Myasthenia Gravis Market Unlocking New Revenue Opportunities and Strategic Expansion by 2036 - DelveInsight

DelveInsight's "Myasthenia Gravis Market Insights, Epidemiology, and Market Forecast-2036′′ report offers an in-depth understanding of the Myasthenia Gravis, historical and forecasted epidemiology as well as the Myasthenia Gravis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

To Know in detail about the Myasthenia Gravis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Myasthenia Gravis Market Forecast
https://www.delveinsight.com/sample-request/myasthenia-gravis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key facts of the Myasthenia Gravis Market Report:
• The Myasthenia Gravis market size across the 7MM was valued at approximately USD 6 billion in 2025 and is projected to reach nearly USD 16 billion by 2036, growing at a CAGR of 9.1% during 2026-2036.
• In May 2026, The FDA has approved a supplemental Biologics License Application (sBLA) for efgartigimod alfa-fcab (Vyvgart; argenx), broadening its indication to include adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). This approval expands the anti-FcRn therapy beyond previously approved AChR-Ab-positive patients, making it the first authorized treatment for the seronegative gMG population and supporting a wider biomarker-independent application of the FcRn inhibitor in generalized myasthenia gravis.
• In May 2026, The FDA has expanded the approval of efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa with hyaluronidase-qvfc (Vyvgart Hytrulo), both developed by argenx, for adult patients with generalized myasthenia gravis (gMG). With this label expansion, the therapies are now approved for use across all major gMG serotypes, including patients who are anti-acetylcholine receptor (AChR-Ab) positive, anti-muscle-specific tyrosine kinase (MuSK) antibody positive, anti-low-density lipoprotein receptor-related protein 4 (LRP4) antibody positive, as well as triple seronegative patients.
• In April 2026, Cemdisiran, an investigational therapy administered as a subcutaneous injection every three months, demonstrated significant and sustained symptom improvement in patients with generalized myasthenia gravis (gMG) during the global late-stage NIMBLE clinical trial. According to investigators and Regeneron Pharmaceuticals, the study findings not only highlighted cemdisiran's therapeutic potential in gMG but also offered important insights into the disease's underlying biological mechanisms.
• In March 2026, UCB announced that the Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the pre-filled pen formulation of zilucoplan (ZILBRYSQ). The recommendation supports its use in adult patients with generalized myasthenia gravis throughout the European Union, subject to final approval by the European Commission.
• In January 2026, Cartesian Therapeutics announced the AURORA Study, which is assessing the safety, tolerability, and effectiveness of an investigational mRNA CAR T-cell therapy, Descartes-08, in adults with acetylcholine receptor autoantibody-positive generalized myasthenia gravis. Part 1 of the study is expected to run for approximately six months, while Part 2 will last around eight months for eligible participants.
• In December 2025, Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for treating adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibodies. This approval provides patients with a new targeted therapy that may offer long-term disease management with only two annual doses following two initial loading doses.
• In June 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
• In May 2025, The FDA approved a new therapy for generalized myasthenia gravis (gMG), a condition characterized by severe muscle weakness, rapid fatigue, and challenges with speech and swallowing. This new treatment, called nipocalimab and marketed as Imaavy, provides a long-lasting option for symptom management, benefiting approximately 100,000 people affected by gMG in the U.S. It is the first and only therapy designed to address the underlying cause of the disease in adults and adolescents aged 12 and older who possess specific antibodies associated with gMG.
