Report Code : CVMI2312274 | Published Date : March 3, 2025
The global companion diagnostics (CDx) market is witnessing a significant transformation as precision medicine reshapes modern healthcare. Valued at USD 6.1 billion in 2023, the market is projected to reach USD 17.8 billion by 2031, growing at a 14.4% CAGR ClearView Market Insights, 2024. Three primary forces are driving this growth surge:
Precision Oncology at the Forefront
- FDA-approved CDx assays now support over 80% of targeted cancer therapies.
- Integration of next-generation sequencing (NGS)-based CDx is enabling pan-cancer applications.
- Liquid biopsy-based CDx platforms are gaining traction for real-time, non-invasive tumor profiling.
Pharma-Diagnostic Co-Development Models
- Co-development of drugs and diagnostics is accelerating therapy timelines and improving trial efficiency.
- Strategic alliances between pharma giants and diagnostics firms (e.g., Roche & Foundation Medicine) are becoming standard.
- Regulatory bodies are mandating CDx development alongside high-risk therapeutics in oncology and rare diseases.
Rising Demand in Non-Oncology Applications
- Expansion of CDx into autoimmune, cardiovascular, and infectious disease domains is diversifying growth.
- Pharmacogenomic CDx for drug metabolism prediction is gaining clinical relevance.
- Companion tests for Alzheimer’s and depression drugs are entering clinical development stages.
Product Innovation Deep Dive
Oncology-Focused Companion Diagnostics
NGS Panels for Solid Tumors
- Comprehensive genomic profiling panels approved for NSCLC, melanoma, and CRC.
- Pan-cancer biomarker detection for MSI, TMB, and NTRK fusions.
Liquid Biopsy Innovations
- ctDNA-based CDx tests enabling real-time treatment decisions.
- MRD (Minimal Residual Disease) monitoring becoming a companion strategy for hematologic malignancies.
Tumor Microenvironment Profiling
- PD-L1 expression and immune gene signatures used to guide checkpoint inhibitor therapies.
- Multiplex immunofluorescence platforms introduced to assess tumor-immune interaction.
Non-Oncology Expansion Areas
Cardiovascular CDx
- Genomic tests identifying responders to anti-thrombotic agents (e.g., clopidogrel).
- RNA-based tests predicting heart failure therapy efficacy.
Neurological Disorders
- CDx for amyloid-targeting Alzheimer’s therapies undergoing regulatory review.
- Development of polygenic risk score-based CDx for psychiatric medication response.
Infectious Disease Applications
- CDx tools stratifying patient response to antiviral therapies (e.g., HCV, HIV).
- Companion tests supporting vaccine development in RSV and influenza.
Industry-Specific Advancements
Pharma-CDx Integration
- Adaptive Trial Designs:
- Biomarker-enriched studies reducing R&D costs by up to 35%.
- Real-time molecular profiling enabling dynamic patient stratification.
- Labeling and Regulatory Alignment:
- Co-labeled drug-CDx products receiving simultaneous FDA and EMA approvals.
- Global harmonization of CDx standards across regulatory regions.
