Smart or AI In-Vitro Diagnostics Market Exclusive Trends Analysis with Forecast to 2034

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 is predicted to reach USD 6.2 Bn by the year 2034 at a 14.8% CAGR during the forecast period for 2025-2034.

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Recent years have witnessed a significant increase in the prevalence of chronic diseases, alongside enhanced research and development efforts aimed at improving in-vitro diagnostics (IVDs) for more accurate and timely diagnoses. Furthermore, the adoption of pandemic-driven innovations-such as digital pathology and remote sample collection-is expected to further drive market growth.

Technological advancements and new product launches designed to streamline in-vitro diagnostic procedures are projected to have a substantial impact on the market throughout the forecast period. Key factors propelling the expansion of the smart or AI-based in-vitro diagnostics market include the rising global incidence of chronic and infectious diseases, increased awareness of early disease detection, a shift from centralized laboratory testing to point-of-care solutions, and the influence of the COVID-19 pandemic.

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
Market Dynamics:

Drivers-
The growth of the Indian in-vitro diagnostics (IVD) market is primarily driven by the high prevalence of chronic diseases, the increased adoption of point-of-care (POC) diagnostics, and the growing emphasis on personalized healthcare and companion diagnostics. The rising incidence of chronic conditions such as cancer and diabetes is a key factor in market expansion. Additionally, large corporations with advanced research and manufacturing capabilities are contributing to market development by supporting early cancer detection initiatives that facilitate more effective and timely treatment.

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Challenges:
The market faces significant hurdles due to stringent regulatory requirements and complex reimbursement procedures, which are likely to impede growth. In regions with developing healthcare infrastructure, prolonged regulatory approval processes delay product commercialization and restrict revenue generation in the IVD sector, despite efforts by regulatory agencies to expedite approval procedures in emerging markets.

Regional Trends:
North America is expected to command a significant share of the smart or AI-based in-vitro diagnostics market and achieve a high compound annual growth rate (CAGR) in the near term. Factors such as population growth, rapid urbanization, increasing industrialization, and robust R&D activities by leading industry players are driving market expansion in the region. Similarly, the Asia-Pacific region holds a substantial market share, propelled by a rising prevalence of chronic and infectious diseases, an increasing geriatric population, improved access to healthcare services, and the expansion of hospitals and clinics. The capability to diagnose conditions such as cancer, diabetes, infectious diseases, and cardiovascular issues in vitro, along with higher healthcare expenditures and increased diabetes incidence, further supports the growth of the IVD market in Asia-Pacific.

Leading manufacturers of this field focus on offering high quality and customizable services to the clients. Also, partnerships, collaborations, mergers, and acquisitions are helping market players to boost their businesses.

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, 2025 to 2034 based on End-User
• Biobank
• Cell Therapy Lab
• Hospital
• Research Institute
• Commercial Organization

Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2025 to 2034 based on Type of Deployment
• Cloud-Based
• On-premises
•
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2025 to 2034 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, 2025 to 2034
• U.S.
• Canada
Europe Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2025 to 2034 Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe
Asia Pacific Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2025 to 2034
• India
• China
• Japan
• South Korea
• Australia & New Zealand
Latin America Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2025 to 2034
• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa Smart or AI In-Vitro Diagnostics market revenue (US$ Million) by Country, 2025 to 2034
• GCC Countries
• South Africa
• Rest of Middle East & Africa

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