Global Immunoassay Market Revenue Grows at a CAGR of 4.64%

Introduction

Straits Research released its highly anticipated report, “Immunoassay Market Size & Outlook, 2026-2034.” According to the study, the market size is valued at USD 28.29 billion in 2025 and is projected to expand to USD 42.43 billion by 2034, registering a compound annual growth rate (CAGR) of 4.64%.

Market Dynamics

The global immunoassay market is primarily growing due to the rising prevalence of chronic and infectious diseases, creating strong demand for reliable diagnostic solutions. Chronic conditions account for nearly 74% of global deaths, according to the WHO. Additionally, as of May 2025, the global SARS-CoV-2 test positivity rate reached 11%, reflecting a resurgence of COVID-19 cases. Immunoassays, with high sensitivity and specificity, are vital for early detection, disease monitoring, treatment guidance, and improving patient outcomes worldwide. Moreover, veterinary diagnostics is becoming a key growth avenue for immunoassays, driven by the rising incidence of companion animal diseases and increasing pet healthcare spending. Immunoassay-based tests provide veterinarians with accurate, rapid, and minimally invasive diagnostic solutions for conditions ranging from infectious diseases to cancer. For instance, in March 2025, VolitionRx partnered with Fujifilm Vet Systems to automate its Nu. Q Vet Cancer Test in Japan, enhancing speed and scalability for cancer screening in pets. As demand for advanced veterinary diagnostics rises globally, immunoassays are poised to play a pivotal role.

Market Highlights

• By product, the reagents and kits segment dominated the market with a revenue share of 63.79%.
• By technology, the ELISA segment is estimated to grow at the fastest pace with a CAGR of 4.56%, fueled by increasing adoption of automated ELISA systems that simplify workflows, reduce manual handling, and improve accuracy.
• By segment, the urine segment is estimated to grow at the fastest pace with a CAGR (5.32%) during the forecast period, supported by its non-invasive collection method and expanding applications in disease diagnostics.
• By application, the infectious diseases segment is estimated to grow at the fastest pace with a CAGR (5.01%) during the forecast period.
• By end-user, the home care settings segment is estimated to grow at the fastest pace with a CAGR (5.32%) during the forecast period.
• Regional Insights: North America dominated the market with a 46.43% share, driven by the increasing disease prevalence, government initiatives, and growing adoption of advanced immunoassay technologies.

Competitive Players

1. Abbott
2. Hoffmann-La Roche Ltd.
3. Siemens Healthineers AG
4. Danaher Corporation
5. Thermo Fisher Scientific Inc.
6. bioMérieux SA
7. QuidelOrtho Corporation
8. BD
9. Bio-Rad Laboratories, Inc.
10. PerkinElmer 
11. Sysmex 
12. Agilent Technologies Inc.
13. Merck KGaA
14. DiaSorin S.p.A.
15. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 
16. Labcorp
17. Beckman Coulter, Inc. 
18. QuidelOrtho Corporation
19. Tosoh Bioscience, Inc.
20. Randox Laboratories Ltd.
21. Others

Recent Developments

July 2025- Spear Bio launched the SPEAR UltraDetect immunoassay platform, which enabled precise detection of neurological biomarkers from small blood samples, and partnered with BioTechne for global distribution.

Segmentation

1. By Product
   1. Reagents & Kits
      1. ELISA Reagents & Kits
      2. Rapid Test Reagent & Kits
      3. ELISpot Reagent & Kits
      4. Western Blot Reagents & Kits
      5. Other Reagents & Kits
   2. Analyzer
      1. Open-ended System
      2. Closed-Ended System
   3. Software and Services
2. By Technology
   1. ELISA
   2. Rapid Tests
   3. Western Blotting
   4. Radioimmunoassay
   5. Other technologies
3. By Specimen
   1. Blood
   2. Saliva
   3. Urine
   4. Other Specimen
4. By Application
   1. Infectious diseases
   2. Endocrinology
   3. Oncology
   4. Bone and mineral disorders
   5. Cardiology
   6. Blood screening
   7. Autoimmune Disorders
   8. Allergy Diagnostics
   9. Toxicology
   10. Other Application
5. By End-User
   1. Hospitals
   2. Clinical Laboratories
   3. Pharmaceutical & Biotechnology Companies and CRO
   4. Blood Banks
   5. Research & Academic Laboratories
   6. Home Care Setting
   7. Others