Companion Diagnostics Market
Companion Diagnostics Market by Product (Assays, Kits, & Reagents, Instruments, Software), Technology (PCR, NGS, ISH, IHC), Indication (Breast, Lung, Colorectal Cancer, CVD, Infectious), Drug Class (MAB, Cell & Gene Therapy) - Global Forecast to 2031
COMPANION DIAGNOSTICS MARKET SIZE, SHARE & GROWTH SNAPSHOT
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The global companion diagnostics market is projected to grow from USD 6.31 billion in 2026 to USD 11.57 billion by 2031, at a CAGR of 12.9% during the forecast period. The market was valued at USD 5.66 billion in 2025. The market is driven by the rapid adoption of precision medicine, targeted therapies, and biomarker-based treatment approaches. Companion diagnostics (CDx) are essential for identifying patient populations most likely to benefit from specific therapies, particularly in oncology, autoimmune diseases, and rare genetic disorders. The market encompasses diagnostic assays, next-generation sequencing (NGS), PCR-based testing, immunohistochemistry, in situ hybridization, liquid biopsy technologies, bioinformatics platforms, and associated analytical services. Increasing regulatory emphasis on personalized therapeutics, growing pharma-diagnostic partnerships, and expanding approvals of targeted drugs are accelerating market growth globally.
KEY TAKEAWAYS
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BY REGIONNorth America accounted for the largest share of 44.7% in 2025.
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BY PRODUCT & SERVICEThe assays, kits & reagents segment captured 67.3% of the total market in 2025.
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BY END USERPharmaceutical & biotechnology companies dominated the companion diagnostics market in 2025.
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COMPETITIVE LANDSCAPE - Key PlayersF. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), and Thermo Fisher Scientific Inc. (US) were identified as stars in the companion diagnostics market, given their strong market share and product and service footprint.
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COMPETITIVE LANDSCAPE - StartupsPillar Biosciences (US) and Biocartis (Belgium) have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas, underscoring their potential as emerging market leaders.
The companion diagnostics market is expanding rapidly, driven by the increasing adoption of precision medicine, rising approvals of targeted therapies, and growing integration of biomarker-based testing into clinical decision-making. Advances in molecular diagnostics, NGS, liquid biopsy, and AI-enabled biomarker discovery are accelerating the adoption of companion diagnostics across drug development, oncology research, and personalized treatment applications.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The companion diagnostics market is rapidly transforming, driven by advances in precision medicine, NGS, liquid biopsy, and AI-enabled biomarker discovery platforms. The growing integration of companion diagnostics into targeted drug development and clinical trial stratification is accelerating demand for highly accurate, personalized diagnostic solutions across oncology and rare disease applications. The rising adoption of liquid biopsy and minimally invasive testing is disrupting traditional tissue-based diagnostic workflows by enabling real-time disease monitoring, therapy response assessment, and early mutation detection. In parallel, advances in digital pathology, multiplex biomarker analysis, cloud-based bioinformatics, and AI-driven clinical interpretation are improving diagnostic precision, turnaround time, and treatment decision support. Strategic collaborations between pharmaceutical companies and molecular diagnostics developers, along with evolving regulatory frameworks that support co-development of drugs and companion diagnostics, are strengthening commercialization opportunities. The expanding use of companion diagnostics beyond oncology into cardiovascular, autoimmune, and infectious diseases is further broadening market potential across hospitals, reference laboratories, CROs/CDMOs, and precision medicine research centers.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Increasing adoption of precision medicine and targeted therapies
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Growing investments in genomics, molecular diagnostics, and biomarker discovery
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High development, clinical validation, and regulatory approval costs
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Expansion of liquid biopsy and non-invasive companion diagnostics
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AI-driven biomarker interpretation and digital pathology integration
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Regulatory complexity associated with simultaneous drug–diagnostic approvals
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Increasing adoption of precision medicine and targeted therapies
The growing focus on precision medicine is significantly driving demand for companion diagnostics, as healthcare providers increasingly rely on biomarker-based testing to personalize treatment decisions. The rising approvals of targeted therapies, particularly in oncology, are accelerating the integration of companion diagnostics into clinical workflows. Pharmaceutical companies are increasingly partnering with diagnostic developers to improve patient stratification and treatment efficacy.
