The auto-immune diseases market was valued at USD 133.30 Billion in 2025 and is expected to grow at a CAGR of 4.20%, reaching USD 201.14 Billion by 2035. The market growth is driven by the increasing prevalence of autoimmune disorders, rising awareness, and improved access to advanced biologics and targeted therapies. Advancements in diagnostic technologies and personalized medicine are boosting patient outcomes. Growing investments in R&D and the launch of novel treatment modalities are expected to enhance market value over the forecast period.
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According to Ritwika Mallik et al., 2024, over 860,000 people live with Type 1 Diabetes in India, each losing around 45 healthy life years, highlighting a growing autoimmune burden driving market growth.
In November 2024, researchers at IASST identified IL-35 as a novel immunotherapy target for type 1 and autoimmune diabetes. This breakthrough is expected to significantly drive auto-immune diseases market growth through innovative treatment development.
The advancement of dual-targeted T cell-engagers is a notable trend driving the growth in the market. For instance, in October 2024, GSK acquired CMG1A46 to treat autoimmune diseases like lupus by enabling deep, sustained B cell depletion.
Compound Annual Growth Rate
4.2%
Value in USD Billion
2026-2035
*this image is indicative*
Autoimmune diseases represent a growing global health concern, significantly impacting quality of life and placing a substantial burden on healthcare systems. These complex disorders are increasingly recognized for their diverse manifestations and challenging treatment needs. Rising incidence, especially among younger populations, has intensified the demand for effective and personalized therapies. The market is experiencing steady expansion due to increasing prevalence, improved diagnostic methods, and the launch of targeted biologics and immunotherapies. Rising awareness, supportive regulatory frameworks, and ongoing research initiatives further contribute to market growth. The market is poised to grow at a CAGR of 4.20% during the forecast period of 2026–2035, reflecting sustained investments and advancements across key therapeutic areas.
Rising Prevalence of IBD to Drive Significant Growth in the Market
The increasing prevalence of inflammatory bowel disease (IBD) has become a key driver in the expansion of the market. As of June 2024, data from the Centers for Disease Control and Prevention (CDC) indicate that the number of IBD patients in the United States ranges from 2.4–2.8 million based on administrative claims data, with up to 3.1 million adults affected according to national survey data. This upward trend reflects a growing burden on healthcare systems and an urgent demand for advanced treatment options, fueling consistent market growth.
The market is experiencing several notable trends, including the rise of emerging molecular targets and the advancement of precision immunotherapies.
Emphasis on Extensive Research Initiatives to Drive Growth in the Market
The advancement in identifying precise molecular mechanisms underlying chronic inflammation is a notable trend shaping the market. In February 2025, researchers at Brigham and Women’s Hospital identified granzyme K as a novel driver of complement system activation, contributing to tissue damage in autoimmune disorders such as rheumatoid arthritis and lupus. This breakthrough highlights a promising therapeutic target for next-generation, pathway-specific treatments. The continued focus on mechanistic discoveries is anticipated to significantly enhance market growth and therapeutic innovation in the coming years.
Precision Immunotherapies to Drive Innovation in Treatment to Strengthen Auto-Immune Diseases Market Value
The market is experiencing a surge in precision immunotherapies targeting key cellular mechanisms. For instance, in April 2025, Amgen's UPLIZNA® (inebilizumab-cdon), a CD19+ B-cell targeted therapy, received FDA approval for treating Immunoglobulin G4-related disease (IgG4-RD), showcasing an 87% reduction in flare risk. This advancement reflects growing demand for precision treatments that minimize corticosteroid dependence and offer long-term remission. As such therapies continue to address critical unmet needs, they are poised to significantly enhance the growth trajectory of the autoimmune diseases market.
Systemic Autoimmune Diseases Projected to Lead the Application Segment
The market comprises a broad spectrum of disorders, including systemic autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis, and localized autoimmune diseases, including type 1 diabetes, multiple sclerosis, and Hashimoto’s thyroiditis. Among these, systemic autoimmune diseases are projected to dominate this segment due to their complex multi-organ involvement, rising global incidence, and the growing demand for advanced immunotherapies. With approximately 20 million Americans affected by thyroid disease and regions like Kentucky reporting higher rates of autoimmune-related cancers, the need for targeted, long-term treatments is accelerating. Continuous innovation in biologic drugs and early diagnostic tools further reinforces the systemic segment’s strong growth outlook.
The regions included in the report are the United States, the United Kingdom, Germany, France, Italy, Spain, Japan, and India. Among these, the United States is expected to lead the market, driven by extensive research and clinical advancements. In April 2025, the Autoimmune Disease Prevention Center at the University of Colorado launched a national trial targeting individuals at risk of rheumatoid arthritis. This initiative reflects the country’s growing focus on early detection and prevention of autoimmune conditions, positioning it at the forefront of market innovation.
The key features of the market report comprise clinical trials analysis, patent analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
AbbVie Inc., a global biopharmaceutical company renowned for its strong immunology portfolio, is a key player in the market. In June 2025, the company announced its acquisition of Capstan Therapeutics, including CPTX2309, an in vivo tLNP anti-CD19 CAR-T therapy in Phase 1, aimed at treating B cell-mediated autoimmune diseases. This move reinforces AbbVie’s commitment to advancing transformative immune-resetting therapies.
Sanofi, a leading global healthcare company, has reinforced its position in the autoimmune diseases market. In March 2025, it announced the acquisition of Dren Bio’s investigational bispecific antibody, DR-0201, a novel myeloid cell engager designed for deep B-cell depletion. This therapy has shown early promise in resetting the immune system in refractory autoimmune conditions, supporting Sanofi’s ambition to lead in immunology innovation.
Novartis AG is actively engaged in the autoimmune diseases market, focusing on improving diagnosis, treatment, and awareness, particularly for women disproportionately affected by these conditions. In May 2025, the company launched an initiative to address the invisible burden of autoimmune diseases like Sjögren’s syndrome, highlighting diagnostic challenges, gender bias, and the need for greater education. Novartis continues to invest in research and patient support to enhance care and outcomes.
Pfizer Inc., a biopharmaceutical company, actively engaged in the autoimmune diseases market through its innovative RSV vaccine, ABRYSVO®. In August 2024, Pfizer reported positive Phase 3 trial results demonstrating strong immune responses in immunocompromised adults, including those with autoimmune inflammatory disorders. This supports the company’s broader commitment to addressing unmet needs in vulnerable populations through advanced immunization solutions.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market are Johnson & Johnson Innovation Inc., F. Hoffmann La Roche, Amgen Inc., Biogen Inc., Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, AstraZeneca plc, Bristol Myers Squibb Co., Merck & Co., Inc., GSK plc, and others.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Application
Market Breakup by Treatment
Market Breakup by Sales Channel
Market Breakup by Region
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Application |
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| Breakup by Treatment |
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| Breakup by Sales Channel |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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