Polymyositis Drugs Market - 2024-2031

Polymyositis Drugs Market - 2024-2031

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

Polymyositis is a rare autoimmune disorder affecting the skeletal muscles involving chronic muscle inflammation, weakness, and pain. The treatment of polymyositis typically consists of a combination of medications, physical therapy, and lifestyle changes.

Polymyositis is treated by corticosteroids, which are the most widely used medications for treating the condition. Corticosteroids, such as prednisone, are used to reduce inflammation and swelling in the muscles.

Market Dynamics: Drivers

Increasing Prevalence & Incidence of Polymyositis and Increasing Research & Developments for Polymyositis Treatment

The demand for the global polymyositis drugs market is driven by multiple factors. One of the key factors is the rising prevalence and incidence of polymyositis and increased R&D activities for polymyositis treatment. Polymyositis affects skeletal muscles on both sides of the body and is rarely seen in people younger than age 20.

According to the NCBI publication in May 2023, the estimated prevalence of polymyositis and dermatomyositis (PM/DM) is 5 to 22 per 100,000 persons, and the incidence is approximately 1.2 to 19 per million persons at risk per year. The incidence of myositis is increasing over time due to an increase in the detection rate.

Moreover, ongoing research studies in the development of treatment for polymyositis would drive this market growth. For instance, in August 2023, Merck and Co. announced Enpatoran drug is under clinical development and is currently in Phase II for Polymyositis. It is under development for the treatment of neuromuscular conditions dermatomyositis and polymyositis. It is administered by oral route and the drug candidate is a new chemical entity that acts by targeting toll-like receptor 7/8.

Restraints

Factors such as the high cost of the treatment, side effects associated with alkylating agents, limited awareness among individuals, limited availability of treatment options, stringent regulatory framework, and limited reimbursement policies are expected to hamper the market.

Segment Analysis

The global polymyositis drugs market is segmented based on drug class, route of administration, distribution channels and region.

The immunosuppressants segment accounted for approximately 56.5% of the global polymyositis drug market share

The immunosuppressants segment is expected to hold the largest market share over the forecast period. A wide range of immunosuppressants has been used in polymyositis and dermatomyositis

The rising clinical trials of treatment drugs globally have contributed to the growing demand for polymyositis treatment. According to clinicalTrials.gov, in August 2023, EMD Serono Research & Development Institute conducted a clinical trial on the Study of M5049 drug in dermatomyositis and polymyositis participants. The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

Similarly, in, April 2023, Immunoforge Co. Ltd. conducted an interventional study to evaluate the Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathies, Dermatomyositis, and Polymyositis. The intervention includes weekly injections of Froniglutide.

Moreover, key places in the market launching new drug products and approvals would drive this segment's growth. For instance, in March 2022, The FDA granted a prior approval supplement to Zydus Lifesciences Limited allowing the company to market its generic mycophenolate mofetil injection USP which is used in polymyositis and dermatomyositis.

Geographical Analysis

North America accounted for approximately 41.3% of the global polymyositis drugs market share

North America region is expected to hold the largest market share over the forecast period owing to the growing prevalence of polymyositis and well-advanced healthcare system, and growing healthcare expenditure would drive this market growth.

Moreover, in this region, major players' presence and new drug approvals and launches would propel this market growth. For instance, in June 2023, UF Health launched a new center to treat myositis and lung disease. Also, in January 2022, ANI Pharmaceuticals announced the commercial availability of purified corticotropin gel (repository corticotropin injection usp) for multiple chronic autoimmune disorders.

In addition, ongoing research studies in the development of treatment for polymyositis and government funding for R&D would drive this market growth in this region. For instance, in August 2022, the University of Florida Center for Regenerative Medicine announced the launch of a clinical trial to test safe dosages of umbilical cord-derived stem cells in the treatment of two debilitating autoimmune disorders. The Phase I trial, in collaboration with the biotechnology company RESTEM, will include nine patients who will receive intravenous infusions of umbilical cord lining stem cells, or ULSCs, to treat dermatomyositis and polymyositis.

Similarly in, March 2024, Atlantic Health System recently announced the enrollment of the first US patient in a study designed to explore the safety and efficacy of Chimeric Antigen Receptor (CAR)-T cell for the treatment of lupus. The phase 1, multicenter, open-label study will focus on patients with severe, refractory systemic lupus erythematosus (SLE), an autoimmune disease that often results in symptoms such as joint pain and swelling, rashes, fever, fatigue, and damage to the heart, kidneys, brain, and lungs.

Market Segmentation

By Drug Class
• Immunosuppressant
• Immunoglobulins
• Corticosteroids
• Alkylating Agents
• Monoclonal Antibodies
• Others

By Route of Administration
• Oral
• Topical
• Parenteral
• Others

By Distribution Channels
• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Italy
Spain
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the polymyositis drugs market include Pfizer Inc., Aspen API, LGM Pharma, Tecoland Corporation, Genentech, Tocris Bioscience, F. Hoffmann-La Roche, Teva Pharmaceuticals, Novartis A.G., Biocon Ltd. among others.

Key Developments

In March 2024, Mallinckrodt announces U.S. FDA approval of a supplemental new drug application for Acthar Gel (repository corticotropin injection) single-dose pre-filled SelfJect injector. A new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.

In October 2023, ANI Pharmaceuticals announced FDA approval and commercial availability of a new 1-ml vial size of purified Cortrophin gel, appropriate for adjunctive treatment of certain patients with acute gouty arthritis flares. Treatment for flares or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).

In November 2022, The Food and Drug Administration (FDA) approved the supplemental New Drug Application for Purified Cortrophin Gel (repository corticotropin injection) for the treatment of certain autoimmune disorders. This product is indicated for maintenance therapy in selected cases of systemic lupus erythematosus and systemic polymyositis.

In January 2022, Roivant and Pfizer unveiled priovant therapeutics and ongoing registrational studies for oral brepocitinib in dermatomyositis and lupus.

Why Purchase the Report?
• To visualize the global polymyositis drugs market segmentation based on drug class, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of global polymyositis drugs market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global polymyositis drugs market report would provide approximately 69 tables, 70 figures, and 183 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies