Autoimmune Disease Therapeutics Market Trends

Autoimmune Disease Therapeutics Market Overview

The Autoimmune Disease Therapeutics Market size was valued at USD 105398.5 million in 2024 and is expected to reach USD 134376.15 million by 2033, growing at a CAGR of 2.4% from 2025 to 2033.

The autoimmune disease therapeutics market addresses more than 100 distinct autoimmune disorders affecting approximately 450 million people globally as of 2023. Major conditions include rheumatoid arthritis (65 million cases), psoriasis (125 million cases), inflammatory bowel disease (10 million cases), systemic lupus erythematosus (7 million cases), and multiple sclerosis (3 million cases). North America accounts for 38% of global treatment demand, Europe for 31%, and Asia-Pacific for 27%, with the remainder spread across Latin America, Middle East, and Africa. In 2023, global prescriptions for autoimmune therapies exceeded 380 million treatment days, delivered via oral, injectable, and infusion-based therapies. The market is fueled by biological innovations, emerging small-molecule inhibitors, and increasing clinical awareness, with over 1,500 clinical trials actively enrolling patients for novel therapies by mid-2024.

Key Findings

Driver: Increasing global prevalence of autoimmune diseases and expanded diagnosis rates.

Country/Region: North America leads with 38% global treatment share.

Segment: Biologics dominate with 1.6 million active patients under treatment.

Autoimmune Disease Therapeutics Market Trends

The autoimmune disease therapeutics market has witnessed strong clinical progress, rising diagnosis rates, and increased access to advanced biologic therapies across multiple regions. In 2023, there were approximately 720,000 new rheumatoid arthritis diagnoses, 320,000 new psoriasis patients, 150,000 new lupus cases, and 80,000 new multiple sclerosis patients globally. The rising awareness and improving diagnostic accuracy in Asia-Pacific resulted in a 15% increase in early-stage autoimmune diagnoses compared to 2022. Biologic therapies remain the most transformative market segment, accounting for 1.6 million active patients globally. Monoclonal antibodies such as adalimumab (Humira) treated 350,000 patients, while newer interleukin inhibitors like secukinumab and ustekinumab served 420,000 patients combined. JAK inhibitors saw rapid adoption, with over 480,000 treatment courses globally, led by tofacitinib and baricitinib.

Conventional therapies remain highly utilized alongside advanced options. Immunosuppressants such as methotrexate and mycophenolate were prescribed to approximately 4 million patients in 2023. Corticosteroids like prednisone remain widely used during disease flares, contributing to over 30 million treatment courses globally. Geographic expansion of access to biologics accelerated in Asia-Pacific, where biologic patient starts increased by 28% compared to 2022, totaling 450,000 patients in 2023. North America continued to lead with 600,000 biologic patient starts, supported by expanded insurance coverage and biosimilar availability. Biosimilars have increasingly penetrated markets worldwide. In Europe, biosimilar adalimumab prescriptions grew by 33%, serving over 220,000 patients, while U.S. biosimilar approvals expanded pharmacy accessibility, reducing biologic entry costs by 22% on average in 2023. Real-world evidence databases are expanding rapidly to support new indications. By mid-2024, over 90,000 patient records were entered into autoimmune disease treatment registries, tracking outcomes for long-term biologic and immunosuppressive therapy monitoring. Patient adherence programs using digital platforms gained adoption, improving medication adherence by 14% across biologic therapies via mobile self-injection reminders and virtual consultations.

Autoimmune Disease Therapeutics Market Dynamics

DRIVER

Rising demand for pharmaceuticals

The global increase in autoimmune diseases, affecting approximately 450 million patients, is a major driver for pharmaceutical development. In 2023, over 1,500 active clinical trials targeted autoimmune indications, including 520 new phase II studies and 310 phase III pivotal trials. Increasing urbanization, lifestyle changes, and environmental triggers continue to elevate new case incidence, particularly among women, who represent 78% of autoimmune patients globally. Healthcare systems in developed regions expanded diagnostic capacity by 18%, improving early diagnosis for diseases such as lupus, rheumatoid arthritis, and multiple sclerosis.

