Nonalcoholic Steatohepatitis (NASH)：市場分析及び予測（～2017）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 12
2 Introduction 13
2.1 Catalyst 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 15
3.2 Symptoms 19
4 Epidemiology 21
4.1 Disease Background 21
4.2 Risk Factors and Comorbidities 22
4.2.1 Increased age is associated with a worsened disease progression, prognosis, and mortality 22
4.2.2 Being a male is an independent risk factor in morbidly obese NASH cases 23
4.2.3 Metabolic conditions, such as type 2 diabetes, considerably increase the risk of NASH 25
4.3 Global and Historical Trends 26
4.3.1 US 28
4.3.2 5EU 29
4.4 Forecast Methodology 31
4.4.1 Sources Used 33
4.4.2 Forecast Assumptions and Methods 35
4.4.3 Sources Not Used 38
4.5 Epidemiology Forecast of Nonalcoholic Steatohepatitis (2012-2022) 39
4.5.1 Total Prevalent Cases of Nonalcoholic Steatohepatitis 39
4.5.2 Age-Specific Prevalent Cases of Nonalcoholic Steatohepatitis 41
4.5.3 Sex-Specific Prevalent Cases of Nonalcoholic Steatohepatitis 44
4.5.4 Age-Standardized Prevalence of Nonalcoholic Steatohepatitis 45
4.6 Discussion 46
4.6.1 Conclusions on Epidemiological Trends 46
4.6.2 Limitations of the Analysis 47
4.6.3 Strengths of the Analysis 48
5 Current Treatment Options 49
5.1 Overview 49
5.2 Product Profiles – Major Off-Label Brands 52
5.2.1 Vitamin E (numerous generics) 52
5.2.2 Pioglitazone (Actos) 56
6 Unmet Needs Assessment and Opportunity Analysis 61
6.1 Overview 61
6.2 Unmet Needs Analysis 63
6.2.1 Lack of Approved Therapies 63
6.2.2 Identification of Biomarkers for Early Diagnosis and Endpoints 64
6.2.3 Physician Awareness Due to Understanding of Pathophysiology 65
6.3 Opportunity Analysis 65
6.3.1 Therapies with Targeted MOA to NASH 65
6.3.2 Better Models to Understand Drug Efficacy 65
6.3.3 Future Tool to Measure Fibrosis in NASH Patients 66
7 R&D Strategies 67
7.1 Overview 67
7.1.1 Understanding Multiple Factors of NASH 67
7.1.2 Potential for a Personalized Approach 68
7.2 Clinical Trial Design 69
7.2.1 Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed 70
7.2.2 Patient Recruitment Issues 70
7.2.3 Appropriate Endpoints 71
7.2.4 Clinical Regulatory Guidelines 72
8 Pipeline Assessment 74
8.1 Overview 74
8.2 Promising Drugs in Clinical Development 75
8.2.1 GFT505 76
8.2.2 Obeticholic Acid (INT-747) 80
8.2.3 Simtuzumab (Formerly GS-6624) 84
8.2.4 Liraglutide (Victoza) 88
8.3 Innovative Early-Stage Approaches 92
8.3.1 Targeting Cytokines 93
9 Pipeline Valuation Analysis 95
9.1 Clinical Benchmark of Key Pipeline Drugs 95
9.2 Commercial Benchmark of Key Pipeline Drugs 98
9.3 Competitive Assessment 100
9.4 Top-Line Five-Year Forecast 101
9.4.1 US 105
9.4.2 5EU 106
10 Appendix 108
10.1 Bibliography 108
10.2 Abbreviations 116
10.3 Methodology 119
10.4 Forecasting Methodology 119
10.4.1 Diagnosed NASH Patients 119
10.4.2 Percent Drug-Treated Patients 120
10.4.3 Drugs Included in Each Therapeutic Class 120
10.4.4 Launch Dates 121
10.4.5 General Pricing Assumptions 121
10.4.6 Individual Off-Label Drug Assumptions 122
10.4.7 Pricing of Pipeline Agents 122
10.5 Physicians and Specialists Included in this Study 123
10.6 About the Authors 124
10.6.1 Author 124
10.6.2 Epidemiologist 125
10.6.3 Global Head of Healthcare 126
10.7 About GlobalData 127
10.8 Disclaimer 127