Myasthenia Gravis Market Summary

Myasthenia Gravis Insights and Trends

• According to DelveInsight’s analysis, myasthenia gravis market size was found to be USD 6 billion in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
• Myasthenia Gravis reported approximately 140,000 diagnosed prevalent cases in the US. The rising prevalence of myasthenia gravis is likely driven by advancements in diagnostic techniques, an expanding elderly population, possible environmental influences, hereditary risk factors, and evolving lifestyle patterns.
• Myasthenia gravis management focuses on symptomatic relief and immunosuppression, with pyridostigmine for symptoms, immunosuppressants for control, IVIg/plasma exchange for crises, and thymectomy in select patients.
• The treatment landscape has expanded to include targeted biologics, offering more precise modulation of disease mechanisms. FDA- and EMA-approved agents like nipocalimab-aahu (IMAAVY), rozanolixizumab (RYSTIGGO), zilucoplan (ZILBRYSQ), efgartigimod alfa-fcab (VYVGART) and ravulizumab (ULTOMIRIS) represent a shift toward complement inhibition and FcRn blockade, addressing disease pathology at its source rather than through broad immunosuppression.
• In the US, severity-specific diagnosed prevalent cases of myasthenia gravis, classified according to the MGFA system, indicate that mild generalized disease accounts for the largest share. In 2025, this category represented approximately 43% of all diagnosed myasthenia gravis cases.
• The current myasthenia gravis market is largely led by argenx and UCB, which dominate due to their strong product portfolios and expanding presence in targeted immunotherapy treatments.
• The myasthenia gravis therapeutics market is poised for expansion, driven by novel entrants such as IMVT-1402, Descartes-08, and remibrutinib, each targeting distinct immune pathways including FcRn blockade, CAR-T cell therapy, and BTK inhibition.
• Many myasthenia gravis patients in the chronic phase experience disease fluctuations despite ongoing treatment. Sustained, symptom-free remission remains elusive for a significant subset. Current therapies often require long-term immunosuppression with variable outcomes, highlighting the need for treatments that provide stable, long-lasting control without cumulative toxicity.
• In February 2026, the European Commission approved UPLIZNA (inebilizumab), developed by Amgen, for the treatment of adults with generalized myasthenia gravis, expanding therapeutic options and reinforcing the role of B-cell–targeted therapies in disease management across Europe.

Myasthenia Gravis Market size and forecast

• 2025 Myasthenia Gravis Market Size in the 7MM: USD ~6 billion
• 2036 Projected Myasthenia Gravis Market Size: USD ~16 billion
• Myasthenia Gravis Growth Rate (2026–2036): 9.1% CAGR

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 myasthenia gravis market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

The myasthenia gravis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, myasthenia gravis patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022–2036) across the 7MM regions. The report highlights key unmet medical needs in myasthenia gravis and maps the competitive and clinical landscape to uncover high‑value opportunities, providing a clear outlook on future market growth potential.

Geography Covered

• North America: The United States
• Europe: Germany, France, Italy, Spain and the United Kingdom
• Asia-Pacific: Japan

Myasthenia Gravis Understanding and Treatment Algorithm

Myasthenia Gravis Overview and Diagnosis

Myasthenia gravis is an autoimmune disease in which the immune system attacks the body’s tissues. In myasthenia gravis, the attack interrupts the connection between nerve and muscle—the neuromuscular junction. It is characterized by autoantibodies against the Acetylcholine Receptor Antibody (AChR-Ab) or against a receptor-associated protein called Muscle-specific tyrosine Kinase Antibody (MuSK-Ab).

The clinical diagnosis of myasthenia gravis is confirmed by Electromyography (EMG) studies, pharmacologic testing, and serum Ab assay. Positive results on EMG confirm a postsynaptic defect of the neuromuscular transmission, the clinical response to Cholinesterase Inhibitors (ChE-Is) supports myasthenia gravis diagnosis, and detection of specific Abs confirms myasthenia gravis and identifies ab-related subgroups. EMG confirmation is crucial in patients with neither AChR nor MuSK Abs on the standard assay. The mainstay of treatment in myasthenia gravis involves cholinesterase enzyme inhibitors, Immunosuppressive agents, and biological therapies.

Further details are provided in the report.