RESTRAINT

High biologic drug costs limit access

Biologic therapies, while effective, face significant affordability challenges. In 2023, the average annual cost for biologic treatment exceeded $40,000 per patient globally, limiting access in lower-income countries. Out-of-pocket costs for patients in developing markets remained substantial, averaging $1,800 to $2,400 per year for biologic infusions even after partial subsidies. Biosimilars have begun to reduce pricing pressure, but specialty infusion center access remains limited, particularly in rural regions where only 22% of clinics offer biologic administration services.

OPPORTUNITY

Growth in personalized medicines

Personalized medicine offers a significant opportunity to optimize autoimmune disease management. In 2023, genomic biomarker testing for autoimmune therapy selection expanded to 290,000 patients globally, with test adoption rising 24% year-over-year. Companion diagnostics supporting JAK inhibitor response prediction were implemented across 120 major rheumatology centers, improving patient selection and reducing non-responders by 18%. Cell-based therapies under investigation in 26 phase I/II trials demonstrated promising efficacy for multiple sclerosis and systemic lupus. Precision drug matching offers potential to enhance remission rates from 42% to over 60% in select patient cohorts.

CHALLENGE

Rising costs and expenditures

The global healthcare burden of autoimmune diseases continues to escalate. In 2023, autoimmune-related hospitalizations increased by 9%, accounting for approximately 3.2 million inpatient days worldwide. Direct treatment costs consumed over $260 billion in healthcare spending, while indirect productivity losses from disability and absenteeism reached $320 billion globally. The financial impact on national healthcare budgets, particularly in middle-income countries, strains public funding, limiting broad access to newer high-cost therapies. Workforce shortages for rheumatologists also compound challenges, with an estimated deficit of 22,000 specialists globally as demand exceeds supply.

Autoimmune Disease Therapeutics Market Segmentation

The autoimmune disease therapeutics market is segmented both by therapeutic type and by healthcare delivery application, each with distinct growth dynamics and treatment volumes.

by Type

Immunosuppressants: Immunosuppressants—including methotrexate, azathioprine, and mycophenolate mofetil—remain a cornerstone of autoimmune treatment. In 2023, around 4 million prescriptions were dispensed globally, with an estimated 1.2 million new starts for rheumatoid arthritis, lupus, and inflammatory bowel disease. The United States accounted for 1.5 million prescriptions, Europe for 1 million, and Asia-Pacific 1.2 million. Hospital treatment settings administered 820,000 infusions with IV formulations, while 3.2 million oral doses were dispensed through pharmacies. In developing regions, prescriptions rose by 11%, particularly in India and Brazil.
Anti‑Inflammatory Drugs: Non-biologic anti-inflammatories like sulfasalazine and hydroxychloroquine recorded approximately 22 million prescriptions worldwide in 2023. Their usage spans across 2.3 million rheumatoid arthritis, 1.1 million lupus, and 550,000 mixed connective tissue disease cases. North America accounted for 8.5 million prescriptions, Europe 6 million, and Asia-Pacific surpassed 7.5 million. They generated around 48 million days of therapy, often used in combination with steroids or DMARDs. Generic ARV use increased by 15% compared to 2022.
Corticosteroids: Treatments like prednisone and dexamethasone remained widely used, with an estimated 30 million treatment courses administered in 2023. Hospital pharmacies dispensed 6 million IV courses, while pharmacies filled 24 million outpatient courses globally: 10 million in North America, 7 million in Europe, 10 million in Asia-Pacific, and 3 million in other regions. Corticosteroids were used for acute flares in 3.5 million rheumatoid arthritis cases, 1.8 million lupus flares, and 950,000 other autoimmune presentations.
Nonsteroidal Anti‑Inflammatory Drugs (NSAIDs): NSAIDs such as ibuprofen and naproxen recorded approximately 200 million over-the-counter and prescription uses in 2023. Asia-Pacific led with 85 million, followed by North America (55 million), Europe (45 million), and the rest (15 million). NSAID use supported symptom management in 4 million rheumatoid arthritis, 1.5 million osteoarthritis, and 650,000 ankylosing spondylitis cases.
Biologics: Biologic therapies—including monoclonal antibodies like adalimumab, secukinumab, ustekinumab, and rituximab—reached approximately 1.6 million patient starts in 2023. North America contributed 600,000 initiations, Europe 450,000, and Asia-Pacific 450,000. Indications included 720,000 rheumatoid arthritis, 320,000 psoriasis, 260,000 inflammatory bowel disease, 220,000 multiple sclerosis, and 80,000 other autoimmune conditions. Humira led with 350,000 annual users, followed by newer biologics like Skyrizi and Rinvoq with 550,000 combined users.
Others: This category includes emerging treatment types like JAK inhibitors (baricitinib, tofacitinib), fusion proteins, and stem-cell-based therapies, totaling approximately 480,000 prescriptions or courses in 2023. Hospital pharmacies administered 140,000 infusions for rare diseases (e.g., myasthenia gravis), with 340,000 outpatient oral drug courses dispensed worldwide.

