Austin, April 12, 2025 (GLOBE NEWSWIRE) — According to a new report by SNS Insider, the Immunoassay Analyzers Market, valued at USD 7.55 billion in 2023, is projected to reach USD 10.16 billion by 2032, expanding at a compound annual growth rate (CAGR) of 3.38% during the forecast period 2024–2032. This growth is fueled by the increasing prevalence of chronic diseases, rising demand for early disease detection, and continuous advancements in immunoassay technology.
The U.S. Immunoassay Analyzers Market, valued at USD 2.47 billion in 2023, is projected to reach USD 3.22 billion by 2032, growing at a CAGR of 3.02% from 2024 to 2032.
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Market Overview
Within the United States, the immunoassay analyzers market share was considerable in North America during 2023. The reason behind this dominance is strong government support and investments that are inspiring companies to develop innovative diagnostic tests. The U.S. Food and Drug Administration (FDA) clearances for high-end immunoassay systems are also driving the widespread use of automated and high-throughput analyzers within hospitals and clinical laboratories.
The worldwide immunoassay analyzers market is growing rapidly because of the increasing rate of infectious diseases, chronic illnesses such as diabetes, and rising demand for accuracy in diagnostics. Automation and integration of artificial intelligence into immunoassay systems have improved the accuracy and efficiency of diagnostics. The COVID-19 pandemic further boosted the demand for fast and accurate diagnostic products, highlighting the importance of immunoassay analyzers in disease detection and monitoring. In addition, increasing healthcare spending and encouraging regulatory measures are driving market growth.
Key Immunoassay Analyzers Companies Profiled in the Report
- Abbott Laboratories
- Roche Diagnostics
- Siemens Healthineers
- Beckman Coulter
- bioMérieux
- Ortho Clinical Diagnostics
- DiaSorin
- Tosoh Bioscience
- Mindray Medical International
- Randox Laboratories
- PerkinElmer
- Thermo Fisher Scientific
- Quidel Corporation
- Luminex Corporation
- Bio-Rad Laboratories
- Meril Life Sciences
- Agilent Technologies
- Becton, Dickinson, and Company
- Hologic, Inc
- Sysmex Corporation
Immunoassay Analyzers Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | US$ 7.55 billion |
| Market Size by 2032 | US$ 10.16 billion |
| CAGR | CAGR of 3.38% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East]), Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia Rest of Latin America) |
Segment Analysis
By Product
The Consumables and Accessories segment dominated the immunoassay analyzers market in 2023, with a share of 37.12% of the overall market. This is because the repeat demand for reagents, kits, and other consumables involved in diagnostic testing provides a steady revenue stream for manufacturers. The increasing use of automated immunoassay analyzers has also fueled the demand for compatible consumables and accessories.
Conversely, the Enzyme-Linked Immunoassay (ELISA) segment is anticipated to experience the highest growth over the forecast period. The growing use of ELISA is due to its high sensitivity, specificity, and cost-effectiveness in the detection of diseases such as infectious and autoimmune diseases. With the development of microplate technology and multiplex ELISA assays, this market is anticipated to experience strong demand.
By Application
In 2023, the Infectious Disease Testing segment held the largest share in the market at 31.21% of overall revenue. The large market share is mainly attributed to the increase in the incidence of infectious diseases like HIV, hepatitis, and COVID-19, where precise and timely diagnostics have become a demand. The growing interest globally in infectious disease outbreaks has also fueled the need for immunoassay analyzers in this segment.
The Endocrinology segment is expected to witness the highest growth over the next few years. With rising cases of hormonal conditions like diabetes and thyroid disorder, demand for endocrine function testing has been on the rise. Immunoassay analyzers are most commonly employed for the measurement of hormone levels, and the emergence of highly sensitive and automated hormone assays is poised to propel market growth.
By End Use
The hospital segment dominated the market share in 2023, with 48.23% of the overall revenue. Hospitals are still the major consumers of immunoassay analyzers because they can offer quick, precise, and high-volume diagnostic testing. With increasing hospital admissions for infectious diseases and chronic conditions, the need for effective diagnostic solutions in hospital labs continues to grow.
In contrast, the Diagnostic Laboratories segment will grow at a high rate. The growing dependence on specialized diagnostic laboratories for immunoassay testing of increasing complexity, as well as a trend toward outsourcing laboratory services, is driving market growth. Diagnostic laboratories are making investments in high-throughput immunoassay analyzers to address the expanding demand for routine and specialty diagnostic tests.
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Immunoassay Analyzers Market Segmentation
By Product
- Chemiluminescence Immunoassay (CLIA)
- Fluorescence Immunoassay (FIA)
- Radioimmunoassay
- Enzyme-Linked Immunoassay
- Consumables and Accessories
By Application
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Disease Testing
- Autoimmune Disease
- Others
By End Use
- Hospitals
- Diagnostic Laboratories
- Research Institutes
Regional Analysis
North America led the immunoassay analyzers market in 2023 with a 43.25% market share. The region’s dominance is driven by its developed healthcare infrastructure, robust regulatory environment, and high uptake of advanced diagnostic technologies. Government programs focused on enhancing disease surveillance and diagnostics have also fortified the market standing of North America.
Asia-Pacific is expected to witness the highest growth rate in the forecast period. Reasons such as a growing geriatric population, higher incidence of chronic and infectious diseases, and enhanced healthcare infrastructure are fueling the growth of the market. Further, the rising usage of automated immunoassay analyzers in emerging markets is expected to drive the growth of the region at a high pace.
Recent Developments
- June 2024: Axis-Shield plc announced the release of an anti-CCP assay for Abbott’s AxSYM platform, enhancing diagnostic capabilities for rheumatoid arthritis.
- November 2024: Roche received CE Mark approval for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for treatment with ELAHERE.
- August 2023: Thermo Fisher Scientific launched the EXENT Solution after receiving IVDR Certification, offering an easy-to-implement system for clinical laboratories.
Statistical Insights and Trends
- The global prevalence of diabetes reached approximately 529 million cases in 2023, highlighting the growing demand for diagnostic tools like immunoassay analyzers.
- The global incidence of infectious diseases requiring immunoassay testing, such as hepatitis and tuberculosis, continues to rise, driving the need for efficient diagnostic systems.
- North America witnessed a significant increase in prescriptions for immunoassay-based tests, driven by rising cases of chronic diseases and infectious outbreaks.
- Asia-Pacific saw a sharp rise in demand for immunoassay tests due to increasing healthcare awareness and improved access to diagnostics.
- The Asia-Pacific region is expected to substantially increase immunoassay analyzer installations, supported by government investments in healthcare infrastructure.
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
6. Competitive Landscape
7. Immunoassay Analyzers Market by Product
8. Immunoassay Analyzers Market by Application
9. Immunoassay Analyzers Market by End Use
10. Regional Analysis
11. Company Profiles
12. Use Cases and Best Practices
13. Conclusion
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