Restraint: High development, clinical validation, and regulatory approval costs
Developing companion diagnostics requires substantial investment in biomarker discovery, assay development, clinical validation, and regulatory compliance. Simultaneous approval requirements for therapeutics and diagnostics increase development complexity and extend commercialization timelines. Smaller diagnostic companies often face financial and operational challenges in conducting large-scale validation studies. Reimbursement policy variability and limited coverage for molecular testing in certain regions further restrict market penetration. In addition, evolving global regulatory standards create additional compliance burdens for market participants.
Opportunity: Expansion of liquid biopsy and non-invasive companion diagnostics
The growing adoption of liquid biopsy technologies presents significant growth opportunities for the companion diagnostics market by enabling minimally invasive cancer detection and treatment monitoring. Liquid biopsy-based companion diagnostics improve patient convenience and support real-time assessment of tumor mutations and treatment response. Advancements in circulating tumor DNA (ctDNA), multi-cancer early detection, and AI-driven biomarker analysis are expanding the scope of precision diagnostics. Growing demand for decentralized and rapid testing solutions is further driving innovation in non-invasive diagnostic platforms. Expanding applications beyond oncology into rare and infectious diseases also offer long-term market potential.
Challenge: Regulatory complexity associated with simultaneous drug–diagnostic approvals
Companion diagnostics face significant regulatory challenges because both the therapeutic product and the associated diagnostic test must be approved in coordination. Differences in regulatory frameworks across regions complicate global commercialization strategies. Delays in aligning clinical trials, validating biomarkers, and submitting regulatory applications can affect product launch timelines and increase overall development costs. Ensuring analytical accuracy, reproducibility, and clinical utility across diverse patient populations remains a major challenge for diagnostic developers. Furthermore, evolving regulatory expectations regarding AI-enabled diagnostics and real-world evidence are adding additional layers of compliance complexity.
COMPANION DIAGNOSTICS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Develops companion diagnostics linked with targeted oncology therapies using PCR, IHC, and NGS platforms to identify biomarker-positive patient populations for therapies such as HER2, EGFR, and PD-L1 targeted treatments. | Enables accurate patient stratification, improves therapy response rates, and supports faster clinical decision-making in precision oncology. |
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Provides companion diagnostic assays through Dako pathology platforms, including PD-L1 and immunohistochemistry-based biomarker testing for immuno-oncology applications. | Improves biomarker detection consistency, supports immunotherapy adoption, and enhances pathology workflow standardization. |
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Provides therascreen companion diagnostic assays for detecting specific gene mutations across cancer indications, supporting therapy selection for targeted drugs in lung, colorectal, and breast cancers. | Enhances treatment selection accuracy, reduces ineffective therapies, and supports regulatory-approved personalized treatment pathways. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The companion diagnostics market is a highly interconnected precision medicine ecosystem in which pharmaceutical and biopharmaceutical companies, diagnostic assay developers, sequencing and pathology platform providers, reference laboratories, hospitals, oncology centers, academic institutions, and regulatory bodies collaborate to enable biomarker-driven treatment decisions. Pharmaceutical companies work closely with in vitro diagnostic manufacturers and specialized molecular diagnostics firms to co-develop and commercialize companion diagnostic tests alongside targeted therapies, immunotherapies, and emerging cell and gene therapies. Diagnostic ecosystem participants provide assays, kits, reagents, instruments, sequencing platforms, IHC/ISH systems, bioinformatics tools, and interpretation software to identify actionable biomarkers such as EGFR, ALK, HER2, KRAS, BRAF, BRCA, PD-L1, MSI/MMR, NTRK, RET, and MET. Reference laboratories, hospital molecular pathology labs, and cancer centers support clinical implementation by performing CDx testing, reporting actionable results, and integrating biomarker data into oncology treatment pathways. CROs and specialized clinical research service providers support biomarker discovery, assay validation, clinical trial patient selection, regulatory submissions, and post-commercialization testing strategies. Regulatory authorities such as the US FDA, EMA, PMDA, and other national agencies, along with payers and health technology assessment bodies, shape the ecosystem through approval pathways, clinical utility requirements, reimbursement policies, and companion diagnostic labeling standards.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Global Companion Diagnostics Market, by Product & Service
Assays, kits & reagents are expected to account for the largest share of the companion diagnostics market due to their recurring use across PCR, NGS, IHC, and ISH-based testing workflows. These consumables are required for every patient test, unlike instruments, which are capital purchases with longer replacement cycles. Growing biomarker testing volumes in oncology, especially for lung, breast, and colorectal cancers and hematologic malignancies, continue to support demand for CDx assay kits and reagents.
Global Companion Diagnostics Market, by Technology
PCR is expected to hold the largest share of the companion diagnostics market due to its wide clinical use, faster turnaround time, lower cost, and strong adoption across targeted mutation testing workflows. PCR-based CDx assays are widely used for actionable biomarkers such as EGFR, KRAS/NRAS, BRAF, BRCA mutations, MSI-related testing, and selected infectious or oncology-linked molecular targets.
Global Companion Diagnostics Market, by Indication
Cancer is expected to dominate the companion diagnostics market, accounting for the vast majority of demand. Within cancer, lung cancer is likely to hold the largest share, driven by a high number of actionable biomarkers, including EGFR, ALK, ROS1, BRAF, MET, RET, NTRK, KRAS, and PD-L1, as well as broader NGS-based profiling. Breast cancer and colorectal cancer also represent major CDx indications, supported by HER2, ER/PR, BRCA/HRD, RAS, BRAF, and MSI/MMR testing.
Global Companion Diagnostics Market, by Sample
Tissue samples are expected to hold the largest share of the companion diagnostics market because most approved and reimbursed CDx workflows remain tissue-based. Tissue testing is central to IHC, ISH/FISH, and many NGS assays used in solid tumors, especially for HER2, PD-L1, ALK, MMR, and comprehensive tumor profiling.
Global Companion Diagnostics Market, by End User
Pharmaceutical & biopharmaceutical companies are expected to account for the largest share of the companion diagnostics market because of their central role in CDx co-development, clinical trial patient selection, regulatory submissions, and the commercialization of targeted therapies. These companies drive demand for companion diagnostic assays throughout drug development and post-approval use, particularly across oncology, immunotherapy, and precision medicine pipelines.
REGION
Asia Pacific to be fastest-growing region during forecast period
During the forecast period, Asia Pacific is expected to be the fastest-growing region in the companion diagnostics market, driven by rising cancer incidence, expanding adoption of precision oncology, increasing use of PCR- and NGS-based biomarker testing, and improving access to targeted therapies across China, Japan, South Korea, Australia, and India. Japan and South Korea are advancing reimbursement and clinical adoption of comprehensive genomic profiling, while China and India are witnessing rapid expansion of molecular diagnostics infrastructure, oncology reference laboratories, and pharma-led biomarker testing programs. Growing clinical trial activity, increasing approvals of targeted therapies, and broader use of liquid biopsy and multi-gene testing are expected to further support regional growth. However, adoption will remain uneven across the region due to differences in reimbursement maturity, testing affordability, and access to advanced oncology care.
