Austin, United States, Aug. 05, 2026 (GLOBE NEWSWIRE) -- The Immunoassay Market size was valued at USD 34.70 Billion in 2025 and is projected to reach USD 56.35 Billion by 2035, growing at a CAGR of 4.97% during 2026–2035, according to a new report by SNS Insider. Increasing demand for immunoassay testing, laboratory automation, biomarker testing, immunodiagnostics, and early disease detection continues to support global market expansion across hospitals, diagnostic laboratories, and pharmaceutical companies.

The Immunoassay Market is expanding as healthcare providers increasingly adopt automated immunoassay platforms for infectious disease testing, oncology diagnostics, endocrinology, cardiology, and autoimmune disease detection. High analytical sensitivity, rapid turnaround time, and laboratory automation continue to make immunoassays one of the most widely used in vitro diagnostic technologies worldwide.

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Early Disease Detection and Laboratory Automation Drive Immunoassay Market Growth

The growing frequency of infections, cancer, heart disease, endocrine ailments, and autoimmune disease is contributing to global demand for rapid and highly sensitive immunoassay tests. The use of automated immunoassays has been growing in the healthcare sector because they provide faster testing, high efficiency, high throughput, and increased laboratory efficiency.

Segmentation Analysis

By Product: Reagents & Kits Dominate the Immunoassay Market

Reagents & Kits was the dominant segment in the Immunoassay Market, holding a 63.00% market share in 2025, owing to their repetitive nature in clinical diagnostics, infection diagnostics, oncology biomarkers, endocrinology tests, and cardiovascular diseases. The Software & Services segment is expected to grow at the highest rate of 7.46% CAGR during the forecast period, backed by growing adoption of cloud LIMS, AI-driven workflows, preventive maintenance, quality management, and laboratory connectivity solutions.

By Technology: Chemiluminescence Immunoassay Leads Technology Adoption

In 2025, the largest share 34.00% of the market was captured by the Chemiluminescence Immunoassay (CLIA) due to its high sensitivity, quick results, automation, and diverse applications in the diagnosis of infectious diseases, cancers, endocrine disorders, cardiovascular diseases, fertility assessment, and autoimmune diseases. Meanwhile, the fastest growth at CAGR 6.21% is anticipated in the Fluorescence Immunoassay due to the growing need for rapid diagnostics, highly sensitive biomarkers detection, portable diagnostic systems, and decentralized testing.

By Application: Infectious Disease Testing Holds the Largest Market Share

Infectious Diseases sub-segment dominated the Immunoassay Market with 28.00% market share in 2025 due to increased need for rapid detection of infectious diseases such as viral infection, bacterial infection, and parasitic infection along with investment in health surveillance and preparedness of laboratories. The sub-segment expected to grow at the highest CAGR of 6.90% during the forecast period is Oncology driven by increasing incidence of cancers and use of biomarkers.

By End User: Hospitals and Diagnostic Laboratories Lead Market Demand

The Hospitals & Diagnostic Laboratories segment captured a dominant share of 48.00% in 2025 because of an increase in the volume of clinical tests being conducted, lab automation, and utilization of high-throughput immunoassay systems. On the other hand, the Pharmaceutical & Biotechnology Companies segment will witness the highest growth rate of 5.97% owing to increased biomarker studies, drug discovery efforts, and clinical trials.

North America Leads the Immunoassay Market While Asia Pacific Records the Fastest Growth

North America held the maximum market share in the Immunoassay Market with 38.00% of the total revenue generated in 2025. The region enjoys the advantage of having highly evolved health care systems, extensive use of automated diagnostics, good reimbursement facilities, and the presence of prominent global in vitro diagnostic companies.

The U.S. Immunoassay Market was valued at USD 12.13 Billion in 2025 and is projected to reach approximately USD 18.14 Billion by 2035, expanding at a CAGR of 4.11% during 2026–2035. Growth will be driven by increased incidence of chronic diseases, increased cancer detection programs, increased testing for infectious diseases, rising diagnostics using biomarkers, and increased spending on immunoassay analyzers, laboratory information systems, and laboratory management software powered by artificial intelligence.

The Europe Immunoassay Market is estimated to be USD 9.13 Billion in 2025 and is projected to reach USD 14.38 Billion by 2035, growing at a CAGR of 4.64% during 2026–2035. Europe still represents a significant regional market for diagnostics due to developed healthcare infrastructure, availability of screening tests conducted on population level, prevalence of automation in immunodiagnostic technologies and development of laboratories.

The Asia Pacific region is anticipated to display the highest growth rate, with a CAGR of 7.03%. The increase in health care spending, development of the diagnostics market infrastructure, increased disease awareness, increased modernization of laboratories, and an unprecedented demand for automated diagnostics devices in China, India, Japan, South Korea, and Southeast Asia are the major drivers behind the expansion of the market.

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Leading Market Players Listed in this Report are:

• Abbott Laboratories
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• bioMérieux SA
• Bio-Rad Laboratories, Inc.
• QuidelOrtho Corporation
• Sysmex Corporation
• DiaSorin S.p.A.
• Agilent Technologies, Inc.
• Merck KGaA
• Revvity, Inc.
• Becton, Dickinson and Company
• Randox Laboratories Ltd.
• Trinity Biotech plc
• EKF Diagnostics Holdings plc
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Werfen S.A.
• Tosoh Corporation

Recent Developments:

• 2026: Abbott expanded its Alinity immunoassay diagnostic portfolio by introducing additional assays for infectious diseases, endocrinology, and cardiac biomarkers, strengthening laboratory testing capabilities while improving workflow automation and diagnostic efficiency.
• 2026: Roche Diagnostics enhanced its integrated diagnostics platform with advanced digital laboratory connectivity and workflow automation solutions, enabling high-volume immunoassay laboratories to improve operational efficiency, data integration, and clinical productivity.

Exclusive Sections of the Report (The USPs):

• IMMUNOASSAY TESTING VOLUME AND DIAGNOSTIC UTILIZATION METRICS – helps you evaluate global adoption trends across infectious diseases, oncology, endocrinology, cardiology, autoimmune disorders, women's health, and routine clinical diagnostics.
• LABORATORY AUTOMATION AND AI-ENABLED DIAGNOSTIC WORKFLOW ANALYSIS – helps you understand how automation, artificial intelligence, digital pathology, cloud-based laboratory management systems, and integrated diagnostic platforms are improving laboratory productivity and diagnostic accuracy.
• BIOMARKER-BASED DIAGNOSTICS AND PRECISION MEDICINE INSIGHTS – helps you assess the growing role of tumor biomarkers, infectious disease markers, cardiac biomarkers, endocrine testing, companion diagnostics, and personalized medicine in driving immunoassay adoption.
• IMMUNOASSAY TECHNOLOGY AND PLATFORM INNOVATION TRENDS – helps you identify advancements in chemiluminescence immunoassays, fluorescence immunoassays, multiplex testing, high-throughput analyzers, automated sample handling systems, and next-generation diagnostic technologies.
• HOSPITAL, DIAGNOSTIC LABORATORY, AND PHARMACEUTICAL ADOPTION ANALYSIS – helps you evaluate immunoassay implementation across hospitals, reference laboratories, diagnostic centers, pharmaceutical companies, biotechnology firms, and clinical research organizations.
• REGIONAL MARKET AND COMPETITIVE LANDSCAPE ANALYSIS – helps you assess regional diagnostic infrastructure, healthcare investments, laboratory modernization initiatives, product innovations, strategic developments, and competitive positioning shaping the global Immunoassay Market.

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Immunoassay Market Report Scope

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