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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: NASH - Opportunity Analysis and Forecasts to 2026

出版商 GlobalData 商品編碼 286301
出版日期 內容資訊 英文 171 Pages
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非酒精性脂肪性肝炎(NASH):機會分析與預測 OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026
出版日期: 2017年05月08日 內容資訊: 英文 171 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: GDHC068POA

Nonalcoholic steatohepatitis (NASH) (ICD-10-CM = K75.81) is a condition that develops as a subgroup of nonalcoholic fatty liver disease (NAFLD) when excessive fat buildup is accompanied by liver cell injury and inflammation. NAFLD is defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver. Progression of this condition to NASH dramatically increases the risk of cirrhosis, liver failure, and hepatocellular carcinoma, and it is therefore a potentially fatal condition.

It is estimated that the 2016 sales for the nonalcoholic steatohepatitis (NASH) market at approximately $618m across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the NASH market will grow at a Compound Annual Growth Rate (CAGR) of 45.0% across the 7MM.

The US and Japanese markets are both anticipated to grow significantly, recording CAGRs of 48.1% and 50.7%, respectively, while the 5EU will record a CAGR of 30.6%. At the end of 2026, the US will contribute around 88% of global sales, while the 5EU and Japan will account for around 10% and 2% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of NASH in the region, as well as the launch of more pipeline agents in this region.

Major drivers of growth in the NASH market include -

  • The growing rate of obesity and diabetes globally, leading to an increase in the number of NASH cases.
  • The launches of multiple late-stage pipeline products, which will transform the market from one dominated by the use of off-label generics to a burgeoning, competitive space.

The report "OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026" analyzes the nuances of the NASH treatment landscape and provides detailed insights into the market dynamics of this highly competitive space. The analysis also includes the evaluation of the commercial and clinical profiles of the late-stage pipeline candidates, and their sales forecasts for the NASH indication over the 2016-2026 time periods.

In particular, this report provides the following -

  • Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global NASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report: Gilead Sciences, Intercept Pharmaceuticals, Genfit SA, Allergan Plc, Galectin Therapeutics, Galmed Pharmaceuticals, Inventiva Pharma, Novo Nordisk, Conatus Pharmaceuticals, Novartis, Immuron Limited, Cirius Therapeutics.

Scope

  • Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global NASH 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 NASH therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NASH therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 Table of Contents 2

  • 1.1 List of Tables 5
  • 1.2 List of Figures 6

2 Executive Summary 7

  • 2.1 Mid-Forecast Surge in Sales for NASH 7
  • 2.2 Manufacturers Are Employing Strategies to Improve Diagnostics while Advancing Drug Development 9
  • 2.3 Vast Unmet Needs Exist in the NASH Market 9
  • 2.4 Opportunities Abound for Tools that Support Accurate Diagnosis 9
  • 2.5 Launches of Novel Pipeline Products Will Revolutionize the NASH Treatment Landscape 10
  • 2.6 What Do the Physicians Think? 12

3 Introduction 15

  • 3.1 Catalyst 15
  • 3.2 Related Reports 15

4 Disease Overview 16

  • 4.1 Etiology and Pathophysiology 16
    • 4.1.1 Etiology 16
    • 4.1.2 Pathophysiology 17
  • 4.2 Disease Staging 22
  • 4.3 Symptoms 23

5 Epidemiology 24

  • 5.1 Risk Factors and Comorbidities 24
  • 5.2 Global Trends 26
    • 5.2.1 US 27
    • 5.2.2 5EU 27
    • 5.2.3 Japan 28
  • 5.3 Forecast Methodology 28
    • 5.3.1 Sources Used Tables 30
    • 5.3.2 Forecast Assumptions and Methods 33
    • 5.3.3 Sources Not Used 41
  • 5.4 Epidemiological Forecast for NASH (2016-2026) 42
    • 5.4.1 Total Prevalent Cases of NASH 42
    • 5.4.2 Age-Specific Total Prevalent Cases of NASH 44
    • 5.4.3 Sex-Specific Total Prevalent Cases of NASH 45
    • 5.4.4 Age-Standardized Prevalence of NASH 47
    • 5.4.5 Diagnosed Prevalent Cases of NASH 48
    • 5.4.6 Diagnosed Prevalent Cases of NASH by Comorbid Disorder 50
  • 5.5 Discussion 52
    • 5.5.1 Epidemiological Forecast Insight 52
    • 5.5.2 Limitations of the Analysis 53
    • 5.5.3 Strengths of the Analysis 54

