Immunoassay Market worth $47.7 billion by 2030 with 6.1% CAGR | MarketsandMarkets™.

DELRAY BEACH, Fla., Sept. 1, 2025 /PRNewswire/ -- The global Immunoassay Market, valued at US$34.4 billion in 2024, stood at US$35.5 billion in 2025 and is projected to advance at a resilient CAGR of 6.1% from 2025 to 2030, culminating in a forecasted valuation of US$47.7 billion by the end of the period. This growth is primarily driven by the increasing prevalence of chronic and infectious diseases worldwide, which has boosted the demand for early and accurate diagnostic solutions. Moreover, the rapid expansion of the biotechnology and biopharmaceutical sectors, along with rising investments in diagnostic research, significantly supports the widespread adoption of immunoassay technologies across various healthcare settings.

The market is also benefiting from advances in immunoassay platforms—such as improved sensitivity, automation, and multiplexing—which support high-throughput testing and faster turnaround times. Additionally, rising healthcare expenditures, government initiatives for disease surveillance, and increasing demand for point-of-care diagnostics are further propelling market growth. However, despite these positive trends, the market faces certain barriers. One major obstacle is the strict regulatory environment governing the approval of immunoassay instruments and consumables. The complex and lengthy approval processes required by agencies like the US FDA and the European Medicines Agency can delay product launches and restrict market entry for new companies. Moreover, high costs for advanced testing platforms and a shortage of skilled laboratory professionals in some regions may also impede wider adoption of immunoassay technologies, especially in low- and middle-income countries.

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By product, 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.

By 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.

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 geography, 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.

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Some of the leading players in the market 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), and Bio- Rad Laboratories, Inc. (US).

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)

F. Hoffmann-La Roche 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.

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