重症肌無力 (MG):市場機會分析與未來預測 (到2028年)

Myasthenia Gravis: Opportunity Analysis and Forecasts to 2028

出版商 GlobalData 商品編碼 917033
出版日期 內容資訊 英文 151 Pages
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重症肌無力 (MG):市場機會分析與未來預測 (到2028年) Myasthenia Gravis: Opportunity Analysis and Forecasts to 2028
出版日期: 2019年10月01日內容資訊: 英文 151 Pages

全球主要7個國家 (美國·法國·德國·義大利·西班牙·英國·日本) 的重症肌無力 (MG) 治療藥市場規模在2018年估算為8億3650萬美元,預計到2028年將擴大到19億美元,並以8.7%的年複合成長率 (CAGR) 擴大。

本報告提供重症肌無力 (MG) 治療藥相關最新的研究·開發趨勢,與今後市場趨勢的預測與分析,提供疾病概要和目前的治療方法,未滿足需求·市場機會的評估,今後10年的患病人數·市場規模的預測值,臨床試驗的進展,新治療藥的開發平台評估,今後的市場·技術趨勢等調查。

第1章 目錄

第2章 重症肌無力:摘要整理

第3章 簡介

第4章 疾病概要

  • 病因與病情生理
  • 分類/病期分類系統

第5章 流行病學

  • 疾病的背景情況
  • 風險要素和共生病症
  • 過去的世界的趨勢
  • 預測手法
    • 利用之資訊來源
    • 預測的前提條件與手法
    • 預測的前提條件:MG的確診患病人數
    • 預測的前提條件與手法:MG的確診患病人數,嚴重程度別
  • 重症肌無力 (MG)的流行病學的預測 (今後11年份)
    • MG的確診患病人數
    • MG的確診患病人數:各年齡
    • MG的確診患病人數:男女
    • MG的確診患病人數:嚴重程度別
  • 議論
    • 流行病學性的預測結果相關考察
    • 分析的限制
    • 分析的優勢

第6章 目前治療選擇

  • 概要
  • 乙醯膽鹼酯?抑制劑
  • 免疫抑制劑
    • 硫唑嘌呤/環孢黴素
    • Tacrolimus
  • 類固醇劑
    • 糖皮質激素受體 (GR) 促效劑
    • Spiranolactone
  • 單株抗體
    • Rituxan/MabThera
    • Soliris
  • MG的非藥物療法
    • 胸腺消除
    • 靜脈內免疫球蛋白·血漿淨化療法
  • 治療流程和頑固性疾病患者

第7章 未滿足需求與市場機會的評估

  • 概要
  • 加強對與疾病有關費用的控制,這些費用使人們無法獲得基本藥物
  • 調整靜脈注射藥的給藥頻率
  • 各種疾病/亞型治療指南的標準化
  • 發現MG預後生物標記

第8章 研究開發 (R&D) 策略

  • 概要
    • 免疫抑製劑在MG治療中的應用綜述
    • 針對免疫系統特定部位的藥物
    • MG合併症的研究
  • 臨床實驗的設計
    • 概要
    • 探索MG無創給藥途徑的可能性
    • 可靠的臨床數據生成,適用於非標治療
    • 評價難治性MG的生物製劑的長期穩定性

第9章 開發中產品的評估

  • 概要
  • 創新的早期方法
  • 其他臨床實驗中的醫藥品

第10章 開發平台評估分析

  • 主要的開發平台藥物臨床方面的比較分析
  • 主要的開發平台藥物的商業方面的比較分析
  • 各企業的評估
  • 主要國家市場預測 (今後10年份)
    • 美國
    • 歐洲主要5個國家 (5EU)
    • 日本

第11章 附錄

Product Code: GDHC104POA

Myasthenia gravis (MG) is a rare chronic autoimmune and neuromuscular disorder. Most patients experience weakness of the muscles around the eye, which can cause drooping of the eyelids and blurred vision. In other types of MG, weakness can extend to other muscles and cause respiratory difficulties that require immediate attention to ensure the survival of the patient. Most cases of MG affect the eyes, and subtypes of MG are defined according to the severity of muscular weakness and patients' response to pharmacotherapy. Patients who are non-refractory respond to first-line treatment options and find these drugs provide sufficient management of the disease. Refractory patients on the other hand have difficulty with first-line therapies and require more aggressive treatment strategies to mitigate symptoms. Ocular or Class I MG affects only the muscles around the eye. The level of weakness can be mild, moderate or pronounced. Generalized or Class II-V MG can include weakness of ocular muscles in addition to other muscles around the body.

