
diagnostic tools.
Analyst View
The Canada companion diagnostics market includes major pharmaceutical companies,
diagnostic assay developers, and diagnostic testing service providers. These entities The Canada market was valued at $192.9 million in 2022 and is expected to reach $848.6
contribute to the research, development, and commercialization of companion diagnostics million by 2033, growing at a CAGR of 14.29% during the forecast period 2023-2033.

Global Companion Diagnostics Market

within the country.
The majority of companion diagnostics in Canada, as in many other regions, are associated
with oncology. These diagnostics help identify patients who are suitable candidates for
targeted cancer therapies, contributing to more effective and personalized cancer treatment
strategies.

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4.3.10 Application
Ta ble 1 4 : Ca na da Com pa nio n Dia g nos tic s Ma rke t (by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2024-2033)

Lung Cancer 72.9 85.0 98.8 114.6 132.7 153.2 176.5 202.9 232.8 266.5 304.4 347.1 15.11%

Breast Cancer 49.4 56.7 65.1 74.4 84.9 96.7 109.8 124.4 140.8 158.9 178.9 201.1 13.49%

Colorectal Cancer 35.1 40.6 46.9 53.9 61.9 71.0 81.2 92.6 105.4 119.8 135.8 153.6 14.23%

Leukemia 11.8 13.4 15.3 17.3 19.6 22.2 25.0 28.1 31.6 35.4 39.6 44.1 12.64%

Stomach 5.4 6.3 7.4 8.7 10.1 11.8 13.7 15.9 18.3 21.2 24.4 28.0 16.01%

Melanoma 3.7 4.2 4.7 5.3 5.9 6.7 7.5 8.3 9.3 10.3 11.5 12.7 11.86%

Others 14.7 17.0 19.6 22.5 25.8 29.5 33.7 38.2 43.3 49.0 55.2 61.9 13.82%

Total 192.9 223.2 257.7 296.8 341.0 391.0 447.3 510.6 581.5 661.0 749.7 848.6 14.29%
Source: BIS Research Analysis

Ta ble 1 5 : Ca na da Com pa nio n Dia g nos tic s Ma rke t (by E nd User) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
72.3 83.4 95.9 110.1 126.0 143.9 164.0 186.6 211.7 239.7 270.9 305.5 13.86%
Biotechnology Companies
Reference Laboratories
82.4 96.0 111.7 129.6 150.0 173.2 199.6 229.5 263.4 301.6 344.6 392.9 15.13%
and Hospitals
Others 38.2 43.8 50.1 57.2 65.1 73.9 83.6 94.5 106.5 119.7 134.2 150.2 13.11%

Total 192.9 223.2 257.7 296.8 341.0 391.0 447.3 510.6 581.5 661.0 749.7 848.6 14.29%
Source: BIS Research Analysis

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4.3.11 Product
Ta ble 1 6 : Ca na da Com pa nio n Dia g nos tic s Ma rke t (by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 66.2 76.6 88.5 102.0 117.2 134.5 153.9 175.8 200.3 227.8 258.5 292.8 14.35%

NGS 35.3 41.5 48.6 56.8 66.2 77.0 89.4 103.5 119.7 138.0 158.8 182.4 15.97%

IHC 49.4 56.9 65.5 75.2 86.1 98.3 112.0 127.4 144.6 163.8 185.1 208.7 13.87%

ISH 34.5 39.6 45.3 51.8 59.0 67.1 76.1 86.1 97.2 109.6 123.2 138.3 13.32%

Others 192.9 223.2 257.7 296.8 341.0 391.0 447.3 510.6 581.5 661.0 749.7 848.6 14.29%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4 Europe Fi g ure 23 : E uro pe Com pa nio n Dia gnos tic s Ma rke t, $Milli o n,
2 022 -2033

3,562.1
3,199.1
2,867.9
2,566.2
2,291.9
2,043.1
1,817.8
1,614.1
1,430.4
1,265.1
1,116.5
983.4
4.4.1 Regional Overview 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Europe’s strong scientific and technological foundations, diverse industries, and commitment Source: BIS Research Analysis

to innovation have been contributing to the growth of its companion diagnostics market.

Several European countries, including Germany, the U.K., France, Italy, and Spain, have a Analyst View
reputation for a strong commitment to innovation in healthcare. Governments, research
In 2022, Europe accounted for a share of 29.80% of the companion diagnostics market. The
organizations, and industry stakeholders often collaborate to create an environment
region is expected to reach $3,562 million in 2033 from $983.4 million in 2022, at a CAGR of

Global Companion Diagnostics Market

conducive to the development and adoption of advanced medical technologies, including
12.30% during the forecast period 2023-2033.
companion diagnostics.
The diverse industries present in Europe, including pharmaceuticals, biotechnology, and
diagnostics, contribute to a dynamic ecosystem for companion diagnostics. Collaborations
4.4.2 Driving Factors for Market Growth and synergies between these industries foster innovation and the translation of scientific

• Rise of personalized medicine discoveries into practical applications.

• Increasing cancer incidence Europe boasts strong scientific and technological foundations, with leading research
institutions and a robust healthcare infrastructure. This foundation has facilitated
advancements in genomics, molecular biology, and other relevant fields, contributing to the
4.4.3 Factors Challenging the Market development of sophisticated companion diagnostics.

• Inconsistent global regulatory standards

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4.4.4 Application
Ta ble 1 7 : Euro pe Com pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 370.5 423.5 483.0 549.8 624.5 707.9 801.0 904.4 1,019.3 1,146.7 1,287.5 1,443.0 13.04%

Breast Cancer 255.5 287.9 323.7 363.2 406.7 454.5 506.8 564.2 626.8 695.1 769.3 850.0 11.43%

Colorectal Cancer 175.0 198.8 225.5 255.1 288.2 324.8 365.4 410.3 459.9 514.5 574.6 640.5 12.41%

Leukemia 60.1 67.3 75.2 83.8 93.3 103.6 114.8 127.0 140.2 154.5 170.0 186.6 10.74%

Stomach 26.5 30.7 35.5 41.0 47.2 54.3 62.3 71.4 81.7 93.3 106.3 121.0 14.71%

Melanoma 19.9 22.0 24.3 26.9 29.6 32.5 35.6 39.0 42.6 46.4 50.6 54.9 9.57%

Others 75.9 86.4 97.9 110.7 124.8 140.2 157.1 175.5 195.6 217.3 240.8 266.0 11.91%

Total 983.4 1,116.5 1,265.1 1,430.4 1,614.1 1,817.7 2,043.1 2,291.9 2,566.2 2,867.9 3,199.1 3,562.1 12.30%
Source: BIS Research Analysis

Ta ble 1 8 : Euro pe Com pa nio n Dia g nos tic s Ma rke t (by E nd User) ,
$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
385.4 436.1 492.4 554.8 623.9 700.2 784.4 876.9 978.5 1,089.9 1,211.7 1,344.7 11.92%
Biotechnology Companies
Reference Laboratories
425.6 487.8 557.9 636.7 725.2 824.4 935.2 1,058.9 1,196.6 1,349.7 1,519.5 1,707.5 13.35%
and Hospitals
Others 172.4 192.7 214.8 238.9 265.0 293.2 323.5 356.1 391.0 428.3 467.9 509.9 10.22%

Total 983.4 1,116.5 1,265.1 1,430.4 1,614.1 1,817.7 2,043.1 2,291.9 2,566.2 2,867.9 3,199.1 3,562.1 12.30%
Source: BIS Research Analysis

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4.4.5 Product
Ta ble 1 9 : Euro pe Com pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 346.7 395.3 449.8 510.8 578.8 654.7 739.0 832.7 936.4 1,051.2 1,177.8 1,317.4 12.79%

NGS 181.2 209.3 241.3 277.6 318.7 365.2 417.7 476.8 543.3 617.9 701.5 795.0 14.28%

IHC 255.4 288.0 324.2 364.1 408.2 456.6 509.9 568.2 632.1 701.8 777.9 860.6 11.57%

ISH 167.6 187.1 208.5 231.8 257.2 284.8 314.6 346.9 381.8 419.3 459.6 502.8 10.39%

Others 32.6 36.8 41.3 46.2 51.2 56.5 61.8 67.2 72.5 77.6 82.3 86.3 8.90%

Total 983.4 1,116.5 1,265.1 1,430.4 1,614.1 1,817.7 2,043.1 2,291.9 2,566.2 2,867.9 3,199.1 3,562.1 12.30%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.6 France Fi g ure 24 : Fr a nce Com pa nio n Dia gnos tic s Ma rke t, $Milli o n,
2 022 -2033

673.2
600.6
534.8
475.3
421.6
373.3
329.9
291.0
256.2
225.0
197.3
172.6
Country Overview
The companion diagnostics market in France is likely driven by advancements in personalized 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
medicine. As the understanding of the genetic and molecular basis of diseases increases,
there is a growing emphasis on tailoring treatments to the individual characteristics of patients. Source: BIS Research Analysis

Companion diagnostics play a crucial role in identifying patients who are most likely to respond
to specific therapies.
Analyst View
France has a robust scientific and academic community with leading research institutions.
The France companion diagnostics market was valued at $172.6 million in 2022 and is
Collaborations between academia and industry contribute to research and development in the
expected to reach $673.2 million by 2033, growing at a CAGR of 13.06% during the forecast

Global Companion Diagnostics Market

companion diagnostics field, fostering innovation and technological advancements.
period 2023-2033.

Regulatory frameworks, overseen by agencies such as the French National Agency for
Medicines and Health Products Safety (ANSM), play a crucial role in ensuring the safety and
efficacy of companion diagnostics. A supportive regulatory environment can facilitate the
timely approval and commercialization of these diagnostics.

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4.4.7 Application
Ta ble 2 0 : Fr a nce Com pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 65.6 75.5 86.7 99.4 113.8 129.9 148.1 168.4 191.2 216.7 245.1 276.7 13.87%

Breast Cancer 45.0 51.1 57.8 65.2 73.4 82.6 92.7 103.8 116.0 129.4 144.1 160.2 12.12%

Colorectal Cancer 28.5 32.6 37.3 42.5 48.4 55.0 62.4 70.6 79.8 90.0 101.3 113.8 13.31%

Leukemia 10.0 11.3 12.7 14.2 15.9 17.7 19.8 22.0 24.4 27.0 29.9 33.0 11.34%

Stomach 4.5 5.3 6.1 7.2 8.3 9.7 11.2 13.0 15.0 17.3 19.9 22.9 15.85%

Melanoma 3.8 4.2 4.7 5.2 5.7 6.3 6.9 7.6 8.3 9.1 9.9 10.8 9.83%

Others 15.2 17.4 19.8 22.5 25.4 28.7 32.3 36.3 40.6 45.3 50.4 55.9 12.41%

Total 172.6 197.3 225.0 256.2 291.0 329.9 373.3 421.6 475.3 534.8 600.6 673.2 13.06%
Source: BIS Research Analysis

Ta ble 2 1 : Fr a nce Com pa nio n Dia g nos tic s Ma rke t (by E nd User) ,
$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
69.2 78.9 89.7 101.9 115.4 130.5 147.3 165.8 186.4 209.2 234.3 261.9 12.75%
Biotechnology Companies
Reference Laboratories
76.8 88.4 101.6 116.5 133.3 152.2 173.5 197.4 224.2 254.0 287.4 324.5 13.88%
and Hospitals
Others 26.6 30.0 33.7 37.8 42.3 47.2 52.6 58.4 64.7 71.5 78.9 86.8 11.23%

Total 172.6 197.3 225.0 256.2 291.0 329.9 373.3 421.6 475.3 534.8 600.6 673.2 13.06%
Source: BIS Research Analysis

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4.4.8 Product
Ta ble 2 2 : Fr a nce Com pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 60.6 69.6 79.9 91.5 104.5 119.2 135.7 154.1 174.7 197.7 223.3 251.8 13.71%

NGS 29.5 34.4 40.0 46.4 53.7 62.1 71.6 82.4 94.7 108.6 124.3 142.1 15.24%

IHC 45.7 52.0 59.0 66.7 75.4 85.0 95.6 107.4 120.4 134.7 150.4 167.6 12.42%

ISH 31.9 35.7 39.9 44.5 49.5 55.0 60.9 67.4 74.4 82.0 90.1 99.0 10.72%

Others 4.8 5.5 6.3 7.0 7.9 8.7 9.5 10.3 11.1 11.8 12.4 12.8 8.76%

Total 172.6 197.3 225.0 256.2 291.0 329.9 373.3 421.6 475.3 534.8 600.6 673.2 13.06%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.9 Germany Fi g ure 25 : Ge rma ny Com pa nion Dia gnos ti cs Mar ke t, $ Millio n,
2 022 -2033

790.8
704.9
627.3
557.1
493.9
437.0
385.9
340.2
299.2
262.7
230.1
201.2
Country Overview
The companion diagnostics market in Germany is driven by a convergence of factors.
Collaboration between pharmaceutical companies, diagnostic assay developers, and other 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
industry stakeholders has been a driving force for the country's companion diagnostics market.
Source: BIS Research Analysis
Partnerships and collaborations can lead to the development of novel diagnostic technologies
and the integration of companion diagnostics into the drug development and treatment
processes. Analyst View
The increasing emphasis on precision medicine, which aims to tailor medical interventions to The Germany companion diagnostics market was valued at $201.2 million in 2022 and is
the characteristics of each patient, is likely to drive the adoption of companion diagnostics. expected to reach $790.8 million by 2033, growing at a CAGR of 13.14% during the forecast

Global Companion Diagnostics Market

period 2023-2033.

Moreover, the country’s well-established healthcare infrastructure and commitment to

providing advanced medical care contribute to the adoption of companion diagnostics.

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4.4.10 Application
Ta ble 2 3 : Ge rma ny C om pa nion Dia g nos ti cs M ar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 76.5 88.0 101.0 115.6 132.0 150.6 171.3 194.6 220.6 249.7 282.0 317.9 13.71%

Breast Cancer 53.1 60.4 68.5 77.6 87.7 98.9 111.3 125.0 140.1 156.8 175.2 195.3 12.46%

Colorectal Cancer 36.4 41.8 47.8 54.6 62.2 70.7 80.3 91.0 102.9 116.1 130.8 147.1 13.42%

Leukemia 13.5 15.2 17.1 19.2 21.5 24.0 26.8 29.9 33.2 36.8 40.8 45.1 11.49%

Stomach 5.6 6.6 7.6 8.8 10.2 11.8 13.6 15.6 18.0 20.6 23.5 26.9 15.15%

Melanoma 3.4 3.8 4.2 4.6 5.1 5.6 6.1 6.7 7.4 8.0 8.7 9.5 9.61%

Others 12.6 14.4 16.5 18.9 21.5 24.4 27.6 31.1 35.0 39.3 43.9 49.0 13.00%

Total 201.2 230.1 262.7 299.2 340.2 385.9 437.0 493.9 557.1 627.3 704.9 790.8 13.14%
Source: BIS Research Analysis

Ta ble 2 4 : Ge rma ny C om pa nion Dia g nos ti cs Mar ke t ( by E nd User) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
79.9 91.2 104.0 118.3 134.3 152.2 172.1 194.2 218.7 245.9 276.0 309.2 12.98%
Biotechnology Companies
Reference Laboratories
85.5 98.3 112.8 129.1 147.5 168.2 191.4 217.4 246.4 278.8 314.9 355.1 13.70%
and Hospitals
Others 35.8 40.6 45.9 51.8 58.4 65.6 73.6 82.3 92.0 102.5 114.0 126.5 12.04%

Total 201.2 230.1 262.7 299.2 340.2 385.9 437.0 493.9 557.1 627.3 704.9 790.8 13.14%
Source: BIS Research Analysis

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4.4.11 Product
Ta ble 2 5 : Ge rma ny C om pa nion Dia g nos ti cs Mar ke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 68.8 79.1 90.8 104.0 118.9 135.6 154.4 175.4 199.0 225.2 254.5 287.1 13.75%

NGS 38.8 45.1 52.4 60.7 70.1 80.8 93.0 106.9 122.5 140.2 160.2 182.7 15.00%

IHC 49.9 56.8 64.6 73.2 82.9 93.6 105.5 118.7 133.3 149.4 167.1 186.6 12.63%

ISH 36.4 40.8 45.6 50.8 56.5 62.8 69.6 76.9 85.0 93.6 103.0 113.1 10.74%

Others 7.2 8.3 9.4 10.6 11.8 13.2 14.5 16.0 17.4 18.8 20.1 21.4 9.96%

Total 201.2 230.1 262.7 299.2 340.2 385.9 437.0 493.9 557.1 627.3 704.9 790.8 13.14%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.12 U.K. Fi g ure 26 : U . K . Co mpa ni on Di agnos tics Mar ke t, $Millio n, 202 2 -
2 033

605.6
532.9
468.1
410.5
359.2
313.8
273.6
238.0
206.7
179.1
154.9
133.7
Country Overview
The U.K.'s National Health Service (NHS) has been a key player in driving advancements in
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
the healthcare ecosystem. Initiatives and policies that prioritize precision medicine and
personalized treatment approaches can contribute to the growth of the companion diagnostics Source: BIS Research Analysis
market.