Clinical and Lab Advancements
Technology |
2024 Benchmark |
Commercialization |
Key Innovation |
Digital Pathology-CDx |
Adopted by 60% of US labs |
2025 |
AI-enhanced image analysis for biomarker quantification |
At-Home CDx Kits |
Pilot launches in EU |
2026 |
Patient-collected saliva tests for pharmacogenomic guidance |
AI-Powered CDx Engines |
Early-phase trials |
2027 |
ML-driven matching of patients to targeted therapies |
Competitive Landscape
Market Leaders
Company |
Specialization |
2024 Initiative |
Market Share |
Roche Diagnostics |
Oncology CDx |
Expansion of FoundationOne CDx for new indications |
22% |
Thermo Fisher |
NGS-Based CDx |
Launch of Oncomine Dx Express Test |
18% |
Qiagen |
PCR-Based CDx |
FDA approval for therascreen EGFR assay expansion |
14% |
Emerging Disruptors
- Guardant Health: Leading in liquid biopsy-based CDx platforms
- Grail: Multi-cancer early detection CDx using methylation patterns
- Strata Oncology: Precision oncology CDx integrated into EHR workflows
Future Outlook
2024–2026
- Rise of multi-analyte CDx panels combining DNA, RNA, and proteomic data
- Standardization of CDx integration into clinical decision support systems
2027–2029
- Real-time CDx monitoring enabled via smart wearables and biosensors
- Expansion of AI-trained CDx platforms in clinical oncology trials
2030+
- Genome-wide predictive CDx become integral to universal health screening
- CDx embedded in digital twins for hyper-personalized drug development and therapy selection
Reasons To Buy

Scope

Key Players
- Roche Diagnostics
- Agilent Technologies
- Thermo Fisher Scientific
- Abbott Laboratories
- Qiagen N.V.
Global Companion Diagnostics Market Report
- 1. Global Companion Diagnostics Market Research Report
- 1.1 Study Objectives
- 1.2 Global Companion Diagnostics Market - Overview
- 1.3 Reason to Read This Report
- 1.4 Methodology and Forecast Analysis
- 2.1 Global Companion Diagnostics Market Research Report – Detailed Scope and Definitions
- 2.1.1 By Type
- 2.1.2 By Application
- 2.1.3 By End-user
- 2.1.4 By Region
- 3.1. Drivers - Macro-Economic Based, Supply Side, and Demand Side Drivers
- 3.2. Restraints – By Type, By Application, By End-user, By Country
- 3.3. Opportunities – By Type, By Application, By End-user, By Country
- 3.4. Trends – By Type, By Application, By End-user, By Country
- 3.5. PEST Analysis
- 3.6. Porters Five Rule Analysis
- 3.7. Company’s Share Analysis (CSA) by Region or By Country
- 3.8. Global Companion Diagnostics Market Research Report – DROTs Impact Analysis
- 4.1. Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 4.2. Annual Market Trend Assessment – Year-on-Year (YoY) Growth Analysis (%)
- 4.3. Incremental Market Value/Volume Opportunity between 2019 - 2023 and 2024 - 2031
- 4.4. Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.1 Genetic Tests
- 5.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.2 Protein Biomarker Tests
- 5.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.3 Companion Drug Tests
- 5.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.1 Oncology
- 6.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.2 Neurology
- 6.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.3 Infectious Diseases
- 6.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.4 Cardiology
- 6.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.1 Hospitals
- 7.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.2 Clinics
- 7.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.3 Research Institutes.
- 7.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.1 North America
- 8.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.2 Europe
- 8.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.3 Asia-Pacific
- 8.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.4 Latin America
- 8.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.5 Middle East & Africa
- 8.5.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.5.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.5.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.5.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.6 Global Companion Diagnostics Market - Opportunity Analysis Index, By Type, By Application, By End-user, and Region, 2024 - 2031
- 9.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 9.1.1 Genetic Tests
- 9.1.2 Protein Biomarker Tests
- 9.1.3 Companion Drug Tests
- 9.2.1 Oncology
- 9.2.2 Neurology
- 9.2.3 Infectious Diseases
- 9.2.4 Cardiology
- 9.3.1 Hospitals
- 9.3.2 Clinics
- 9.3.3 Research Institutes.
- 9.4.1 United States
- 9.4.2 Canada
9.6 Regional Trends Analysis
9.7 North America Global Companion Diagnostics Market Research Report - Company Profiles- 9.7.1 Company 1 (United States)
- 9.7.2 Company 2 (Canada)
- 9.7.3 Company 3 (Canada)
- 10.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 10.1.1 Genetic Tests
- 10.1.2 Protein Biomarker Tests
- 10.1.3 Companion Drug Tests
- 10.2.1 Oncology
- 10.2.2 Neurology
- 10.2.3 Infectious Diseases
- 10.2.4 Cardiology
- 10.3.1 Hospitals
- 10.3.2 Clinics
- 10.3.3 Research Institutes.
