Polymyositis Drugs Market Set for Steady Growth to USD 132.6 Million by 2031, Led by North America's 41.3% Market Share | DataM Intelligence

The global Polymyositis drugs market reached USD 103.1 million in 2023 and is expected to reach USD 132.6 million by 2031, growing with a CAGR of 3.2% during the forecast period 2024-2031.

Market growth is driven by the rising prevalence of autoimmune disorders like polymyositis, increasing adoption of corticosteroids, immunosuppressants, and IVIG therapies, along with emerging biologics such as Anifrolumab and PF-06823859. Advancements in diagnostic tools including autoantibody testing and MRI, growing clinical research activity, an aging population susceptible to inflammatory myopathies, and expanded treatment pipelines from companies like Pfizer and AstraZeneca further fuel expansion.
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United States: Key Industry Developments
✅ December 2025: Pfizer received FDA accelerated approval for a novel JAK inhibitor targeting polymyositis inflammation, enhancing treatment efficacy for refractory cases with reduced steroid dependency.

✅ October 2025: Bristol Myers Squibb expanded clinical trials for its BTK inhibitor in polymyositis patients, reporting promising Phase II data on muscle strength improvement at the American College of Rheumatology meeting.

✅ August 2025: Octapharma launched a new intravenous immunoglobulin formulation optimized for polymyositis maintenance therapy, improving patient tolerability and dosing convenience in the US market.​

Asia Pacific / Japan: Key Industry Developments
✅ November 2025: Takeda Pharmaceutical launched a localized biologic therapy for polymyositis in Japan, focusing on anti-IFN pathways with PMDA approval after successful regional trials.

✅ September 2025: Eisai Corporation introduced an enhanced immunosuppressant combination regimen for polymyositis, supported by Japanese health ministry subsidies for rare disease treatments.

✅ July 2025: CSL Behring expanded access to its hyperimmune globulin product across Asia Pacific markets, including Australia and Japan, amid rising polymyositis diagnoses.

Market Segmentation Analysis:
-By Drug Class: Corticosteroids Dominate Treatment Protocols
Corticosteroids command 60% market share in 2025, serving as first-line therapy for rapid inflammation control in polymyositis patients. Immunosuppressants like methotrexate hold 25%, used for steroid-sparing maintenance to reduce long-term side effects. Biologics and immunoglobulins capture 10% and 5%, respectively, targeting refractory cases with precision but higher costs limiting broader use.​

-By Route of Administration: Oral Leads for Convenience
Oral administration leads at 50% share, favored for home-based dosing and patient compliance in chronic polymyositis management. Intravenous routes follow at 35%, essential for acute flares and high-dose therapies in hospitals. Parenteral and others split 15%, offering alternatives for non-responders.​

-By Distribution Channel: Hospital Pharmacies Drive Access
Hospital pharmacies hold 45% share, central to initial prescriptions and monitoring in clinical settings. Retail pharmacies take 30%, supporting ongoing refills for outpatients. Online pharmacies account for 25%, growing via telemedicine for rare disease access.​

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Why is the Polymyositis Drugs Market Growing?
The Polymyositis Drugs Market in 2026 is expanding steadily due to rising autoimmune disease cases and innovations in targeted therapies.​

-Rising Disease Prevalence
An aging global population increases susceptibility to polymyositis and other inflammatory myopathies, expanding the patient pool and demand for long-term treatments. Enhanced epidemiological awareness reveals higher incidence rates, particularly in regions like North America.​

-Diagnostic Advancements
Improved tools such as autoantibody testing, MRI, and muscle biopsies enable earlier diagnosis, boosting treatment initiation rates. Greater clinician and patient awareness further accelerates adoption of therapies.​

-Treatment Innovations
Emerging biologics like SAPHNELO (Anifrolumab), Dazukibart, and KZR-616, alongside established options such as corticosteroids, immunosuppressants, and IVIG, broaden therapeutic choices. Ongoing clinical trials and R&D investments drive pipeline growth and market innovation.​

-Regional and Investment Momentum
North America leads with advanced infrastructure and funding, while global efforts in personalized medicine and regulatory support propel commercialization.​

Regional Insights:
-North America leads the Polymyositis Drugs Market with approximately 41.3% share, driven by advanced healthcare infrastructure, high prevalence of the condition, and substantial investments in rare disease treatments.​

-Europe follows as the second-largest region, benefiting from established pharmaceutical hubs in countries like Germany and the UK, along with growing access to innovative immunosuppressant therapies.​

-Asia Pacific ranks third, showing rapid growth potential due to rising awareness, expanding geriatric populations in Japan and China, and increasing healthcare expenditures.​

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Key Players:
Pfizer Inc. | Aspen API | LGM Pharma | Tecoland Corporation | Genentech | Tocris Bioscience | F. Hoffmann-La Roche | Teva Pharmaceuticals | Novartis A.G. | Biocon Ltd.

Key Highlights (Top 5 Key Players) for Polymyositis Drugs Market:
-Pfizer Inc. advances Phase III trials for Brepocitinib, a dual TYK2/JAK1 inhibitor targeting immune suppression in polymyositis patients.
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-Genentech develops monoclonal antibodies and biologics like rituximab for refractory autoimmune muscle inflammation in polymyositis treatment.

-F. Hoffmann-La Roche supplies immunosuppressants and immunoglobulins essential for managing chronic polymyositis symptoms.

-Teva Pharmaceuticals provides generic corticosteroids and alkylating agents used in first-line polymyositis therapy regimens.

-Novartis A.G. innovates with targeted therapies like tocilizumab to reduce inflammation and improve muscle strength in polymyositis cases.

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