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OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update

Summary

GlobalData has released its new Opportunity Analyzer report, “OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update”. The NASH market is currently deserted and awaits its first NASH-specific therapy. With novel mechanism of action awaiting approval such as: Genfit’s PPAR agonist, GFT505 and Intercept Pharmaceuticals/Dainippon Sumitomo Pharma’s FXR agonist, Obeticholic Acid. These compounds will race to be the first approved therapy thus claiming first in class.

Scope

- Overview of NASH, including epidemiology, etiology, symptoms, diagnosis, pathology and disease management.
- Analysis of the current and future market competition in the global NASH therapeutics market.
- Pipeline analysis: comprehensive data split across Phase II/IIb, emerging trends and mechanisms of action under development, including: oral Proliferator Activated Receptor alpha, delta (PPARa,d) agonist, oral Farnesoid X Receptor (FXR) agonist, subcutaneous Lysyl Oxidase-Like 2 (LOXL2) inhibitor and subcutaneous Glucagon-like Peptide-1 (GLP-1) agonist.
- Annualized NASH therapeutics market forecast, annual cost of therapy and treatment usage pattern data from 2012-2017.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
- Key topics covered include strategic clinical and commercial benchmarking assessment of the pipeline and standard of care, market outlook, R&D strategies, and unmet needs for the NASH therapeutics market.

Reasons to buy

Develop business strategies and perform superior market quantification analysis by -
- Understanding the trends shaping and driving the global NASH Therapeutics market.
- Understanding treatment preferences of physicians in disease state and across treatment flow.
- Accessing market sizing, forecasts and quantified growth opportunities in the global NASH Therapeutics market till 2017.
- Quantifying patient population in the global NASH Therapeutics market to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape by
- Performing benchmarking analysis and growth opportunities against currently marketed products.
- Identifying market entry points based on safety, efficacy, and pricing parameters.
- Assessing competitiveness of products in market by understanding the strength and weakness of current competition.
- Develop and design your in-licensing and out-licensing strategies by
- Taking a comprehensive look of at the disease pipeline and identifying most promising paradigm shifting products.
- Assessing strength of pipeline based on first in class and lifecycle management of products.
- Analyze the potential impact of novel oral therapies such as Genfit’s GFT505 on the NASH treatment paradigm.
- Track drug sales in the global NASH Therapeutics market from 2012 to 2017.
- Identify the 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 the best opportunities for consolidation, investments and strategic partnerships.
- What’s the next big thing in the global NASH Therapeutics market landscape? Identify, understand, and capitalize.

Table Of Contents

OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update
1 Table of Contents

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 RandD 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

1.1 List of Tables

Table 1: Symptoms of NASH 19
Table 2: Risk Factors and Comorbidities for NASH 21
Table 3: Reported Prevalence of NASH in the US and 5EU 25
Table 4: Reported Prevalence of NAFLD in the US and 5EU 25
Table 5: 6MM, Sources of Prevalence Data Used in the NASH Epidemiological Forecast 29
Table 6: 6MM, Prevalent Cases of NASH, Ages ?20 Years, Men and Women, N, Selected Years, 2012-2022 36
Table 7: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N (Row %), 2012 37
Table 8: 6MM, Prevalent Cases of NASH, Ages ?20 Years, By Sex, N (Row %), 2012 39
Table 9: Off-Label Treatments for NASH 45
Table 10: Product Profile - Vitamin E 46
Table 11: Vitamin E SWOT Analysis in NASH, 2013 48
Table 12: Product Profile - Pioglitazone 50
Table 13: Pioglitazone SWOT Analysis in NASH, 2013 52
Table 14: Overall Unmet Needs in NASH - Current Level of Attainment 54
Table 15: Current Clinical Trial Design of Key Pipeline Drugs for NASH, 2013 62
Table 16: NASH - Mid-Late-Stage Pipeline, 2013 64
Table 17: Product Profile - GFT505 66
Table 18: GFT505 SWOT Analysis, 2013 68
Table 19: Product Profile - Obeticholic Acid (INT-747) 70
Table 20: Obeticholic Acid (INT-747) SWOT Analysis, 2013 72
Table 21: Product Profile - Simtuzumab 74
Table 22: Simtuzumab SWOT Analysis, 2013 76
Table 23: Product Profile - Liraglutide 77
Table 24: Liraglutide Safety Profile from the LEAD Program 79
Table 25: Liraglutide SWOT Analysis, 2013 80
Table 26: Early-Stage Pipeline Products in NASH, 2013 81
Table 27: Clinical Benchmark of Key Pipeline Drugs for NASH, 2013 86
Table 28: Commercial Benchmark of Key Pipeline Drugs for NASH, 2013 88
Table 29: Top-Line Sales Forecasts ($m) for NASH, 2012-2017 90
Table 30: Key Events Impacting Sales for NASH, 2017 92
Table 31: NASH Market: US and 5EU - Drivers and Barriers, 2012-2017 92
Table 32: Key Launch Dates 110

1.2 List of Figures

Figure 1: Two-Hit and Multiple-Hits Theories in NASH 17
Figure 2: Distinct-Hit Pathogenesis in NASH 18
Figure 3: Stages of Liver Disease 19
Figure 4: 5EU, Prevalence of NAFLD and Obesity, Ages ?20 Years, Men and Women, % 27
Figure 5: 6MM, Prevalent Cases of NASH, Ages ?20 Years, Men and Women, N, Selected Years, 2012-2022 36
Figure 6: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N, 2012 38
Figure 7: 6MM, Prevalent Cases of NASH, Ages ?20 Years, By Sex, N, 2012 39
Figure 8: Liver Biopsy to Confirm NASH 44
Figure 9: Competitive Assessment of Mid-Stage Pipeline Agents in NASH, 2012-2017 89
Figure 10: Global Sales for NASH by Region, 2012-2017 91

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