Top Companies in the Autoimmunity Diagnostics

The autoimmunity diagnostics market is projected to reach USD 8.98 billion by 2031 from USD 5.57 billion in 2025, at a CAGR of 8.3% during this period. The global prevalence of autoimmune disorders is rising significantly, driven by genetic and lifestyle factors, which increases the demand for accurate and timely diagnosis. Furthermore, advancements in diagnostic technologies, such as automated immunoassays, multiplex testing systems, and new biomarker assays, are improving detection accuracy and turnaround times. Increased awareness among healthcare providers and patients about the critical role of early diagnosis in managing autoimmune diseases is fueling demand for innovative diagnostic solutions. Additionally, supportive government initiatives and expanding healthcare infrastructure globally contribute to the market growth.

Some of the leading players in the global autoimmunity diagnostics market include F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), Revvity, Inc. (US), Thermo Fisher Scientific Inc. (US), and Siemens Healthineers AG (Germany). These companies have adopted a variety of growth strategies, both organic and inorganic, such as acquisitions, product launches, partnerships, agreements, and expansions. These strategies have enabled them to strengthen their international presence and capture a larger share of the autoimmunity diagnostics market. The market players have successfully expanded their offerings across different geographies by implementing these approaches.

• In January 2023, Revvity, Inc. (US) launched the UNIQO 160 (CE-IVDR), an automated indirect immunofluorescence testing (IIFT) system for autoimmunity diagnostics.
• In December 2023, Thermo Fisher Scientific Inc. (US) entered into a distribution agreement with AESKU.GROUP GmbH (Germany). Under this agreement, Thermo Fisher will handle sales, marketing, and related activities for Aesku products exclusively in the US.

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F. Hoffmann-La Roche Ltd. (Switzerland)

F. Hoffmann-La Roche Ltd. (Switzerland) provides a comprehensive range of instruments and consumables for the autoimmunity diagnostics market. The company focuses on innovation, as reflected in its substantial R&D investments, which support the development of integrated and automated testing platforms. Roche continues to expand its immunoassay test menu, covering a broad spectrum of autoimmune markers. It also benefits from a well-established global distribution network, ensuring widespread access to its diagnostic solutions across diverse healthcare systems. Furthermore, Roche’s integrated approach, combining automation, digital diagnostics, and an expanding test portfolio, enables laboratories to streamline workflows and deliver faster, more reliable results.

Abbott Laboratories (US)

Abbott plays a key role in the autoimmunity diagnostics market through its wide range of instruments and consumables, which are supported by strong quality standards and advanced laboratory automation capabilities. The company’s diagnostic systems are designed to deliver high throughput, accuracy, and operational efficiency, enabling effective testing for various autoimmune conditions such as lupus, rheumatoid arthritis, and celiac disease. Abbott’s global manufacturing and distribution infrastructure ensures reliable product availability across major healthcare markets, enabling the company to effectively serve hospitals and diagnostic laboratories globally.

Market Ranking

F. Hoffmann-La Roche Ltd. (Switzerland) differentiates itself in the autoimmunity diagnostics market through its advanced instruments and strong R&D capabilities, enabling the development of efficient and reliable diagnostic solutions. Abbott Laboratories (US) capitalizes on its broad product portfolio and extensive global distribution network to serve a wide range of healthcare providers, expanding its market presence. Revvity, Inc. (US) contributes to the market with diverse instruments and consumables tailored for autoimmune disease testing. Thermo Fisher Scientific Inc. (US) strengthens its position through strategic partnerships that enhance its diagnostic offerings. Siemens Healthineers AG (Germany) builds its competitive edge through global scale and strategic partnership. Overall, competition in the market is driven by continuous product innovation and the growing need to meet stringent regulatory requirements.

Related Reports:

Autoimmunity Diagnostics Market by Product (Consumables, Instruments), Test Type (Routine, Autoantibody, Inflammatory, Urinalysis Tests), Disease (RA, SLE, MS, IBD), End User (Clinical Laboratories, Hospitals & Clinics) - Global Forecast to 2031

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