OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026

Publisher Name :
Date: 08-May-2017
No. of pages: 171

OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026

Summary

Nonalcoholic steatohepatitis (NASH) (ICD-10-CM = K75.81) is a condition that develops as a subgroup of nonalcoholic fatty liver disease (NAFLD) when excessive fat buildup is accompanied by liver cell injury and inflammation. NAFLD is defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver. Progression of this condition to NASH dramatically increases the risk of cirrhosis, liver failure, and hepatocellular carcinoma, and it is therefore a potentially fatal condition.

It is estimated that the 2016 sales for the nonalcoholic steatohepatitis (NASH) market at approximately $618m across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the NASH market will grow at a Compound Annual Growth Rate (CAGR) of 45.0% across the 7MM.

The US and Japanese markets are both anticipated to grow significantly, recording CAGRs of 48.1% and 50.7%, respectively, while the 5EU will record a CAGR of 30.6%. At the end of 2026, the US will contribute around 88% of global sales, while the 5EU and Japan will account for around 10% and 2% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of NASH in the region, as well as the launch of more pipeline agents in this region.

Major drivers of growth in the NASH market include -

- The growing rate of obesity and diabetes globally, leading to an increase in the number of NASH cases.

- The launches of multiple late-stage pipeline products, which will transform the market from one dominated by the use of off-label generics to a burgeoning, competitive space.

The report "OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026" analyzes the nuances of the NASH treatment landscape and provides detailed insights into the market dynamics of this highly competitive space. The analysis also includes the evaluation of the commercial and clinical profiles of the late-stage pipeline candidates, and their sales forecasts for the NASH indication over the 2016-2026 time periods.

In particular, this report provides the following -

- Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

- Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.

- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

- Analysis of the current and future market competition in the global NASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Companies mentioned in this report: Gilead Sciences, Intercept Pharmaceuticals, Genfit SA, Allergan Plc, Galectin Therapeutics, Galmed Pharmaceuticals, Inventiva Pharma, Novo Nordisk, Conatus Pharmaceuticals, Novartis, Immuron Limited, Cirius Therapeutics.

Scope

- Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

- Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.

- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

- Analysis of the current and future market competition in the global NASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

- Develop business strategies by understanding the trends shaping and driving the global NASH therapeutics market.

- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NASH therapeutics market in the future.

- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

- Identify 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 maximum opportunities for consolidations, investments, and strategic partnerships.

OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Executive Summary 7
2.1 Mid-Forecast Surge in Sales for NASH 7
2.2 Manufacturers Are Employing Strategies to Improve Diagnostics while Advancing Drug Development 9
2.3 Vast Unmet Needs Exist in the NASH Market 9
2.4 Opportunities Abound for Tools that Support Accurate Diagnosis 9
2.5 Launches of Novel Pipeline Products Will Revolutionize the NASH Treatment Landscape 10
2.6 What Do the Physicians Think? 12
3 Introduction 15
3.1 Catalyst 15
3.2 Related Reports 15
4 Disease Overview 16
4.1 Etiology and Pathophysiology 16
4.1.1 Etiology 16
4.1.2 Pathophysiology 17
4.2 Disease Staging 22
4.3 Symptoms 23
5 Epidemiology 24
5.1 Risk Factors and Comorbidities 24
5.2 Global Trends 26
5.2.1 US 27
5.2.2 5EU 27
5.2.3 Japan 28
5.3 Forecast Methodology 28
5.3.1 Sources Used Tables 30
5.3.2 Forecast Assumptions and Methods 33
5.3.3 Sources Not Used 41
5.4 Epidemiological Forecast for NASH (2016-2026) 42
5.4.1 Total Prevalent Cases of NASH 42
5.4.2 Age-Specific Total Prevalent Cases of NASH 44
5.4.3 Sex-Specific Total Prevalent Cases of NASH 45
5.4.4 Age-Standardized Prevalence of NASH 47
5.4.5 Diagnosed Prevalent Cases of NASH 48
5.4.6 Diagnosed Prevalent Cases of NASH by Comorbid Disorder 50
5.5 Discussion 52
5.5.1 Epidemiological Forecast Insight 52
5.5.2 Limitations of the Analysis 53
5.5.3 Strengths of the Analysis 54
6 Current Treatment Options 56
6.1 Overview 56
6.2 Diagnosis 56
6.3 Treatment Guidelines and Leading Prescribed Drugs 56
6.4 Product Profiles 58
6.4.1 Vitamin E 58
6.4.2 Pentoxifylline 61
6.4.3 Pioglitazone 64
7 Unmet Needs Assessment and Opportunity Analysis 68
7.1 Overview 68
7.2 Unmet Needs Analysis 69
7.2.1 Approved Therapies 69
7.2.2 Identification of Biomarkers for Early Diagnosis and Clinical Endpoint Determination 71
7.2.3 Physician Awareness 74
7.2.4 Understanding Disease Pathophysiology and Characterizing the Disease 75
7.2.5 Understanding the Impact and Burden of NASH on Healthcare Service 77
8 R&D Strategies 79
8.1 Overview 79
8.1.1 NASH-Specific Drugs with Multiple Physiological Targets 79
8.1.2 Combination Therapies 79
8.2 Clinical Trial Design 80
8.2.1 Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed 81
8.2.2 Patient Recruitment Issues 81
8.2.3 Appropriate Endpoints 82
8.2.4 Clinical Regulatory Guidelines 83
9 Pipeline Assessment 90
9.1 Overview 90
9.2 Promising Drugs in Clinical Development 91
9.2.1 Ocaliva (Obeticholic Acid) 92
9.2.2 Elafibranor (GFT505) 97
9.2.3 Aramchol 102
9.2.4 Cenicriviroc 106
9.2.5 Emricasan 109
9.2.6 IMM-124E 114
9.2.7 Selonsertib (GS-4997) 117
9.2.8 IVA337 120
9.2.9 GR-MD-02 123
9.2.10 Semaglutide (NN9931) 126
9.2.11 MSDC-0602K 129
9.3 Innovative Early-Stage Approaches 131
10 Pipeline Valuation Analysis 133
10.1 Clinical Benchmark of Key Pipeline Drugs 133
10.2 Commercial Benchmark of Key Pipeline Drugs 137
10.3 Competitive Assessment 140
10.4 Top Line 10-Year Forecast 142
10.4.1 US 145
10.4.2 5EU 146
10.4.3 Japan 147
11 Appendix 148
11.1 Bibliography 148
11.2 Abbreviations 160
11.3 Methodology 164
11.4 Forecasting Methodology 164
11.4.1 Total Prevalent Cases of NASH 164
11.4.2 Diagnosed Prevalent Cases of NASH 164
11.4.3 Patient Segmentation 164
11.4.4 Percent Drug-Treated Patients 165
11.4.5 Launch Dates for Pipeline Drugs 165
11.4.6 General Pricing Assumptions 166
11.5 Physicians and Specialists Included in this Study 166
11.6 About the Authors 168
11.6.1 Analyst 168
11.6.2 Directors 169
11.6.3 Epidemiologist 169
11.6.4 Global Director of Therapy Analysis and Epidemiology 170
11.6.5 Global Head and EVP of Healthcare Operations and Strategy 170
11.7 About GlobalData 171
11.8 Contact Us 171
11.9 Disclaimer 171