The subtypes of MG included in this report are: Non-refractory Ocular MG, Non-refractory Class II-V MG, Refractory Ocular MG and Refractory Class II-V MG

The most prevalent form of MG is non-refractory class II-V MG. Across the 7MM there are few approved therapies for MG.

Patients are first treated with Mestinon (pyridostigmine bromide). The autoimmune component of the disease is generally treated with immunosuppressants such as azathioprine and cyclosporine. These drugs are not effective for all patients, may be carcinogenic or teratogenic and can take several months to exhibit therapeutic effects. Steroids such as prednisone are commonly used for all types of MG, but side effects include potential blindness, hypertension and diabetes and so there is significant unmet needs for MG pharmacotherapy for safe, effective and affordable therapies. Soliris (eculizumab) was the first biologic approved for MG and while its use has been successful, the annual cost of therapy is $678,392. This substantially restricts access, leaving many refractory patients with uncontrolled myasthenia, significantly reducing their quality of life.

GlobalData estimates that drug sales for MG in 2018 were approximately $836.5M across the seven major markets (US, France, Germany, Italy, Spain, UK, Japan) covered in this report. Over the 10-year forecast period, the market is expected to grow to $1.9B at a CAGR of 8.7%. This growth will be driven by the launch of eight late-stage pipeline products. The two highest selling drugs are expected to be Ra Pharma's zilucoplan and Alexion's ravulizumab, which address some of the clinical unmet needs in the market.

Key Questions Answered in This Report

  • What were the key MG treatments in 2018?
  • When will the late stage pipeline products launch in each of the 7MM?
  • How will the late-stage pipeline agents affect drug sales in the 7MM?

Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?


  • Overview of MG, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized MG therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (non-refractory ocular MG, non-refractory class II-V MG, refractory ocular MG and refractory class II-V MG) forecast from 2018 to 2028.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the MG therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for MG therapy. The most promising candidates in Phase II-b and Phase III stages of development are profiled.
  • Analysis of the current and future market competition in the global MG therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global MG therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MG therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2 Myasthenia Gravis: Executive Summary

  • 2.1 MG Market Is Expected to Grow to $1.9B by 2028
  • 2.2 Potential for Label Expansion for Immunosuppressants and Anti-Myasthenic Agents
  • 2.3 Treatment-Related Costs Pose a Threat to Patient Compliance Rates
  • 2.4 Steroid-Sparing Immunosuppressive Strategies Increasingly Favored by Clinicians and Patients
  • 2.5 Complement Inhibitors Zilucoplan and Ravulizumab to Be Top-Selling Drugs in 2028
  • 2.6 What Do Physicians Think?

3 Introduction

  • 3.1 Catalyst
  • 3.2 Related Reports

4 Disease Overview

  • 4.1 Etiology and Pathophysiology
    • 4.1.1 Etiology
    • 4.1.2 Pathophysiology
  • 4.2 Classification or Staging Systems

5 Epidemiology

  • 5.1 Disease Background
  • 5.2 Risk Factors and Comorbidities
  • 5.3 Global and Historical Trends
  • 5.4 Forecast Methodology
    • 5.4.1 Sources Used
    • 5.4.1 Forecast Assumptions and Methods
    • 5.4.2 Forecast Assumptions - Diagnosed Prevalent Cases of MG
    • 5.4.3 Forecast Assumptions and Methods - Diagnosed Prevalent Cases of MG by Severity
  • 5.5 Epidemiological Forecast for Myasthenia Gravis (2018-2028)
    • 5.5.1 Diagnosed Prevalent Cases of MG
    • 5.5.2 Age-Specific Diagnosed Prevalent Cases of Myasthenia Gravis
    • 5.5.3 Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis
    • 5.5.4 Diagnosed Prevalent Cases of Myasthenia Gravis by Severity
  • 5.6 Discussion
    • 5.6.1 Epidemiological Forecast Insight
    • 5.6.2 Limitations of Analysis
    • 5.6.3 Strengths of Analysis

