AI in Pathology Markets: Market Forecast, Competitive Landscape, Regulation and World Metropolitan Area Market Sizes by Cancer Type, AI Function, Specimen Type, End User, Product and Country - Strategic Analysis of 32 Companies, 2027 to 2031

Table of Contents

List of Tables

List of Figures

1. Executive Summary

• 1.1 Situation Analysis
• 1.2 Market Snapshot
• 1.3 Key Findings
• 1.4 Investment & Strategic Thesis

2. Research Methodology & Scope

• 2.1 Definition and Scope
• 2.2 Value Basis and the 'AI Light' Base
• 2.3 The Five Market Segments
• 2.4 The Bridge to HSR's AI in In Vitro Diagnostics Report
• 2.5 Sizing, Forecasting and Sources
• 2.6 Country and Metropolitan Area Estimates
• 2.7 Comparability and Limitations

3. Introduction to AI in Pathology

• 3.1 Digital Pathology: Scanners, Whole-Slide Images and Image Management
• 3.2 From Image Analysis to Deep Learning and Foundation Models
• 3.3 AI in the Pathology Workflow
• 3.4 "AI as the Test" versus "AI as an Assistant"
• 3.5 Evidence, Bias and Generalisability
• 3.6 The Industry and Its Players
• 3.7 IVD – The Big Picture

4. The Global Market for AI in Pathology

• 4.1 Global Market Overview by Country
• 4.2 Global Market by Cancer Type – Overview
• 4.3 Global Market by AI Function – Overview
• 4.4 Global Market by Specimen Type – Overview
• 4.5 Global Market by End User – Overview
• 4.6 Global Market by Product – Overview

5. Cancer Types

• 5.1 Prostate
• 5.2 Breast
• 5.3 Lung
• 5.4 Colorectal & GI
• 5.5 Hematologic & Other Cancers
• 5.6 Non-Oncology
• 5.7 Leading Pathology AI Products

6. AI Functions

• 6.1 Detection & Diagnosis
• 6.2 Grading & Quantification
• 6.3 Biomarker Prediction
• 6.4 Prognosis & Response Prediction
• 6.5 Workflow, QC & Triage

7. Specimen Types

• 7.1 H&E Histology
• 7.2 IHC & Special Stains
• 7.3 Cytology
• 7.4 Hematopathology & Bone Marrow
• 7.5 Multiplex & Spatial

8. End Users, Products & Business Models

• 8.1 Hospital & Academic Labs
• 8.2 Commercial & Reference Labs
• 8.3 Pharma & CROs
• 8.4 Research Institutions
• 8.5 Product Lines and How They Are Valued
• 8.6 Per-Case and Per-Slide Fees
• 8.7 Enterprise Licences and Subscriptions
• 8.8 Platform App Stores and Marketplaces
• 8.9 Pharma Services and CDx Development
• 8.10 Data Licensing
• 8.11 Consolidation and What It Means for Buyers

9. Regulation & Reimbursement

• 9.1 The Regulatory Landscape for Pathology AI
• 9.2 United States: FDA
• 9.3 European Union: IVDR and the AI Act
• 9.4 United Kingdom, China and Japan
• 9.5 US Reimbursement: Codes, Pricing and Coverage

10. Technology: Foundation Models, Scanners, Compute & Data

• 10.1 Foundation Models in Pathology
• 10.2 Generative and Agentic AI
• 10.3 Scanners, Image Quality and Standards
• 10.4 Multiplex, Spatial and Virtual Staining
• 10.5 Compute, Storage and Cloud
• 10.6 Data, Partnerships and Federated Learning

11. International Markets & World Metropolitan Areas

• 11.1 The Global Picture
• 11.2 North America
• 11.3 Europe
• 11.4 Asia-Pacific
• 11.5 Latin America, the Middle East and Africa
• 11.6 World Metropolitan Area Market Sizes

12. Recent Developments

• 12.1 About This Section
• 12.2 Agilent Agrees to Acquire Proscia
• 12.3 Roche Agrees to Acquire PathAI
• 12.4 Grundium Acquires Visiopharm
• 12.5 FDA Clears ArteraAI Breast, the First AI Breast Cancer Prognostic Test
• 12.6 Tempus Launches Paige Predict to Read Biomarkers from a Single H&E Slide
• 12.7 AstraZeneca and Daiichi Sankyo Start the First Pivotal Trial Enrolling on an AI-Scored Biomarker
• 12.8 FDA Qualifies PathAI's AIM-NASH, the First AI Pathology Tool Qualified for MASH Drug Trials
• 12.9 Labcorp Expands PathAI Deal to Deploy AISight Dx Across Its US Network
• 12.10 FDA Clears Leica's Aperio iQC DX AI Slide-Quality Software
• 12.11 AMA Places Whole-Slide AI Services in Category III as the PLA Moratorium Continues

13. Digital Pathology Adoption, Validation & Workflow

• 13.1 How Far Digitisation Has Gone
• 13.2 United Kingdom: NHS Networks and NPIC
• 13.3 The Netherlands
• 13.4 The Nordic Countries
• 13.5 Validation: CAP Guidance and Laboratory Responsibility
• 13.6 Primary Diagnosis and the Regulatory Path
• 13.7 LIS Integration and the Digital Workflow
• 13.8 Scanner Fleets and Storage
• 13.9 The Pathologist Workforce
• 13.10 The ROI Case
• 13.11 Change Management and Adoption
• 13.12 Implications for the AI Market

14. Competitive Landscape

• 14.1 Six Tiers of Competitor
• 14.2 Leaders by Segment
• 14.3 Leaders by Region
• 14.4 Positioning Map
• 14.5 Consolidation and M&A

15. SWOT, Porter's Five Forces & Investment Risk Analysis

• 15.1 SWOT Analysis of the Industry
• 15.2 Porter's Five Forces
• 15.3 Investment Risk Analysis
• 15.4 Conclusions for Strategy

16. Strategic Recommendations

• 16.1 The Core Advice: Scope, Value and Premium Price
• 16.2 Recommendations for Specialist Algorithm Developers
• 16.3 Recommendations for AI-Test Developers
• 16.4 Recommendations for Platform Owners and Scanner and IVD Majors
• 16.5 Recommendations for Pharma and CROs
• 16.6 Recommendations for Foundation-Model and Technology Companies
• 16.7 Recommendations for Laboratories
• 16.8 Recommendations for Investors
• 16.9 Where to Locate: Using the Metropolitan Tables
• 16.10 Summary

17. Market Forecast by Cancer Type, 2026–2031

• 17.1 Prostate
• 17.2 Breast
• 17.3 Lung
• 17.4 Colorectal & GI
• 17.5 Hematologic & Other Cancers
• 17.6 Non-Oncology

18. Market Forecast by AI Function, 2026–2031

• 18.1 Detection & Diagnosis
• 18.2 Grading & Quantification
• 18.3 Biomarker Prediction
• 18.4 Prognosis & Response Prediction
• 18.5 Workflow, QC & Triage

19. Market Forecast by Specimen Type, 2026–2031

• 19.1 H&E Histology
• 19.2 IHC & Special Stains
• 19.3 Cytology
• 19.4 Hematopathology & Bone Marrow
• 19.5 Multiplex & Spatial

20. Market Forecast by End User, 2026–2031

• 20.1 Hospital & Academic Labs
• 20.2 Commercial & Reference Labs
• 20.3 Pharma & CROs
• 20.4 Research Institutions

21. Market Forecast by Product, 2026–2031

• 21.1 AI Algorithms & Apps
• 21.2 AI-Based Tests & Lab Services
• 21.3 AI-Enabled Platforms
• 21.4 Services & Data

22. Company Profiles

• 22.1 3DHISTECH
• 22.2 Agilent Technologies (Pathology and Proscia)
• 22.3 Aiforia Technologies
• 22.4 ArteraAI (Artera)
• 22.5 AstraZeneca
• 22.6 Bioptimus
• 22.7 CellaVision
• 22.8 Deciphex
• 22.9 Deep Bio
• 22.10 Hamamatsu Photonics (NanoZoomer)
• 22.11 Hologic (Genius Digital Diagnostics)
• 22.12 Ibex Medical Analytics
• 22.13 Indica Labs
• 22.14 Labcorp
• 22.15 Leica Biosystems (Danaher)
• 22.16 Lunit (Lunit SCOPE)
• 22.17 Mindpeak
• 22.18 Modella AI (AstraZeneca)
• 22.19 Nucleai
• 22.20 Paige (Tempus AI)
• 22.21 PathAI
• 22.22 Philips (Digital Pathology)
• 22.23 PreciseDx
• 22.24 Proscia
• 22.25 Quanterix (including Akoya Biosciences)
• 22.26 Roche (Digital Pathology)
• 22.27 Scopio Labs
• 22.28 Sectra (Digital Pathology)
• 22.29 Techcyte
• 22.30 Valar Labs
• 22.31 Visiopharm (Grundium)
• 22.32 Waiv (Owkin diagnostics spin-out)

23. Appendix

• 23.1 Glossary of AI and Pathology Terms
• 23.2 Abbreviations
• 23.3 Regulations, Guidance, Codes and Standards
• 23.4 Report Limitations Restated

