AI in Pathology Markets 2027–2031

AI in Pathology Markets: Market Forecast, Competitive Landscape, Regulation and World Metropolitan Area Market Sizes, 2027–2031

Global forecasts by cancer type, AI function, specimen type, end user and product, for 14 countries and regions and 237 metropolitan areas, with 32 company profiles. Artificial intelligence applied to pathology slides and images: AI algorithms and apps, AI-based tests and lab services, the AI value of digital pathology platforms, and services and data.

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Our Take

Pathology is the first wave of AI in diagnostics. Algorithms that once helped pathologists find cancer on the slide now grade it, score biomarkers and predict who will respond to which therapy, from the same H&E slide. The market grows from $810.0 million in 2026 to $1,600.0 million in 2031, at 14.6% a year, as the slide itself becomes a test and the platforms consolidate into the hands of the diagnostics majors.

Market Size 2026: USD $810M Market Size 2031: USD $1,600M CAGR: 14.6%

Situation Analysis: what is really happening

• From finding cancer to predicting it. Biomarker prediction and prognosis AI rise from 24.0% to 31.0% of the market; Prognosis & Response Prediction grows 21.7% a year.
• The slide becomes a test. AI-Based Tests & Lab Services are the fastest-growing product line at 17.6% a year, after the FDA cleared ArteraAI Breast and Tempus launched Paige Predict.
• The platforms consolidate. Agilent agreed to acquire Proscia, Roche agreed to acquire PathAI, Grundium bought Visiopharm and AstraZeneca bought Modella AI.
• Pharma pays for the answer. The first Phase 3 trial enrolling on an AI-scored biomarker began, and the FDA qualified PathAI's AIM-NASH for MASH drug trials.
• Beyond H&E. Multiplex & Spatial AI grows 28.6% a year, the fastest specimen type, while Breast overtakes Prostate as the largest cancer type by 2031.
• Payment is the brake. The AMA moved whole-slide AI services into Category III codes without national payment, and China grows 23.4% a year, the fastest of any country.

Company Analysis: who is positioned, who is exposed

• Paige (Tempus AI), PathAI, Ibex, Proscia, Aiforia, Lunit, Waiv and Indica Labs: Leading computational pathology developers and platforms.
• ArteraAI, Visiopharm, Deep Bio, Mindpeak, Modella AI, Techcyte, Nucleai and Deciphex: Specialists in AI-based tests, image analysis, generative AI, cytology, spatial biology and pathology services.
• Roche, Leica Biosystems, Philips, Agilent, Hamamatsu, 3DHISTECH, Hologic and Sectra: Scanner, platform and diagnostics majors building AI into digital pathology.
• AstraZeneca, Quanterix, Bioptimus, CellaVision, Scopio Labs, Labcorp, PreciseDx and Valar Labs: Pharma, spatial, foundation-model, bone marrow and laboratory players.

In all, 32 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 large is the market for AI in pathology, and how fast will it grow?
• Which cancer types, AI functions and specimen types grow fastest?
• How do algorithms and apps, AI-based tests, platforms and services compare?
• What do FDA, IVDR, the EU AI Act and the new CPT codes mean for pathology AI?
• What does consolidation mean for independent developers and laboratories?
• How large is each country market, and which metropolitan areas lead?

What's inside

• 357 pages, 23 chapters, 108 tables and 59 figures
• Forecasts for 2027–2031 from a 2026 base year, by cancer type, AI function, specimen type, end user and product, for 14 countries and regions
• Market sizes for 237 world metropolitan areas in 2026 and 2031, with the top 30 and fastest-growing metros
• Cancer types, AI functions and specimen types; end users and business models; foundation models, scanners and data; digital pathology adoption, validation and workflow; IVD – The Big Picture
• Regulation and reimbursement; 10 market-moving developments; SWOT, Porter's Five Forces and strategic recommendations
• 32 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Pathology AI developers: size target segments, plan regulatory and reimbursement routes and assess partners and acquirers.
• IVD, scanner and platform companies: decide where to build, buy or partner in pathology AI.
• Pharma and CROs: plan AI-scored biomarkers and companion diagnostics.
• Laboratory and pathology leaders, and investors: benchmark adoption and the business case, and assess consolidation and growth.

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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, co-author of "The Radioimmunoassay of Angiotensinogen by Antibody Trapping," and has worked in laboratory testing and management for over 20 years. He has written HSR's research on artificial intelligence in diagnostics since its first edition and presents HSR's Smart IVD webinars.