Global Oncology Companion Diagnostic Market Size & Trends Report Segmented by Product & Services (Instrument, Consumables, Software), Technology (PCR, NGS, IHC, ISH), Cancer Type (Lung, Breast, Prostate), End-user & Regional Forecast to 2030
The oncology companion diagnostic market is projected to grow at a CAGR of ~10% over the forecast period. The market is driven by the growing adoption of precision medicine, rising cancer incidence, and advancements in molecular diagnostics, including next-generation sequencing (NGS) and liquid biopsy. Regulatory support for personalized medicine and increasing collaborations between pharmaceutical and diagnostic firms further accelerate growth. To learn more about the research report, download a sample report.
Report Overview
Oncology companion diagnostics are specialized tests that help determine the most effective cancer treatment for individual patients by identifying specific biomarkers. These diagnostics ensure that targeted therapies are administered to patients who are most likely to benefit, improving treatment efficacy and minimizing adverse effects. They play a crucial role in personalized medicine by guiding oncologists in selecting therapies based on a patient's genetic profile. The development of these tests is often linked with targeted cancer drugs, making them essential in modern oncology care.
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Expanding role of companion diagnostics in targeted cancer therapies
The increasing reliance on targeted therapies in oncology has significantly driven the demand for companion diagnostics (CDx). These diagnostics help identify specific cancer mutations, enabling precise treatment selection and minimizing side effects. Regulatory agencies like the FDA advocate for broader CDx applications, allowing single tests to guide multiple drug options for the same mutation, improving clinical efficiency. Despite these advancements, gaps in genomic testing remain—highlighted by a 2020 study showing that nearly a quarter of advanced NSCLC (Non-Small Cell Lung Cancer) patients in the US did not receive recommended biomarker testing before treatment. Given that most NSCLC patients could benefit from targeted therapy, improving CDx accessibility and adoption remains critical. As awareness of personalized medicine grows and regulatory support strengthens, oncology companion diagnostics continue to play an essential role in optimizing cancer treatment outcomes.
Technological innovations enhancing companion diagnostics market growth
Advancements in liquid biopsy and next-generation sequencing (NGS) are transforming oncology diagnostics by enabling non-invasive, comprehensive genetic testing. Liquid biopsy allows for ctDNA analysis from blood samples, improving early cancer detection and treatment monitoring. Meanwhile, NGS facilitates multi-gene profiling in a single test, enhancing precision in therapy selection. However, the rapid development of targeted therapies has created challenges in aligning CDx availability with new drug launches. To address this, regulatory agencies require clinical validation of at least one diagnostic test per drug class, ensuring consistent biomarker detection. AI-driven analytics further refine diagnostic accuracy and efficiency, accelerating the integration of personalized medicine. As these technologies advance, they are expected to enhance accessibility, improve patient outcomes, and drive the continued expansion of the oncology companion diagnostics market.
To learn more about this report, download the PDF brochure
Competitive Landscape Analysis
The global oncology companion diagnostic market is marked by the presence of established and emerging market players such as Agilent Technologies Inc.; Illumina Inc.; QIAGEN; Thermo Fisher Scientific Inc.; Foundation Medicine Inc.; Myriad Genetics, Inc.; F. Hoffmann-La Roche Ltd.; BioMérieux; Abbott; Leica Biosystems; Guardant Health, Inc.; and EntroGen, Inc. among others. Some of the key strategies adopted by market players include new product development, strategic partnerships and collaborations, and geographic expansion.
Report Scope
| Report Metric | Details |
| Base Year Considered | 2024 |
| Historical Data | 2023 - 2024 |
| Forecast Period | 2025 – 2030 |
| Growth Rate | 10% |
| Market Drivers |
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| Attractive Opportunities |
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| Segment Scope | Product & Services, Technology, Cancer Type, and End-User |
| Regional Scope |
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| Key Companies Mapped | Agilent Technologies Inc.; Illumina Inc.; QIAGEN; Thermo Fisher Scientific Inc.; Foundation Medicine Inc.; Myriad Genetics, Inc.; F. Hoffmann-La Roche Ltd.; BioMérieux; Abbott; Leica Biosystems; Guardant Health, Inc.; and EntroGen, Inc. among others |
| Report Highlights | Market Size & Forecast, Growth Drivers & Restraints, Trends, Competitive Analysis |
Global Oncology Companion Diagnostic Market Segmentation
This report by Medi-Tech Insights provides the size of the global oncology companion diagnostic market at the regional- and country-level from 2023 to 2030. The report further segments the market based on product & services, technology, cancer type, and end-user.
Market Size & Forecast (2023-2030), By Product & Services, USD Million
- Product
- Instrument
- Consumables
- Software
- Services
Market Size & Forecast (2023-2030), By Technology, USD Million
- Polymerase Chain Reaction (PCR)
- Next-Generation Sequencing (NGS)
- Immunohistochemistry (IHC)
- In Situ Hybridization (ISH)
- Others
Market Size & Forecast (2023-2030), By Cancer Type, USD Million
- Lung Cancer
- Breast Cancer
- Leukaemia
- Colorectal Cancer
- Prostate Cancer
- Others
Market Size & Forecast (2023-2030), By End-user, USD Million
- Hospitals
- Diagnostic Laboratory
- Academic & Research Institutes
- Others
Market Size & Forecast (2023-2030), By Region, USD Million
- North America
- US
- Canada
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Rest of Asia Pacific
- Latin America
- Middle East & Africa
Key Strategic Questions Addressed
- What is the market size & forecast of the oncology companion diagnostic market?
