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市場調查報告書

重症肌無力 - 市場機會分析與到2024年前的預測

OpportunityAnalyzer: Myasthenia Gravis - Opportunity Analysis and Forecasts to 2024

出版商 GlobalData 商品編碼 339387
出版日期 內容資訊 英文 153 Pages
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重症肌無力 - 市場機會分析與到2024年前的預測 OpportunityAnalyzer: Myasthenia Gravis - Opportunity Analysis and Forecasts to 2024
出版日期: 2015年06月03日 內容資訊: 英文 153 Pages
簡介

重症肌無力是影響神經系統的自體免疫疾病。多數患者最初 眼睛肌肉局部兼侷限性的出現眼臉下垂或複視等症狀。之後嚴重化變為全身性,擴及到手腳及呼吸器官肌肉。因此可能造成呼吸困難必須仰賴人工呼吸器。最後可能惡化到重症肌無力危象等攸關生死的狀態。一般來說會在重症肌無力發病起二年內發生。

本報告提供重症肌無力的流行病學,病因,病理學,症狀,診斷,治療指南等概要,以及市場收益及到2024年前的預測,並彙整未滿足需求與開發平台分析,市場上競爭趨勢等資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病理學
  • 重症肌無力危象及其他症狀
  • 診斷標準

第4章 流行病學

  • 疾病的背景
  • 風險因素和共生病症
  • 全球的趨勢
  • 預測方法
  • 重症肌無力的流行病學的預測
  • 考察

第5章 目前治療方法

  • 概要
  • 產品簡介:領導品牌

第6章 未滿足需求的評估與機會分析

  • 概要
  • 未滿足需求分析
  • 研究開發策略
  • 臨床實驗設計

第7章 開發平台評估

  • 概要
  • 臨床開發的潛力藥劑
  • 創新的早期階段的方法
  • 極為早期的方法

第8章 開發平台價值分析

  • 概要
  • 主要的開發平台藥物臨床基準
  • 主要的開發平台藥物的商業基準
  • 競爭評估
  • 主要地區的10年預測
    • 美國
    • 歐洲5個國家
    • 日本

第9章 附錄

圖表

目錄
Product Code: GDHC024POA

Myasthenia gravis is an autoimmune disease affecting the nervous system . While myasthenia gravis is a rare disease, it is considered to be the most common neuromuscular disorder and presents itself as a weakness of the muscles. In the majority of patients the disease is initially localized and limited to the eye muscles causing a drooping of the eyelid and double vision. The majority of patients progress to a more severe and generalized form, where the disease spreads to other muscles such as bulbar, limb, and respiratory muscles. Weakness of the respiratory muscles can lead to shortness of breath or in more severe cases it can lead to the patients requiring assisted ventilation. A worsening of myasthenia gravis of this sort is referred to as myasthenia crisis and is a life threatening condition, which typically occurs within the first two years after myasthenia gravis onset.

Highlights

Key Questions Answered

  • The myasthenia gravis market has been dominated by short and long-term-immunosuporessants and acetylcholinesterase inhibitors in the last decades. New classes of drugs are anticipated the reach the market within the forecast period. How will these drugs change the myasthenia gravis market? What impact will they have on the market size?
  • The current late stage myasthenia gravis pipeline is dominated by monoclonal antibodies. Which monoclonal antibody will have the biggest impact on the market? What strategies are developers undertaking to penetrate this highly generic market? Will the new drugs fulfil any unmet needs?
  • Population aging is occurring in almost all countries worldwide, particularly in the 7MM. This is expected to have a significant impact on the prevalence of myasthenia gravis. How will epidemiological changes impact the growth of the future market?

