Autoimmune Diagnostics Market is expected to reach USD 11.45 billion by 2032 | Top key players - Aurora Life Sciences, Bio-Rad Laboratories, Inc, ZEUS Scientific, Inc.

Market Size and Growth:

The Global Autoimmune Diagnostics Market size reached USD 6.91 billion in 2025 and is expected to reach USD 11.45 billion by 2032, growing with a CAGR of 7.5% during the forecast period 2025-2032. The Market Growth is driven by the rising prevalence of autoimmune diseases and increasing adoption of advanced, automated diagnostic technologies for early detection.

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The Autoimmune Diagnostics Market refers to the industry focused on developing and providing diagnostic tests and tools used to detect autoimmune diseases, where the immune system mistakenly attacks the body's own tissues. These diagnostics include assays, analyzers, and reagents that identify autoantibodies, biomarkers, and inflammatory indicators to enable early detection, accurate diagnosis, and effective disease management.

Industry Recent Developments: United States

✅ August 2025: Advancement in diagnostic technologies such as molecular diagnostics, next-generation sequencing, and immunodiagnostics is boosting the accuracy and efficiency of autoimmune disease detection. Increased public awareness and personalized medicine emphasis are promoting routine and early screening in hospitals and diagnostic centers.

✅ September 2025: The U.S. autoimmune disease diagnostics market is supported by rising government funding for chronic disease management, with increased adoption of autoantibody assays, ELISA, and advanced sequencing for precise diagnosis. Hospitals and specialty clinics are investing in sophisticated diagnostic platforms to meet growing demand.

✅ October 2025: The autoimmune disease diagnostics market valuation grows with enhanced biomarker discovery and digital health platform integration, facilitating personalized treatment pathways. Innovations for rapid and precise testing solutions are driving market expansion amid rising autoimmune disorder prevalence.

Industry Recent Developments: Japan

✅ August 2025: The autoimmune disease diagnostics market in Japan is projected to grow with a CAGR around 9.8%, driven by technological advancements including multiplex immunoassays, chemiluminescence platforms, and molecular diagnostics for complex autoimmune conditions. Market expansion is fostered by aging population and increasing disease prevalence.

✅ September 2025: The diagnostics landscape in Japan sees increased use of high-throughput and efficient testing solutions, with companies diversifying test portfolios beyond ANA and ELISA tests to address rheumatoid arthritis, lupus, and other autoimmune disorders. Collaborations between academia and industry accelerate new assay development.

✅ October 2025: Japan's autoimmune diagnostics market growth is supported by rising demand for rapid diagnostics, expanding laboratory automation, and ongoing research to develop novel diagnostic tools tailored to autoimmune diseases in an aging population.

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FDA / U.S. Regulatory Activity (2025):

✅ AliveDx (MosaiQ AiPlex CTDplus) - AliveDx announced it submitted a U.S. FDA 510(k) premarket notification for its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) multiplex microarray in April 2025 (this was a submission, not yet a clearance).

✅ General observation: Public records and press coverage in 2025 show more activity around FDA submissions / designations for neurology-related biomarkers (e.g., earlier breakthrough designations for NfL) and fewer publicly announced new FDA clearances for novel autoimmune IVDs in 2025 compared with CE/IVDR activity and platform launches. (Searches of FDA 510(k)/Breakthrough lists and industry coverage in 2025 returned few new, standalone FDA clearances specifically labelled as autoimmune IVD approvals.)

EU / International Regulatory Approvals (2025):

✅ AliveDx (MosaiQ AiPlex CTDplus) - the MosaiQ AiPlex CTDplus gained IVDR / CE certification in February 2025, enabling use in EU markets prior to a U.S. 510(k) clearance effort.

✅ Revvity / EUROIMMUN - Revvity (EUROIMMUN) announced CE marking for diagnostic assays in 2025 (example: a CE-marked anti-measles assay announced March 3, 2025) and launched new automated instrumentation (IDS i20) for specialty immunoassay workflows in 2025 - signalling continued regulatory/commercial activity in Europe for immunodiagnostics platforms. While that measles assay is infectious-disease focused, EUROIMMUN is a major supplier of autoimmune immunoassays, and these moves reflect platform and CE-mark momentum in the IVD space in 2025.

Mergers & Acquisitions (2025):

✅ Source BioScience → Cambridge Clinical Laboratories (CCL) - Source BioScience announced and completed the acquisition of Cambridge Clinical Laboratories in April 2025, expanding its clinical diagnostics and laboratory testing capabilities (relevant to the broader diagnostics market, including autoimmune testing services handled by clinical labs).

✅ Broader dealmaking trend: H1 2025 saw active dealmaking around autoimmune R&D, diagnostics platforms, and testing services (multiple partnership/M&A announcements among large pharmas and diagnostics/life-science companies). Industry reviews from H1 2025 highlight continued consolidation and platform-buying behaviour (companies buying diagnostics capabilities, automation platforms and specialty labs).

Major Key Players:

Aurora Life Sciences
Bio-Rad Laboratories, Inc
ZEUS Scientific, Inc.
Thermo Fisher Scientific Inc.
Scimedx Corporation
Merck KGaA
Medsource Ozone Biomedicals Pvt. Ltd.
Proteometech Inc
ImmunoDiagnostics Limited.
Cambridge Life Sciences Limited.

Segments Covered in the Autoimmune Diagnostics Market:

By Diagnostic Tests: Autoantibody Tests​, Complete Blood Count (CBC)​, Antinuclear Antibody Tests​, C-reactive Protein (CRP), Rheumatoid Factor Test, Others​.

By Product Type: Instruments, Assay Kits, Others.

By Disease Type: Systemic Autoimmune Disease, Localized Autoimmune Disease.

By End User: Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, Others.

Regional Analysis for Autoimmune Diagnostics Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Autoimmune Diagnostics market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Autoimmune Diagnostics Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Autoimmune Diagnostics market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Autoimmune Diagnostics Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Autoimmune Diagnostics market?

➠ Who are the global key manufacturers of the Autoimmune Diagnostics Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Autoimmune Diagnostics market opportunities and threats faced by the vendors in the global Autoimmune Diagnostics Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Autoimmune Diagnostics market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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