Global Companion Diagnostic Tests Market Report (2025–2036)
Market Overview
The global companion diagnostic tests market was valued at USD xxxx million in 2025 and is projected to reach USD xxxx million by 2036, growing at a CAGR of xx%. Companion diagnostics are critical tools that enable personalized medicine by identifying patients most likely to benefit from specific therapies. They are widely used in oncology, infectious diseases, and rare genetic disorders. Rising demand for precision medicine, regulatory support, and technological advancements in molecular diagnostics are driving market growth.
Impact of COVID-19
The pandemic disrupted clinical trials and diagnostic services in 2020, slowing adoption in some areas. However, COVID-19 accelerated demand for molecular diagnostics and biomarker-based testing, indirectly boosting companion diagnostics. Post-pandemic, investments in precision medicine and digital health platforms have strengthened the role of companion diagnostics in healthcare.
Market Segmentation
By Type
- Protein Detection – immunohistochemistry and ELISA-based assays.
- DNA Detection – PCR, next-generation sequencing (NGS), and microarrays.
- Hybridization – fluorescence in situ hybridization (FISH) and related technologies.
- Biomarker-Based Tests – predictive and prognostic biomarker assays.
- Others – RNA-based assays and multiplex diagnostics.
By Application
- Pharmaceutical and Biotechnology Companies – drug development and clinical trials.
- Medical Device Companies – integration of diagnostics with therapeutic devices.
- Research Institutes – academic and translational research in personalized medicine.
- Hospitals & Clinics – patient stratification and treatment monitoring.
Regional Analysis
- North America: Largest market; driven by strong regulatory frameworks, advanced healthcare infrastructure, and leading biopharma companies.
- Europe: Significant growth; Germany, U.K., and France lead adoption with rare disease initiatives and oncology-focused programs.
- Asia-Pacific: Fastest-growing region; China, India, and Japan expanding molecular diagnostics and investing in precision medicine.
- South America: Brazil and Argentina showing growth in oncology diagnostics and clinical trial participation.
- Middle East & Africa: Emerging demand; increasing investments in healthcare infrastructure and rare disease awareness campaigns.
Key Players
- Hoffmann-La Roche Ltd.
· QIAGEN
· Illumina Inc.
· Abbott Laboratories
· Agilent Technologies Inc.
· Genomic Health Inc.
· bioMérieux
· BioGenex
· Agendia NV
· Siemens Healthineers GmbH
· Thermo Fisher Scientific Inc.
Additional Players:
- Danaher Corporation (U.S.)
- Myriad Genetics (U.S.)
- Foundation Medicine (U.S.)
- Guardant Health (U.S.)
- Exact Sciences Corporation (U.S.)
- ArcherDX (U.S.)
- Invitae Corporation (U.S.)
- Sysmex Corporation (Japan)
- Becton, Dickinson and Company (U.S.)
- NanoString Technologies (U.S.)
Porter’s Five Forces
- Threat of New Entrants – Moderate; requires high R&D investment and regulatory approvals.
- Bargaining Power of Suppliers – Moderate; specialized reagents and sequencing platforms influence costs.
- Bargaining Power of Buyers – High; hospitals and pharma companies demand cost-effective, accurate diagnostics.
- Threat of Substitutes – Low; companion diagnostics are integral to precision medicine.
- Industry Rivalry – High; global players compete on innovation, partnerships, and regulatory compliance.
SWOT Analysis
Strengths:
- Essential role in personalized medicine
- Strong presence of global diagnostic leaders
- Expanding oncology applications
Weaknesses:
- High costs of advanced molecular diagnostics
- Dependence on regulatory approvals
- Limited adoption in low-income regions
Opportunities:
- Growth in NGS-based companion diagnostics
- Expansion in Asia-Pacific and Middle East markets
- Rising demand for biomarker discovery and validation
Threats:
- Regulatory hurdles for new diagnostic technologies
- Competition from alternative diagnostic methods
- Supply chain vulnerabilities
Trend Analysis
- NGS Integration: Increasing use of sequencing for biomarker discovery.
- Liquid Biopsy: Rising adoption for non-invasive cancer diagnostics.
- Digital Health Platforms: AI-driven diagnostics improving patient stratification.
- Global Collaborations: Pharma-diagnostic partnerships accelerating drug development.
- Multiplex Assays: Growth in multi-biomarker testing for complex diseases.
Drivers & Challenges
Drivers:
- Rising prevalence of cancer and rare genetic disorders
- Increasing demand for precision medicine
- Technological advancements in molecular diagnostics
- Expansion of healthcare infrastructure in emerging markets
Challenges:
- High costs of companion diagnostics
- Regulatory complexity across regions
- Limited awareness in developing countries
- Integration challenges with therapeutic pipelines
Value Chain Analysis
- Raw Materials: Reagents, consumables, and sequencing platforms.
- Manufacturing: Development of assays, kits, and diagnostic devices.
- Distribution: Hospitals, diagnostic labs, pharma companies, and CROs.
- End Users: Patients, healthcare providers, and research institutions.
- After-Sales Services: Technical support, assay optimization, and training.