Key Findings

  • The main driver of growth in the myasthenia gravis market will be the introduction of monoclonal antibodies over the forecast period. The increase in prevalence will support the market growth and a high level of unmet needs will insure that the market remains interesting in the future.
  • The biggest barrier for growth in the myasthenia gravis market are anticipated difficulties for the reimbursement of monoclonal antibodies. Furthermore, the myasthenia gravis market is dominated by generics and off-label drugs, limiting treatment cost for patients who have an acceptable level of disease control.
  • The largest unmet needs in myasthenia gravis is a targeted, steroid sparing therapy. Approximately 10% of patients are currently treatment refractory and urgently need new treatment options. Patients currently treated with steroids also would benefit from treatment regimen additions.

Scope

  • Overview of myasthenia gravis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized myasthenia gravis a market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
  • Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the myastenia gravis therapeutics market.
  • Pipeline analysis: focus on the late-stage pipeline myasthenia gravis drugs discussing emerging trends as well as overview of earlier phase drugs.
  • Analysis of the current and future market competition in the global myasthenia gravisa 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

  • 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.
  • Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global myasthenia gravis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global myasthenia gravis therapeutics market in 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.
  • Track drug sales in the global myasthenia gravis therapeutics market from 2014-2024.
  • 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 9

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction 15

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Reports

3. Disease Overview 17

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. The Complement System and Myasthenia Gravis
    • 3.1.2. B-Cells and Myasthenia Gravis
    • 3.1.3. Thymoma and Thymectomy
    • 3.1.4. Mechanisms of Action of Current and Future Myasthenia Gravis Treatments
  • 3.2. Myasthenic Crisis and Other Symptoms
  • 3.3. Diagnostic Criteria
    • 3.3.1. MGFA and Osserman Classification Systems
    • 3.3.2. Diagnostic Tools
    • 3.3.3. Treatment Guidelines

4. Epidemiology 26

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast of Myasthenia Gravis (2014-2024)
    • 4.5.1. Diagnosed Prevalent Cases of Myasthenia Gravis
    • 4.5.2. Age-Specific Diagnosed PrevaIent Cases of Myasthenia Gravis
    • 4.5.3. Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis
    • 4.5.4. Age-Standardized Diagnosed Prevalence of Myasthenia Gravis
    • 4.5.5. Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Class
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options 47

  • 5.1. Overview
    • 5.1.1. Acetylcholine Inhibitors
    • 5.1.2. Short-Term Immunosuppressants
    • 5.1.3. Long-Term Immunosuppressants
    • 5.1.4. Rapid, Short-Term Immunomodulation
    • 5.1.5. Biologics
  • 5.2. Product Profiles - Major Brands
    • 5.2.1. Rituxan/MabThera (Rituximab)
    • 5.2.2. Prograf (Tacrolimus)

6. Unmet Needs Assessment and Oppportunity Analysis 73

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Fast, Targeted Therapy Restoring Muscle Strength
    • 6.2.2. Reduction of steroid side effects
    • 6.2.3. Reimbursement of Biologics
    • 6.2.4. Difficult-to-Treat Myasthenia Gravis Patient: Refractory, Cancer, Diabetic, and Pregnant patients
    • 6.2.5. Biomarkers
    • 6.2.6. Undiagnosed Myasthenia Gravis
  • 6.3. R&D Strategies
    • 6.3.1. Overview
    • 6.3.2. Monoclonal Antibodies
    • 6.3.3. Targeting of Complement System
    • 6.3.4. Targeting of B-cells
    • 6.3.5. Myasthenia Gravis as an Add-on Indication
  • 6.4. Clinical Trial Design
    • 6.4.1. Recommendation for Clinical Research Standards
    • 6.4.2. Trial Design Tailored to Fit Individual Pipeline Drug
    • 6.4.3. Pitfalls of Clinical Trials in Myasthenia Gravis

7. Pipeline Assessment 96

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development
    • 7.2.1. Soliris (Eculizumab)
  • 7.3. Innovative Early-Stage Approaches
    • 7.3.1. Benlysta (Belimumab)
    • 7.3.2. Tirasemtiv (CK-2017357)
    • 7.3.3. Alternative Approaches for Targeting the Complement System
  • 7.4. Very Early-Stage Approaches

