AI in In Vitro Diagnostics Markets: Market Forecast, Competitive Landscape, Regulation and World Metropolitan Area Market Sizes by Application, AI Function, Lab Discipline, End User, Product and Country - Strategic Analysis of 40 Companies, 2027 to 2031

AI will drive faster growth in IVD. This edition, which replaces our Smart In Vitro Diagnostics report, sizes the market for artificial intelligence applied to patient specimens — AI-based tests, software and SaaS, AI-embedded instruments, and services and data — at $2,200.0 million in 2026, growing 18.3% a year to $5,100.0 million in 2031. Tests that cannot give a result without a trained AI model are the largest product line at $1,078.0 million (49.0%) in 2026, and AI-embedded instruments grow fastest at 20.0% a year. Oncology is 42.5% of the market, neurology grows fastest at 25.9% a year as Alzheimer's blood tests arrive, and China is the fastest-growing country at 26.6% a year.

The past year changed the industry: Abbott completed its acquisition of Exact Sciences, Medicare multi-cancer early detection coverage became law, an FDA advisory panel backed GRAIL's Galleri, the FDA approved Freenome's SimpleScreen CRC blood test, Roche agreed to acquire PathAI, Tempus launched Paige Predict, and the EU moved AI Act duties for IVDs to August 2028. The report also sizes the roughly $6–7 billion 'AI light' base of classical-algorithm tests that machine learning is now upgrading, and covers regulation and reimbursement, foundation models, validation and lab operations.

"IVD does the heavy lifting. The diagnosis job is essentially done by the lab almost before the patient exam is complete."

Greg Powell, President, Howe Sound Research

40 companies are profiled in this report.

This report includes Major Metropolitan Market Size Tables for 2026 and 2031 covering 237 metropolitan areas.

If their country is not already listed purchasers can request Individual Country Market Size information, or other customization, without additional charge.

All the important facts are here. Industry growth rates. Geographic, application, technology and end-user breakdowns of market size. Explore the potential of artificial intelligence in diagnostics and gain an appreciation of the big picture for an industry that is moving from commodity testing to tests that answer the diagnostic question.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

Product Code: AIIVD 1126

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 Sizing, Forecasting and Sources
2.5 Country and Metropolitan Area Estimates
2.6 Comparability and Limitations

3. Introduction to AI in In Vitro Diagnostics

3.1 What AI Means in the Laboratory
3.2 From Rules to Deep Learning: A Short History
3.3 Where AI Sits in the Testing Pathway
3.4 "AI Is the Diagnostic" versus "AI as Add-On"
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 In Vitro Diagnostics

4.1 Global Market Overview by Country
4.2 Global Market by Application – Overview
4.3 Global Market by AI Function – Overview
4.4 Global Market by Lab Discipline – Overview
4.5 Global Market by End User – Overview
4.6 Global Market by Product – Overview

5. Applications

5.1 Oncology
5.2 Infectious Disease & Sepsis
5.3 Cardiometabolic & Renal
5.4 Neurology
5.5 Reproductive & Genetic Health
5.6 Other
5.7 Leading AI-Based Tests and the 'AI Light' Base

6. AI Functions

6.1 Image & Morphology Analysis
6.2 Genomic & Multi-Omic Interpretation
6.3 Multianalyte Risk Algorithms
6.4 Lab Operations & Quality
6.5 Lab-Data Decision Support

7. Lab Disciplines

7.1 Anatomic Pathology & Cytology
7.2 Hematology & Cell Analysis
7.3 Microbiology
7.4 Molecular & Genomics
7.5 Clinical Chemistry & Immunoassay

8. End Users, Products & Business Models

8.1 Hospital & Health-System Labs
8.2 Commercial Reference Labs
8.3 Specialty Test Developers
8.4 Research & Biopharma
8.5 Product Lines and How They Are Valued
8.6 Business Models: Test Pricing, SaaS and Per-Case Fees
8.7 Instrument Bundling and Data Licensing

9. Regulation & Reimbursement

9.1 The Regulatory Landscape for AI in IVD
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
9.6 Medicare Coverage of Multi-Cancer Early Detection

10. Technology: Foundation Models, Multimodal AI & Data

10.1 Foundation Models in Pathology
10.2 Genomic and Multi-Omic Models
10.3 Large Language Models in Lab Reporting and Interpretation
10.4 Multimodal Integration
10.5 Data, Partnerships and Federated Learning
10.6 Compute, Cloud and Cybersecurity

