Autoimmune Disease Testing Market Size, Share, Competitive Landscape and Trend Analysis Report, by Product Type, by Disease Type, by Test Type, by End User : Global Opportunity Analysis and Industry Forecast, 2024-2033

Key Market Dynamics 

The major factors driving the autoimmune disease testing market growth includes increasing incidence of autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and type 1 diabetes. In addition, rise in technological advancements led to the development of more accurate, efficient, and less invasive diagnostic tests thereby supporting the market growth. Innovations such as enzyme-linked immunosorbent assay (ELISA) , indirect immunofluorescence (IIF) , chemiluminescence immunoassay (CLIA) , and multiplex immunoassay are transforming autoimmune disease testing. These methods offer higher sensitivity, specificity, and quicker turnaround times, improving patient outcomes and driving market growth. 

Furthermore, the increase in public awareness and education about autoimmune diseases are encouraging more people to seek medical advice and testing thereby driving autoimmune disease testing market size. Educational campaigns by healthcare organizations and patient advocacy groups emphasize the importance of early diagnosis and management, contributing to the growing demand for testing services. 

Moreover, government initiatives and funding for research on autoimmune diseases play a crucial role in market expansion. Many governments are investing in healthcare infrastructure, funding research projects, and promoting public health campaigns to combat autoimmune diseases. For instance, the National Institutes of Health (NIH) in the U.S. allocates substantial funds for autoimmune disease research, which includes improving diagnostic methods. Thus, rise in government initiatives for autoimmune diseases supports the growth during the autoimmune disease testing market forecast period. 

However, the lack of awareness and understanding of autoimmune diseases among both healthcare providers and the general public can lead to misdiagnosis or delayed diagnosis, reducing the demand for specialized testing and hampering the market growth. On the other hand, the increasing adoption of point-of-care testing (POCT) technologies allows for rapid and convenient diagnostics, meeting the demand for early detection and personalized treatment strategies which provides autoimmune disease testing market opportunity. 

Prevalence of Rheumatoid Arthritis Worldwide

According to data from the Institute for Health Metrics and Evaluation (IHME) , the prevalence of Rheumatoid Arthritis (RA) is projected to increase significantly from 17.6 million cases in 2020 to 31.7 million by 2050. This rise in prevalence of autoimmune diseases globally, necessitates advancements in diagnostic technologies and healthcare strategies to meet future healthcare demands effectively. The rise in prevalence of RA and other autoimmune diseases directly influences the autoimmune disease testing market. With the rise in number of diagnosed cases, there will be an increased demand for accurate and efficient diagnostic tools that can facilitate early detection and monitoring of these conditions. This trend is expected to drive innovation among diagnostic companies, prompting investments in research and development aimed at enhancing test sensitivity, specificity, and accessibility.    

Prevalence of Rheumatoid Arthritis Worldwide (in Million)

Market Segmentation 

The autoimmune disease testing market is segmented into product type, disease type, test type, end user, and region. On the basis of the product type, the market is classified into instruments and consumables and kits. As per disease type, the market is divided into rheumatoid arthritis, systemic lupus erythematous, scleroderma, vasculitis, inflammatory bowel disease, and others. On the basis of test type, the market is divided into antibodies and immunologic test, inflammatory markers, routine laboratory tests, anti-thyroglobulin antibody, and others. By end user, the market is segregated into hospitals and clinics, clinical laboratories, and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.                                    

Regional/Country Market Outlook 

North America dominated the autoimmune disease testing market share in 2023 owing to high awareness levels, and substantial healthcare expenditure. In addition, rise in adoption of advanced diagnostic technologies and personalized medicine approaches, contributes to an autoimmune disease testing market growth. The Asia-Pacific region is expected to witness the fastest growth, fueled by rising healthcare expenditure, increasing awareness, and improved diagnostic facilities in countries such as China and India. LAMEA also shows promising growth prospects due to improving healthcare access and rising incidences of autoimmune diseases. 

Industry Trends 

• The Foundation for the National Institutes of Health (FNIH) also celebrated their Accelerating Medicines Partnership (AMP) program in 2024, which included the autoimmune and immune-mediated diseases (AMP AIM) program. This research project has the potential to uncover new information about autoimmune diseases such as Sjögren's syndrome and how they may be similar. Thus, rise in awareness about autoimmune diseases and improving diagnostic capabilities have the potential to expand the autoimmune disease testing market. 

• An article published by National Institute of Environmental Health Sciences, in 2024 nearly 80% of people with a chronic autoimmune condition are women. These autoimmune diseases include rheumatoid arthritis, multiple sclerosis, scleroderma, lupus, Sjögren’s syndrome, and others. The high prevalence of autoimmune diseases among women led to an increased demand for diagnostic tests which further drives the market growth. 

Competitive Landscape 

The major players operating in the autoimmune disease testing market include F. Hoffmann-La Roche Ltd, Siemens, Thermo Fisher Scientific Inc., Quest Diagnostics, Abbott, Werfen, S.A., Trinity, Biotech, Bio-Rad Laboratories, Inc., Grifols, S.A., and Exagen Inc. Other players in autoimmune disease testing market include HYCOR Biomedical, Cambridge Lifesciences Limited and so on. 

Recent Key Strategies and Developments in Autoimmune Disease Testing Industry 

• In July 2023, Roche Diagnostics India announced the launch of the Elecsys HCV Duo which is India’s first commercially available fully automated immunoassay that allows simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample.? 

• In May 2022, the new Phadia 2500+ series of instruments is now available for autoimmune testing in the U.S. The family of high-capacity, intuitive lab instruments supplied by Thermo Fisher Scientific, the world leader in serving science, offers reliable and unparalleled high throughput for both allergy diagnostics and autoimmune testing. 

Key Sources Referred 

• National Center for Biotechnology and Information (NCBI)  
• Centers for Medicare & Medicaid Services (CMS)  
• National Health Service (NHS)  
• Australian Government Department of Health and Aged Care 
• Government of Canada's Health and Wellness 
• Ministry of Health and Family Welfare (MoHFW)  
• National Health Mission (NHM)  
• Ayushman Bharat - Health and Wellness Centres (AB-HWCs)  
• Centers for Disease Control and Prevention (CDC)  
• Food and Drug Administration (FDA)  
• National Institutes of Health (NIH)  
• World Health Organization (WHO)  

Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the autoimmune disease testing market analysis from 2024 to 2033 to identify the prevailing autoimmune disease testing market opportunities.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the autoimmune disease testing market segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as global autoimmune disease testing market trends, key players, market segments, application areas, and market growth strategies.