COMPANION DIAGNOSTICS MARKET: COMPANY EVALUATION MATRIX
F. Hoffmann-La Roche AG is a leading player in the companion diagnostics market, supported by its broad portfolio spanning tissue diagnostics, immunohistochemistry, in situ hybridization, PCR-based testing, and comprehensive genomic profiling through Foundation Medicine. The company has strong pharmaceutical linkages, regulatory experience, and a wide installed base across pathology and oncology testing workflows, positioning it well in therapy-linked biomarker testing. Guardant Health and Tempus are emerging high-growth players, supported by liquid biopsy, AI-enabled molecular profiling, and the extensive use of NGS-based companion diagnostics in advanced oncology.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
- F. Hoffmann-La Roche AG (Switzerland)
- Agilent Technologies, Inc. (US)
- QIAGEN (Netherlands)
- Thermo Fisher Scientific Inc. (US)
- Danaher (US)
- Guardant Health, Inc (US)
- Abbott (US)
- Illumina, Inc. (US)
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 5.66 BN |
| Market Forecast in 2031 (Value) | USD 11.57 BN |
| Growth Rate | CAGR of 12.9 from 2026 to 2031 |
| Years Considered | 2024–2031 |
| Base Year | 2025 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD BN/MN) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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| Regions Covered | North America, Europe, Asia Pacific, Latin America, Middle East, Africa |
WHAT IS IN IT FOR YOU: COMPANION DIAGNOSTICS MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Evaluate competitive positioning of key players in the companion diagnostics market | Benchmarked leading companies across CDx assays, kits, reagents, instruments/systems, NGS platforms, IHC/ISH solutions, liquid biopsy tests, bioinformatics, and reference laboratory services based on technology coverage, approved CDx portfolio, pharma partnerships, geographic reach, regulatory approvals, and end-user focus. | Identifies competitive gaps, partnership opportunities, and differentiation strategies |
| Assess high-growth technologies and segment opportunities in companion diagnostics | Evaluated growth potential across PCR, NGS, IHC, ISH/FISH, liquid biopsy, tissue-based testing, blood-based testing, and software-enabled interpretation workflows, including differences in adoption across oncology, infectious disease, cardiovascular, neurological, and other indications | Supports investment prioritization, product development, CDx co-development planning, regional expansion, and technology roadmap decisions, especially around NGS, liquid biopsy, and biomarker-driven oncology testing |
RECENT DEVELOPMENTS
- May 2026 : F. Hoffmann-La Roche AG agreed to acquire PathAI to strengthen its digital pathology and AI-enabled precision diagnostics capabilities. The deal builds on Roche and PathAI’s earlier collaboration, which expanded in 2024 to include AI-enabled companion diagnostic algorithm development, supporting Roche’s position in tissue-based oncology diagnostics and biomarker interpretation
- December 2025 : The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with F. Hoffmann-La Roche AG's Perjeta for first-line treatment of HER2-positive metastatic breast cancer, with the approval linked to FDA-approved companion diagnostic testing for HER2-positive patient identification. This reinforces the continued importance of HER2 testing in therapy selection.
Table of Contents
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Methodology
This study involved four major activities in estimating the current size of the companion diagnostics market. Exhaustive secondary research was conducted to gather information on the market, its peer markets, and its parent market. These findings, assumptions, and sizing were then validated with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. Following this, the data triangulation procedure was used to estimate the market size of segments and subsegments.
Secondary Research
Secondary research was primarily used to identify and gather information for the extensive, technical, market-oriented, and commercial study. The secondary sources referred for this research study include publications from government sources, such as the National Center for Biotechnology Information (NCBI), National Institutes of Health (NIH), World Health Organization (WHO), Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical Research and Manufacturers of America (PhRMA), Global Cancer Observatory (GLOBOCAN), Centers for Disease Control and Prevention (CDC), and European Federation of Biotechnology,. Secondary sources also included corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations. These sources were also used to obtain key information on major players, global product revenues, market classification, and segmentation by industry trends, regional/country-level markets, market developments, and technology perspectives. Secondary data were collected and analyzed to determine the overall size of the global companion diagnostics market, and the findings were validated through primary research.