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 Abbott Completes Its Acquisition of Exact Sciences
12.3 Medicare Multi-Cancer Early Detection Screening Coverage Act Becomes Law
12.4 FDA Advisory Panel Backs GRAIL's Galleri After NHS-Galleri Misses Its Primary Endpoint
12.5 FDA Approves Freenome's SimpleScreen CRC Blood Test, Sold in the US by Abbott
12.6 Roche Agrees to Acquire PathAI
12.7 Tempus Launches Paige Predict After Acquiring Paige
12.8 EU Digital Omnibus Delays AI Act High-Risk Duties for IVDs to August 2028
12.9 FDA Clears Copan's PhenoMATRIX AI Culture-Plate Reading Software
12.10 FDA Approves Natera's Signatera CDx, the First Blood-Based MRD Companion Diagnostic
12.11 FDA Clears Alzheimer's Blood Tests from C2N and Roche

13. Validation, Adoption & Lab Operations

13.1 Validating AI Under CLIA, CAP and ISO 15189
13.2 Performance Drift and Ongoing Monitoring
13.3 LIS, LIMS and IT Integration
13.4 The ROI Case
13.5 Pathologist and Laboratory Workforce
13.6 Change Management and Adoption

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 Specialty Test Developers
16.3 Recommendations for IVD Majors and Instrument Specialists
16.4 Recommendations for Pathology-AI and Software Firms
16.5 Recommendations for Genomics Platforms and Data Companies
16.6 Recommendations for Laboratories
16.7 Recommendations for Investors
16.8 Where to Locate: Using the Metropolitan Tables
16.9 Summary

17. Market Forecast by Application, 2026–2031

17.1 Oncology
17.2 Infectious Disease & Sepsis
17.3 Cardiometabolic & Renal
17.4 Neurology
17.5 Reproductive & Genetic Health
17.6 Other

18. Market Forecast by AI Function, 2026–2031

18.1 Image & Morphology Analysis
18.2 Genomic & Multi-Omic Interpretation
18.3 Multianalyte Risk Algorithms
18.4 Lab Operations & Quality
18.5 Lab-Data Decision Support

19. Market Forecast by Lab Discipline, 2026–2031

19.1 Anatomic Pathology & Cytology
19.2 Hematology & Cell Analysis
19.3 Microbiology
19.4 Molecular & Genomics
19.5 Clinical Chemistry & Immunoassay

20. Market Forecast by End User, 2026–2031

20.1 Hospital & Health-System Labs
20.2 Commercial Reference Labs
20.3 Specialty Test Developers
20.4 Research & Biopharma

21. Market Forecast by Product, 2026–2031

21.1 AI-Based Tests
21.2 Software & SaaS
21.3 AI-Embedded Instruments
21.4 Services & Data

22. Company Profiles

22.1 Abbott (Diagnostics)
22.2 Adaptive Biotechnologies
22.3 Aiforia Technologies
22.4 BD (Diagnostic Solutions, now Waters)
22.5 bioMerieux
22.6 C2N Diagnostics
22.7 CareDx
22.8 Caris Life Sciences
22.9 CellaVision
22.10 Copan
22.11 Cytovale
22.12 Danaher (Leica Biosystems, Beckman Coulter, Cepheid)
22.13 DELFI Diagnostics
22.14 Exact Sciences
22.15 Freenome
22.16 GRAIL
22.17 Guardant Health
22.18 Ibex Medical Analytics
22.19 Illumina
22.20 Indica Labs
22.21 Inflammatix
22.22 Labcorp
22.23 Lunit (Lunit SCOPE)
22.24 Natera
22.25 Owkin (incl. Waiv)
22.26 Paige (Tempus AI)
22.27 PathAI
22.28 Prenosis
22.29 Proscia
22.30 QIAGEN (incl. QIAGEN Digital Insights)
22.31 Quest Diagnostics
22.32 Renalytix
22.33 Roche Diagnostics
22.34 Scopio Labs
22.35 Siemens Healthineers (Diagnostics)
22.36 SOPHiA GENETICS
22.37 Sysmex
22.38 Tempus AI
22.39 Thermo Fisher Scientific
22.40 Veracyte

