The artificial intelligence (AI) in in vitro diagnostics (ivd) market size has grown exponentially in recent years. It will grow from $0.53 billion in 2025 to $0.64 billion in 2026 at a compound annual growth rate (CAGR) of 20.2%. The growth in the historic period can be attributed to increasing demand for accurate diagnostics, expansion of laboratory infrastructure, rising prevalence of chronic diseases, growing adoption of digital diagnostic tools, and advancements in biomarker research.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market size is expected to see rapid growth in the next few years. It will grow to $1.33 billion in 2030 at a compound annual growth rate (CAGR) of 19.8%. The growth during the forecast period can be attributed to the expansion of cloud-based diagnostic platforms, increasing integration of AI with genomics, development of AI-enabled point-of-care diagnostics, growing investments in personalized medicine, and rising demand for rapid and cost-effective testing. Major trends during the forecast period include AI-enabled laboratory automation, predictive disease diagnostics, data-driven test interpretation, expansion of cloud-based diagnostic platforms, and personalized patient profiling.
The increasing demand for personalized medicine is anticipated to support the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market going forward. Personalized medicine refers to a healthcare approach that tailors prevention, diagnosis, and treatment according to an individual’s genetic profile, lifestyle, and environmental factors. Personalized medicine is expanding as advancements in genomic data and sequencing technologies enable more accurate, targeted, and effective treatments that are customized to individual patients. Artificial intelligence (AI) in in vitro diagnostics (IVD) supports personalized medicine by analyzing complex diagnostic information to identify patient-specific disease patterns, enabling accurate, timely, and customized treatment decisions. For instance, in February 2024, according to the Personalized Medicine Coalition, a US-based non-profit organization, in 2023, the FDA approved 16 new personalized treatments for patients with rare diseases, compared with six in 2022. The newly approved personalized treatments in 2023 also included seven cancer drugs and three treatments for other diseases and conditions. Therefore, the increasing demand for personalized medicine is driving the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market.
Key companies operating in the artificial intelligence (AI) in in vitro diagnostics (IVD) market are focusing on developing advanced solutions, such as CE-IVDR-certified transparent AI platforms, to improve diagnostic accuracy, streamline workflows, and support personalized patient care. A CE-IVDR-certified transparent AI platform is an AI system used for in vitro diagnostics that complies with EU regulatory standards and provides clear, auditable, and understandable decision-making processes. For example, in May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, a smart solution designed to accelerate and improve PCR diagnostics. The solution automates and accelerates the interpretation of real-time PCR diagnostics with more than 99.9% accuracy. It provides transparency by clearly demonstrating how each result is generated, supporting regulatory compliance and increasing clinical trust. This substantially improves laboratory efficiency, minimizes errors, and enables seamless regulatory adherence for molecular diagnostics.
In April 2025, bioMérieux SA, a France-based technology company specializing in artificial intelligence (AI) for in vitro diagnostics (IVD), entered into a partnership with Mila to advance AI-driven diagnostic research and innovation. This partnership aims to develop advanced AI solutions that improve the accuracy and efficiency of in vitro diagnostic tools and enhance the detection of antibiotic resistance. Mila is a Canada-based artificial intelligence research institute recognized for its cutting-edge research in machine learning.
Major companies operating in the artificial intelligence (AI) in in vitro diagnostics (ivd) market are Roche Diagnostics GmbH, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Illumina Inc., Hologic Inc., Sysmex Corporation, QIAGEN N.V., Tempus Labs Inc., BillionToOne Inc., PathAI Inc., Proscia Inc., Indica Labs Inc., Visiopharm A/S, aetherAI Co. Ltd., Ibex Medical Analytics Ltd., Mindpeak GmbH, OncoHost Ltd., Qritive, Aiforia Technologies Oyj.
