Autoimmune Disease Diagnosis Market to Surge to USD 8.98 Billion by 2031

Dublin, Dec. 12, 2025 (GLOBE NEWSWIRE) — The “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” has been added to ResearchAndMarkets.com’s offering.

The autoimmune disease diagnosis market is projected to reach USD 8.98 billion by 2031, up from USD 5.57 billion in 2025, marking a compound annual growth rate (CAGR) of 8.3% over the forecast period. Key drivers include a rise in autoimmune disorders, enhanced awareness of early diagnoses, and technological advancements such as multiplex immunoassays and biomarker-based tests. Moreover, the adoption of automated platforms and supportive government policies are promoting increased testing volumes and enhancing diagnostic precision.

By disease type, the systemic autoimmune diseases segment led the market in 2024. Globally, the autoimmune disease diagnosis market divides into systemic and organ-specific autoimmune diseases. Systemic autoimmune diseases held the largest market share in 2024 due to the high prevalence of conditions like rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis. These conditions often impact multiple organs, necessitating comprehensive diagnostic evaluations. The complex nature of these diagnoses, dependence on advanced immunological tests, and continuous monitoring fuel demand for diagnostic solutions in this segment.

By end user, clinical laboratories dominated the market during the forecast period. The market is segmented into clinical laboratories, hospitals & clinics, and other end users. Clinical laboratories emerged as the largest market share holder due to their specialized expertise, advanced diagnostic technologies, and high-throughput capabilities. These labs utilize automated platforms, including ELISA, chemiluminescence, and immunofluorescence, to conduct complex tests efficiently. Their role as centralized hubs allows for processing large sample volumes cost-effectively.

Asia Pacific: The fastest-growing region in the autoimmune disease diagnosis market during the forecast period. Regionally, the market segments into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific market is poised to grow the fastest, driven by a rise in autoimmune diseases, increasing healthcare expenditure, and adoption of advanced diagnostics. Additionally, improved healthcare infrastructure and governmental initiatives are bolstering market growth in the Asia Pacific.

Breakdown of primary participants in the autoimmune disease diagnosis market:

• By Company Type: Tier 1 – 40%, Tier 2 – 30%, Tier 3 – 30%
• By Designation: C-level – 27%, D-level – 18%, Others – 55%
• By Region: North America – 51%, Europe – 21%, Asia Pacific – 18%, Latin America – 6%, Middle East & Africa – 4%

Leading market players include Thermo Fisher Scientific Inc. (US), Siemens Healthineers AG (Germany), Abbott Laboratories (US), Bio-Rad Laboratories, Inc. (US), and Grifols S.A. (Spain), among others.

Research Coverage: The report categorizes the autoimmune disease diagnosis market by product, test type, disease type, end user, and region. It provides detailed insights into significant factors like drivers, restraints, opportunities, and challenges impacting market growth. A comprehensive analysis of key industry players, including their business overview, key strategies, acquisitions, and new product launches, is featured. Furthermore, the report examines the competitive landscape, focusing on upcoming startups within the ecosystem.

Reasons to buy this report: The report assists market leaders and entrants in understanding revenue projections for the autoimmune disease diagnosis market and its subsegments. Stakeholders gain insights into the competitive landscape, enhancing their ability to position businesses strategically and plan effective go-to-market approaches. Additionally, insights into key market drivers, restraints, opportunities, and challenges are provided.

The report provides insights on the following pointers:

• Analysis of key drivers, such as the high incidence of autoimmune diseases and advancements in diagnostic technologies; restraints like high capital needs; opportunities including biosensor utilization; and challenges like diagnosis complexities and lack of skilled professionals.
• Product Development/Innovation: Insights on new technologies, R&D activities, and product launches.
• Market Development: Analysis of lucrative markets across different regions.
• Market Diversification: Information on new products and recent developments.
• Competitive Assessment: In-depth analysis of market shares and strategies of leading players such as F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), Revvity, Inc. (US), and Thermo Fisher Scientific Inc. (US).

Key Attributes:

Company Profiles

• F. Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Revvity, Inc.
• Thermo Fisher Scientific Inc.
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Grifols SA
• Werfen SA
• Exagen Inc.
• Trinity Biotech PLC
• Tecan Group Ltd.
• Danaher Corporation
• Biosynex SA
• Quidelortho Corporation
• Biomerieux SA
• Diasorin S.P.A.
• Becton, Dickinson and Company
• Sd Biosensor, Inc.
• Cambridge Life Sciences Ltd.
• A. Menarini Diagnostics S.R.L
• Sebia
• Kronus
• Erba Group
• Aesku.Group GmbH
• Medsource Ozone Biomedicals Pvt. Ltd.
• Epitope Diagnostics Inc.

For more information about this report visit https://www.researchandmarkets.com/r/ywaszr

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• Autoimmunity Diagnostics Market