Current Myasthenia Gravis Treatment Landscape

Treatment of myasthenia gravis remains largely symptomatic, with acetylcholinesterase inhibitors, corticosteroids, and immunosuppressants providing variable control. The approval of targeted therapies such as efgartigimod alfa (VYVGART) and rozanolixizumab (RYSTIGGO) has reinforced the shift toward mechanism-based immunotherapy, with further opportunities in complement inhibition, FcRn blockade, and cell-based therapies. Heterogeneous treatment pathways and variability in disease severity continue to present challenges, while increasing disease awareness and novel approvals are expected to support market growth through 2036.

Further details related to country-based variations are provided in the report.

Myasthenia Gravis Unmet Needs

The section “unmet needs of myasthenia gravis” outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

• Limited Diagnostic Accuracy of AChR and MuSK Negative Antibodies in Ocular Myasthenia Gravis
• Inadequate Tools for Early Detection of Exacerbations
• Lack of Therapies Ensuring Sustained Remission
• Limited Fast-acting and Tolerable Options for Refractory Myasthenia Gravis
• Lack of Disease-modifying Therapies (DMTs) to Improve Survival

and others…..

Note: Comprehensive unmet needs insights in myasthenia gravis and their strategic implications are provided in the full report.

Myasthenia Gravis Epidemiology

Key Findings from Myasthenia Gravis Epidemiological Analysis and Forecast

• 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.

Myasthenia Gravis Drug Analysis & Competitive Landscape

The myasthenia gravis drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the myasthenia gravis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the myasthenia gravis therapeutics market.

Approved Therapies for Myasthenia Gravis

Rozanolixizumab (RYSTIGGO): UCB

Rozanolixizumab is a subcutaneous (SC) humanized monoclonal IgG4 antibody designed to bind with high affinity to the neonatal Fc receptor (FcRn). By blocking the interaction between FcRn and IgG, it enhances IgG degradation, thereby reducing circulating pathogenic IgG autoantibodies—key contributors to autoimmune diseases such as gMG. The therapy is FDA-approved for adult patients with gMG who are positive for anti-AChR or anti-MuSK antibodies, the two most prevalent gMG subtypes.

In January 2026, KORU Medical Systems received FDA 510(k) clearance for delivering RYSTIGGO (rozanolixizumab-noli) via the FreedomEDGE infusion system, expanding its label. This advancement enhances subcutaneous delivery options, improves treatment convenience, and supports broader adoption of FcRn-targeted therapies in myasthenia gravis management.

Myasthenia Gravis Pipeline Analysis

IMVT-1402: Immunovant/Roivant Sciences

IMVT-1402 is a next-generation, SC administered anti-FcRn mAb developed by Immunovant for the treatment of IgG-mediated autoimmune diseases. It effectively lowers pathogenic IgG while preserving normal albumin and cholesterol levels, mitigating safety issues seen with previous FcRn inhibitors. As per the company’s 2025 report, top-line results from the IMVT-1402 study are anticipated to be reported in 2027, marking a key milestone in the clinical development timeline for this investigational therapy.

Myasthenia Gravis Key Players, Market Leaders and Emerging Companies

• UCB
• Johnson & Johnson
• Amgen
• Argenx
• Novartis
• Merck KGaA and others

Myasthenia Gravis Drug Updates

• In March 2026, UCB reported that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the pre-filled pen version of zilucoplan (ZILBRYSQ), supporting its use in adults with generalized myasthenia gravis across the European Union, pending final regulatory approval from the European Commission.
• In June 2025, RemeGen reported that the EMA granted orphan drug designation (ODD) to its recombinant BLyS/APRIL dual-target fusion protein, Telitacicept, for the treatment of myasthenia gravis, making it the first dual-target biologic for MG to receive ODD from both the FDA and EMA.
• In January 2026, Regeneron Pharmaceuticals stated in its corporate presentation that its ongoing Phase III study remains on track, with topline data expected in Q4 2026 or Q1 2027.

Myasthenia Gravis Market Outlook

The therapeutic market size of myasthenia gravis is mainly accounted for by symptomatic treatments, including ACh inhibitors (mestinon). It is challenging to reach clinical remission on symptomatic therapy alone; therefore, the addition of an immunosuppressive drug is often required. First-line immunotherapy is represented by oral prednisone and prednisolone, which have a rapid effect, especially when given at high doses, since a higher dosage corresponds to a more rapid response, usually within 2–4 weeks. Nonsteroidal Immunosuppressants (NSISTs) are employed as steroid-sparing agents to improve clinical stability, as there is great variability in steroid-monotherapy response.

