Companion Diagnostics Market worth $11.57 billion by 2031
The report "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" is projected to reach USD 11.57 billion by 2031, from USD 6.31 billion in 2026, with a CAGR of 12.9%.
Browse 350 market data Tables and 250 Figures spread through 450 Pages and in-depth TOC on "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"
View detailed Table of Content here - https://www.marketsandmarkets.com/Market-Reports/companion-diagnostics-market-155571681.html
The global market for companion diagnostics is growing rapidly, driven by the rising adoption of precision medicine, increasing use of targeted therapies, expanding oncology biomarker testing, and growing drug–diagnostic co-development activity.
In 2025, the polymerase chain reaction (PCR) captured a major share in the technology segment.
PCR held a major share in 2025 due to its high sensitivity, faster turnaround time, established regulatory acceptance, and broad use in mutation detection and therapy-related testing. However, next-generation sequencing (NGS) is expected to grow faster over the forecast period, supported by elevated demand for multi-gene testing, comprehensive genomic profiling, and broader precision oncology applications.
In 2025, cancer was the leading indication segment in the companion diagnostics market.
Cancer was the largest segment in 2025, as most companion diagnostics are linked to oncology therapies. Rising cancer incidence, increasing approvals of targeted therapies and immunotherapies, and the growing need to identify biomarker-positive patients continue to support this segment’s dominance.
North America was the largest market for companion diagnostics in 2025.
North America accounted for the highest share in 2025, driven by advanced adoption of precision medicine, a strong oncology testing infrastructure, favorable regulatory pathways, high healthcare spending, and the presence of leading diagnostic and pharmaceutical companies. Meanwhile, the Asia Pacific is expected to grow faster, driven by expanding oncology care, rising adoption of molecular diagnostics, and increasing healthcare investments.
Key players in the companion diagnostics market include F. Hoffmann-La Roche AG (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US), Guardant Health, Inc (US), Danaher (US), Abbott (US), Illumina, Inc. (US), Almac Group (UK), bioMérieux (France), Myriad Genetics, Inc. (US), Sysmex Corporation (Japan), ARUP Laboratories (UK), Icon Plc (Ireland), Quest Diagnostics(US), Amoy Diagnostics Co., Ltd (China), Tempus AI, Inc (US), Caris Life Sciences, Inc (US), Arup Laboratories(US), Abnova Corporation (Taiwan), Invivoscribe Technologies (US), Q2 Solutions(US), Pillar Biosciences(US), Creative Biolabs(US), EntroGen, Inc.(US), and Biocartis (Belgium).
About MarketsandMarkets™
MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe.
Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem.
The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter , LinkedIn and Facebook .
Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA: +1-888-600-6441
Email: [email protected]
Visit Our Website: https://www.marketsandmarkets.com
- Triangulate with your Own Data
- Get Data as per your Format and Definition
- Gain a Deeper Dive on a Specific Application, Geography, Customer or Competitor
- Any level of Personalization
- What are the Known and Unknown Adjacencies Impacting the Companion Diagnostics Market
- What will your New Revenue Sources be?
- Who will be your Top Customer; what will make them switch?
- Defend your Market Share or Win Competitors
- Get a Scorecard for Target Partners
