Global Autoimmune Drugs Market Outlook, 2031

The global autoimmune drugs industry covers medicines that treat diseases in which the immune system attacks the body's own tissues, including rheumatoid arthritis, psoriasis and psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus and lupus nephritis, multiple sclerosis, type 1 diabetes, myasthenia gravis, Sjögren's disease, systemic sclerosis, vasculitis, autoimmune hepatitis, immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy, Graves' disease and thyroid eye disease, alopecia areata, vitiligo, hidradenitis suppurativa and many rare autoimmune conditions. More than 80 autoimmune diseases have been identified, together affecting an estimated 5% to 10% of the population in developed countries, with women affected far more often than men. Treatments include conventional immunosuppressants such as methotrexate, azathioprine and mycophenolate; corticosteroids; biologics targeting TNF, interleukins, B cells, T-cell co-stimulation and the complement system; JAK and TYK2 inhibitors; S1P receptor modulators; neonatal Fc receptor blockers; and emerging cell therapies. Leading companies include AbbVie, Johnson & Johnson, Sanofi and Regeneron, Novartis, Roche, Eli Lilly, Amgen, UCB, Bristol Myers Squibb, Pfizer, GSK, AstraZeneca, argenx, Biogen, Takeda and Merck KGaA, along with biosimilar makers and a growing number of biotechnology companies developing cell therapies and precision immunology drugs.

Autoimmune disease treatment is undergoing a significant transformation. The first generation of blockbuster biologics, led by Humira, faces biosimilar competition, and Medicare negotiated prices for Enbrel and Stelara took effect in 2026, while newer drugs targeting IL-23, IL-17 and other pathways have taken over growth. Oral therapies have advanced, including JAK inhibitors, TYK2 inhibitors and, in March 2026, Johnson & Johnson's icotrokinra, the first oral peptide targeting the IL-23 receptor, approved for psoriasis. Neonatal Fc receptor blockers, which lower levels of harmful antibodies, have created a new class for antibody-driven diseases, with argenx's Vyvgart, UCB's Rystiggo and Johnson & Johnson's Imaavy, approved in April 2025, used in myasthenia gravis and being tested in many other conditions. Type 1 diabetes has moved toward prevention and cure, with Tzield approved in 2022 to delay onset and Vertex's stem cell-derived islet therapy zimislecel producing insulin independence in most patients in trial results published in June 2025. The most striking development has been the use of CD19-targeted CAR-T cell therapy, which produced long-lasting drug-free remissions in patients with severe lupus, myositis and systemic sclerosis in small studies from Germany, prompting dozens of companies to start trials of cell therapies and T-cell engagers designed to reset the immune system.

Market Dynamics Market Drivers • Rising Prevalence and Improved DiagnosisThe incidence of many autoimmune diseases appears to be rising, particularly in industrialised and urbanising countries, and better awareness, antibody testing and imaging lead to earlier and more frequent diagnosis. Autoimmune diseases are chronic and usually require lifelong treatment, and ageing populations and longer survival increase the number of people living with them. Women's health research is drawing more attention to autoimmune conditions.
• New Mechanisms and Broader Treatment OptionsNew drug classes, including IL-23 and IL-17 inhibitors, JAK and TYK2 inhibitors, FcRn blockers, complement inhibitors, B-cell depleting antibodies and cell therapies, are expanding options for patients who fail older drugs and for diseases with few approved treatments. Drugs are increasingly tested across several autoimmune diseases sharing common pathways, and approvals in lupus, Sjögren's disease, myasthenia gravis and other conditions are creating new markets.

Market Challenges • Biosimilar Competition and Pricing PressureBiosimilars for adalimumab, etanercept, infliximab, rituximab, tocilizumab and ustekinumab have reduced prices sharply, and more biologics will lose exclusivity during the forecast period. Medicare price negotiation and payer step therapy requirements limit revenue growth, while European tenders drive rapid biosimilar uptake. Companies must develop new therapies with clear advantages to maintain premium pricing.
• Safety Risks and Incomplete EfficacyImmunosuppressive treatments increase the risk of infections and, for some classes, cardiovascular events, blood clots and cancer, as reflected in boxed warnings on JAK inhibitors. Many patients do not reach remission, and diseases such as lupus, Sjögren's disease and systemic sclerosis have high unmet need. Cell therapies involve chemotherapy conditioning and risks such as cytokine release syndrome, and their long-term effects in autoimmune disease are still unknown.