Key marketed therapies shaping current management

Eculizumab (SOLIRIS): Approved in 2017, was the first to validate this targeted approach by inhibiting C5 and preventing the formation of the Membrane Attack Complex (MAC). Ravulizumab (ULTOMIRIS), approved by the US FDA, EMA, and MHLW in 2022, further refined this strategy with extended dosing intervals, improving patient adherence without compromising efficacy.

Zilucoplan (ZILBRYSQ): As a self-administered, once-daily SC peptide, it offers meaningful benefits in terms of patient autonomy, treatment flexibility, and compatibility with other interventions like IVIg and plasma exchange. Its design as a non-antibody therapeutic also reduces immunogenicity concerns and allows seamless integration into complex treatment regimens. Together, these agents illustrate a trend toward more precise, patient-centric therapies that go beyond symptomatic relief to target disease mechanisms directly.

Nipocalimab-aahu (IMAAVY): Approved by the US FDA in April 2025, is a human FcRn-blocking antibody offering targeted IgG reduction for both adult and pediatric gMG patients (≥12 years) positive for anti-AChR or anti-MuSK antibodies. It demonstrated durable disease control and functional improvement for up to 20 months in clinical studies. With broad applicability and a favorable safety profile, IMAAVY expands the FcRn class to a wider gMG population with sustained efficacy.

And more

Oral corticosteroids were the most commonly prescribed therapy across all cohorts—used in 84.1% of the total JMDC cohort, 83.3% in NHI, and 78.7% in LSEHS—indicating their central role in early immunosuppression. Cholinesterase inhibitors, such as pyridostigmine, were prescribed in approximately 58–61% of patients, reflecting their continued role in symptomatic relief. Calcineurin inhibitors were also moderately used, with the highest rate in the elderly LSEHS cohort (44.2%), suggesting a preference for steroid-sparing strategies in older patients. Use of advanced therapies like eculizumab was absent across all cohorts, indicating limited access or availability during the study period. Acute-phase interventions such as IV methylprednisolone (16.9–20.1%), plasma exchange (5–7.6%), and IVIg (10.2–12.1%) were used selectively in patients with more severe disease presentations.

• 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.

Further details will be provided in the report….

Drug Class/Insights into Leading Emerging and Marketed Therapies in Myasthenia Gravis (2022–2036 Forecast)

The myasthenia gravis market comprises of four primary therapies symptomatic treatment, chronic immunotherapies, rapid but short-acting immunomodulating treatments, surgical treatment (thymectomy).

Anticholinesterase medications: Medications to treat myasthenia gravis include anticholinesterase agents such as mestinon or pyridostigmine, which slow the breakdown of acetylcholine at the neuromuscular junction and improve neuromuscular transmission and increase muscle strength.

Corticosteroids and immunosuppressants: A group of drugs that improve muscle strength by suppressing the production of abnormal antibodies, such as prednisone, azathioprine, mycophenolate mofetil, and tacrolimus. The drugs can cause significant side effects and must be carefully monitored by a physician. Corticosteroid treatment was the first widely used IS therapy introduced in myasthenia gravis.

Biological therapies: These medications are made from a biological source. They modulate immune system activity and can also be referred to as “immunomodulators.” Immunoglobulins, monoclonal antibodies (rituximab, efgartigimod, ravulizumab, zilucoplan, etc.), and stem cells all fall into this category.

Thymectomy: This surgery consists of removing the thymus in order to eradicate the cells that take part in the autoimmune response. Offered to those with anti-AChR autoantibodies, it is essential in cases of thymoma. A NINDS-funded study of 126 people with myasthenia gravis with thymoma and those with no visible thymoma found that the surgery reduced muscle weakness and the need for IS drugs.

Myasthenia Gravis Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026–2036). The analysis covers the myasthenia gravis drug’s uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The treatment patterns for gMG in the United States were examined, addressing a notable gap in existing knowledge. The study followed 7,194 patients for up to 10 years, with 99% of the 6,539 treated patients receiving AChEI and/or CS, predominantly as their first-line treatment, while 33% were prescribed at least one nonsteroid IST and 2% received biologics. Notably, patients starting on the first IST displayed a 42% higher incidence of exacerbations and a 94% higher incidence of IVIg use than those initially on AChEI and/or CS.

