美国Zybrisco 市场规模、份额、趋势分析报告：按适应症、分销管道、细分市场预测，2025-2030 年

美国Zilbrysk（Zilcoplan）市场的趋势：

预计 2024 年美国Zilbrysk（Zilcoplan）市场规模为 6,061 万美元，预估 2025 年至 2030 年的复合年增长率为 21.64%。

美国Zilbrysk（zilucoplan）药物于2023年10月获得FDA核准，用于治疗抗乙酰胆碱受体抗体阳性的全身性重症肌无力（gMG）。自此之后，该药物产业正经历强劲成长。孤儿药资格认定和快速通道核准加速了该药物进入美国神经肌肉治疗领域，该领域对靶向、基于机制的治疗的需求持续增长。

Zilbrysk 每日一次皮下自行给药的疗法，为住院患者补体抑制剂输注提供了一种颇具吸引力的替代方案，并支持门诊和居家护理中的长期疾病管理。其差异化特性使其迅速被治疗难治性或皮质类固醇不耐受的鉅细胞病毒性肌炎 (gMG) 患者的神经科所采用。成熟的专科药房网络、良好的私人保险覆盖以及处方医生对补体途径抑製剂的熟悉，进一步增强了 Zilbrysk 的早期市场准入优势。截至 2024 年，Zilbrysk 在美国唯一核准的适应症是鉅细胞病毒性肌炎 (gMG)，但以患者为中心的配方和持续的疗效数据预计将使 Zilbrysk 在与 IV C5 抑製剂疗法和针对 FcRn 的新兴疗法的竞争中保持优势。

Zilbrysk 专注于抗 AChR 抗体阳性的全身性重症肌无力 (gMG) 适应症，这在美国提供了清晰且差异化的商业性途径，在美国约 85% 的确诊 gMG 患者为 AChR 抗体阳性。 FDA 以孤儿药资格和优先审查核准该疗法，凸显了这种罕见慢性疾病中存在大量未满足的需求。与广谱免疫抑制剂相比，Zilbrysk 选择性抑制补体 C5，直接针对导致神经肌肉接头功能障碍的病理学连锁。这种特异性在越来越倾向于具有明确分子标靶标靶的生物製药的治疗领域中尤其重要。鑑于 gMG 是一种需要持续控制的终身疾病，Zilbrysk 的标靶机制和监管保护支持溢价定价和长期付款人协调，巩固了 Zilbrysk 在治疗定序中的地位。

Zilucoplan 的每日一次皮下製剂在美国医疗保健领域具有显着的战略优势，在美国，患者和付款人都在积极寻求需要频繁就诊的静脉注射治疗方法的替代方案。与Soliris和 Ultomiris 不同，Zilbraisk 可以使用预填充式注射器在家中自行注射。这种方法符合分散慢性病管理、降低输液相关成本和提高治疗顺从性的日益增长的需求。在美国，专科药房主导着罕见疾病生技药品的分销，Zilucoplan 的 SC 形式允许快速整合到付款人首选的药房网络和患者援助计划中，有助于减少启动障碍并改善现实世界的结果。它也适用于商业和基于医疗保险的报销，进一步促进在分散的报销环境中的采用。

截至 2024 年，Zilbrysk 在美国与 SC C5 补体抑制剂的直接竞争有限，没有正在开发的生物仿製药，其他已通过核准的C5 抑制剂Soliris和 Ultomiris 仅限于静脉注射。较新的 FcRn 抑制剂如 Vyvgart 和 Rozanolixizumab 提供了差异化的机制，但与补体途径不重迭，在难治性病例中可被视为补充而非替代。这种分散的竞争格局减少了治疗重迭，有助于市场共存，并允许处方人员根据个别患者概况和反应历史量身定制治疗方法。由于至少在 2030 年之前没有直接的 SC C5 竞争对手，再加上 UCB 在收集真实世界临床数据和教育医疗保健提供者方面的持续投资，Zilbrysk 在美国罕见神经系统疾病市场的临床和经济优势预计将得以维持。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国Zilbrice（Zilcoplan）市场变数、趋势与范围

• 市场体系展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 商业环境分析
  • 产业分析-波特五力分析
  • PESTLE分析
• 管道分析
• 专利到期分析
• 定价分析

第四章美国Zilbrik（Zilcoplan）市场：按适应症进行的业务分析

• 2024 年及 2030 年各适应症市场占有率
• 指示细分仪表板
• 市场规模、预测与趋势分析（2018-2030 年）
• 全身性重症肌无力（gMG）
• 其他的