Market Trends • Immune Reset with Cell Therapies and T-Cell EngagersCAR-T cell therapies targeting CD19 or BCMA, in vivo CAR-T approaches, allogeneic off-the-shelf cell therapies and T-cell engaging bispecific antibodies aim to deplete disease-causing B cells deeply and reset the immune system, potentially allowing patients to stop long-term treatment. Companies including Kyverna, Cabaletta, Novartis, Bristol Myers Squibb, Autolus, Amgen and many Chinese developers are running trials in lupus, myositis, systemic sclerosis, multiple sclerosis and myasthenia gravis.
• Oral Targeted Drugs and Precision ImmunologyCompanies are developing oral drugs that match biologic efficacy, including icotrokinra, TYK2 inhibitors, oral IL-17 inhibitors and oral TNF inhibitors, to reach patients who prefer pills. Precision approaches use biomarkers and genetic data to match patients with the most suitable therapy and identify disease subgroups. Antigen-specific tolerance therapies, which aim to switch off only the harmful immune response, are in early development.



Segment Analysis Biologics account for the largest share of autoimmune drug value, while targeted oral drugs are growing and cell therapies represent a potential new segment. Biologics, including TNF inhibitors such as adalimumab, etanercept and infliximab; interleukin inhibitors targeting IL-23, IL-17, IL-6, IL-4/13 and IL-12/23; B-cell targeting antibodies such as rituximab, ocrelizumab, ofatumumab, belimumab, obinutuzumab and inebilizumab; the T-cell co-stimulation modulator abatacept; integrin blockers such as vedolizumab and natalizumab; the type I interferon receptor antibody anifrolumab; complement inhibitors such as eculizumab, ravulizumab and zilucoplan; FcRn blockers such as efgartigimod, rozanolixizumab and nipocalimab; and teprotumumab for thyroid eye disease, account for most autoimmune drug revenue. Targeted synthetic small molecules include JAK inhibitors such as upadacitinib, tofacitinib and baricitinib, the TYK2 inhibitor deucravacitinib, PDE4 inhibitors, S1P receptor modulators such as ozanimod, etrasimod, siponimod and ponesimod, BTK inhibitors in development and approved for immune thrombocytopenia, and the oral peptide icotrokinra. Conventional immunosuppressants and corticosteroids, including methotrexate, hydroxychloroquine, azathioprine, mycophenolate, calcineurin inhibitors and prednisone, remain widely used and inexpensive. Immunomodulators for type 1 diabetes, such as teplizumab, and cell-based therapies, including CAR-T cells and stem cell-derived islets, represent emerging segments. Biosimilars form a large and growing share of biologic volume.

Rheumatic, dermatological and gastrointestinal autoimmune diseases account for the largest shares of autoimmune drug value, while neurological, renal and rare autoimmune diseases are fast-growing areas. Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis form the largest rheumatic autoimmune segments, treated with biologics, JAK inhibitors and conventional drugs. Psoriasis is one of the most valuable autoimmune indications, with many competing biologics and new oral options. Inflammatory bowel disease, including Crohn's disease and ulcerative colitis, is a major and fast-growing area. Multiple sclerosis, often classified separately as a neurological disease, has a large market for anti-CD20 antibodies, S1P modulators and other disease-modifying therapies. Systemic lupus erythematosus and lupus nephritis are areas of high unmet need with growing numbers of approved drugs and late-stage trials. Myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and neuromyelitis optica spectrum disorder have become fast-growing markets for FcRn blockers and complement inhibitors. Type 1 diabetes, treated mainly with insulin, is seeing the arrival of disease-modifying and potentially curative therapies. Thyroid eye disease, alopecia areata, vitiligo, hidradenitis suppurativa and atopic conditions add dermatological and ophthalmic segments. Sjögren's disease, systemic sclerosis, vasculitis, immune thrombocytopenia, autoimmune hepatitis, IgG4-related disease and other rare autoimmune diseases are attracting drug development.

Subcutaneous injections account for the largest share of autoimmune drug value, while oral therapies are gaining share and intravenous infusions remain important for certain treatments. Subcutaneous injection is the main route for many autoimmune biologics, including adalimumab, etanercept, IL-23 and IL-17 inhibitors, dupilumab, ofatumumab, belimumab, rozanolixizumab and subcutaneous formulations of efgartigimod and vedolizumab, allowing patients to self-inject at home at intervals from weekly to every few months. Oral therapies, including JAK inhibitors, TYK2 inhibitors, S1P modulators, icotrokinra, apremilast and conventional immunosuppressants, are gaining share as their efficacy improves and patients prefer tablets. Intravenous infusions are used for infliximab, rituximab, ocrelizumab, natalizumab, vedolizumab induction, anifrolumab, eculizumab, ravulizumab, teprotumumab, intravenous efgartigimod and nipocalimab, and teplizumab, typically given in infusion centres. Intravenous immunoglobulin and plasma exchange are used in some antibody-driven diseases, although FcRn blockers are replacing some of this use. Cell therapies are given as one-time infusions after conditioning. Topical treatments are used for mild skin disease. The move from intravenous to subcutaneous and oral forms reduces treatment burden and infusion costs.