Increased public awareness of personalized medicine and the role of companion diagnostics, Analyst View
along with advocacy efforts from patient groups, can drive demand and acceptance of these
advanced diagnostic tools. The U.K. companion diagnostics market was valued at $133.7 million in 2022 and is expected
to reach $605.6 million by 2033, growing at a CAGR of 14.60% during the forecast period

Global Companion Diagnostics Market

2023-2033.

Advances in diagnostic technologies, such as next-generation sequencing (NGS) and other

molecular diagnostic techniques, are likely to drive the growth of companion diagnostics.
These technologies provide more accurate and detailed information about patients' genetic
and molecular profiles.

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4.4.13 Application
Ta ble 2 6 : U.K. Co mpa ni on Di agnos tics Mar ke t ( by Ap pl ica tio n ),
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 50.9 59.4 69.1 80.3 93.1 107.6 124.3 143.2 164.7 189.0 216.6 247.7 15.35%

Breast Cancer 34.8 39.9 45.6 52.0 59.3 67.4 76.5 86.6 97.9 110.5 124.4 139.9 13.38%

Colorectal Cancer 23.8 27.6 32.0 37.1 42.8 49.3 56.7 65.1 74.5 85.2 97.3 110.8 14.89%

Leukemia 7.6 8.7 10.0 11.4 12.9 14.7 16.7 18.8 21.3 24.0 27.0 30.3 13.25%

Stomach 3.3 4.0 4.7 5.6 6.7 7.9 9.3 10.9 12.8 15.1 17.6 20.6 17.85%

Melanoma 2.8 3.2 3.6 4.1 4.6 5.2 5.9 6.6 7.4 8.3 9.2 10.3 12.42%

Others 10.4 12.1 14.0 16.2 18.7 21.4 24.5 28.0 31.8 36.1 40.8 46.0 14.27%

Total 133.7 154.9 179.1 206.7 238.0 273.6 313.8 359.2 410.5 468.1 532.9 605.6 14.60%
Source: BIS Research Analysis

Ta ble 2 7 : U . K . Co mpa ni on Di agnos tics Mar ke t ( by End Use r) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
50.3 58.0 66.8 76.7 87.9 100.6 114.9 130.9 148.9 169.1 191.6 216.8 14.09%
Biotechnology Companies
Reference Laboratories
55.9 65.6 76.8 89.7 104.6 121.7 141.3 163.8 189.4 218.7 252.1 290.1 16.03%
and Hospitals
Others 27.5 31.4 35.6 40.3 45.6 51.3 57.6 64.6 72.1 80.3 89.2 98.7 12.15%

Total 133.7 154.9 179.1 206.7 238.0 273.6 313.8 359.2 410.5 468.1 532.9 605.6 14.60%
Source: BIS Research Analysis

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4.4.14 Product
Ta ble 2 8 : U . K . Co mpa ni on Di agnos tics Mar ke t ( by Tec hno log y) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 48.7 56.6 65.7 76.1 88.0 101.5 116.9 134.4 154.2 176.5 201.7 230.1 15.05%

NGS 25.7 30.3 35.7 41.9 49.2 57.6 67.3 78.4 91.3 106.0 123.0 142.3 16.73%

IHC 34.8 40.0 46.0 52.8 60.4 69.0 78.6 89.5 101.6 115.2 130.3 147.2 13.90%

ISH 20.6 23.3 26.4 29.8 33.6 37.8 42.4 47.5 53.0 59.2 65.9 73.3 12.12%

Others 4.0 4.6 5.3 6.1 6.9 7.7 8.6 9.5 10.4 11.2 12.0 12.7 10.61%

Total 133.7 154.9 179.1 206.7 238.0 273.6 313.8 359.2 410.5 468.1 532.9 605.6 14.60%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.15 Spain Fi g ure 27 : S pai n Co mpa nio n Diagnos tics Ma rke t, $Mi lli on, 20 22 -
2 033

295.7
269.2
244.7
222.0
201.1
181.8
164.0
147.6
132.7
119.0
106.5
95.1
Country Overview
Spain's active pharmaceutical, biotechnology, and healthcare sectors demand enhanced
efficiency, accurate data management, and increased throughput, thereby driving the
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
integration of diagnostics solutions and contributing to the growth of the companion
diagnostics market. Source: BIS Research Analysis

Government policies and healthcare initiatives in Spain play a significant role in shaping the
adoption and integration of companion diagnostics. Policy support for precision medicine and
Analyst View
targeted therapies can positively impact market growth.
The Spain companion diagnostics market was valued at $95.1 million in 2022 and is expected
to reach $295.7 million by 2033, growing at a CAGR of 10.75% during the forecast period

Global Companion Diagnostics Market

2023-2033.

In Spain, the reimbursement landscape, including policies related to the reimbursement of

companion diagnostics, can influence the adoption rate. Clear and favorable reimbursement
policies encourage healthcare providers to incorporate these tests into routine clinical practice.

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4.4.16 Application
Ta ble 2 9 : S pai n Co mp a nio n Diag nos tics Ma rke t ( by A p plic at ion ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 34.8 39.4 44.5 50.2 56.6 63.5 71.2 79.7 89.0 99.3 110.5 122.7 12.03%

Breast Cancer 24.6 27.3 30.1 33.2 36.6 40.2 44.0 48.2 52.6 57.3 62.3 67.7 9.52%

Colorectal Cancer 17.6 19.6 21.9 24.3 26.9 29.8 32.9 36.3 39.9 43.9 48.1 52.6 10.37%

Leukemia 6.0 6.6 7.3 8.0 8.7 9.5 10.4 11.3 12.3 13.4 14.5 15.7 9.03%

Stomach 2.6 2.9 3.4 3.8 4.4 5.0 5.7 6.4 7.2 8.2 9.2 10.3 13.40%

Melanoma 1.9 2.1 2.3 2.5 2.7 2.9 3.1 3.3 3.6 3.9 4.1 4.4 7.90%

Others 7.6 8.5 9.5 10.6 11.8 13.1 14.4 15.8 17.3 18.9 20.5 22.2 10.02%

Total 95.1 106.5 119.0 132.7 147.6 164.0 181.8 201.1 222.0 244.7 269.2 295.7 10.75%
Source: BIS Research Analysis

Ta ble 3 0 : S pai n Co mp a nio n Diag nos tics Ma rke t ( by E nd User ),

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
36.8 41.2 46.0 51.3 57.1 63.5 70.3 77.8 85.9 94.7 104.2 114.4 10.75%
Biotechnology Companies
Reference Laboratories and
41.7 47.2 53.2 59.8 67.2 75.3 84.2 94.1 104.8 116.6 129.4 143.4 11.76%
Hospitals
Others 16.5 18.1 19.7 21.5 23.3 25.2 27.2 29.2 31.3 33.5 35.6 37.8 7.66%

Total 95.1 106.5 119.0 132.7 147.6 164.0 181.8 201.1 222.0 244.7 269.2 295.7 10.75%
Source: BIS Research Analysis

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4.4.17 Product
Ta ble 3 1 : S pai n Co mp a nio n Diag nos tics Ma rke t ( by Tec hnol ogy ),
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 32.6 36.5 40.8 45.6 50.7 56.4 62.5 69.2 76.5 84.3 92.8 102.0 10.81%

NGS 17.4 19.8 22.4 25.4 28.6 32.3 36.3 40.8 45.7 51.1 57.0 63.6 12.39%

IHC 24.3 27.2 30.2 33.6 37.2 41.2 45.5 50.2 55.2 60.6 66.5 72.7 10.35%

ISH 17.0 18.9 20.9 23.1 25.5 28.1 30.9 33.9 37.1 40.6 44.3 48.2 9.82%

Others 3.7 4.1 4.5 5.0 5.4 5.9 6.5 7.0 7.5 8.1 8.6 9.2 8.36%

Total 95.1 106.5 119.0 132.7 147.6 164.0 181.8 201.1 222.0 244.7 269.2 295.7 10.75%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.18 Italy Fi g ure 28 : I t aly Co mpa ni on Di agnos tics Mar ke t, $Millio n, 202 2 -
2 033

395.4
358.1
323.7
292.0
263.0
236.4
212.1
189.9
169.7
151.3
134.7
119.6
Country Overview
The strategies employed by companies to gain market access, including pricing strategies
and partnerships with healthcare providers, impact the market's overall dynamics in Italy. 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
Effective market access strategies contribute to the successful commercialization of
companion diagnostics. Source: BIS Research Analysis

As companion diagnostics often involve the analysis of genetic and molecular data, adherence
to data privacy regulations and ensuring patient confidentiality is critical. Companies operating Analyst View
in Italy must comply with data protection laws and regulatory requirements.
The Italy companion diagnostics market was valued at $119.6 million in 2022 and is expected
to reach $395.4 million by 2033, growing at a CAGR of 11.37% during the forecast period

Global Companion Diagnostics Market

2023-2033.

Collaboration with international organizations, research consortia, and industry partnerships

at the European level can facilitate the exchange of knowledge and resources, contributing to
advancements in companion diagnostics in Italy.

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4.4.19 Application
Ta ble 3 2 : Italy Co mpa ni on Di agnos tics Mar ke t ( by Ap pl ica tio n ),
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 43.9 49.6 55.9 62.9 70.6 79.1 88.4 98.7 109.9 122.2 135.6 150.3 11.73%

Breast Cancer 31.1 34.8 38.9 43.4 48.3 53.7 59.5 65.8 72.7 80.2 88.2 96.9 10.77%

Colorectal Cancer 21.2 23.9 26.9 30.2 33.8 37.8 42.2 47.0 52.3 58.1 64.4 71.2 11.54%

Leukemia 7.1 7.9 8.8 9.7 10.8 11.9 13.2 14.5 15.9 17.5 19.2 21.0 10.29%

Stomach 3.1 3.6 4.2 4.8 5.5 6.3 7.2 8.3 9.4 10.7 12.2 13.8 14.42%

Melanoma 3.0 3.3 3.6 4.0 4.4 4.8 5.2 5.7 6.2 6.7 7.3 7.9 9.14%

Others 10.3 11.6 13.1 14.7 16.5 18.5 20.6 23.0 25.5 28.2 31.2 34.4 11.46%

Total 119.6 134.7 151.3 169.7 189.9 212.1 236.4 263.0 292.0 323.7 358.1 395.4 11.37%
Source: BIS Research Analysis

Ta ble 3 3 : Italy Co mpa ni on Di agnos tics Mar ke t ( by End Use r) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
47.4 53.0 59.2 66.0 73.4 81.5 90.3 99.9 110.3 121.5 133.6 146.7 10.71%
Biotechnology Companies
Reference Laboratories
52.0 59.2 67.3 76.3 86.4 97.6 110.0 123.7 138.9 155.7 174.2 194.5 12.63%
and Hospitals
Others 20.2 22.4 24.8 27.3 30.1 33.0 36.1 39.4 42.8 46.4 50.2 54.2 9.23%

Total 119.6 134.7 151.3 169.7 189.9 212.1 236.4 263.0 292.0 323.7 358.1 395.4 11.37%
Source: BIS Research Analysis

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4.4.20 Product
Ta ble 3 4 : Italy Co mpa ni on Di agnos tics Mar ke t ( by Tec hno log y) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 42.0 47.6 53.9 60.8 68.5 77.1 86.5 96.9 108.4 121.0 134.8 149.9 12.15%

NGS 22.7 26.1 29.9 34.2 39.1 44.6 50.7 57.5 65.2 73.7 83.2 93.7 13.63%

IHC 31.7 35.3 39.3 43.7 48.4 53.5 59.1 65.1 71.6 78.6 86.1 94.1 10.29%

ISH 18.5 20.4 22.4 24.5 26.8 29.3 31.9 34.6 37.6 40.7 44.0 47.4 8.81%

Others 4.7 5.2 5.8 6.4 7.0 7.7 8.3 8.8 9.3 9.8 10.1 10.3 7.00%

Total 119.6 134.7 151.3 169.7 189.9 212.1 236.4 263.0 292.0 323.7 358.1 395.4 11.37%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.4.21 Rest-of-Europe Fi g ure 29 : Res t -of -Eur ope Compa nio n Diagnos tics Ma rke t,
$Mil lio n, 20 22 -2 033

801.5
733.4
669.3
609.2
553.1
500.8
452.3
407.4
366.0
328.0
293.1
261.3
Country Overview
Rest-of-Europe consists of several dynamic economies, such as Switzerland, Sweden, 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
Belgium, Portugal, the Netherlands, and Ireland. There has been a rise in the emphasis on
scientific research and technological innovation in the region, which fosters an environment Source: BIS Research Analysis

that encourages the adoption of companion diagnostics solutions.

Moreover, there is a diverse array of industries in the region, including pharmaceuticals, Analyst View
biotechnology, healthcare, and more, that demand increased efficiency, accurate data The Rest-of-Europe companion diagnostics market was valued at $261.3 million in 2022 and
management, and heightened throughput, thereby propelling the integration of companion is expected to reach $801.5 million by 2033, growing at a CAGR of 10.58% during the forecast

Global Companion Diagnostics Market

diagnostics solutions. period 2023-2033.

However, since each nation has a unique regulatory, reimbursement, and funding system,
there is still a problem in Rest-of-Europe with regard to equal access to companion diagnostic
solutions.

