Why the Immunoassay Market is Key to Advancing Global Healthcare
Immunoassay Market by Product (Reagents & Kits, Analyzers), Technology (ELISA, CLIA, Western Blot), Specimen (Blood, Saliva, Urine), Application (Infectious Diseases, Endocrinology), End User (Hospitals & Clinics, Laboratories)—Global Forecast to 2030", is projected to reach USD 47.7 billion by 2030 from USD 35.5 billion in 2025, at a CAGR of 6.1% during the forecast period.
The growth of the immunoassay market is mainly driven by several key factors. One of the leading causes is the expanding elderly population, which is closely connected to a rising incidence of chronic and age-related diseases like cancer, diabetes, and heart conditions. This demographic change has increased the demand for early, accurate, and efficient diagnostic tools, where immunoassays play an essential role. Additionally, emerging markets offer new growth opportunities, fueled by increasing R&D investments in these regions, thereby improving the environment for market players.
By product, the reagents & kits segment accounted for the largest immunoassay product market share in 2024.
The immunoassay market, by product, is segmented into reagents & kits and analyzers. In 2024, the reagents and kits segment held the largest market share. This significant share is mainly due to the recurring use of reagents and kits across diagnostic workflows. Unlike analyzers, which are a one-time capital investment used over several years, reagents and kits are consumed with each test, making them essential for daily operations in both centralized labs and decentralized testing environments. These consumables are vital for maintaining the continuity and scalability of testing services, especially in high-throughput laboratories and clinical settings. Their role in supporting diverse immunoassay platforms across applications like infectious diseases, endocrinology, and oncology has further cemented their market dominance.
In 2024, ELISA accounted for the largest share in the immunoassay technology market.
Based on technology, the immunoassay market is segmented into ELISA, CLIA, IFA, rapid tests, ELISpot, western blotting, and other technologies. In 2024, ELISA (enzyme-linked immunosorbent assay) held the largest market share. ELISA's dominance comes from its versatile diagnostic uses, especially in infectious disease and cancer screening, where high sensitivity and specificity are crucial. Its strong standardization, compatibility with high-throughput automation, and cost-effectiveness have made ELISA a preferred choice in clinical laboratories. Additionally, ongoing improvements in ELISA-based assay design and integration with digital result interpretation systems are improving diagnostic accuracy and workflow efficiency, reinforcing its leadership in the field.
In 2024, the hospitals & clinics held the largest market share in the immunoassay end user market.
By end user, the immunoassay market is segmented into hospitals & clinics, clinical laboratories, blood banks, and home care settings. In 2024, hospitals and clinics held the largest market share. This is mainly because they play a central role in performing most diagnostic tests, especially for acute and chronic conditions that need quick and reliable results. Hospitals are often equipped with advanced immunoassay platforms capable of handling complex diagnostic panels and large patient volumes. Additionally, their integration with emergency care, specialized departments, and surgical units makes them a key hub for immunoassay-based diagnostics. As hospitals increasingly adopt automated and multiplexed immunoassay systems to improve turnaround time and diagnostic accuracy, their demand for high-performance testing solutions continues to fuel growth in this segment.
By region, North America accounted for the largest regional market share in 2024.
In 2024, North America led the immunoassay market mainly because of its strong presence of established diagnostic companies and advanced healthcare infrastructure. The US was a key contributor to this regional leadership, driven by high demand for sophisticated immunoassay-based diagnostics in both clinical and research settings. This demand is heavily influenced by the increasing prevalence of chronic and infectious diseases, along with the widespread use of automated and point-of-care immunoassay platforms. Furthermore, collaborations between regulatory agencies and national research organizations have boosted innovation and improved quality standards in diagnostic testing. For example, partnerships involving the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have resulted in the creation of standardized immunoassay guidelines and reference materials. These joint efforts have enhanced assay validation, traceability, and consistency of results, increasing confidence in test performance. Such strategic initiatives not only ensure regulatory compliance but also support the quick adoption of new immunoassay technologies in hospitals, labs, and public health programs across North America. Consequently, the region remains a hub for technological innovation, regulatory leadership, and market adoption in the global immunoassay industry.
