Global Immunoassay Market Set to Reach USD 45.78 Billion by 2032, Driven by Surge in Infectious Diseases and Technological Innovations | FMI

The global immunoassay market is poised for substantial expansion, projected to reach USD 45.78 billion by 2032, up from USD 29.51 billion in 2022, growing at a steady CAGR of 5%. This growth is largely driven by the rising incidence of chronic and infectious diseases, increasing awareness around early diagnosis, and the proliferation of cutting-edge diagnostic technologies.

Governments and healthcare institutions are ramping up investments in research and development, particularly in response to the ongoing risks posed by emerging infectious diseases such as COVID-19 and Monkeypox. Immunoassay-based diagnostics, especially antibody testing, have become central to early disease detection efforts worldwide.

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Key Market Takeaways

Leading Product Segment: Reagents and Kits Dominate

Among the various product types, reagents and kits continue to hold the lion’s share—60% of global revenue—and are projected to retain this lead through 2032. Their broad application in testing new and evolving pathogens, especially during global health crises, has propelled demand. The launch of novel, highly sensitive reagent kits is accelerating the pace of testing, making this segment indispensable for hospitals, labs, and point-of-care diagnostics.

Technology Spotlight: EIA/ELISA Leads the Pack

Enzyme Immunoassays (EIA), including ELISA, account for approximately 60% of the technology segment, thanks to their accuracy, quick turnaround time, and efficiency in managing high testing volumes. This technology is especially impactful in reducing assay time for immunodiffusion and immunoelectrophoresis. Meanwhile, rapid test technologies are gaining ground in managing outbreaks related to Zika, Salmonella, Campylobacter, and Listeria.

Infectious Disease Testing Remains the Primary Application

By application, infectious disease testing dominates the immunoassay space, generating 30% of global revenue. The consistent rise in HIV, influenza, malaria, and COVID-19 cases has fueled the need for accurate and scalable diagnostic solutions. This trend is expected to continue as new virus strains emerge and global healthcare systems prioritize rapid containment and diagnosis.

Geographic Insights

North America Maintains Market Leadership

North America accounted for 35% of global immunoassay market revenue in 2022, and is projected to maintain its dominance through 2032. This is attributed to:

• A growing geriatric population
• High incidence of chronic illnesses such as cancer and autoimmune diseases
• Readily available advanced diagnostic infrastructure
• Increased adoption of molecular diagnostic kits and automated testing platforms

Asia-Pacific: The Fastest Growing Market

The Asia-Pacific region emerges as the fastest-growing market, driven by increased government spending on healthcare infrastructure, especially in India and China. Rapid urbanization, a booming elderly population, and a surge in chronic lifestyle diseases contribute to the rising demand for diagnostic tools. The aftershock of COVID-19 has further spurred a widespread need for mass testing capabilities, significantly boosting sales of immunoassay kits.

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Market Challenges and Opportunities

While the market is on an upward trajectory, it faces certain challenges, such as stringent regulatory protocols for new product approvals and technical complexities associated with immunoassay reagents and platforms. Despite these constraints, the ongoing diagnostic push in both public and private sectors, combined with the growing home-based and decentralized testing trend, opens new avenues for market players.

Competitive Landscape: Innovation Fuels Growth

The global immunoassay market remains relatively young and innovation-driven, offering ample room for technological advancements and market penetration. Key players are focusing on automation, decentralization, and user-friendly designs to capture a wider user base.

• Siemens Healthineers has rolled out an upgraded series of automated immunoassay platforms, offering over 100 disease-specific test options with a focus on high throughput and accuracy.
• BioMérieux SA, with a footprint of 26,000+ immunoassay systems globally, is investing in its R&D programs that emphasize high medical value applications, expanding automation, and decentralization of testing.
• Abbott Laboratories is leveraging its ChIA technology, introducing solutions like the Abbott Prism, which streamlines workflow and improves turnaround time in clinical laboratories.

Other notable players making significant strides include Danaher Corporation (Beckman Coulter), Quidel Corporation, Sysmex Corporation, Ortho Clinical Diagnostics, Bio-Rad Laboratories, Becton Dickinson and Company, Roche, and Thermo Fisher Scientific.

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Immunoassay Market Segmentation

By Product:

• Reagents & Kits
• Analyzers/Instruments
• Open-ended Systems
• Closed-ended Systems
• Software & Services

By Technology:

• Radioimmunoassay (RIA)
• Enzyme Immunoassays (EIA)
• Rapid Test
• Chemiluminescence Immunoassays (CLIA)
• Fluorescence Immunoassays (FIA)
• Others

By End Use:

• Therapeutic Drug Monitoring
• Oncology
• Cardiology
• Endocrinology
• Infectious Disease Testing
• Autoimmune Diseases

By Application:

• Hospitals
• Blood Banks
• Clinical Laboratories
• Pharmaceutical and Biotech Companies
• Academic Research Centers
• Others

By Form:

• Natural Immunoassay
• Synthetic Immunoassay

By Region:

• North America
• Latin America
• Europe
• East Asia
• South Asia
• Oceania
• Middle East & Africa (MEA)

Conclusion

The global immunoassay market stands at the forefront of the evolving diagnostics landscape. With public health emergencies, growing disease burden, and the demand for high-accuracy, high-throughput testing, the industry is set for long-term growth. Technological advancements and expanding access to healthcare services will continue to shape this dynamic sector, presenting unprecedented opportunities for existing players and new entrants alike.

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