"The Global Companion Diagnostics Oncology Market was valued at USD 4.58 billion in 2025 and is projected to reach USD 12.31 billion by 2034, growing at a CAGR of 11.61%."
The Companion Diagnostics Oncology Market is a critical and evolving segment within precision medicine, focused on diagnostic tests that identify specific genetic mutations, biomarkers, or protein expressions to guide the use of targeted cancer therapies. These diagnostics enable the stratification of patients based on their likelihood of response to a particular drug, thereby enhancing treatment efficacy, minimizing adverse effects, and improving overall outcomes. The growing importance of personalized cancer care, coupled with the rise of targeted therapies and immunotherapies, is accelerating the demand for companion diagnostics. These tests are often developed in parallel with oncology drugs under co-development models between diagnostic firms and pharmaceutical companies, gaining regulatory approval alongside therapeutic agents for indications such as non-small cell lung cancer, breast cancer, and colorectal cancer.
Market expansion is supported by technological advancements in next-generation sequencing, digital PCR, and liquid biopsy platforms that offer non-invasive and highly specific biomarker analysis. Regulatory agencies are increasingly emphasizing the need for companion diagnostics as prerequisites for approval of certain cancer therapies, reinforcing their clinical value. As oncology care shifts toward biomarker-driven protocols, payers and providers are adopting companion diagnostics to improve clinical outcomes and optimize healthcare spending. With strong investments in translational research, molecular diagnostics infrastructure, and strategic partnerships, the companion diagnostics oncology market is poised for sustained growth across major therapeutic categories and global regions.
North America Companion Diagnostics Oncology MarketThe North American companion diagnostics oncology market is driven by advanced genomic infrastructure, high adoption of precision therapies, and a supportive regulatory environment. The U.S. leads with a robust pipeline of targeted oncology drugs approved alongside FDA-designated companion diagnostics. Increasing incidence of cancers such as NSCLC, breast, and colorectal is pushing demand for molecular-based stratification tools. Healthcare systems and insurers are endorsing biomarker-guided therapies, which is fostering investment in next-generation sequencing and liquid biopsy technologies. Strategic collaborations between pharmaceutical companies and diagnostic developers are accelerating co-development programs. Academic research centers and biopharma innovation hubs are also propelling clinical adoption, making North America a hub for high-value diagnostic and therapeutic integration in oncology care.
Asia Pacific Companion Diagnostics Oncology MarketAsia Pacific is emerging as a high-growth region for companion diagnostics in oncology, fueled by rising cancer burden, healthcare modernization, and increasing access to molecular testing. Countries like China, Japan, South Korea, and India are investing in biomarker research, digital pathology, and genomic medicine infrastructure. Government-led oncology programs and regulatory updates are encouraging local validation of companion diagnostics, while global pharmaceutical companies are forming regional alliances for drug-diagnostic co-launches. The growing presence of clinical laboratories offering targeted testing and the demand for non-invasive diagnostics such as liquid biopsies are opening new avenues. In addition, the region's large patient pool and expanding biopharma manufacturing base provide opportunities for localized innovation and scalable implementation of precision oncology solutions.
Europe Companion Diagnostics Oncology MarketEurope’s companion diagnostics oncology market is characterized by established clinical guidelines, collaborative research ecosystems, and integration of precision diagnostics into national cancer plans. Regulatory authorities such as EMA are mandating biomarker-driven treatment pathways, supporting co-approval of targeted drugs with CE-marked companion tests. The region has seen rising clinical adoption of multi-biomarker assays in advanced cancers, supported by academic institutions and hospital networks with in-house molecular diagnostics capabilities. Trends include increasing use of multiplex panels, real-world data analytics, and integration of AI in result interpretation. With growing emphasis on early detection, minimal residual disease monitoring, and personalized treatment selection, Europe offers a fertile ground for diagnostic companies aiming to expand precision oncology offerings through scalable, evidence-backed solutions.
