Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "U.S. Zilbrysq (Zilucoplan) Market Size, Share & Trends Analysis Report By Indication (Generalized Myasthenia Gravis (gMG)), By Distribution Channel (Specialty Pharmacies, Hospital/Institution-Based, Home Healthcare Providers), And Segment Forecasts, 2025 - 2030" report has been added to ResearchAndMarkets.com's offering.
The U.S. Zilbrysq (Zilucoplan) market size was estimated at USD 60.61 million in 2024 and is projected to grow at a CAGR of 21.64% from 2025 to 2030
The U.S. Zilbrysq (Zilucoplan) industry is witnessing robust growth following its FDA approval in October 2023 for the treatment of anti-AChR antibody-positive generalized myasthenia gravis (gMG). The approval under orphan drug designation and priority review pathways has accelerated its entry into the U.S. neuromuscular therapeutics space, where demand for targeted, mechanism-based treatments continues to rise.
Zilbrysq's once-daily subcutaneous self-administration offers a compelling alternative to hospital-based intravenous complement inhibitors, supporting long-term disease management in both outpatient and home-care settings. Its differentiated profile has led to rapid adoption among neurologists treating refractory or corticosteroid-intolerant gMG patients.
The presence of a well-established specialty pharmacy network, favorable commercial insurance coverage, and prescriber familiarity with complement pathway inhibition further strengthen Zilbrysq's early market trajectory. While gMG remains the only approved indication in the U.S. as of 2024, its patient-centric formulation and durable efficacy data continue to position the product competitively against both IV C5 inhibitors and emerging FcRn-targeted therapies.
Zilbrysq's focused label for anti-AChR antibody-positive generalized myasthenia gravis (gMG) provides a clear and differentiated commercial pathway in the U.S., where approximately 85% of diagnosed gMG patients test positive for AChR antibodies. The therapy's approval under orphan drug designation and priority review by the FDA underscores the high unmet need in this rare, chronic condition.
In contrast to broad-spectrum immunosuppressants, Zilucoplan's selective inhibition of complement C5 directly targets the pathophysiologic cascade driving neuromuscular junction damage. This specificity is especially relevant in a treatment landscape increasingly oriented toward biologics with well-defined molecular targets. With gMG recognized as a lifelong condition requiring sustained control, Zilbrysq's targeted mechanism and regulatory protections support premium pricing and long-term payer alignment, solidifying its role in treatment sequencing.
The once-daily subcutaneous (SC) formulation of Zilucoplan provides a significant strategic advantage in the U.S. healthcare setting, where patients and payers are actively seeking alternatives to intravenous (IV) therapies that require frequent clinical visits. Unlike Soliris or Ultomiris-which are delivered via infusions administered in hospital or outpatient infusion centers-Zilbrysq can be self-injected at home using a prefilled syringe. This approach aligns with growing demand for decentralized chronic disease management, reducing infusion-related costs and improving treatment adherence.
In the U.S., where specialty pharmacies dominate the distribution of rare disease biologics, Zilucoplan's SC format has enabled rapid integration into payer-preferred pharmacy networks and patient support programs, helping to mitigate initiation barriers and improve real-world outcomes. Its suitability for both commercial and Medicare populations further enhances uptake in a fragmented reimbursement landscape.
As of 2024, Zilbrysq faces limited direct competition in the U.S. for SC C5 complement inhibition, with no biosimilars in development and other approved C5 inhibitors-Soliris and Ultomiris-confined to intravenous administration. While newer FcRn inhibitors such as Vyvgart and Rozanolixizumab offer differentiated mechanisms, they do not overlap with the complement pathway and are often considered complementary rather than substitutive in refractory cases.
This segmented competitive environment reduces therapeutic redundancy and supports market coexistence, allowing prescribers to tailor therapies based on individual patient profiles and response history. The lack of direct SC C5 competitors through at least 2030, combined with UCB's ongoing investments in real-world data collection and provider education, is expected to preserve Zilbrysq's clinical and economic moat in the U.S. rare neurology market.
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U.S. Zilbrysq (Zilucoplan) Market Report Segmentation
Indication Outlook (Revenue, USD Million, 2018 - 2030)
- Generalized Myasthenia Gravis (gMG)
- Others
Distribution Channel Outlook (Revenue, USD Million, 2018 - 2030)
- Specialty Pharmacies
- Hospital/Institution-Based Pharmacies
- Home Healthcare Providers
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