• In April 2025, Nipocalimab-aahu is a human IgG1 monoclonal antibody designed to target the neonatal Fc receptor (FcRn) with high affinity, thereby reducing circulating IgG levels. Its approval was supported by results from the Phase 3 Vivacity-MG3 trial (ClinicalTrials.gov ID: NCT04951622), a randomized, double-blind, placebo-controlled study. The trial involved adult patients with generalized myasthenia gravis (gMG), classified as class II to IV by the Myasthenia Gravis Foundation of America, who had an inadequate response to standard therapies, indicated by an MG-ADL score of 6 or above.
• In April 2025, Promising results from the Phase 3 clinical trial (NCT05737160) assessing the safety and efficacy of Telitacicept (RC18; brand name: 泰爱®) in patients with generalized myasthenia gravis (gMG) were shared during the Late-Breaking Science Session at the 2025 American Academy of Neurology (AAN) Annual Meeting.
• In April 2025, Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotech company focused on developing cell therapies for autoimmune disorders, has reported 12-month efficacy and safety results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). Patients who received a single six-week treatment course of Descartes-08 showed sustained improvement in MG symptoms, which persisted through the 12-month follow-up evaluation.
• In March 2025, Immunovant decided not to pursue regulatory approval for its myasthenia gravis (MG) treatment, batoclimab, despite the Phase III study meeting its primary endpoint of reducing disease symptoms. Instead, the company will leverage the data to further develop its alternative therapy, IMVT-1402. The Phase III randomized trial (NCT05403541) assessed the impact of weekly or bi-monthly doses of batoclimab on acetylcholine receptor antibody-positive (AChR+) patients, using the Myasthenia Gravis Activities of Daily Living (MG-ADL) score over a 12-week period.
• The total number of diagnosed prevalent cases of myasthenia gravis in the 7MM is around ~300,000 in 2025.
• In the US, the anti-AchR Ab (+ve) category recorded the highest number of gMG cases at 76,500 in 2025. This was followed by anti-MuSK Ab (+ve) group with 4,500 cases, while the double seronegative group (including anti-LRP4-ab, anti-Argin-ab, and others), totaling 9,000 cases.
• According to DelveInsight's estimates, in the US, females accounted for approximately 81,000 cases and males for 54,000 cases of myasthenia gravis in 2025.
• In 2025, myasthenia gravis diagnoses across Spain showed a gender disparity, with 54% of cases occurring in females and 46% in males, highlighting a greater susceptibility among women.
• In 2025, Japan recorded the highest number of diagnosed prevalent myasthenia gravis cases under the MGFA classification in Class II, with 16,000 cases, followed by Class I with 13,000 cases.
• Overall, the launch of first-in-class therapies, improved testing, and rising disease awareness are expected to drive steady growth in the 7MM myasthenia gravis market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.
• Among the 7MM, the US accounted for the largest market size of myasthenia gravis i.e., USD ~ 4.7 billion in 2025.
• In 2036, among all the therapies for myasthenia gravis, the highest revenue is estimated to be generated by efgartigimod alfa and hyaluronidase-qvfc (VYVGART HYTRULO/ VYVDURA), in the 7MM.
• Japan's myasthenia gravis market remains resilient and increasingly competitive, buoyed by the January 2024 approval of VYVDURA (VYVGART HYTRULO). This follows the market entries of RYSTIGGO, ZILBRYSQ, and VYVGART in 2023, which have diversified the therapeutic landscape.
• Key Myasthenia Gravis Companies: Alexion, AstraZeneca, Argenx, Novartis, Alpine Immune Science, Toleranzia, Cabaletta Bio, Rallybio, Alexion Pharmaceuticals, Takeda, Cartesian Therapeutics, RemeGen, Horizon Therapeutics, and others
• Key Myasthenia Gravis Therapies: ULTOMIRIS (ravulizumab), VYVGART (efgartigimod alfa-fcab), Gefurulimab (ALXN-1720), FABHALTA (Iptacopan), Povetacicept, TOL 2, MuSK-CAART, RLYB116, ALXN2050, TAK-079, Descartes-08, Telitacicept, Inebilizumab, and others
• The Myasthenia Gravis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Myasthenia Gravis pipeline products will significantly revolutionize the Myasthenia Gravis market dynamics.

