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Global Generalized Myasthenia Gravis Market $7.5 Billion by 2031

The global market for generalized myasthenia gravis drugs projected to reach $7.5 billion by 2031, expanding at a double-digit CAGR of 16.5% over the forecast period, driven by recently approved drugs coupled with high costs, and rapidly evolving new treatment landscape on the horizon for patients with moderate to severe disease.

Global Generalized Myasthenia Gravis Market

According to the Myasthenia Gravis Association (MGA), the generalized myasthenia gravis (gMG) is an autoimmune disorder that affects the neuromuscular junction, leading to muscle weakness and fatigue.

  • MG is caused by antibodies against the acetylcholine receptor (AChR), the muscle-specific kinase (MuSK) or other AChR-related proteins that are expressed in the postsynaptic muscle membrane. Myasthenia gravis, similar to other autoimmune disorders, occurs in genetically susceptible individuals and has no specific cure.

The standard therapeutic approach for gMG has relied on acetylcholinesterase (AChE) inhibitors, corticosteroids and immunosuppressants, which have shown good efficacy in improving MG-related symptoms in most people with the disease; however, these therapies can carry a considerable burden of long-term adverse effects. The mainstays of treatment are acetylcholinesterase inhibitors, and immunosuppressive and immunomodulatory therapies.

  • The emergence of molecular therapies for gMG, including monoclonal antibodies, B cell-depleting agents and chimeric antigen receptor T cell-based therapies, has the potential to revolutionize the MG treatment landscape.
    • New strategies have been proposed for the treatment of MG and include complement blockade (i.e., eculizumab, ravulizumab, and zilucoplan) and neonatal Fc receptor antagonism (i.e., efgartigimod and rozanolixizumab).
      • The long-term efficacy, safety, and tolerability of these treatments have yet to be determined but use of these newer therapeutics and traditional treatments might not need to be mutually exclusive.

The global market for generalized myasthenia gravis treatment research report provides market size ($million 2021 to 2031), market share analysis, growth trends and forecast (CAGR%, 2024 to 2031).

The global market for generalized myasthenia gravis market segmented by drug class (product/brand) – [acetylcholinesterase inhibitors [Soliris (eculizumab), Ultomiris (ravulizumab), Zilbrysq (zilucoplan)], neonatal Fc receptor inhibitors [Vyvgart (efgartigimod alfa), Rystiggo (rozanolixizumab)], others], pipeline analysis, and geography. The others category includes B-cell depleting monoclonal antibody, interleukin-6 inhibitors, and others.

Since 2017, the U.S. FDA-approval of five new drugs that either act by blocking the complement system (i.e., eculizumab, ravulizumab, and zilucoplan) or by blocking the neonatal Fc receptor thus preventing immunoglobulin recycling and reducing imunoglobulin G (IgG) antibodies (i.e., efgartigimod, and rozanolixizumab). Other drugs, with similar mechanism of action, are currently either under clinical trials or being reviewed for approval.

  • It is anticipated that, a combined approach, targeting different pathomechanisms of the disease simultaneously, will lead to improved outcomes. Complement inhibitors, especially eculizumab, have been used increasingly in the clinical management of patients with refractory AChR+gMG since its approval; efgartigimod alfa is getting lots of attention for its new mechanism and safety profile.
  • Among the drug classes, the acetylcholinesterase (AChE) inhibitors class is the most prescribed first line treatment for gMG, which is projected to have high volume but flat sales during the forecast period. Peripherally acting AChE inhibitors are used as symptomatic treatments for temporarily alleviating muscle weakness in gMG patients.
    • For example, Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections.
  • However, the current market leader expected to lose its position to a drug which acts by inhibiting the FcRn inhibitors and offers better efficacy without any boxed warning.
    • By the end of forecast period, the neonatal Fc receptor (FcRN) inhibitors segment estimated to expand at the fastest double-digit CAGR by the end of forecast period, leading to the largest share of the generalized myasthenia gravis treatment market.
      • In 2021, the U.S. FDA-approved neonatal Fc receptor blocker, Vyvgart (efgartigimod alfa) for the treatment of generalized myasthenia gravis in adult patients who have a specific antibody receptor.
  • The landscape of gMG treatment is set to change significantly, with new drugs targeting intricate nuances of the body’s immune response. For example, therapies that inhibit FcRn aim to reduce the pathogenic autoantibodies that contribute to gMG, potentially offering a more direct and refined approach to mitigating disease symptoms.

The global market for generalized myasthenia gravis drugs research report is further segmented by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World.

  • In terms of geographical distribution, the North America and Europe regions dominated the global market for gMG treatment, owing to rapid approval, availability of newer treatments, and premium-priced drugs in the developed countries.
    • The dynamics of the gMG market are expected to undergo significant changes in the forthcoming years due to advancement in diagnostic methods, increased disease awareness, growing global healthcare expenditure, a growing geriatric population and the anticipated introduction of emerging healthcare therapies.
  • According to Myasthenia Gravis Foundation of America, Inc. (MGFA), myasthenia gravis has a prevalence of 14 to 20 per 100,000 population, with approximately 36,000 to 60,000 cases in the United States. It exhibits a female predominance in those less than 40 years of age and a male predominance in those greater than 50 years of age.
    • European studies reported prevalence rates between 11 and 36 per 100,000 persons.
    • Childhood MG is quite uncommon in the western populations but is prevalent in Asian countries, with the involvement of around 50% of patients aged less than 15 years, and usually present with symptoms of extraocular muscle weakness.

In addition, the global market for generalized myasthenia gravis report provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis, and market profitability analysis by key products and regions or countries. The report also tracks the major competitors operating in the global market by company overview, financial snapshot, major products, technologies, services offered and recent developments.

Major competitors operating in the global generalized myasthenia gravis drugs market and profiled in this report include AstraZeneca plc (Alexion Pharmaceuticals, Inc.), Argenx SE, and UCB (Union Chimique Belge).

  • Drug Class (Product/Brand)
    • Acetylcholinesterase (AChE) Inhibitors
      • Soliris (Eculizumab)
      • Ultomiris (Ravulizumab)
      • Zilbrysq (Zilucoplan)
    • Neonatal Fc Receptor (FcRn) Inhibitors
      • Vyvgart (Efgartigimod Alfa)
      • Rystiggo (Rozanolixizumab)
    • Others
  • Pipeline Analysis
  • Geography
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC)
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • AstraZeneca plc (Alexion Pharmaceuticals, Inc.)
    • Argenx SE
    • UCB (Union Chimique Belge)

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