Polymyositis Market
- The Polymyositis Market Size in the 7MM was ~USD 114 million in 2023, which is further anticipated to increase during the forecast period (2024-2034).
- In 2023, the Polymyositis Market Size was highest in the US among the 7MM, accounting for approximately USD 86 million which is further expected to rise at a CAGR of 15.8% during the forecast period.
- In 2023, the Polymyositis Prevalence was highest in the US among the 7MM, accounting for nearly 37 thousand cases which are further expected to increase by 2034.
- In the United States, in 2023, ~14 thousand males and ~22 thousand females were affected with Polymyositis.
- The Polymyositis Market is driven by growing awareness, advancements in treatment options, and increased R&D. Barriers include high treatment costs, limited effective therapies, and side effects. Reimbursement challenges persist, especially for newer treatments. Unmet needs include safer, more effective therapies, improved diagnostics, and affordable long-term disease management solutions
- The current Polymyositis Market includes glucocorticoids, immunosuppressive agents, TNF inhibitors/rituximab, intravenous immunoglobulin and Acthar Gel, making up a market size of USD 114 million in the 7MM in 2023. The Polymyositis Market Size is expected to increase with the projected launch of emerging therapies during the forecast period (2024–2034).
- The European Medicines Agency (EMA) granted PRIME drug designation to dazukibart for treating patients with Polymyositis.
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DelveInsight’s “Polymyositis Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Polymyositis, historical and forecasted epidemiology as well as the Polymyositis therapeutics market trends in the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.
The Polymyositis Treatment Market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Polymyositis market size from 2020 to 2034. The Report also covers current Polymyositis treatment market practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the Polymyositis treatment market.
| Study Period | 2020 to 2034 |
| Forecast Period | 2024-2034 |
| Geographies Covered |
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| Polymyositis Market |
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| Polymyositis Market Size | |
| Polymyositis Companies |
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Polymyositis Treatment Market
Polymyositis is a disorder of inflammatory myopathies characterized pathologically by the presence of inflammatory infiltrates in striated muscle. The foremost clinical manifestation of polymyositis is proximal muscle weakness. The etiology of polymyositis is unknown, but current evidence suggests that it is an autoimmune disorder. The prevalence of idiopathic inflammatory myopathies (IIMs) is fairly low as reported by different research. Polymyositis is rare in childhood and presents mainly after the second decade of life, and the most common time of presentation is between 45 and 60 years of age. Polymyositis can affect people of all ages but most commonly presents between 50 and 70 years. Polymyositis is rarely seen in people younger than 18 and is twice as common among females as males. The classic symptom of polymyositis is proximal weakness, which may manifest as difficulty holding arms over the head, climbing stairs, or rising from a chair. Weakness of the striated muscle of the upper esophagus may result in dysphagia, dysphonia, and aspiration. The chest wall muscles may be affected, leading to ventilator compromises.
Polymyositis Diagnosis
Polymyositis is an inflammatory muscle disease characterized by progressive muscle weakness, typically affecting the proximal muscles, such as those in the hips, thighs, and shoulders. Diagnosis involves a combination of clinical evaluation, laboratory tests, and imaging. Key indicators include elevated levels of muscle enzymes like creatine kinase, abnormal electromyography (EMG) results, and characteristic findings on muscle biopsy showing inflammatory infiltrates and muscle fiber damage. MRI can help identify affected muscles. Differential diagnosis is crucial to rule out other conditions with similar symptoms. Prompt diagnosis is essential for effective management and treatment to prevent muscle damage.
Further details related to diagnosis are provided in the report…
Polymyositis Treatment
Polymyositis treatment primarily involves corticosteroids like prednisone to reduce inflammation and improve muscle strength. Patients typically start with high doses, which are gradually tapered based on response. Immunosuppressive drugs, such as methotrexate or azathioprine, are often prescribed as steroid-sparing agents to minimize long-term steroid use. For patients not responding to these therapies, intravenous immunoglobulin (IVIG) or biologic agents like rituximab may be considered. Physical therapy is essential to maintain muscle function and prevent atrophy. Early and aggressive treatment can help prevent complications such as respiratory issues or permanent muscle damage. Regular monitoring is crucial for managing side effects.
Polymyositis Epidemiology
As the market is derived using a patient-based model, the Polymyositis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Polymyositis, Gender-specific Diagnosed Prevalent Cases of Polymyositis, and Age-specific Diagnosed Prevalent Cases of Polymyositis 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.
- In the assessment done by DelveInsight, the estimated total diagnosed prevalent cases of Polymyositis in the 7MM were nearly 80 thousand in 2023.