List of Tables

• Table 1 Key Market Indicators, AI in Pathology
• Table 2 Global AI in Pathology Market, 2026–2031 (constant 2026 US$M)
• Table 3 AI in Pathology by Segment, 2026 and 2031 (constant 2026 US$M)
• Table 4 AI in Pathology by Region, 2026 and 2031 (constant 2026 US$M)
• Table 5 Scope of the Market
• Table 6 Examples of the Value Basis
• Table 7 Segment Definitions
• Table 8 Bridge from AIIVD Anatomic Pathology & Cytology to AIPATH, 2026
• Table 9 Sizing Anchors: Disclosed Revenues and Deal Values
• Table 10 AI-Adoption Index by Country
• Table 11 Overlap with HSR's Sister Reports
• Table 12 The Digital Pathology Stack and How This Report Treats Each Layer
• Table 13 Milestones in AI for Pathology
• Table 14 Where AI Sits in the Pathology Workflow
• Table 15 How Pathology AI Products Are Counted in This Report
• Table 16 Main Player Groups in AI for Pathology
• Table 17 Health spending in selected countries and groups, latest available year
• Table 18 The four large IVD market segments
• Table 19 IVD market players by type
• Table 20 Key IVD features and their competitive role
• Table 21 Growth of the Medicare Clinical Laboratory Fee Schedule (HCPCS codes)
• Table 22 CMS preliminary CY 2027 CLFS rates by category (before the 15% annual cap)
• Table 23 Global Market by Country
• Table 24 Global Market by Cancer Type
• Table 25 Global Market by AI Function
• Table 26 Global Market by Specimen Type
• Table 27 Global Market by End User
• Table 28 Global Market by Product
• Table 29 AI in Pathology by Cancer Type, 2026 and 2031 (US$ millions, constant 2026 dollars)
• Table 30 Leading Pathology AI Products by Cancer Type
• Table 31 AI Function Lines: Size, Growth and Share of New Revenue
• Table 32 Selected Detection and Diagnosis Products
• Table 33 Grading and Quantification by Score
• Table 34 Selected Biomarker Prediction Products
• Table 35 Selected AI Prognostic and Predictive Tests
• Table 36 Workflow, QC and Triage Tasks
• Table 37 Specimen Type Lines: Size, Growth and Share of New Revenue
• Table 38 AI Across the Five Specimen Types
• Table 39 How AI Uses the H&E Slide
• Table 40 AI on IHC and Special Stains
• Table 41 Selected Cytology AI Products
• Table 42 Selected Haematopathology and Bone Marrow AI Products
• Table 43 Selected Multiplex and Spatial AI Suppliers
• Table 44 AI in Pathology Market by End User, 2026 and 2031 (US$ million)
• Table 45 How Hospital and Academic Labs Buy Pathology AI
• Table 46 AI in Pathology Market by Product, 2026 and 2031 (US$ million)
• Table 47 Business Models in Pathology AI
• Table 48 Regulatory Frameworks for Pathology AI, Selected Regions
• Table 49 Selected FDA Precedents for Digital Pathology and Pathology AI
• Table 50 EU Regulatory Timeline for Pathology AI
• Table 51 US Codes Relevant to Digital Pathology and Pathology AI
• Table 52 Payment Routes for Pathology AI in the US
• Table 53 Selected Pathology Foundation Models
• Table 54 Main Whole-Slide Scanner Families and AI-Related Developments
• Table 55 Compute and Deployment Patterns in Pathology AI
• Table 56 Data Strategies in Pathology AI
• Table 57 AI in pathology market by country and region, 2026 and 2031 (US$ millions, constant 2026 dollars)
• Table 58 Digital pathology adoption, regulation and payment for pathology AI, selected markets
• Table 59 Top 30 Metropolitan AI in Pathology Markets, 2031
• Table 60 Fastest-Growing Metropolitan AI in Pathology Markets, 2026–2031 (2026 market of US$0.5M or more)
• Table 61 World Metropolitan Areas AI in Pathology Market, 2026 and 2031
• Table 62 US Digital Pathology Adoption Indicators, 2026
• Table 63 Selected European Digital Pathology Programmes
• Table 64 Validation Duties for Digital Pathology and AI in US Laboratories
• Table 65 Integration Points in an AI-Enabled Digital Pathology Workflow
• Table 66 Where the Return on Investment Comes From
• Table 67 Stages of Digital Pathology and AI Adoption
• Table 68 Tiers of Competitor in AI in Pathology
• Table 69 Leading Competitors by Cancer Type (constant 2026 US$M)
• Table 70 Leading Competitors by Product Line (constant 2026 US$M)
• Table 71 Leading Competitors by Region (constant 2026 US$M)
• Table 72 Positioning Map of AI in Pathology Competitors, Described as a Table
• Table 73 Selected Consolidation and Financing Deals in AI in Pathology, 2025–2026
• Table 74 What Wins the Award, by Customer Type
• Table 75 SWOT Analysis: Strengths and Weaknesses
• Table 76 SWOT Analysis: Opportunities and Threats
• Table 77 SWOT Summary by Competitor Tier
• Table 78 Porter's Five Forces: HSR Ratings for AI in Pathology
• Table 79 Investment Risk Register for AI in Pathology, 2027–2031
• Table 80 Forecast Sensitivity by Line
• Table 81 Largest Growth Increments by Segment, 2026–2031 (constant 2026 US$M)
• Table 82 Location Priorities by Player Type
• Table 83 Summary of Strategic Recommendations
• Table 84 Prostate by Country
• Table 85 Breast by Country
• Table 86 Lung by Country
• Table 87 Colorectal & GI by Country
• Table 88 Hematologic & Other Cancers by Country
• Table 89 Non-Oncology by Country
• Table 90 Detection & Diagnosis by Country
• Table 91 Grading & Quantification by Country
• Table 92 Biomarker Prediction by Country
• Table 93 Prognosis & Response Prediction by Country
• Table 94 Workflow, QC & Triage by Country
• Table 95 H&E Histology by Country
• Table 96 IHC & Special Stains by Country
• Table 97 Cytology by Country
• Table 98 Hematopathology & Bone Marrow by Country
• Table 99 Multiplex & Spatial by Country
• Table 100 Hospital & Academic Labs by Country
• Table 101 Commercial & Reference Labs by Country
• Table 102 Pharma & CROs by Country
• Table 103 Research Institutions by Country
• Table 104 AI Algorithms & Apps by Country
• Table 105 AI-Based Tests & Lab Services by Country
• Table 106 AI-Enabled Platforms by Country
• Table 107 Services & Data by Country
• Table 108 Main Regulations, Guidance, Codes and Standards for AI in Pathology