- What are historical, present, and forecasted market shares and growth rates of various segments and sub-segments of the oncology companion diagnostic market?
- What are the key trends defining the market?
- What are the major factors impacting the market?
- What are the opportunities prevailing in the market?
- Which region has the highest share in the global market? Which region is expected to witness the highest growth rate in the next 5 years?
- Who are the major players operating in the market?
- What are the key strategies adopted by players?
- Introduction
- Introduction
- Market Scope
- Market Definition
- Segments Covered
- Regional Segmentation
- Research Timeframe
- Currency Considered
- Study Limitations
- Stakeholders
- List of Abbreviations
- Key Conferences and Events (2025-2026)
- Research Methodology
- Secondary Research
- Primary Research
- Market Estimation
- Bottom-Up Approach
- Top-Down Approach
- Market Forecasting
- Executive Summary
- Oncology Companion Diagnostic Market Snapshot (2025-2030)
- Segment Overview
- Regional Snapshot
- Competitive Insights
- Market Overview
- Market Dynamics
- Drivers
- Rising prevalence of cancer worldwide
- Increasing adoption of precision medicine in oncology
- Growing demand for targeted cancer therapies
- Advancements in molecular diagnostics, including NGS and liquid biopsy
- Regulatory support for companion diagnostics in drug approvals
- Restraints
- High costs associated with developing and validating companion diagnostics
- Stringent regulatory requirements delaying market entry
- Limited reimbursement policies affecting test accessibility
- Opportunities
- Growing demand for minimally invasive and blood-based diagnostics
- Development of multi-cancer early detection (MCED) technologies
- Growth of comprehensive genomic profiling using NGS
- Expansion in emerging markets with rising healthcare investments
- Key Market Trends
- Increasing integration of AI and machine learning in diagnostic tools
- Co-development of companion diagnostics with therapeutic product
- Shift toward decentralized and point-of-care companion diagnostics
- Unmet Market Needs
- Industry Speaks
- Drivers
- Market Dynamics
- Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Product & Services, USD Million
- Introduction
- Product
- Instrument
- Consumables
- Software
- Services
- Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Technology, USD Million
- Introduction
- Polymerase Chain Reaction (PCR)
- Next-Generation Sequencing (NGS)
- Immunohistochemistry (IHC)
- In Situ Hybridization (ISH)
- Others
- Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Cancer Type, USD Million
- Introduction
- Lung Cancer
- Breast Cancer
- Leukaemia
- Colorectal Cancer
- Prostate Cancer
- Others
- Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By End-user, USD Million
- Introduction
- Hospitals
- Diagnostic Centers
- Academic & Research Institutes
- Others
- Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Region, USD Million
- Introduction
- North America Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Country, USD Million
- US
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Canada
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- US
- Europe Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Country, USD Million
- UK
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Germany
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- France
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Italy
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Spain
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Rest of Europe
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- UK
- Asia Pacific (APAC) Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Country, USD Million
- China
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Japan
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- India
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Rest of Asia Pacific
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- China
- Latin America (LATAM) Oncology Companion Diagnostic Market Size & Forecast (2023-2030), USD Million
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Middle East & Africa (MEA) Oncology Companion Diagnostic Market Size & Forecast (2023-2030), USD Million
- Market Size & Forecast, By Product & Services (USD Million)
- Market Size & Forecast, By Technology (USD Million)
- Market Size & Forecast, By Cancer Type (USD Million)
- Market Size & Forecast, By End-user (USD Million)
- Competitive Landscape
- Key Players and their Competitive Positioning
- Key Player Comparison
- Segment-wise Player Mapping
- Market Share Analysis (2024)
- Company Categorization Matrix
- Dominants/Leaders
- New Entrants
- Emerging Players
- Innovative Players
- Key Strategies Assessment, By Player (2022-2025)
- New Product Launches
- Partnerships, Agreements, & Collaborations
- Mergers & Acquisitions
- Geographic Expansion
- Key Players and their Competitive Positioning
- Company Profiles*
(Business Overview, Financial Performance**, Products Offered, Recent Developments)
- Agilent Technologies Inc.
- Illumina Inc.
- QIAGEN
- Thermo Fisher Scientific Inc.
- Foundation Medicine Inc.
- Myriad Genetics, Inc.
- Hoffmann-La Roche Ltd.
- BioMérieux
- Abbott
- Leica Biosystems
- Other Prominent Players
Note: *Indicative list
**For listed companies
The study has been compiled based on extensive primary and secondary research.
Secondary Research (Indicative List)
Primary Research
To validate research findings (market size & forecasts, market segmentation, market dynamics, competitive landscape, key industry trends, etc.), extensive primary interviews were conducted with both supply and demand-side stakeholders.
Supply Side Stakeholders:
- Senior Management Level: CEOs, Presidents, Vice-Presidents, Directors, Chief Technology Officers, Chief Commercial Officers
- Mid-Management Level: Product Managers, Sales Managers, Brand Managers, R&D Managers, Business Development Managers, Consultants
Demand Side Stakeholders:
- Stakeholders from Hospitals, Diagnostic Laboratory, and Others
Breakdown of Primary Interviews
Market Size Estimation
Both ‘Top-Down & Bottom-Up Approaches’ were used to derive market size estimates and forecasts
Data Triangulation
Research findings derived through secondary sources & internal analysis was validated with Primary Interviews, Internal Knowledge Repository and Company’s Sales Data
