Autoimmune Disease Diagnostics Market Report

Autoimmune diseases are challenging to diagnose due to the involve a variety of complicated symptoms. Several invasive and painful diagnostic procedures are currently available on the market. For instance, celiac disease, which has symptoms including minor gastrointestinal pain and certain neurological issues, is triggered by gluten. The celiac disease diagnosis procedures are painful and can require a gut sample for evaluation. As a result, the market has experienced an increase in the development of novel diagnostic methods to overcome these painful and invasive procedures. For instance, a web-based Clinical Support System (CDSS) combined with an automated classifier was built to build a database for the detection of celiac disease. Increased use of artificial intelligence techniques, such as nearest neighbour algorithm, support vector machines, decision trees, Bayesian inference and artificial neural networks, among others, is likely to contribute to market expansion over the forecast period. 

Detecting autoimmune diseases takes time and involves a variety of testing scenarios, including blood testing for Addison’s disease, rheumatoid arthritis, and hashimoto's disease. Furthermore, no one laboratory test can effectively diagnose the presence of an autoimmune disease with high accuracy. To provide a complete picture, several laboratory tests are required. The absence of epidemiological data and access to efficient diagnostic tools, as well as a lower number of competent healthcare professionals, are limiting crucial product market penetration in numerous emerging nations. Furthermore, the general public's lack of awareness of these diseases limits the number of new and follow-up consultations for these patients. This is projected to limit the market's faster expansion throughout the forecast period.

However, the diagnosing autoimmune diseases is complicated by the often vague and overlapping symptoms, necessitating specialized expertise and advanced diagnostic tools, which increases healthcare costs. Differences in healthcare access, especially in developing regions, exacerbate delays in diagnosis and treatment, impacting patient outcomes. Additionally, securing reimbursement for diagnostic tests remains challenging, with strict coverage criteria imposed by payers such as insurance companies and government programs. This financial burden, compounded by the US$100 billion annual treatment cost in the U.S., further hinders market growth.

Major industry leaders utilize strategies that focus on launching new products, merging with competitors, and purchasing companies to grow their customer base and enhance their range of products. In May 2024, a significant milestone was reached in autoimmune disease diagnostics with the launch of Progentec Diagnostics' advanced biomarker tests in partnership with Mayo Clinic Laboratories. Following their 2023 collaboration, Progentec's DX Lupus Disease Activity Index and DX Lupus Flare Risk Index are now available to Mayo Clinic Laboratories' clients. These innovative blood tests offer enhanced tools for proactive management and early detection of systemic lupus erythematosus, marking a notable advancement in personalized autoimmune disease care.

Furthermore, in June 2023, Revvity's EUROIMMUN division launched the UNIQO 160, a cutting-edge automated indirect immunofluorescence test (IIFT) system for autoimmune disease diagnostics. This all-in-one platform enhances efficiency across the IIFT workflow, streamlining sample preparation, incubation, slide washing, mounting, image capture, and analysis. With CE mark certification, the UNIQO 160 addresses common lab challenges by minimizing manual intervention and reducing the need for specialized training, thus improving overall diagnostic accuracy and laboratory productivity.

In the global autoimmune disease diagnostics market, the Americas, particularly North America, are poised for significant growth due to the increasing incidence of autoimmune disorders such as rheumatoid arthritis (RA), inflammatory bowel disease and systemic lupus erythematosus (SLE). According to the American Autoimmune Related Diseases Association (AARDA), autoimmune diseases impact over 50 million individuals annually in the U.S., positioning it as a leading cause of death and chronic illness among women under 65. This high prevalence underscores a critical need for advanced diagnostic solutions.

Moreover, the aging population in the U.S. further propels market expansion. The Population Reference Bureau forecasts that Americans aged 65 and older will grow over 58 million in 2023 to 82 million by 2050, a 47% increase. This demographic shift, along with the rising prevalence of rheumatoid arthritis, highlights North America's dominant position in the global autoimmune diagnostics market, driving innovations in precision medicine and diagnostic technologies.