The U.S. market alone is forecast to climb from USD 8.91 billion in 2024 to USD 13.67 billion by 2032 as clinical laboratories and point-of-care testing transform the diagnostic landscape.
Austin, Nov. 04, 2025 (GLOBE NEWSWIRE) — Immunodiagnostics Market Size & Growth Analysis
According to a report by SNS Insider, the global Immunodiagnostics Market was valued at USD 22.24 billion in 2024 and is projected to reach USD 38.40 billion by 2032, at a compound annual growth rate (CAGR) of 7.09% during 2025-2032. The US led the global market with USD 8.91 billion in 2024. The market in the US is expected to reach USD 13.67 billion by 2032, driven by the expansion of diagnostic testing, technological advancements in immunoassay platforms, and increasing adoption of decentralized and point-of-care testing solutions.
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The increasing incidence of infectious and chronic diseases, rising healthcare expenditure, and emphasis on early diagnosis are driving the market. Continuous advancements in high-sensitivity reagents, automation, and multiplex testing formats are driving its use in clinical laboratories and diagnostic centers worldwide. Immunodiagnostics is an important part of clinical diagnostics, which uses antigen-antibody reactions to identify diseases. It plays a key role in the diagnosis of infections, endocrine disorders, cancer, and autoimmune conditions. The increasing need for accurate and rapid diagnostic tools, coupled with the global emphasis on preventive healthcare, has increased the demand for immunodiagnostic tests and devices.
The US has maintained its position as the largest consumer market for immunodiagnostics due to its advanced laboratory infrastructure, high diagnostic awareness, and strong presence of major diagnostic companies. Growing clinical applications for the diagnosis of cancer, endocrine, and infectious diseases are helping the market grow globally.
Major Players in the Immunodiagnostics Market Include:
- Abbott Laboratories
- Roche Diagnostics
- DiaSorin S.p.A.
- Danaher Corporation
- QIAGEN N.V.
- bioMérieux SA
- Thermo Fisher Scientific Inc.
- Quest Diagnostics Incorporated
- Siemens Healthineers AG
- Becton, Dickinson and Company
Immunodiagnostics Market Segment Insights
By Product
The reagents & consumables segment is projected to be the fastest-growing during the forecast period, as they are highly consumed in each testing cycle and are relatively inexpensive and easy to replace. Manufacturers are now scaling up production lines of reagents due to the increasing prevalence of diseases globally, in decentralized and point-of-care conditions.
By Application
The oncology & endocrinology application field held the largest market share of 28.6% in 2024 due to the increasing occurrence of cancer and hormonal diseases, including diabetes and thyroid malfunction. The infectious diseases application is expected to be the fastest-growing segment due to the rising incidence of viral infections, such as COVID-19, RSV, or monkeypox.
By End-user
The clinical laboratories end-user category is projected to witness the highest CAGR as a result of the progressive conversion of diagnostic testing from hospitals to specialized labs in an attempt to achieve better operational efficiency, reduced turnaround times, and low costs.
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Regional Analysis:
The immunodiagnostics market in North America is estimated to be the largest in 2024 and is also the fastest-growing region over the forecast period. The region’s growth is driven by the high healthcare expenditure, the presence of diagnostic majors, such as Abbott and Quest Diagnostics, and well-established infrastructure for laboratory and POC testing.
Asia Pacific is a growing region in the immunodiagnostics market, as it has a large patient base and increasing healthcare expenditure, and demand for high-quality diagnostic products.
Recent Developments in the Immunodiagnostics Market:
- In October 2024, Bio-Rad Laboratories introduced its External Quality Assurance Services (EQAS) Specialty Immunoassay (SPIA) Program, covering 13 complex immunoassay analytes such as procalcitonin and IL-6. These liquid-format, ISO/IEC 17043-accredited proficiency testing kits enhance lab accuracy while reducing costs through consolidated testing.
- In May 2023, the U.S. FDA granted clearance for Thermo Fisher’s B·R·A·H·M·S PlGF plus KRYPTOR and sFlt‑1 KRYPTOR immunoassays. These are the first blood-based biomarkers with breakthrough designation to assess the risk of severe preeclampsia, delivering results in under 30 minutes.
Exclusive Sections of the Report (The USPs):
- DISEASE BURDEN & DIAGNOSTIC DEMAND METRICS – helps you assess the growing global need for immunodiagnostic tests in 2024, driven by rising incidences of infectious and chronic diseases, and the expanding use of early disease detection tools.
- IMMUNOASSAY TYPE DISTRIBUTION ANALYSIS – helps you understand the performance trends of key assay types (ELISA, CLIA, FIA, and RIA) from 2021 to 2032, highlighting the market transition toward automated and high-sensitivity testing platforms.
- REIMBURSEMENT & HEALTHCARE SPENDING INSIGHTS – helps you evaluate regional variations in healthcare funding and insurance coverage for diagnostic procedures, influencing affordability and access to advanced immunodiagnostic solutions.
- LABORATORY CAPACITY & INFRASTRUCTURE BENCHMARKS – helps you analyze testing infrastructure readiness across regions in 2024, including automation levels, throughput capacity, and integration with digital laboratory systems.
- TECHNOLOGICAL INNOVATION LANDSCAPE – helps you identify advancements in point-of-care immunodiagnostics, multiplex assays, and AI-driven interpretation tools that are shaping faster and more accurate disease diagnostics.
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Immunodiagnostics Market Report Scope
| Report Attributes | Details |
| Market Size in 2024 | USD 22.24 billion |
| Market Size by 2032 | USD 38.40 billion |
| CAGR | CAGR of 7.09% From 2025 to 2032 |
| Base Year | 2024 |
| Forecast Period | 2025-2032 |
| Historical Data | 2021-2023 |
| Key Segments | By Product (Instruments, Reagents & Consumables)
By Application (Oncology & Endocrinology, Hepatitis & Retrovirus, Cardiac Markers, Infectious Diseases, and Others) By End user (Clinical Laboratories, Hospitals, Physicians’ Offices, and Others) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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