Generalized Myasthenia Gravis (gMG) - Market Insight, Epidemiology And Market Forecast - 2032

This ‘Generalized Myasthenia Gravis (gMG) - Market Insights, Epidemiology, and Market Forecast - 2032' report deliver an in-depth understanding of the Generalized Myasthenia Gravis (gMG), historical and forecasted epidemiology as well as the market trends in the United States, EU-5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Generalized Myasthenia Gravis (gMG) market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted Generalized Myasthenia Gravis (gMG) symptoms market size from 2019 to 2032 segmented by the seven major markets. The report also covers current Generalized Myasthenia Gravis (gMG) symptoms, diagnostic and treatment practice guidelines/algorithm and unmet medical needs to curate the best opportunities. It assesses the underlying potential of the market.

Geography Covered

• The United States
• EU-5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Generalized Myasthenia Gravis (gMG) Disease Background and Treatment Algorithm

Generalized Myasthenia Gravis (gMG) Overview

Myasthenia gravis (MG) is an autoimmune disease that occurs when the immune system attacks the body's own tissues. In MG, that attack interrupts the connection between nerve and muscle - the neuromuscular junction. MG is characterized mostly by autoantibodies against the acetylcholine receptor (AChR-Ab) or against a receptor-associated protein called muscle-specific tyrosine kinase (MuSK-Ab).

Generalized Myasthenia Gravis (gMG) Diagnosis and Treatment

This section covers the details of conventional and current medical therapies and diagnosis available in the Generalized Myasthenia Gravis (gMG) market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

This Generalized Myasthenia Gravis (gMG) market report thoroughly understands Generalized Myasthenia Gravis (gMG) symptoms by including disease definition, symptoms, causes, physiology, and diagnosis. It also provides Generalized Myasthenia Gravis (gMG) treatment algorithms and treatment guidelines for Generalized Myasthenia Gravis (gMG) symptoms in the US, Europe, and Japan.

At present, the therapeutic market size of Myasthenia Gravis is mainly accounted by symptomatic treatments, including acetylcholinesterase inhibitors (Pyridostigmine), short-term immunosuppressants (corticosteroids), long-term immunosuppressant (azathioprine, cyclosporine, cyclophosphamide, methotrexate, mycophenolate mofetil, rituximab, tacrolimus), rapid-acting short- term immunomodulators (intravenous immunoglobulin, plasma exchange), and long-term immunomodulatory procedures (thymectomy).

Few major unmet needs in the market include therapeutic and diagnostic challenges, economic and humanistic burden, role of thymus and thymectomy warrants further research, and incidence of meningococcal infection in people treated with Soliris (eculizumab).

Generalized Myasthenia Gravis (gMG) Epidemiology

The Generalized Myasthenia Gravis (gMG) symptoms epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends and assumptions.

Key Findings

The total diagnosed prevalent cases of Generalized Myasthenia Gravis (gMG) patients in the 7MM are increasing during the study period, i.e., 2019-2032.

The disease epidemiology covered in the report provides historical as well as forecasted Generalized Myasthenia Gravis (gMG) epidemiology segmented as the total diagnosed prevalent cases of Generalized Myasthenia Gravis (gMG), gender-specific cases of Generalized Myasthenia Gravis (gMG), and antibodies-specific cases of Generalized Myasthenia Gravis (gMG). The report includes the diagnosed prevalent cases scenario of Generalized Myasthenia Gravis (gMG) in the 7MM covering the United States, EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country-wise Generalized Myasthenia Gravis (gMG) Epidemiology

The epidemiology segment also provides the Generalized Myasthenia Gravis (gMG) epidemiology data and findings across the United States, EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The total number of diagnosed prevalent cases of Generalized Myasthenia Gravis (gMG) associated in the 7MM countries was approximately 116,100 in 2021.

Generalized Myasthenia Gravis (gMG) Drug Chapters

The Generalized Myasthenia Gravis (gMG) report's drug chapter segment encloses the detailed analysis of Generalized Myasthenia Gravis (gMG) early-stage (Phase I, II, and III) pipeline drugs. It also helps understand the Generalized Myasthenia Gravis (gMG) 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.

