The report includes an in-depth analysis of the Global Immunoassay Market, including market size and trends, product mix, Applications, and supplier analysis. The market for immunoassays was estimated to be worth USD 26.98 billion in 2024 and is expected to expand at a compound annual growth rate (CAGR) of 4.84% between 2025 and 2034. Immunoassays are essential for determining which treatments are most beneficial for patients, as the demand for targeted therapy has increased due to the rising prevalence of cancer, cardiovascular disease, and autoimmune disorders. This methodology reduces adverse effects and enhances treatment effectiveness, thereby improving patient outcomes. The transition from a universal treatment model to personalized medicine is a significant factor driving market growth.

In 2024, reagents and kits dominated the market, mainly due to the growing demand for personalized medicine and targeted therapies for various diseases. Among these, ELISA and Rapid test kits are becoming increasingly important, as they help detect specific antigens for determining patient eligibility for tailored treatments, particularly in areas like oncology, infectious diseases, and rare genetic disorders. The development of lateral flow assays, enzyme-linked immunosorbent assays (ELISA), chemiluminescent assays, and radiographic assays has aided market expansion by allowing for faster, more accurate testing. The market is characterised by a wide range of product advancements and expanded services for clinical diagnostics and non-healthcare applications. Changes in laws, particularly in-vitro diagnostic regulations in Europe and FDA guidelines in the United States, have pushed companies to offer regulatory consulting services to help manufacturers navigate complex approval processes.

The immunoassay industry's infectious disease segment generated the largest revenue share and is predicted to grow at a rapid rate. The rise of infectious diseases, as well as an emphasis on early detection and personalised treatment, are driving this growth. Immunoassays in this discipline are designed to optimise pharmaceutical options while also managing risks. Advances in biomarker discovery and targeted therapeutics allow healthcare providers to provide personalised treatments that improve patient outcomes while minimising negative effects. As technology advances, immunoassays will become increasingly important in personalised medicine, point-of-care testing, and early detection.

In 2024, the most commonly used specimen for immunoassays was blood. Different blood components, including plasma, serum, and whole blood, are examined based on the test. Blood includes key macromolecules including proteins and hormones, making it necessary for detecting many disorders. Accurate testing is achieved using a variety of techniques, including ELISA and Western blot. The rise in cancer and chronic disorders has fuelled the need for these diagnostics.

In 2024, hospitals had the largest revenue share in the immunoassay industry. They provide many cancer diagnostic tests to meet the needs of aging populations and rising cancer rates. Hospitals are adopting advanced technologies for early cancer detection and personalized treatment, moving towards automated and high-precision methods instead of traditional immunoassays.

The North American immunoassay market had the highest revenue share in 2024, owing to robust healthcare systems, a high prevalence of chronic diseases, and growing awareness of novel diagnostic technologies. The region's hospitals and clinical laboratories promote innovation by developing sophisticated diagnostic techniques. These factors, taken together, position North America for consistent growth in the immunoassay market over the projection period.

The Asia Pacific region is anticipated to experience the highest CAGR, driven by healthcare reforms, improvements in infrastructure, and a substantial patient population. Emerging economies like China, India, and Japan are driving the rapid expansion of the immunoassay industry in Asia-Pacific. The enhancement of healthcare infrastructure, the rising incidence of chronic illnesses, and the advancement of healthcare facilities are the primary factors contributing to the growing demand for immunoassays.

Leading companies are embracing innovative trends in the immunoassay market to introduce new diagnostic products. They are establishing strategic partnerships and mergers to increase their production capabilities and expand their presence in international markets. Key players are implementing advanced techniques for the diagnosis and treatment of infectious diseases to enhance their business performance. Additionally, they are providing immunoassay methods for cancer biomarkers.

SpinChip Diagnostics ASA ("SpinChip"), a privately held Norwegian diagnostics company that has developed a ground-breaking immunoassay diagnostics technology, was acquired by bioMérieux in January 2025. This compact benchtop analyzer is ideally suited for near-patient testing, as it can provide results from a whole blood sample in just 10 minutes, maintaining the same high-sensitivity performance as laboratory instruments.