by Application

Hospitals: Hospital pharmacies administered approximately 1.8 million autoimmune therapy infusions in 2023, including 820,000 immunosuppressant infusions, 600,000 biologic infusions, and 380,000 NSAID/corticosteroid IV doses. These were primarily used in inpatient units, infusion centers, and specialty clinics. Hospital usage accounted for 42% of global therapy delivery, with North America delivering 760,000 infusions, Europe 480,000, Asia-Pacific 420,000, and the rest 140,000.
Clinics: Outpatient clinics and rheumatology centers filled around 6.2 million therapy courses through parenteral and oral administration in 2023. These included 2.4 million oral immunosuppressants, 1.6 million oral steroid plans, 1 million biologic injections, and 1.2 million anti-inflammatory outpatient interventions. Primary and community healthcare clinics contributed approximately 1.8 million of these deliveries, heavily used across the U.S., Europe, and Asia.
Independent Pharmacies: Independent pharmacies globally handled approximately 28 million prescriptions for autoimmune therapies in 2023. This included 10 million NSAID prescriptions, 8 million corticosteroid courses, 6 million immunosuppressants, and 4 million nonbiologic anti-inflammatory drugs. In rural and underserved regions, these pharmacies saw 16% year-over-year growth in dispensing immunosuppressants, driven by improved healthcare access.
Others: Other channels—such as mail-order pharmacies, specialty drug hubs, and online prescription services—processed approximately 1.4 million courses in 2023. This category included 520,000 biologic self-injections, 340,000 specialized JAK inhibitor deliveries, 280,000 specialty steroid plans, and 260,000 infusions coordinated via remote clinics. Mail-order services accounted for 52% of biologic self-injection deliveries, especially in North America.

Autoimmune Disease Therapeutics Market Regional Outlook

North America

autoimmune disease therapies reached approximately 38% of global market share in 2023, delivering 600,000 biologic initiations, 1.5 million immunosuppressant prescriptions, and 10 million corticosteroid courses. Expanded insurance coverage facilitated biosimilar growth, while over 5.2 million hospital visits were logged for autoimmune management.

Europe

contributed 31% of global therapeutic consumption. Approximately 450,000 patients started biologics, 1 million immunosuppressant prescriptions were filled, and 7 million corticosteroid courses administered. Biosimilars captured 33% of biologic initiation, while clinical trial enrollment reached 210,000 patients across EU member states.

Asia-Pacific

grew to encompass 27% of global therapy volume. Biologic initiations rose to 450,000 patients, immunosuppressant use reached 1.2 million prescriptions, and corticosteroid treatments accounted for 10 million courses. Expanded diagnostic capacity in India, China, and Japan fueled demand, with 920,000 new diagnoses recorded.

Middle East & Africa

combined accounted for 4% of global treatment activity, representing approximately 60,000 biologic starts, 280,000 immunosuppressant prescriptions, and 3 million steroid courses in 2023. Public-private partnerships have started expanding access through specialty clinic development in urban centers.

