Autoimmune Treatment Market Forecast to Reach USD 108.07 Bn by 2031 at 5.19% CAGR, Powered by Precision Therapies and Digital Adherence Tools | Key Players -Abbott Laboratories, Amgen, Johnson & Johnson, Eli Lilly & Co.

The Autoimmune Treatment Market is projected to expand from USD 79.74 billion in 2025 to USD 83.92 billion in 2026, reaching USD 108.07 billion by 2031, growing at a CAGR of 5.19% during 2026-2031. Market growth is driven by increasing early-onset autoimmune diagnoses, growing adoption of biosimilars, and faster regulatory approvals of advanced cell-based therapies.

The treatment paradigm is shifting from conventional broad immunosuppression toward targeted, precision-based interventions. Innovative CAR-T therapies for conditions such as lupus and multiple sclerosis, along with wider payer acceptance of outcome-based pricing models, are reshaping value assessment in the market. Additionally, digital therapeutics are improving patient adherence and lowering relapse rates, strengthening long-term disease management. Regionally, North America remains the largest revenue contributor, while Asia-Pacific is witnessing the fastest growth due to expanding specialty healthcare infrastructure.

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Key Development 2026-

✅ October 2025: Mary Brunkow, Fred Ramsdell (USA), and Shimon Sakaguchi (Japan) received the Nobel Prize in Physiology or Medicine for discoveries on regulatory T cells and FOXP3 gene, advancing over 200 clinical trials for autoimmune diseases.
​This breakthrough supports targeted immunotherapies for conditions like rheumatoid arthritis and lupus.

✅ August 2025: SetPoint Medical raised $140 million to commercialize its FDA-approved SetPoint System, a neuroimmune modulation implant for rheumatoid arthritis patients failing biologics.
​The device offers a non-drug alternative by stimulating vagus nerve pathways to reduce inflammation.

✅ July 2025: Bristol Myers Squibb and Bain Capital launched a new biopharma firm with $300 million for immunology therapies, in-licensing five assets for autoimmune treatments.

✅ October 2025: Harness Therapeutics debuted its MISBA® Duo platform for dual-target modulation and partnered with Ono Venture Investment for rare autoimmune disorders.
​This enables precise therapy for conditions like systemic sclerosis with fewer side effects.

✅ July 2025: Otsuka Pharmaceutical acquired global rights to Cantargia's CAN10, an IL-1RAP antibody targeting autoimmune diseases such as rheumatoid arthritis.
​The deal includes development and commercialization exclusivity worldwide.

✅ February 2025: CSL Behring gained approval from Japan's Ministry of Health for ANDEMBRY® (garadacimab), a monoclonal antibody preventing hereditary angioedema attacks.

Recent M&A Activity-

✅ Bristol Myers Squibb acquired Orbital Therapeutics Inc. - Bristol Myers Squibb completed the purchase of Orbital Therapeutics, a privately held biotech developing RNA-based in vivo CAR-T therapies for autoimmune diseases, in an all-cash deal valued at USD 1.5 billion. The acquisition strengthens BMS's advanced cell and RNA therapeutic capabilities against immune disorders and reprogramming of immune system function.

✅ Sanofi acquired Blueprint Medicines Corporation - Sanofi agreed to acquire Blueprint Medicines for up to USD 9.5 billion, expanding its rare immunological disease portfolio, including marketed and pipeline assets in immunology and targeted therapies relevant to immune-mediated conditions.

✅ AbbVie acquired Capstan Therapeutics - AbbVie completed the acquisition of Capstan Therapeutics in June 2025 for up to USD 2.1 billion, securing next-generation in vivo CAR-T and RNA delivery platforms targeted at autoimmune disease mechanisms (e.g., anti-CD19 autoimmunity programs).

✅ Alumis merged with Acelyrin, Inc. - Alumis and Acelyrin completed a merger, combining to form a clinical-stage biopharma entity focused on immune-mediated disease treatments and shared pipelines for autoimmune indications. This all-stock transaction created a combined firm with diversified immunology programs.