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4.4.22 Application
Ta ble 3 5 : Res t -of -E ur ope Comp a nio n Diag nos tics Ma rke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 98.8 111.6 125.8 141.4 158.5 177.2 197.6 219.8 243.9 269.8 297.8 327.8 11.38%

Breast Cancer 66.9 74.5 82.8 91.7 101.4 111.8 122.9 134.8 147.5 160.9 175.0 189.9 9.81%

Colorectal Cancer 47.6 53.3 59.6 66.5 74.0 82.1 90.9 100.3 110.4 121.3 132.8 145.1 10.53%

Leukemia 15.9 17.6 19.4 21.4 23.4 25.7 28.0 30.5 33.1 35.8 38.7 41.7 8.99%

Stomach 7.3 8.3 9.5 10.7 12.1 13.6 15.3 17.2 19.2 21.4 23.8 26.4 12.25%

Melanoma 5.0 5.5 6.0 6.5 7.1 7.7 8.4 9.0 9.7 10.5 11.2 12.0 8.23%

Others 19.9 22.3 24.9 27.8 30.9 34.2 37.7 41.4 45.4 49.6 54.0 58.5 10.13%

Total 261.3 293.1 328.0 366.0 407.4 452.3 500.8 553.1 609.2 669.3 733.4 801.5 10.58%
Source: BIS Research Analysis

Ta ble 3 6 : Res t -of -E ur ope Comp a nio n Diag nos tics Ma rke t ( by E nd
User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
101.9 113.7 126.6 140.6 155.7 172.0 189.5 208.2 228.2 249.5 272.0 295.7 10.03%
Biotechnology Companies
Reference Laboratories
113.7 129.1 146.3 165.3 186.3 209.4 234.8 262.5 292.8 325.7 361.4 399.9 11.97%
and Hospitals
Others 45.7 50.3 55.1 60.1 65.4 70.9 76.5 82.3 88.2 94.1 100.0 105.8 7.73%

Total 261.3 293.1 328.0 366.0 407.4 452.3 500.8 553.1 609.2 669.3 733.4 801.5 10.58%
Source: BIS Research Analysis

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4.4.23 Product
Ta ble 3 7 : Res t -of -E ur ope Comp a nio n Diag nos tics Ma rke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 94.1 105.8 118.7 132.7 148.1 164.9 183.0 202.6 223.7 246.4 270.7 296.5 10.86%

NGS 47.0 53.6 60.9 69.0 78.0 87.9 98.8 110.8 123.9 138.3 153.8 170.7 12.29%

IHC 69.0 76.7 85.1 94.1 103.9 114.3 125.5 137.4 150.1 163.4 177.5 192.4 9.63%

ISH 43.1 48.0 53.3 59.1 65.2 71.9 79.0 86.6 94.7 103.3 112.3 121.8 9.76%

Others 8.1 9.0 10.0 11.1 12.2 13.3 14.5 15.6 16.8 17.9 19.0 20.0 8.29%

Total 261.3 293.1 328.0 366.0 407.4 452.3 500.8 553.1 609.2 669.3 733.4 801.5 10.58%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5 Asia-Pacific 4.5.3 Factors Challenging the Market
▪ Competitive pricing pressure
▪ Complexity of companion diagnostic development

Fi g ure 30 : A sia -P acific Companio n Dia gnos tics Mar ke t, $Mill ion,
2 022 -2033

2,849.7
2,509.4
2,205.7
1,935.3
1,694.7
1,481.3
1,292.3
1,125.1
977.6
847.8
733.7
633.6
4.5.1 Regional Overview
The Asia-Pacific region consists of many emerging economies that are undergoing significant
technological advancements along with improvements in their life sciences sector. The region 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
consists of various developed and developing economies, including China, Japan, Australia,
Source: BIS Research Analysis
India, South Korea, and Singapore.

The region comprises many countries that offer high potential for scientific achievement in the
Analyst View

Global Companion Diagnostics Market

field of companion diagnostics.
In 2022, Asia-Pacific accounted for a share of 19.20% of the companion diagnostics market.
The low- and middle-income countries in the Asia-Pacific regions face a burden in the adoption
The region is expected to reach $2,849.7 million in 2033 from $633.6 million in 2022, at a
of companion diagnostics solutions due to the requirement of high capital investments and
CAGR of 14.53% during the forecast period 2023-2033.
complexity in data analysis systems.
The Asia-Pacific companion diagnostics market is shaped by several key drivers. The region's
rapid economic growth and technological advancement foster an environment that
4.5.2 Driving Factors for Market Growth encourages the adoption of companion diagnostics.
▪ Increasing strategic collaborations between pharmaceutical industries
Moreover, the thriving pharmaceutical, biotechnology, healthcare, and research sectors in
▪ Growing patient demand for personalized care Asia-Pacific demand increased efficiency, precise data management, and accelerated
throughput, which is expected to drive the demand for companion diagnostics.

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4.5.4 Application
Ta ble 3 8 : Asia -P acific C omp anio n Dia g nos tics Mar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 235.3 274.3 319.1 370.5 429.4 496.6 573.2 660.3 759.3 871.5 998.5 1,141.8 15.33%

Breast Cancer 162.6 186.7 213.9 244.5 279.0 317.7 361.1 409.6 463.8 524.1 591.1 665.5 13.56%

Colorectal Cancer 113.4 131.5 152.2 175.8 202.7 233.1 267.6 306.7 350.7 400.3 456.1 518.7 14.71%

Leukemia 39.1 44.7 50.9 57.8 65.6 74.2 83.9 94.6 106.5 119.6 134.1 150.2 12.89%

Stomach 16.3 19.3 22.9 27.0 31.8 37.4 43.8 51.4 60.0 70.1 81.6 94.9 17.25%

Melanoma 13.5 15.2 17.1 19.3 21.6 24.2 27.0 30.2 33.6 37.4 41.5 45.9 11.69%

Others 53.4 62.0 71.7 82.7 95.1 109.0 124.6 142.0 161.4 182.8 206.5 232.6 14.14%

Total 633.6 733.7 847.8 977.6 1,125.1 1,292.3 1,481.3 1,694.7 1,935.3 2,205.7 2,509.4 2,849.7 14.53%
Source: BIS Research Analysis

Ta ble 3 9 : Asia -P acific C omp anio n Dia g nos tics Mar ke t ( by E nd

User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
244.7 282.0 324.3 372.2 426.2 487.0 555.5 632.3 718.3 814.5 921.7 1,041.2 13.95%
Biotechnology Companies
Reference Laboratories
269.1 314.9 367.7 428.5 498.4 578.7 670.5 775.5 895.3 1,031.8 1,186.9 1,363.0 15.78%
and Hospitals
Others 119.8 136.8 155.8 177.0 200.5 226.5 255.3 286.9 321.6 359.5 400.8 445.5 12.53%

Total 633.6 733.7 847.8 977.6 1,125.1 1,292.3 1,481.3 1,694.7 1,935.3 2,205.7 2,509.4 2,849.7 14.53%
Source: BIS Research Analysis

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4.5.5 Product
Ta ble 4 0 : Asia -P acific C omp anio n Dia g nos tics Mar ke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 224.2 260.8 302.6 350.5 405.1 467.3 538.0 618.1 708.8 811.3 926.9 1,056.9 15.02%

NGS 116.2 137.1 161.3 189.5 222.2 260.0 303.5 353.7 411.5 477.7 553.6 640.3 16.67%

IHC 166.3 191.3 219.5 251.4 287.4 327.9 373.3 424.2 481.2 544.8 615.7 694.6 13.77%

ISH 105.5 119.9 136.0 154.0 174.0 196.2 220.8 248.1 278.2 311.5 348.1 388.3 12.47%

Others 21.4 24.7 28.3 32.2 36.4 40.9 45.7 50.5 55.5 60.4 65.2 69.6 10.92%

Total 633.6 733.7 847.8 977.6 1,125.1 1,292.3 1,481.3 1,694.7 1,935.3 2,205.7 2,509.4 2,849.7 14.53%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.6 China Fi g ure 31 : C hina Compa nio n Diagnos tics Ma rke t , $Mi lli on, 20 22 -
2 033

672.5
588.7
514.4
448.6
390.5
339.3
294.2
254.7
220.0
189.6
163.1
140.0
Country Overview
The companion diagnostics market in China is driven by a combination of factors. Robust
post-market surveillance mechanisms ensure the ongoing safety and effectiveness of 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
companion diagnostics, monitoring real-world performance and addressing any issues that
arise, which contribute to the long-term success of these diagnostics in clinical practice in Source: BIS Research Analysis

China.

The competitive landscape, including the presence of local and international companies, Analyst View
influences market dynamics in the country. Furthermore, understanding market competition
The China companion diagnostics market was valued at $140.0 million in 2022 and is
helps companies tailor their strategies to stand out and meet specific market needs.
expected to reach $672.5 million by 2033, growing at a CAGR of 15.22% during the forecast

Global Companion Diagnostics Market

period 2023-2033.

The strategies employed by companies to gain market access, including pricing strategies
and partnerships with healthcare providers, impact the market's overall dynamics. Moreover,
effective market access strategies contribute to the successful commercialization of
companion diagnostics.

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4.5.7 Application
Ta ble 4 1 : China Comp a nio n Diag nos tics Ma rke t ( by A p plic at ion ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 52.2 61.0 71.3 83.0 96.5 112.0 129.8 150.0 173.1 199.4 229.2 263.0 15.73%

Breast Cancer 35.3 40.9 47.3 54.5 62.8 72.1 82.7 94.6 108.1 123.3 140.3 159.4 14.58%

Colorectal Cancer 25.9 30.2 35.2 40.9 47.5 55.0 63.5 73.2 84.3 96.8 111.0 127.1 15.44%

Leukemia 9.1 10.5 12.0 13.8 15.8 18.0 20.5 23.3 26.5 30.0 34.0 38.3 13.85%

Stomach 4.2 4.9 5.8 6.8 8.0 9.3 10.9 12.7 14.7 17.1 19.8 22.9 16.54%

Melanoma 2.8 3.2 3.7 4.2 4.8 5.5 6.2 7.0 8.0 9.0 10.2 11.4 13.53%

Others 10.6 12.3 14.4 16.7 19.3 22.3 25.7 29.5 33.9 38.8 44.3 50.4 15.12%

Total 140.0 163.1 189.6 220.0 254.7 294.2 339.3 390.5 448.6 514.4 588.7 672.5 15.22%
Source: BIS Research Analysis

Ta ble 4 2 : China Comp a nio n Diag nos tics Ma rke t ( by E nd User ),

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
55.3 63.9 73.7 84.8 97.4 111.6 127.6 145.7 166.0 188.8 214.3 242.8 14.28%
Biotechnology Companies
Reference Laboratories
60.4 71.3 84.0 98.7 115.8 135.7 158.6 185.0 215.4 250.3 290.4 336.3 16.78%
and Hospitals
Others 24.4 28.0 32.0 36.5 41.5 47.0 53.1 59.9 67.2 75.3 84.0 93.5 12.83%

Total 140.0 163.1 189.6 220.0 254.7 294.2 339.3 390.5 448.6 514.4 588.7 672.5 15.22%
Source: BIS Research Analysis

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4.5.8 Product
Ta ble 4 3 : China Comp a nio n Diag nos tics Ma rke t ( by Tec hnol ogy ),
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 48.0 56.0 65.1 75.6 87.5 101.2 116.8 134.4 154.5 177.3 203.0 232.0 15.28%

NGS 25.6 30.3 35.7 42.1 49.4 57.9 67.8 79.2 92.3 107.4 124.7 144.6 16.92%

IHC 35.8 41.6 48.2 55.7 64.3 74.0 85.0 97.5 111.6 127.5 145.3 165.4 14.80%

ISH 25.1 28.9 33.4 38.4 44.1 50.5 57.7 65.9 75.0 85.3 96.8 109.6 14.24%

Others 5.5 6.3 7.2 8.3 9.4 10.7 12.0 13.6 15.2 17.0 18.9 20.8 12.73%

Total 140.0 163.1 189.6 220.0 254.7 294.2 339.3 390.5 448.6 514.4 588.7 672.5 15.22%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.9 India Fi g ure 32 : I ndi a Compa nio n Diagnos tics Ma rke t, $Mi lli on, 20 22 -
2 033

481.6
416.9
360.2
310.7
267.5
229.8
197.1
168.7
144.1
122.8
104.5
88.7
Country Overview
The companion diagnostics market in India is expected to witness growth, driven by factors 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
such as the increasing prevalence of chronic diseases, rising awareness of personalized
Source: BIS Research Analysis
medicine, and advancements in diagnostic technologies.

Like many global markets, companion diagnostics in India have a strong focus on oncology.
The identification of specific biomarkers and genetic mutations is crucial for guiding targeted Analyst View
therapies in cancer treatment. The India companion diagnostics market was valued at $88.7 million in 2022 and is expected
to reach $481.6 million by 2033, growing at a CAGR of 16.51% during the forecast period

Global Companion Diagnostics Market

2023-2033.

Government initiatives to strengthen healthcare infrastructure, promote research and

development, and enhance access to advanced medical technologies contribute to the growth
of the companion diagnostics market. Schemes launched in the country, such as the National
Health Mission, may have an impact on diagnostic advancements.

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4.5.10 Application
Ta ble 4 4 : Indi a Comp a nio n Diag nos tics Ma rke t ( by A p plic at ion ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 31.3 37.2 44.1 52.3 61.7 72.8 85.7 100.6 117.9 138.0 161.1 187.8 17.57%

Breast Cancer 22.3 26.0 30.2 35.1 40.7 47.1 54.3 62.6 72.0 82.7 94.7 108.4 15.36%

Colorectal Cancer 16.0 18.8 22.2 26.1 30.5 35.7 41.7 48.7 56.6 65.7 76.2 88.1 16.68%

Leukemia 5.6 6.5 7.5 8.6 9.9 11.4 13.0 14.9 17.0 19.4 22.1 25.0 14.49%

Stomach 2.0 2.4 2.9 3.4 4.2 5.0 6.0 7.2 8.6 10.2 12.2 14.4 19.84%

Melanoma 1.7 1.9 2.2 2.5 2.9 3.3 3.7 4.2 4.7 5.3 6.0 6.7 13.32%

Others 9.9 11.7 13.7 16.1 18.8 21.8 25.3 29.3 33.8 38.9 44.6 51.0 15.87%

Total 88.7 104.5 122.8 144.1 168.7 197.1 229.8 267.5 310.7 360.2 416.9 481.6 16.51%
Source: BIS Research Analysis

Ta ble 4 5 : Indi a Comp a nio n Diag nos tics Ma rke t ( by E nd User ),

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Global Companion Diagnostics Market

Pharmaceutical and
32.4 37.9 44.3 51.7 60.2 69.9 81.1 93.8 108.4 125.0 143.8 165.2 15.85%
Biotechnology Companies
Reference Laboratories
37.3 44.4 52.7 62.4 73.8 87.1 102.5 120.4 141.3 165.4 193.2 225.4 17.64%
and Hospitals
Others 19.0 22.2 25.8 29.9 34.7 40.1 46.2 53.2 61.0 69.9 79.9 91.0 15.18%

Total 88.7 104.5 122.8 144.1 168.7 197.1 229.8 267.5 310.7 360.2 416.9 481.6 16.51%
Source: BIS Research Analysis

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4.5.11 Product
Ta ble 4 6 : Indi a Comp a nio n Diag nos tics Ma rke t ( by Tec hnol ogy ),
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 32.9 38.8 45.8 53.8 63.1 73.9 86.4 100.8 117.3 136.3 158.1 183.0 16.76%

NGS 16.6 19.9 23.8 28.3 33.7 40.1 47.5 56.3 66.5 78.4 92.2 108.4 18.49%

IHC 22.4 26.4 30.9 36.1 42.2 49.1 57.1 66.3 76.8 88.8 102.4 118.0 16.17%

ISH 14.1 16.3 18.8 21.7 24.9 28.6 32.7 37.4 42.7 48.6 55.2 62.6 14.40%

Others 2.7 3.1 3.6 4.1 4.7 5.3 6.0 6.7 7.5 8.2 8.9 9.6 12.01%

Total 88.7 104.5 122.8 144.1 168.7 197.1 229.8 267.5 310.7 360.2 416.9 481.6 16.51%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.12 Australia Fi g ure 33 : A us tr alia Com pa nion Dia gnos ti cs Mar ke t, $Millio n,
2 022 -2033

313.5
277.2
244.6
215.5
189.5
166.3
145.6
127.3
111.1
96.7
84.0
72.9
Country Overview
The concept of precision medicine has gradually gained traction in Australia, with a focus on 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
tailoring medical interventions based on individual patient characteristics. Companion
Source: BIS Research Analysis
diagnostics play a key role in facilitating personalized treatment approaches.

Advances in diagnostic technologies, such as next-generation sequencing (NGS) and

Analyst View
molecular diagnostics, play a pivotal role in shaping the companion diagnostics landscape.
Continuous innovation contributes to the accuracy and efficiency of diagnostic tests. The Australia companion diagnostics market was valued at $72.9 million in 2022 and is
expected to reach $313.5 million by 2033, growing at a CAGR of 14.07% during the forecast

Global Companion Diagnostics Market

period 2023-2033.

The companion diagnostics market in Australia faces challenges related to market access,
and reimbursement. However, these challenges also present opportunities for companies to
address unmet needs and contribute to the development of the market.