Myasthenia Gravis Overview
Myasthenia gravis is a chronic autoimmune neuromuscular disorder characterized by weakness and rapid fatigue of voluntary muscles. It occurs when the immune system produces antibodies that interfere with communication between nerves and muscles, most commonly targeting acetylcholine receptors at the neuromuscular junction. Symptoms often fluctuate and may include drooping eyelids, double vision, slurred speech, difficulty chewing or swallowing, and weakness in the arms and legs that worsens with activity and improves with rest. Diagnosis typically involves antibody testing, nerve conduction studies, and imaging of the thymus gland. Management focuses on symptom control and may include acetylcholinesterase inhibitors, immunosuppressive therapies, corticosteroids, thymectomy, and, in severe cases, plasmapheresis or intravenous immunoglobulin.

Get a Free sample for the Myasthenia Gravis Market Forecast, Size & Share Analysis Report:
https://www.delveinsight.com/report-store/myasthenia-gravis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Myasthenia Gravis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Myasthenia Gravis Epidemiology Segmentation:
The Myasthenia Gravis market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total Diagnosed Prevalent Cases of Myasthenia Gravis in the 7MM
• Gender-specific Diagnosed Prevalent Cases of Myasthenia Gravis in the 7MM
• Age-specific Diagnosed Prevalent Cases of Myasthenia Gravis in the 7MM
• Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Classification in the 7MM
• Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology in the 7MM

Download the report to understand which factors are driving Myasthenia Gravis epidemiology trends @ Myasthenia Gravis Epidemiology Forecast
https://www.delveinsight.com/sample-request/myasthenia-gravis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Myasthenia Gravis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Myasthenia Gravis market or expected to get launched during the study period. The analysis covers Myasthenia Gravis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Myasthenia Gravis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Myasthenia Gravis Therapies and Key Companies
• ULTOMIRIS (ravulizumab): Alexion: AstraZeneca Rare Disease
• VYVGART (efgartigimod alfa-fcab): Argenx
• Gefurulimab (ALXN-1720): Alexion, AstraZeneca Rare Disease
• FABHALTA (Iptacopan): Novartis
• Tolebrutinib: Sanofi
• Descartes-08: Cartesian Therapeutics
• Mezagitamab (TAK-079): Takeda
• DAS-001: DAS Therapeutics, Inc.
• Rozanolixizumab: UCB Biopharma
• Zilucoplan: UCB Biopharma
• Subcutaneous Efgartigimod: Argenx-Halozyme Therapeutics
• Uplizna (Inebilizumab): Horizon Therapeutics
• Enspryng (Satralizumab): Hoffmann-La Roche
• Nipocalimab: Janssen Research & Development, LLC
• Batoclimab: Immunovant Sciences GmbH

Discover more about therapies set to grab major Myasthenia Gravis market share @ Myasthenia Gravis Treatment Landscape
https://www.delveinsight.com/sample-request/myasthenia-gravis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Myasthenia Gravis Market Strengths
• The growing prevalence of myasthenia gravis (MG) and the geriatric population offers a stable market demand for treatments and therapies.
• Myasthenia gravis treatments may qualify for orphan drug status, offering regulatory incentives, such as extended market exclusivity and tax benefits.

Myasthenia Gravis Market Opportunities
• Potential for developing new, more effective therapies, such as gene therapy or targeted biologics, could address unmet medical needs.
• Improved diagnostic techniques using clear biomarkers and an increase in awareness will likely lead to a diagnosis of more patients, expanding the market.

Scope of the Myasthenia Gravis Market Report
• Study Period: 2022-2036
• Coverage: 7MM Countries
• Key Myasthenia Gravis Companies: Alexion, AstraZeneca, Argenx, Novartis, Alpine Immune Science, Toleranzia, Cabaletta Bio, Rallybio, Alexion Pharmaceuticals, Takeda, Cartesian Therapeutics, RemeGen, Horizon Therapeutics, and others
• Key Myasthenia Gravis Therapies: ULTOMIRIS (ravulizumab), VYVGART (efgartigimod alfa-fcab), Gefurulimab (ALXN-1720), FABHALTA (Iptacopan), Povetacicept, TOL 2, MuSK-CAART, RLYB116, ALXN2050, TAK-079, Descartes-08, Telitacicept, Inebilizumab, and others
• Myasthenia Gravis Therapeutic Assessment: Myasthenia Gravis current marketed and Myasthenia Gravis emerging therapies
• Myasthenia Gravis Market Dynamics: Myasthenia Gravis market drivers and Myasthenia Gravis market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Myasthenia Gravis Unmet Needs, KOL's views, Analyst's views, Myasthenia Gravis Market Access and Reimbursement

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Gaurav Bora
Email: info@delveinsight.com
Contact No.: +14699457679
City: 304 S. Jones Blvd #2432, Las Vegas
State: Nevada (89107)
Country: United States
Website: https://www.delveinsight.com/consulting

About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

This release was published on openPR.