- Among the European countries, Germany had the highest diagnosed prevalent cases of Polymyositis with ~9 thousand cases, followed by France, which had diagnosed prevalent population of ~7 thousand in 2023. On the other hand, Spain had the lowest prevalent population (3 thousand cases).
- Japan had nearly 12 thousand total diagnosed prevalent cases of Polymyositis in 2023, accounting for approximately 16% in 7MM.
- The DelveInsight analysis indicates that in Japan, females were more affected than males, with approximately 9 thousand female cases and 3 thousand male cases in 2023.
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Polymyositis Recent Developments
- In January 2025, RESTEM announced that the FDA granted Fast Track designation for its Restem-L program, using umbilical cord outer lining stem cells (ULSCs) to treat Polymyositis and Dermatomyositis (PM/DM), now classified as Idiopathic Inflammatory Myopathy (IIM). This follows the recent Orphan Drug Designation for Restem-L in IIM.
Polymyositis Drug Chapters
The drug chapter segment of the Polymyositis drugs market report encloses a detailed analysis of Polymyositis off-label drugs and late-stage (Phase-III and Phase-II) Polymyositis pipeline drugs analysis. It also helps to understand the Polymyositis clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Polymyositis news and press releases.
Polymyositis Emerging Drugs
- SAPHNELO (Anifrolumab): AstraZeneca
SAPHNELO (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. Type I IFNs, such as IFN-alpha, IFN-beta, and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. The majority of adults with SLE have increased type I IFN signaling, which is associated with increased disease activity and severity.
Dazukibart (PF-06823859): Pfizer
The drug dazukibart (PF-06823859) is being developed to treat moderate to severe dermatomyositis and Polymyositis by Pfizer along with other indications like systemic lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), and chronic cutaneous lupus erythematosus (CCLE). Neutralizing antibodies against humanized immunoglobulin and a new biological entity (NBE) make up the therapeutic candidate. It works by specifically targeting interferon beta 1 (IFNB1) and is injected intravenously and subcutaneously.
| Drug | MoA | RoA | Company | Logo | Phase |
| SAPHNELO (Anifrolumab) | IFN alpha-beta receptor antagonists | SC | AstraZeneca | III | |
| Dazukibart (PF-06823859) | IFN-β antagonist | SC | Pfizer | III | |
| XXX | TLR7/8 antagonist | XXX | XXX | II |
Polymyositis Market Outlook
Polymyositis is an inflammatory muscle disease that requires a multifaceted approach to treatment, primarily focusing on reducing inflammation, managing symptoms, and preventing long-term complications. The mainstay of treatment is corticosteroids, such as prednisone, which are often administered as the first line of therapy due to their potent anti-inflammatory effects. These steroids are typically prescribed in high doses initially and gradually tapered based on the patient’s response. For patients who do not respond adequately to corticosteroids or who experience significant side effects, immunosuppressive agents such as methotrexate or azathioprine are commonly used. These medications help to modulate the immune system and can be used as steroid-sparing agents to reduce the dependency on corticosteroids.
In more severe or refractory cases, biologic agents, including rituximab, are considered. These targeted therapies focus on specific pathways involved in the disease process, offering a more tailored approach to treatment. Physical therapy is also a critical component of Polymyositis management. Regular, supervised exercise can help maintain muscle strength and flexibility, preventing muscle atrophy and contractures. Additionally, patients may benefit from nutritional support, pain management, and the treatment of associated conditions such as interstitial lung disease, which can occur in conjunction with Polymyositis.
The Polymyositis Drugs Market is poised for transformation with the anticipated introduction of therapies like Anifrolumab (SAPHNELO), PF-06823859, and Enpatoran (M5049). The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.
- The Polymyositis Market Size in the 7MM was ~USD 114 million in 2023, which is further anticipated to increase during the forecast period.
- The United States accounted for the highest Polymyositis Market Size approximately 75% of the total market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Among the EU countries, Germany had the highest Polymyositis market size with nearly USD 6 million in 2023, while Spain had the lowest market size for Polymyositis with USD ~2 million in 2023.
- The Polymyositis Market Size in Japan was USD 9 million in 2023, which is expected to rise at a CAGR of 16.4% by 2034.
- With the expected launch of upcoming therapies, such as Anifrolumab (SAPHNELO), PF-06823859, and Enpatoran (M5049), among others, the total Polymyositis Market Size is expected to show change in the upcoming years.
Polymyositis Drugs Uptake
This section focuses on the uptake rate of potential Polymyositis drugs analysis expected to launch in the market during 2020–2034. For example, Enpatoran (M5049) in the US is expected to be launched by 2028 with a peak share of 10%. Enpatoran (M5049) is anticipated to take 8 years to peak with a Slow-medium uptake.
