High rates of biologic naivety, limited switching, and ongoing unmet needs across the gMG landscape create opportunity for brand differentiation.
EXTON, Pa, May 15, 2025 — The treatment landscape for generalized myasthenia gravis (gMG) has entered a new era of therapeutic innovation. Since 2022, seven novel targeted biologics have launched, with a robust pipeline poised to continue this momentum. However, findings from Spherix Global Insights’ latest Patient Chart Dynamix™: Generalized Myasthenia Gravis (US) reveal that the biologic market remains far from saturated. Adoption barriers on both the provider and patient sides create meaningful opportunities for current and emerging brands to expand their reach.
In a survey of 147 biologic-prescribing neurologists, approximately half of gMG patients remain biologic-naïve. Notably, one-third are deemed clinically eligible for a targeted biologic but have not yet started treatment. This gap highlights the complex interplay of prescribing behaviors, patient hesitations, and the need for tailored manufacturer strategies to capture market share. The gMG biologic market continues to shift as recent and anticipated approvals reshape the field. In March 2025, Amgen launched Bkemv, the first Soliris biosimilar, followed by Teva’s Epysqli just one month later. Shortly thereafter, argenx received FDA approval for a pre-filled syringe formulation of Vyvgart Hytrulo, enhancing patient convenience. Meanwhile, Johnson & Johnson’s Imaavy, an FcRn inhibitor, gained FDA approval in late April, while Amgen’s Uplizna is also expected to join the market soon.
Pipeline innovation in the gMG landscape remains robust, with several candidates introducing novel mechanisms of action and more convenient delivery methods. Notable developments include Alexion/AstraZeneca’s gefurulimab, a subcutaneous C5 inhibitor aimed at improving administration convenience; Regeneron’s combination of pozelimab and cemdisiran, offering a dual-modality approach to potentially enhance treatment response; and Novartis’ oral therapies—Fabhalta (iptacopan) and remibrutinib—positioned to advance the treatment paradigm. Additional promising candidates include EMD Serono’s Mavenclad (cladribine) and RemeGen’s telitacicept, both of which may offer differentiation through efficacy, ease of use, and the targeting of persistent unmet needs.
According to Spherix’s Patient Chart Dynamix™: Generalized Myasthenia Gravis (US), which audited 564 patient charts, the majority of gMG patients currently treated with a biologic remain on their initial therapy. This high level of brand retention underscores both the early stage of market development and the strong satisfaction neurologists report with available agents. However, the path to market success is far from guaranteed. In a landscape where switching remains limited, differentiation at launch is critical. Significant opportunity remains for products that can address clearly defined subpopulations—particularly those experiencing rapid disease progression, refractory to existing biologics, or presenting with rare serotypes such as anti-LRP4+ and seronegative gMG. These patient groups represent areas of persistent unmet need that neurologists continue to prioritize in treatment decisions.
Importantly, while clinical positioning is essential, patient influence in treatment initiation cannot be overlooked. Spherix’s findings reveal that half of biologic-naïve gMG patients play a significant role in the decision to start therapy. However, patient-initiated requests remain uncommon, indicating that uptake is largely driven by how neurologists frame and present available options. In this context, physician education must extend beyond product knowledge to include effective communication strategies that support shared decision-making and actively engage patients in the treatment journey.
While surveyed neurologists generally identify as early adopters of new therapies, the future growth of the gMG market will depend heavily on strategic launch execution, comprehensive provider education, and precise targeting of high-opportunity patient segments. Manufacturers that recognize and respond to these dynamics, tailoring their approaches to meet both clinical and commercial needs, will be best positioned to succeed in an increasingly competitive and rapidly evolving treatment landscape.
Spherix will continue to monitor launch performance, shifting prescriber attitudes, and patient-level dynamics through ongoing updates through their suite of gMG services.
Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
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Spherix Global Insights Contacts
Andy Stankus, Dermatology Franchise Head
andy.stankus@spherixglobalinsights.com
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