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4.5.13 Application
Ta ble 4 7 : Aus tr alia C om pa nion Dia g nos ti cs Mar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 27.2 31.5 36.3 41.9 48.1 55.2 63.3 72.4 82.6 94.0 106.9 121.3 14.45%

Breast Cancer 18.7 21.4 24.5 28.0 31.9 36.3 41.2 46.7 52.8 59.6 67.2 75.6 13.45%

Colorectal Cancer 13.8 15.9 18.4 21.2 24.4 28.0 32.1 36.7 41.8 47.6 54.1 61.4 14.45%

Leukemia 4.7 5.3 6.0 6.8 7.6 8.6 9.6 10.8 12.0 13.4 14.9 16.6 12.13%

Stomach 1.5 1.8 2.1 2.5 3.0 3.6 4.3 5.1 6.1 7.2 8.5 10.0 19.05%

Melanoma 2.0 2.2 2.5 2.7 3.0 3.4 3.7 4.1 4.5 5.0 5.4 6.0 10.48%

Others 5.2 6.0 7.0 8.1 9.3 10.6 12.2 13.8 15.7 17.8 20.1 22.6 14.14%

Total 72.9 84.0 96.7 111.1 127.3 145.6 166.3 189.5 215.5 244.6 277.2 313.5 14.07%
Source: BIS Research Analysis

Ta ble 4 8 : Aus tr alia C om pa nion Dia g nos ti cs Mar ke t ( by E nd User) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
27.2 31.3 35.9 41.1 46.9 53.5 60.9 69.2 78.5 88.8 100.4 113.2 13.73%
Biotechnology Companies
Reference Laboratories
29.5 34.5 40.2 46.7 54.2 62.8 72.6 83.8 96.5 110.9 127.3 145.8 15.51%
and Hospitals
Others 16.2 18.3 20.7 23.3 26.2 29.3 32.7 36.5 40.5 44.9 49.5 54.5 11.53%

Total 72.9 84.0 96.7 111.1 127.3 145.6 166.3 189.5 215.5 244.6 277.2 313.5 14.07%
Source: BIS Research Analysis

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4.5.14 Product
Ta ble 4 9 : Aus tr alia C om pa nion Dia g nos ti cs Mar ke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 26.7 31.0 35.8 41.3 47.6 54.7 62.7 71.8 82.0 93.6 106.5 121.0 14.60%

NGS 14.0 16.5 19.3 22.6 26.5 30.9 36.0 41.8 48.5 56.2 64.9 74.9 16.36%

IHC 20.0 22.8 26.0 29.5 33.4 37.8 42.6 48.0 54.0 60.6 67.9 75.9 12.75%

ISH 10.0 11.3 12.7 14.3 16.1 18.1 20.2 22.6 25.2 28.0 31.1 34.5 11.82%

Others 2.1 2.5 2.9 3.3 3.7 4.2 4.7 5.2 5.8 6.3 6.8 7.2 11.33%

Total 72.9 84.0 96.7 111.1 127.3 145.6 166.3 189.5 215.5 244.6 277.2 313.5 14.07%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.15 Japan Fi g ure 34 : J apa n Com pa nio n Dia gnos tic s Ma rke t, $Milli o n, 202 2 -
2 033

550.0
481.7
421.2
367.6
320.2
278.4
241.5
209.2
180.8
156.0
134.2
115.3
Country Overview
The companion diagnostics market in Japan is propelled by its technological prowess, 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
addressing labor shortages, advancing precision medicine and diagnostics, and supporting its
strong pharmaceutical, biotechnology, and research sectors. Source: BIS Research Analysis

With a rigorous regulatory environment, partnerships with global entities, and a focus on
healthcare modernization and sustainability, companion diagnostics play a crucial role in Analyst View
enhancing research efficiency, data accuracy, and industrial competitiveness in the country. The Japan companion diagnostics market was valued at $115.3 million in 2022 and is
expected to reach $550.0 million by 2033, growing at a CAGR of 15.15% during the forecast

Global Companion Diagnostics Market

period 2023-2033.

Educating healthcare professionals and patients about the importance and benefits of
companion diagnostics is essential for market acceptance. Furthermore, increased
awareness can lead to broader integration of these diagnostics into routine clinical practice.

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4.5.16 Application
Ta ble 5 0 : J apa n C om pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 42.2 49.7 58.4 68.5 80.1 93.6 109.1 126.9 147.4 170.9 197.7 228.3 16.47%

Breast Cancer 29.9 34.4 39.5 45.3 51.8 59.2 67.4 76.7 87.1 98.6 111.6 126.0 13.86%

Colorectal Cancer 21.3 24.8 28.7 33.1 38.2 43.9 50.4 57.8 66.1 75.5 86.1 97.9 14.74%

Leukemia 7.3 8.3 9.5 10.9 12.4 14.1 16.0 18.1 20.4 23.0 25.9 29.2 13.35%

Stomach 3.1 3.7 4.4 5.2 6.2 7.3 8.7 10.2 12.0 14.1 16.5 19.3 17.89%

Melanoma 2.3 2.6 3.0 3.3 3.8 4.2 4.8 5.3 6.0 6.7 7.4 8.3 12.17%

Others 9.2 10.8 12.5 14.5 16.7 19.2 22.0 25.2 28.6 32.5 36.7 41.3 14.38%

Total 115.3 134.2 156.0 180.8 209.2 241.6 278.4 320.2 367.6 421.2 481.7 550.0 15.15%
Source: BIS Research Analysis

Ta ble 5 1 : J apa n C om pa nio n Dia g nos tic s Ma rke t (by E nd User) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
45.0 52.1 60.2 69.5 80.0 91.9 105.3 120.6 137.7 157.0 178.7 203.0 14.57%
Biotechnology Companies
Reference Laboratories
50.2 59.1 69.6 81.7 95.7 111.8 130.5 152.0 176.7 205.0 237.4 274.5 16.59%
and Hospitals
Others 20.2 23.0 26.2 29.7 33.6 37.9 42.5 47.6 53.2 59.2 65.7 72.6 12.17%

Total 115.3 134.2 156.0 180.8 209.2 241.6 278.4 320.2 367.6 421.2 481.7 550.0 15.15%
Source: BIS Research Analysis

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4.5.17 Product
Ta ble 5 2 : J apa n C om pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 40.5 47.5 55.5 64.8 75.5 87.8 101.9 118.0 136.4 157.4 181.3 208.5 15.95%

NGS 21.9 26.0 30.9 36.5 43.1 50.7 59.7 70.0 82.0 95.9 111.9 130.4 17.48%

IHC 30.6 35.2 40.5 46.5 53.3 61.0 69.6 79.2 90.1 102.2 115.8 130.9 14.03%

ISH 17.9 20.3 23.1 26.1 29.5 33.3 37.5 42.2 47.3 53.0 59.2 66.0 12.50%

Others 4.5 5.2 6.0 6.9 7.8 8.7 9.7 10.7 11.8 12.7 13.6 14.3 10.62%

Total 115.3 134.2 156.0 180.8 209.2 241.6 278.4 320.2 367.6 421.2 481.7 550.0 15.15%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.18 South Korea Fi g ure 35 : S outh Ko rea Co mpanio n Dia gnos ti cs Market, $Millio n,
2 022 -2033

250.8
220.1
192.9
168.7
147.3
128.3
111.6
96.9
83.9
72.5
62.6
53.9
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Source: BIS Research Analysis

Country Overview
Government initiatives supporting healthcare research, development, and the adoption of
Analyst View
advanced medical technologies contribute to the growth of the companion diagnostics market.
Policies aimed at enhancing precision medicine may also impact the market landscape. The South Korea companion diagnostics market was valued at $53.9 million in 2022 and is
expected to reach $250.8 million by 2033, growing at a CAGR of 14.89% during the forecast

Global Companion Diagnostics Market

The regulatory landscape in South Korea, overseen by the Ministry of Food and Drug Safety
period 2023-2033.
(MFDS), plays a crucial role in the approval and commercialization of companion diagnostics.
Compliance with regulatory standards is essential for market entry. Collaborations between local and international pharmaceutical companies, diagnostic
developers, and research institutions contribute to advancements in companion diagnostics.
Partnerships and joint ventures are instrumental in bringing innovative diagnostic technologies
to the South Korea market.

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4.5.19 Application
Ta ble 5 3 : S outh Ko rea Co mpanio n Dia g nos ti cs Mark et (b y
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 20.5 24.0 28.0 32.6 37.9 43.9 50.8 58.7 67.7 77.9 89.5 102.6 15.64%

Breast Cancer 14.0 16.1 18.5 21.1 24.1 27.5 31.3 35.5 40.2 45.5 51.4 57.9 13.67%

Colorectal Cancer 9.6 11.2 13.0 15.0 17.4 20.1 23.2 26.7 30.6 35.1 40.2 45.9 15.18%

Leukemia 3.1 3.5 4.0 4.6 5.3 6.0 6.8 7.7 8.7 9.9 11.1 12.5 13.53%

Stomach 1.3 1.6 1.9 2.3 2.7 3.2 3.8 4.5 5.3 6.2 7.3 8.5 18.15%

Melanoma 1.1 1.3 1.5 1.7 1.9 2.1 2.4 2.7 3.0 3.4 3.8 4.3 12.71%

Others 4.2 4.9 5.7 6.6 7.6 8.7 10.0 11.5 13.1 14.9 16.9 19.1 14.56%

Total 53.9 62.6 72.5 83.9 96.8 111.6 128.3 147.3 168.7 192.9 220.1 250.8 14.89%
Source: BIS Research Analysis

Ta ble 5 4 : S outh Ko rea Co mpanio n Dia g nos ti cs Mark et (b y E nd

User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
20.2 23.4 27.0 31.1 35.8 41.0 47.0 53.7 61.2 69.7 79.2 89.8 14.38%
Biotechnology Companies
Reference Laboratories
22.5 26.5 31.1 36.4 42.5 49.6 57.8 67.1 77.9 90.1 104.1 120.1 16.33%
and Hospitals
Others 11.1 12.7 14.4 16.4 18.5 20.9 23.6 26.5 29.6 33.1 36.8 40.9 12.43%

Total 53.9 62.6 72.5 83.9 96.8 111.6 128.3 147.3 168.7 192.9 220.1 250.8 14.89%
Source: BIS Research Analysis

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4.5.20 Product
Ta ble 5 5 : S outh Ko rea Co mpanio n Dia g nos ti cs Mark et (b y
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 18.9 22.1 25.8 30.1 35.0 40.6 47.0 54.3 62.6 72.1 82.9 95.0 15.70%

NGS 10.2 12.1 14.3 16.9 19.9 23.4 27.5 32.2 37.6 43.9 51.1 59.4 17.23%

IHC 14.3 16.4 18.8 21.6 24.7 28.2 32.1 36.4 41.3 46.8 52.9 59.7 13.78%

ISH 8.3 9.5 10.7 12.1 13.7 15.4 17.3 19.4 21.7 24.2 27.0 30.1 12.25%

Others 2.1 2.4 2.8 3.2 3.6 4.0 4.5 4.9 5.4 5.8 6.2 6.5 10.38%

Total 53.9 62.6 72.5 83.9 96.8 111.6 128.3 147.3 168.7 192.9 220.1 250.8 14.89%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.5.21 Rest-of-Asia-Pacific Fi g ure 36 : Res t -of -Asia -Pac ific Com pa nion Dia gnos t i cs Mar ke t,
$Mil lio n, 20 22 -2 033

581.3
524.8
472.5
424.2
379.9
339.2
302.2
268.4
237.8
210.2
185.2
162.8
Country Overview
The Rest-of-Asia-Pacific region includes emerging economies such as Malaysia, Indonesia, 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
the Philippines, Thailand, Singapore, and Taiwan.
Source: BIS Research Analysis
Companies entering the Asia-Pacific companion diagnostics market need effective market
access strategies. Understanding local regulatory requirements, reimbursement policies, and
market dynamics would be crucial for successful market entry. Analyst View
The Rest-of-Asia-Pacific companion diagnostics market was valued at $162.8 million in 2022
and is expected to reach $581.3 million by 2033, growing at a CAGR of 12.12% during the

Global Companion Diagnostics Market

forecast period 2023-2033.

The companies in the Rest-of-Asia-Pacific region actively engage in international

collaborations in research and development. Collaborative efforts with global industry leaders
and research institutions contribute to the integration of advanced diagnostic technologies.

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4.5.22 Application
Ta ble 5 6 : Res t -of -Asia -Pac ific C om pa nion Dia g nos ti cs Mar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 20.5 24.0 28.0 32.6 37.9 43.9 50.8 58.7 67.7 77.9 89.5 102.6 15.64%

Breast Cancer 14.0 16.1 18.5 21.1 24.1 27.5 31.3 35.5 40.2 45.5 51.4 57.9 13.67%

Colorectal Cancer 9.6 11.2 13.0 15.0 17.4 20.1 23.2 26.7 30.6 35.1 40.2 45.9 15.18%

Leukemia 3.1 3.5 4.0 4.6 5.3 6.0 6.8 7.7 8.7 9.9 11.1 12.5 13.53%

Stomach 1.3 1.6 1.9 2.3 2.7 3.2 3.8 4.5 5.3 6.2 7.3 8.5 18.15%

Melanoma 1.1 1.3 1.5 1.7 1.9 2.1 2.4 2.7 3.0 3.4 3.8 4.3 12.71%

Others 162.8 185.2 210.2 237.8 268.4 302.2 339.2 379.9 424.2 472.5 524.8 581.3 12.12%
Source: BIS Research Analysis

Ta ble 5 7 : Res t -of -Asia -Pac ific C om pa nion Dia g nos ti cs Mar ke t ( by
End User ), $Millio n , 2 022 -2033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Global Companion Diagnostics Market

Pharmaceutical and
64.6 73.4 83.2 94.0 106.0 119.1 133.6 149.3 166.6 185.2 205.5 227.3 11.96%
Biotechnology Companies
Reference Laboratories
69.2 79.1 90.2 102.6 116.4 131.7 148.6 167.2 187.6 210.0 234.5 261.0 12.68%
and Hospitals
Others 29.0 32.7 36.7 41.2 46.1 51.4 57.1 63.3 70.0 77.2 84.9 93.0 11.03%

Total 162.8 185.2 210.2 237.8 268.4 302.2 339.2 379.9 424.2 472.5 524.8 581.3 12.12%
Source: BIS Research Analysis

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4.5.23 Product
Ta ble 5 8 : Res t -of -Asia -Pac ific C om pa nion Dia g nos ti cs Mar ke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 57.2 65.4 74.6 84.9 96.4 109.2 123.3 138.8 155.9 174.7 195.1 217.4 12.77%

NGS 27.8 32.3 37.3 43.1 49.6 56.9 65.1 74.3 84.5 96.0 108.6 122.7 14.28%

IHC 43.2 48.8 55.1 62.0 69.5 77.8 86.9 96.8 107.4 119.0 131.4 144.8 11.48%

ISH 30.1 33.6 37.3 41.3 45.7 50.4 55.4 60.7 66.4 72.4 78.8 85.5 9.80%

Others 4.6 5.2 5.9 6.5 7.3 8.0 8.7 9.3 9.9 10.4 10.8 11.1 7.85%

Total 162.8 185.2 210.2 237.8 268.4 302.2 339.2 379.9 424.2 472.5 524.8 581.3 12.12%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.6 Latin America Fi g ure 37 : La ti n Ameri ca Com pa ni on Di agnos tics Mar ke t,
$Mil lio n, 20 22 -2 033

400.0
372.7
345.4
318.5
292.2
266.9
242.7
219.8
198.2
178.0
159.2
141.9
4.6.1 Regional Overview
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
Several Latin American countries, including Brazil, Mexico, and Argentina, are working toward
Source: BIS Research Analysis
enhancing the adoption of companion diagnostics.

Latin America has a rapidly growing healthcare industry, which is majorly driven by
advancements in medical research and technology and a focus on providing advanced Analyst View
healthcare services. This growth has implications for the adoption of companion diagnostics. In 2022, Latin America accounted for a share of 4.30% of the global companion diagnostics
market. The region is expected to reach $400.0 million in 2033 from $141.9 million in 2022, at
a CAGR of 9.65% during the forecast period 2023-2033.
4.6.2 Driving Factors for Market Growth

Global Companion Diagnostics Market

The market is expected to remain in a growth phase due to the increasing need for growing
▪ Increasing application of companion diagnostics beyond oncology
healthcare and life sciences sectors, as well as the entry of several market players in the Latin
▪ Rising prevalence of chronic diseases fueling the demand for companion diagnostics America companion diagnostics market.

4.6.3 Factors Challenging the Market

▪ Economic downturns or budget constraints
▪ Lack of awareness and understanding of companion diagnostics among healthcare
professionals

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4.6.4 Application
Ta ble 5 9 : La ti n Ameri ca Com pa ni on Di agnos tics Mar ke t ( by
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 53.6 60.5 68.0 76.2 85.1 94.6 104.7 115.3 126.5 138.1 149.9 161.9 10.35%

Breast Cancer 36.5 40.6 45.1 49.9 54.9 60.2 65.7 71.4 77.3 83.2 89.1 95.0 8.86%

Colorectal Cancer 24.9 27.9 31.3 34.9 38.7 42.8 47.2 51.7 56.5 61.3 66.3 71.2 9.80%

Leukemia 8.6 9.5 10.5 11.5 12.6 13.7 14.9 16.1 17.3 18.5 19.7 20.8 8.13%

Stomach 3.9 4.5 5.1 5.8 6.5 7.3 8.2 9.2 10.2 11.2 12.3 13.5 11.64%

Melanoma 2.9 3.2 3.5 3.8 4.1 4.5 4.8 5.1 5.5 5.8 6.1 6.4 7.16%

Others 11.5 12.9 14.4 16.1 17.8 19.6 21.4 23.4 25.3 27.3 29.2 31.1 9.19%

Total 141.9 159.2 178.0 198.2 219.8 242.7 266.9 292.2 318.5 345.4 372.7 400.0 9.65%
Source: BIS Research Analysis

Ta ble 6 0 : La ti n Ameri ca Com pa ni on Di agnos tics Mar ke t ( by End

User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
55.6 62.1 69.1 76.6 84.6 93.0 101.8 110.9 120.4 129.9 139.6 149.1 9.15%
Biotechnology Companies
Reference Laboratories
61.9 70.0 79.0 88.8 99.3 110.7 122.8 135.7 149.2 163.3 177.8 192.6 10.64%
and Hospitals
Others 24.4 27.1 29.9 32.8 35.9 39.1 42.3 45.6 48.9 52.1 55.3 58.2 7.96%

Total 141.9 159.2 178.0 198.2 219.8 242.7 266.9 292.2 318.5 345.4 372.7 400.0 9.65%
Source: BIS Research Analysis

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4.6.5 Product
Ta ble 6 1 : La ti n Ameri ca Com pa ni on Di agnos tics Mar ke t ( by
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 49.2 55.3 62.0 69.3 77.0 85.3 94.1 103.3 112.9 122.8 132.9 143.0 9.96%

NGS 25.2 28.8 32.7 37.0 41.7 46.9 52.4 58.3 64.6 71.3 78.2 85.3 11.48%

IHC 36.9 41.2 45.9 50.8 56.1 61.7 67.5 73.6 79.8 86.2 92.6 98.9 9.15%

ISH 25.8 28.5 31.4 34.5 37.7 41.1 44.6 48.2 51.8 55.4 59.0 62.4 8.15%

Others 4.8 5.4 6.0 6.6 7.2 7.7 8.3 8.9 9.3 9.8 10.1 10.3 6.70%

Total 141.9 159.2 178.0 198.2 219.8 242.7 266.9 292.2 318.5 345.4 372.7 400.0 9.65%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.6.6 Brazil Fi g ure 38 : B ra zil Com pa nio n Dia gnos tic s Ma rke t, $Milli o n, 202 2 -
2 033

172.8
161.3
149.8
138.4
127.3
116.5
106.2
96.3
87.1
78.3
70.2
62.7
Country Overview
The companion diagnostics market in Brazil is driven by factors such as the expanding
healthcare sector's need for precise diagnostics and the pharmaceutical industry's focus on
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
efficient R&D processes. Furthermore, institutions leading in genomic research contribute to
advancements in biomarker discovery for companion diagnostics in the country. Source: BIS Research Analysis

Analyst View
The Brazil companion diagnostics market was valued at $62.7 million in 2022 and is expected
to reach $172.8 million by 2033, growing at a CAGR of 9.42% during the forecast period 2023-

Global Companion Diagnostics Market

2033.

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4.6.7 Application
Ta ble 6 2 : B ra zil Com pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 23.8 26.9 30.2 33.8 37.7 41.8 46.2 50.8 55.7 60.7 65.8 71.0 10.20%

Breast Cancer 16.4 18.2 20.1 22.2 24.3 26.6 28.9 31.3 33.8 36.3 38.7 41.1 8.51%

Colorectal Cancer 10.3 11.6 13.0 14.5 16.0 17.7 19.5 21.3 23.2 25.2 27.2 29.2 9.66%

Leukemia 3.6 4.0 4.4 4.8 5.3 5.7 6.2 6.6 7.1 7.6 8.0 8.5 7.75%

Stomach 1.6 1.9 2.1 2.4 2.8 3.1 3.5 3.9 4.4 4.9 5.4 5.9 12.12%

Melanoma 1.4 1.5 1.6 1.8 1.9 2.0 2.2 2.3 2.4 2.5 2.7 2.8 6.30%

Others 5.5 6.2 6.9 7.6 8.4 9.2 10.1 10.9 11.8 12.7 13.5 14.3 8.79%

Total 62.7 70.2 78.3 87.1 96.3 106.2 116.5 127.3 138.4 149.8 161.3 172.8 9.42%
Source: BIS Research Analysis

Ta ble 6 3 : B ra zil Com pa nio n Dia g nos tic s Ma rke t (by E nd User) ,
$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
25.2 28.1 31.2 34.6 38.2 42.0 46.0 50.1 54.3 58.6 62.9 67.2 9.12%
Biotechnology Companies
Reference Laboratories
27.9 31.5 35.4 39.6 44.1 49.0 54.2 59.6 65.3 71.2 77.2 83.3 10.22%
and Hospitals
Others 9.7 10.7 11.7 12.8 14.0 15.2 16.4 17.6 18.8 20.0 21.2 22.3 7.65%

Total 62.7 70.2 78.3 87.1 96.3 106.2 116.5 127.3 138.4 149.8 161.3 172.8 9.42%
Source: BIS Research Analysis

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4.6.8 Product
Ta ble 6 4 : B ra zil Com pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 22.0 24.8 27.8 31.1 34.6 38.4 42.3 46.5 50.9 55.4 60.0 64.6 10.05%

NGS 10.7 12.2 13.9 15.8 17.8 20.0 22.3 24.9 27.6 30.4 33.4 36.5 11.53%

IHC 16.6 18.5 20.5 22.7 25.0 27.3 29.8 32.4 35.1 37.7 40.4 43.0 8.80%

ISH 11.6 12.7 13.9 15.1 16.4 17.7 19.0 20.3 21.7 23.0 24.2 25.4 7.16%

Others 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.1 3.2 3.3 3.3 3.3 5.26%

Total 62.7 70.2 78.3 87.1 96.3 106.2 116.5 127.3 138.4 149.8 161.3 172.8 9.42%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.6.9 Mexico Fi g ure 39 : Mexi co Com pa nio n Dia gnos tic s Ma rke t, $Milli o n,
2 022 -2033

112.0
103.8
95.7
87.7
80.1
72.8
65.8
59.3
53.2
47.5
42.3
37.5
Country Overview
Similar to global trends, companion diagnostics in Mexico lay a strong emphasis on oncology.
The identification of specific biomarkers and genetic mutations is crucial for guiding targeted
therapies, and this is particularly relevant in cancer treatment.
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Source: BIS Research Analysis

Analyst View
The Mexico companion diagnostics market was valued at $37.5 million in 2022 and is
expected to reach $112.0 million by 2033, growing at a CAGR of 10.24% during the forecast

Global Companion Diagnostics Market

period 2023-2033.

Government initiatives supporting healthcare research, development, and the adoption of

advanced medical technologies contribute to the growth of the companion diagnostics market.
Furthermore, policies aimed at enhancing precision medicine may also impact the market
landscape.

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4.6.10 Application
Ta ble 6 5 : Mexi co Com pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 14.0 15.8 17.8 20.1 22.5 25.1 27.8 30.8 33.9 37.1 40.4 43.8 10.72%

Breast Cancer 9.4 10.6 11.8 13.2 14.6 16.1 17.7 19.4 21.1 22.9 24.7 26.5 9.62%

Colorectal Cancer 6.9 7.8 8.8 9.9 11.1 12.3 13.6 15.0 16.5 18.0 19.6 21.2 10.45%

Leukemia 2.4 2.7 3.0 3.3 3.7 4.0 4.4 4.8 5.2 5.6 6.0 6.4 8.93%

Stomach 1.1 1.3 1.5 1.7 1.9 2.1 2.3 2.6 2.9 3.2 3.5 3.8 11.50%

Melanoma 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.6 1.7 1.8 1.9 8.62%

Others 2.8 3.2 3.6 4.0 4.5 5.0 5.5 6.1 6.6 7.2 7.8 8.4 10.14%

Total 37.5 42.3 47.5 53.2 59.3 65.8 72.8 80.1 87.7 95.7 103.8 112.0 10.24%
Source: BIS Research Analysis

Ta ble 6 6 : Mexi co Com pa nio n Dia g nos tic s Ma rke t (by E nd User) ,
$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Global Companion Diagnostics Market

Pharmaceutical and
14.8 16.6 18.5 20.5 22.7 25.0 27.4 29.9 32.5 35.1 37.8 40.4 9.34%
Biotechnology Companies
Reference Laboratories
16.1 18.5 21.0 23.9 27.0 30.3 34.0 37.9 42.1 46.6 51.2 56.0 11.73%
and Hospitals
Others 6.5 7.2 8.0 8.8 9.7 10.5 11.4 12.3 13.2 14.0 14.8 15.6 7.95%

Total 37.5 42.3 47.5 53.2 59.3 65.8 72.8 80.1 87.7 95.7 103.8 112.0 10.24%
Source: BIS Research Analysis

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4.6.11 Product
Ta ble 6 7 : Mexi co Com pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 12.8 14.5 16.3 18.3 20.4 22.6 25.0 27.6 30.2 33.0 35.8 38.6 10.29%

NGS 6.9 7.8 9.0 10.2 11.5 13.0 14.5 16.2 18.1 20.0 22.0 24.1 11.86%

IHC 9.6 10.8 12.1 13.5 15.0 16.5 18.2 20.0 21.8 23.7 25.6 27.5 9.84%

ISH 6.7 7.5 8.4 9.3 10.3 11.3 12.4 13.5 14.7 15.9 17.1 18.3 9.30%

Others 1.5 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.3 3.5 7.86%

Total 37.5 42.3 47.5 53.2 59.3 65.8 72.8 80.1 87.7 95.7 103.8 112.0 10.24%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.6.12 Rest-of-Latin America Fi g ure 40 : Res t -of -Lati n America Co mpanio n Dia gnos tics
Mar ke t, $Milli o n, 202 2 -20 33

115.2
107.6
99.9
92.3
84.8
77.6
70.7
64.2
58.0
52.2
46.7
41.7
Country Overview
The Rest-of-Latin America region consists of emerging economies, including Chile, Argentina,
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
Columbia, Peru, and Venezuela, among others. The demand for increasing focus on
Source: BIS Research Analysis
biomarker discovery and the rising pharmaceutical and biotechnology industry can provide
attractive potential for the market’s players to enter the area.
Analyst View
The Rest-of-Latin America companion diagnostics market was valued at $41.7 million in 2022
and is expected to reach $115.2 million by 2033, growing at a CAGR of 9.44% during the

Global Companion Diagnostics Market

forecast period 2023-2033.

The companion diagnostics market in Rest-of-Latin America faces challenges such as

reimbursement considerations and competition. However, these challenges also present
opportunities for companies to address specific market needs and contribute to the
development of the market.

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4.6.13 Application
Ta ble 6 8 : Res t -of -Lat i n America Co mp anio n Dia g nos tics Mar ke t
( by Appl ica tio n ) , $Milli o n, 20 22-2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 15.8 17.8 20.0 22.4 25.0 27.7 30.6 33.7 36.9 40.3 43.7 47.1 10.23%

Breast Cancer 10.7 11.9 13.2 14.5 16.0 17.5 19.1 20.7 22.3 24.0 25.7 27.3 8.68%

Colorectal Cancer 7.6 8.5 9.5 10.5 11.7 12.8 14.1 15.4 16.7 18.1 19.5 20.8 9.39%

Leukemia 2.5 2.8 3.1 3.4 3.7 4.0 4.3 4.7 5.0 5.3 5.7 6.0 7.86%

Stomach 1.2 1.3 1.5 1.7 1.9 2.1 2.4 2.6 2.9 3.2 3.5 3.8 11.09%

Melanoma 0.8 0.9 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.6 1.7 7.11%

Others 3.2 3.6 4.0 4.4 4.9 5.3 5.8 6.4 6.9 7.4 7.9 8.4 9.00%

Total 41.7 46.7 52.2 58.0 64.2 70.7 77.6 84.8 92.3 99.9 107.6 115.2 9.44%
Source: BIS Research Analysis

Ta ble 6 9 : Res t -of -Lat i n America Co mp anio n Dia g nos tics Mar ke t
( by End User) , $Millio n , 202 2 -20 33

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
15.6 17.5 19.4 21.5 23.7 26.0 28.5 31.0 33.6 36.2 38.9 41.5 9.03%
Biotechnology Companies
Reference Laboratories
17.8 20.1 22.6 25.3 28.2 31.3 34.6 38.1 41.8 45.6 49.4 53.3 10.25%
and Hospitals
Others 8.3 9.2 10.1 11.2 12.2 13.4 14.5 15.7 16.9 18.1 19.3 20.4 8.32%

Total 41.7 46.7 52.2 58.0 64.2 70.7 77.6 84.8 92.3 99.9 107.6 115.2 9.44%
Source: BIS Research Analysis

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4.6.14 Product
Ta ble 7 0 : Res t -of -Lat i n America Co mp anio n Dia g nos tics Mar ke t
( by Te c hnol og y) , $Mill io n , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 14.3 16.0 17.9 19.9 22.1 24.3 26.7 29.2 31.8 34.4 37.1 39.7 9.50%

NGS 7.6 8.7 9.8 11.1 12.5 13.9 15.5 17.2 19.0 20.9 22.8 24.8 11.06%

IHC 10.7 11.9 13.3 14.7 16.2 17.8 19.4 21.2 22.9 24.7 26.6 28.3 9.04%

ISH 7.5 8.3 9.2 10.1 11.1 12.1 13.2 14.3 15.4 16.6 17.7 18.8 8.51%

Others 1.6 1.8 2.0 2.2 2.4 2.6 2.8 2.9 3.1 3.3 3.4 3.6 7.08%

Total 41.7 46.7 52.2 58.0 64.2 70.7 77.6 84.8 92.3 99.9 107.6 115.2 9.44%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.7 Middle East and Africa Fi g ure 41 : Mi ddle East a nd Afri ca Co mpanio n D ia gnos tics
Mar ke t, $Milli o n, 202 2 -20 33

350.0
318.6
289.5
262.6
237.8
214.8
193.8
174.4
156.7
140.5
125.7
112.2
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
4.7.1 Regional Overview
Source: BIS Research Analysis
The Middle East and Africa region includes countries such as Israel, Turkiye, and South Africa.