Market segmentation-

Component segmentation often aligns with drug types or mechanisms of action, encompassing small molecule drugs, biologic drugs, and others like monoclonal antibodies; these components fuel market expansion via advanced R&D, with biologics dominating owing to superior outcomes in chronic conditions and biosimilars reducing costs to enhance accessibility globally.

Although Deployment is less standardized in this therapeutics-focused market, it may refer to administration routes (e.g., oral, injectable, intravenous) or settings (inpatient vs. outpatient); injectable biologics drive growth through precise dosing for severe cases, underscoring the market's shift toward convenient home-based deployment amid patient preference for non-hospital care.
​
Application segments by disease type or indication, including rheumatoid arthritis, psoriasis, lupus, multiple sclerosis, inflammatory bowel disease, localized vs. systemic autoimmune diseases, and others; rheumatoid arthritis and psoriasis segments grow fastest due to high incidence and novel therapies like JAK inhibitors, highlighting the market's importance in addressing debilitating, high-burden conditions.

End-User categories include hospitals, clinics, drug stores (retail pharmacies), hospital pharmacies, and specialty providers; hospitals command the largest share owing to advanced diagnostics and surgical integrations, with growth propelled by infrastructure upgrades and skilled workforce, while retail pharmacies gain traction for chronic disease management accessibility.

Market Drivers:-

The global burden of autoimmune diseases is expanding significantly, with conditions affecting approximately 9% of the population and increasing incidence and prevalence rates year-over-year. This expanding patient base directly fuels demand for therapeutic interventions.

Biologics and Targeted Therapy Adoption
The shift toward biologics, including monoclonal antibodies and targeted immunomodulators, is transforming treatment paradigms. Biologics are projected to capture a substantial share of the therapeutic portfolio due to higher efficacy and improved safety profiles, with biosimilars alone forecast to reach a multi-billion-dollar market by 2034.

Small Molecule Drugs Gaining Traction
Small molecule therapies valued for targeted action and cost advantages over biologics are the fastest-growing segment, projected to grow at a 10.5% CAGR, driven by advances in drug discovery technologies like high-throughput screening.

Accelerated R&D and Clinical Pipeline Expansion
Pharmaceutical investment in autoimmune research continues to swell, with hundreds of new clinical trials underway globally, and an estimated $200 + billion in pharmaceutical R&D investment benefiting novel autoimmune treatments.

Improved Diagnosis and Early Detection
Enhanced diagnostic capabilities including advanced biomarker identification and AI-enhanced imaging are increasing early disease detection rates. This boosts treatment initiation and expands the treatable population.

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Market key players:-

Pfizer Inc. - Holds an approximate 8.5% share of the global autoimmune treatment market with a broad portfolio including JAK inhibitors and TNF inhibitors; strong R&D and global reach support sustained leadership.
Johnson & Johnson - Accounts for roughly 6.8% market share driven by diversified immunology offerings across multiple autoimmune indications; benefits from deep clinical pipeline and extensive commercialization network.

Roche Holding AG - Controls about 6.1% of the market with biologics targeting complex autoimmune diseases like lupus and MS; core strengths include targeted therapies and robust clinical development.
Bristol-Myers Squibb Co. - Captures an estimated 4.9% market share with therapies for psoriasis and spondyloarthritis; strategic focus on specialty immunology bolsters competitive positioning.

Amgen Inc. - Represents around 4.5% of the autoimmune treatment market with products for lupus and arthritis; leverages strong biologics expertise and growing global presence.

Dominating Regions:

North America:
North America is the largest regional market, holding around 44% of global share due to advanced healthcare infrastructure, high adoption of biologics, strong R&D investment, and high disease awareness.

Europe:
Europe accounts for approximately 29% of the market, supported by well-established healthcare systems, regulatory frameworks encouraging innovation and biosimilar uptake, and substantial chronic disease prevalence.

Asia-Pacific:
Asia Pacific holds roughly 18% of the market share and is among the fastest-growing regions, driven by rising patient populations, improving healthcare access, increasing disease awareness, and expanding healthcare expenditure.

Latin America:
Latin America contributes an estimated ~8% share, with growth underpinned by increasing healthcare investments, rising autoimmune disease prevalence, and improved access to treatment options across countries like Brazil and Argentina.

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