- 10.4.1 Germany
- 10.4.2 United Kingdom
- 10.4.3 France
- 10.4.4 Spain
- 10.4.5 Italy
- 10.4.6 Russia
- 10.4.7 Netherlands
- 10.4.8 Poland
- 10.4.9 Rest of Europe
10.6 Regional Trends Analysis
10.7 Europe Global Companion Diagnostics Market Research Report - Company Profiles- 10.7.1 Company 1 (Germany)
- 10.7.2 Company 2 (United Kingdom)
- 10.7.3 Company 3 (United Kingdom)
- 11.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 11.1.1 Genetic Tests
- 11.1.2 Protein Biomarker Tests
- 11.1.3 Companion Drug Tests
- 11.2.1 Oncology
- 11.2.2 Neurology
- 11.2.3 Infectious Diseases
- 11.2.4 Cardiology
- 11.3.1 Hospitals
- 11.3.2 Clinics
- 11.3.3 Research Institutes.
- 11.4.1 China
- 11.4.2 Japan
- 11.4.3 India
- 11.4.4 South Korea
- 11.4.5 Australia & NZ
- 11.4.6 ASEAN
- 11.4.7 Rest of Asia-Pacific
11.6 Regional Trends Analysis
11.7 Asia-Pacific Global Companion Diagnostics Market Research Report - Company Profiles- 11.7.1 Company 1 (China)
- 11.7.2 Company 2 (Japan)
- 11.7.3 Company 3 (Japan)
- 12.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 12.1.1 Genetic Tests
- 12.1.2 Protein Biomarker Tests
- 12.1.3 Companion Drug Tests
- 12.2.1 Oncology
- 12.2.2 Neurology
- 12.2.3 Infectious Diseases
- 12.2.4 Cardiology
- 12.3.1 Hospitals
- 12.3.2 Clinics
- 12.3.3 Research Institutes.
- 12.4.1 Brazil
- 12.4.2 Mexico
- 12.4.3 Argentina
- 12.4.4 Peru
- 12.4.5 Colombia
- 12.4.6 Rest of Latin America
12.6 Regional Trends Analysis
12.7 Latin America Global Companion Diagnostics Market Research Report - Company Profiles- 12.7.1 Company 1 (Brazil)
- 12.7.2 Company 2 (Mexico)
- 12.7.3 Company 3 (Mexico)
- 13.1 By Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 13.1.1 Genetic Tests
- 13.1.2 Protein Biomarker Tests
- 13.1.3 Companion Drug Tests
- 13.2.1 Oncology
- 13.2.2 Neurology
- 13.2.3 Infectious Diseases
- 13.2.4 Cardiology
- 13.3.1 Hospitals
- 13.3.2 Clinics
- 13.3.3 Research Institutes.
- 13.4.1 Saudi Arabia
- 13.4.2 UAE
- 13.4.3 South Africa
- 13.4.4 Egypt
- 13.4.5 Israel
- 13.4.6 Rest of Middle East and Africa
13.6 Regional Trends Analysis
13.7 Middle East & Africa Global Companion Diagnostics Market Research Report - Company Profiles- 13.7.1 Company 1 (Saudi Arabia)
- 13.7.2 Company 2 (UAE)
- 13.7.3 Company 3 (UAE)
- 14.1 Strategic Dashboard of Top Market Players
14.2 Company Profiles (Introduction, Financial Assessments, Portfolio of Offerings, Milestones and Achievements, Strategic Initiative, and SWOT Analysis)- 14.2.1 Roche Diagnostics
- 14.2.2 Agilent Technologies
- 14.2.3 Thermo Fisher Scientific
- 14.2.4 Abbott Laboratories
- 14.2.5 Qiagen N.V.
16. Principal Presumptions and Acronyms