DelveInsight’s “Myasthenia Gravis Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of Myasthenia Gravis, historical and forecasted epidemiology as well as the MG market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
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Key Takeaways from the Myasthenia Gravis Market Report
- In March 2026, UCB reported that the CHMP issued a positive opinion for the pre-filled pen version of zilucoplan (ZILBRYSQ) for adults with generalized myasthenia gravis across the European Union, pending final European Commission approval.
- In February 2026, the European Commission approved UPLIZNA (inebilizumab), developed by Amgen, for the treatment of adults with generalized myasthenia gravis, expanding B-cell–targeted therapeutic options across Europe.
- In January 2026, KORU Medical Systems received FDA 510(k) clearance for delivering RYSTIGGO (rozanolixizumab-noli) via the FreedomEDGE infusion system, enhancing subcutaneous delivery options and supporting broader adoption of FcRn-targeted therapies.
- In June 2025, RemeGen reported that the EMA granted Orphan Drug Designation to Telitacicept, its recombinant BLyS/APRIL dual-target fusion protein, for myasthenia gravis — making it the first dual-target biologic for MG to receive ODD from both the FDA and EMA.
- According to DelveInsight’s analysis, the Myasthenia Gravis market size was found to be USD 6 billion in the 7MM in 2025, with the market anticipated to grow at a significant CAGR during the study period 2022–2036.
- The total number of diagnosed prevalent cases of myasthenia gravis in the 7MM was approximately 300,000 in 2025. In the US, the anti-AChR Ab-positive category recorded the highest gMG cases at 76,500 in 2025. Females accounted for approximately 81,000 and males for 54,000 US MG cases in 2025.
- In the US, mild generalized disease under the MGFA classification represented approximately 43% of all diagnosed myasthenia gravis cases in 2025. In Japan, MGFA Class II recorded the highest diagnosed prevalent cases at 16,000, followed by Class I with 13,000 cases.
- The current myasthenia gravis market is largely led by argenx and UCB, which dominate through strong product portfolios in targeted immunotherapy. The market is poised for further expansion driven by novel entrants including IMVT-1402, Descartes-08, and remibrutinib.
- The Myasthenia Gravis Companies include Argenx, Alexion Pharmaceuticals, AstraZeneca, UCB S.A., Novartis AG, Johnson & Johnson, Pfizer, Roche, Regeneron Pharmaceuticals, Immunovant, Cartesian Therapeutics, and others.
- Promising MG Therapies include Rozanolixizumab (RYSTIGGO), Zilucoplan (ZILBRYSQ), Nipocalimab-aahu (IMAAVY), Efgartigimod alfa-fcab (VYVGART), Ravulizumab (ULTOMIRIS), IMVT-1402 (Immunovant; Phase III), Descartes-08 (Cartesian Therapeutics; Phase III), Remibrutinib (Novartis; Phase III), Iptacopan/FABHALTA (Novartis; Phase III), Telitacicept (RemeGen), and others.
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Myasthenia Gravis Epidemiology Segmentation in the 7MM
The epidemiology section provides historical, current, and forecasted MG prevalence scenarios across the 7MM — covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2022 to 2036.
- Total Diagnosed Prevalent Cases of Myasthenia Gravis in the 7MM
- Antibody-Specific Diagnosed Prevalent Cases (Anti-AChR, Anti-MuSK, Double Seronegative)
- Gender-Specific Diagnosed Prevalent Cases of Myasthenia Gravis
- MGFA Classification-Specific Diagnosed Prevalent Cases (Classes I–V)
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Myasthenia Gravis Emerging Drugs
IMVT-1402: Immunovant / Roivant Sciences
IMVT-1402 is a next-generation subcutaneously administered anti-FcRn monoclonal antibody developed by Immunovant for the treatment of IgG-mediated autoimmune diseases including gMG. It effectively lowers pathogenic IgG while preserving normal albumin and cholesterol levels, mitigating safety concerns observed with earlier FcRn inhibitors. Top-line results from the Phase III IMVT-1402 study are anticipated to be reported in 2027, with a projected US launch in 2029.
