Hyderabad, India, Jan. 06, 2026 (GLOBE NEWSWIRE) -- According to Mordor Intelligence, the global in vitro diagnostics (IVD) market is valued at USD 113.08 billion in 2026, and is projected to surpass USD 152.54 billion by 2031, at a CAGR of 6.17% during the forecast period (2026-2031). The market is strengthening as molecular diagnostic technologies advance, point-of-care (POC) solutions become more widely adopted, and chronic disease testing needs to increase worldwide. Growth is further fueled by rising demand for early disease detection, decentralized testing models, and rapid adoption of automated and AI-enabled diagnostic platforms across clinical settings.
Regional Market Dynamics
North America continues to dominate the global IVD market due to strong diagnostic infrastructure, high testing volumes, robust reimbursement frameworks, and early adoption of next-generation molecular and genetic testing systems.
Asia-Pacific, on the other hand, is projected to be the fastest-growing region through 2031, driven by increasing investments in laboratory modernization, rising awareness of preventive diagnostics, rapid expansion of private diagnostic chains, and government-led initiatives to strengthen infectious disease surveillance and chronic disease screening programs.
Emerging Market Trends
AI-Integrated Diagnostics Enhancing Accuracy and Workflow Efficiency
Artificial intelligence is increasingly embedded across laboratory and point-of-care diagnostic platforms. AI-driven analytics now support faster interpretation of imaging-based assays, automated reading of immunoassays, enhanced molecular test accuracy, and predictive insights for patient risk stratification. These integrations reduce manual error, shorten turnaround times, and deliver actionable clinical data more rapidly.
High-speed digital connectivity is also enabling remote reporting and centralized data interpretation, particularly benefiting multi-site diagnostic networks and telehealth-linked care models.
Regulatory Advancements Supporting Innovation and Standardization
Regulatory bodies are advancing frameworks to support faster approvals for next-generation diagnostics. The FDA is enabling more flexible pathways for novel molecular tests, software-enabled diagnostics, and multiplex platforms. Strengthened cybersecurity guidelines and quality standards enhance reliability and safety. In Europe, updated regulatory oversight is improving post-market surveillance and product traceability, prompting strategic partnerships and consolidation among IVD manufacturers to optimize compliance across regions.
Market Segmentation Insights
By Test Type
- Clinical Chemistry
- Immunoassay
- Molecular Diagnostics
- Hematology
- Coagulation
- Microbiology
- Urinalysis
- Other Test Types
By Product
- Instruments
- Reagents & Kits
- Software & Services
By Application
- Infectious Diseases
- Diabetes
- Oncology
- Cardiology
- Auto-immune Disorders
- Nephrology
- Other Applications
By End User
- Reference Laboratories
- Hospital-based Laboratories
- Point-of-Care Settings
- Homecare & Self-testing Users
By Geography:
- North America
- Europe
- Asia-Pacific
- Middle East & Africa
- South America
For a full breakdown of market size, segmentation data, and competitive intelligence, access the details of the Mordor Intelligence report:
https://www.mordorintelligence.com/industry-reports/in-vitro-diagnostics-market?utm_source=globenewswire
Competition Outlook
The global IVD market is moderately fragmented, comprising established diagnostic technology companies, global healthcare manufacturers, and emerging molecular and POC innovators. Key competitive strategies include collaboration between diagnostic platform developers and biotech companies, acquisitions of specialty molecular diagnostic firms, and accelerated R&D investments focused on automation, miniaturization, and connected diagnostics.
Major companies include:
- F. Hoffmann-La Roche Ltd
- Thermo Fischer Scientific Inc
- Siemens Healthineers AG
- Abbott Laboratories
- bioMerieux SA
Check out related reports published by Mordor Intelligence:
In-vitro Colorectal Cancer Screening Tests Market: In-vitro colorectal cancer screening tests market is segmented by test type (guaiac-based FOBT, FIT, multi-target stool-DNA test, & more), technology platform (immunoassay, PCR-based molecular assays, & more), end user (hospitals & ASCs, clinical reference laboratories, & more), and geography (North America, Europe, Asia Pacific, Middle East & Africa, South America).
Oncology Molecular Diagnostics Market: The Oncology Molecular Diagnostics Market is segmented by product type (instrument, and more), technology (polymerase chain reaction, and more), cancer type (breast cancer, and more), sample type (tissue biopsy, and more), end user (hospitals, and more), and geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America).
Illumina Inc., Qiagen N.V., F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc. and Danaher Corporation are the major companies operating in this market.
Read more about companies active in Oncology Molecular Diagnostics: https://www.mordorintelligence.com/industry-reports/global-oncology-molecular-diagnostics-market?utm_source=globenewswire
Self-testing Market: The Self-Testing Market is Segmented by test type (blood glucose tests, pregnancy & fertility tests, and more), sample type (blood, urine, saliva, and more), distribution channel (retail pharmacies & drug stores, online pharmacies & DTC websites, supermarkets/hypermarkets, and more), and geography (North America, Europe, Asia Pacific, Middle East & Africa, and More).
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