Myasthenia Gravis - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The Myasthenia Gravis market is projected to witness consistent growth throughout the forecast period (2024-2034). The market size of Myasthenia gravis in the 7MM is expected to increase, driven by the launch of emerging therapies.
• The analyst's analyst projects that among the total diagnosed prevalent cases of myasthenia gravis in 7MM approximately 45% of cases were from the US. As per our estimations, in 2023, the EU4 and the UK accounted for nearly 125 thousand diagnosed prevalent cases of myasthenia gravis.
• In the 7MM, the market mainly consisted of refractory treatment, which generated nearly USD 4.95 billion in 2023.
• The total market size of the Myasthenia gravis treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely, Nipocalimab, Batoclimab, Descartes-08, and others.

This report delivers an in-depth understanding of the myasthenia gravis, historical and forecasted epidemiology and the Myasthenia Gravis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The myasthenia gravis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Myasthenia Gravis market size from 2020 to 2034. The report also covers current Myasthenia Gravis treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Myasthenia Gravis Overview

According to the Muscular Dystrophy Association, myasthenia gravis is an autoimmune disease when the immune system attacks the body’s tissues. In myasthenia gravis, that attack interrupts the connection between nerve and muscle - the neuromuscular junction.

The most common target of pathogenic autoantibodies in myasthenia gravis is the nicotinic acetylcholine receptor (AChR), followed by a muscle-specific kinase (MuSK) and lipoprotein receptor-related protein 4 (LRP4). Myasthenia gravis presents with painless, fluctuating, fatigable weakness involving specific muscle groups. The most typical initial presentation includes ocular weakness with asymmetric ptosis and binocular diplopia, while the less common presentation includes early or isolated oropharyngeal or limb weakness.

Myasthenia Gravis Diagnosis

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 NMT, 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.

Myasthenia Gravis Treatment

Currently, there is no known cure. Available treatments can control symptoms and often allow you to have a relatively high quality of life.

The primary approach for managing myasthenia gravis typically includes the use of cholinesterase enzyme inhibitors, immunosuppressive medications, and biological therapies. In cases where symptoms do not respond well to these standard treatments or when there is a need for quick symptom relief, options such as plasmapheresis or intravenous immunoglobulins may be employed. These interventions are particularly useful during myasthenic crises.

Several emerging treatments for myasthenia gravis are currently in the process of development. These encompass Fc receptor antagonists, Anti C5, Interleukin-6 receptor antagonists, T lymphocyte replacements, and other options.

Myasthenia Gravis Epidemiology

As the market is derived using the patient-based model, the Myasthenia Gravis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Myasthenia Gravis, Gender-specific Diagnosed Prevalent cases of Myasthenia Gravis, Age-specific Diagnosed Prevalent cases of Myasthenia Gravis, Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA classification, Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034. As per the analyst's estimations, the total diagnosed prevalent cases of Myasthenia Gravis in the 7MM were approximately 287 thousand cases in 2023 and are projected to increase during the forecast period.

• The overall count of individuals diagnosed with myasthenia gravis in the United States was approximately 129 thousand in 2023, and it is expected to increase at an estimated CAGR throughout the study period (2020-2034).
• Among the 7MM, EU4 and the UK accounted for nearly 125 thousand diagnosed prevalent cases of myasthenia gravis, and these cases are expected to increase during the forecast period (2023-2034).
• Among EU4 and the UK, Germany had the highest diagnosed prevalent population of myasthenia gravis, with 39 thousand cases, followed by the UK and France in 2023. On the other hand, Spain had the lowest diagnosed prevalent population in EU4 and the UK in 2023.
• In Japan, there were around 32 thousand diagnosed prevalent cases of myasthenia gravis in 2023. These cases are expected to increase at a significant CAGR.
• Gender-specific diagnosed prevalent cases of myasthenia gravis showed that females were more affected by myasthenia gravis than males in the 7MM in 2023.
• The highest proportion of myasthenia gravis cases was estimated in the 65 years and above age group in the 7MM, while the least cases were in the age group 0-17 years.
• Based on MGFA classification, diagnosed prevalent cases of myasthenia gravis were categorized into five classes: Class I (ocular), Class II (mild generalized), Class III (moderate generalized), Class IV (severe generalized), and Class V (intubated). A higher number of cases were estimated in Class II, with 56 thousand cases in 2023 in the US.
• The antibody serology-specific cases of generalized myasthenia gravis were divided into anti-AchR Ab (+ve), anti-MuSK Ab (+ve), and double seronegative (anti-LRP4-ab and anti-Argin-ab) and others. In 2023, there were more cases estimated in the AchR Ab (+ve) category, with nearly 73 thousand cases reported in the United States.

Myasthenia Gravis Drug Chapters

The drug chapter segment of the Myasthenia gravis report encloses a detailed analysis of myasthenia gravis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands myasthenia gravis clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

SOLIRIS (eculizumab): Alexion, AstraZeneca Rare Disease

SOLIRIS is a first-in-class complement inhibitor that works by inhibiting the terminal part of the complement cascade, a part of the immune system that, when activated in an uncontrolled manner, plays a role in ultrarare severe disorders like anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis. The drug is designed to have an IV infusion route of administration.

VYVGART (efgartigimod alfa-fcab): Argenx

VYVGART (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody-positive and in Japan for the treatment of adults with gMG who do not have a sufficient response to steroids or nonsteroidal immunosuppressive therapies (ISTs). VYVGART has IV infusion route of administration.

Emerging Drugs

Nipocalimab: Janssen Research & Development, LLC

Nipocalimab (M281) is a high affinity, fully human, aglycosylated, effectors IgG1 anti-FcRn monoclonal antibody. In patients with gMG, nipocalimab is expected to improve nerve-to-muscle signals and muscle function, thus alleviating the clinical signs and symptoms of gMG. The drug is currently being evaluated in a Phase III trial to assess the safety and efficacy of nipocalimab in patients with myasthenia gravis at multiple locations around the globe.

Batoclimab: Immunovant Sciences GmbH

Batoclimab is a novel, fully humanized mAB that inhibits neonatal Fc receptors by blocking FcRn-IgG interactions and accelerating the degradation of autoantibodies. The drug is currently being evaluated in a Phase III trial to assess the efficacy and safety of batoclimab as induction and maintenance therapy in adult participants with gMG.

DESCARTES-08: Cartesian Therapeutics

DESCARTES-08 is the first RNA CAR T-cell (rCAR-T) therapy for autoimmune diseases. DESCARTES-08 contains killer T-cells engineered to hunt down pathogenic plasma cells that secrete autoantibodies. Descartes-08 is a T-cell therapy custom-made from a patient’s blood. Cartesian Therapeutics is enrolling patients with gMG in a Phase IIb randomized controlled trial (RCT).

Myasthenia Gravis Market Outlook

Myasthenia gravis has a diverse treatment classification associated with the disease landscape. The management of myasthenia gravis primarily revolves around the utilization of cholinesterase enzyme inhibitors, immunosuppressive agents, biological therapies, and thymectomy as needed.

Refractory treatment options (VYVGART [efgartigimod alfa-fcab]; SOLIRIS; ULTOMIRIS [Ravulizumab (genetical recombination)], Plasma exchange/IVIG, and other therapies) are major revenue generators in the current treatment landscape.

The market for myasthenia gravis is expected to experience positive growth with the approval of potential drugs like Nipocalimab, Batoclimab, Descartes-08, and others.

• The Myasthenia Gravis market’s total size in the 7MM reached approximately USD 4.95 billion in 2023. Projections indicate a substantial growth during the forecast period.
• Out of the 7MM, the United States dominated the market in 2023, representing the largest share at nearly 76%.
• In 2023, EU4 and the UK captured an estimated USD 893 million, which is anticipated to increase at a substantial CAGR. Among the European countries, Germany covered the largest market share in 2023, followed by the UK, France, and Italy. Spain accounted for the least market in the same year.
• Japan alone represented approximately 6% of the total myasthenia gravis market in 2023, projected to increase at a substantial CAGR during the study period.
• The total market size of the myasthenia gravis treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments.

Myasthenia Gravis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Nipocalimab in the US is expected to be launched by 2025.

Myasthenia Gravis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Myasthenia Gravis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on myasthenia gravis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of California, UCSF Medical Center, San Francisco; Department of Neurology, University of Virginia, Charlottesville, Virginia, USA; Department of Neurology, Kamillus-Hospital, Asbach, Germany; Dipartimento di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Neurology, National Hospital Organization, Nagasaki Kawatana Medical Center, Nagasaki, Japan, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or myasthenia gravis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, 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. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and 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.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

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.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Myasthenia Gravis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact 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 the 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 shape and drive the 7MM Myasthenia Gravis market.

Myasthenia Gravis Report Insights

• Patient Population
• Therapeutic Approaches
• Myasthenia Gravis Pipeline Analysis
• Myasthenia Gravis Market Size and Trends
• Existing and Future Market Opportunity

Myasthenia Gravis Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Myasthenia Gravis Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Myasthenia Gravis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the Myasthenia Gravis total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Myasthenia Gravis?
• What are the patents of emerging therapies for myasthenia gravis?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• 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 of Myasthenia Gravis?
• What is the historical and forecasted Myasthenia Gravis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which country is more prevalent for Myasthenia Gravis and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Myasthenia Gravis? What are the current guidelines for treating Myasthenia Gravis in the US and Europe?
• How many companies are developing therapies for treating Myasthenia Gravis?
• How many emerging therapies are in the mid-stage and late stage of development for treating Myasthenia Gravis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Myasthenia Gravis?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Myasthenia Gravis?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Myasthenia Gravis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around 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.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Myasthenia Gravis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2023 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the myasthenia gravis market?

The myasthenia gravis market is quite robust. The major players are Janssen Research & Development, LLC; Immunovant Sciences GmbH; Cartesian Therapeutics, and others which are currently developing drugs for the treatment of myasthenia gravis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the myasthenia gravis market?

The increase in diagnosed prevalent cases of myasthenia gravis and the launch of emerging therapies are attributed to be the key drivers for increasing myasthenia gravis market.

5. What is the expected impact of emerging therapies or advancements in myasthenia gravis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the myasthenia gravis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Myasthenia Gravis market.