PUBLISHER: Grand View Research | PRODUCT CODE: 1941483
PUBLISHER: Grand View Research | PRODUCT CODE: 1941483
The global autoimmune disease diagnostics market size was estimated at USD 6.07 billion in 2025 and is projected to reach USD 9.58 billion by 2033, growing at a CAGR of 5.84% from 2026 to 2033. The increasing prevalence of autoimmune disorders such as type 1 diabetes in newborn babies, coupled with the demand for rapid diagnostics, is the key driver accentuating growth.
In addition, there is an increasing focus on investments and funding for research related to autoimmune diseases, which further propels market growth. Furthermore, developing countries offer untapped opportunities for market expansion, presenting significant growth prospects in the years to come.
The establishment of technological advancements and the expansion of lab automation rates are anticipated to boost market growth. Clinicians are implementing advanced technology to conduct several tests at the same time with faster and more precise results.
Autoimmune diseases are a group of more than 100 chronic, debilitating conditions that affect approximately 3% of the US population. Some of the most common autoimmune diseases include obesity, cardiovascular diseases, type 2 diabetes mellitus, and all cancers. Thus, genetic factors, environmental influences, specific hormones, and susceptibility to certain infections are key contributors to the rising prevalence of autoimmune diseases globally. According to an article published by the National Health Council in September 2024, autoimmune diseases affect approximately 50 million Americans, and women account for 80% of this number. Given the inherent complexity involved in diagnosing these conditions, this figure is likely understated. More concerning is the fact that autoimmune diseases are approaching epidemic proportions, with several studies indicating annual growth rates in the range of 3%-12%.
An increasing rate of novel technological advancements and the corresponding emergence of laboratory automation technologies significantly contribute to market expansion. This trend is driven by the growing adoption of advanced technologies among clinicians, enabling them to conduct a wide range of tests while achieving faster and more accurate results. For instance, in January 2025, Werfen received FDA clearance for Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents. These assays enhance the accuracy of antiphospholipid syndrome (APS) diagnosis, addressing a significant unmet need in the diagnosis of autoimmune diseases.
In addition, the implementation of government initiatives across economies supports market developments. Work by organizations such as the Autoimmunity Centers of Excellence (ACE), the Cooperative Study Group for Autoimmune Disease Prevention (CSGADP), and the North American Rheumatoid Arthritis Consortium (NARAC) contributes to market growth by creating awareness among patients and healthcare professionals regarding proper diagnosis and treatment protocols.
The involvement of organizations such as the Autoimmunity Centers of Excellence, Cooperative Study Group for Autoimmune Disease Prevention, and North American Rheumatoid Arthritis Consortium in educating patients and healthcare professionals about proper diagnosis and treatment is anticipated to have a positive impact on market dynamics, as it promotes awareness and early intervention in autoimmune diseases. This, in turn, is expected to drive the growth of the autoimmune disease diagnostics market. Besides, favorable government initiatives aimed at increasing access to diagnostic tests, improving disease management and reducing healthcare costs, among other factors, are also expected to boost market growth during the forecast period.
Global Autoimmune Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global autoimmune disease diagnostics market report based on type, product, test, end use, and region.