Immunoassay Market size was valued at USD 35.12 billion in 2023 to USD 54.27 billion by 2031, growing at a CAGR of 5.59% in the forecast period (2024-2031). An immunoassay is a bioanalytical technique that uses antigen-antibody affinity to differentiate and measure molecules of interest in biological samples. Immunoassays are laboratory techniques that can quickly and accurately detect specific compounds. Increased R&D efforts, as well as disease diagnosis, cancer markers, cardiac diagnostics, drug therapy monitoring, and clinical research methodologies are likely to boost market growth. The roles of immunoassays have many bioanalytical applications such as testing drive market expansion.
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Global Leadership: Innovation and Market Power
Major players such as Roche Diagnostics, Abbott Laboratories, Siemens Healthiners and Danaher Corporation lead the immunoassay market. These companies dominate through continued investment in the research and development, and their strong global distribution networks focused on high test sensitivity, turnaround time, and the ability to expanded automation provides a competitive edge for healthcare facilities worldwide.
Strategic Partnerships Widening Market Access
Many companies are forming partnerships and strategic alliances to strengthen their presence. Collaborations between diagnostic institutes and biotechnology companies are common, with the aim of developing next-generation immunoassays, e.g multiplex testing, point-of-care testing (POCT) solutions and these agreements enable faster innovation and greater market penetration.
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Emerging Players Disruption by Niche Technologies
Smaller biotech companies and startups focus on niche areas such as immunoassays for specialty applications, including oncology, infectious diseases and personalized medicine. Their agility allows them to innovate faster, often pioneering new approaches such as digital immunoassays and microfluidic platforms, challenging the dominance of large players.
In June 2022, Roche received an Immediate Use Authorization from the FDA for Cobas SARS-CoV- 2 Duo for use on a fully functional Cobas 6800/8800 system.
In September 2021, Thermo Fisher Scientific, Inc. Estimated to possess 100,000 shares generated from their latest innovation- fully automatic analyzers. The Thermo Scientific Gallery Enzyme Master and Thermo Scientific Gallery Plus Enzyme Master, specifically designed for enzyme testing applications
In May 2021, Beckman Coulter (USA) introduced their fully functional and positive COVID-19 immunoassay, Access SARS-CoV-2 IgG. The immunoassay is an absolute quantitative laboratory-based immunoglobulin G (IgG) serology test aimed at quantifying antibodies against the virus that causes COVID-19.
This report covers the following segments:
A. Product
Reagents & Kits
Analyzers
B. Technology
ELISA
CLIA
IFA
Rapid Tests
Western Blotting
ELISPOT
Other Technologies
C. Specimen
Blood
Saliva
Urine
Other Specimens
D. Application
Infectious Diseases
Endocrinology
Cardiology
Autoimmune Disorders
Allergy Diagnostics
Oncology
Bone & Mineral Disorders
Drug Monitoring and Testing
Blood Screening
Newborn Screening
Other Applications
E. End-Use
Hospitals & Clinics
Clinical Laboratories
Pharmaceutical & Biotechnology Companies and Contract Research Organizations
Home Care Settings
Blood Banks
Research & Academic Laboratories
This report covers the following players:
Abbott Laboratories (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Siemens Healthineers AG (Germany)
Danaher Corporation (US)
Thermo Fisher Scientific Inc. (US)
Revvity (US)
Becton, Dickinson and Company (US)
Diasorin S.p.A. (Italy)
Bio-Rad Laboratories, Inc. (US)
QuidelOrtho Corporation (US)
BioMérieux (France)
Qiagen N.V. (Netherlands)
Sysmex Corporation (Japan)
Agilent Technologies, Inc. (US)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (China)
Merck KGaA (Germany)
Meridian Bioscience (US)
Bio-Techne (US)
Cellabs (Australia)
Abnova Corporation (Taiwan)
J. Mitra & Co. Pvt. Ltd. (India)
Tosoh Corporation (Tosoh Bioscience) (Japan)
Cell Sciences (US)
Enzo Biochem (US)
Creative Diagnostics (US)
Boster Biological Technology (US)
Elabscience (China)
Wako-Chemie Medical (Germany)
Seracare Lifesciences Inc. (US)
Epitope Diagnostics (US)
Kamiya Biomedical Company (US)
Gyros Protein Technologies (Sweden)
Trivitron Healthcare (India)
Inbios International, Inc. (US)
Maccura Biotechnology Co., Ltd. (China)
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Immunoassay Market Pioneering Precision in Diagnostics
The immunoassay market is growing rapidly, driven by the growing demand for diagnostic accuracy, personalized medicine, and biotechnological innovations. When healthcare with increasing focus on early drug discovery and personalized medicine, immunology research continues to gain importance in a variety of industries. Advances in point-of-care testing (POCT) are transforming the immunoassay market. POCT immunoassays can provide rapid and reliable results outside of traditional laboratories, they are driving a push for healthcare delivery in different settings, improving patient care. As personalized medicine becomes an important part of healthcare, immunoassays play a vital role in identifying biomarkers and modifying treatments. This trend will further drive market growth.
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