The global immunoassay market is a consolidated market, featuring companies such as Abbott (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (US), Danaher (US), Revvity (US), and Becton, Dickinson and Company (BD) (US). These market players have implemented several strategies, including product launches, acquisitions, agreements, collaborations, and expansions, to enhance their positions in the market.
Abbott (US) Abbott has established itself as a formidable player in the immunoassay market as of 2024, leveraging its strong technological foundation and broad diagnostic capabilities. The company’s prominence in this space is largely driven by its highly reliable and widely adopted immunoassay platforms, such as the ARCHITECT and Alinity series, which are known for delivering high-throughput, accurate, and consistent results across a wide range of clinical applications. Abbott’s product portfolio is further complemented by its comprehensive range of reagents, calibrators, and controls, designed to support diagnostic testing for infectious diseases, oncology, cardiology, and endocrine disorders.
To sustain and grow its market leadership, Abbott employs a multi-pronged strategy that includes continuous product innovation, strategic partnerships, and expansion into emerging markets. A landmark initiative that underscores its innovation-driven approach is the development and global rollout of the Alinity i system, which streamlines workflow efficiencies in laboratories while maintaining high diagnostic accuracy. Abbott also emphasizes digitally enabled healthcare solutions, including connectivity tools and informatics that support real-time data analytics, facilitating better clinical decision-making.
Abbott's global footprint spans more than 160 countries, with manufacturing and distribution capabilities that allow it to swiftly adapt to regional market dynamics and regulatory landscapes. Its presence is particularly strong in North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa, which enhances its ability to serve a diverse range of healthcare providers and patients. Moreover, Abbott’s proactive response during global health emergencies, such as its rapid deployment of immunoassay-based COVID-19 tests, has reinforced its reputation as a trusted diagnostic partner. These efforts collectively strengthen Abbott’s position as a leading innovator and provider in the global immunoassay market.
F. Hoffmann-La Roche (Switzerland) has become a key player in the immunoassay market as of 2024, thanks to its strong diagnostics division, Roche Diagnostics, which provides cutting-edge solutions across clinical chemistry, immunoassays, and molecular diagnostics. The company's success in this area is supported by its highly trusted cobas® platform, including systems like cobas e 411, e 601, and e 801, which are widely used in laboratories worldwide for their reliability, scalability, and ability to handle a broad testing menu with high throughput and accuracy. Roche’s immunoassay portfolio covers a wide range of clinical areas, including infectious diseases, oncology, cardiology, women’s health, and metabolic disorders. Roche maintains its leadership in the immunoassay field through a consistent focus on innovation, automation, and system integration. The company continues to invest in AI-powered diagnostic tools, data-driven decision-making platforms, and next-generation assay development, ensuring its products stay at the forefront of clinical diagnostics. A notable initiative involves the ongoing enhancement of its cobas® pro integrated solutions, designed to improve laboratory workflow, reduce turnaround times, and boost operational efficiency.
In terms of market strategy, Roche pursues both organic growth through R&D investment and strategic collaborations that enhance its technology pipeline and global presence. Its partnerships with major research institutions and healthcare networks have allowed it to expand its test menu and develop personalized diagnostic solutions aligned with the future of precision medicine. With operations in over 150 countries, Roche benefits from a well-established global distribution network and localized regulatory expertise, helping it meet the diverse and changing needs of clinical laboratories worldwide. Its strong presence in key markets such as Europe, North America, Asia-Pacific, Latin America, and the Middle East & Africa reinforces its ability to quickly respond to global healthcare challenges. Roche’s focus on clinical excellence, automation, and innovation continues to affirm its leadership in the global immunoassay diagnostics market.