AI In-Vitro Diagnostics Market Poised for 14.8 Percent CAGR Growth Driven by Chronic Disease Surge and Next-Gen Sequencing 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 incidence of chronic diseases has increased markedly, accompanied by intensified research and development efforts aimed at improving the speed and precision of in-vitro diagnostics (IVD). The adoption of innovative solutions during the COVID-19 pandemic-such as digital pathology and remote sample collection-has further propelled the growth of the IVD market.

Technological progress and the launch of advanced products designed to enhance diagnostic efficiency are expected to play a pivotal role in accelerating the adoption of smart and AI-enabled IVD solutions throughout the forecast period. Key growth drivers include the increasing prevalence of both chronic and infectious diseases, growing awareness of the benefits of early diagnosis, the ongoing shift from centralized laboratory testing to point-of-care diagnostics, and the transformative impact of the COVID-19 pandemic on diagnostic infrastructure.

Additionally, the market is poised to benefit from substantial opportunities in emerging economies, continuous innovation in diagnostic technologies, and advancements in complementary fields such as genomics and proteomics. The pandemic underscored the critical importance of diagnostic testing, leading to a significant increase in test volumes. In response, leading industry players have prioritized the development and commercialization of novel diagnostic kits and assays to address escalating 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 expansion of the Indian in-vitro diagnostics (IVD) market is primarily influenced by the rising prevalence of chronic diseases, increased adoption of point-of-care (POC) testing, and a growing focus on personalized medicine and companion diagnostics. The high incidence of conditions such as cancer and diabetes continues to drive demand for timely and accurate diagnostic solutions. Moreover, the presence of strong research and manufacturing capabilities among key industry stakeholders is fostering technological innovation and product development. The importance of early diagnosis-especially in oncology-has gained prominence, significantly boosting the demand for IVD products. Emerging technologies, including biosensors, lab-on-a-chip platforms, wearable diagnostics, and next-generation POC systems, are playing an increasingly critical role in enhancing diagnostic precision and healthcare delivery.

Challenges:
Despite robust growth potential, the IVD market faces several obstacles, notably stringent regulatory requirements and complex reimbursement protocols. While some emerging markets have made strides in streamlining medical device and diagnostic kit approval processes, others continue to experience prolonged regulatory delays. These inefficiencies hamper the timely commercialization of innovative diagnostic products, ultimately limiting revenue potential and impeding overall market momentum.

Regional Trends:
North America is anticipated to dominate the smart or AI-driven in-vitro diagnostics market, supported by strong revenue growth and a high compound annual growth rate (CAGR). This growth is underpinned by factors such as population expansion, urbanization, accelerated industrialization, and increased research and development investments from leading market participants. Simultaneously, the Asia-Pacific region is emerging as a significant contributor to market growth, driven by a rising burden of chronic and infectious diseases, a growing elderly population, improved access to healthcare services, and an expanding network of healthcare facilities. The capability of IVD technologies to diagnose conditions such as cancer, diabetes, infectious diseases, and cardiovascular disorders continues to elevate regional demand. Enhanced healthcare expenditure and the increasing incidence of diabetes are further stimulating market growth in Asia-Pacific. To strengthen their market presence, major manufacturers are focusing on the delivery of high-quality, customizable diagnostic solutions and pursuing strategic initiatives, including partnerships, mergers, acquisitions, and collaborative agreements.

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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