Polymyositis Market on Track for Major Expansion by 2034, According to DelveInsight

DelveInsight's "Polymyositis Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Polymyositis, historical and forecasted epidemiology as well as the Polymyositis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Polymyositis Market Report:
• The Polymyositis market size was valued approximately ~USD 114 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In May 2025, Teva Pharmaceuticals, in collaboration with Alvotech, has received FDA approval for SELARSIDTM, a biosimilar to Stelara®. This approval enhances their portfolio in immunomodulatory therapies applicable to polymyositis treatment approaches.
• In January 2025, RESTEM announced that the FDA has granted Fast Track designation for its Restem-L program, which utilizes umbilical cord outer lining stem cells (ULSCs) to treat Polymyositis and Dermatomyositis (PM/DM), now classified as Idiopathic Inflammatory Myopathy (IIM). This follows the program's recent Orphan Drug Designation for IIM.
• In December 2024, RESTEM, a clinical-stage biotech company focused on developing next-generation, off-the-shelf cell therapies to regulate the immune system, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its umbilical cord outer lining stem cells (ULSCs) program for treating Polymyositis (PM) and Dermatomyositis (DM).
• In November 2024, RESTEM announced Phase 1 trial results for its innovative umbilical cord outer lining-derived stem cells (ULSCs) program targeting adults with Polymyositis (PM) and Dermatomyositis (DM), now recognized by the FDA as Idiopathic Inflammatory Myopathy (IIM), a rare orphan disease with significant unmet medical needs.
• In 2023, Germany had the largest Polymyositis market size among EU countries, valued at approximately USD 6 million, while Spain recorded the smallest market size at around USD 2 million.
• The anticipated introduction of new therapies, including Anifrolumab (SAPHNELO), PF-06823859, and Enpatoran (M5049), among others, is expected to drive changes in the total market size of Polymyositis in the coming years.
• In 2023, the United States had the largest market size for Polymyositis among the 7MM, reaching approximately USD 86 million. This figure is anticipated to grow at a compound annual growth rate (CAGR) of 15.8% throughout the forecast period.
• According to DelveInsight's analysis, the estimated total number of diagnosed prevalent cases of Polymyositis in the 7MM was approximately 80,000 in 2023.
• In 2023, Germany had the highest number of diagnosed prevalent cases of Polymyositis among European countries, with around 9,000 cases, followed by France with approximately 7,000 cases. In contrast, Spain had the lowest prevalent population, with about 3,000 cases.
• In 2023, Japan reported around 12,000 diagnosed prevalent cases of Polymyositis, representing roughly 16% of the total cases across the 7MM.
• According to DelveInsight's analysis, females in Japan were more commonly affected by Polymyositis than males, with around 9,000 female cases compared to 3,000 male cases in 2023.
• Key Polymyositis Companies: Argenx, Immunoforge Co. Ltd., Chester Oddis, Kezar Life Sciences, Inc., Mallinckrodt, Merck KGaA, Astellas Pharma Inc, Genentech, Immunoforge Co. Ltd., Pfizer, Bristol-Myers Squibb, and others
• Key Polymyositis Therapies: Efgartigimod, PF1801, tocilizumab, KZR-616, Adrenocorticotropic Hormone Gel, M5049 high dose, Tacrolimus, Rituximab, Froniglutide, PF-06823859, Abatacept subcutaneous, and others
• The Polymyositis epidemiology based on gender analyzed that Polymyositis affects females more as compared to males
• The Polymyositis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Polymyositis pipeline products will significantly revolutionize the Polymyositis market dynamics.

Polymyositis Overview
Polymyositis is a rare, chronic inflammatory muscle disease characterized by muscle weakness and inflammation. It belongs to a group of diseases called inflammatory myopathies and primarily affects the skeletal muscles, which are responsible for movement.

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Polymyositis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Polymyositis Epidemiology Segmentation:
The Polymyositis market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Polymyositis
• Prevalent Cases of Polymyositis by severity
• Gender-specific Prevalence of Polymyositis
• Diagnosed Cases of Episodic and Chronic Polymyositis

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Polymyositis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Polymyositis market or expected to get launched during the study period. The analysis covers Polymyositis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Polymyositis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Polymyositis Therapies and Key Companies
• Efgartigimod: Argenx
• PF1801: Immunoforge Co. Ltd.
• tocilizumab: Chester Oddis
• KZR-616: Kezar Life Sciences, Inc.
• Adrenocorticotropic Hormone Gel: Mallinckrodt
• M5049 high dose: Merck KGaA
• Tacrolimus: Astellas Pharma Inc
• Rituximab: Genentech
• Froniglutide: Immunoforge Co. Ltd.
• PF-06823859: Pfizer
• Abatacept subcutaneous: Bristol-Myers Squibb

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Scope of the Polymyositis Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Polymyositis Companies: Argenx, Immunoforge Co. Ltd., Chester Oddis, Kezar Life Sciences, Inc., Mallinckrodt, Merck KGaA, Astellas Pharma Inc, Genentech, Immunoforge Co. Ltd., Pfizer, Bristol-Myers Squibb, and others
• Key Polymyositis Therapies: Efgartigimod, PF1801, tocilizumab, KZR-616, Adrenocorticotropic Hormone Gel, M5049 high dose, Tacrolimus, Rituximab, Froniglutide, PF-06823859, Abatacept subcutaneous, and others
• Polymyositis Therapeutic Assessment: Polymyositis current marketed and Polymyositis emerging therapies
• Polymyositis Market Dynamics: Polymyositis market drivers and Polymyositis market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Polymyositis Unmet Needs, KOL's views, Analyst's views, Polymyositis Market Access and Reimbursement

Media Contact
Company Name: DelveInsight Business Research LLP
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About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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