List of Figures

• Figure 1 Key Graphic – From finding cancer to predicting it
• Figure 2 IVD – The Big Picture: four large segments, defined by who performs the test
• Figure 3 Health spending as a share of GDP, selected countries and groups, latest year
• Figure 4 Who pays for US healthcare: shares of national health expenditure, 2024
• Figure 5 The road to diagnostics: how a new test reaches the patient
• Figure 6 Key US and EU regulatory and payment milestones, 2024–2030
• Figure 7 What buyers pay for: IVD product features from table stakes to the next basis of competition
• Figure 8 Growth of the Medicare Clinical Laboratory Fee Schedule test menu, 2011–2026
• Figure 9 Average change in preliminary 2027 Medicare lab rates vs 2026, by test category
• Figure 10 Global Market Pareto Chart
• Figure 11 Global Market by Cancer Type - Base vs. Final
• Figure 12 Global Market by Cancer Type Base Year
• Figure 13 Global Market by Cancer Type End Year
• Figure 14 Cancer Type Share by Year
• Figure 15 Cancer Type Segments Growth
• Figure 16 Global Market by AI Function - Base vs. Final
• Figure 17 Global Market by AI Function Base Year
• Figure 18 Global Market by AI Function End Year
• Figure 19 AI Function Share by Year
• Figure 20 AI Function Segments Growth
• Figure 21 Global Market by Specimen Type - Base vs. Final
• Figure 22 Global Market by Specimen Type Base Year
• Figure 23 Global Market by Specimen Type End Year
• Figure 24 Specimen Type Share by Year
• Figure 25 Specimen Type Segments Growth
• Figure 26 Global Market by End User - Base vs. Final
• Figure 27 Global Market by End User Base Year
• Figure 28 Global Market by End User End Year
• Figure 29 End User Share by Year
• Figure 30 End User Segments Growth
• Figure 31 Global Market by Product - Base vs. Final
• Figure 32 Global Market by Product Base Year
• Figure 33 Global Market by Product End Year
• Figure 34 Product Share by Year
• Figure 35 Product Segments Growth
• Figure 36 Prostate Growth
• Figure 37 Breast Growth
• Figure 38 Lung Growth
• Figure 39 Colorectal & GI Growth
• Figure 40 Hematologic & Other Cancers Growth
• Figure 41 Non-Oncology Growth
• Figure 42 Detection & Diagnosis Growth
• Figure 43 Grading & Quantification Growth
• Figure 44 Biomarker Prediction Growth
• Figure 45 Prognosis & Response Prediction Growth
• Figure 46 Workflow, QC & Triage Growth
• Figure 47 H&E Histology Growth
• Figure 48 IHC & Special Stains Growth
• Figure 49 Cytology Growth
• Figure 50 Hematopathology & Bone Marrow Growth
• Figure 51 Multiplex & Spatial Growth
• Figure 52 Hospital & Academic Labs Growth
• Figure 53 Commercial & Reference Labs Growth
• Figure 54 Pharma & CROs Growth
• Figure 55 Research Institutions Growth
• Figure 56 AI Algorithms & Apps Growth
• Figure 57 AI-Based Tests & Lab Services Growth
• Figure 58 AI-Enabled Platforms Growth
• Figure 59 Services & Data Growth