Artificial Intelligence (AI) in in Vitro Diagnostics (IVD) Market Report 2025

The artificial intelligence (AI) in in vitro diagnostics (IVD) market size has grown rapidly in recent years. It will grow from $2.57 billion in 2024 to $3.04 billion in 2025 at a compound annual growth rate (CAGR) of 18.5%. Growth in the historic period was driven by a shortage of skilled healthcare professionals and radiologists, increasing government and regulatory support for AI-based diagnostics, growing application of AI in genomic and molecular diagnostics, rising awareness among clinicians of AI-enabled diagnostic accuracy, and greater availability of cloud-based AI diagnostic solutions.

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 $5.94 billion in 2029 at a compound annual growth rate (CAGR) of 18.2%. Growth in the forecast period is expected to result from increasing demand for rapid and accurate diagnostic results, higher prevalence of chronic and infectious diseases, growing need for personalized and precision medicine approaches, stronger focus on early disease detection and prevention, and greater healthcare digitization with widespread adoption of electronic health records. Primary trends anticipated for the forecast period include advancements in deep learning for pathology and imaging, innovations in fully automated high-throughput analyzers, integration of natural language processing in diagnostic reporting, development of AI-enabled remote diagnostic platforms, and integration of AI with wearable and point-of-care devices.

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 players 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, and Aiforia Technologies Oyj.

North America was the largest region in the artificial intelligence (AI) in in vitro diagnostics (IVD) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI) in in vitro diagnostics (IVD) report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and 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, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

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 market research report is one of a series of new reports that provides artificial intelligence (AI) in in vitro diagnostics market statistics, including artificial intelligence (AI) in the in vitro diagnostics industry's global market size, regional shares, competitors with an artificial intelligence (AI) in the in vitro diagnostics market share, detailed artificial intelligence (AI) in in vitro diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in the in vitro diagnostics industry. This artificial intelligence (AI) in vitro diagnostics 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.

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.

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