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市場調查報告書

非酒精性脂肪性肝炎(NASH):機會分析與預測

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

出版商 GlobalData 商品編碼 286301
出版日期 內容資訊 英文 117 Pages
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非酒精性脂肪性肝炎(NASH):機會分析與預測 OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update
出版日期: 2014年03月19日 內容資訊: 英文 117 Pages
簡介

本報告提供非酒精性脂肪性肝炎(NASH)市場上機會相關分析、全球NASH治療市場上現在及未來的競爭情形分析、開發平台分析、治療市場預測、年度的治療成本、治療利用模式資料,及主要產業成長要素與阻礙要素、課題分析等等,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理學
    • 病因
    • 病理學
  • 症狀

第4章 病理學

  • 疾病的背景
  • 風險因素、共生病症
    • 年齡的上升與著疾病發展,預測及死亡率的惡化有關聯
    • 男性在病態肥胖的NASH案例上獨立的風險因素
    • 第二型糖尿病等的代謝條件,大幅度提高NASH的風險
  • 全球、歷史性趨勢
  • 預測手法
  • 非酒精性脂肪性肝炎(NASH)的病理學的預測
  • 議論

第5章 目前可供選擇的治療方案

  • 概要
  • 產品簡介:主要的非標籤藥物品牌
    • 維他命E(多數的學名藥)
    • PIOGLITAZONE(Actos)

第6章 未滿足需求的評估、機會分析

  • 概要
  • 未滿足需求分析
    • 已批准治療方法的不足
    • 早期診斷、試驗指標用生物標記的特定
    • 由於理解病理學的醫生意識
  • 機會分析
    • 把NASH的MOA做為標的治療
    • 理解藥物功效的出色模式
    • 測量NASH患者的線維症的未來工具

第7章 R&D策略

  • 概要
    • 理解NASH的多因素性
    • 個人化方法的可能性
  • 臨床實驗設計
    • 診斷、監測及靈敏度高的影像化法的差異是必須的
    • 募集患者的課題
    • 恰當的試驗指標
    • 臨床法規指南

第8章 開發平台評估

  • 概要
  • 臨床開發有潛力的藥劑
  • 創新的初期階段的方法

第9章 開發平台評估分析

  • 主要開發平台藥物的臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的5年預測
    • 美國
    • EU5個國家

第10章 附錄

  • 參考文獻
  • 簡稱
  • 調查手法
  • 預測手法
  • 從事本調查的醫生、專家
  • 關於作者
  • 關於GlobalData
  • 免責聲明

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目錄
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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