Key Insights
Companion diagnostics play a central role in precision oncology by enabling patient selection based on specific biomarkers, ensuring targeted therapies are prescribed only to those likely to benefit from them, thereby improving treatment efficacy and reducing unnecessary side effects.
The increasing approval of targeted cancer therapies is driving parallel demand for associated companion diagnostics, especially in areas such as lung, breast, colorectal, and melanoma cancers where biomarker-driven treatment protocols are becoming the standard of care.
Next-generation sequencing (NGS) is transforming the companion diagnostics landscape by allowing simultaneous analysis of multiple mutations and biomarkers in a single test, improving diagnostic efficiency and facilitating multi-target drug development strategies.
Liquid biopsies are emerging as a preferred non-invasive alternative to tissue biopsies for companion diagnostics, offering real-time monitoring of tumor mutations and enabling dynamic treatment adjustments in oncology care pathways.
Collaborations between diagnostic companies and pharmaceutical firms are accelerating co-development of diagnostic-drug pairs, with regulatory agencies increasingly requiring biomarker validation before approval of precision oncology drugs.
Artificial intelligence and data analytics are being integrated into companion diagnostics to support biomarker discovery, predictive modeling, and automated interpretation of complex genomic datasets for improved clinical decision-making.
Regulatory frameworks in the U.S., EU, and Japan are evolving to support faster review and approval of companion diagnostics alongside their corresponding therapies, encouraging investment in personalized oncology solutions.
Healthcare systems and payers are recognizing the cost-effectiveness of companion diagnostics in oncology, as they reduce trial-and-error treatments and facilitate early detection of resistance or disease progression through molecular profiling.
Major industry players are expanding their portfolios with multi-gene panels, CE-IVD and FDA-cleared tests, and integrated platforms that combine diagnostics, data analytics, and reporting for use in hospitals, labs, and oncology networks.
Emerging markets are gradually adopting companion diagnostics driven by the expansion of molecular pathology infrastructure, government-led cancer programs, and access to innovative targeted therapies through global pharma collaborations.
Market Scope
| Parameter | Detail |
|---|---|
| Base Year | 2024 |
| Estimated Year | 2025 |
| Forecast Period | 2026-2034 |
| Market Size-Units | USD billion |
| Market Splits Covered | By Product Type , By Application , By End User , By Technology , By Distribution Channel |
| Countries Covered | North America (USA, Canada, Mexico) Europe (Germany, UK, France, Spain, Italy, Rest of Europe) Asia-Pacific (China, India, Japan, Australia, Rest of APAC) The Middle East and Africa (Middle East, Africa) South and Central America (Brazil, Argentina, Rest of SCA) |
| Analysis Covered | Latest Trends, Driving Factors, Challenges, Supply-Chain Analysis, Competitive Landscape, Company Strategies |
| Customization | 10 % free customization (up to 10 analyst hours) to modify segments, geographies, and companies analyzed |
| Post-Sale Support | 4 analyst hours, available up to 4 weeks |
| Delivery Format | The Latest Updated PDF and Excel Datafile |
Companion Diagnostics Oncology Market Segmentation
By Product Type
- Biomarkers
- Test Kits
- Software
By Application
- Breast Cancer
- Lung Cancer
- Colorectal Cancer
- Hematologic Malignancies
By End User
- Hospitals
- Diagnostic Laboratories
- Research Institutes
By Technology
- PCR
- NGS
- IHC
By Distribution Channel
- Direct Sales
- Distributors
- E-commerce
By Geography
- North America (USA, Canada, Mexico)
- Europe (Germany, UK, France, Spain, Italy, Rest of Europe)
- Asia-Pacific (China, India, Japan, Australia, Vietnam, Rest of APAC)
- The Middle East and Africa (Middle East, Africa)
- South and Central America (Brazil, Argentina, Rest of SCA)
Key Companies Covered
F. Hoffmann‑La Roche Ltd., Agilent Technologies Inc., Illumina Inc., QIAGEN N.V., Thermo Fisher Scientific Inc., Foundation Medicine Inc., Myriad Genetics Inc., BioMérieux SA, Abbott Laboratories, Leica Biosystems, Guardant Health Inc., EntroGen Inc., ARUP Laboratories, Eurofins Scientific, Danaher Corporation, Exact Sciences Corporation, Natera, Inc.Recent Developments
July 2025: The FDA approved the Oncomine Dx Express Test as a companion diagnostic for sunvozertinib in EGFR exon 20 insertion–positive NSCLC, enabling decentralized NGS tumor profiling and 24-hour result turnaround.