Primary Research
In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, among others, to obtain and verify critical qualitative and quantitative information and assess market prospects. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
The global size of the companion diagnostics market was estimated through multiple approaches. A detailed market estimation approach was used to estimate and validate the market value and other dependent submarkets. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
Data Triangulation
After estimating the overall market size from the market size estimation process, the total market was split into several segments. To complete the overall market engineering process and arrive at the exact statistics for all segments, the data triangulation procedure was employed; it involved studying various factors and trends from both the demand and supply sides.
Market Definition
A companion diagnostic (CDx) is an in vitro diagnostic (IVD) device that is used to make biomarker assessments to identify whether a patient with certain chronic diseases, such as cancer, infectious diseases, and cardiovascular diseases, could benefit from a particular drug provides information essential for the safe and effective use of a specific therapeutic product, particularly targeted therapies and biologics. These tests help identify patients who are most likely to benefit from a treatment, may experience adverse reactions, or require therapy selection based on biomarker or molecular profiling. The market includes assay kits, reagents, instruments, software, and laboratory testing services across technologies such as polymerase chain reaction, next-generation sequencing, immunohistochemistry, and in situ hybridization, among others.
Key Stakeholders
- Manufacturers and Distributors of Companion Diagnostics Products
- In Vitro Diagnostic (IVD) Companies
- Hospital Laboratories
- Diagnostic Laboratories
- Diagnostics Suppliers
- Pharmaceutical Companies
- Research Laboratories and Academic Institutes
- Clinical Research Organizations (CROs)
- Research & Development (R&D) Companies
- Academic Medical Centers/Government Research Organizations
- Companion Diagnostics Service Providers
- Government Associations
- Market Research & Consulting Firms
- Venture Capitalists & Investors
Report Objectives
- To define, describe, segment, and forecast the global companion diagnostics market, by product & service, technology, Indication, Sample type, Drug Class Associated with CDX, Application, end user, and region
- To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
- To analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall companion diagnostics market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market segments with respect to six regions: North America(US and Canada), Europe (Germany, France, the UK, Switzerland Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, and the Rest of Latin America), the Middle East [GCC and the Rest of Middle East], and Africa
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
- To track and analyze company developments such as product launches & approvals, partnerships, acquisitions, agreements, collaborations, expansions, and other developments
- To benchmark players within the market using the proprietary “Company Evaluation Matrix” framework, which analyzes market players on various parameters within the broad categories of business and product excellence strategy
Available customizations:
With the given market data, MarketsandMarkets offers customizations per the company’s specific needs. The following customization options are available for the report:
Geographical Analysis
- Further breakdown of the Rest of Europe companion diagnostics market, by country
- Further breakdown of the Rest of Asia Pacific companion diagnostics market, by country
Company Information
- Detailed analysis and profiling of additional market players (up to five)
Segment Analysis
- Cross-segment analysis
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Growth opportunities and latent adjacency in Companion Diagnostics Market
Alisa
Jul, 2022
What is the Companion Diagnostics Market trend by Product (Assays, Kits, Software & Services), Technology (PCR, NGS, ISH, IHC), Indication (Breast, Blood, Lung, Colorectal Cancer, Neurology Diseases), End User (Pharma Companies, CROs), Regional Analysis - Global Forecast to 2031.
Alan
Dec, 2022
Companion Diagnostics Market Report provides the global forecasts for the next five years. Companies like ResearchDx is profiled as one of the key players in this report. Included the comprehensive 360 degree competitive mapping by profiling major players of Companion Diagnostics Market. Key Questions Addressed in the Report: • Where will all these products & services take the industry in the mid to long term? • What are the growth opportunities in the Companion Diagnostics Market across major regions in the future? • Which are the key players in the market and how intense is the competition? • What are the current industry developments for companion diagnostics? We have given a comprehensive 360 degree competitive mapping by profiling major players of Companion Diagnostics Market..