6 Current Treatment Options 56

  • 6.1 Overview 56
  • 6.2 Diagnosis 56
  • 6.3 Treatment Guidelines and Leading Prescribed Drugs 56
  • 6.4 Product Profiles 58
    • 6.4.1 Vitamin E 58
    • 6.4.2 Pentoxifylline 61
    • 6.4.3 Pioglitazone 64

7 Unmet Needs Assessment and Opportunity Analysis 68

  • 7.1 Overview 68
  • 7.2 Unmet Needs Analysis 69
    • 7.2.1 Approved Therapies 69
    • 7.2.2 Identification of Biomarkers for Early Diagnosis and Clinical Endpoint Determination 71
    • 7.2.3 Physician Awareness 74
    • 7.2.4 Understanding Disease Pathophysiology and Characterizing the Disease 75
    • 7.2.5 Understanding the Impact and Burden of NASH on Healthcare Service 77

8 R&D Strategies 79

  • 8.1 Overview 79
    • 8.1.1 NASH-Specific Drugs with Multiple Physiological Targets 79
    • 8.1.2 Combination Therapies 79
  • 8.2 Clinical Trial Design 80
    • 8.2.1 Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed 81
    • 8.2.2 Patient Recruitment Issues 81
    • 8.2.3 Appropriate Endpoints 82
    • 8.2.4 Clinical Regulatory Guidelines 83

9 Pipeline Assessment 90

  • 9.1 Overview 90
  • 9.2 Promising Drugs in Clinical Development 91
    • 9.2.1 Ocaliva (Obeticholic Acid) 92
    • 9.2.2 Elafibranor (GFT505) 97
    • 9.2.3 Aramchol 102
    • 9.2.4 Cenicriviroc 106
    • 9.2.5 Emricasan 109
    • 9.2.6 IMM-124E 114
    • 9.2.7 Selonsertib (GS-4997) 117
    • 9.2.8 IVA337 120
    • 9.2.9 GR-MD-02 123
    • 9.2.10 Semaglutide (NN9931) 126
    • 9.2.11 MSDC-0602K 129
  • 9.3 Innovative Early-Stage Approaches 131

10 Pipeline Valuation Analysis 133

  • 10.1 Clinical Benchmark of Key Pipeline Drugs 133
  • 10.2 Commercial Benchmark of Key Pipeline Drugs 137
  • 10.3 Competitive Assessment 140
  • 10.4 Top Line 10-Year Forecast 142
    • 10.4.1 US 145
    • 10.4.2 5EU 146
    • 10.4.3 Japan 147

11 Appendix 148

  • 11.1 Bibliography 148
  • 11.2 Abbreviations 160
  • 11.3 Methodology 164
  • 11.4 Forecasting Methodology 164
    • 11.4.1 Total Prevalent Cases of NASH 164
    • 11.4.2 Diagnosed Prevalent Cases of NASH 164
    • 11.4.3 Patient Segmentation 164
    • 11.4.4 Percent Drug-Treated Patients 165
    • 11.4.5 Launch Dates for Pipeline Drugs 165
    • 11.4.6 General Pricing Assumptions 166
  • 11.5 Physicians and Specialists Included in this Study 166
  • 11.6 About the Authors 168
    • 11.6.1 Analyst 168
    • 11.6.2 Directors 169
    • 11.6.3 Epidemiologist 169
    • 11.6.4 Global Director of Therapy Analysis and Epidemiology 170
    • 11.6.5 Global Head and EVP of Healthcare Operations and Strategy 170
  • 11.7 About GlobalData 171
  • 11.8 Contact Us 171
  • 11.9 Disclaimer 171

List of Tables

1.1 List of Tables

  • Table 1: NASH: Key Metrics in Seven Major Pharmaceutical Markets 7
  • Table 2: NASH Clinical Research Network Histological Scoring System 22
  • Table 3: Major symptoms of NASH 23
  • Table 4: Risk Factors and Comorbidities for NASH 25
  • Table 5: 7MM, Sources of Epidemiological Data Used to Forecast Total Prevalent Cases of NASH 30
  • Table 6: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of NASH 31
  • Table 7: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of NASH by Comorbid Disorder 32
  • Table 8: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages ≥4 Years, Select Years, 2016-2026 43
  • Table 9: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, N (Row %), 2016 44
  • Table 10: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages ≥4 Years, N (Row %), 2016 46
  • Table 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages ≥4 Years, Select Years, 2016-2026 49
  • Table 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages ≥4 Years, N (Row %), 2016 51
  • Table 13: Treatment Guidelines Available for NASH 56
  • Table 14: Off-Label Treatments for NASH 58
  • Table 15: Product Profile - Vitamin E 59
  • Table 16: Vitamin E SWOT Analysis in NASH 61
  • Table 17: Product Profile - Pentoxifylline 62