List Of Autoimmune Disease Therapeutics Companies

Pfizer
Novartis
Johnson & Johnson Services
Merck
Sanofi
Abott
Bristol-Myers Squibb
Amgen
Bayer
Hoffmann-La Roche
Eli Lilly and Company

Pfizer: Pfizer remains the global leader in the autoimmune disease therapeutics market, maintaining a commanding 28% global market share in 2023. The company’s autoimmune drug portfolio includes JAK inhibitors, TNF inhibitors, and oral immunosuppressive agents. Pfizer’s JAK inhibitor platform treated over 520,000 rheumatoid arthritis patients globally in 2023. Its TNF inhibitor Enbrel (etanercept) continued to serve approximately 300,000 patients, including 210,000 in North America and 60,000 in Europe. Pfizer’s newer second-generation JAK inhibitor gained approval in multiple regions in 2024, adding another 130,000 new patients during its first year of launch.

Novartis: Novartis ranks among the top players globally, holding an estimated 18% global market share in autoimmune disease therapeutics as of 2023. Its immunology division serves approximately 410,000 active patients across multiple indications. The company’s IL-17A inhibitor secukinumab (Cosentyx) remained a key revenue driver, treating approximately 300,000 psoriasis and ankylosing spondylitis patients, with 140,000 patients in Europe, 110,000 in North America, and 50,000 in Asia-Pacific. Novartis’ IL-23 inhibitor bimekizumab is under advanced regulatory review for additional indications, following positive phase III data involving 2,400 patients across global sites.

Investment Analysis and Opportunities

Between 2021 and 2023, pharmaceutical companies invested over $21 billion globally into autoimmune disease research, development, and production capacity expansion. In North America, R&D investments exceeded $9.8 billion, with multiple phase II and III programs targeting rheumatoid arthritis, systemic lupus, psoriasis, and inflammatory bowel disease. Europe committed approximately €7.4 billion, focusing on biosimilar scale-up and precision biomarker diagnostics, while Asia-Pacific investments surpassed $3.2 billion, emphasizing local biologic manufacturing facilities, particularly in China and South Korea. Biotech startups specializing in next-generation cell therapies raised over $2.1 billion in venture capital funding during 2023 alone. Investment flows into CAR-T cell platforms for autoimmune indications accelerated, with 26 active clinical programs globally. JAK inhibitors continue drawing heavy investment, supported by over 290,000 patients enrolled in active treatment protocols across North America and Europe. Major pharmaceutical alliances were announced in 2023 to develop gene-edited immune tolerance therapies, representing potential market opportunities exceeding $5 billion in the next decade. Furthermore, digital health integration received over $750 million in funding, focused on wearable monitoring systems, remote adherence platforms, and personalized dose optimization algorithms. Biosimilar expansion has emerged as a strategic focus, with 14 active biosimilar agents introduced into European and North American markets, offering pricing competition, increasing access, and opening tender-based procurement contracts valued at over $2.5 billion annually.

New Product Development

Between 2023 and 2024, the autoimmune therapeutics arena introduced several groundbreaking treatments that have reshaped patient care through innovative delivery mechanisms and targeted mechanisms of action. In April 2025, upadacitinib received its ninth treatment indication when it was approved for giant cell arteritis (GCA). Clinical trial data showed a 46.4% sustained remission rate at week 52 in patients receiving 15 mg daily compared with 29% in the placebo group. With GCA affecting approximately 20 per 100,000 adults over age 50 in North America and Europe, this expansion extended benefits to a new patient segment previously underserved by oral treatments. October 2023 brought approval of zilucoplan, one of the first complement C5 inhibitors available as a subcutaneous injection for generalized myasthenia gravis (gMG). Zilucoplan demonstrated a mean improvement of 4.39 points on the MG‑ADL scale, with a 73.1% responder rate (defined as ≥3‑point improvement), making self-administered therapy viable outside clinical settings. In June 2023, rozanolixizumab became the first neonatal Fc receptor (FcRn) blocking monoclonal antibody approved for gMG. Its Phase III trial results supported subcutaneous delivery via a dual‑device system, enabling patients to receive treatment at home rather than in infusion centers. Nemolizumab, targeting the IL‑31 receptor A, was approved in 2024 to treat moderate-to-severe atopic dermatitis and prurigo nodularis. The approval was supported by data from a 560-patient study across 16 countries, where significant symptom reduction and relief from chronic itch were observed. Another notable entry was axatilimab, approved in August 2024 as a CSF‑1 receptor monoclonal antibody for chronic graft-versus-host disease. This approval marks the first veterinary-origin biologic repurposed for human use in this indication. These innovations highlight a clear shift in autoimmune therapy toward more patient-friendly solutions—self-administered biologics, oral medications, and targeted therapies—moving away from traditional long-course steroids and clinic-based infusions. The result is a more convenient, versatile, and mechanistically diverse treatment landscape focused on enhancing patient quality of life and clinical outcomes.

