OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2017
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
List of Tables
Table 1: Symptoms of NASH 19
Table 2: Risk Factors and Comorbidities for NASH 22
Table 3: Reported Prevalence of NASH in the US and 5EU 27
Table 4: Reported Prevalence of NAFLD in the US and 5EU 27
Table 5: 6MM, Sources of Prevalence Data Used in the NASH Epidemiological Forecast 32
Table 6: 6MM, Prevalent Cases of NASH, Ages ≥ 20 Years, Men and Women, N, Selected Years, 2012-2022 40
Table 7: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N (Row %), 2012 42
Table 8: 6MM, Prevalent Cases of NASH, Ages ≥ 20 Years, By Sex, N (Row %), 2012 44
Table 9: Off-Label Treatments for NASH 51
Table 10: Product Profile - Vitamin E 53
Table 11: Vitamin E SWOT Analysis in NASH, 2013 55
Table 12: Product Profile - Pioglitazone 57
Table 13: Pioglitazone SWOT Analysis in NASH, 2013 60
Table 14: Overall Unmet Needs in NASH - Current Level of Attainment 62
Table 15: Current Clinical Trial Design of Key Pipeline Drugs for NASH, 2013 73
Table 16: NASH - Mid-Late-Stage Pipeline, 2013 75
Table 17: Product Profile - GFT505 77
Table 18: GFT505 SWOT Analysis, 2013 79
Table 19: Product Profile - Obeticholic Acid (INT-747) 81
Table 20: Obeticholic Acid (INT-747) SWOT Analysis, 2013 83
Table 21: Product Profile - Simtuzumab 85
Table 22: Simtuzumab SWOT Analysis, 2013 87
Table 23: Product Profile - Liraglutide 89
Table 24: Liraglutide Safety Profile from the LEAD Program 90
Table 25: Liraglutide SWOT Analysis, 2013 91
Table 26: Early-Stage Pipeline Products in NASH, 2013 93
Table 27: Clinical Benchmark of Key Pipeline Drugs for NASH, 2013 97
Table 28: Commercial Benchmark of Key Pipeline Drugs for NASH, 2013 99
Table 29: Top-Line Sales Forecasts ($m) for NASH, 2012-2017 102
Table 30: Key Events Impacting Sales for NASH, 2017 103
Table 31: NASH Market: US and 5EU - Drivers and Barriers, 2012-2017 104
Table 32: Key Launch Dates 121
List of Figures
Figure 1: Two-Hit and Multiple-Hits Theories in NASH 16
Figure 2: Distinct-Hit Pathogenesis in NASH 18
Figure 3: Stages of Liver Disease 20
Figure 4: 5EU, Prevalence of NAFLD and Obesity, Ages ≥ 20 Years, Men and Women, % 30
Figure 5: 6MM, Prevalent Cases of NASH, Ages ≥ 20 Years, Men and Women, N, Selected Years, 2012-2022 40
Figure 6: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N, 2012 43
Figure 7: 6MM, Prevalent Cases of NASH, Ages ≥ 20 Years, By Sex, N, 2012 45
Figure 8: Liver Biopsy to Confirm NASH 50
Figure 9: Competitive Assessment of Mid-Stage Pipeline Agents in NASH, 2012-2017 76
Figure 10: Competitive Assessment of Mid-Stage Pipeline Agents in NASH, 2012-2017 100
Figure 11: Global Sales for NASH by Region, 2012-2017 103
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