AI In-Vitro Diagnostics Market Expands Rapidly as Point-of-Care Testing and Personalized Healthcare Gain Traction

InsightAce Analytic Pvt. Ltd. announces the release of market assessment report on "Global Smart or AI In-Vitro Diagnostics Market (By Application Area (Cancer Diagnostics, Infectious Disease Testing, Metabolic Testing, Cardiac Testing, Diabetes Testing, and Other Disease Testing), By Technology (Next-Generation Sequencing (NGS)Technology, PCR Technology, Chemistry/IA Technology, Pathology Technology, and Other Technology), By End-User (Research, Pharmaceutical Research, and Clinical), By Region, Trends, Industry Competition Analysis, Revenue And Forecast Till 2034"

According to the latest research by InsightAce Analytic, the global Smart or AI In-Vitro Diagnostics market size is valued at USD 1.6 Bn in 2024, and it is expected to reach USD 6.2 Bn by the year 2034, recording a promising CAGR of 14.8% during the forecast period of 2025-2034.

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In recent years, the prevalence of chronic diseases has risen significantly, accompanied by increased research and development activities aimed at enhancing the accuracy and speed of in-vitro diagnostics (IVD). Additionally, the widespread adoption of innovations necessitated by the COVID-19 pandemic-such as digital pathology and remote sample collection-has further accelerated market expansion.

Technological advancements and the introduction of new products designed to streamline IVD processes are expected to substantially influence the growth of the smart or AI-based IVD market over the forecast period. Key drivers include the rising global incidence of chronic and infectious diseases, heightened awareness of the importance of early diagnosis, a growing shift from centralized laboratory testing to point-of-care diagnostics, and the catalytic effect of the COVID-19 pandemic on testing infrastructure.

Moreover, the market offers significant growth opportunities due to emerging economies, continued innovation in diagnostic technologies, and advancements in fields such as genomics and proteomics. The pandemic notably underscored the essential role of diagnostic testing, leading to a surge in test volumes. In response, leading manufacturers have prioritized the development of novel diagnostic kits and assays to meet growing demand.

Some of the prominent players in the Smart or AI In-Vitro Diagnostics market are:
Adaptive Biotechnologies
Aidoc
Anumana
ARUP Laboratories
Atomwise
Bayesian Health
Behold.ai
BGI Genomics Co. Ltd
bioMérieux Diagnostics
Bio-Rad Laboratories, Inc
Cambridge Cognition
Cardiologs (Phillips)
CareDx
Caris Molecular Diagnostics
Cleerly
ClosedLoop AI
CloudMedX Health
Deepcell
Digital Diagnostics
EKF Diagnostics Holdings
Freenome
GE Healthcare
Glooko
Idoven
Illumina
Infohealth
Jade
K Health
Lunit
MaxCyte
Mayo Clinic Laboratories
Medtronic
Merative
Nanox
NIOX Group
Niramai Health Analytix
NVIDIA
Oncohost
OraLiva
Owkin
Oxford Nanopore Technologies
Pacific Biosciences
Paige.AI
PathAI
Perthera
Philips Healthcare
Prognos
Qiagen
Qure.ai
Renalytix
Seegene
Siemens Healthineers
Sophia Genetics
Sysmex
Viz.ai

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Market Dynamics
Drivers:
The growth of the Indian in-vitro diagnostics (IVD) market is primarily driven by the high prevalence of chronic diseases, increasing adoption of point-of-care (POC) diagnostics, and the rising emphasis on personalized healthcare and companion diagnostics. The escalating incidence of chronic conditions such as cancer and diabetes continues to be a major contributor to market expansion. Additionally, the presence of robust research and manufacturing capabilities among leading industry players is facilitating innovation and development within the sector. Early diagnosis, particularly for cancer, has become increasingly vital for effective and timely treatment, thereby accelerating demand for IVD solutions. Technological innovations such as biosensors, lab-on-a-chip devices, wearable diagnostics, and advanced POC testing systems are also playing a growing role in enhancing healthcare delivery.

Challenges:
The growth of the IVD market is expected to face challenges due to stringent regulatory frameworks and complex reimbursement processes. While regulatory bodies in some emerging markets have streamlined approval timelines for medical devices and diagnostic kits, many regions with developing healthcare infrastructure continue to experience significant delays in the approval process. These delays hinder the timely commercialization of products, thereby constraining revenue generation and slowing market progress.

Regional Trends:
North America is projected to capture a significant share of the smart or AI-driven in-vitro diagnostics market, with strong revenue performance and a high compound annual growth rate (CAGR) anticipated. Key growth drivers include an expanding population, urbanization, rapid industrialization, and increasing R&D investments by prominent players in the region. Meanwhile, the Asia-Pacific market also holds a considerable share, supported by the rising prevalence of chronic and infectious diseases, an ageing population, broader access to healthcare services, and the growing number of healthcare facilities. The ability to diagnose conditions such as cancer, diabetes, infectious diseases, and cardiovascular disorders through IVD technologies is fueling regional demand. Enhanced healthcare spending and the rising incidence of diabetes further contribute to market growth in Asia-Pacific. To strengthen their market position, leading manufacturers are focusing on delivering high-quality, customizable diagnostic solutions, while also engaging in strategic partnerships, mergers, acquisitions, and collaborative ventures.

Key developments in the market:
• In Jan 2023, Qiagen introduced the EZ2 Connect MDx IVD platform for automated laboratory sampling. Eighteen months after making the platform accessible for research, the company has made it available for widespread use. Recently, Qiagen and Neuron23 signed an agreement to develop a next-generation sequencing (NGS) companion diagnostic (CDx) for the treatment of Parkinson's disease with Neuron23's brain penetrant leucine-rich repeat kinase (LRRK2) inhibitor.
• In Feb 2023, Ibex Medical Analytics' pathology diagnostics platform, Galen Prostate, was granted a CE mark under the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). The new platform has been devised to assist pathologists with prostate biopsy primary diagnosis. The platform employs AI to analyze specimens prior to pathologist evaluation, thereby enhancing the efficiency and accuracy of cancer diagnosis and streamlining pathology workflows.
• In June 2022, The CoviEasy Self-test Rapid Antigen kit for COVID-19, accompanied by an AI-driven mobile app, was introduced by Genes2Me Pvt. Ltd.
• In February 2022, CoviSwift, a point-of-care (POC) testing solution comprised of the CoviSwift assay and Compact-Q machines, was introduced by Mylab Discovery Solutions. It processes 16 samples in 40 minutes, four times faster than the standard RT-PCR testing approach.

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Market Segments
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Application Area
• Donor eligibility assessment
• Sample collection
• Manufacturing
• Logistics
• Patient verification and treatment follow-up
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Software Solution
• Cell orchestration platform
• Enterprise manufacturing system
• Inventory management system
• Laboratory information management system
• Logistics management system
• Patient management system
• Quality management system
• Tracking and tracing system
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on End-User
• Biobank
• Cell Therapy Lab
• Hospital
• Research Institute
• Commercial Organization
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Deployment
• Cloud-Based
• On-premises
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
North America Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2023 to 2031
• U.S.
• Canada
Europe Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2023 to 2031
• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe
Asia Pacific Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2023 to 2031
• India
• China
• Japan
• South Korea
• Australia & New Zealand
Latin America Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2023 to 2031
• Brazil
• Mexico
• Rest of Latin America
Middle East & Africa Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2023 to 2031
• GCC Countries
• South Africa
• Rest of Middle East & Africa

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