중증근무력증 치료 시장 평가 : 약물 종류별, 최종사용자별, 지역별 기회 및 예측(2018-2032년)

Global myasthenia gravis treatment market is projected to witness a CAGR of 7.15% during the forecast period 2025-2032, growing from USD 1.94 billion in 2024 to USD 3.37 billion in 2032. The market demand for myasthenia gravis treatment is anticipated to thrive drastically in the forecast years due to the increasing prevalence of myasthenia gravis and technological advancements in immunotherapy for their treatment, as well as the growing interest of investors in the myasthenia gravis treatment market.

Myasthenia gravis is a chronic neuromuscular junction disease, an autoimmune disorder caused by antibodies blocking or destroying nicotinic acetylcholine receptors at the nerve and muscle junction. With a prevalence of around 100-350 cases per million people, a recent population study revealed that 51% of myasthenia gravis cases present initial symptoms as ocular issues, such as double vision or drooping eyelids. Approximately 54.5% of individuals with ocular MG progress to generalized myasthenia gravis, characterized by widespread muscle weakness. Symptoms typically peak in severity within two years of diagnosis, with 15%-20% of patients experiencing myasthenia crises, posing a risk of respiratory failure. The launch of new products and therapies further fuels market growth. For instance, in September 2023, Recipharm AB partnered with AHEAD THERAPEUTICS S.L. to develop a novel therapy for myasthenia gravis. Recipharm AB will provide analytical, process development, and GLP manufacturing services for lipid nanoparticles encapsulating an antigen peptide. This collaboration aims to scale up production for commercializing therapy, addressing the unmet need in a market affecting around 150,000 people globally.

Increasing Prevalence of Myasthenia Gravis

Incidences of myasthenia gravis are increasing worldwide, and this is contributing to the growth of the myasthenia gravis treatment market. Some contributing factors to this incidence include genetic predisposition and rising awareness levels, thereby increasing demand for proper treatment solutions. High diagnosis rates of myasthenia gravis are obtained because of improved diagnosis capabilities and a better understanding of the abilities involved. As the diagnosis rate rises and the patient population seeks better treatments, the subsequent demand for treatment rises, shortly depicting significant growth of the myasthenia gravis treatment market. For instance, in June 2023, argenx SE announced that the United States FDA had approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), a subcutaneous injection for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, representing approximately 85% of the patient population.

Advancements in Diagnostic Techniques

Diagnostic technology advancements are a major growth driver of the global myasthenia gravis treatment market. Advanced diagnostic technologies, including next-generation antibody tests, neuroimaging, and electromyography, have increased the sensitivity of early detection and improved diagnostic accuracy, thus making clinicians raise myasthenia gravis quickly and at higher accuracy. Thus, with earlier interventions, patients' chances of management and relief from quality of life have increased considerably. These advances also require treatment since more cases will be diagnosed at an earlier phase, encouraging pharmaceutical and biotechnology companies to invest in innovative therapies addressing the initial and progressive stages of myasthenia gravis. For instance, in April 2023, CSL Limited announced FDA approval of a 50mL/10g prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid), the first and only immune globulin available in prefilled syringes. Hizentra offers a convenient, ready-to-use option for patients with primary immunodeficiency or chronic inflammatory demyelinating polyneuropathy.

Monoclonal Antibodies Segment to Dominate Myasthenia Gravis Treatment Market

The market for myasthenia gravis treatment is likely to be dominated by the monoclonal antibody segment because monoclonal antibodies are relatively effective for targeted therapy to manage an autoimmune response. This blockage of specific immune pathways, such as the complement system and acetylcholine receptor-related pathways, reduces symptom severity and disease progression among myasthenia gravis patients. This segment is expected to grow rapidly in the myasthenia gravis treatment market owing to its high efficacy, adoption, and pricing. For instance, in August 2023, AstraZeneca plc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved Soliris (eculizumab) for the extended treatment of generalized myasthenia gravis in pediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and have difficulty controlling symptoms with other treatments. Soliris is the first drug approved in Japan for children and adolescents with generalized myasthenia gravis.

North America Dominates Myasthenia Gravis Treatment Market

North America is likely to dominate the global myasthenia gravis treatment market due to high-class healthcare infrastructure and a strong pharmaceutical landscape. According to a report published in Muscle & Nerve journal, in December 2023, the diagnosed prevalence and incidence of myasthenia gravis in the United States were 37.0 and 3.1 per 100,000 persons, respectively. Higher rates were observed in younger women under the age of 50 years and older men above the age of 65 years, highlighting age- and gender-related trends in myasthenia gravis prevalence and incidence. Contributing factors for the largest share held by North America in its regional market are the increase in awareness of myasthenia gravis and growth in the myasthenia gravis treatment options. For instance, in October 2023, UCB S.A., a global biopharmaceutical company, announced that the United States Food and Drug Administration had approved ZILBRYSQ (zilucoplan) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ is the first once-daily, subcutaneous C5 inhibitor offering a self-administered, targeted therapy for generalized myasthenia gravis patients.

