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市場調査レポート

非アルコール性脂肪性肝炎(NASH):機会の分析と予測

OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update

発行 GlobalData 商品コード 286301
出版日 ページ情報 英文 117 Pages
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非アルコール性脂肪性肝炎(NASH):機会の分析と予測 OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update
出版日: 2014年03月19日 ページ情報: 英文 117 Pages
概要

当レポートは、非アルコール性脂肪性肝炎(NASH)市場における機会について分析し、世界のNASH治療市場における現在・将来の競合情勢の分析、パイプライン分析、治療市場の予測、年間の治療コスト・治療利用パターンデータ、および主な産業促進因子・阻害因子・課題の分析などを提供しており、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 疾病の概要

  • 病因・病態生理学
    • 病因
    • 病態生理学
  • 症状

第4章 病態生理学

  • 疾病の背景
  • リスク因子・併存疾患
    • 年齢の上昇は病気の進行、予後および死亡率の悪化に関連している
    • 男性であることは、病的肥満のNASH事例における独立したリスク因子
    • 2型糖尿病などの代謝条件は、NASHのリスクを大幅に高める
  • 世界的・歴史的動向
  • 予測手法
  • 非アルコール性脂肪性肝炎(NASH)の病態生理学の予測
  • 議論

第5章 現在の治療選択肢

  • 概要
  • 製品プロファイル:主なオフラベルブランド
    • ビタミンE(多数のジェネリック医薬品)
    • ピオグリタゾン(Actos)

第6章 アンメットニーズの評価・機会分析

  • 概要
  • アンメットニーズの分析
    • 承認された治療法の不足
    • 早期診断・エンドポイント用バイオマーカーの特定
    • 病態生理学の理解による医師の認識
  • 機会の分析
    • NASHのMOAを標的にした治療
    • 薬剤効能を理解するのに優れたモデル
    • NASH患者の線維症を測定する将来のツール

第7章 R&D戦略

  • 概要
    • NASHの多因性の理解
    • パーソナライズドアプローチの可能性
  • 治験設計
    • 診断、モニタリングおよび感度の高い画像化法における違いが必要
    • 患者募集の課題
    • 適切なエンドポイント
    • 臨床規制ガイドライン

第8章 パイプライン評価

  • 概要
  • 臨床開発における有望な薬剤
  • 革新的な初期段階のアプローチ

第9章 パイプライン評価分析

  • 主要パイプライン薬剤の臨床ベンチマーク
  • 主要パイプライン薬剤の商業ベンチマーク
  • 競合評価
  • 売上の5カ年予測
    • 米国
    • EU5カ国

第10章 付録

  • 参考文献
  • 略語
  • 調査手法
  • 予測手法
  • 本調査に携わった医師・専門家
  • 著者について
  • GlobalDataについて
  • 免責事項

図表

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目次
Product Code: GDHC034POA

GlobalData has released its new Opportunity Analyzer report, "OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update". The NASH market is currently deserted and awaits its first NASH-specific therapy. With novel mechanism of action awaiting approval such as: Genfit's PPAR agonist, GFT505 and Intercept Pharmaceuticals/Dainippon Sumitomo Pharma's FXR agonist, Obeticholic Acid. These compounds will race to be the first approved therapy thus claiming first in class.

Scope

  • Overview of NASH, including epidemiology, etiology, symptoms, diagnosis, pathology and disease management.
  • Analysis of the current and future market competition in the global NASH therapeutics market.
  • Pipeline analysis: comprehensive data split across Phase II/IIb, emerging trends and mechanisms of action under development, including: oral Proliferator Activated Receptor alpha, delta (PPARa,d) agonist, oral Farnesoid X Receptor (FXR) agonist, subcutaneous Lysyl Oxidase-Like 2 (LOXL2) inhibitor and subcutaneous Glucagon-like Peptide-1 (GLP-1) agonist.
  • Annualized NASH therapeutics market forecast, annual cost of therapy and treatment usage pattern data from 2012-2017.
  • Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
  • Key topics covered include strategic clinical and commercial benchmarking assessment of the pipeline and standard of care, market outlook, R&D strategies, and unmet needs for the NASH therapeutics market.

Reasons to buy

Develop business strategies and perform superior market quantification analysis by -

