Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Industry Overview 2025: Growth Projections and Market Trends
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What Are The Current (2025) And Forecast (2029) Sizes Of The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?
The artificial intelligence (AI) in in vitro diagnostics (IVD) market size has seen rapid expansion in recent years. It is forecast to increase from $2.57 billion in 2024 to $3.04 billion in 2025, exhibiting a compound annual growth rate (CAGR) of 18.5%. This historical growth can be attributed to several factors, including an escalating shortage of skilled healthcare professionals and radiologists, increasing governmental and regulatory support for artificial intelligence-based diagnostics, the expanding application of artificial intelligence in genomic and molecular diagnostics, growing awareness among clinicians about the accuracy offered by artificial intelligence-enabled diagnostics, and the rising availability of cloud-based artificial intelligence diagnostic solutions.
The artificial intelligence (AI) in in vitro diagnostics (IVD) market is anticipated to expand significantly in the upcoming years. It is projected to reach $5.94 billion by 2029, growing at a compound annual growth rate (CAGR) of 18.2%. This growth over the forecast period is driven by factors such as a greater need for quick and accurate diagnostic results, an increasing occurrence of chronic and infectious diseases, a rising demand for personalized and precision medicine methods, an enhanced focus on early disease detection and prevention, and the growing digitalization of healthcare along with the adoption of electronic health records (EHR). Key trends expected during this period include advancements in deep learning for pathology and imaging, innovations in fully automated high-throughput analyzers, the integration of natural language processing into diagnostic reporting, progress in AI-enabled remote diagnostic platforms, and the incorporation of AI with wearable and point-of-care devices.
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Which Drivers Are Shaping The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Industry’s Market Share?
The escalating demand for personalized medicine is projected to drive the growth of artificial intelligence (AI) in in vitro diagnostics (IVD) market moving ahead. Personalized medicine refers to a healthcare strategy that tailors prevention, diagnosis, and treatment according to an individual’s genetic profile, lifestyle, and environment. Its increasing adoption is propelled by advancements in genomic data and sequencing technologies, which enable more accurate, targeted, and effective treatments specifically designed for individual patients. Artificial intelligence (AI) in in vitro diagnostics (IVD) aids personalized medicine by scrutinizing complex diagnostic data to identify patient-specific disease patterns, thereby allowing for precise, timely, and customized treatment decisions. For instance, in February 2024, the Personalized Medicine Coalition, a US-based non-profit organization, reported that in 2023, the FDA sanctioned 16 new personalized treatments for rare disease patients, an increase from six in 2022. The newly approved personalized treatments for 2023 also included seven cancer drugs and three for other diseases and conditions. Consequently, the rising demand for personalized medicine is powering the growth of artificial intelligence (AI) in in vitro diagnostics (IVD) market.
What Are The Different Segment Classifications Within The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market?
The artificial intelligence (AI) in in vitro diagnostics (IVD) market covered in this report is segmented as
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
Which Market Trends Are Creating New Opportunities In The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Industry?
Major companies operating in the artificial intelligence (AI) in in vitro diagnostics (IVD) market are concentrating their efforts 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 refers to an AI system for in vitro diagnostics that fulfills EU regulatory standards and offers clear, auditable, and understandable decision-making. For instance, in May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, an intelligent solution engineered to accelerate and enhance PCR diagnostics. This tool automates and speeds up the interpretation of real-time PCR diagnostics with over 99.9% accuracy. It provides transparency by clearly demonstrating how each result is generated, thereby ensuring regulatory compliance and boosting clinical trust. This significantly improves laboratory efficiency, reduces errors, and supports seamless regulatory adherence for molecular diagnostics.
Which Major Firms Are Strengthening Their Position In The Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Industry?
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, and Aiforia Technologies Oyj.
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How Is Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Demand Varying Across Different Regions?
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.
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