May 2025: Roche received FDA approval for its VENTANA MET (SP44) RxDx Assay, marking the first companion diagnostic to identify MET protein overexpression in non-squamous NSCLC and guide treatment with telisotuzumab vedotin.
April 2025: Roche was granted Breakthrough Device Designation by the FDA for its VENTANA TROP2 (EPR20043) RxDx computational pathology platform, the first AI-driven companion diagnostic for NSCLC.
January 2025: Foundation Medicine’s FoundationOne CDx was approved by the FDA as the first companion diagnostic for tovorafenib (OJEMDA) in pediatric low-grade glioma harboring BRAF mutations or fusions.
November 2024: FDA cleared Caris Life Sciences’ MI Cancer Seek, the first CDx built on simultaneous whole-exome and whole-transcriptome sequencing to support pan-cancer and tumor-specific therapeutic decisions.
What You Receive
• Global Companion Diagnostics Oncology market size and growth projections (CAGR), 2024- 2034• Impact of recent changes in geopolitical, economic, and trade policies on the demand and supply chain of Companion Diagnostics Oncology.
• Companion Diagnostics Oncology market size, share, and outlook across 5 regions and 27 countries, 2025- 2034.
• Companion Diagnostics Oncology market size, CAGR, and Market Share of key products, applications, and end-user verticals, 2025- 2034.
• Short and long-term Companion Diagnostics Oncology market trends, drivers, restraints, and opportunities.
• Porter’s Five Forces analysis, Technological developments in the Companion Diagnostics Oncology market, Companion Diagnostics Oncology supply chain analysis.
• Companion Diagnostics Oncology trade analysis, Companion Diagnostics Oncology market price analysis, Companion Diagnostics Oncology Value Chain Analysis.
• Profiles of 5 leading companies in the industry- overview, key strategies, financials, and products.
• Latest Companion Diagnostics Oncology market news and developments.
The Companion Diagnostics Oncology Market international scenario is well established in the report with separate chapters on North America Companion Diagnostics Oncology Market, Europe Companion Diagnostics Oncology Market, Asia-Pacific Companion Diagnostics Oncology Market, Middle East and Africa Companion Diagnostics Oncology Market, and South and Central America Companion Diagnostics Oncology Markets. These sections further fragment the regional Companion Diagnostics Oncology market by type, application, end-user, and country.
