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重症筋無力症 (MG):市場機会の分析と将来予測 (2028年まで)

Myasthenia Gravis: Opportunity Analysis and Forecasts to 2028

出版日: | 発行: GlobalData | ページ情報: 英文 151 Pages | 納期: 即納可能 即納可能とは

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重症筋無力症 (MG):市場機会の分析と将来予測 (2028年まで)
出版日: 2019年10月01日
発行: GlobalData
ページ情報: 英文 151 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の主要7ヶ国 (米国・フランス・ドイツ・イタリア・スペイン・英国・日本) における重症筋無力症 (MG) 治療薬の市場規模は、2018年には8億3650万米ドル、2028年には19億米ドルと、8.7%のCAGR (複合年間成長率) で拡大する見通しです。

当レポートでは、重症筋無力症 (MG) 治療薬に関する最新の研究・開発動向と、今後の市場動向の見通しとを分析し、疾患の概要や現段階の治療法、アンメットニーズ・市場機会の評価、今後10年間の有病者数・市場規模の予測値、臨床試験の進行状況、新規治療薬のパイプライン評価、今後の市場・技術動向などを調査しております。

第1章 目次

第2章 重症筋無力症:エグゼクティブサマリー

第3章 イントロダクション

第4章 疾患概要

  • 病因と病態生理
  • 分類/病期分類システム

第5章 疫学

  • 疾患の背景事情
  • リスク要因と共存症
  • 過去の世界的傾向
  • 予測手法
    • 利用した情報源
    • 予測の前提条件と手法
    • 予測の前提条件:MGの受診済み有病者数
    • 予測の前提条件と手法:MGの受診済み有病者数、重症度別
  • 重症筋無力症 (MG) の疫学的予測 (今後11年間分)
    • MGの受診済み有病者数
    • MGの受診済み有病者数:年齢別
    • MGの受診済み有病者数:男女別
    • MGの受診済み有病者数:重症度別
  • 議論
    • 疫学的な予測結果に関する考察
    • 分析の限界
    • 分析の強み

第6章 現在の治療オプション

  • 概要
  • アセチルコリンエステラーゼ阻害剤
  • 免疫抑制剤
    • アザチオプリン・シクロスポリン
    • タクロリムス
  • ステロイド剤
    • グルココルチコイド受容体 (GR) 作動薬
    • スピロノラクトン
  • モノクローナル抗体
    • Rituxan/MabThera
    • Soliris
  • MGの非薬物療法
    • 胸腺除去
    • 静脈内免疫グロブリン・血漿浄化療法
  • 治療アルゴリズムと難病患者

第7章 アンメットニーズと市場機会の評価

  • 概要
  • 必須医薬品へのアクセスを妨げてきた、疾患関連コストへの制御力の強化
  • 静脈注射薬の投与頻度の調整
  • 各種疾患/サブタイプ向け治療ガイドラインの標準化
  • MG向け予後バイオマーカーの発見

第8章 研究開発 (R&D) 戦略

  • 概要
    • MG治療のための、免疫抑制剤の利用の見直し
    • 免疫系の特定部位を標的とする医薬品
    • MGの共存症の研究
  • 治験の設計
    • 概要
    • MG向け・非侵襲投与経路の可能性の探求
    • オフラベル治療薬に関する、信頼性の高い臨床データの生成
    • 難治性MG治療用の生物製剤の長期的安定性の評価

第9章 パイプライン製品の評価

  • 概要
  • 革新的な初期段階のアプローチ
  • 他の治験中の医薬品

第10章 パイプライン評価の分析

  • 主要なパイプライン薬剤の臨床面での比較分析
  • 主要なパイプライン薬剤の商業面での比較分析
  • 企業別の評価
  • 主要国市場の予測 (今後10年間分)
    • 米国
    • 欧州主要5ヶ国 (5EU)
    • 日本

第11章 付録

図表

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
目次
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?

Scope

  • 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
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