Autoimmune Disease Testing Market to Reach US$13.4 Bn by 2032 | Persistence Market Research

The autoimmune disease testing market has witnessed substantial growth, driven by the increasing prevalence of autoimmune disorders and advancements in diagnostic technologies. The global market is projected to grow from USD 6.6 billion in 2025 to USD 13.4 billion by 2032, with a compound annual growth rate (CAGR) of 10.8% during the forecast period. This growth can be attributed to various factors, including technological innovations, rising awareness, and an increasing demand for early diagnosis and personalized medicine.

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Overview of the Autoimmune Disease Testing Market

Autoimmune diseases are disorders where the immune system attacks the body's own tissues, leading to chronic conditions such as rheumatoid arthritis, systemic lupus erythematosus (SLE), and Hashimoto's thyroiditis. These diseases have been on the rise globally, contributing to a growing demand for diagnostic testing. The need for accurate and early diagnosis is critical, as autoimmune diseases often have overlapping symptoms with other conditions, making them difficult to detect without specialized testing.

Technological advancements have played a key role in shaping the autoimmune disease testing market. Immunoassays, such as enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and multiplex immunoassays, have become crucial tools in autoimmune disease diagnosis. These technologies offer high sensitivity and specificity, enabling healthcare providers to diagnose these conditions at an earlier stage and improve patient outcomes.

The market is divided into various segments based on product types, disease types, and regions. Among these, the reagents and consumables segment is expected to maintain dominance due to their essential role in autoimmune disease testing. Furthermore, North America holds the largest share of the market, driven by advancements in healthcare infrastructure, while the Asia Pacific region is anticipated to witness the fastest growth during the forecast period.

Key Highlights from the Report

• The global autoimmune disease testing market is expected to grow from USD 6.6 billion in 2025 to USD 13.4 billion by 2032, at a CAGR of 10.8%.
• North America is the leading region in terms of market share, accounting for 37% in 2025.
• The localized autoimmune disease segment holds the largest share, driven by high prevalence and advancements in diagnostic technologies.
• Reagents and consumables lead the market with a 68% share in 2025, due to their importance in laboratory testing.
• ELISA and IFA are the dominant test types, owing to their sensitivity and compatibility with autoantibody testing.
• The Asia Pacific region is expected to be the fastest-growing region, driven by rising awareness and increased access to diagnostic technologies.

Market Segmentation

The autoimmune disease testing market is segmented based on product type, end-user, and disease type.

Product Type

The autoimmune disease testing market is primarily segmented into reagents and consumables, diagnostic instruments, and software. Among these, the reagents and consumables segment holds the largest share, accounting for 68% of the market in 2025. This is due to the essential role reagents and consumables play in various autoimmune diagnostic tests. These consumables, including test kits, antibodies, and other consumable materials, are essential for conducting autoantibody tests, a common diagnostic method for autoimmune diseases. The growing prevalence of autoimmune diseases, advancements in biomarker research, and the increasing availability of specialized consumables continue to drive demand in this segment.

Disease Type

The market can also be segmented based on the type of autoimmune diseases being tested for, such as localized autoimmune diseases and systemic autoimmune diseases. Localized autoimmune diseases, which include conditions like celiac disease, rheumatoid arthritis, and thyroid disorders, are expected to dominate the market, accounting for a significant share of 67% in 2025. This is largely due to the high prevalence of these conditions, as well as advances in diagnostic methods, which enable earlier and more accurate diagnosis.

End-User

The primary end-users of autoimmune disease testing services include hospitals, clinical laboratories, and diagnostic centers. Hospitals are expected to be the largest segment due to the high volume of diagnostic testing required in these settings. Clinical laboratories and diagnostic centers are also significant contributors to the market, as they provide specialized diagnostic services and test kits to healthcare providers.

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Regional Insights
North America

North America remains the largest market for autoimmune disease testing, with the region accounting for nearly 37% of the market share in 2025. This dominance is driven by the rising prevalence of autoimmune diseases, advanced healthcare infrastructure, and growing awareness of these conditions. In the United States, nearly 23.5 million people suffer from autoimmune diseases, according to the CDC, further emphasizing the need for improved diagnostic solutions. The increasing adoption of advanced diagnostic technologies, such as ELISA and multiplex immunoassays, has significantly enhanced the accuracy and efficiency of autoimmune disease testing in the region.

Europe

Europe is another key market for autoimmune disease testing, with strong growth driven by an aging population and a rising burden of autoimmune diseases. Countries such as Germany, the UK, and France have integrated advanced diagnostic technologies like immunofluorescence and immunoblotting into their public healthcare systems. These countries are also expanding national screening programs to facilitate early diagnosis and improve patient outcomes. The centralized healthcare model in Europe, along with government support for diagnostic advancements, positions the region for continued growth.

