The global immunoassay market is entering a high-growth phase, supported by rising diagnostic demand, expanding aging populations, and rapid technological developments across healthcare and life sciences. Valued at USD 35.53 billion in 2025, the market is projected to reach USD 47.76 billion by 2030, growing at a CAGR of 6.1%. This steady expansion reflects the essential role immunoassays play in disease detection, therapeutic monitoring, and clinical decision-making across a broad spectrum of medical conditions.
Growing pressure on healthcare systems to identify diseases earlier and manage chronic illnesses more effectively has accelerated the adoption of high-performance, automated, and point-of-care (POC) immunoassay platforms. From infectious disease surveillance and cancer diagnostics to endocrinology testing and drug monitoring, immunoassays continue to serve as the backbone of modern diagnostic workflows.
Key Growth Drivers of the Immunoassay Market
Several powerful forces are shaping the growth trajectory of the immunoassay industry.
- Increasing Prevalence of Chronic and Infectious Diseases
The global rise in cancer, cardiovascular disorders, autoimmune diseases, diabetes, and infectious outbreaks is directly increasing demand for immunoassay-based diagnostics. These conditions require accurate, rapid, and cost-effective testing—capabilities that immunoassays are well-positioned to deliver.
- Expanding Elderly Population
A major driver of the market is the growing geriatric population, which is more vulnerable to chronic illnesses and requires continuous health monitoring. Immunoassays are widely used for routine screening, disease management, and therapeutic monitoring in elderly patients, strengthening long-term market demand.
- Rising Adoption of Automated and High-Throughput Platforms
Automation has become a core focus for laboratories striving to improve throughput and reduce manual errors. Modern immunoassay analyzers now integrate:
- High-throughput processing
- Multiplexing capabilities
- Digital interpretation
- Advanced analytics
- Workflow automation
These technological advancements enhance efficiency and accelerate turnaround times—factors critical for both clinical laboratories and hospital settings.
- Growth in Point-of-Care (POC) Immunoassays
From emergency departments to home-based testing, POC immunoassays provide rapid results that support immediate clinical decisions. Their expansion is driven by increasing demand for decentralized, patient-centric diagnostic solutions.
- Emerging Markets Unlock New Opportunities
Growing investments in healthcare infrastructure, R&D, and diagnostic modernization across Asia Pacific, Latin America, and the Middle East offer significant growth potential. These regions are rapidly expanding their diagnostic capabilities, fostering opportunities for global market players.
Reagents & Kits Lead the Immunoassay Product Market
Based on product type, the reagents and kits segment accounted for the largest market share in 2024. Their dominance stems from:
- High consumption rate per test
- Essential use across every immunoassay platform
- Recurring demand in both centralized and decentralized settings
- Critical role in infectious disease, oncology, and hormone testing
Unlike analyzers, which require a one-time capital investment, reagents and kits generate continuous revenue streams. Their indispensable role in maintaining testing continuity makes them the most influential product category within the immunoassay ecosystem.
ELISA Remains the Gold Standard in Immunoassay Technology
In 2024, ELISA (enzyme-linked immunosorbent assay) represented the largest share of the immunoassay technology market. ELISA maintains its leadership due to:
- High sensitivity and specificity
- Strong standardization across labs
- Wide application in infectious disease screening
- Cost-effective scalability
- Compatibility with automated systems
Continuous innovation in assay design, microplate technology, and digital interpretation tools is further enhancing ELISA’s reliability and workflow integration.
Other growing technologies—such as CLIA, IFA, and rapid tests—also continue to contribute significantly to market expansion, especially in settings requiring quick diagnostic results.
Hospitals & Clinics Dominate the End-User Landscape
In 2024, hospitals and clinics represented the largest end-user segment. Their leading position is attributed to:
- Central role in acute and chronic disease diagnostics
- High patient throughput
- Adoption of advanced immunoassay analyzers
- Integration with emergency care and specialized units
- Need for rapid and reliable diagnostic insights
As hospitals increasingly deploy automated and multiplexed immunoassay platforms, the demand for high-efficiency analyzers and consumables continues to rise.
North America Leads the Global Immunoassay Market
North America remained the largest regional market in 2024, driven by:
- Strong presence of leading diagnostics manufacturers
- Advanced healthcare infrastructure
- High disease burden requiring regular diagnostic monitoring
- Strong uptake of automated and POC immunoassay systems
- Continuous innovation in diagnostic assays and platforms
Collaborative initiatives between regulatory agencies and research bodies—such as the CDC and FDA—have played a substantial role in improving assay standardization, quality control, and validation processes. These efforts have elevated diagnostic reliability and created a supportive environment for technological innovation.
Leading Players in the Immunoassay Market
Key companies shaping the global immunoassay landscape include:
- Abbott (US)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Siemens Healthineers AG (Germany)
- Thermo Fisher Scientific Inc. (US)
- Danaher (US)
- Revvity (US)
- Becton, Dickinson and Company (BD) (US)
- DiaSorin S.p.A. (Italy)
- Bio-Rad Laboratories, Inc. (US)
These companies are expanding their portfolios through automation, multiplex testing, advanced biomarkers, and digital integration to address evolving diagnostic needs.
Conclusion
The global immunoassay market is poised for strong growth through 2030, driven by increasing disease prevalence, greater demand for early and accurate diagnostics, and significant technological advancements. With reagents and kits leading product demand, ELISA dominating technology adoption, and hospitals serving as primary end users, the market continues to evolve toward faster, more efficient, and more scalable diagnostic solutions. Supported by strong industry innovation and expanding opportunities in emerging markets, immunoassays will remain a cornerstone of modern clinical diagnostics for years to come.