Polymyositis Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Prevalence, Medication, Statistics, Revenue and Companies by DelveInsight

(Albany, USA) The Polymyositis market across the 7MM was valued at ~USD 114 million in 2023, dominated by the US with ~USD 86 million, projected to grow at a CAGR of 15.8% through 2034. Prevalence was highest in the US (~37K cases), with ~14K males and ~22K females affected. Japan accounted for ~12K cases, while Germany led in Europe. Market growth is fueled by rising awareness, R&D, and emerging therapies, though challenges include high costs, limited treatments, and reimbursement hurdles. Current therapies encompass glucocorticoids, immunosuppressants, TNF inhibitors, IVIG, and Acthar Gel. EMA granted PRIME status to dazukibart, and FDA awarded Fast Track to Restem-L. Pipeline agents like AstraZeneca's SAPHNELO highlight future potential. Despite advances, unmet needs persist for safer, effective, and affordable options.

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.

The Polymyositis market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Polymyositis market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Polymyositis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Polymyositis market.

To Know in detail about the Polymyositis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Polymyositis Market Forecast - https://www.delveinsight.com/sample-request/polymyositis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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 April 2025, Argnex announced a Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
• In March 2025, AstraZeneca announced a Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
• In March 2025, EMD Serono announced a Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA)
• 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 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 that primarily affects the skeletal muscles, leading to progressive muscle weakness, especially in the proximal muscles such as those in the hips, thighs, shoulders, and upper arms. Polymyositis typically develops in adults between the ages of 30 and 60 and is more commonly seen in women than men. Polymyositis is categorized under idiopathic inflammatory myopathies, a group of autoimmune conditions that also includes dermatomyositis and inclusion body myositis.
Polymyositis is believed to be caused by an abnormal immune response in which the body's immune system mistakenly attacks its own muscle tissues. Polymyositis symptoms usually develop gradually and may include difficulty climbing stairs, lifting objects, or rising from a seated position. Polymyositis can also be associated with other autoimmune disorders and may involve complications such as difficulty swallowing or breathing.
Polymyositis diagnosis is based on clinical examination, elevated muscle enzymes, electromyography (EMG), MRI imaging, and muscle biopsy. Polymyositis treatment typically involves high-dose corticosteroids and immunosuppressive medications to reduce inflammation and slow disease progression. Polymyositis patients may also benefit from physical therapy to maintain muscle strength and flexibility. Polymyositis awareness and early diagnosis are essential to managing symptoms and improving quality of life.

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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

Download the report to understand which factors are driving Polymyositis epidemiology trends @ Polymyositis Epidemiology Forecast - https://www.delveinsight.com/sample-request/polymyositis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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

Discover more about therapies set to grab major Polymyositis market share @ Polymyositis Treatment Landscape - https://www.delveinsight.com/sample-request/polymyositis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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 (EBR: ARGX), Immunoforge Co. Ltd. (KOSDAQ: 377950), Kezar Life Sciences, Inc. (NASDAQ: KZR), Mallinckrodt (OTC: MNKTQ), Merck KGaA (ETR: MRK), Astellas Pharma Inc. (TSE: 4503), Genentech (a subsidiary of Roche Holding AG, SWX: ROG), Pfizer (NYSE: PFE), Bristol-Myers Squibb (NYSE: BMY), 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

To know more about Polymyositis companies working in the treatment market, visit @ Polymyositis Clinical Trials and Therapeutic Assessment - https://www.delveinsight.com/sample-request/polymyositis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Polymyositis Market Report Introduction
2. Executive Summary for Polymyositis
3. SWOT analysis of Polymyositis
4. Polymyositis Patient Share (%) Overview at a Glance
5. Polymyositis Market Overview at a Glance
6. Polymyositis Disease Background and Overview
7. Polymyositis Epidemiology and Patient Population
8. Country-Specific Patient Population of Polymyositis
9. Polymyositis Current Treatment and Medical Practices
10. Polymyositis Unmet Needs
11. Polymyositis Emerging Therapies
12. Polymyositis Market Outlook
13. Country-Wise Polymyositis Market Analysis (2020-2034)
14. Polymyositis Market Access and Reimbursement of Therapies
15. Polymyositis Market Drivers
16. Polymyositis Market Barriers
17. Polymyositis Appendix
18. Polymyositis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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