The artificial intelligence (ai) in in vitro diagnostics (ivd) market size has grown rapidly in recent years. It will grow from $3.04 billion in 2025 to $3.6 billion in 2026 at a compound annual growth rate (CAGR) of 18.4%. The growth in the historic period can be attributed to rising demand for accurate diagnostics, growth of laboratory infrastructure, increasing prevalence of chronic diseases, adoption of digital diagnostic tools, 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 $7.01 billion in 2030 at a compound annual growth rate (CAGR) of 18.1%. The growth in the forecast period can be attributed to expansion of cloud-based diagnostic platforms, integration of ai with genomics, development of point-of-care ai diagnostics, growing investments in personalized medicine, increasing demand for rapid and cost-effective testing. Major trends in the forecast period include AI-enabled laboratory automation, predictive disease diagnostics, data-driven test interpretation, cloud-based diagnostic platforms, personalized patient profiling.
The growing demand for personalized medicine is expected to drive the expansion of the artificial intelligence (AI) in in vitro diagnostics (IVD) market. Personalized medicine involves tailoring prevention, diagnosis, and treatment based on an individual’s genetic profile, lifestyle, and environment. The increasing adoption of personalized medicine is largely fueled by advancements in genomic data and sequencing technologies, which allow for more precise, effective, and targeted treatments. AI in IVD plays a vital role by analyzing complex diagnostic data to identify disease patterns specific to each patient, helping healthcare providers make timely and accurate treatment decisions. For example, the Personalized Medicine Coalition reported that in February 2024, the FDA approved 16 new personalized treatments for rare diseases in 2023, a significant increase from six in 2022. This includes seven cancer drugs and three treatments for other conditions. The rising demand for personalized medicine is thus driving the growth of AI in IVD.
Companies in the AI in IVD market are focused 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 that meets EU regulatory standards, providing clear, auditable decision-making. In May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, an advanced solution designed to speed up and improve PCR diagnostics. This platform automates real-time PCR result interpretation with over 99.9% accuracy, offering transparency by clearly displaying how each result is derived. This feature ensures regulatory compliance and enhances clinical trust. It also significantly boosts laboratory efficiency, reduces errors, and supports seamless regulatory adherence for molecular diagnostics.
In April 2025, bioMérieux SA, a France-based company specializing in AI for IVD, partnered with Mila, a Canadian AI research institute, to advance research and innovation in AI-driven diagnostics and antibiotic resistance detection. The collaboration aims to create cutting-edge AI solutions that enhance the accuracy and efficiency of IVD tools, with a particular focus on improving the detection of antibiotic resistance. Mila is renowned for its pioneering work in machine learning and AI research.
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.
Tariffs are impacting the ai in vitro diagnostics market by increasing costs of importing laboratory instruments, diagnostic software, and biomarker testing kits, particularly in asia-pacific and european regions. Hardware-heavy segments like laboratory instruments and imaging devices are most impacted, causing delays and higher operational costs for diagnostic laboratories. On the positive side, tariffs are driving local production and innovation, leading to more cost-efficient ai-based diagnostic solutions and regional manufacturing capabilities.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market research report is one of a series of new reports that provides artificial intelligence (AI) in in vitro diagnostics (ivd) market statistics, including artificial intelligence (AI) in in vitro diagnostics (ivd) industry global market size, regional shares, competitors with a artificial intelligence (AI) in in vitro diagnostics (ivd) market share, detailed artificial intelligence (AI) in in vitro diagnostics (ivd) market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in in vitro diagnostics (ivd) industry. This artificial intelligence (AI) in in vitro diagnostics (ivd) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Artificial intelligence (AI) in in vitro diagnostics (IVD) refers to the application of advanced algorithms to analyze medical data obtained from laboratory tests on samples such as blood, tissue, or urine. It enables faster, more accurate, and data-driven interpretation of test results, supporting early disease detection, personalized treatment decisions, and enhanced diagnostic efficiency.
The primary components of AI in in vitro diagnostics include software, hardware, and services. Software consists of programs and data that instruct a computer to perform specific tasks. It leverages technologies such as machine learning, natural language processing, computer vision, robotic process automation, and deep learning, and can be deployed through cloud-based, on-premise, or hybrid methods. Applications include diagnostic imaging, laboratory testing, pathology, genomics, and personalized medicine. Primary end users include hospitals and clinics, diagnostic laboratories, research institutes, pharmaceutical companies, and medical device manufacturers.