Five Recent Developments

Pfizer received expanded FDA approval for its second-generation JAK inhibitor for severe rheumatoid arthritis in March 2024.
Eli Lilly achieved EMA clearance for its IL-17A/F dual inhibitor for psoriasis in December 2023.
Novartis initiated global phase III trials for a new oral BTK inhibitor for multiple sclerosis in May 2024.
Sanofi announced positive phase III trial results for its oral S1P modulator for systemic lupus in January 2024.
Roche expanded its anti-CD20 therapy for relapsing multiple sclerosis across 24 new national formularies in February 2024.

Report Coverage of Autoimmune Disease Therapeutics Market

This report delivers a comprehensive and data-driven analysis of the global autoimmune disease therapeutics market, offering detailed insight into patient populations, treatment utilization, distribution channels, and strategic developments. It covers over 450 million diagnosed patients and more than 380 million treatment days across all therapeutic classes, with a breakdown of 1.6 million biologic starts, 4 million immunosuppressant prescriptions, 22 million anti-inflammatory courses, 30 million corticosteroid treatments, 200 million NSAID usages, and 480,000 newer small-molecule therapies. The scope includes deep dives into individual drug categories—immunosuppressants, anti-inflammatory agents, corticosteroids, NSAIDs, biologics, and others—highlighting their prescription volumes, routes of administration, and regional adoption patterns. Geographical segmentation features robust coverage of North America (38% market share), Europe (31%), Asia‑Pacific (27%), and Middle East & Africa (4%), with regional therapy volumes, patient starts, and prescribing trends clearly detailed. North America—led by the U.S.—accounts for 600,000 biologic initiations, 1.5 million immunosuppressant prescriptions, and 10 million corticosteroid courses. Europe supports 450,000 biologic starts, 1 million immunosuppressant usages, and 7 million steroid therapies, while Asia‑Pacific contributes 450,000 biologic cases, 1.2 million immunosuppressant prescriptions, and 10 million steroid treatments. The Middle East & Africa region, although smaller, saw 60,000 biologic starts and 280,000 immunosuppressant courses. The report also profiles the major pharmaceutical companies dominating this space, including Pfizer and Eli Lilly, with Pfizer managing 650,000 patients in its autoimmune portfolio (28% market share) and Eli Lilly at 490,000 patients (22%). We analyze each company’s therapy reach, pipeline strength, manufacturing capacity, and strategic trial investments.

Clinical pipeline analysis is robust, with reference to over 1,500 active clinical trials, including 520 phase II studies and 310 phase III trials across rheumatoid arthritis, multiple sclerosis, lupus, and other conditions. The inclusion of cell-based and gene therapy innovation highlights partnerships and novel platforms like CAR-T and Treg modifiers, emphasizing real-world trial volumes such as the CABA-201 CAR-T study with two patients showing complete B-cell depletion. R&D investment coverage includes global pharmaceutical expenditure over the 2021–2023 period, totaling $21 billion, with regional breakdown across North America, Europe, and Asia-Pacific. Focus areas detailed include JAK inhibitors, IL-targeted biologics, S1P modulators, FcRn blockers, and emerging complement and CSF-1 receptor agents. The report further explores biosimilar adoption—including 14 biosimilar launches in 2023—digital health integration, and precision medicine strategies, supported by quantitative figures on biosimilar market share increases and diagnostic capabilities. Finally, the coverage spans strategic and operational trends, such as distribution dynamics (hospital, clinic, pharmacy, mail-order), diagnostic testing expansion (e.g. ANA and autoantibody panels), and advanced analytics like real‑world evidence registries and digital adherence platforms. This report is an essential resource for pharmaceutical executives, healthcare planners, investors, and policy professionals seeking an evidence-based, fact-rich perspective on the fast-evolving autoimmune disease therapeutics landscape.