The report "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" is projected to reach USD 8.98 billion by 2031 from USD 5.57 billion in 2025, at a CAGR of 8.3% during the forecast period.
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The autoimmunity diagnostics market is witnessing robust growth, driven by several key factors. A primary driver is the rising global prevalence of autoimmune disorders, including both systemic autoimmune diseases and organ-specific autoimmune diseases, which is significantly increasing the demand for reliable and timely diagnostic solutions. Additionally, there is a notable rise in research activities focused on autoimmune diseases, contributing to the development of advanced testing methods. Technological advancements are also crucial; innovative diagnostic tools enable faster, more accurate, and earlier detection of these conditions. Furthermore, expanding healthcare infrastructure, particularly in emerging markets, improves access to diagnostic services, fueling overall market growth.
The consumables segment is expected to register the highest CAGR during the forecast period.
Based on product, the autoimmunity diagnostics market is divided into two segments: consumables and instruments. The consumables segment accounted for the highest CAGR over the forecast period, which was led by the continuous need for consumables for various diagnostic tests. This growth is driven by the increasing frequency of autoimmune disease testing, the rising adoption of advanced immunoassay kits, and the preference for single-use consumables that ensure accuracy and reduce contamination risks. Additionally, ongoing innovations in reagent formulations and the expanding availability of specialized consumables for different autoimmune conditions further contribute to the robust growth of this segment.
The organ-specific autoimmune diseases segment is expected to register the highest CAGR during the forecast period.
Based on disease type, the global autoimmunity diagnostics market is divided into systemic autoimmune disease and organ-specific autoimmune disease. The organ-specific autoimmune diseases segment accounted for the highest CAGR during the forecast period due to the rising prevalence of organ-specific conditions like type 1 diabetes, celiac disease, and inflammatory bowel disease, and other. Additionally, increasing adoption of targeted diagnostic tests, growing awareness about early and accurate diagnosis, and advancements in technologies enabling quicker, more precise detection of organ-specific autoantibodies are driving rapid market growth in this segment.
North America accounted for the largest share of the autoimmunity diagnostics market in 2024.
The market for autoimmunity diagnostics is segmented into five regions: North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. North America accounted for the largest share of the market in 2024. The large share of this region is primarily attributed to the high growth presence of countries such as the US and Canada. These countries have established healthcare infrastructure and high healthcare spending, thus supporting the adoption of advanced autoimmunity diagnostics products. The region also experiences a high incidence of autoimmune diseases. The availability of key players and R&D investments are also expected to sustain market growth.
The leading players operating in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), Revvity, Inc. (US), Thermo Fisher Scientific Inc. (US), Siemens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (US), Danaher Corporation (US), Werfen S.A. (Spain), Grifols S.A. (Spain), and QuidelOrtho Corporation (US).
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