23. Appendix

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

Product Code: AIIVD 1126

List of Tables

Table 1 Key Market Indicators, AI in In Vitro Diagnostics
Table 2 Global AI in In Vitro Diagnostics Market, 2026–2031 (constant 2026 US$M)
Table 3 AI in In Vitro Diagnostics by Segment, 2026 and 2031 (constant 2026 US$M)
Table 4 AI in In Vitro Diagnostics by Region, 2026 and 2031 (constant 2026 US$M)
Table 5 Scope of the Market
Table 6 The 'AI Light' Base: Leading Classical-Algorithm Tests (outside the forecast)
Table 7 Examples of the Value Basis
Table 8 Segment Definitions
Table 9 AI-Adoption Index by Country
Table 10 Overlap with HSR's Sister Reports
Table 11 Levels of Automation and Learning in Laboratory Software
Table 12 Milestones in AI for In Vitro Diagnostics
Table 13 AI Across the Laboratory Testing Pathway
Table 14 How AI Products Are Counted in This Report
Table 15 Health spending in selected countries and groups, latest available year
Table 16 The four large IVD market segments
Table 17 IVD market players by type
Table 18 Key IVD features and their competitive role
Table 19 Growth of the Medicare Clinical Laboratory Fee Schedule (HCPCS codes)
Table 20 CMS preliminary CY 2027 CLFS rates by category (before the 15% annual cap)
Table 21 Global Market by Country
Table 22 Global Market by Application
Table 23 Global Market by AI Function
Table 24 Global Market by Lab Discipline
Table 25 Global Market by End User
Table 26 Global Market by Product
Table 27 Leading AI-Based and 'AI Light' Tests and Products by Application
Table 28 The 'AI Light' Base: Leading Classical-Algorithm Tests (outside the forecast)
Table 29 The Five AI Function Lines
Table 30 Selected Genomic and Multi-Omic AI Products
Table 31 Examples on Each Side of the Boundary
Table 32 Commercial Features of the AI Function Lines
Table 33 AI Across the Five Lab Disciplines
Table 34 Selected AI Products in Hematology
Table 35 AI in Core-Laboratory Software from Major IVD Suppliers
Table 36 How Hospital Laboratories Buy AI
Table 37 Selected Specialty Test Developers
Table 38 AI in IVD Product Lines
Table 39 AI in IVD Business Models Compared
Table 40 Regulatory Frameworks for AI in IVD, Selected Regions
Table 41 Selected FDA Precedents for AI in Pathology and Laboratory Medicine
Table 42 IVDR Transition Deadlines under Regulation (EU) 2024/1860
Table 43 EU Regulatory Timeline for AI-Based IVDs
Table 44 US Regulatory and Reimbursement Timeline for AI-Based IVDs
Table 45 Selected Pathology Foundation Models
Table 46 Selected Genomic AI Models and Tools
Table 47 Data Strategies in AI Diagnostics
Table 48 AI in IVD market by country and region, 2026 and 2031 (US$ millions, constant 2026 dollars)
Table 49 Regulatory and reimbursement setting for AI in IVD by region
Table 50 Top 30 Metropolitan AI in IVD Markets, 2031
Table 51 Fastest-Growing Metropolitan AI in IVD Markets, 2026–2031 (2026 market of US$1M or more)
Table 52 World Metropolitan Areas AI in IVD Market, 2026 and 2031
Table 53 Frameworks for Validating AI in Laboratories
Table 54 Integration Points for AI in the Laboratory
Table 55 Stages of AI Adoption in the Laboratory
Table 56 Tiers of Competitor in AI in In Vitro Diagnostics
Table 57 Leading Competitors by Application (constant 2026 US$M)
Table 58 Leading Competitors by Product Line (constant 2026 US$M)
Table 59 Leading Competitors by Region (constant 2026 US$M)
Table 60 Positioning Map of AI in IVD Competitors, Described as a Table
Table 61 Selected Consolidation and Financing Deals in AI in IVD, 2025–2026
Table 62 What Wins the Award, by Customer Type
Table 63 SWOT Analysis: Strengths and Weaknesses
Table 64 SWOT Analysis: Opportunities and Threats
Table 65 SWOT Summary by Competitor Tier
Table 66 Porter's Five Forces: HSR Ratings for AI in In Vitro Diagnostics
Table 67 Investment Risk Register for AI in In Vitro Diagnostics, 2027–2031
Table 68 Forecast Sensitivity by Line
Table 69 Largest Growth Increments by Segment, 2026–2031 (constant 2026 US$M)
Table 70 Location Priorities by Player Type
Table 71 Summary of Strategic Recommendations
Table 72 Oncology by Country
Table 73 Infectious Disease & Sepsis by Country
Table 74 Cardiometabolic & Renal by Country
Table 75 Neurology by Country
Table 76 Reproductive & Genetic Health by Country
Table 77 Other by Country
Table 78 Image & Morphology Analysis by Country
Table 79 Genomic & Multi-Omic Interpretation by Country
Table 80 Multianalyte Risk Algorithms by Country
Table 81 Lab Operations & Quality by Country
Table 82 Lab-Data Decision Support by Country
Table 83 Anatomic Pathology & Cytology by Country
Table 84 Hematology & Cell Analysis by Country
Table 85 Microbiology by Country
Table 86 Molecular & Genomics by Country
Table 87 Clinical Chemistry & Immunoassay by Country
Table 88 Hospital & Health-System Labs by Country
Table 89 Commercial Reference Labs by Country
Table 90 Specialty Test Developers by Country
Table 91 Research & Biopharma by Country
Table 92 AI-Based Tests by Country
Table 93 Software & SaaS by Country
Table 94 AI-Embedded Instruments by Country
Table 95 Services & Data by Country
Table 96 Main Regulations, Guidance and Standards for AI in In Vitro Diagnostics

