GlobalData has released its new Opportunity Analyzer report, “Nonalcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2017”. 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

 

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