Generalized Myasthenia Gravis (gMG) Emerging Drugs

Rozanolixizumab: UCB Biopharma

Rozanolixizumab is a subcutaneously administered, humanized monoclonal antibody that specifically binds, with high affinity, to the human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and Immunoglobulin G (IgG), accelerating antibodies' catabolism and reducing pathogenic IgG autoantibodies' concentration. Rozanolixizumab is under clinical development to improve the lives of people with pathogenic IgG-autoantibody-driven autoimmune diseases, including gMG, primary immune thrombocytopenia (ITP), myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) and autoimmune encephalitis (AIE) by driving removal of pathogenic IgG autoantibodies.

The drug is currently being evaluated in Phase III of its clinical trials for the treatment of generalized myasthenia gravis.

Subcutaneous Efgartigimod: Argenx-Halozyme Therapeutics

Subcutaeous Efgartigimod is a novel formulation of the drug VYVGART (efgartigimod alfa-fcab). VYVGART is the first and only approved FcRn blocker. It is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies Subcutaneous Efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20). Halozyme's ENHANZE drug delivery technology allows for subcutaneous delivery of biologics that are typically administered via infusion. This new formulation aims to provide subcutaneous administration options for patients based on individual preferences. SC Efgratigimod completed its Phase III clinical trials and positive results of pivotal studies were released in March 2022.

Other Products detailed in the report…

Generalized Myasthenia Gravis (gMG) Market Outlook

The report's Generalized Myasthenia Gravis (gMG) market outlook helps to better understand the historic, current, and forecasted Generalized Myasthenia Gravis (gMG) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Generalized Myasthenia Gravis (gMG) market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to view the market at first sight.

According to the publisher, the Generalized Myasthenia Gravis (gMG) market in the 7MM is expected to grow steadily during the study period 2019-2032.

The mainstay of treatment in MG involves cholinesterase enzyme inhibitors and immunosuppressive agents. Symptoms resistant to primary treatment modalities or those requiring rapid resolution of symptoms (myasthenic crisis), plasmapheresis, or intravenous immunoglobulins can be used.

The major market players in Generalized Myasthenia Gravis (gMG) therapeutic market are UCB Biopharma, Argenx-Halozyme Therapeutics, Horizon Therapeutics, among others.

Key Findings

This section includes a glimpse of the Generalized Myasthenia Gravis (gMG) market in 7MM. Generalized Myasthenia Gravis (gMG) market size in the seven major markets was USD 2,690 million in 2021.

The United States Market Outlook

This section provides the total Generalized Myasthenia Gravis (gMG) market size and market size by therapies in the United States.

The United States accounts for the largest market size of Generalized Myasthenia Gravis (gMG) compared to the EU-5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

EU-5 Countries: Market Outlook

The total Generalized Myasthenia Gravis (gMG) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Generalized Myasthenia Gravis (gMG) market size and market size by therapies in Japan are also mentioned.

Generalized Myasthenia Gravis (gMG) Drugs Uptake

This section focuses on the uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2019-2032. The analysis covers the Generalized Myasthenia Gravis (gMG) market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps understand the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and the comparison of the drugs based on market share and size, which will again be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Generalized Myasthenia Gravis (gMG) Pipeline Development Activities

The report provides insights into the therapeutic candidate in Phase I, II, and III stages. It also analyses Generalized Myasthenia Gravis (gMG) key players involved in developing targeted therapeutics.

Major market players includes UCB Biopharma, Argenx-Halozyme Therapeutics, Horizon Therapeutics, among others.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Generalized Myasthenia Gravis (gMG) emerging therapies.

In April 2020, UCB Biopharma announced that the European Commission had granted Orphan Drug Designation to Rozanolixizumab to treat myasthenia gravis.

Reimbursement Scenario in Generalized Myasthenia Gravis (gMG)

Proactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with better market access can be a critical business and price strategy.

Medical treatment is based on cholinesterase inhibitors, corticosteroids, and immunosuppressants. Long-term maintenance therapy poses some caveats. Many patients need high doses of prednisone to do well, but the potential side effects of corticosteroids make the clinicians substitute prednisone for immunosuppressive drugs, including azathioprine, cyclosporine, tacrolimus, mycophenolate, and Rituximab. Plasma exchange/Plasmapheresis (PE/PP) is also effective against anti-AChR antibody-negative MG.

The My VYVGART Path by Argnex offers multiple resources to patients, including insurance and reimbursement support. Similarly, Alexion OneSource CoPay Program helps patients have commercial or private insurance and unapproved prescription coverage. The program pays for eligible out-of-pocket medication and infusion costs associated with Soliris (eculizumab) up to USD 15,000 US dollars per calendar year.