Table 18: Pentoxifylline SWOT Analysis 64

  • Table 19: Product Profile - Pioglitazone 65
  • Table 20: Pioglitazone SWOT Analysis in NASH 67
  • Table 21: Unmet Needs and Opportunities in NASH, 2017 69
  • Table 22: Phase III Clinical Trial Design of Key Pipeline Drugs for NASH 85
  • Table 23: Phase IIb Clinical Trial Design of Key Pipeline Drugs for NASH 87
  • Table 24: NASH - Late-Stage Pipeline, 2017 91
  • Table 25: Product Profile - Ocaliva 95

Table 26: Ocaliva SWOT Analysis 97

  • Table 27: Product Profile - Elafibranor (GFT505) 99

Table 28: Elafibranor (GFT505) SWOT Analysis 102

  • Table 29: Product Profile - Aramchol 103

Table 30: Aramchol SWOT Analysis 106

  • Table 31: Product Profile - Cenicriviroc 108

Table 32: Cenicriviroc SWOT Analysis 109

  • Table 33: Product Profile - Emricasan 112

Table 34: Emricasan SWOT Analysis 114

  • Table 35: Product Profile - IMM-124E 116

Table 36: IMM-124E SWOT Analysis 117

  • Table 37: Product Profile - Selonsertib 119

Table 38: Selonsertib SWOT Analysis 120

  • Table 39: Product Profile - IVA337 121

Table 40: IVA337 SWOT Analysis 122

  • Table 41: Product Profile - GR-MD-02 124

Table 42: GR-MD-02 SWOT Analysis 126

  • Table 43: Product Profile - Semaglutide 128

Table 44: Semaglutide SWOT Analysis 129

  • Table 45: Product Profile - MSDC-0602K 130

Table 46: MSDC-0602K SWOT Analysis 131

  • Table 47: Innovative Early-Stage Approaches in NASH 131
  • Table 48: Clinical Benchmark of Key Pipeline Drugs for NASH 134
  • Table 49: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 135
  • Table 50: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 136
  • Table 51: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 137
  • Table 52: Commercial Benchmark of Key Pipeline Drugs for NASH 138
  • Table 53: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 139
  • Table 54: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 139
  • Table 55: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 140
  • Table 56: Top Line Sales Forecasts ($m) for NASH, 2016-2026 142
  • Table 57: Key Events Impacting Sales for NASH, 2016-2026 145
  • Table 58: NASH Market: 7MM - Drivers and Barriers, 2016-2026 145
  • Table 59: Projected Launch Dates for Key Drugs in NASH Across the 7MM 165
  • Table 60: High-Prescribing Physicians Surveyed, by Country 166

List of Figures

1.2 List of Figures

  • Figure 1: Sales for NASH by Region, 2016-2026 8
  • Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in NASH 11
  • Figure 3: Stages of Liver Disease 17
  • Figure 4: The Multiple Hits Theory in NASH 19
  • Figure 5: Major Drug Targets for NASH Treatment 21
  • Figure 6: 5EU, Total Prevalence of NAFLD and Obesity (%), Ages ≥20 Years, Both Sexes 28
  • Figure 7: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages ≥4 Years, Selected Years, 2016-2026 43
  • Figure 8: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, 2016 45
  • Figure 9: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages ≥4 Years, 2016 47
  • Figure 10: 7MM, Age-Standardized Total Prevalence of NASH, Ages ≥4 Years, 2016 48
  • Figure 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages ≥4 Years, Selected Years, 2016-2026 50
  • Figure 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages ≥4 Years, N, 2016 51
  • Figure 13: NASH - Phase II?III Pipeline, 2017 92
  • Figure 14: Competitive Assessment of Late-Stage Pipeline Agents in NASH 141
  • Figure 15: Global Sales for NASH by Region, 2016-2026 144
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