Further detailed analysis of emerging therapies drug uptake in the report…
Polymyositis Pipeline Development Activities
The Polymyositis therapeutics market report provides insights into different Polymyositis clinical trials within Phase III, Phase II, and Phase I stage. It also analyzes key Polymyositis Companies involved in developing targeted therapeutics.
Pipeline Development Activities
The Polymyositis therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Polymyositis emerging therapies.
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KOL Views
To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Polymyositis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Stanford University School of Medicine, Northwestern University Feinberg School of Medicine, University of California, San Francisco , US; University of Milan, Italy; Hospital Universitario La Paz, Spain; Pitié-Salpêtrière Hospital, Paris; Royal Liverpool University Hospital, Osaka University Hospital and Kyoto University Hospital, Japan; and others.
Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Polymyositis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Polymyositis Therapeutics Market: Qualitative Analysis
We perform Qualitative and Polymyositis Therapeutics Market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Polymyositis Therapeutics Market Access and Reimbursement
The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment. The Polymyositis therapeutics market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Polymyositis Treatment Market Report Scope
- The Polymyositis therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, and currently available therapies.
- Comprehensive insight has been provided into the Polymyositis epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
- Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Polymyositis treatment market landscape.
- A detailed review of the Polymyositis treatment market, historical and forecasted Polymyositis treatment market size, Polymyositis drugs market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
- The Polymyositis therapeutics market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Polymyositis drugs market.
Polymyositis Treatment Market Report Insights
- Patient-based Polymyositis Market Forecasting
- Polymyositis Therapeutic Approaches
- Polymyositis Pipeline Drugs Analysis
- Polymyositis Market Size
- Polymyositis Market Trends
- Existing and Future Polymyositis Drugs Market Opportunity
Polymyositis Treatment Market Report Key Strengths
- 11 years Polymyositis Market Forecast
- The 7MM Coverage
- Polymyositis Epidemiology Segmentation
- Key Cross Competition
- Conjoint Analysis
- Polymyositis Drugs Analysis Uptake
- Key Polymyositis Market Forecast Assumptions
Polymyositis Treatment Market Report Assessment
- Current Polymyositis Treatment Market Practices
- Polymyositis Unmet Needs
- Polymyositis Pipeline Drugs Analysis Profiles
- Polymyositis Drugs Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
- Polymyositis Market Drivers
- Polymyositis Barriers
Key Questions Answered In The Polymyositis Market Forecast Report
Polymyositis Treatment Market Insights
- What was the Polymyositis drugs market share (%) distribution in 2020 and how it would look like in 2034?
- What would be the Polymyositis treatment market size as well as market size by therapies across the 7MM during the forecast period (2024–2034)?
- What are the key findings pertaining to the Polymyositis market across the 7MM and which country will have the largest Polymyositis market size during the forecast period (2024–2034)?
- At what CAGR, the Polymyositis drugs market is expected to grow at the 7MM level during the forecast period (2024–2034)?
- What would be the Polymyositis market outlook across the 7MM during the forecast period (2024–2034)?
- What would be the Polymyositis market growth till 2034 and what will be the resultant market size in the year 2034?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Polymyositis Epidemiology Insights
- What is the disease risk, burden, and Polymyositis unmet needs?
- What is the historical Polymyositis patient population in the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan?
- What would be the forecasted Polymyositis patient population at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Polymyositis?
- Out of the above-mentioned countries, which country would have the highest prevalent population of Polymyositis during the forecast period (2024–2034)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2024–2034)?
Current Polymyositis Treatment Market Scenario, Marketed Drugs, and Emerging Therapies
- What are the current options for the treatment of Polymyositis along with the approved therapy?
- What are the current treatment guidelines for the treatment of Polymyositis in the US, Europe, And Japan?
- What are the Polymyositis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of Polymyositis?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of Polymyositis?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Polymyositis therapies?
- What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Polymyositis and their status?
- What are the key designations that have been granted for the Polymyositis emerging therapies?
- What are the 7MM historical and forecasted Polymyositis Market?
Reasons to Buy Polymyositis Market Forecast Report
- The Polymyositis Therapeutics Market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Polymyositis Drugs Market.
- Insights on patient burden/disease Polymyositis Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- To understand the existing Polymyositis therapeutics market opportunity in varying geographies and the growth potential over the coming years.
- Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identification of strong upcoming players in the Polymyositis therapeutics market will help in devising strategies that will help in getting ahead of competitors.
- Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading Polymyositis emerging drugs.
- Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
- To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
- Detailed insights on the unmet need of the existing Polymyositis therapeutics market so that the upcoming players can strengthen their development and launch strategy.
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