6 Current Treatment Options

  • 6.1 Overview
  • 6.2 Reversible Acetylcholinesterase Inhibitors
  • 6.3 Immunosuppressants
    • 6.3.1 Azathioprine and Cyclosporine
    • 6.3.2 Tacrolimus
  • 6.4 Steroids
    • 6.4.1 Glucocorticosteroid Receptor Agonists
    • 6.4.2 Spironolactone
  • 6.5 Monoclonal Antibodies
    • 6.5.1 Rituxan/MabThera
    • 6.5.2 Soliris
  • 6.6 Non-pharmacotherapeutic Management of MG
    • 6.6.1 Thymectomy
    • 6.6.2 Intravenous Immunoglobulin and Plasmapheresis
  • 6.7 Treatment Algorithms for Difficult-to-Treat Patients

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 Greater Control over Treatment-Related Costs Blocking Access to Essential Medicines
  • 7.3 Making Frequency of Administration Manageable for Intravenous Agents
  • 7.4 Standardization of Treatment Guidelines for Different Disease Subtypes
  • 7.5 Identifying Prognostic Biomarkers for MG

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 Repurposing Immunosuppressive Therapies for MG
    • 8.1.2 Drugs Targeting Specific Components of the Immune System
    • 8.1.3 Targeting Comorbidities of MG
  • 8.2 Clinical Trials Design
    • 8.2.1 Overview
    • 8.2.2 Investigating the Feasibility of Non-invasive Routes of Administration in Treating MG
    • 8.2.3 Generating Reliable Clinical Data for Off-Label Therapeutics
    • 8.2.4 Assessing the Long-Term Safety of Biologics in Treating Refractory MG

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Innovative Early Stage Approaches
  • 9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

  • 10.1 Clinical Benchmark of Key Pipeline Drugs
  • 10.2 Commercial Benchmark of Key Pipeline Drugs
  • 10.3 Competitive Assessment
  • 10.4 Top-Line 10-Year Forecast
    • 10.4.1 US
    • 10.4.2 5EU
    • 10.4.3 Japan

11 Appendix

  • 11.7 About GlobalData
  • 11.8 Contact Us
  • 11.9 Disclaimer

List of Tables

  • Table 1: Myasthenia Gravis: Key Metrics in the 7MM
  • Table 2: MGFA Classification of MG
  • Table 3: Osserman Classification System
  • Table 4: Risk Factors and Comorbidities for MG
  • Table 5: Treatment Guidelines for MG in the 7MM
  • Table 6: Comparison

List of Figures

  • Figure 1: Global Sales Forecast by Country for MG in 2018 and 2028
  • Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Mestinon
  • Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Soliris
  • Figure 4: AChR and MuSK Blocked by Autoantibodies at the Neuromuscular Junction in MG
  • Figure 5: 7MM, Diagnosed Prevalence of MG, %, Both Sexes, All Ages, 2018
  • Figure 6: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of MG
  • Figure 7: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of MG by Severity
  • Figure 8: 7MM, Diagnosed Prevalent Cases of MG, N, Both Sexes, All Ages, 2018
  • Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of MG, N, Both Sexes, All Ages, 2018
  • Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of MG, N, All Ages, 2018
  • Figure 11: 7MM, Diagnosed Prevalent Cases of MG by Severity, N, Both Sexes, All Ages, 2018
  • Figure 12: Unmet Needs and Opportunities in MG
  • Figure 13: Overview of the Development Pipeline in MG
  • Figure 14: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for MG in the 7MM, 2018-2028
  • Figure 15: Competitive Assessment of Firdapse, the Pipeline Therapy Enhancing Neurotransmission of ACh, Benchmarked Against the SOC, Mestinon
  • Figure 16: Competitive Assessment of the Pipeline Immunosuppressants Benchmarked Against the SOC, Soliris
  • Figure 17: Global (7MM) Sales Forecast by Country for MG, 2018 and 2028
  • Figure 18: Global Sales Forecast by Class for MG, 2018 and 2028
  • Figure 19: Sales Forecast by Class for MG in the US, 2018 and 2028
  • Figure 20: Sales Forecast by Class for MG in the 5EU, 2018 and 2028
  • Figure 21: Sales Forecast by Class for MG in Japan, 2018 and 2028
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