In an economic evaluation, the mean per-patient annual direct medical cost of illness was estimated at between USD 760 in Japan and USD 28,780 in the US, and the cost per hospitalization between USD 2,550 and USD 164,730. The indirect cost of illness was estimated at USD 80 and USD 3,550.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the Generalized Myasthenia Gravis (gMG) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Generalized Myasthenia Gravis (gMG) market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs a Competitive and Market Intelligence analysis of the Generalized Myasthenia Gravis (gMG) Market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Generalized Myasthenia Gravis (gMG), explaining its causes, signs and symptoms, physiology, and currently available therapies.
• Comprehensive insight has been provided into the Generalized Myasthenia Gravis (gMG) epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for Generalized Myasthenia Gravis (gMG) is provided, along with the assessment of new therapies, which will impact the current treatment landscape.
• A detailed review of the Generalized Myasthenia Gravis (gMG) market, historical and forecasted, is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Generalized Myasthenia Gravis (gMG) market.

Report Highlights

• In the coming years, the Generalized Myasthenia Gravis (gMG) market is set to change due to the rising awareness of the disease, development of diagnostic techniques, and the favorable environment from regulators, for innovative first-in-class curative drugs, are likely to expand the market's size and enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Generalized Myasthenia Gravis (gMG) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Generalized Myasthenia Gravis (gMG). The launch of emerging therapies will significantly impact the Generalized Myasthenia Gravis (gMG) market.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase I, II, and III), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, and launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Generalized Myasthenia Gravis (gMG) Report Insights

• Patient Population
• Therapeutic Approaches
• Generalized Myasthenia Gravis (gMG) Pipeline Analysis
• Generalized Myasthenia Gravis (gMG) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Generalized Myasthenia Gravis (gMG) Report Key Strengths

• 11-Year Forecast
• 7MM Coverage
• Generalized Myasthenia Gravis (gMG) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Generalized Myasthenia Gravis (gMG) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions Answered

Market Insights:

• What was the Generalized Myasthenia Gravis (gMG) Market share (%) distribution in 2019, and how would it look in 2032?
• What would be the Generalized Myasthenia Gravis (gMG) total market size and market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings of the market across the 7MM, and which country will have the largest Generalized Myasthenia Gravis (gMG) market size during the forecast period (2019-2032)?
• At what CAGR, the Generalized Myasthenia Gravis (gMG) market is expected to grow in the 7MM during the forecast period (2019-2032)?
• What would be the Generalized Myasthenia Gravis (gMG) market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the Generalized Myasthenia Gravis (gMG) market growth till 2032, and what will be the resultant market Size in the year 2032?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Generalized Myasthenia Gravis (gMG)?
• What is the historical Generalized Myasthenia Gravis (gMG) patient pool in the seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Generalized Myasthenia Gravis (gMG) in the seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What will be the growth opportunities in the 7MM concerning the patient population about Generalized Myasthenia Gravis (gMG)?
• Out of all the 7MM countries, which country would have the largest prevalent population of Generalized Myasthenia Gravis (gMG) during the forecast period (2019-2032)?
• At what CAGR is the population expected to grow in the 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Generalized Myasthenia Gravis (gMG) along with the approved therapy?
• What are the current treatment guidelines for treating Generalized Myasthenia Gravis (gMG) in the US, Europe, and Japan?
• What are the Generalized Myasthenia Gravis (gMG) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Generalized Myasthenia Gravis (gMG)?
• How many therapies are developed by each company for the treatment of Generalized Myasthenia Gravis (gMG)?
• How many emerging therapies are in the mid-stage and late stages of development to treat Generalized Myasthenia Gravis (gMG)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to Generalized Myasthenia Gravis (gMG) therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Generalized Myasthenia Gravis (gMG) and their status?
• What key designations have been granted for the emerging therapies for Generalized Myasthenia Gravis (gMG)?
• What are the global historical and forecasted markets of Generalized Myasthenia Gravis (gMG)?

Reasons to Buy

• The report will help develop business strategies by understanding trends shaping and driving the Generalized Myasthenia Gravis (gMG) market.
• To understand the future market competition in the Generalized Myasthenia Gravis (gMG) market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Generalized Myasthenia Gravis (gMG) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Generalized Myasthenia Gravis (gMG) market.
• To understand the future market competition in the Generalized Myasthenia Gravis (gMG) market.