第五章美国Zilbrice（Zilcoplan）市场：依通路进行的业务分析

• 2024 年和 2030 年按分销管道分類的市场占有率
• 按分销管道细分仪表板
• 按分销管道分類的市场规模、预测和趋势分析（2018-2030 年）
• 专业药房
• 医院/机构药房
• 家庭医疗保健提供者

第六章 竞争态势

• 参与者概览
• 企业市场分析
• 公司分类
• 战略地图
• 公司简介/上市公司
  • UCB

第七章 结论

U.S. Zilbrysq (Zilucoplan) Market Trends:

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.

U.S. Zilbrysq (Zilucoplan) Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. Zilbrysq (Zilucoplan) market report based on indication, and distribution channel:

• 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

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Indication
  • 1.2.2. Distribution Channel
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Zilbrysq (Zilucoplan) Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
• 3.4. Pipeline Analysis
• 3.5. Patent Expiry Analysis
• 3.6. Pricing Analysis

Chapter 4. U.S. Zilbrysq (Zilucoplan) Market: Indication Business Analysis

• 4.1. Indication Market Share, 2024 & 2030
• 4.2. Indication Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Indication, 2018 to 2030 (USD Million)
• 4.4. Generalized Myasthenia Gravis (gMG)
  • 4.4.1. Generalized Myasthenia Gravis (gMG) Market, 2018 - 2030 (USD Million)
• 4.5. Others
  • 4.5.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. U.S. Zilbrysq (Zilucoplan) Market: Distribution Channel Business Analysis

• 5.1. Distribution Channel Market Share, 2024 & 2030
• 5.2. Distribution Channel Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2018 to 2030 (USD Million)
• 5.4. Specialty Pharmacies
  • 5.4.1. Specialty Pharmacies Market, 2018 - 2030 (USD Million)
• 5.5. Hospital/Institution-Based Pharmacies
  • 5.5.1. Hospital/Institution-Based Pharmacies Market, 2018 - 2030 (USD Million)
• 5.6. Home Healthcare Providers
  • 5.6.1. Home Healthcare Providers Market, 2018 - 2030 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Participant Overview
• 6.2. Company Market Position Analysis
• 6.3. Company Categorization
• 6.4. Strategy Mapping
• 6.5. Company Profiles/Listing
  • 6.5.1. UCB
    • 6.5.1.1. Overview
    • 6.5.1.2. Financial Performance
    • 6.5.1.3. Product Benchmarking
    • 6.5.1.4. Strategic Initiatives

Chapter 7. Conclusion

List of Tables

• Table 1. List of secondary sources
• Table 2. List of abbreviations
• Table 3. U.S. Zilbrysq (Zilucoplan) Market, by indication, 2018 - 2030 (USD Million)
• Table 4. U.S. Zilbrysq (Zilucoplan) Market, by Distribution Channel, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 U.S. Zilbrysq (Zilucoplan) Market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value-chain-based sizing & forecasting
• Fig. 7 Market formulation & validation
• Fig. 8 Market snapshot
• Fig. 9 Indication and Distribution Channel outlook (USD Million)
• Fig. 10 Competitive landscape
• Fig. 11 U.S. Zilbrysq (Zilucoplan) Market dynamics
• Fig. 12 U.S. Zilbrysq (Zilucoplan) Market: Porter's five forces analysis
• Fig. 13 U.S. Zilbrysq (Zilucoplan) Market: PESTLE analysis
• Fig. 14 Indication market, 2018 - 2030 (USD Million)
• Fig. 15 Generalized Myasthenia Gravis (gMG) market, 2018 - 2030 (USD Million)
• Fig. 16 Others market, 2018 - 2030 (USD Million)
• Fig. 17 Distribution Channel market, 2018 - 2030 (USD Million)
• Fig. 18 Specialty Pharmacies market, 2018 - 2030 (USD Million)
• Fig. 19 Hospital/Institution-Based Pharmacies market, 2018 - 2030 (USD Million)
• Fig. 20 Home Healthcare Providers market, 2018 - 2030 (USD Million)
• Fig. 21 U.S. Zilbrysq (Zilucoplan) Market revenue, 2018 - 2030 (USD Million)
• Fig. 22 Company categorization
• Fig. 23 Company market position analysis
• Fig. 24 Strategic framework