Top Companies in the Immunoassay

Leading Companies in the Immunoassay Market - Abbott (US) and F. Hoffmann-La Roche (Switzerland)

The global immunoassay market 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 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.

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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.

Market Ranking

As of 2024, the global immunoassay market remains highly consolidated, with five main companies—Abbott, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Bio-Rad Laboratories, and Danaher Corporation—together holding about 50–55% of the total market share. Abbott leads the market with its advanced Alinity and ARCHITECT systems, while Roche closely follows with its cobas® platforms. Siemens Healthineers strengthens its position through automation-focused solutions like Atellica, and Bio-Rad is prominent in specialized assay kits. Danaher, through Beckman Coulter, makes a significant contribution with its high-throughput analyzers. The remaining 45–50% is held by regional and emerging players. Growth is driven by technological innovations, product development, automation, and increasing demand from pharma & biopharma sectors, especially in emerging regions such as the Asia Pacific and Latin America.

Related Reports:

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

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Immunoassay Market Size,  Share & Growth Report
Report Code
MD 4751
RI Published ON
9/1/2025
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