Autoimmune Disease Diagnostics Market Study by Product, Type, and End-use Segments

The global autoimmune disease diagnostics market was valued at USD 5.72 billion in 2024 and is projected to reach USD 8.20 billion by 2030, growing at a CAGR of 6.18% from 2025 to 2030. The rising prevalence of autoimmune disorders, such as type 1 diabetes in newborns, along with growing demand for rapid diagnostics, is a major factor driving market growth.

Investments and funding in autoimmune disease research are increasing, further supporting market expansion. Developing countries also present significant untapped opportunities, offering potential for growth in the coming years. Technological advancements and expanding lab automation rates are anticipated to accelerate market development. Advanced technologies allow clinicians to conduct multiple tests simultaneously, delivering faster and more accurate results.

Key Market Trends & Insights

• North America dominated the market with a 42.7% share in 2024.
• The U.S. autoimmune disease diagnostics industry is expected to exert substantial influence on the global market.
• By type, the localized segment accounted for 64.25% of global revenue in 2024.
• By product, the consumables & assays segment held the largest revenue share at 70.43% in 2024.
• By test type, antinuclear antibody tests dominated the market with a 42.62% revenue share in 2024.

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Market Size & Forecast

• 2024 Market Size: USD 5.72 Billion
• 2030 Projected Market Size: USD 8.20 Billion
• CAGR (2025–2030): 6.18%
• North America: Largest market in 2024

Competitive Landscape

Key players in the autoimmune disease diagnostics market are actively pursuing strategic initiatives such as product innovation, collaborations, and partnerships to expand market share. For example, in June 2023, TruDiagnostic RVTY announced that its subsidiary EUROIMMUN launched the UNIQO 160 (CE-IVDR), an automated system for indirect immunofluorescence tests (IIFT) used in autoimmune disease diagnostics.

Prominent Companies

• Hoffmann-La Roche Ltd
• Siemens Healthcare Private Limited
• Abbott
• Beckman Coulter, Inc.
• Danaher Corporation
• Quest Diagnostics
• EUROIMMUN Medizinische Labordiagnostika AG
• Nova Diagnostics Pte Ltd.
• BIOMÉRIEUX
• Hemagen Diagnostics, Inc.

Recent Developments

• February 2025: The Benaroya Research Institute introduced a novel approach for early detection of autoimmune diseases by adding autoantibody testing to routine blood checkups. This test can identify conditions like type 1 diabetes and rheumatoid arthritis before symptoms appear, enabling earlier intervention. Pilot testing is currently underway.
• January 2025: RheumaGen, a biotechnology company in Aurora, Colorado, secured $15 million in Series A funding co-led by SPRIM Global Investments and William Taylor Nominees. The funds will support Phase I trials of RG0401, a gene-editing therapy targeting treatment-resistant rheumatoid arthritis by modifying HLA genes. The therapy aims to develop curative treatments for autoimmune diseases, including multiple sclerosis and type 1 diabetes.

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Conclusion

The autoimmune disease diagnostics market is poised for steady growth, driven by rising disease prevalence, technological advancements, increased research funding, and expanding adoption of rapid diagnostic solutions. Innovations in lab automation and gene-editing therapies will continue to shape market dynamics, creating opportunities for both established diagnostics providers and emerging biotechnology companies.