Autoimmune Disease Testing Market to Reach USD 8.9 Billion by 2035, Growing at 6.8% CAGR

According to the report, the autoimmune disease testing market is anticipated to grow from USD 4.6 Billion in 2025 to USD 8.9 Billion in 2035 at a CAGR of 6.8% during the forecast. The market for autoimmune disease testing is quietly transforming fueled by an increase in chronic immune conditions, delayed diagnosis, and the opportunity for precision diagnostics. The introduction of new autoantibody multiplex testing, machine-learning-based analysis, and multi-omics technologies is going to enable detection of autoimmune disorder even earlier than is currently possible with existing methods.

Meanwhile in Canada and parts of the U.S.; patient advocacy organizations are teaming with mobile testing services and community health networks to develop low-cost research opportunities with underserved populations who have historically been undiagnosed. Further, it is discussed that awareness, accessibility to tests and cost are a factor in underserved places with limited health care access.

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Regional Analysis of Global Autoimmune Disease Testing Market

North America is the leading region in the autoimmune disease testing market due to the high prevalence of disease, sophisticated healthcare infrastructure and the high concentration of large diagnostic companies like Abbott, Thermo Fisher, and Roche. Europe is a close second, due to the presence of screening programs and government-sponsored healthcare.

Further, the Asia-Pacific region is showing large growth potential as awareness is increasing and healthcare systems are incorporating greater access to specialized diagnostics. Meanwhile, some regions in Latin America and Africa will face a more slow growth potential, primarily due to limited testing facilities and lower levels of awareness, unless there is targeted investment.

Key players operating in the autoimmune disease testing market include Abbott Laboratories, Beckman Coulter, Inc., bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, EUROIMMUN AG, Exagen Inc., F. Hoffmann-La Roche Ltd, Grifols, S.A., Hologic, Inc., Inova Diagnostics, Inc., Myriad Genetics, Inc., ORGENTEC Diagnostika GmbH, Phadia AB (a Thermo Fisher brand), Quest Diagnostics Incorporated, Siemens Healthineers, SRL Diagnostics, Thermo Fisher Scientific Inc., Trinity Biotech plc, Werfen Life Group, and other key players contributing to market growth through innovation, strategic partnerships, and global expansion.

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Key Driver, Restraint, and Growth Opportunity Defining the Global Autoimmune Disease Testing Market

The prevalence of autoimmune diseases, such as rheumatoid arthritis, lupus, and type 1 diabetes, is the most significant market growth factor in the autoimmune disease testing market. As autoimmune disorders become more well-known, and, more generally, chronic and debilitating diseases in general, the need for early diagnostic testing is expanding, especially in older individuals, however more so with undiagnosed health complaints in younger individuals. This urgency drives health systems and diagnostic companies to enhance screening accuracy and screening opportunities.

A key constraint for the future of the market is the complexity of the diagnosis and high-cost of testing. Autoimmune diseases typically present with non-specific and overlapping complaints, requiring multiple, often expensive tests to establish a diagnosis. Moreover, lengthy diagnostic delays upwards of years are frequent, even in the most advanced healthcare systems, thus further eroding the accuracy of the testing that follows. Lastly, restrictions on advanced diagnostic tests in several developing regions, creates additional barriers to market penetration and expansion.

The largest opportunity is the adoption of the use of AI-enabled diagnostics and multi-omics testing (genomics, proteomics, etc.) to quickly and accurately identify disease biomarkers. This not only assists in the early detection of disease, however is also leverages personalized medicine strategies and includes the growth of mobile units, and point-of-care (POC) diagnostics used in rural and poor regions.

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Recent Development and Strategic Overview:

In April 2025, Abbott Laboratories is excited to announce the launch of its next generation autoimmune diagnostic platform, ImmunoSure DX, designed to facilitate earlier and more accurate identification of complex autoimmune disorders. With advanced multiplex autoantibody profiling combined with AI-assisted interpretation of results, ImmunoSure DX accurately identifies overlapping autoimmune signals like never before.

In March 2025, Siemens Healthineers announced the launching of its novel diagnostic platform, "AutoDetect Ultra", aimed to simplify detection of autoimmune diseases through laboratory automation and machine learning based test analytics. AutoDetect Ultra allows for high throughput testing for multiple autoantibodies while reducing human error and turnaround time. The initial implementation in several leading academic hospitals in Germany, India and Brazil reported up to 40% faster diagnosis, and 15% has improved result accuracy on test results in patients with early-stage rheumatoid arthritis and systemic autoimmune disorders.

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Key Trend: Integration of Multi-Omics and AI Enhancing Diagnostic Accuracy in Autoimmune Disease Testing Market

The field of autoimmune illness diagnosis is now changing significantly toward multi-omics approaches including genomics, proteomics, transcriptomics, and metabolomics to provide a more thorough knowledge of immune-mediated illnesses. More detail and integration enable a more precise and early diagnosis especially of disorders that manifest with comparable or hazy symptoms among those impacted.

Further, multi-omic approaches are even more relevant when utilizing artificial intelligence and machine learning multi-omic data can be processed faster and with greater accuracy, allowing pre-symptomatic patterns to be sensed and potential treatments determined in an expedited manner. The ability for earlier-stage diagnosis and treatment alongside rising autoimmune disease prevalence, in combination with patients requiring more true data-driven care, makes this transition particularly timely.

Lastly, research laboratories, diagnostic companies, and biotechnology companies are collaborating, along with other relevant stakeholders, to bring these new, more sophisticated methods of testing from laboratories into clinical practice and continuing to develop next-generation diagnostics for autoimmune disease.

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