North America was the largest region in the artificial intelligence (AI) in in vitro diagnostics (IVD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The artificial intelligence (AI) in in vitro diagnostics (IVD) market includes revenues earned by entities by providing services such as predictive analytics services, remote diagnostic and telepathology services, workflow automation, optimization services, data annotation, and clinical decision support services. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) in in vitro diagnostics (IVD) market also includes sales of automated laboratory instruments, artificial intelligence-enabled digital pathology scanners, and liquid biopsy diagnostic kits. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
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The artificial intelligence (AI) in in vitro diagnostics (ivd) market size is expected to see rapid growth in the next few years. It will grow to $1.33 billion in 2030 at a compound annual growth rate (CAGR) of 19.8%. The growth during the forecast period can be attributed to the expansion of cloud-based diagnostic platforms, increasing integration of AI with genomics, development of AI-enabled point-of-care diagnostics, growing investments in personalized medicine, and rising demand for rapid and cost-effective testing. Major trends during the forecast period include AI-enabled laboratory automation, predictive disease diagnostics, data-driven test interpretation, expansion of cloud-based diagnostic platforms, and personalized patient profiling.
The increasing demand for personalized medicine is anticipated to support the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market going forward. Personalized medicine refers to a healthcare approach that tailors prevention, diagnosis, and treatment according to an individual’s genetic profile, lifestyle, and environmental factors. Personalized medicine is expanding as advancements in genomic data and sequencing technologies enable more accurate, targeted, and effective treatments that are customized to individual patients. Artificial intelligence (AI) in in vitro diagnostics (IVD) supports personalized medicine by analyzing complex diagnostic information to identify patient-specific disease patterns, enabling accurate, timely, and customized treatment decisions. For instance, in February 2024, according to the Personalized Medicine Coalition, a US-based non-profit organization, in 2023, the FDA approved 16 new personalized treatments for patients with rare diseases, compared with six in 2022. The newly approved personalized treatments in 2023 also included seven cancer drugs and three treatments for other diseases and conditions. Therefore, the increasing demand for personalized medicine is driving the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market.
Key companies operating in the artificial intelligence (AI) in in vitro diagnostics (IVD) market are focusing on developing advanced solutions, such as CE-IVDR-certified transparent AI platforms, to improve diagnostic accuracy, streamline workflows, and support personalized patient care. A CE-IVDR-certified transparent AI platform is an AI system used for in vitro diagnostics that complies with EU regulatory standards and provides clear, auditable, and understandable decision-making processes. For example, in May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, a smart solution designed to accelerate and improve PCR diagnostics. The solution automates and accelerates the interpretation of real-time PCR diagnostics with more than 99.9% accuracy. It provides transparency by clearly demonstrating how each result is generated, supporting regulatory compliance and increasing clinical trust. This substantially improves laboratory efficiency, minimizes errors, and enables seamless regulatory adherence for molecular diagnostics.
In April 2025, bioMérieux SA, a France-based technology company specializing in artificial intelligence (AI) for in vitro diagnostics (IVD), entered into a partnership with Mila to advance AI-driven diagnostic research and innovation. This partnership aims to develop advanced AI solutions that improve the accuracy and efficiency of in vitro diagnostic tools and enhance the detection of antibiotic resistance. Mila is a Canada-based artificial intelligence research institute recognized for its cutting-edge research in machine learning.
Major companies operating in the artificial intelligence (AI) in in vitro diagnostics (ivd) market are Roche Diagnostics GmbH, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Illumina Inc., Hologic Inc., Sysmex Corporation, QIAGEN N.V., Tempus Labs Inc., BillionToOne Inc., PathAI Inc., Proscia Inc., Indica Labs Inc., Visiopharm A/S, aetherAI Co. Ltd., Ibex Medical Analytics Ltd., Mindpeak GmbH, OncoHost Ltd., Qritive, Aiforia Technologies Oyj.
