The myasthenia gravis market across the seven major markets is poised for substantial growth, with projections indicating an increase from $6.1 billion in 2024 to $10.3 billion by 2034, according to GlobalData's recently published market analysis. This represents a compound annual growth rate of 5.3%, driven primarily by an increase in diagnosed prevalent cases and the anticipated introduction of seven promising late-stage pipeline products.
Pipeline Therapies Driving Market Expansion
The seven late-stage pipeline products expected to transform the treatment landscape include CRD-1, Descartes-08, Imaavy, gefurulimab (nipocalimab), inebilizumab, pozelimab + cemdisiran combination therapy, and telitacicept. GlobalData forecasts that these pipeline products could drive combined sales of approximately $2.96 billion by 2034 across the seven major markets.
Among these candidates, the combination therapy of Regeneron Pharmaceuticals' pozelimab and Alnylam Pharmaceuticals' cemdisiran stands out as the most promising. This therapy is indicated for the treatment of AChR antibody-positive generalized and seronegative/LRP4 antibody-positive generalized myasthenia gravis, positioning it to address a critical gap in treatment options for seronegative patients.
Current Treatment Paradigm and Unmet Needs
Myasthenia gravis treatment regimens are currently determined through classification of a patient's clinical status and autoantibody status. Patients are categorized into ocular MG, where symptoms are limited to eye muscles, and generalized MG, involving broader muscle groups. Additionally, patients are grouped by the presence or absence of anti-AChR, anti-MuSK, or anti-LRP4 autoantibodies, with a seronegative population showing no detectable antibodies.
Four main treatment categories are currently employed: corticosteroids, immunosuppressants, acetylcholinesterase inhibitors, and monoclonal antibodies. Most patients initially receive either corticosteroids such as prednisone or acetylcholinesterase inhibitors like pyridostigmine. For refractory cases, disease-modifying therapies including monoclonal antibodies are utilized.
Six disease-modifying therapies are currently approved for myasthenia gravis treatment, including three complement 5 inhibitors and three FcRn receptor inhibitors. However, these agents face limitations in accessibility due to their high cost and specificity to certain antibody statuses. For instance, AChR-positive patients typically receive FcRn inhibitors such as Argenx SE's Vyvgart (efgartigimod alfa) or complement 5 inhibitors like Alexion Pharmaceuticals' Soliris (eculizumab), but both classes show limited efficacy in MuSK patients.
Addressing Treatment Gaps
A significant shift in the treatment paradigm is anticipated, as six of the seven late-stage pipeline agents are expected to be effective across patients with multiple antibody statuses. This represents a move toward more broadly applicable targeted therapies, addressing current limitations in treatment specificity.
The seronegative myasthenia gravis population represents a particularly significant unmet need, with limited effective treatment options currently available. The pozelimab + cemdisiran combination therapy is specifically anticipated to serve this patient segment and is expected to gain substantial market share due to its unique positioning.
Market Challenges and Competitive Dynamics
Despite the positive growth outlook, the myasthenia gravis market faces several challenges. Generic erosion and the entry of biosimilars are expected to be important barriers to growth, particularly in the US market. Disease-modifying therapies facing patent expiries include Argenx SE's Vyvgart products, Alexion Pharmaceuticals' Soliris and Ultomiris, and UCB Pharma's Zilbrysq. These high-grossing therapies generated an estimated combined $5 billion in sales across the seven major markets in 2024.
The treatment landscape for disease-modifying therapies is expected to become highly competitive as new products enter the market. However, the introduction of late-stage pipeline products, coupled with the increase in diagnosed prevalent cases, is anticipated to serve as the main driver of growth across the seven major markets through 2034.
Recent Regulatory Developments
The market has seen several significant regulatory milestones recently. In March 2025, the FDA approved an expanded indication for Alexion/AstraZeneca's eculizumab (Soliris) for pediatric patients aged six years and older with generalized myasthenia gravis who are anti-AChR antibody positive, making it the first treatment available for pediatric patients with this condition.
In January 2025, Cartesian Therapeutics secured FDA agreement under the Special Protocol Assessment process for its phase 3 AURORA trial of Descartes-08, an mRNA cell therapy candidate for myasthenia gravis. Additionally, UCB's ZILBRYSQ (zilucoplan) received FDA approval in October 2023 for treating generalized myasthenia gravis in adults who are anti-AChR antibody-positive.
The myasthenia gravis market's evolution reflects both the challenges and opportunities in treating this complex autoimmune disorder, with emerging therapies offering hope for improved outcomes across diverse patient populations while market dynamics continue to shift with competitive pressures and regulatory developments.
