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市場調查報告書
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2080183

重症肌無力（MG）：市場展望、流行病學、競爭格局、市場預測報告（2025-2035年）

Myasthenia Gravis (MG) - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035
出版日期: | 出版商: Thelansis Knowledge Partners | 英文 154 Pages | 商品交期: 2-3個工作天內

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簡介目錄

市場概覽

  • 德國重症肌無力市場預計將從 2025 年的 9,500 萬美元成長到 2035 年的 2 億美元。
  • 推動市場成長的因素如下：
  • 標靶生技藥品和補體抑制劑的應用日益廣泛
  • 擴大新型免疫療法的研發
  • 未來的成長取決於安全性是否有所提高，以及是否有能夠持續控制疾病的治療方法。

重症肌無力（MG）概述

重症肌無力（MG）是一種慢性自體免疫神經肌肉疾病，其特徵是骨骼肌無力波動。此病是由針對乙醯膽鹼受體、肌肉特異性激酶或LRP4的自身抗體引起，這些抗體抑制神經肌肉接頭處的訊號傳導。患者可能出現眼瞼下垂、複視、延髓麻痺或近端肢體無力。現代治療方案結合了快速標靶治療和基準乙醯膽鹼酯酶抑制劑（如吡啶斯的明）以及傳統免疫抑制劑。治療主要集中在新生兒Fc受體抑制劑上，除尼波卡利單抗外，FDA已擴大了efgaltigimod衍生物的核准範圍，涵蓋成人全身型重症肌無力的所有血清型，包括三陰性血清型和MuSK陽性血清型。此外，標靶治療包括靶向CD19的B細胞清除抗體inebilizumab，以及補體抑制劑，例如用於治療重症和難治性病例的Eculizumab、lavlizumab或zircoplan。對於非胸腺瘤性乙醯膽鹼受體陽性患者，胸腺切除術仍是維持長期緩解的重要外科介入措施。密切監測重症肌無力危象、確保患者用藥依從性以及多學科協作可最佳化功能預後。

主要亮點

  • 根據預測，德國重症肌無力確診病例數將從 2025 年的 7,567 例增加到 2035 年的 8,099 例。
  • 重症肌無力是一種罕見的自體免疫神經肌肉疾病，會導致肌肉無力和疲勞波動。
  • 儘管有多種治療方案可供選擇，但許多患者仍然無法充分控制病情，並且經常出現病情惡化的情況。
  • 目前仍有大量未被滿足的、標靶治療，能夠提供持續的症狀控制和改善生活品質。

格式化和更新訊息

  • 詳細報告（PDF）
  • 市場預測模型（基於微軟Excel）
  • 流行病學數據（MS Excel，互動式工具）
  • 高階主管洞察（PPT簡報）
  • 其他功能：定期更新、自訂和顧問支援。
  • 根據 Thelansis 的政策，我們確保所有最新更新在發布前都反映在報告內容和市場模型中。

主要問題

  • 如何最佳化 G8 市場（美國、歐盟 5 國、日本、中國）的藥物開發與生命週期管理策略？
  • 從發病率、盛行率、人群組成以及接受藥物治療的患者人數來看，患者數量分別是多少？
  • 未來十年市場收入和病患佔有率的預測是多少？
  • 哪些因素對市場趨勢影響最大？
  • 受訪專家對目前和新興的治療方法有何看法？
  • 哪款在研發線產品最有前景？其上市潛力及未來市場定位如何？
  • 主要未被滿足的需求是什麼？ KOL 對目標受眾有何期望？
  • 為確保藥物獲得批准並順利進入市場，必須滿足哪些關鍵的監管和支付方要求？

目標國家

  • G8
    • 美國
    • EU5
      • 法國
      • 德國
      • 義大利
      • 西班牙
      • 英國
    • 日本
    • 中國

大公司

  • ImmunAbs Inc.
  • NMD Pharma A/S
  • Kyverna Therapeutics
  • Amgen
  • Janssen Research &Development, LLC
  • UCB Biopharma SRL
  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  • Harbour BioMed（Guangzhou）Co. Ltd.
  • Argenx
  • COUR Pharmaceutical Development Company, Inc.
  • RemeGen Co., Ltd.
  • Aurinia Pharmaceuticals Inc.
  • Vertex Pharmaceuticals Incorporated
  • Dianthus Therapeutics
  • Cartesian Therapeutics
  • Ra Pharmaceuticals, Inc.
  • Clinique Neuro-Outaouais
  • Kite, A Gilead Company
  • Arcellx, Inc.