IMVT-1402, developed by Immunovant/Roivant Sciences, is a SC administered anti-FcRn mAb developed by Immunovant for the treatment of IgG-mediated autoimmune diseases. It effectively lowers pathogenic IgG while preserving normal albumin and cholesterol levels, mitigating safety issues seen with previous FcRn inhibitors. IMVT-1402 is positioned as Immunovant’s lead asset and is advancing through clinical trials for conditions such as myasthenia gravis and other autoimmune disorders.

Immunovant has strategically opted not to pursue regulatory approval for batoclimab in the indications of myasthenia gravis. Instead, the company aims to capitalize on insights gained from batoclimab clinical studies to guide and expedite the development of its next-generation program, IMVT-140. As per the company’s 2025 report, top-line results from the IMVT-1402 study are anticipated to be reported in 2027, marking a key milestone in the clinical development timeline for this investigational therapy. IMVT-1402 is also well protected by patents that will last until 2043. This gives strong legal coverage and helps secure its long-term commercial potential.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Myasthenia Gravis

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

EU4 and the UK

Reimbursement is a crucial factor that affects the drug’s access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report….

Myasthenia Gravis therapies Price Scenario & Trends

Pricing and analogue assessment of myasthenia gravis therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Pricing of Myasthenia Gravis Approved Drugs

Nipocalimab (IMAAVY), approved for myasthenia gravis, represents a meaningful expansion of Johnson & Johnson’s immunology portfolio. Treatment course cost of IMAAVY was around USD 280,000 in the US in 2025.

RYSTIGGO (rozanolixizumab) is the first therapy approved for both anti-AChR and anti-MuSK antibody-positive gMG, based on positive results from the MycarinG study. It significantly improves symptoms such as breathing, speech, swallowing, and mobility. As a subcutaneous FcRn inhibitor, RYSTIGGO competes directly with intravenous VYVGART, expanding personalized treatment options. Mild side effects like headaches are typically manageable with over-the-counter medications, supporting RYSTIGGO’s viability as a competitive and patient-friendly option in the evolving myasthenia gravis treatment landscape. Treatment course cost of RYSTIGGO was nearly USD 275,000 in the US in 2025.

Industry Experts and Physician Views for Myasthenia Gravis

To keep up with myasthenia gravis market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the myasthenia gravis emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in myasthenia gravis , including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight’s analysts connected with 8+ KOLs to gather insights at country level. Centers such as the University of Santo Tomas, Berlin Institute of Health at Charité , Paris-Est Créteil University, UCL Queen Square Institute of Neurology etc. were contacted.

Their opinion helps understand and validate current and emerging myasthenia gravis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in myasthenia gravis.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of myasthenia gravis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated, whereas the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report

• The report covers a segment of key events, an executive summary, a descriptive overview of myasthenia gravis, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the myasthenia gravis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM myasthenia gravis market.

Report Insights

• Myasthenia Gravis Patient Population Forecast
• Myasthenia Gravis Therapeutics Market Size
• Myasthenia Gravis Pipeline Analysis
• Myasthenia Gravis Market Size and Trends
• Myasthenia Gravis Market Opportunity (Current and Forecasted)

Report Key Strengths

• Epidemiology‑based (Epi‑based) bottom‑up forecasting
• Artificial Intelligence (AI)-enabled market research report
• 11-year forecast
• Myasthenia Gravis Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (by geography)
• Myasthenia Gravis Treatment Addressable Market (TAM)
• Myasthenia Gravis Competitive Landscape
• Myasthenia Gravis Major Companies Insights
• Myasthenia Gravis Price Trends and Analogue Assessment
• Myasthenia Gravis Therapies Drug Adoption/Uptake
• Myasthenia Gravis Therapies Peak Patient Share analysis

Report Assessment

• Myasthenia Gravis Current Treatment Practices
• Myasthenia Gravis Unmet Needs
• Myasthenia Gravis Clinical Development Analysis
• Myasthenia Gravis Emerging Drugs Product Profiles
• Myasthenia Gravis Market Attractiveness
• Myasthenia Gravis Qualitative Analysis (SWOT and conjoint analysis)

FAQs

Market Insights

• What was the myasthenia gravis market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of myasthenia gravis?
• What are the disease risks, burdens, and unmet needs of myasthenia gravis? What will be the growth opportunities across the 7MM concerning the patient population with myasthenia gravis?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of myasthenia gravis? What are the current guidelines for treating myasthenia gravis in the US, Europe, and Japan?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the myasthenia gravis market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs’ perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.