Specialty pharmacies and hospital pharmacies are the main distribution channels for autoimmune drugs, with retail pharmacies dispensing conventional therapies. Specialty pharmacies dispense most self-injected biologics and oral targeted autoimmune drugs in the United States, providing prior authorisation support, injection training and financial assistance, and they are central to biosimilar switching strategies by PBMs. Hospital pharmacies and infusion centres supply intravenous biologics, immunoglobulin and cell therapies and treat severe disease flares. In Europe and many other countries, hospital pharmacies dispense biologics for home use, and national tenders determine which products and biosimilars are used. Retail pharmacies dispense conventional immunosuppressants, corticosteroids, insulin for type 1 diabetes and some oral drugs. Physician offices, particularly rheumatology, gastroenterology, neurology and dermatology practices, administer infusions and injectables and play a central role in treatment choice. Online and mail-order pharmacies supply chronic oral medications. Government procurement and national reimbursement negotiations determine access in China, Japan and many other countries. Manufacturer patient support programmes provide nurse support, adherence tools and financial assistance.

Regional Analysis North America leads the autoimmune drugs market because of high use and prices of biologics and targeted therapies, broad insurance coverage and early adoption of new treatments, while Asia-Pacific is the fastest-growing region. North America, led by the United States, accounts for the largest share of autoimmune drug revenue. The United States has high rates of diagnosed autoimmune disease, broad use of biologics and oral targeted drugs, high prices and rapid adoption of new mechanisms, with the FDA approving Imaavy in 2025, Gazyva for lupus nephritis in 2025 and icotrokinra in 2026. Biosimilars for Humira and Stelara and Medicare negotiated prices for Enbrel and Stelara from 2026 have reduced revenue from older drugs. The United States also hosts most autoimmune cell therapy trials. Canada has high biosimilar adoption. Europe is the second largest market, with strong use of biologics at lower prices, fast biosimilar uptake through tenders and leading academic research, including the German studies that first reported CAR-T remissions in lupus. Asia-Pacific is the fastest-growing region, driven by increasing diagnosis and access in China, Japan, South Korea and India. Japan has a large autoimmune drug market, and China has expanded access to biologics through national reimbursement negotiations and has become a leading centre for autoimmune cell therapy development, with companies such as BRL Medicine, Bioheng and others running trials. India relies on conventional drugs and biosimilars from Biocon, Intas and others. Latin America, led by Brazil and Mexico, provides access through public procurement, while the Middle East, particularly Saudi Arabia and the UAE, is expanding access to advanced therapies.

Key Developments March 2026: Johnson & Johnson's Icotyde became the first oral peptide that blocks the IL-23 receptor, approved for adults and adolescents with moderate to severe plaque psoriasis.
October 2025: Roche's obinutuzumab was approved with standard therapy for adults with active lupus nephritis, expanding B-cell depletion options for autoimmune kidney disease.
June 2025: Vertex published data showing that most patients with severe type 1 diabetes treated with its stem cell-derived islet therapy became insulin-independent, advancing cell-based cures.
April 2025: Johnson & Johnson's FcRn blocker nipocalimab was approved for generalised myasthenia gravis, adding to a fast-growing class of antibody-lowering therapies.
January 2025: Biosimilars to Stelara entered the US market, reducing prices for a major autoimmune biologic used in psoriasis and inflammatory bowel disease.
November 2022: Teplizumab became the first drug approved to delay the onset of stage 3 type 1 diabetes in people at high risk, marking a shift toward disease modification.

Considered in this report
• Historic Year: 2020
• Base Year: 2025
• Estimated Year: 2026
• Forecast Year: 2031

Aspects covered in this report
• Global Autoimmune Drugs Market with its value and forecast along with its segments
• Various drivers and challenges
• Ongoing trends and developments
• Top profiled companies
• Strategic recommendation

By Drug Class
• TNF Inhibitors
• Interleukin Inhibitors
• B-Cell and T-Cell Targeted Therapies
• JAK and TYK2 Inhibitors
• FcRn Blockers and Complement Inhibitors
• Conventional Immunosuppressants
• Cell Therapies

By Disease
• Rheumatoid Arthritis and Spondyloarthritis
• Psoriasis
• Inflammatory Bowel Disease
• Multiple Sclerosis
• Lupus
• Myasthenia Gravis and Neuroimmune Diseases
• Type 1 Diabetes
• Other Autoimmune Diseases

By Route of Administration
• Subcutaneous
• Oral
• Intravenous

By Distribution Channel
• Specialty Pharmacies
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies