Companion Diagnostics Markets 2027–2031

Companion Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027–2031 (6th Edition, October 2026)

Global forecasts by disease area, therapy class, technology, sample type and product & service, for 14 countries and regions, with 102 company profiles.

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Our Take

Companion diagnostics are moving from a single test at diagnosis to platforms that guide treatment over time. The market grows from $9.5 billion in 2026 to $17.1 billion in 2031, at 12.4% a year. Sequencing panels take most of the new spending, blood tests catch up with tissue, and antibody-drug conjugates and AI-scored pathology bring tissue testing back into growth.

Market Size 2026: USD $9.5B Market Size 2031: USD $17.1B CAGR: 12.4%

Situation Analysis: what is really happening

• Sequencing takes the lead. NGS-based companion diagnostics grow 17.5% a year, from $3.3 billion to $7.4 billion, and take 54% of the $7.6 billion of new spending. Their share of the market rises from 35% to 43%.
• Blood joins tissue. Blood-based companion diagnostics grow 19.4% a year to $5.9 billion, and their share rises from 26% to 35%. Guardant360 CDx was approved in September 2026 for repeat testing every three months, and Signatera CDx became the first MRD companion diagnostic.
• Antibody-drug conjugates revive tissue testing. Antibodies and ADCs grow 15.1% a year to $4.7 billion and supply 31% of the growth, as HER2-low and HER2-ultralow, CLDN18.2, c-Met and TROP2 drive new protein tests.
• AI is becoming part of the test. Digital pathology and AI is the fastest-growing technology, rising from $190 million to $599 million at 25.7% a year. A Phase 3 trial now selects patients with an AI-scored TROP2 test.
• Growth beyond oncology. Neurology grows 33.2% a year as blood tests for amyloid select patients for Alzheimer's drugs, and gene therapy and rare disease tests grow 20.7% a year.
• Regulation diverges. The FDA renamed its companion diagnostics list in July 2026 to cover every regulatory route, the EU's IVDR reached its main deadline for companion diagnostics in May 2026, and U.S. laboratories can still offer therapy-selection tests without FDA review.

Company Analysis: who is positioned, who is exposed

• Roche (Roche Tissue Diagnostics and Foundation Medicine): The largest participant, with the leading IHC portfolio, the broadest NGS claims and an AI-scored TROP2 test in Phase 3.
• Agilent: PD-L1 IHC 22C3 and 28-8 pharmDx gained new oesophageal and gastric cancer indications with Opdivo in 2026.
• Guardant Health: 29 CDx indications globally and the first approval for repeat blood testing during treatment.
• Thermo Fisher Scientific and Illumina: Distributable NGS kits, Oncomine Dx Express and TruSight Oncology Comprehensive, bring comprehensive testing into hospital laboratories.
• Tempus AI: Bought the AI pathology company Paige to combine sequencing, pathology and clinical data.
• Labcorp, Natera and SOPHiA GENETICS: PGDx elio approved for BRAF melanoma, the first MRD companion diagnostic, and two decentralised CDx programmes with AstraZeneca.

Plus 93 more company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products.

Questions this report answers

• How fast will NGS panels take share from single-analyte PCR and IHC tests?
• How large can blood-based and repeat-testing companion diagnostics become?
• Which antibody-drug conjugate biomarkers will drive new tissue tests, and where does AI scoring fit?
• How will the IVDR in Europe and the end of the FDA's LDT rule in the U.S. change the market?
• Who are the leading companies and partners, and what are CDx deals worth?
• How large is each country market, and how fast is China growing?

What's inside

• 412 pages, 24 chapters, 50 tables and 63 figures
• Forecasts for 2027–2031 from a 2026 base year, by disease area, therapy class, technology, sample type and product & service, for 14 countries and regions
• Approved companion diagnostic landscape, clinical evidence and biomarker pipeline, technology landscape, pharma partnerships and business models
• Regulation and reimbursement, intellectual property and pricing, a China chapter, a deal database and laboratory operations
• 10 market-moving developments from 2025 and 2026, SWOT, Porter's Five Forces and strategic recommendations
• 102 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostics executives and business development teams: size CDx opportunities by technology and therapy class and find pharma partners and acquisition targets.
• Pharma companion diagnostic teams: choose diagnostic partners and platforms early and plan for global regulatory requirements.
• Investors and analysts: model the growth of NGS, blood-based and AI-scored testing and benchmark deal values.
• Laboratory and instrument suppliers: judge demand for sequencing, PCR, IHC and software in central and hospital laboratories.

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ABOUT THE LEAD AUTHOR

Mr. Greg Powell, B.Sc., M.B.A., is the President of Howe Sound Research. His education includes:

Finance for Senior Executives - Harvard Business School

Market Research - Burke Institute

M.B.A. (Finance and Policy) - University of British Columbia

B.Sc. (Chemistry) - University of British Columbia

He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years.