Smart or AI In-Vitro Diagnostics Market Opportunities Accelerated by Genomics and Proteomics Integration

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 global prevalence of chronic diseases has increased markedly, driving intensified research and development efforts to enhance the accuracy, reliability, and efficiency of in-vitro diagnostic (IVD) solutions. The COVID-19 pandemic further accelerated market growth by promoting the adoption of innovative diagnostic technologies, including digital pathology platforms and remote sample collection methods.

Technological advancements and the introduction of next-generation diagnostic products are expected to facilitate the broader implementation of smart, AI-enabled IVD systems. Market growth is being propelled by multiple factors, including the rising incidence of chronic and infectious diseases, increasing awareness of the value of early and precise diagnosis, a shift from centralized laboratory testing to point-of-care models, and the enduring impact of the pandemic on global diagnostic infrastructure.

Moreover, the IVD market is well-positioned to benefit from emerging opportunities in developing regions, alongside ongoing innovations in diagnostic methodologies and related fields such as genomics and proteomics. The COVID-19 crisis underscored the critical importance of diagnostic testing, resulting in elevated testing volumes and prompting leading industry players to accelerate the development and commercialization of advanced assays and diagnostic kits to meet growing global 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 Indian in-vitro diagnostics (IVD) market is experiencing strong growth, driven by factors such as the increasing prevalence of chronic diseases, rising adoption of point-of-care (POC) testing, and an expanding focus on personalized medicine and companion diagnostics. High incidences of conditions including cancer and diabetes are fueling demand for timely and accurate diagnostic solutions.

Furthermore, the robust research and manufacturing capabilities of leading industry participants are promoting continuous innovation and the development of new products. The emphasis on early diagnosis, particularly in oncology, is intensifying demand for advanced IVD technologies. Emerging solutions such as biosensors, lab-on-a-chip platforms, wearable diagnostic devices, and next-generation POC systems are enhancing diagnostic precision and optimizing healthcare delivery.

Challenges:
Despite promising growth prospects, the market faces challenges related to regulatory complexity and reimbursement constraints. While certain emerging markets have implemented reforms to streamline medical device and diagnostic approvals, others continue to contend with protracted and intricate regulatory processes. Such delays can impede the timely launch of innovative products, adversely affecting revenue generation and slowing overall market progression.

Regional Trends:
North America is projected to maintain a leading position in the smart and AI-enabled IVD segment, supported by strong revenue generation and a high compound annual growth rate (CAGR). Growth is underpinned by population expansion, rapid urbanization, industrial development, and significant R&D investments by major market participants. Simultaneously, the Asia-Pacific region is emerging as a high-growth market, driven by increasing incidences of chronic and infectious diseases, an aging population, enhanced healthcare infrastructure, and wider access to medical services.

The adoption of IVD technologies for diagnosing cancer, diabetes, infectious diseases, and cardiovascular disorders is significantly boosting regional demand. Rising healthcare expenditures and the growing prevalence of diabetes are further accelerating market expansion. To strengthen their competitive positioning, key players are focusing on the development of high-quality, customized diagnostic solutions and engaging in strategic initiatives including mergers, acquisitions, partnerships, 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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