非アルコール性脂肪肝炎(NASH)：市場機会分析及び予測（～2018）...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
2.2 Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 16
3.2 Symptoms 19
4 Epidemiology 20
4.1 Disease Background 20
4.2 Risk Factors and Comorbidities 21
4.2.1 Increased age is associated with a worsened disease progression, prognosis, and mortality 21
4.2.2 Being a male is an independent risk factor in morbidly obese NASH cases 22
4.2.3 Metabolic conditions, such as type 2 diabetes, considerably increase the risk of NASH 23
4.3 Global Trends 24
4.3.1 US 25
4.3.2 5EU 26
4.4 Forecast Methodology 28
4.4.1 Sources Used 29
4.4.2 Forecast Assumptions and Methods 31
4.4.3 Sources Not Used 34
4.5 Epidemiology Forecast of NASH (2012-2022) 35
4.5.1 Total Prevalent Cases of NASH 35
4.5.2 Age-Specific Prevalent Cases of NASH 37
4.5.3 Sex-Specific Prevalent Cases of NASH 38
4.5.4 Age-Standardized Prevalence of NASH 40
4.6 Discussion 40
4.6.1 Conclusions on Epidemiological Trends 40
4.6.2 Limitations of the Analysis 41
4.6.3 Strengths of the Analysis 42
5 Current Treatment Options 43
5.1 Overview 43
5.2 Product Profiles – Major Off-Label Brands 45
5.2.1 Vitamin E (numerous generics) 45
5.2.2 Pioglitazone (Actos) 49
6 Unmet Needs Assessment and Opportunity Analysis 53
6.1 Overview 53
6.2 Unmet Needs Analysis 54
6.2.1 Lack of Approved Therapies 54
6.2.2 Identification of Biomarkers for Early Diagnosis and Endpoints 55
6.2.3 Physician Awareness Due to Understanding of Pathophysiology 55
6.3 Opportunity Analysis 56
6.3.1 Therapies with Targeted MOA to NASH 56
6.3.2 Better Models to Understand Drug Efficacy 56
6.3.3 Future Tool to Measure Fibrosis in NASH Patients 56
7 R&D Strategies 57
7.1 Overview 57
7.1.1 Understanding Multiple Factors of NASH 57
7.1.2 Potential for a Personalized Approach 57
7.2 Clinical Trial Design 58
7.2.1 Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed 59
7.2.2 Patient Recruitment Issues 59
7.2.3 Appropriate Endpoints 60
7.2.4 Clinical Regulatory Guidelines 61
8 Pipeline Assessment 63
8.1 Overview 63
8.2 Promising Drugs in Clinical Development 64
8.2.1 GFT505 64
8.2.2 Obeticholic Acid (INT-747) 68
8.2.3 Simtuzumab (Formerly GS-6624) 73
8.2.4 Liraglutide (Victoza) 76
8.3 Innovative Early-Stage Approaches 80
8.3.1 Targeting Cytokines 82
9 Pipeline Valuation Analysis 84
9.1 Clinical Benchmark of Key Pipeline Drugs 84
9.2 Commercial Benchmark of Key Pipeline Drugs 87
9.3 Competitive Assessment 89
9.4 Top-Line Five-Year Forecast 89
9.4.1 US 93
9.4.2 5EU 94
10 Appendix 96
10.1 Bibliography 96
10.2 Abbreviations 105
10.3 Methodology 108
10.4 Forecasting Methodology 108
10.4.1 Diagnosed NASH Patients 108
10.4.2 Percent Drug-Treated Patients 109
10.4.3 Drugs Included in Each Therapeutic Class 109
10.4.4 Launch Dates 110
10.4.5 General Pricing Assumptions 110
10.4.6 Individual Off-Label Drug Assumptions 111
10.4.7 Pricing of Pipeline Agents 111
10.5 Physicians and Specialists Included in this Study 112
10.6 About the Authors 113
10.6.1 Author 113
10.6.2 Epidemiologist 114
10.6.3 Global Head of Healthcare 115
10.7 About GlobalData 116
10.8 Disclaimer 116