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.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
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 $7.01 billion in 2030 at a compound annual growth rate (CAGR) of 18.1%. The growth in the forecast period can be attributed to expansion of cloud-based diagnostic platforms, integration of ai with genomics, development of point-of-care ai diagnostics, growing investments in personalized medicine, increasing demand for rapid and cost-effective testing. Major trends in the forecast period include AI-enabled laboratory automation, predictive disease diagnostics, data-driven test interpretation, cloud-based diagnostic platforms, personalized patient profiling.
The growing demand for personalized medicine is expected to drive the expansion of the artificial intelligence (AI) in in vitro diagnostics (IVD) market. Personalized medicine involves tailoring prevention, diagnosis, and treatment based on an individual’s genetic profile, lifestyle, and environment. The increasing adoption of personalized medicine is largely fueled by advancements in genomic data and sequencing technologies, which allow for more precise, effective, and targeted treatments. AI in IVD plays a vital role by analyzing complex diagnostic data to identify disease patterns specific to each patient, helping healthcare providers make timely and accurate treatment decisions. For example, the Personalized Medicine Coalition reported that in February 2024, the FDA approved 16 new personalized treatments for rare diseases in 2023, a significant increase from six in 2022. This includes seven cancer drugs and three treatments for other conditions. The rising demand for personalized medicine is thus driving the growth of AI in IVD.
Companies in the AI in IVD market are focused 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 that meets EU regulatory standards, providing clear, auditable decision-making. In May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, an advanced solution designed to speed up and improve PCR diagnostics. This platform automates real-time PCR result interpretation with over 99.9% accuracy, offering transparency by clearly displaying how each result is derived. This feature ensures regulatory compliance and enhances clinical trust. It also significantly boosts laboratory efficiency, reduces errors, and supports seamless regulatory adherence for molecular diagnostics.
In April 2025, bioMérieux SA, a France-based company specializing in AI for IVD, partnered with Mila, a Canadian AI research institute, to advance research and innovation in AI-driven diagnostics and antibiotic resistance detection. The collaboration aims to create cutting-edge AI solutions that enhance the accuracy and efficiency of IVD tools, with a particular focus on improving the detection of antibiotic resistance. Mila is renowned for its pioneering work in machine learning and AI research.
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.
Tariffs are impacting the ai in vitro diagnostics market by increasing costs of importing laboratory instruments, diagnostic software, and biomarker testing kits, particularly in asia-pacific and european regions. Hardware-heavy segments like laboratory instruments and imaging devices are most impacted, causing delays and higher operational costs for diagnostic laboratories. On the positive side, tariffs are driving local production and innovation, leading to more cost-efficient ai-based diagnostic solutions and regional manufacturing capabilities.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market research report is one of a series of new reports that provides artificial intelligence (AI) in in vitro diagnostics (ivd) market statistics, including artificial intelligence (AI) in in vitro diagnostics (ivd) industry global market size, regional shares, competitors with a artificial intelligence (AI) in in vitro diagnostics (ivd) market share, detailed artificial intelligence (AI) in in vitro diagnostics (ivd) market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in in vitro diagnostics (ivd) industry. This artificial intelligence (AI) in in vitro diagnostics (ivd) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Artificial intelligence (AI) in in vitro diagnostics (IVD) refers to the application of advanced algorithms to analyze medical data obtained from laboratory tests on samples such as blood, tissue, or urine. It enables faster, more accurate, and data-driven interpretation of test results, supporting early disease detection, personalized treatment decisions, and enhanced diagnostic efficiency.
The primary components of AI in in vitro diagnostics include software, hardware, and services. Software consists of programs and data that instruct a computer to perform specific tasks. It leverages technologies such as machine learning, natural language processing, computer vision, robotic process automation, and deep learning, and can be deployed through cloud-based, on-premise, or hybrid methods. Applications include diagnostic imaging, laboratory testing, pathology, genomics, and personalized medicine. Primary end users include hospitals and clinics, diagnostic laboratories, research institutes, pharmaceutical companies, and medical device manufacturers.
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.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 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
List of Tables
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.
Report 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 Segmentation: 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
The companies featured in this AI in in Vitro Diagnostics (IVD) market report include:- 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
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 250 |
| Published | February 2026 |
| Forecast Period | 2026 - 2030 |
| Estimated Market Value ( USD | $ 3.6 Billion |
| Forecasted Market Value ( USD | $ 7.01 Billion |
| Compound Annual Growth Rate | 18.1% |
| Regions Covered | Global |
| No. of Companies Mentioned | 22 |
