多発性筋炎治療薬市場：2024年～2031年

概要

世界の多発性筋炎治療薬市場は、2023年に1億310万米ドルに達し、2031年には1億3,260万米ドルに達すると予測されています。

多発性筋炎は、慢性的な筋炎症、筋力低下、疼痛を伴う骨格筋を侵すまれな自己免疫疾患です。多発性筋炎の治療は、通常、薬物療法、理学療法、生活習慣の改善を組み合わせて行われます。

多発性筋炎の治療には副腎皮質ステロイドが最も広く用いられています。プレドニゾンなどの副腎皮質ステロイドは、筋肉の炎症や腫れを抑えるために使用されます。

市場力学：

促進要因

多発性筋炎の有病率と発症率の増加、多発性筋炎治療の研究開発の増加

世界の多発性筋炎治療薬市場の需要は、複数の要因によって牽引されています。主な要因のひとつは、多発性筋炎の有病率および発症率の上昇と、多発性筋炎治療の研究開発活動の活発化です。多発性筋炎は体の両側の骨格筋を侵し、20歳未満ではほとんど見られません。

2023年5月のNCBIの発表によると、多発性筋炎および皮膚筋炎（PM/DM）の推定有病率は10万人あたり5～22人であり、発症リスクは100万人あたり年間約1.2～19人です。筋炎の罹患率は、発見率の増加により、時間の経過とともに増加しています。

さらに、多発性筋炎の治療開発における継続的な研究開発は、この市場の成長を促進すると思われます。例えば、2023年8月、Merck and Co.はEnpatoran薬剤が臨床開発中であり、現在多発性筋炎のフェーズIIにあると発表しました。神経筋疾患である皮膚筋炎と多発性筋炎の治療薬として開発中です。経口投与で、薬剤候補はtoll様受容体7/8を標的として作用する新しい化学体です。

抑制要因

治療費の高さ、アルキル化剤に伴う副作用、個人間の認知度の低さ、治療法の選択肢の少なさ、厳しい規制の枠組み、限られた償還政策などの要因が市場の妨げになると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 多発性筋炎の有病率および発症率の増加と多発性筋炎治療の研究開発の増加
    • 生物製剤と免疫療法の進歩
  • 抑制要因
    • 治療費の高騰
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• アンメットニーズ
• 規制分析
• DMIの見解

第6章 薬剤クラス別

• 免疫抑制剤
• 免疫グロブリン
• 副腎皮質ステロイド
• アルキル化剤
• モノクローナル抗体
• その他

第7章 投与経路別

• 経口剤
• 局所
• 非経口
• その他

第8章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 製品ベンチマーク
• 企業シェア分析
• 主な発展と戦略

第11章 企業プロファイル

• Pfizer Inc.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Aspen API
• LGM Pharma
• Tecoland Corporation
• Genentech
• Tocris Bioscience
• F. Hoffmann-La Roche
• Teva Pharmaceuticals
• Novartis A.G
• Biocon Ltd.

第12章 付録

Overview

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

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Drug Class
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channels
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence & Incidence of Polymyositis and Increasing Research & Developments for Polymyositis Treatment
    • 4.1.1.2. Advancements in Biologics and Immunotherapy
  • 4.1.2. Restraints
    • 4.1.2.1. High Cost of the Treatment
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's 5 Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Unmet Needs
• 5.4. Regulatory Analysis
• 5.5. DMI Opinion

6. By Drug Class

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 6.1.2. Market Attractiveness Index, By Drug Class
• 6.2. Immunosuppressant
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Immunoglobulins
• 6.4. Corticosteroids
• 6.5. Alkylating Agents
• 6.6. Monoclonal Antibodies
• 6.7. Others

7. By Route of Administration

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 7.1.2. Market Attractiveness Index, By Route of Administration
• 7.2. Oral
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Topical
• 7.4. Parenteral
• 7.5. Others

8. By Distribution Channel

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.1.2. Market Attractiveness Index, By Distribution Channel
• 8.2. Hospital Pharmacy
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacy
• 8.4. Online Pharmacy
• 8.5. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Italy
    • 9.3.6.5. Spain
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Product Benchmarking
• 10.3. Company Share Analysis
• 10.4. Key Developments and Strategies

11. Company Profiles

• 11.1. Pfizer Inc.*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Aspen API
• 11.3. LGM Pharma
• 11.4. Tecoland Corporation
• 11.5. Genentech
• 11.6. Tocris Bioscience
• 11.7. F. Hoffmann-La Roche
• 11.8. Teva Pharmaceuticals
• 11.9. Novartis A.G
• 11.10. Biocon Ltd.

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us