In the Middle East and Africa, there's an increasing focus on developing biotechnological
Analyst View
capabilities, including companion diagnostics. This growth is evident in the rising number of
research initiatives and biotech startups in countries such as Israel, Turkiye, and South Africa. The Middle East and Africa companion diagnostics market was valued at $33.0 million in 2022
and is expected to reach $100.8 million by 2033, growing at a CAGR of 10.78% during the

Global Companion Diagnostics Market

forecast period 2023-2033.
4.7.2 Driving Factors for Market Growth
▪ Rising demand for personalized medicine fueling growth in the companion diagnostics
market
▪ Clear regulatory pathways and guidelines for the development and approval of
companion diagnostics

4.7.3 Factors Challenging the Market

▪ Lack of standardization
▪ Limited awareness among physicians and patients

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4.7.4 Application
Ta ble 7 1 : Mi ddle E ast a nd Afri ca Co mp anio n Dia g nos tics Mar ke t
( by Appl ica tio n ) , $Milli o n, 20 22-2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 41.3 46.6 52.5 59.0 66.2 74.0 82.7 92.1 102.5 113.8 126.2 139.6 11.58%

Breast Cancer 28.8 32.0 35.5 39.2 43.2 47.6 52.3 57.4 62.8 68.6 74.9 81.5 9.79%

Colorectal Cancer 20.2 22.6 25.3 28.3 31.6 35.2 39.1 43.3 48.0 53.0 58.4 64.3 11.02%

Leukemia 7.0 7.7 8.5 9.3 10.2 11.2 12.2 13.3 14.5 15.8 17.1 18.5 9.14%

Stomach 2.7 3.2 3.6 4.1 4.7 5.4 6.1 6.9 7.9 8.9 10.0 11.3 13.61%

Melanoma 2.1 2.3 2.5 2.8 3.0 3.2 3.5 3.8 4.1 4.4 4.7 5.0 7.93%

Others 10.0 11.2 12.5 13.9 15.5 17.1 18.9 20.8 22.9 25.0 27.3 29.8 10.28%

Total 112.2 125.7 140.5 156.7 174.4 193.8 214.8 237.8 262.6 289.5 318.6 350.0 10.78%
Source: BIS Research Analysis

Ta ble 7 2 : Mi ddle E ast a nd Afri ca Co mp anio n Dia g nos tics Mar ke t

( by End User) , $Millio n , 202 2 -20 33

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
42.3 47.1 52.5 58.3 64.7 71.6 79.0 87.1 95.8 105.3 115.4 126.3 10.35%
Biotechnology Companies
Reference Laboratories and
47.3 53.4 60.3 67.8 76.2 85.4 95.6 106.8 119.0 132.4 147.1 163.0 11.80%
Hospitals
Others 22.7 25.1 27.7 30.5 33.5 36.8 40.2 43.9 47.7 51.8 56.1 60.7 9.23%

Total 112.2 125.7 140.5 156.7 174.4 193.8 214.8 237.8 262.6 289.5 318.6 350.0 10.78%
Source: BIS Research Analysis

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4.7.5 Product
Ta ble 7 3 : Mi ddle E ast a nd Afri ca Co mp anio n Dia g nos tics Mar ke t
( by Te c hnol og y) , $Mill io n , 2 022 -203 3

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 40.5 45.6 51.1 57.2 63.9 71.2 79.2 88.0 97.5 107.9 119.1 131.3 11.17%

NGS 21.3 24.3 27.6 31.4 35.5 40.1 45.3 51.0 57.3 64.2 71.9 80.3 12.70%

IHC 28.5 31.7 35.3 39.2 43.5 48.1 53.1 58.5 64.4 70.6 77.4 84.7 10.30%

ISH 18.3 20.1 22.0 24.1 26.3 28.6 31.1 33.8 36.5 39.5 42.6 45.9 8.59%

Others 3.5 3.9 4.4 4.8 5.2 5.7 6.1 6.5 6.9 7.3 7.6 7.8 7.03%

Total 112.2 125.7 140.5 156.7 174.4 193.8 214.8 237.8 262.6 289.5 318.6 350.0 10.78%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.7.1 U.A.E. Fi g ure 42 : U.A.E. Com pa nio n Dia gnos tic s Ma rke t, $Milli o n, 202 2 -
2 033

151.2
137.9
125.6
114.2
103.6
93.8
84.8
76.5
68.8
61.8
55.4
49.6
Country Overview
Companies in the U.A.E. often have a global outlook, and several companies in the diagnostic
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
sector may operate internationally. This global perspective can influence the strategies and
technologies adopted in the local companion diagnostics market. Source: BIS Research Analysis

Analyst View
The U.A.E. companion diagnostics market was valued at $49.6 million in 2022 and is expected
to reach $151.2 million by 2033, growing at a CAGR of 10.55% during the forecast period

Global Companion Diagnostics Market

2023-2033.

Government efforts backing healthcare research, development, and the integration of

advanced medical technologies play a role in fostering growth in the companion diagnostics
market. Additionally, policies designed to advance precision medicine may exert influence on
the overall market landscape.

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4.7.2 Application
Ta ble 7 4 : U.A.E. C om pa nio n Dia g nos tic s Ma rke t (by A pp lica tio n ) ,
$Mil lio n, 20 22 -2 033

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 17.5 19.7 22.2 25.0 28.0 31.3 35.0 39.0 43.3 48.1 53.3 59.0 11.56%

Breast Cancer 12.4 13.8 15.2 16.8 18.4 20.2 22.2 24.2 26.5 28.8 31.3 34.0 9.46%

Colorectal Cancer 8.9 10.0 11.2 12.4 13.8 15.4 17.0 18.8 20.8 22.9 25.2 27.7 10.72%

Leukemia 3.1 3.4 3.8 4.1 4.5 4.9 5.3 5.8 6.3 6.8 7.3 7.9 8.64%

Stomach 1.1 1.3 1.4 1.6 1.9 2.1 2.4 2.8 3.1 3.6 4.0 4.5 13.72%

Melanoma 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.9 2.0 2.1 7.53%

Others 5.6 6.2 6.9 7.7 8.5 9.4 10.3 11.4 12.4 13.6 14.8 16.0 9.95%

Total 49.6 55.4 61.8 68.8 76.5 84.8 93.8 103.6 114.2 125.6 137.9 151.2 10.55%
Source: BIS Research Analysis

Ta ble 7 5 : U.A.E. C om pa nio n Dia g nos tic s Ma rke t (by E nd User) ,

$Mil lio n , 20 22 -2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
18.1 20.1 22.3 24.7 27.3 30.1 33.1 36.3 39.8 43.6 47.6 51.9 9.93%
Biotechnology Companies
Reference Laboratories
20.9 23.6 26.5 29.8 33.4 37.4 41.8 46.6 51.9 57.7 63.9 70.8 11.62%
and Hospitals
Others 10.6 11.8 13.0 14.3 15.7 17.2 18.9 20.6 22.4 24.4 26.4 28.6 9.29%

Total 49.6 55.4 61.8 68.8 76.5 84.8 93.8 103.6 114.2 125.6 137.9 151.2 10.55%
Source: BIS Research Analysis

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4.7.3 Product
Ta ble 7 6 : U.A.E. C om pa nio n Dia g nos tic s Ma rke t (by Tec hnolo gy) ,
$Mil lio n , 20 22 -2 033

CAGR
Technology 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 18.4 20.6 23.0 25.7 28.6 31.8 35.3 39.0 43.1 47.5 52.3 57.4 10.80%

NGS 9.3 10.5 12.0 13.5 15.3 17.2 19.4 21.8 24.4 27.3 30.5 34.0 12.43%

IHC 12.5 14.0 15.6 17.3 19.1 21.1 23.3 25.7 28.2 31.0 33.9 37.0 10.23%

ISH 7.9 8.7 9.5 10.4 11.3 12.3 13.4 14.5 15.7 16.9 18.3 19.7 8.55%

Others 1.5 1.6 1.8 2.0 2.1 2.3 2.5 2.6 2.7 2.9 3.0 3.0 6.29%

Total 49.6 55.4 61.8 68.8 76.5 84.8 93.8 103.6 114.2 125.6 137.9 151.2 10.55%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.7.4 South Africa Fi g ure 43 : S outh Afric a Com panio n Dia gnos ti cs Market,
$Mil lio n, 20 22 -2 033

98.0
88.7
80.2
72.4
65.2
58.6
52.5
47.0
42.0
37.5
33.4
29.6
Country Overview 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

The approaches adopted by companies to secure market access, encompassing pricing Source: BIS Research Analysis
strategies and collaborations with healthcare providers, influence the overall dynamics of the
market in South Africa.
Analyst View
Successful commercialization of companion diagnostics has been facilitated by effective
The South Africa companion diagnostics market was valued at $29.6 million in 2022 and is
market access strategies. Given that companion diagnostics often entail the analysis of
expected to reach $98.0 million by 2033, growing at a CAGR of 11.38% during the forecast

Global Companion Diagnostics Market

genetic and molecular data, adherence to data privacy regulations and the assurance of
period 2023-2033.
patient confidentiality are paramount. Companies operating in South Africa must align with
data protection laws and regulatory mandates. Engaging in partnerships with international organizations, research consortia, and industry
collaborations at the country level can foster the exchange of knowledge and resources,
playing a vital role in propelling advancements in companion diagnostics within South Africa.

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4.7.5 Application
Ta ble 7 7 : S outh Afric a Com panio n Dia gnos ti cs Mark et (b y
Applic at ion ) , $Million, 2 022 -203 3

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 11.3 12.8 14.4 16.2 18.3 20.5 23.0 25.7 28.7 31.9 35.5 39.4 11.94%

Breast Cancer 7.8 8.8 9.8 10.9 12.1 13.5 14.9 16.5 18.2 20.1 22.0 24.2 10.71%

Colorectal Cancer 5.4 6.1 6.8 7.7 8.6 9.6 10.8 12.0 13.4 14.8 16.5 18.2 11.65%

Leukemia 2.0 2.2 2.4 2.7 3.0 3.3 3.6 3.9 4.3 4.7 5.1 5.6 9.75%

Stomach 0.8 1.0 1.1 1.2 1.4 1.6 1.8 2.1 2.3 2.6 3.0 3.3 13.36%

Melanoma 0.5 0.5 0.6 0.6 0.7 0.8 0.8 0.9 1.0 1.0 1.1 1.2 7.91%

Others 1.9 2.1 2.4 2.7 3.0 3.3 3.7 4.1 4.5 5.0 5.5 6.1 11.25%

Total 29.6 33.4 37.5 42.0 47.0 52.5 58.6 65.2 72.4 80.2 88.7 98.0 11.38%
Source: BIS Research Analysis

Ta ble 7 8 : S outh Afric a Com panio n Dia gnos ti cs Mark et (b y E nd

User) , $Milli o n , 20 22-2 033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
11.8 13.2 14.8 16.6 18.6 20.7 23.1 25.6 28.4 31.4 34.7 38.3 11.22%
Biotechnology Companies
Reference Laboratories
12.6 14.2 16.1 18.1 20.4 22.9 25.6 28.7 32.0 35.7 39.6 44.0 11.94%
and Hospitals
Others 5.3 5.9 6.6 7.3 8.1 8.9 9.9 10.9 11.9 13.1 14.3 15.7 10.30%

Total 29.6 33.4 37.5 42.0 47.0 52.5 58.6 65.2 72.4 80.2 88.7 98.0 11.38%
Source: BIS Research Analysis

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4.7.6 Product
Ta ble 7 9 : S outh Afric a Com panio n Dia gnos ti cs Mark et (b y
Tec hnol ogy ), $Mill ion , 2 022 -203 3

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 10.1 11.5 13.0 14.6 16.4 18.5 20.7 23.1 25.8 28.8 32.0 35.6 11.98%

NGS 5.7 6.5 7.5 8.5 9.7 11.0 12.5 14.1 15.9 17.9 20.2 22.6 13.21%

IHC 7.3 8.2 9.2 10.3 11.5 12.7 14.1 15.7 17.3 19.1 21.0 23.1 10.88%

ISH 5.4 5.9 6.5 7.1 7.8 8.5 9.3 10.2 11.0 12.0 13.0 14.0 9.02%

Others 1.1 1.2 1.3 1.5 1.6 1.8 1.9 2.1 2.3 2.4 2.5 2.6 8.25%

Total 29.6 33.4 37.5 42.0 47.0 52.5 58.6 65.2 72.4 80.2 88.7 98.0 11.38%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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4.7.7 Rest-of-Middle East and Africa Fi g ure 44 : Res t -of -Middle East a nd Afri ca Com pa ni on
D iagnosti cs M arke t, $Mil lio n, 20 22 -2 033

100.8
91.9
83.7
76.1
69.0
62.5
56.5
50.9
45.8
41.2
36.9
33.0
Country Overview
The Rest-of-Middle East and Africa region includes emerging economies such as Oman,
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
Kenya, and the U.A.E., among others. Similar to various other regions, Rest-of-Middle East
and Africa has been placing growing emphasis on personalized medicine strategies. Source: BIS Research Analysis
Companion diagnostics assume a crucial role in customizing treatments for individual patients,
particularly within the realm of oncology. The identification of specific biomarkers has become
imperative in guiding targeted therapies for more effective and personalized patient care within Analyst View
the region. The Rest-of-Middle East and Africa companion diagnostics market was valued at $33.0 million
in 2022 and is expected to reach $100.8 million by 2033, growing at a CAGR of 10.58% during

Global Companion Diagnostics Market

the forecast period 2023-2033.

The aging population in Rest-of-Middle East and Africa is driving an increased demand for
precise diagnostics specifically tailored to address age-related health concerns, thereby
bolstering the companion diagnostics market. Additionally, the region has been experiencing
widespread adoption of advanced technologies such as next-generation sequencing,
contributing significantly to the growth of the companion diagnostics market.

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4.7.8 Application
Ta ble 8 0 : Res t -of -Mid dle E ast a nd Afri ca Com pa ni on Dia g nos ti cs
Mar ke t ( by Ap pli ca tio n ) , $Millio n, 202 2 -20 33

CAGR
Application 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

Lung Cancer 12.6 14.1 15.9 17.8 19.9 22.2 24.7 27.5 30.5 33.8 37.4 41.2 11.29%

Breast Cancer 8.6 9.5 10.5 11.5 12.7 13.9 15.2 16.6 18.2 19.8 21.5 23.3 9.39%

Colorectal Cancer 5.9 6.6 7.4 8.2 9.2 10.2 11.3 12.5 13.8 15.2 16.8 18.4 10.85%

Leukemia 1.9 2.1 2.3 2.5 2.8 3.0 3.3 3.6 3.9 4.3 4.7 5.0 9.27%

Stomach 0.8 0.9 1.1 1.2 1.4 1.6 1.8 2.1 2.4 2.7 3.0 3.4 13.71%

Melanoma 0.7 0.8 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 8.47%

Others 2.6 2.9 3.2 3.6 4.0 4.4 4.9 5.4 5.9 6.5 7.0 7.7 10.26%

Total 33.0 36.9 41.2 45.8 50.9 56.5 62.5 69.0 76.1 83.7 91.9 100.8 10.58%
Source: BIS Research Analysis

Ta ble 8 1 : Res t -of -Mid dle E ast a nd Afri ca Com pa ni on Dia g nos ti cs
Mar ke t ( by E nd Use r), $Millio n , 2 022 -2033

CAGR
End User 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033

Global Companion Diagnostics Market

(2023-2033)

Pharmaceutical and
12.4 13.8 15.3 17.0 18.8 20.8 22.9 25.2 27.6 30.2 33.1 36.1 10.08%
Biotechnology Companies
Reference Laboratories
13.8 15.6 17.6 19.9 22.4 25.1 28.1 31.5 35.1 39.1 43.5 48.3 11.95%
and Hospitals
Others 6.8 7.5 8.2 8.9 9.7 10.6 11.5 12.4 13.4 14.4 15.4 16.4 8.20%

Total 33.0 36.9 41.2 45.8 50.9 56.5 62.5 69.0 76.1 83.7 91.9 100.8 10.58%
Source: BIS Research Analysis

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4.7.9 Product
Ta ble 8 2 : Res t -of -Mid dle E ast a nd Afri ca Com pa ni on Dia g nos ti cs
Mar ke t ( by Tec hnolog y) , $Millio n , 202 2 -20 33

CAGR
Product Type 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
(2023-2033)

PCR 12.0 13.5 15.1 16.9 18.8 21.0 23.3 25.8 28.6 31.6 34.8 38.3 11.01%

NGS 6.3 7.2 8.2 9.3 10.5 11.9 13.4 15.1 16.9 19.0 21.2 23.7 12.63%

IHC 8.6 9.5 10.6 11.7 12.9 14.2 15.7 17.2 18.8 20.6 22.5 24.5 9.90%

ISH 5.1 5.6 6.1 6.6 7.2 7.8 8.4 9.1 9.8 10.6 11.4 12.2 8.18%

Others 1.0 1.1 1.2 1.3 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.1 6.72%

Total 33.0 36.9 41.2 45.8 50.9 56.5 62.5 69.0 76.1 83.7 91.9 100.8 10.58%
Source: BIS Research Analysis

Global Companion Diagnostics Market

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5. Markets - Competitive
Benchmarking & Company Profiles

Market

Global Companion Diagnostics Market

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5.1 Next Frontiers…..