  • Understanding the trends shaping and driving the global NASH Therapeutics market.
  • Understanding treatment preferences of physicians in disease state and across treatment flow.
  • Accessing market sizing, forecasts and quantified growth opportunities in the global NASH Therapeutics market till 2017.
  • Quantifying patient population in the global NASH Therapeutics market to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape by
  • Performing benchmarking analysis and growth opportunities against currently marketed products.
  • Identifying market entry points based on safety, efficacy, and pricing parameters.
  • Assessing competitiveness of products in market by understanding the strength and weakness of current competition.
  • Develop and design your in-licensing and out-licensing strategies by
  • Taking a comprehensive look of at the disease pipeline and identifying most promising paradigm shifting products.
  • Assessing strength of pipeline based on first in class and lifecycle management of products.
  • Analyze the potential impact of novel oral therapies such as Genfit's GFT505 on the NASH treatment paradigm.
  • Track drug sales in the global NASH Therapeutics market from 2012 to 2017.
  • Identify the 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 the best opportunities for consolidation, investments and strategic partnerships.
  • What's the next big thing in the global NASH Therapeutics market landscape? Identify, understand, and capitalize.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
    • 4.2.1. Increased age is associated with a worsened disease progression, prognosis, and mortality
    • 4.2.2. Being a male is an independent risk factor in morbidly obese NASH cases
    • 4.2.3. Metabolic conditions, such as type 2 diabetes, considerably increase the risk of NASH
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Forecast Assumptions and Methods
    • 4.4.3. Sources Not Used
  • 4.5. Epidemiology Forecast of NASH (2012-2022)
    • 4.5.1. Total Prevalent Cases of NASH
    • 4.5.2. Age-Specific Prevalent Cases of NASH
    • 4.5.3. Sex-Specific Prevalent Cases of NASH
    • 4.5.4. Age-Standardized Prevalence of NASH
  • 4.6. Discussion
    • 4.6.1. Conclusions on Epidemiological Trends
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles - Major Off-Label Brands
    • 5.2.1. Vitamin E (numerous generics)
    • 5.2.2. Pioglitazone (Actos)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Lack of Approved Therapies
    • 6.2.2. Identification of Biomarkers for Early Diagnosis and Endpoints
    • 6.2.3. Physician Awareness Due to Understanding of Pathophysiology
  • 6.3. Opportunity Analysis
    • 6.3.1. Therapies with Targeted MOA to NASH
    • 6.3.2. Better Models to Understand Drug Efficacy
    • 6.3.3. Future Tool to Measure Fibrosis in NASH Patients

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Understanding Multiple Factors of NASH
    • 7.1.2. Potential for a Personalized Approach
  • 7.2. Clinical Trial Design
    • 7.2.1. Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed
    • 7.2.2. Patient Recruitment Issues
    • 7.2.3. Appropriate Endpoints
    • 7.2.4. Clinical Regulatory Guidelines

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. GFT505
    • 8.2.2. Obeticholic Acid (INT-747)
    • 8.2.3. Simtuzumab (Formerly GS-6624)
    • 8.2.4. Liraglutide (Victoza)
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Targeting Cytokines

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed NASH Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Off-Label Drug Assumptions
    • 10.4.7. Pricing of Pipeline Agents
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Epidemiologist
    • 10.6.3. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Symptoms of NASH
  • Table 2: Risk Factors and Comorbidities for NASH
  • Table 3: Reported Prevalence of NASH in the US and 5EU
  • Table 4: Reported Prevalence of NAFLD in the US and 5EU
  • Table 5: 6MM, Sources of Prevalence Data Used in the NASH Epidemiological Forecast
  • Table 6: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, Men and Women, N, Selected Years, 2012-2022
  • Table 7: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N (Row %), 2012
  • Table 8: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, By Sex, N (Row %), 2012
  • Table 9: Off-Label Treatments for NASH
  • Table 10: Product Profile - Vitamin E
  • Table 11: Vitamin E SWOT Analysis in NASH, 2013
  • Table 12: Product Profile - Pioglitazone
  • Table 13: Pioglitazone SWOT Analysis in NASH, 2013
  • Table 14: Overall Unmet Needs in NASH - Current Level of Attainment
  • Table 15: Current Clinical Trial Design of Key Pipeline Drugs for NASH, 2013
  • Table 16: NASH - Mid-Late-Stage Pipeline, 2013
  • Table 17: Product Profile - GFT505
  • Table 18: GFT505 SWOT Analysis, 2013
  • Table 19: Product Profile - Obeticholic Acid (INT-747)
  • Table 20: Obeticholic Acid (INT-747) SWOT Analysis, 2013
  • Table 21: Product Profile - Simtuzumab
  • Table 22: Simtuzumab SWOT Analysis, 2013
  • Table 23: Product Profile - Liraglutide
  • Table 24: Liraglutide Safety Profile from the LEAD Program
  • Table 25: Liraglutide SWOT Analysis, 2013
  • Table 26: Early-Stage Pipeline Products in NASH, 2013
  • Table 27: Clinical Benchmark of Key Pipeline Drugs for NASH, 2013
  • Table 28: Commercial Benchmark of Key Pipeline Drugs for NASH, 2013
  • Table 29: Top-Line Sales Forecasts ($m) for NASH, 2012-2017
  • Table 30: Key Events Impacting Sales for NASH, 2017
  • Table 31: NASH Market: US and 5EU - Drivers and Barriers, 2012-2017
  • Table 32: Key Launch Dates

List of Figures

  • Figure 1: Two-Hit and Multiple-Hits Theories in NASH
  • Figure 2: Distinct-Hit Pathogenesis in NASH
  • Figure 3: Stages of Liver Disease
  • Figure 4: 5EU, Prevalence of NAFLD and Obesity, Ages ≥20 Years, Men and Women, %
  • Figure 5: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, Men and Women, N, Selected Years, 2012-2022
  • Figure 6: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N, 2012
  • Figure 7: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, By Sex, N, 2012
  • Figure 8: Liver Biopsy to Confirm NASH
  • Figure 9: Competitive Assessment of Mid-Stage Pipeline Agents in NASH, 2012-2017
  • Figure 10: Global Sales for NASH by Region, 2012-2017
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