目錄

第1章：主要調查結果及分析師說明

  • 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章：疾病背景

  • 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

  • 重點
  • 發病率/盛行率
  • 已確診並正在接受藥物治療的患者族群。
  • 合併症
  • 其他相關患者群

第4章 市場規模及預測

  • 重點
  • 市場促進因素與限制因素
  • 按藥物類別分類的趨勢
  • 各國具體趨勢

第5章 競爭情勢

  • 目前的治療方法
  • 重點
  • 診斷和治療過程/演算法
  • 目前主要療法－概述及關鍵意見領袖見解
  • 新興療法
  • 重點
  • 值得關注的後期新興療法—概述、市場上市預期和關鍵意見領袖見解
  • 值得關注的早期研發管線

第6章：未滿足的需求與目標產品分析

  • 尚未滿足的主要需求及其透過新興療法實現的潛力。
  • TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

簡介目錄

Myasthenia Gravis (MG) Market Outlook

Thelansis's "Myasthenia Gravis (MG) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Myasthenia Gravis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Myasthenia Gravis (MG) Overview

Myasthenia Gravis is a chronic autoimmune neuromuscular disorder marked by fluctuating skeletal muscle weakness. It is driven by autoantibodies against the acetylcholine receptor, muscle-specific kinase, or LRP4 that disrupt signal transmission at the neuromuscular junction. Patients present with ptosis, diplopia, bulbar symptoms, or proximal limb weakness. Modern management pairs baseline acetylcholinesterase inhibitors like pyridostigmine and traditional immunosuppressants with rapid, targeted therapies. The treatment landscape centers heavily on neonatal Fc receptor blockers; alongside nipocalimab, the FDA expanded the approval of efgartigimod variants to cover all adult generalized myasthenia gravis serotypes, including triple-seronegative and MuSK-positive presentations. Furthermore, targeted choices include the CD19-directed B-cell depleting antibody inebilizumab alongside complement inhibitors like eculizumab, ravulizumab, or zilucoplan for severe, refractory cases. Thymectomy remains a key surgical intervention for non-thymomatous acetylcholine receptor-positive patients to support long-term remission. Careful monitoring for myasthenic crisis, medication compliance, and multidisciplinary care optimize functional outcomes.

Key Highlights

  • In Germany, diagnosed Myasthenia Gravis cases are projected to increase from 7,567 in 2025 to 8,099 by 2035.
  • Myasthenia Gravis is a rare autoimmune neuromuscular disorder causing fluctuating muscle weakness and fatigue.
  • Despite available therapies, many patients continue to experience inadequate disease control and frequent exacerbations.
  • Significant unmet need remains for targeted therapies that provide sustained symptom control and improved quality of life.

Market Overview

  • The Germany Myasthenia Gravis market is projected to grow from $95M in 2025 to $200M by 2035.
  • Market growth is driven by:
  • Increasing adoption of targeted biologics and complement inhibitors
  • Expanding development of novel immunotherapies
  • Future growth will depend on therapies offering durable disease control with improved safety profiles.

Insights driven by robust research, including:

  • In-depth interviews with leading KOLs and payers
  • Physician surveys
  • RWE analysis for claims and EHR datasets
  • Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

  • Detailed Report (PDF)
  • Market Forecast Model (MS Excel-based automated dashboard)
  • Epidemiology (MS Excel; interactive tool)
  • Executive Insights (PowerPoint presentation)
  • Others: regular updates, customizations, consultant support
  • As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

  • 10-year market forecast (2025-2035)
  • Bottom-up patient-based market forecasts validated through the top-down sales methodology
  • Covers clinically and commercially-relevant patient populations/ line of therapies
  • Annualized drug-level sales and patient share projections
  • Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
  • Detailed methodology/sources & assumptions
  • Graphical and tabular outputs
  • Users can customize the model based on requirements

Key business questions answered:

  • How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
  • How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
  • What is the 10-year market outlook for sales and patient share?
  • Which events will have the greatest impact on the market's trajectory?
  • What insights do interviewed experts provide on current and emerging treatments?
  • Which pipeline products show the most promise, and what is their potential for launch and future positioning?
  • What are the key unmet needs and KOL expectations for target profiles?
  • What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

  • G8
    • United States
    • EU5
      • France
      • Germany
      • Italy
      • Spain
      • U.K.
    • Japan
    • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

  • ImmunAbs Inc.
  • NMD Pharma A/S
  • Kyverna Therapeutics
  • Amgen
  • Janssen Research & Development, LLC
  • UCB Biopharma SRL
  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  • Harbour BioMed (Guangzhou) Co. Ltd.
  • Argenx
  • COUR Pharmaceutical Development Company, Inc.
  • RemeGen Co., Ltd.
  • Aurinia Pharmaceuticals Inc.
  • Vertex Pharmaceuticals Incorporated
  • Dianthus Therapeutics
  • Cartesian Therapeutics
  • Ra Pharmaceuticals, Inc.
  • Clinique Neuro-Outaouais
  • Kite, A Gilead Company
  • Arcellx, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

  • Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

  • Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

  • Key takeaways
  • Incidence / Prevalence
  • Diagnosed and Drug-Treated populations
  • Comorbidities
  • Other relevant patient segments

4. Market Size and Forecast

  • Key takeaways
  • Market drivers and constraints
  • Drug-class specific trends
  • Country-specific trends

5. Competitive Landscape

  • Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies - profiles and KOL insights
  • Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

  • Top unmet needs and future attainment by emerging therapies
  • TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)