Descartes-08: Cartesian Therapeutics
Descartes-08 is an investigational RNA CAR T-cell therapy targeting plasma cells that produce pathogenic autoantibodies in generalized myasthenia gravis, currently in Phase III clinical evaluation. As a potentially disease-modifying cellular approach, Descartes-08 represents a transformative shift in MG management, aiming to address the underlying B-cell–driven immune dysregulation rather than providing symptomatic or broad immunosuppressive relief.
Remibrutinib: Novartis
Remibrutinib is an investigational oral BTK inhibitor being evaluated in Phase III for generalized myasthenia gravis. By targeting BTK signaling pathways critical to B-cell activation and autoantibody production, remibrutinib offers a novel oral mechanism of action that could provide a convenient and differentiated treatment option for MG patients, particularly those seeking alternatives to injectables or infusion-based biologics.
Myasthenia Gravis Market Outlook
Myasthenia Gravis is a rare chronic autoimmune neuromuscular disorder characterized by weakness and rapid fatigue of voluntary muscles, resulting from immune system attacks on acetylcholine receptors (AChR) or related proteins at the neuromuscular junction. Common symptoms include drooping eyelids, double vision, difficulty speaking, swallowing problems, and muscle weakness that worsens with activity and improves with rest.
The MG treatment landscape has expanded significantly with the approval of targeted biologics representing a shift toward complement inhibition and FcRn blockade. FDA- and EMA-approved agents including nipocalimab-aahu (IMAAVY), rozanolixizumab (RYSTIGGO), zilucoplan (ZILBRYSQ), efgartigimod alfa-fcab (VYVGART), and ravulizumab (ULTOMIRIS) address disease pathology at its source rather than through broad immunosuppression. The market is highly competitive and rapidly evolving, with argenx and UCB currently leading due to strong product portfolios and expanding targeted immunotherapy presence.
Despite these advances, significant unmet needs persist — including delayed diagnosis, limited long-term treatment efficacy in a substantial patient subset, high therapy costs, treatment-related side effects, and inadequate options for refractory patients. Sustained symptom-free remission remains elusive for many patients, highlighting the continued demand for treatments providing stable, long-lasting control without cumulative toxicity.
“The Myasthenia Gravis market size was found to be USD 6 billion in the 7MM in 2025 and is anticipated to grow at a significant CAGR through 2036, driven by the expanding landscape of approved FcRn inhibitors, complement inhibitors, and a robust pipeline of CAR-T, BTK inhibitor, and next-generation biologic therapies.”
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Scope of the Myasthenia Gravis Market Report
- Coverage: 7MM
- Study Period: 2022–2036
- Forecast Period: 2026–2036
- MG Companies: Argenx, Alexion Pharmaceuticals, AstraZeneca, UCB S.A., Novartis AG, Johnson & Johnson, Pfizer, Roche, Regeneron Pharmaceuticals, Immunovant, Cartesian Therapeutics, and others
- MG Therapies: RYSTIGGO, ZILBRYSQ, IMAAVY, VYVGART, ULTOMIRIS, UPLIZNA, IMVT-1402, Descartes-08, Remibrutinib, Iptacopan/FABHALTA, Telitacicept, and others
- MG Therapeutic Assessment: Current marketed and emerging therapies across gMG antibody subtypes and disease severity classifications
- Market Dynamics: Market drivers and barriers, SWOT and conjoint analysis, KOL views, and reimbursement landscape
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Table of Content
- Key Insights
- Myasthenia Gravis Market Report Introduction
- Myasthenia Gravis Market Overview at a Glance
- Myasthenia Gravis Epidemiology and Market Forecast Methodology
- Myasthenia Gravis Key Events
- Myasthenia Gravis Executive Summary
- Myasthenia Gravis Disease Background and Overview
- Myasthenia Gravis Epidemiology and Patient Population
- Myasthenia Gravis Patient Journey
- Myasthenia Gravis Emerging Therapies
- Myasthenia Gravis: Seven Major Market Analysis
- Myasthenia Gravis KOL Views
- Myasthenia Gravis SWOT and Conjoint Analysis
- Myasthenia Gravis Unmet Needs
- Myasthenia Gravis Market Access and Reimbursement
- Myasthenia Gravis Drug Uptake and Price Trends
- Myasthenia Gravis Appendix
- Myasthenia Gravis Market Report Methodology
- DelveInsight Capabilities
- Disclaimer
- Bibliography
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