North America was the largest region in the artificial intelligence (AI) in in vitro diagnostics (IVD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The artificial intelligence (AI) in in vitro diagnostics (IVD) market includes revenues earned by entities by providing services such as predictive analytics services, remote diagnostic and telepathology services, workflow automation, optimization services, data annotation, and clinical decision support services. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) in in vitro diagnostics (IVD) market also includes sales of automated laboratory instruments, artificial intelligence-enabled digital pathology scanners, and liquid biopsy diagnostic kits. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
This product will be delivered within 3-5 business days.
Table of Contents
1. Executive Summary
2. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Characteristics
3. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Supply Chain Analysis
4. Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Trends And Strategies
5. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Analysis Of End Use Industries
7. Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis
8. Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Total Addressable Market (TAM) Analysis for the Market
9. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Segmentation
10. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Regional And Country Analysis
11. Asia-Pacific Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
12. China Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
13. India Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
14. Japan Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
15. Australia Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
16. Indonesia Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
17. South Korea Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
18. Taiwan Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
19. South East Asia Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
20. Western Europe Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
21. UK Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
22. Germany Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
23. France Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
24. Italy Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
25. Spain Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
26. Eastern Europe Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
27. Russia Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
28. North America Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
29. USA Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
30. Canada Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
31. South America Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
32. Brazil Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
33. Middle East Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
34. Africa Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market
36. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Competitive Landscape And Company Profiles
37. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Other Major And Innovative Companies
40. Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market High Potential Countries, Segments and Strategies
41. Appendix
Executive Summary
Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Global Report 2026 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses artificial intelligence (ai) in in vitro diagnostics (ivd) market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for artificial intelligence (ai) in in vitro diagnostics (ivd)? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The artificial intelligence (ai) in in vitro diagnostics (ivd) market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
- The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
- The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
- The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
- The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
- The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
- Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.
Scope
Markets Covered:
1) By Component: Software; Hardware; Services2) By Technology: Machine Learning; Natural Language Processing; Computer Vision; Robotics Process Automation; Deep Learning
3) By Deployment Model: Cloud-Based; On-Premise; Hybrid
4) By Application: Diagnostic Imaging; Laboratory Testing; Pathology; Genomics; Personalized Medicine
5) By End User: Hospitals And Clinics; Diagnostic Laboratories; Research Institutes; Pharmaceutical Companies; Medical Device Manufacturers
Subsegments:
1) By Software: Diagnostic Algorithms; Data Analytics Platforms; Decision Support Systems2) By Hardware: Laboratory Instruments; Imaging Devices; Point-Of-Care Devices
3) By Services: Consulting And Implementation; Maintenance And Support; Training And Education
Companies Mentioned: Roche Diagnostics GmbH; Thermo Fisher Scientific Inc.; Abbott Laboratories; Danaher Corporation; Siemens Healthineers AG; Illumina Inc.; Hologic Inc.; Sysmex Corporation; QIAGEN N.V.; Tempus Labs Inc.; BillionToOne Inc.; PathAI Inc.; Proscia Inc.; Indica Labs Inc.; Visiopharm A/S; aetherAI Co. Ltd.; Ibex Medical Analytics Ltd.; Mindpeak GmbH; OncoHost Ltd.; Qritive; Aiforia Technologies Oyj
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain.
Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentations: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: Word, PDF or Interactive Report + Excel Dashboard
Added Benefits
- Bi-Annual Data Update
- Customisation
- Expert Consultant Support
Companies Mentioned
- Roche Diagnostics GmbH
- Thermo Fisher Scientific Inc.
- Abbott Laboratories
- Danaher Corporation
- Siemens Healthineers AG
- Illumina Inc.
- Hologic Inc.
- Sysmex Corporation
- QIAGEN N.V.
- Tempus Labs Inc.
- BillionToOne Inc.
- PathAI Inc.
- Proscia Inc.
- Indica Labs Inc.
- Visiopharm A/S
- aetherAI Co. Ltd.
- Ibex Medical Analytics Ltd.
- Mindpeak GmbH
- OncoHost Ltd.
- Qritive
- Aiforia Technologies Oyj