List of Figures

Figure 1 Key Graphic – The algorithm is the test
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 Application - Base vs. Final
Figure 12 Global Market by Application Base Year
Figure 13 Global Market by Application End Year
Figure 14 Application Share by Year
Figure 15 Application 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 Lab Discipline - Base vs. Final
Figure 22 Global Market by Lab Discipline Base Year
Figure 23 Global Market by Lab Discipline End Year
Figure 24 Lab Discipline Share by Year
Figure 25 Lab Discipline 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 Oncology Growth
Figure 37 Infectious Disease & Sepsis Growth
Figure 38 Cardiometabolic & Renal Growth
Figure 39 Neurology Growth
Figure 40 Reproductive & Genetic Health Growth
Figure 41 Other Growth
Figure 42 Image & Morphology Analysis Growth
Figure 43 Genomic & Multi-Omic Interpretation Growth
Figure 44 Multianalyte Risk Algorithms Growth
Figure 45 Lab Operations & Quality Growth
Figure 46 Lab-Data Decision Support Growth
Figure 47 Anatomic Pathology & Cytology Growth
Figure 48 Hematology & Cell Analysis Growth
Figure 49 Microbiology Growth
Figure 50 Molecular & Genomics Growth
Figure 51 Clinical Chemistry & Immunoassay Growth
Figure 52 Hospital & Health-System Labs Growth
Figure 53 Commercial Reference Labs Growth
Figure 54 Specialty Test Developers Growth
Figure 55 Research & Biopharma Growth
Figure 56 AI-Based Tests Growth
Figure 57 Software & SaaS Growth
Figure 58 AI-Embedded Instruments Growth
Figure 59 Services & Data Growth

AI in In Vitro Diagnostics Markets: Market Forecast, Competitive Landscape, Regulation and World Metropolitan Area Market Sizes by Application, AI Function, Lab Discipline, End User, Product and Country - Strategic Analysis of 40 Companies, 2027 to 2031

Description

Table of Contents

List of Tables

Report Overview:

Table of Contents

List of Tables

List of Figures

1. Executive Summary

2. Research Methodology & Scope

3. Introduction to AI in In Vitro Diagnostics

4. The Global Market for AI in In Vitro Diagnostics

5. Applications

6. AI Functions

7. Lab Disciplines

8. End Users, Products & Business Models

9. Regulation & Reimbursement

10. Technology: Foundation Models, Multimodal AI & Data

11. International Markets & World Metropolitan Areas

12. Recent Developments

13. Validation, Adoption & Lab Operations

14. Competitive Landscape

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

16. Strategic Recommendations

17. Market Forecast by Application, 2026–2031

18. Market Forecast by AI Function, 2026–2031

19. Market Forecast by Lab Discipline, 2026–2031

20. Market Forecast by End User, 2026–2031

21. Market Forecast by Product, 2026–2031

22. Company Profiles

23. Appendix

List of Tables

List of Figures