Future Market Scenario (2025-2032F)

The market for myasthenia gravis treatment is promising growth in the forecast period, mainly due to the continued advancement in the development of biological therapies, especially monoclonal antibodies, as well as an increasing pipeline of targeted therapies. Improved diagnostic competencies will lead to proper and timely diagnosis and intervention, fueling demand for more effective treatments. The rising incidence of autoimmune disorders, particularly among the geriatric population, will also contribute positively to the market growth. For instance, in June 2024, Johnson & Johnson Services, Inc. announced positive results from the Phase 3 Vivacity-MG3 study, showing that nipocalimab, combined with standard of care (SOC), outperformed placebo plus SOC in improving the MG-ADL (Myasthenia Gravis - Activities of Daily Living) score in generalized myasthenia gravis patients over 24 weeks. These findings will be presented at the EAN 2024 Congress and submitted to regulatory authorities later this year.

Key Players Landscape and Outlook

Myasthenia gravis treatment market is mainly dominated by larger pharmaceutical market players. Market activity reported in recent years includes business agreements, collaborations, clinical advancements, and regulatory approvals for market players' products. The market also fosters several smaller players, collaborating with other players to cater to a larger market. For instance, in November 2023, Selecta Biosciences, Inc., merged with Cartesian Therapeutics, Inc., a clinical-stage biotech focused on RNA cell therapies for autoimmune diseases. Following the merger, Selecta secured USD 60.25 million in private financing, bringing total funds to over USD 110 million. The combined company will advance Cartesian's pipeline, including the Phase 3 study of Descartes-08, a potential first-in-class RNA-engineered CAR-T therapy for myasthenia gravis.

In October 2024, Amgen Inc. announced positive top-line results from the Phase 3 MINT trial evaluating the efficacy and safety of UPLIZNA (inebilizumab-cdon) for treating adults with generalized myasthenia gravis. The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo at Week 26 for the combined study population.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Myasthenia Gravis Treatment Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Drug Class
    • 4.2.1.1. Cholinesterase Inhibitors
    • 4.2.1.2. Corticosteroids
    • 4.2.1.3. Monoclonal Antibodies
    • 4.2.1.4. Rapid Immunotherapies
    • 4.2.1.5. Others
  • 4.2.2. By End-user
    • 4.2.2.1. Hospital Pharmacies
    • 4.2.2.2. Retail Pharmacies
    • 4.2.2.3. Online Pharmacies
  • 4.2.3. By Region
    • 4.2.3.1. North America
    • 4.2.3.2. Europe
    • 4.2.3.3. Asia-Pacific
    • 4.2.3.4. South America
    • 4.2.3.5. Middle East and Africa
  • 4.2.4. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Drug Class
  • 4.3.2. By End-user
  • 4.3.3. By Region

5. North America Myasthenia Gravis Treatment Market Outlook, 2018-2032F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Drug Class
    • 5.2.1.1. Cholinesterase Inhibitors
    • 5.2.1.2. Corticosteroids
    • 5.2.1.3. Monoclonal Antibodies
    • 5.2.1.4. Rapid Immunotherapies
    • 5.2.1.5. Others
  • 5.2.2. By End-user
    • 5.2.2.1. Hospital Pharmacies
    • 5.2.2.2. Retail Pharmacies
    • 5.2.2.3. Online Pharmacies
  • 5.2.3. By Country Share
    • 5.2.3.1. United States
    • 5.2.3.2. Canada
    • 5.2.3.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Myasthenia Gravis Treatment Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Drug Class
        • 5.3.1.2.1.1. Cholinesterase Inhibitors
        • 5.3.1.2.1.2. Corticosteroids
        • 5.3.1.2.1.3. Monoclonal Antibodies
        • 5.3.1.2.1.4. Rapid Immunotherapies
        • 5.3.1.2.1.5. Others
      • 5.3.1.2.2. By End-user
        • 5.3.1.2.2.1. Hospital Pharmacies
        • 5.3.1.2.2.2. Retail Pharmacies
        • 5.3.1.2.2.3. Online Pharmacies
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Myasthenia Gravis Treatment Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Myasthenia Gravis Treatment Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Myasthenia Gravis Treatment Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Myasthenia Gravis Treatment Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework and Innovation

• 17.1. Regulatory Approvals
• 17.2. Clinical Trials

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. Astellas Pharma Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 20.3.2. Novartis AG
  • 20.3.3. F. Hoffmann-La Roche Ltd
  • 20.3.4. Veloxis Pharmaceuticals, Inc.
  • 20.3.5. Grifols, S.A.
  • 20.3.6. Alexion Pharmaceuticals, Inc.,
  • 20.3.7. AbbVie Inc.
  • 20.3.8. Pfizer Inc.
  • 20.3.9. Bausch Health Companies Inc.
  • 20.3.10. GlaxoSmithKline plc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

21. Strategic Recommendations

22. About Us and Disclaimer