Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Report 2026

Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Overview

• Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) market size has reached to $3.04 billion in 2025 • Expected to grow to $7.01 billion in 2030 at a compound annual growth rate (CAGR) of 18.1% • Growth Driver: Increasing Demand For Personalized Medicine Driving Growth Of The Market Due To Advances In Genomics And Targeted Therapies • Market Trend: Advancements In AI-Driven Transparent Platforms For Enhanced Diagnostic Accuracy • North America was the largest region in 2025 and Asia Pacific is the fastest growing region.

What Is Covered Under Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?

Artificial intelligence (AI) in in vitro diagnostics (IVD) refers to the use of advanced algorithms to analyze medical data obtained from laboratory tests performed 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 improved diagnostic efficiency. The main components of artificial intelligence (AI) in in vitro diagnostics (IVD) include software, hardware, and services. Software is a collection of programs and data that directs a computer to perform specific tasks. It leverages technologies such as machine learning, natural language processing, computer vision, robotics process automation, and deep learning, and is deployed through cloud-based, on-premise, and hybrid methods. These are applied in applications including diagnostic imaging, laboratory testing, pathology, genomics, and personalized medicine, and serve end users such as hospitals and clinics, diagnostic laboratories, research institutes, pharmaceutical companies, and medical device manufacturers.

What Is The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Growth Forecast?

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.

Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Segmentation

1) By Component: Software, Hardware, Services 2) 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 Systems 2) By Hardware: Laboratory Instruments, Imaging Devices, Point-Of-Care Devices 3) By Services: Consulting And Implementation, Maintenance And Support, Training And Education

What Is The Driver Of The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?

The increasing demand for personalized medicine is expected to propel the growth of artificial intelligence (AI) in in vitro diagnostics (IVD) market going forward. Personalized medicine refers to a healthcare approach that customizes prevention, diagnosis, and treatment based on an individual’s genetic profile, lifestyle, and environment. Personalized medicine is increasing as advances in genomic data and sequencing technologies enable more accurate, targeted, and effective treatments tailored to individual patients. Artificial intelligence (AI) in in vitro diagnostics (IVD) helps personalized medicine by analyzing complex diagnostic data to identify patient-specific disease patterns, enabling precise, timely, and tailored 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 rare disease patients, up from six in 2022. The newly approved personalized treatments for 2023 also include seven cancer drugs and three for other diseases and conditions. Therefore, the increasing demand for personalized medicine is driving the growth of artificial intelligence (AI) in in vitro diagnostics (IVD) industry.

Key Players In The Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market

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

Global Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Trends and Insights

Major 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 enhance diagnostic accuracy, streamline workflows, and support personalized patient care. A CE-IVDR-certified transparent AI platform is an AI system for in vitro diagnostics that meets EU regulatory standards and provides clear, auditable, and understandable decision-making. For instance, in May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, a smart solution to accelerate and enhance PCR diagnostics. That automates and accelerates the interpretation of real-time PCR diagnostics with over 99.9% accuracy. It offers transparency by clearly showing how each result is derived, ensuring regulatory compliance and boosting clinical trust. This significantly enhances laboratory efficiency, reduces errors, and supports seamless regulatory adherence for molecular diagnostics.

What Are Latest Mergers And Acquisitions In The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?

In April 2025, bioMérieux SA, a France-based technology company specializing in artificial intelligence (AI) for in vitro diagnostics (IVD), partnered with Mila to promote AI-driven diagnostic research and innovation. This partnership aims to create advanced AI solutions to enhance the accuracy and efficiency of in vitro diagnostic tools and improve the detection of antibiotic resistance. Mila is a Canada-based artificial intelligence research institute known for its cutting-edge machine learning research.

Regional Outlook

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 this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain

What Defines the Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?

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.

How is Market Value Defined and Measured?

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.