Asia Pacific

The Asia Pacific region is emerging as one of the fastest-growing markets for autoimmune disease testing. Factors such as an increasing prevalence of autoimmune diseases, improved healthcare infrastructure, and growing public awareness are driving demand for diagnostic testing in countries like China, India, and Japan. In particular, the adoption of point-of-care diagnostic kits and multiplex immunoassays has enhanced the accessibility of autoimmune testing in both urban and rural areas. As the region continues to invest in healthcare and diagnostic infrastructure, the autoimmune disease testing market is expected to experience rapid growth.

Market Drivers

The growth of the autoimmune disease testing market is largely driven by the rising prevalence of autoimmune disorders globally. Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease are becoming more common, increasing the demand for accurate and early diagnostic tests. Furthermore, advancements in diagnostic technologies have significantly improved the speed and accuracy of tests, making it easier to diagnose autoimmune diseases at an earlier stage.

Another important driver is the growing adoption of personalized medicine. Personalized approaches to healthcare are increasingly being used to tailor treatments based on individual patient needs. Autoimmune disease testing plays a crucial role in this, as it enables healthcare providers to diagnose patients accurately and develop tailored treatment plans. Moreover, the rise of point-of-care testing solutions, which offer faster and more accessible testing, is contributing to market growth.

Market Restraints

Despite the significant advancements in autoimmune disease testing, several challenges remain. One of the key restraints is the lack of standardization in diagnostic protocols, especially in developing regions. Variability in test results, particularly in tests like indirect fluorescent antibody (IFA) assays, can lead to diagnostic ambiguity. This lack of standardization can result in misdiagnosis or delays in treatment, affecting patient outcomes.

Another restraint is the limited awareness of autoimmune diseases and diagnostic testing in many emerging economies. In low-resource settings, healthcare infrastructure is often insufficient, and primary care physicians may have limited access to specialized testing services. Additionally, the high cost of multiplex tests and poor reimbursement coverage in certain regions further limits market penetration.

Market Opportunities

The autoimmune disease testing market presents several opportunities, particularly in the area of point-of-care testing and personalized medicine. As the demand for rapid and affordable diagnostic solutions increases, there is significant potential for market players to develop new diagnostic tools and technologies. The integration of artificial intelligence (AI) in diagnostic interpretation, as well as the development of portable diagnostic devices, offers exciting opportunities for innovation.

In addition, the Asia Pacific and Middle East regions present substantial growth opportunities. While these regions face challenges related to healthcare infrastructure and awareness, government initiatives and partnerships with private organizations are improving access to diagnostic services. The increasing incidence of autoimmune diseases in these regions further amplifies the need for improved diagnostic solutions.

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Company Insights

Key players in the autoimmune disease testing market include:

• Abbott Laboratories
• Thermo Fisher Scientific
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers
• Bio-Rad Laboratories
• Beckman Coulter (Danaher Corporation)
• Quest Diagnostics
• PerkinElmer, Inc.
• bioMérieux
• Werfen (Inova Diagnostics)
• Ortho Clinical Diagnostics
• Trinity Biotech
• EUROIMMUN (A PerkinElmer Company)

Market Segmentation

By Product

Instruments
Reagents and Consumables

By Disease Type

Systemic autoimmune disease
Rheumatoid arthritis
Systemic lupus erythematosus (SLE)
Psoriasis
Multiple sclerosis
Others
Localized autoimmune disease
Inflammatory bowel disease
Type 1 diabetes
Thyroid
Others

By Test Type

Antinuclear antibody tests
Autoantibody tests
C-reactive protein (CRP)
Complete blood count (CBC)
Urinalysis
Others

By End-user

Hospitals and Clinics
Diagnostic Laboratories
Research Laboratories
Others

By Region

North America
Europe
East Asia
South Asia and Oceania
Latin America
Middle East and Africa

Recent Developments

• In October 2024, Pathkind Diagnostics expanded its autoimmunity testing services through a partnership with Sebia to incorporate the Alegra Monotest technology.
• In September 2024, Dr. Eugenia Chock from Yale School of Medicine received funding from the FDA's Office of Women's Health to develop AI-assisted tools aimed at improving autoimmune disease diagnosis in women.

Conclusion

The autoimmune disease testing market is poised for significant growth over the coming years. Technological advancements, increasing disease prevalence, and rising awareness are driving the demand for accurate and efficient diagnostic solutions. However, challenges such as the lack of standardization and limited awareness in emerging markets remain. Despite these hurdles, the opportunities for innovation in point-of-care testing, personalized medicine, and AI-assisted diagnostics provide a promising outlook for the industry. As the market continues to evolve, key players in the industry must capitalize on these opportunities to drive growth and expand their market presence.

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