8. Pipeline Valuation Analysis 111

  • 8.1. Overview
  • 8.2. Clinical Benchmark of Key Pipeline Drugs
  • 8.3. Commercial Benchmark of Key Pipeline Drugs
  • 8.4. Competitive Assessment
  • 8.5. Top Line Ten-Year Forecast
    • 8.5.1. US
    • 8.5.2. 5EU
    • 8.5.3. Japan

9. Appendix 122

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed Myasthenia Gravis patients
    • 9.4.2. Percent Drug-Treated Patients
    • 9.4.3. Drugs Included in Each Therapeutic Class
    • 9.4.4. Launch and Patent Expiry Dates
    • 9.4.5. General Pricing Assumptions
    • 9.4.6. Individual Drug Assumptions
    • 9.4.7. Generic Erosion
    • 9.4.8. Pricing of Pipeline Agents
  • 9.5. Physicians and Specialists Included in this Study
    • 9.5.1. Primary Research - Prescriber Survey
  • 9.6. About the Authors
    • 9.6.1. Author
    • 9.6.2. Reviewer
    • 9.6.3. Epidemiologists
    • 9.6.4. Global Head of Healthcare
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Current and Future Myasthenia Gravis Treatments and Their MOAs
  • Table 2: Osserman Classifications
  • Table 3: MGFA Clinical Classifications
  • Table 4: Myasthenia Gravis Diagnostics
  • Table 5: Myasthenia Gravis Guidelines
  • Table 6: Risk Factors and Comorbidities for Myasthenia Gravis
  • Table 7: Global Estimates for the Diagnosed Prevalence of Myasthenia Gravis
  • Table 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Myasthenia Gravis
  • Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Myasthenia Gravis Segmented by MGFA Classifications
  • Table 10: 8MM, Sources Not Used in Epidemiological Analysis of Myasthenia Gravis
  • Table 11: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, All Ages, N, Select Years 2014-2024
  • Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, N (Row %), 2014
  • Table 13: 7MM: Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, All Ages, N (Row %), 2014
  • Table 14: Treatment Recommendations and Clinical Evidence
  • Table 15: Leading Treatments and Formulations for Myasthenia Gravis
  • Table 16: Product Profile - Rituxan/MabThera
  • Table 17: Rituxan SWOT analysis, 2015
  • Table 18: Product Profile - Prograf
  • Table 19: Prograf SWOT analysis, 2015
  • Table 20: Overall Unmet Needs - Current Level of Attainment
  • Table 21: Myasthenia Gravis - Late Stage Pipeline, 2015
  • Table 22: Product Profile - Eculizumab
  • Table 23: Soliris SWOT Analysis, 2015
  • Table 24: Early-Stage Pipeline Products for Myasthenia Gravis, April 2015
  • Table 25: Clinical Benchmark of Key Pipeline Drugs
  • Table 26: Commercial Benchmark of Key Pipeline Drugs
  • Table 27: Top Line Sales Forecast ($m) for Myasthenia Gravis, 2014-2024
  • Table 28: Key Events Impacting Sales for Myasthenia Gravis, 2014-2024
  • Table 29: Myasthenia Gravis Market - Drivers and Barriers, 2014-2024
  • Table 30: Key Launch Dates
  • Table 31: Key Patent Expiries
  • Table 32: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Neuromuscular Terminals and their Role in Myasthenia Gravis
  • Figure 2: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, All Ages, N, 2014-2024
  • Figure 3: 7MM, Age-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, N, 2014
  • Figure 4: 7MM, Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, All Ages, 2014
  • Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of Myasthenia Gravis (Cases per 100,000 Population), Both Sexes, All Ages, 2014
  • Figure 6: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Class, Both Sexes, All Ages, N, 2014
  • Figure 7: Current Myasthenia Gravis Treatments
  • Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in Myasthenia Gravis , 2014-2024
  • Figure 9: Global Sales for Myasthenia Gravis by Region, 2014and 2024
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