The global immunoassay market size was estimated at USD 26.83 billion in 2024 and is projected to reach USD 35.10 billion by 2030, growing at a CAGR of 4.59% from 2025 to 2030. Immunoassays are playing an increasingly vital role in personalized medicine by enabling the identification of specific biomarkers that can predict how individual patients will respond to certain therapies, thereby tailoring treatments more effectively.

A major factor driving the expansion of this market is the rapid progress in diagnostic technologies. Advances in techniques such as lateral flow assays, enzyme-linked immunosorbent assay (ELISA), and radioimmunoassay have substantially enhanced the accuracy and efficiency of biomarker detection. These innovations allow for faster and more precise identification of infectious agents, cancer-related biomarkers, genetic markers, drugs, toxins, and hormones—all of which are essential components for making personalized treatment decisions. Moreover, the integration of artificial intelligence (AI) and machine learning (ML) into these diagnostic processes is significantly improving diagnostic accuracy and the interpretation of complex data. This enables healthcare providers to make more informed and timely treatment decisions, ultimately elevating patient care.

The widespread adoption of these advanced diagnostic tools in both research laboratories and clinical healthcare settings is further propelling market growth. Healthcare professionals increasingly rely on immunoassays to gain accurate, data-driven insights that inform patient management strategies. Additionally, the growing preference for point of care testing (POCT), which allows for rapid and reliable diagnosis outside traditional laboratory environments, is a key growth driver. Immunoassays’ capability to deliver quick results in settings such as emergency rooms, outpatient clinics, and even home environments has significantly boosted their demand. The rising trend of digital health and telemedicine is also encouraging the adoption of digital immunoassay platforms that integrate with mobile applications and cloud-based systems, enabling enhanced monitoring and management of patient outcomes.

Furthermore, the increasing incidence of chronic diseases such as cancer, cardiovascular disorders, and autoimmune conditions has heightened the need for targeted therapies. Immunoassays assist in identifying the most effective treatments for individual patients, reducing adverse side effects while maximizing therapeutic efficacy. This personalized approach to medicine marks a shift away from the traditional one-size-fits-all treatment paradigm and is a fundamental driver of market growth. In parallel, pharmaceutical companies are progressively incorporating immunoassay technologies into their drug development pipelines to improve the success rates of new therapeutics. This integration accelerates the pace of innovation and further fuels the expansion of the immunoassay market globally.

Key Market Trends Insights:

• From a regional perspective, North America emerged as the largest revenue-generating market in 2024, reflecting the region’s strong adoption of immunoassay technologies and well-established healthcare infrastructure. This leadership position highlights North America’s pivotal role in driving market growth through significant investments in diagnostic research, advanced healthcare facilities, and widespread use of innovative immunoassay products.

• Looking at the market on a country-specific level, the United States is expected to register a substantial compound annual growth rate (CAGR) from 2025 to 2030. This anticipated growth is driven by factors such as increasing healthcare expenditure, growing prevalence of chronic diseases, advancements in diagnostic technologies, and a strong focus on personalized medicine within the country.

• When analyzed by product type, kits and reagents held a dominant position in the market in 2024, accounting for a substantial share of 66.10%. This indicates that these components are critical to the functionality and widespread application of immunoassay tests, as they provide the essential materials required for conducting accurate and reliable diagnostic procedures.

• In terms of technology, the infectious disease segment led the market with a significant share of 66.10% in 2024. This dominance can be attributed to the ongoing demand for rapid and precise diagnostic solutions to detect various infectious diseases, which remain a major concern globally. The emphasis on early detection and management of infectious diseases continues to fuel the need for effective immunoassay technologies in healthcare settings.

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Market Size Forecast:

• 2024 Market Size: USD 26.83 Billion

• 2030 Projected Market Size: USD 35.10 Billion

• CAGR (2025-2030): 4.59%

• North America: Largest market in 2024

Key Companies Market Share Insights:

Key leading companies operating in the immunoassay market include major industry players such as Abbott; Siemens Healthineers; Danaher Corporation (which owns Beckman Coulter); bioMérieux SA; Quidel Corporation; Sysmex Corporation; Ortho Clinical Diagnostics; Bio-Rad Laboratories, Inc.; F. Hoffmann-La Roche AG; Becton, Dickinson, and Company; and Thermo Fisher Scientific, Inc. These companies are actively engaged in the development of innovative technologies and solutions to strengthen their position within the market.

To enhance their competitive edge and maximize market share, these organizations are implementing a variety of strategic initiatives. These include forming product collaborations with other companies, expanding their presence into new geographic regions, and entering into strategic agreements aimed at broadening their product portfolios. Such moves enable them to tap into emerging market opportunities and meet the evolving demands of customers more effectively.

Furthermore, to maintain and expand their market presence, industry players are increasingly focusing on collaborative partnerships, mergers and acquisitions, and securing necessary product approvals from regulatory authorities. These approaches not only help companies strengthen their product offerings but also facilitate faster market penetration and innovation adoption, ensuring sustained growth in a highly competitive landscape.

Key Players

• Abbott

• Siemens Healthineers

• Danaher Corporation (Beckman Coulter)

• bioMérieux SA

• Quidel Corporation

• Sysmex Corporation

• Ortho Clinical Diagnostics

• Bio-Rad Laboratories, Inc.

• F. Hoffmann-La Roche AG

• Becton, Dickinson, and Company

• Thermo Fisher Scientific, Inc.

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Conclusion:

The immunoassay market is expected to experience steady growth driven by advancements in diagnostic technologies and the increasing focus on personalized medicine. Growing demand for rapid, accurate detection of diseases, especially infectious and chronic conditions, is fueling market expansion. Strategic initiatives by key players, including collaborations and technological innovations, are further accelerating market development globally.