Autoimmune Disease Diagnosis Market

The global market value of the autoimmune disease diagnosis market was estimated to be USD 7.8 billion in 2024 and is projected to grow at a CAGR of 8.4% during the forecast period. Rising healthcare expenditure and increasing awareness about early disease diagnosis and treatment are the key factors behind the growth in the autoimmune disease diagnosis market. High incidence and prevalence of autoimmune disease are driving the market towards success.

Increasing numbers of hospitals and clinical laboratories are driving the demand in the autoimmune disease diagnosis market. With increasing growth in the geriatric population, the increasing number of patients with rheumatoid arthritis, lupus, and multiple sclerosis are fueling the growth in the market. Advancements in diagnostic technologies and technological innovations have led to the development of more sensitive and efficient diagnostic tools. These include molecular diagnostics, next-generation sequencing, multiple assays, and advanced imaging techniques.

Growth Drivers

Growing awareness about the autoimmune diseases among both healthcare providers and the general public has led to increased diagnostic rates. Educational campaigns and patient advocacy groups have played a pivotal role in encouraging individuals to seek medical attention earlier, resulting in timely diagnoses and treatment. The application of AI and machine learning algorithms in diagnostics enhances the efficiency and accuracy of detecting autoimmune diseases. Rising disposable income and increasing healthcare expenditure in emerging economies like India, China, and Brazil are raising the demand for diagnostic tools.

The increasing number of rheumatoid arthritis patients all over the world is a key factor behind the growth in the market.

Segmentation

By Test Type

·         Routine Laboratory Tests

·         Inflammatory Markers

·         Autoantibodies & Immunologic Test

·         Other Tests

By Disease

·         Rheumatoid Arthritis

·         Systemic Lupus Erythematosus

·         Sjögren’s Syndrome

·         Thyroiditis

·         Scleroderma

·         Other Diseases

By End User

·         Clinical Laboratories

·         Hospitals

·         Other End Users

By Product

·         Consumables & Assay Kits

·         Instruments

By Region

·         Asia-Pacific

·         Middle East and Africa

·         North America

·         Europe

·         Latin America

The Autoimmune disease diagnosis market by end-user segmentation

On the basis of the end-user, the autoimmune disease diagnosis market is segmented into hospitals, clinical laboratories, and other end-users. Clinical laboratories especially large reference labs handle a large volume of tests than hospitals or other end-users. Autoimmune diagnostics often require specialized assays for example ANA, RF, or Elisa panels, which are more cost-effectively, and efficiently processed in labs with high throughput capabilities.

Clinical laboratories invest heavily in automated analyzers, and specialized testing platforms, which are essential for the complex and diverse nature of autoimmune disease testing. Hospitals are still important due to acute care settings, and for initial diagnostic assessments.

The Autoimmune disease diagnosis market by disease type segmentation

On the basis of the type, the autoimmune disease diagnosis market is segmented into Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjögren’s Syndrome, Thyroiditis, Scleroderma and Other Diseases. Rheumatoid arthritis is the leading segment because it affects a larger portion of population compared to others.

There is a well-established and competitive market for RA drugs, specially biologics, and JAK inhibitors. RA historically held the largest market share among autoimmune conditions, and many major pharma companies focus heavily on RA because of the demand for long-term therapies and ongoing innovation.

Systematic lupus erythematosus, Sjogren’s syndrome, thyroiditis, and scleroderma are other rapidly spreading autoimmune diseases. Scleroderma is rare, with a smaller market size and fewer treatments available. Thyroiditis is highly prevalent but often managed with inexpensive, generic hormone replacement, so the market value is lower. Type 1 diabetes prevalence has doubled drastically in last 40 years.

Increasing number of hospitals, and clinical laboratories are driving growth in the market significantly.

Regional Outlook

On the basis of the regions, the autoimmune disease diagnosis market is analyzed into 5 regions: Asia-Pacific, North America, Latin America, the Middle East and Africa, and Europe. North America is currently the leading region in the autoimmune disease diagnosis market because the United States of America has reported the highest number of autoimmune diseases in recent years. Conditions like type 1 diabetes, rheumatoid arthritis, lupus, and multiple sclerosis are increasingly common. North America benefits well-established healthcare infrastructure, with widespread access to diagnostic services. High healthcare spending per capita supports real screenings and early diagnosis.

A strong presence of the majority of key players and biotechnology companies like Thermo Fisher Scientific, Abbott Laboratories, and Bio-Rad are based in North America. This ensures quick adoption of advanced diagnostic technologies. Ongoing investment in research and development leads to an innovation in diagnostic tests, including AI-based solutions. Government programs and private insurance coverage in the US support early screening and diagnosis, helping to detect autoimmune disorders at an early stage.

The European market, including tries like Germany, France, the United Kingdom, Italy, and Spain, is witnessing significant growth due to increasing awareness, and healthcare expenditure is driving growth in the market. Expanding middle-class population, which is more health-conscious, and urban lifestyle shifts leading to higher autoimmune prevalence. Asia-Pacific, due to the presence of emerging markets like China and India, is another leading market. Rapidly growing population and an emerging middle-class population, which is more health-conscious, are driving the demand in the market. Urban lifestyle is significantly responsible for the prevalence of autoimmune diseases.

Dietary changes, pollution, and genetic susceptibility in some populations are driving demand in the market. Governments, NGOs, and healthcare providers are prompting awareness campaigns, leading to earlier diagnoses and increased testing. The digital health platforms and social media also help patients recognize symptoms and seek help sooner.

National health programs are increasingly incorporating autoimmune disease management into broader non-communicable disease strategies. India’s Ayushman Bharat and China’s healthcare reforms. Global companies are expanding into Asia-Pacific to tap into to emerging markets. Local payers are also innovating with cost-effective diagnostics tailored for regional healthcare systems and budgets. Expansion of public and private insurance schemes in countries like China is reducing the cost burden of patients. Rapidly growing investment in healthcare infrastructure and stiff competition among the diagnostic labs in emerging economies are driving growth in the market.

Key Players

·         Thermo Fisher Scientific

·         Siemens

·         Abbott

·         Danaher 

·         Bio-Rad Laboratories

·         Grifols

·         Trinity Biotech 

·         Werfen (Spain),

·         HYCOR Biomedical (US),

·         EUROIMMUN AG

·         Oncimmune

·         HTG Molecular Diagnostics

·         Seramun Diagnostica GmbH

·         Exagen Inc.

·         Cambridge Life Sciences Limited

·         Menarini Diagnostics s.r.l

·         ORGENTEC Diagnostika

·         KRONUS

·         AESKU GROUP GMBH & CO. KG

·         Other Players