美國Zybrisco 市場規模、佔有率、趨勢分析報告：按適應症、分銷管道、細分市場預測，2025-2030 年

美國Zilbrysk（Zilcoplan）市場的趨勢：

預計 2024 年美國Zilbrysk（Zilcoplan）市場規模為 6,061 萬美元，預估 2025 年至 2030 年的複合年成長率為 21.64%。

美國Zilbrysk（zilucoplan）藥物於2023年10月獲得FDA核准，用於治療抗乙醯膽鹼受體抗體陽性的全身性重症肌無力（gMG）。自此之後，該藥物產業正經歷強勁成長。孤兒藥資格認定和快速通道核准加速了該藥物進入美國神經肌肉治療領域，該領域對靶向、基於機制的治療的需求持續成長。

Zilbrysk 每日一次皮下自行給藥的療法，為住院患者補體抑制劑輸注提供了一種頗具吸引力的替代方案，並支持門診和居家護理中的長期疾病管理。其差異化特性使其迅速被治療難治性或皮質類固醇不耐受的鉅細胞病毒性肌炎 (gMG) 患者的神經科所採用。成熟的專科藥房網路、良好的私人保險覆蓋以及處方醫生對補體途徑抑製劑的熟悉，進一步增強了 Zilbrysk 的早期市場准入優勢。截至 2024 年，Zilbrysk 在美國唯一核准的適應症是鉅細胞病毒性肌炎 (gMG)，但以患者為中心的配方和持續的療效數據預計將使 Zilbrysk 在與 IV C5 抑製劑療法和針對 FcRn 的新興療法的競爭中保持優勢。

Zilbrysk 專注於抗 AChR 抗體陽性的全身性重症肌無力 (gMG) 適應症，這在美國提供了清晰且差異化的商業性途徑，在美國約 85% 的確診 gMG 患者為 AChR 抗體陽性。 FDA 以孤兒藥資格和優先審查核准該療法，凸顯了這種罕見慢性疾病中存在大量未滿足的需求。與廣譜免疫抑制劑相比，Zilbrysk 選擇性抑制補體 C5，直接針對導致神經肌肉接頭功能障礙的病理學連鎖。這種特異性在越來越傾向於具有明確分子標靶標靶的生物製藥的治療領域中尤其重要。鑑於 gMG 是一種需要持續控制的終身疾病，Zilbrysk 的標靶機制和監管保護支持溢價定價和長期付款人協調，鞏固了 Zilbrysk 在治療定序中的地位。

Zilucoplan 的每日一次皮下製劑在美國醫療保健領域具有顯著的戰略優勢，在美國，患者和付款人都在積極尋求需要頻繁就診的靜脈注射治療方法的替代方案。與Soliris和 Ultomiris 不同，Zilbraisk 可以使用預填充式注射器在家中自行注射。這種方法符合分散慢性病管理、降低輸液相關成本和提高治療順從性的日益成長的需求。在美國，專科藥屋主導著罕見疾病生技藥品的分銷，Zilucoplan 的 SC 形式允許快速整合到付款人首選的藥房網路和患者援助計劃中，有助於減少啟動障礙並改善現實世界的結果。它也適用於商業和基於醫療保險的報銷，進一步促進在分散的報銷環境中的採用。

截至 2024 年，Zilbrysk 在美國與 SC C5 補體抑制劑的直接競爭有限，沒有正在開發的生物學名藥，其他已通過核准的C5 抑制劑Soliris和 Ultomiris 僅限於靜脈注射。較新的 FcRn 抑制劑如 Vyvgart 和 Rozanolixizumab 提供了差異化的機制，但與補體途徑不重疊，在難治性病例中可被視為補充而非替代。這種分散的競爭格局減少了治療重疊，有助於市場共存，並允許處方人員根據個別患者概況和反應歷史量身定做治療方法。由於至少在 2030 年之前沒有直接的 SC C5 競爭對手，再加上 UCB 在收集真實世界臨床數據和教育醫療保健提供者方面的持續投資，Zilbrysk 在美國罕見神經系統疾病市場的臨床和經濟優勢預計將得以維持。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國Zilbrice（Zilcoplan）市場變數、趨勢與範圍

• 市場體系展望
• 市場動態
  • 市場促進因素分析
  • 市場限制因素分析
• 商業環境分析
  • 產業分析-波特五力分析
  • PESTLE分析
• 管道分析
• 專利到期分析
• 定價分析

第4章美國Zilbrik（Zilcoplan）市場：按適應症進行的業務分析

• 2024 年及 2030 年各適應症市場佔有率
• 指示細分儀表板
• 市場規模、預測與趨勢分析（2018-2030 年）
• 全身性重症肌無力（gMG）
• 其他

第5章美國Zilbrice（Zilcoplan）市場：依通路進行的業務分析

• 2024 年和 2030 年按分銷管道分類的市場佔有率
• 按分銷管道細分儀表板
• 按分銷管道分類的市場規模、預測和趨勢分析（2018-2030 年）
• 專業藥房
• 醫院/機構藥房
• 家庭醫療保健提供者

第6章 競爭態勢

• 參與者概覽
• 企業市場分析
• 公司分類
• 戰略地圖
• 公司簡介/上市公司
  • UCB

第7章 結論

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