Quick Recommendations for Stakeholders
- Manufacturers: Invest in NGS and liquid biopsy-based companion diagnostics.
- Healthcare Providers: Expand adoption of biomarker-driven patient stratification.
- Policy Makers: Strengthen regulatory frameworks and reimbursement policies.
- Investors: Focus on Asia-Pacific and Europe for high-growth opportunities.
- Research Institutions: Collaborate with pharma companies to accelerate biomarker innovation.
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1. Market Overview of Companion Diagnostic Tests
1.1 Companion Diagnostic Tests Market Overview
1.1.1 Companion Diagnostic Tests Product Scope
1.1.2 Market Status and Outlook
1.2 Companion Diagnostic Tests Market Size by Regions: 2015 VS 2021 VS 2026
1.3 Companion Diagnostic Tests Historic Market Size by Regions
1.4 Companion Diagnostic Tests Forecasted Market Size by Regions
1.5 Covid-19 Impact on Key Regions, Keyword Market Size YoY Growth
1.5.1 North America
1.5.2 East Asia
1.5.3 Europe
1.5.4 South Asia
1.5.5 Southeast Asia
1.5.6 Middle East
1.5.7 Africa
1.5.8 Oceania
1.5.9 South America
1.5.10 Rest of the World
1.6 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth
1.6.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections
1.6.2 Covid-19 Impact: Commodity Prices Indices
1.6.3 Covid-19 Impact: Global Major Government Policy
2. Covid-19 Impact Companion Diagnostic Tests Sales Market by Type
2.1 Global Companion Diagnostic Tests Historic Market Size by Type
2.2 Global Companion Diagnostic Tests Forecasted Market Size by Type
2.3 Protein Detection
2.4 DNA Detection
2.5 Hybridization
2.6 Biomarker
2.7 Others
3. Covid-19 Impact Companion Diagnostic Tests Sales Market by Application
3.1 Global Companion Diagnostic Tests Historic Market Size by Application
3.2 Global Companion Diagnostic Tests Forecasted Market Size by Application
3.3 Pharmaceutical and Biotechnology Companies
3.4 Medical Device Companies
3.5 Research Institutes
4. Covid-19 Impact Market Competition by Manufacturers
4.1 Global Companion Diagnostic Tests Production Capacity Market Share by Manufacturers
4.2 Global Companion Diagnostic Tests Revenue Market Share by Manufacturers
4.3 Global Companion Diagnostic Tests Average Price by Manufacturers
5. Company Profiles and Key Figures in Companion Diagnostic Tests Business
5.1 F. Hoffman LA Roche Ltd.
5.1.1 F. Hoffman LA Roche Ltd. Company Profile
5.1.2 F. Hoffman LA Roche Ltd. Companion Diagnostic Tests Product Specification
5.1.3 F. Hoffman LA Roche Ltd. Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.2 QIAGEN
5.2.1 QIAGEN Company Profile
5.2.2 QIAGEN Companion Diagnostic Tests Product Specification
5.2.3 QIAGEN Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.3 Illumina
5.3.1 Illumina Company Profile
5.3.2 Illumina Companion Diagnostic Tests Product Specification
5.3.3 Illumina Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.4 Inc.
5.4.1 Inc. Company Profile
5.4.2 Inc. Companion Diagnostic Tests Product Specification
5.4.3 Inc. Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.5 Abbott
5.5.1 Abbott Company Profile
5.5.2 Abbott Companion Diagnostic Tests Product Specification
5.5.3 Abbott Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.6 Agilent Technologies
5.6.1 Agilent Technologies Company Profile
5.6.2 Agilent Technologies Companion Diagnostic Tests Product Specification
5.6.3 Agilent Technologies Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.7 Inc.
5.7.1 Inc. Company Profile
5.7.2 Inc. Companion Diagnostic Tests Product Specification
5.7.3 Inc. Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.8 Genomic Health
5.8.1 Genomic Health Company Profile
5.8.2 Genomic Health Companion Diagnostic Tests Product Specification
5.8.3 Genomic Health Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.9 Inc.
5.9.1 Inc. Company Profile
5.9.2 Inc. Companion Diagnostic Tests Product Specification
5.9.3 Inc. Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.10 Biomerieux
5.10.1 Biomerieux Company Profile
5.10.2 Biomerieux Companion Diagnostic Tests Product Specification
5.10.3 Biomerieux Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.11 BioGenex
5.11.1 BioGenex Company Profile
5.11.2 BioGenex Companion Diagnostic Tests Product Specification
5.11.3 BioGenex Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.12 AGENDIA NV
5.12.1 AGENDIA NV Company Profile
5.12.2 AGENDIA NV Companion Diagnostic Tests Product Specification
5.12.3 AGENDIA NV Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.13 Siemens Healthcare GmBH
5.13.1 Siemens Healthcare GmBH Company Profile
5.13.2 Siemens Healthcare GmBH Companion Diagnostic Tests Product Specification
5.13.3 Siemens Healthcare GmBH Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.14 Thermo Fisher Scientific
5.14.1 Thermo Fisher Scientific Company Profile
5.14.2 Thermo Fisher Scientific Companion Diagnostic Tests Product Specification
5.14.3 Thermo Fisher Scientific Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
5.15 Inc.
5.15.1 Inc. Company Profile
5.15.2 Inc. Companion Diagnostic Tests Product Specification
5.15.3 Inc. Companion Diagnostic Tests Production Capacity, Revenue, Price and Gross Margin
6. North America
6.1 North America Companion Diagnostic Tests Market Size
6.2 North America Companion Diagnostic Tests Key Players in North America
6.3 North America Companion Diagnostic Tests Market Size by Type
6.4 North America Companion Diagnostic Tests Market Size by Application
7. East Asia
7.1 East Asia Companion Diagnostic Tests Market Size
7.2 East Asia Companion Diagnostic Tests Key Players in North America
7.3 East Asia Companion Diagnostic Tests Market Size by Type
7.4 East Asia Companion Diagnostic Tests Market Size by Application
8. Europe
8.1 Europe Companion Diagnostic Tests Market Size
8.2 Europe Companion Diagnostic Tests Key Players in North America
8.3 Europe Companion Diagnostic Tests Market Size by Type
8.4 Europe Companion Diagnostic Tests Market Size by Application
9. South Asia
9.1 South Asia Companion Diagnostic Tests Market Size
9.2 South Asia Companion Diagnostic Tests Key Players in North America
9.3 South Asia Companion Diagnostic Tests Market Size by Type
9.4 South Asia Companion Diagnostic Tests Market Size by Application
10. Southeast Asia
10.1 Southeast Asia Companion Diagnostic Tests Market Size
10.2 Southeast Asia Companion Diagnostic Tests Key Players in North America
10.3 Southeast Asia Companion Diagnostic Tests Market Size by Type
10.4 Southeast Asia Companion Diagnostic Tests Market Size by Application
11. Middle East
11.1 Middle East Companion Diagnostic Tests Market Size
11.2 Middle East Companion Diagnostic Tests Key Players in North America
11.3 Middle East Companion Diagnostic Tests Market Size by Type
11.4 Middle East Companion Diagnostic Tests Market Size by Application
12. Africa
12.1 Africa Companion Diagnostic Tests Market Size
12.2 Africa Companion Diagnostic Tests Key Players in North America
12.3 Africa Companion Diagnostic Tests Market Size by Type
12.4 Africa Companion Diagnostic Tests Market Size by Application
13. Oceania
13.1 Oceania Companion Diagnostic Tests Market Size
13.2 Oceania Companion Diagnostic Tests Key Players in North America
13.3 Oceania Companion Diagnostic Tests Market Size by Type
13.4 Oceania Companion Diagnostic Tests Market Size by Application
14. South America
14.1 South America Companion Diagnostic Tests Market Size
14.2 South America Companion Diagnostic Tests Key Players in North America
14.3 South America Companion Diagnostic Tests Market Size by Type
14.4 South America Companion Diagnostic Tests Market Size by Application
15. Rest of the World
15.1 Rest of the World Companion Diagnostic Tests Market Size
15.2 Rest of the World Companion Diagnostic Tests Key Players in North America
15.3 Rest of the World Companion Diagnostic Tests Market Size by Type
15.4 Rest of the World Companion Diagnostic Tests Market Size by Application
16 Companion Diagnostic Tests Market Dynamics
16.1 Covid-19 Impact Market Top Trends
16.2 Covid-19 Impact Market Drivers
16.3 Covid-19 Impact Market Challenges
16.4 Porter
Market Segmentation
By Type
- Protein Detection – immunohistochemistry and ELISA-based assays.
- DNA Detection – PCR, next-generation sequencing (NGS), and microarrays.
- Hybridization – fluorescence in situ hybridization (FISH) and related technologies.
- Biomarker-Based Tests – predictive and prognostic biomarker assays.
- Others – RNA-based assays and multiplex diagnostics.
By Application
- Pharmaceutical and Biotechnology Companies – drug development and clinical trials.
- Medical Device Companies – integration of diagnostics with therapeutic devices.
- Research Institutes – academic and translational research in personalized medicine.
- Hospitals & Clinics – patient stratification and treatment monitoring.
Regional Analysis
- North America: Largest market; driven by strong regulatory frameworks, advanced healthcare infrastructure, and leading biopharma companies.
- Europe: Significant growth; Germany, U.K., and France lead adoption with rare disease initiatives and oncology-focused programs.
- Asia-Pacific: Fastest-growing region; China, India, and Japan expanding molecular diagnostics and investing in precision medicine.
- South America: Brazil and Argentina showing growth in oncology diagnostics and clinical trial participation.
- Middle East & Africa: Emerging demand; increasing investments in healthcare infrastructure and rare disease awareness campaigns.
Key Players
- Hoffmann-La Roche Ltd.
· QIAGEN
· Illumina Inc.
· Abbott Laboratories
· Agilent Technologies Inc.
· Genomic Health Inc.
· bioMérieux
· BioGenex
· Agendia NV
· Siemens Healthineers GmbH
· Thermo Fisher Scientific Inc.
