Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 12
2.4.1 Etiology 12
2.4.2 Pathophysiology 12
2.5 Diagnosis 16
2.5.1 Non-invasive Tests 17
2.6 Disease Classification 18
2.7 Prognosis 20
2.8 Co-morbidities 20
2.9 Treatment Options and Treatment Algorithm 20
2.9.1 Treatment Options 20
2.9.2 Treatment Algorithm 23
2.9.3 Non-pharmacological Treatments 25
3 Marketed Products 27
3.1 Overview 27
3.1.1 Vitamin E 27
3.1.2 Pentoxifylline 27
3.1.3 Pioglitazone 28
3.2 Comparative Efficacy and Safety of Marketed Products 29
4 Pipeline Analysis 32
4.1 Overview 32
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 32
4.3 Pipeline by Molecular Target 34
4.4 Promising Pipeline Candidates 35
4.4.1 Selonsertib – Gilead 35
4.4.2 Elafibrinor – Genfit 37
4.4.3 Saroglitazar – Zydus 39
4.4.4 Ocaliva (obeticholic acid) – Intercept Pharmaceuticals 40
4.4.5 Cenicriviroc – Allergan 42
4.4.6 Aramchol – Galmed 44
4.5 Comparative Efficacy and Safety of Pipeline Products 44
4.6 Product Competitiveness Framework 46
5 Clinical Trial Analysis 48
5.1 Failure Rate 48
5.1.1 Overall Failure Rate 48
5.1.2 Failure Rate by Phase and Molecule Type 50
5.1.3 Failure Rate by Phase and Molecular Target 51
5.2 Clinical Trial Size 52
5.2.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 52
5.2.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 54
5.3 Clinical Trial Duration 55
5.3.1 Clinical Trial Duration by Molecule Type 55
5.3.2 Clinical Trial Duration by Molecular Target 57
5.4 Summary of Clinical Trial Metrics 58
6 Multi-scenario Forecast 59
6.1 Geographical Markets 59
6.2 Asia-Pacific Market 59
6.3 India 61
6.3.1 Treatment Usage Patterns 61
6.3.2 Annual Cost of Therapy 62
6.3.3 Market Size 63
6.4 China 64
6.4.1 Treatment Usage Patterns 64
6.4.2 Annual Cost of Therapy 65
6.4.3 Market Size 67
6.5 Australia 67
6.5.1 Treatment Usage Patterns 67
6.5.2 Annual Cost of Therapy 69
6.5.3 Market Size 71
6.6 South Korea 72
6.6.1 Treatment Usage Patterns 72
6.6.2 Annual Cost of Therapy 73
6.6.3 Market Size 74
6.7 Japan 75
6.7.1 Treatment Usage Patterns 75
6.7.2 Annual Cost of Therapy 75
6.7.3 Market Size 77
7 Drivers and Barriers 78
7.1 Drivers 78
7.1.1 Rising Awareness and Growing Prevalence of the Disease 78
7.1.2 Launch of NASH-Specific Therapies 78
7.1.3 Advancements in Diagnostic Procedures for NASH 78
7.1.4 Increasing Awareness and Diversified Healthcare Reform 79
7.2 Barriers 79
7.2.1 Delayed Diagnosis Due to Complex Pathophysiology 79
7.2.2 Low Diagnosis and Treatment Rate 79
7.2.3 High Cost Therapies May Lead to Reimbursement issues 80
8 Deals and Strategic Consolidations 81
8.1 Licensing Deals 81
8.1.1 Deals by Region and Value 81
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 82
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 83
8.1.4 Key Licensing Deals 85
8.2 Co-development Deals 87
8.2.1 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 88
8.2.2 Deal Value by Stage of Development, Molecule Type, and Molecular Target 89
8.2.3 Key Co-development Deals 91
9 Appendix 93
9.1 All Pipeline Drugs by Stage of Development 93
9.1.1 Discovery 93
9.1.2 Preclinical 95
9.1.3 IND/CTA-filed 98
9.1.4 Phase I 99
9.1.5 Phase II 100
9.1.6 Phase III 101
9.2 Summary of Multi-scenario Market Forecasts to 2024 101
9.2.1 Asia-Pacific 101
9.2.2 India 102
9.2.3 China 102
9.2.4 Australia 103
9.2.5 South Korea 103
9.2.6 Japan 104
9.3 Bibliography 104
9.4 Abbreviations 107
9.5 Research Methodology 108
9.5.1 Secondary Research 109
9.5.2 Marketed Product Profiles 109
9.5.3 Late-Stage Pipeline Candidates 110
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 110
9.5.5 Product Competitiveness Framework 110
9.5.6 Pipeline Analysis 110
9.5.7 Forecasting Model 111
9.5.8 Deals Data Analysis 112
9.6 Contact Us 112
9.7 Disclaimer 112