Myasthenia Gravis Market Expected to Witness Substantial Growth by 2034, Driven by Recent FDA Approvals and Positive Clinical Trial Outcomes | DelveInsight

May 08 08:56 2025
Myasthenia Gravis Market Expected to Witness Substantial Growth by 2034, Driven by Recent FDA Approvals and Positive Clinical Trial Outcomes | DelveInsight
Myasthenia Gravis – Market Insight, Epidemiology And Market Forecast – 2034
The Myasthenia Gravis treatment market is projected to experience significant expansion in the coming years, propelled by the development of innovative therapies from key myasthenia gravis companies including Horizon Therapeutics, Amgen, Janssen Research & Development, Hoffmann-La Roche, Immunovant Sciences GmbH, Alexion, AstraZeneca Rare Disease, Regeneron Pharmaceuticals, Kyverna Therapeutics, and Cartesian Therapeutics, among others.

DelveInsight’s “Myasthenia Gravis – Market Insight, Epidemiology And Market Forecast – 2034” report provides comprehensive insights into the historical and forecasted myasthenia gravis epidemiology, as well as market trends across the 7MM (United States, EU4 countries including Germany, France, Italy, and Spain, along with the United Kingdom, and Japan). The myasthenia gravis market size in the 7MM reached approximately USD 5 billion in 2023, with projections indicating substantial growth throughout the forecast period (2024-2034). This expansion is primarily driven by increasing disease prevalence, enhanced diagnostic capabilities, and the anticipated launch of novel therapeutic options targeting specific disease mechanisms.

According to DelveInsight’s analysis, the US dominated the myasthenia gravis market in 2023, representing nearly 76% of the total market share. This dominance is attributed to favorable reimbursement policies, high healthcare expenditure, and rapid adoption of innovative therapies. The EU4 countries and the United Kingdom collectively form the second-largest market, followed by Japan, which is expected to experience significant growth during the forecast period.

Download the Myasthenia Gravis Market Forecast Report to understand which factors are driving the Myasthenia Gravis market @ Myasthenia Gravis Market Trends.

The report also delivers detailed epidemiological insights, indicating that total diagnosed myasthenia gravis prevalent cases across 7MM were approximately 300K in 2023, with the US accounting for approximately 130K cases. EU4 and the UK together accounted for nearly 125K diagnosed prevalent cases, while Japan reported a little more than 32K cases. These figures are projected to increase at a notable CAGR throughout the study period (2020-2034).

Discover evolving trends in the Myasthenia Gravis patient pool forecasts @ Myasthenia Gravis Epidemiological Analysis.

The current myasthenia gravis treatment landscape encompasses cholinesterase enzyme inhibitors, immunosuppressive medications, and biological therapies. VYVGART (efgartigimod alfa-fcab), developed by Argenx, has established itself as a groundbreaking FcRn blocker approved in multiple regions for treating generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody-positive. Other significant therapies in the market include SOLIRIS and ULTOMIRIS, manufactured by Alexion Pharmaceuticals, which have demonstrated efficacy in managing refractory cases.

The myasthenia gravis pipeline is robust, with several promising therapies in late-stage clinical development. Batoclimab from Immunovant Sciences GmbH has shown positive results in Phase III studies, demonstrating significant improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores. Additionally, DESCARTES-08, Cartesian Therapeutics’ RNA CAR T-cell therapy specifically designed for autoimmune diseases, represents an innovative approach in the treatment paradigm.

In a notable recent development, Cartesian Therapeutics announced in January 2025 that it received a written agreement from the FDA under the Special Protocol Assessment (SPA) process for the design of its planned Phase III AURORA trial for Descartes-08, its lead mRNA cell therapy candidate targeting myasthenia gravis. This milestone underscores the evolving treatment landscape and highlights the industry’s commitment to addressing the unmet medical needs of the myasthenia gravis patient population.

Additionally, in April 2025, the FDA approved Johnson & Johnson’s nipocalimab, marketed as IMAAVY, as a new treatment for adults and pediatric patients aged 12 years and older who have generalized myasthenia gravis and are anti-acetylcholine receptor or anti-muscle-specific kinase antibody positive.

Promising myasthenia gravis therapeutic updates also include positive outcomes and steroid-sparing effects from inebilizumab. Furthermore, new safety and efficacy data have emerged for efgartigimod, rozanolixizumab, nipocalimab, and complement inhibitors such as zilucoplan and ravulizumab.

Discover evolving trends in the Myasthenia Gravis treatment landscape @ Myasthenia Gravis Recent Developments.

DelveInsight’s analysis indicates that the myasthenia gravis market is highly competitive and rapidly evolving, with leading pharmaceutical companies such as Roche (SWX: ROG), UCB Pharma (EBR: UCB), Alexion Pharmaceuticals (NASDAQ: ALXN), Mitsubishi Tanabe Pharma (MTZPY), Sanofi (EPA: SAN), Grifols (BME: GRF), Amgen (NASDAQ: AMGN), Eisai (TYO: 4523), Merck & Co. (NYSE: MRK), Novartis (SWX: NOVN), GlaxoSmithKline (LON: GSK), AbbVie (NYSE: ABBV), Teva Pharmaceutical (TLV: TEVA), Sandoz (SWX: SDZ), Argenx (EBR: ARGX), Bristol-Myers Squibb (NYSE: BMY), and Catalysts Pharmaceuticals (NASDAQ: CPRX), among others, are actively developing and marketing treatments.

The integration of innovative treatment modalities, including FcRn inhibitors and cell therapies, is expected to significantly improve patient outcomes in this rare autoimmune neuromuscular disorder characterized by muscle weakness and fatigue. However, challenges such as high treatment costs and limited accessibility in certain regions continue to impact market dynamics.

As research advances and clinical trials progress, the myasthenia gravis market is expected to witness a paradigm shift in treatment approaches, moving toward more personalized therapeutic strategies based on antibody serological profiles and disease severity classifications. This evolution, coupled with increasing disease awareness and improved diagnostic capabilities, will continue to drive market growth and address the myasthenia gravis patients unmet needs.

Table of Contents

1. Key Insights

2. Report Introduction

3. Myasthenia Gravis Market Overview at a Glance

4. Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

8. Myasthenia Gravis Epidemiology and Patient Population

9. Myasthenia Gravis Patient Journey

10. Myasthenia Gravis Marketed Therapies

11. Myasthenia Gravis Emerging Therapies

12. Myasthenia Gravis: Market Analysis

13. Key Opinion Leaders’ Views

14. SWOT Analysis

15. Myasthenia Gravis Unmet Needs

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

Related Reports

Myasthenia Gravis Pipeline Insight

Myasthenia Gravis Pipeline Insight provides comprehensive insights about the Myasthenia Gravis pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Myasthenia Gravis companies, including Harbour BioMed (Guangzhou) Co. Ltd., Kyverna Therapeutics, Cabaletta Bio, Takeda, Hoffmann-La Roche, Immunovant Sciences GmbH, Regeneron Pharmaceuticals, Novartis Pharmaceuticals, Janssen Research & Development, LLC, Momenta Pharmaceuticals, Inc., Amgen, Dianthus Therapeutics, Cartesian Therapeutics, COUR Pharmaceutical Development Company, Inc., and Alexion Pharmaceuticals Inc, among others.

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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