3 person CT patients were diagnosed with patients were diagnosed with MDD, anxiety A double blinded CT trial of 3 2 people using
MDD, patients received treatment as usual, and disorder, and ma or depression with anxiety disorder. europharmagen P x text was conducted, which
patients received treatment with P x Patients with severe depression (HAMD 2 , n 0) howed significant improvements in HAM D
The patients showed significant clinical showed greater treatment response and remission scores at six week follow ups
improvements when HCPs used the P x test to relative to TAU (per HAM D at 2 week follow ups) Improvement was lost at the 2 week follow up
switch medication per test (p 0.002). using P x guided treatment. Patients with treatment guided by P x reported
The primary outcome of symptom improvements ignificant reductions in anxiety symptoms were greater perceived response to treatment than TAU
was not statistically significant. observed for all patients receiving P x testing (measured P I I scale)
A more recent CT (2022) also showed symptom relative to controls.
improvements, response, and remission rates, but
these differences were not statistically significant.

Global Companion Diagnostics Market

Source: BIS Research Analysis

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5.2 Geographic Assessment Fi g ure 46 : S ha re o f Stra te gic Ini tia tives , 20 21 -2 023

The following figure shows the leaders in different aspects of the companion diagnostics Total Number of Strategic Initiatives: 37
market:

ese r ers e ers

5.41%
Synergistic Activities
37.84% Product Launches and Approvals
ienti i n
ini ese r 56.76% Funding and Expansions

r s s ir nts Source: BIS Research Analysis

t e o er e e ti it n o tion

Source: BIS Research Analysis Analyst View

The companies operating in the global companion diagnostics market focused on product
Fi g ure 45 : S tr ate gic Ini tia tives , 2 02 1 -2023 launches and approvals the most during January 2021-December 2023.

▪ Agilent Technologies Inc., Thermo Fisher Scientific Inc., and Amoy Diagnostics Co., Ltd. are
Thermo Fisher Scientific Inc. 2 2 a few companies that have been highly active in undertaking strategic decisions within the
Abbott Laboratories 1 market.

Global Companion Diagnostics Market

Amoy Diagnostics Co., Ltd. 3 3
Agilent Technologies, Inc. 6 2 1
F. Hoffmann-La Roche Ltd 4
Illumina, Inc. 1 3
Invivoscribe Technologies, Inc. 1 1
Myriad Genetic Laboratories, Inc. 1 1
QIAGEN N.V. 2 2
Sysmex Corporation 1
Product Launches and Approvals Funding and Expansions Synergistic Activities

Source: BIS Research Analysis

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5.2.1 Abbott Laboratories 5.2.1.5 Key Personnel
5.2.1.1 Overview ▪ Robert B. Ford (Chief Executive Officer)
▪ Philip P. Boudreau (Vice President)
Abbott Laboratories is a healthcare giant that supports people in living better throughout their
lives. It offers a range of important technologies that cover different aspects of healthcare, ▪ Robert E. Funck, Jr. (Chief Financial Officer)
including tests, medical tools, nutrition, and generic medicines, with well-known brands.

5.2.1.6 Analyst View

Year of Establishment Company Type Company Financials ▪ The company's commitment to life-changing technologies positions it as a key player
1888 Public (2022)
in the industry. Abbott Laboratories’ emphasis on innovation and research has been
Headquarters No. of Employees Revenue: R&D Expenditure: evident in its cutting-edge diagnostics and medical devices.
U.S. 115,000 $43,653.0 Million $2,888.0 Million
▪ This focus not only contributes to the company's growth but also underscores its
Source: Abbott Laboratories Website and BIS Research Analysis
dedication to advancing healthcare solutions.

5.2.1.2 Top Products/Product Portfolio

▪ Vysis ALK Break Apart FISH Probe Kit
▪ Abbott RealTime IDH1

5.2.1.3 Top Competitors

▪ Danaher Corporation
▪ Illumina, Inc.
▪

Global Companion Diagnostics Market

Thermo Fisher Scientific Inc.
▪ Agilent Technologies, Inc.

5.2.1.4 Target Customers

▪ Diagnostic Laboratories
▪ Biopharmaceutical Industries

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5.2.2 Agilent Technologies, Inc. 5.2.2.5 Key Personnel
5.2.2.1 Overview ▪ Henrik Ancher-Jensen (Senior Vice President)
▪ Michael R. McMullen (Chief Executive Officer)
Agilent Technologies, Inc. is a global company that specializes in providing targeted solutions
for the life sciences, diagnostics, and applied chemical markets. Operating under three main ▪ Robert W. McMahon (Chief Financial Officer)
segments, namely, life sciences and applied markets, diagnostics and genomics, and Agilent
CrossLab, the company offers a diverse range of products and services.
5.2.2.6 Analyst View
▪ Agilent Technologies, Inc. provides instruments, services, applications,
Year of Establishment Company Type Company Financials consumables/kits, and expertise that help customers gain the insights they seek.
1999 Public (2023)
▪ The company is highly confident in its expertise and provides customers with solutions.
Headquarters No. of Employees Revenue: R&D Expenditure: ▪ Furthermore, the company’s expertise lies in six key markets, namely, environment
U.S. 18,100 $6,833 Million $481 Million
and forensics, chemical and energy, food, pharmaceutical, and research and
Source: Agilent Technologies, Inc. Website and BIS Research Analysis
diagnostics.

5.2.2.2 Top Products/Product Portfolio

▪ EGFR pharmDx
▪ PD-L1 IHC 22C3 pharmDx

5.2.2.3 Top Competitors

▪ Danaher Corporation

Global Companion Diagnostics Market

▪ Illumina, Inc.
▪ Thermo Fisher Scientific Inc.

5.2.2.4 Target Customers

▪ Diagnostic Centers
▪ Biopharmaceutical Industries

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5.2.3 Amoy Diagnostics Co., Ltd. 5.2.3.5 Key Personnel
5.2.3.1 Overview ▪ Li-Mou Zheng (Chairman)
▪ Ruan Li (Director)
Amoy Diagnostics Co., Ltd. focuses on providing diagnostic tools for cancer treatment using
advanced technology. The company uses different methods such as PCR, NGS, FISH, and
IHC to develop products such as single-gene testing kits, multi-gene testing panels, and
5.2.3.6 Analyst View
advanced NGS systems. Over the years, more than 20 diagnostic kits from AmoyDx have
been approved by Chinese authorities, the NMPA, and Europe (CE mark). ▪ The company helps many hospitals in China and around the world that focus on
treating cancer. It works with over 500 top hospitals in China and more than 50
countries globally.

Year of Establishment Company Type ▪ Each year, hundreds of thousands of people with cancer get help from the company’s
2008 Public products and services.

Headquarters No. of Employees

China ~5000 (as per LinkedIn)
Source: Amoy Diagnostics Co., Ltd. Website and BIS Research Analysis

5.2.3.2 Top Products/Product Portfolio

▪ AmoyDx ROS1 Kit
▪ AmoyDx Super-ARMS EGFR Mutation Detection Kit

Global Companion Diagnostics Market

5.2.3.3 Top Competitors
▪ Agilent Technologies, Inc.
▪ bioMérieux
▪ QIAGEN N.V.

5.2.3.4 Target Customers

▪ Biopharmaceutical Companies
▪ Diagnostic Laboratories

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5.2.4 bioMérieux 5.2.4.5 Key Personnel
5.2.4.1 Overview ▪ Akexandre Mérieux (Chairman and Chief Operating Officer)
▪ Bhargab Barua (Vice President Global Marketing Integrated Solutions)
bioMérieux manufactures tools that help identify the origin of diseases and contaminations.
The company provides different components such as machines, substances, computer ▪ Mélanie Pélissard (Product Sustainability Manager)
programs, and services to figure out the cause of diseases and contamination. Furthermore,
its tools are mostly used to identify and diagnose infectious diseases.
5.2.4.6 Analyst View
▪ bioMérieux focuses primarily on in-vitro diagnostics (IVD) using conventional
Year of Establishment Company Type Company Financials techniques such as immunoassays and microbiological culture.
1963 Public (2022)
▪ It operates in 45 countries and maintains its reach across 160 countries through a vast
Headquarters No. of Employees Revenue: R&D Expenditure:
$3,906.9 Million $484.4 Million
network of distributors.
France 13,800
Source: bioMérieux Website and BIS Research Analysis ▪ The company makes investments heavily in high medical value biomarkers through its
in-house R&D programs licensing, thus providing high dynamicity to the company's
ever-expanding portfolio.
5.2.4.2 Top Products
▪ THXID-BRAF

5.2.4.3 Top Competitors

▪ Illumina, Inc.
▪ Thermo Fisher Scientific
▪ Agilent Technologies

Global Companion Diagnostics Market

5.2.4.4 Target Customers
▪ Biopharmaceutical Companies
▪ Diagnostic Laboratories

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5.2.5 Danaher Corporation 5.2.5.5 Key Personnel
5.2.5.1 Overview ▪ Rainer M. Blair (Chief Executive Officer)
▪ Steven M. Railes (Chairman of the Board)
Danaher Corporation (Leica Biosystems) stands as a prominent global innovator in life
sciences and diagnostics, actively contributing to addressing some of the most critical health ▪ Joakim Weidemanis (Executive Vice President)
challenges worldwide. Its efforts have not only enhanced the quality of life for billions of people
but also established the groundwork for a healthier and more sustainable future.
5.2.5.6 Analyst View
▪ Danaher Corporation’s expertise in the development and distribution of antibodies,
Year of Establishment Company Type Company Financials reagents, and research tools positions it strongly in the companion diagnostics market.
1984 Public (2022)
▪ Its focus on innovative product development, combined with a robust e-commerce
Headquarters No. of Employees Revenue: R&D Expenditure: platform, enhances its ability to meet the diverse needs of researchers in the life
U.S. 130,000 $31,471.0 Million $1,745.0 Million sciences sector.
Source: Danaher Corporation Website and BIS Research Analysis

5.2.5.2 Top Products/Product Portfolio

▪ Bond Oracle HER2 IHC System

5.2.5.3 Top Competitors

▪ Abbott Laboratories
▪ Thermo Fisher Scientific Inc.

Global Companion Diagnostics Market

▪ F. Hoffmann-La Roche Ltd

5.2.5.4 Target Customers

▪ Biopharmaceutical Industries
▪ Diagnostic Laboratories
▪ Others

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5.2.6 DiaCarta 5.2.6.5 Key Personnel
5.2.6.1 Overview ▪ Aiguo Zhang, Ph.D. (President and Chief Executive Officer)
▪ Paul Okunieff, M.D. (Founder and Consultant)
DiaCarta is a company that focuses on translational genomics and personalized diagnostics.
It offers highly sensitive tools for detecting cancer, helping with diagnosis, identifying suitable
therapies, and monitoring how well treatments are working. The company's mission is to bring
5.2.6.6 Analyst View
advanced and highly sensitive technologies to the field of molecular diagnostics and
translational genomics. ▪ The company’s mission has been to enhance the lives of cancer patients by introducing
innovative precision diagnostics.
▪ The company is dedicated to delivering precise, dependable, and cost-effective
Year of Establishment Company Type diagnostic solutions that empower physicians to make well-informed decisions about
2012 Private treatment.

Headquarters No. of Employees

U.S. ~50 (as per LinkedIn)
Source: DiaCarta Website and BIS Research Analysis

5.2.6.2 Top Products/Product Portfolio

▪ Qclamp KRAS Mutation Detection Test
▪ OptiSeq Next-Generation Sequencing Platform

Global Companion Diagnostics Market

5.2.6.3 Top Competitors
▪ Danaher Corporation
▪ Agilent Technologies, Inc.

5.2.6.4 Target Customers

▪ Diagnostics Laboratories
▪ Pharmaceutical Industry

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5.2.7 F. Hoffmann-La Roche Ltd 5.2.7.5 Key Personnel
5.2.7.1 Overview ▪ Dr Severin Schwan (Chairman of the Board of Directors)
▪ André Hoffmann (Vice-Chairman of the Board of Directors)
The company is a global healthcare key player, majorly focusing on the development of
innovative diagnostic tests and medicines that can help patients get personalized treatment.
It operates majorly in two business segments, namely, pharmaceuticals and diagnostics,
5.2.7.6 Analyst View
focusing on advancing science to improve people’s lives.
▪ The company’s &D procedures are distinct. When working on internal projects, the
two sectors of the corporation might share research facilities, technologies, and
Year of Establishment Company Type Company Financials discoveries.
1896 Public (2022)
▪ This is a distinct advantage that distinguishes the company from its competitors. In

Headquarters No. of Employees Revenue: R&D Expenditure: pharmaceutical research, diagnostic tools are becoming increasingly popular.
Switzerland 103,613 $63,281 Million $16,023 Million
Source: F. Hoffmann-La Roche Ltd Website and BIS Research Analysis

5.2.7.2 Top Products/Product Portfolio

▪ INFORM HER2 Dual ISH DNA Probe Cocktail Assay
▪ cobas EGFR Mutation Test v2

5.2.7.3 Top Competitors

▪ QIAGEN N.V.

Global Companion Diagnostics Market

▪ Thermo Fisher Scientific Inc.
▪ Agilent Technologies, Inc.

5.2.7.4 Target Customers

▪ Diagnostics Laboratories
▪ Pharmaceutical Industry

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5.2.8 ICON plc 5.2.8.5 Key Personnel
5.2.8.1 Overview ▪ Dr. Steve Cutler (Chief Executive Officer)
▪ Mr. Brendan Brennan (Chief Financial Officer)
The company provides a comprehensive suite of consulting, development, and
commercialization services through a worldwide network of offices spanning 53 countries. Its
innovation is centered on key client needs, including speeding up time to market, cutting costs,
5.2.8.6 Analyst View
and enhancing quality. Furthermore, the company’s team of global experts brings extensive
experience across various therapeutic areas, ensuring its clients receive top-notch support in ▪ ICON offers services for molecular diagnostics in laboratories. These capabilities help
achieving their goals. create and promote precise medicines, especially in the field of cancer treatment.
▪ The company offers services to various organizations, including biopharmaceutical,
biotechnology, medical device, and government sectors.
Year of Establishment Company Type Company Financials
1990 Public (2022) ▪ The company has a strong global network in 40 countries across the globe

Headquarters No. of Employees Revenue:

Ireland ~41,100 $7,741.3 Million
Source: ICON plc Website and BIS Research Analysis

5.2.8.2 Top Products/Product Portfolio

▪ MRDx BCR-ABL Test

5.2.8.3 Top Competitors

▪ Thermo Fisher Scientific Inc.

Global Companion Diagnostics Market

▪ Agilent Technologies, Inc.

5.2.8.4 Target Customers

▪ Pharma and Biotech Companies
▪ Diagnostics Laboratories
▪ Others

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5.2.9 Illumina, Inc. 5.2.9.5 Key Personnel
5.2.9.1 Overview ▪ Francis A. deSouza (Chief Executive Officer)
▪ Joydeep Goswami (Chief Financial Officer)
Illumina, Inc. is renowned for its contributions to the field of companion diagnostics. The
company's technologies enable researchers to sequence and analyze biological data with
high accuracy and efficiency. Furthermore, the company’s platforms are widely used in various
5.2.9.6 Analyst View
applications, including genetic research, clinical diagnostics, and personalized medicine.
▪ The company is known for its next-generation sequencing (NGS) technologies,
providing researchers with powerful tools for genomic analysis.
Year of Establishment Company Type Company Financials ▪ Illumina has a significant global presence and is considered a key player in the
1998 Public (2022)
companion diagnostics and life sciences industries.

Headquarters No. of Employees Revenue: R&D Expenditure: ▪ The company's continuous efforts in rapid innovation and up-gradation of
U.S. 10,200 $4,584 Million $1,321 Million commercialized products to support clinical advances toward precision medicine, have
Source: Illumina, Inc. Website and BIS Research Analysis significantly positioned Illumina as a juggernaut in companion diagnsotics market.

5.2.9.2 Top Products/Product Portfolio

▪ Praxis Extended RAS Panel

5.2.9.3 Top Competitors

▪ Agilent Technologies, Inc.
▪ Danaher Corporation

Global Companion Diagnostics Market

▪ Thermo Fisher Scientific Inc.

5.2.9.4 Target Customers

▪ Clinical Laboratories
▪ Biopharmaceutical Companies
▪ Others

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5.2.10 Invivoscribe Technologies, Inc. 5.2.10.5 Key Personnel
5.2.10.1 Overview ▪ Jeffrey Edward Miller, Ph.D. (Chief Executive Officer)
▪ Meghna Bhatnagar (Chief Financial Officer)
The company is a key player committed to enhancing lives through precision diagnostics
worldwide. Furthermore, the company strives to improve healthcare quality by offering
innovative products and clinical services specifically tailored for oncology. Its streamlined CDx
5.2.10.6 Analyst View
(companion diagnostics) model speeds up the development of new therapies, allowing for
personalized approaches to patient care. ▪ The company’s products consistently exceed both industry and regulatory standards.
▪ They play a vital role in identifying, categorizing, and monitoring hematologic cancers.
▪ These products contribute to scientific progress and empower clinicians by providing
Year of Establishment Company Type the information needed to make well-informed treatment decisions.
1995 Private

Headquarters No. of Employees

U.S. ~500 (as per LinkedIn)
Source: Invivoscribe Technologies, Inc. Website and BIS Research Analysis

5.2.10.2 Top Products/Product Portfolio

▪ LeukoStrat CDx FLT3 Mutation Assay

5.2.10.3 Top Competitors

▪ Myriad Genetic Laboratories, Inc.

Global Companion Diagnostics Market

▪ Novogene Corporation.

5.2.10.4 Target Customers

▪ Biopharmaceutical Industries
▪ Diagnostic Centers

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5.2.11 Myriad Genetics, Inc. 5.2.11.5 Key Personnel
5.2.11.1 Overview ▪ Paul J. Diaz (President and Chief Executive Officer)
▪ Mark C. Capone (Chief Financial Officer)
Myriad Genetics is a prominent genetic testing and precision medicine company committed to
promoting health and well-being for everyone. The company specializes in developing and
providing genetic tests. These tests assist in evaluating the risk of developing diseases or the
5.2.11.6 Analyst View
progression of diseases, and they offer guidance for treatment decisions.
▪ The company’s mission is to enhance everyone's health and well-being. Furthermore,
the company empowers each individual by uncovering the answers that lie within.
Year of Establishment Company Type Company Financials ▪ Being a key player in genetic testing and precision medicine, the company offers
1991 Public (2022)
valuable insights that empower individuals to take control of their health.
Headquarters No. of Employees Revenue: R&D Expenditure:
U.S. ~2,600 $678.4 Million $85.4 Million

Source: Myriad Genetics, Inc. Website and BIS Research Analysis

5.2.11.2 Top Products/Product Portfolio

▪ BRACAnalysis CDx
▪ Myriad myChoice CDx

5.2.11.3 Top Competitors

▪ Novogene Corporation.
▪ ICON plc

Global Companion Diagnostics Market

▪ QIAGEN N.V.

5.2.11.4 Target Customers

▪ Diagnostic Centers
▪ Biopharmaceutical Companies

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5.2.12 Novogene Co, Ltd. 5.2.12.5 Key Personnel
5.2.12.1 Overview ▪ Dr. Ruiqiang Li (Chief Executive Officer)
▪ Douglas (Shifang) Zhang, PhD (President)
Novogene Co, Ltd. is a specialist in applying advanced molecular biotechnology and high-
performance computing in life sciences and human health research. The company’s aim is to
emerge as a global key player in offering genetic science services and technology products.
5.2.12.6 Analyst View
Furthermore, the company has experienced rapid growth, establishing sequencing labs
globally in Asia, America, and Europe. ▪ The company stands as a top provider of genomic services and solutions. It possesses
advanced next-generation sequencing (NGS) and bioinformatics expertise.
▪ The company boasts the world's largest sequencing capacity to deliver high-quality
Year of Establishment Company Type genomic services and advanced research in various scientific domains.
2011 Private

Headquarters No. of Employees

China ~5000 (as per LinkedIn)
Source: Novogene Co, Ltd. Website and BIS Research Analysis

5.2.12.2 Top Products/Product Portfolio

▪ NovoFocus NSCLC CDx Test
▪ NovoFocus PARPi CDx

5.2.12.3 Top Competitors

Global Companion Diagnostics Market

▪ Agilent Technologies, Inc.
▪ Abbott Laboratories
▪ QIAGEN N.V.

5.2.12.4 Target Customers

▪ Biopharmaceutical Industries
▪ Diagnostic Laboratories
▪ Others

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5.2.13 QIAGEN N.V. 5.2.13.5 Key Personnel
5.2.13.1 Overview ▪ Stephany Foster (Senior Vice President, Head of Global Human Resources)
▪ Thierry Bernard (Chief Executive Officer)
QIAGEN N.V., a biotechnology company, specializes in providing molecular testing solutions
for both human healthcare and life sciences. With a primary focus on serving industries ▪ Roland Sackers (Chief Financial Officer)
engaged in applied testing and molecular diagnostics, the company plays a significant role in ▪ Thomas Ebeling (Nomination and ESG)
advancing these fields.

5.2.13.6 Analyst View

Year of Establishment Company Type Company Financials
1896 Public (2022) ▪ QIAGEN N.V. is a leading player in the companion diagnostics market, providing
solutions that bridge diagnostics and pharmaceuticals. The company operates
Headquarters No. of Employees Revenue: R&D Expenditure:
$2,141.5 Million $189.0 Million
globally, offering a range of products and services in the life sciences and molecular
Germany 6,178
diagnostics sectors.
Source: QIAGEN N.V. Website and BIS Research Analysis
▪ In August 2023, QIAGEN N.V. announced the U.S. Food and Drug Administration
(FDA) approval of its therascreen PDGFRA RGQ PCR kit. This companion diagnostic
5.2.13.2 Top Products/Product Portfolio
is designed to assist clinicians in identifying patients with gastrointestinal stromal
▪ therascreen KRAS RGQ PCR Kit
tumors (GIST) who may be eligible for treatment with AYVAKIT (avapritinib).
▪ therascreen FGFR RGQ RT-PCR Kit

5.2.13.3 Top Competitors

▪ Agilent Technologies, Inc.
▪ Thermo Fisher Scientific Inc.

Global Companion Diagnostics Market

5.2.13.4 Target Customers
▪ Diagnostic Laboratories
▪ Biopharmaceutical Companies

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5.2.14 Sysmex Corporation 5.2.14.5 Key Personnel
5.2.14.1 Overview ▪ Kaoru Asano (President)
▪ Hisashi Ietsugu (Chief Executive Officer)
Sysmex Corporation is a top player in medical testing worldwide. The company has made
diagnostic testing a central part of its business and helps people in over 190 countries.
Furthermore, the company keeps coming up with new ideas for testing and works with others
5.2.14.6 Analyst View
to bring unique benefits in personalized medicine and new treatments.
▪ The company’s mission is to contribute to the advances in healthcare and human
health.
Year of Establishment Company Type Company Financials ▪ Furthermore, its focus has been on developing innovative and valuable testing and
1968 Public (2023)
diagnostic technologies.
Headquarters No. of Employees Revenue: ▪ These advancements aim to bring personalized medicine to the forefront, tailored
Japan ~10,001 $3,602.6 Million
specifically for individuals to optimize their health.
Source: Sysmex Corporation Website and BIS Research Analysis

5.2.14.2 Top Products/Product Portfolio

▪ OncoGuide NCC Oncopanel System

5.2.14.3 Top Competitors

▪ Thermo Fisher Scientific Inc.
▪ Agilent Technologies, Inc.
▪ Danaher Corporation

Global Companion Diagnostics Market

5.2.14.4 Target Customers
▪ Diagnostics Laboratories
▪ Biopharmaceutical Industries

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5.2.15 Thermo Fisher Scientific Inc. 5.2.15.5 Key Personnel
5.2.15.1 Overview ▪ Marc N. Casper (Chairman, President & Chief Executive Officer)
▪ Jennifer M. Johnson (Director)
Thermo Fisher Scientific Inc. is a manufacturer and producer of analytical systems, reagents,
software, services, and consumables for researching, manufacturing, discovering, analyzing,
and diagnosing variable samples. The company serves as a global key player in serving
5.2.15.6 Analyst View
science, offering products under several premier brands, including Thermo Scientific, Applied
Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services. ▪ The company has made numerous advancements in understanding the underlying
genomic alterations and biological pathways in companion diagnostics development
and progression.
Year of Establishment Company Type Company Financials ▪ In September 2022, the U.S. Food and Drug Administration (FDA) granted approval to
1956 Public (2022)
the company's Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in

Headquarters No. of Employees Revenue: R&D Expenditure: the selection of patients with RET-fusion-positive locally advanced or metastatic non-
U.S. 92,979 $44,915 Million $1,471 Million small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid
Source: Thermo Fisher Scientific Inc. Website and BIS Research Analysis cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer
(MTC), who may be eligible for treatment with Lilly’s etevmo (selpercatinib).
5.2.15.2 Top Products/Product Portfolio
▪ SPOT-LIGHT HER2 CISH Kit
▪ Oncomine Dx Target Test

5.2.15.3 Top Competitors

Global Companion Diagnostics Market

▪ QIAGEN N.V.
▪ Illumina, Inc.
▪ F. Hoffmann-La Roche Ltd

5.2.15.4 Target Customers

▪ Diagnostic Laboratories
▪ Biopharmaceutical Companies

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6. Research Methodology The key data points taken from secondary research include:
▪ segmentations and percentage shares
6.1 Data Sources ▪ data for market value
▪
6.1.1 Primary Data Sources key industry trends of the top players of the market
▪ qualitative insights into various aspects of the market, key trends, and emerging areas
The primary sources involve industry experts from the healthcare industry and various
of innovation
stakeholders such as companion diagnostics manufacturers and suppliers, hospitals, and
reference laboratories. Respondents such as CEOs, vice presidents, marketing directors, and ▪ quantitative data for mathematical and statistical calculations
technology and innovation directors have been interviewed to obtain and verify both qualitative
and quantitative aspects of this research study.
6.1.3 Data Triangulation
This research study involves the usage of extensive secondary sources, such as certified
The key data points taken from primary sources Include: publications, articles from recognized authors, white papers, annual reports of companies,
▪ validation and triangulation of all the numbers and graphs directories, and major databases to collect useful and effective information for an extensive,
▪ validation of reports segmentation and key qualitative findings technical, market-oriented, and commercial study of the global companion diagnostics market.

▪ understanding the competitive landscape The process of market engineering involves the calculation of the market statistics, market

▪ validation of the numbers of various markets for market type size estimation, market forecast, market crackdown, and data triangulation (the methodology
for such quantitative data processes is explained in further sections). The primary research
▪ percentage split of individual markets for geographical analysis
study has been undertaken to gather information and validate the market numbers for
segmentation types and industry trends of the key players in the market.

6.1.2 Secondary Data Sources

This research study involves the usage of extensive secondary research, directories, company

Global Companion Diagnostics Market

websites, and annual reports. It also makes use of databases, such as ITU, Hoovers,
Bloomberg, Businessweek, and Factiva, to collect useful and effective information for an
extensive, technical, market-oriented, and commercial study of the global market. In addition
to the aforementioned data sources, the study has been undertaken with the help of other
data sources and websites.

econdary research was done in order to obtain crucial information about the industry’s value
chain, revenue models, the market’s monetary chain, the total pool of key players, and the
current and potential use cases and applications.

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Fi g ure 47 : D ata Tri ang ula tio n

INFORMATION SOURCED
• Key Players
• Competitive Landscape
• Opportunities/Challenges
• Market Size and Market Share
• Influencing Factors
• Market Estimates
• Regional Analysis

SECONDARY SOURCES
• Annual Reports of Key
• Industrial Players
• SEC Filings
• 10K Reports
PRIMARY SOURCES
• Investor Presentations
INTERVIEWS WITH
• Companies Operating in the Companion Diagnostics Market • Industry Associations
DATA
• Companion Diagnostics Manufacturing Companies TRIANGULATION • Journals
• Press Releases

Global Companion Diagnostics Market

• R&D Experts of Various Companies
• Product Managers of Companies Operating in the Market • Analyst Presentations

• Sales Managers of Companies Operating in the Market • Paid and Unpaid Databases

Source: BIS Research Analysis

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6.2 Market Estimation and Forecast Factors for Data Prediction and Modelling
The section exhibits the standard assumptions and limitations followed throughout the
The main task for a thorough analysis of the global companion diagnostics market has been
research study named global companion diagnostics market:
to identify the set of underlying factors. In this case, the following figure exhibits the detailed
▪ The scope of this report has been focused on various types of companion diagnostics
methodology adopted for estimating and forecasting the global companion diagnostics
market: applications and technologies.
▪ The base currency considered for the market analysis is US$. Currencies other than
the US$ have been converted to the US$ for all statistical calculations, considering the
Fi g ure 48 : To p -Do wn a nd Bo ttom -Up A pp ro ac h
average conversion rate for that particular year.
▪ The currency conversion rate has been taken from the historical exchange rate of the
Global Companion Diagnostics Market Oanda website.

Global
▪ Nearly all the recent developments from January 2021 to December 2023 have been
Companion
Diagnostics Summation of Revenue by Each considered in this research study.
Market Technology
▪ The information rendered in the report is a result of in-depth primary interviews,
surveys, and secondary analysis.
Percentage Split by
Percentage Split of Application, End User, and
Application, End User, Technology ▪ Where relevant information was not available, proxy indicators and extrapolation were
and Technology
employed.

Geographical Splits
▪ Any economic downturn in the future has not been taken into consideration for the
Percentage Split of Regional
Market by Region market estimation and forecast.
and Country
▪ Technologies currently used are expected to persist through the forecast with no major

Percentage Split of Regional Market Sizes breakthroughs in technology.

into Countries

Global Companion Diagnostics Market

Source: BIS Research Analysis

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Fi g ure 49 : Assump tions and Li mi ta tio ns

CURRENCY CONVERSION LIMITATIONS

The base currency considered for this Technologies currently used are
study is US$. expected to persist through the forecast
In the company profiles section, the with no breakthrough in the technology.
revenues of companies in any other The economic downturn in future was
currency have been converted into US$. not taken under consideration for market
Currencies other than US$ have been estimation and forecast.
converted into US$ for all the statistical
calculations, considering the average
conversion rate for the particular year.
The currency conversion rate is taken
from historical exchange rate of Oanda
website.

AVERAGE SELLING PRICE (ASP) ASSUMPTIONS FOR MARKET

ESTIMATION
The ASP has been calculated for the
year 2022 and the currency considered The base year considered for the
for this study is US$. calculation of market size was 2022. In
For calculating the ASP of marketed instances where the market size of
products, the weighted average of the FY2022 was not available from primary
list price of products has been or secondary sources, the values were
considered. estimated based on the Delphi method.
The historical year analysis was done

Global Companion Diagnostics Market

from the FY2019 to FY2021, and the
market size was estimated for FY2022,
and projected from the year 2023 to
2033.

Source: BIS Research Analysis

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