1.1 List of Tables
1.2 List of Figures
2. Companion Diagnostics Oncology Market Latest Trends, Drivers and Challenges, 2024- 2034
2.1 Companion Diagnostics Oncology Market Overview
2.2 Market Strategies of Leading Companion Diagnostics Oncology Companies
2.3 Companion Diagnostics Oncology Market Insights, 2024- 2034
2.3.1 Leading Companion Diagnostics Oncology Types, 2024- 2034
2.3.2 Leading Companion Diagnostics Oncology End-User industries, 2024- 2034
2.3.3 Fast-Growing countries for Companion Diagnostics Oncology sales, 2024- 2034
2.4 Companion Diagnostics Oncology Market Drivers and Restraints
2.4.1 Companion Diagnostics Oncology Demand Drivers to 2034
2.4.2 Companion Diagnostics Oncology Challenges to 2034
2.5 Companion Diagnostics Oncology Market- Five Forces Analysis
2.5.1 Companion Diagnostics Oncology Industry Attractiveness Index, 2024
2.5.2 Threat of New Entrants
2.5.3 Bargaining Power of Suppliers
2.5.4 Bargaining Power of Buyers
2.5.5 Intensity of Competitive Rivalry
2.5.6 Threat of Substitutes
3. Global Companion Diagnostics Oncology Market Value, Market Share, and Forecast to 2034
3.1 Global Companion Diagnostics Oncology Market Overview, 2024
3.2 Global Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
3.3 Global Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
3.4 Global Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
3.5 Global Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
3.6 Global Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
3.7 Global Companion Diagnostics Oncology Market Size and Share Outlook by Region, 2024- 2034
4. Asia Pacific Companion Diagnostics Oncology Market Value, Market Share and Forecast to 2034
4.1 Asia Pacific Companion Diagnostics Oncology Market Overview, 2024
4.2 Asia Pacific Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
4.3 Asia Pacific Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
4.4 Asia Pacific Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
4.5 Asia Pacific Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
4.6 Asia Pacific Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
4.7 Asia Pacific Companion Diagnostics Oncology Market Size and Share Outlook by Country, 2024- 2034
5. Europe Companion Diagnostics Oncology Market Value, Market Share, and Forecast to 2034
5.1 Europe Companion Diagnostics Oncology Market Overview, 2024
5.2 Europe Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
5.3 Europe Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
5.4 Europe Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
5.5 Europe Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
5.6 Europe Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
5.7 Europe Companion Diagnostics Oncology Market Size and Share Outlook by Country, 2024- 2034
6. North America Companion Diagnostics Oncology Market Value, Market Share and Forecast to 2034
6.1 North America Companion Diagnostics Oncology Market Overview, 2024
6.2 North America Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
6.3 North America Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
6.4 North America Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
6.5 North America Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
6.6 North America Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
6.7 North America Companion Diagnostics Oncology Market Size and Share Outlook by Country, 2024- 2034
7. South and Central America Companion Diagnostics Oncology Market Value, Market Share and Forecast to 2034
7.1 South and Central America Companion Diagnostics Oncology Market Overview, 2024
7.2 South and Central America Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
7.3 South and Central America Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
7.4 South and Central America Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
7.5 South and Central America Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
7.6 South and Central America Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
7.7 South and Central America Companion Diagnostics Oncology Market Size and Share Outlook by Country, 2024- 2034
8. Middle East Africa Companion Diagnostics Oncology Market Value, Market Share and Forecast to 2034
8.1 Middle East Africa Companion Diagnostics Oncology Market Overview, 2024
8.2 Middle East and Africa Companion Diagnostics Oncology Market Revenue and Forecast, 2024- 2034 (US$ billion)
8.3 Middle East Africa Companion Diagnostics Oncology Market Size and Share Outlook By Product, 2024- 2034
8.4 Middle East Africa Companion Diagnostics Oncology Market Size and Share Outlook By Application, 2024- 2034
8.5 Middle East Africa Companion Diagnostics Oncology Market Size and Share Outlook By End User, 2024- 2034
8.6 Middle East Africa Companion Diagnostics Oncology Market Size and Share Outlook By Technology, 2024- 2034
8.7 Middle East Africa Companion Diagnostics Oncology Market Size and Share Outlook by Country, 2024- 2034
9. Companion Diagnostics Oncology Market Structure
9.1 Key Players
9.2 Companion Diagnostics Oncology Companies - Key Strategies and Financial Analysis
9.2.1 Snapshot
9.2.3 Business Description
9.2.4 Products and Services
9.2.5 Financial Analysis
10. Companion Diagnostics Oncology Industry Recent Developments
11 Appendix
11.1 Publisher Expertise
11.2 Research Methodology
11.3 Annual Subscription Plans
11.4 Contact Information
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FAQ's
The Global Companion Diagnostics Oncology Market is estimated to generate USD 4.58 billion in revenue in 2025.
The Global Companion Diagnostics Oncology Market is expected to grow at a Compound Annual Growth Rate (CAGR) of 11.61% during the forecast period from 2025 to 2034.
The Companion Diagnostics Oncology Market is estimated to reach USD 12.31 billion by 2034.
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