1.1 List of Tables
Table 1: NASH: Key Metrics in Seven Major Pharmaceutical Markets 7
Table 2: NASH Clinical Research Network Histological Scoring System 22
Table 3: Major symptoms of NASH 23
Table 4: Risk Factors and Comorbidities for NASH 25
Table 5: 7MM, Sources of Epidemiological Data Used to Forecast Total Prevalent Cases of NASH 30
Table 6: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of NASH 31
Table 7: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of NASH by Comorbid Disorder 32
Table 8: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages ?4 Years, Select Years, 2016-2026 43
Table 9: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, N (Row %), 2016 44
Table 10: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages ?4 Years, N (Row %), 2016 46
Table 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages ?4 Years, Select Years, 2016-2026 49
Table 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages ?4 Years, N (Row %), 2016 51
Table 13: Treatment Guidelines Available for NASH 56
Table 14: Off-Label Treatments for NASH 58
Table 15: Product Profile - Vitamin E 59
Table 16: Vitamin E SWOT Analysis in NASH 61
Table 17: Product Profile - Pentoxifylline 62
Table 18: Pentoxifylline SWOT Analysis 64
Table 19: Product Profile - Pioglitazone 65
Table 20: Pioglitazone SWOT Analysis in NASH 67
Table 21: Unmet Needs and Opportunities in NASH, 2017 69
Table 22: Phase III Clinical Trial Design of Key Pipeline Drugs for NASH 85
Table 23: Phase IIb Clinical Trial Design of Key Pipeline Drugs for NASH 87
Table 24: NASH - Late-Stage Pipeline, 2017 91
Table 25: Product Profile - Ocaliva 95
Table 26: Ocaliva SWOT Analysis 97
Table 27: Product Profile - Elafibranor (GFT505) 99
Table 28: Elafibranor (GFT505) SWOT Analysis 102
Table 29: Product Profile - Aramchol 103
Table 30: Aramchol SWOT Analysis 106
Table 31: Product Profile - Cenicriviroc 108
Table 32: Cenicriviroc SWOT Analysis 109
Table 33: Product Profile - Emricasan 112
Table 34: Emricasan SWOT Analysis 114
Table 35: Product Profile - IMM-124E 116
Table 36: IMM-124E SWOT Analysis 117
Table 37: Product Profile - Selonsertib 119
Table 38: Selonsertib SWOT Analysis 120
Table 39: Product Profile - IVA337 121
Table 40: IVA337 SWOT Analysis 122
Table 41: Product Profile - GR-MD-02 124
Table 42: GR-MD-02 SWOT Analysis 126
Table 43: Product Profile - Semaglutide 128
Table 44: Semaglutide SWOT Analysis 129
Table 45: Product Profile - MSDC-0602K 130
Table 46: MSDC-0602K SWOT Analysis 131
Table 47: Innovative Early-Stage Approaches in NASH 131
Table 48: Clinical Benchmark of Key Pipeline Drugs for NASH 134
Table 49: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 135
Table 50: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 136
Table 51: Clinical Benchmark of Key Pipeline Drugs for NASH (continued) 137
Table 52: Commercial Benchmark of Key Pipeline Drugs for NASH 138
Table 53: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 139
Table 54: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 139
Table 55: Commercial Benchmark of Key Pipeline Drugs for NASH (continued) 140
Table 56: Top Line Sales Forecasts ($m) for NASH, 2016-2026 142
Table 57: Key Events Impacting Sales for NASH, 2016-2026 145
Table 58: NASH Market: 7MM - Drivers and Barriers, 2016-2026 145
Table 59: Projected Launch Dates for Key Drugs in NASH Across the 7MM 165
Table 60: High-Prescribing Physicians Surveyed, by Country 166

1.2 List of Figures
Figure 1: Sales for NASH by Region, 2016-2026 8
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in NASH 11
Figure 3: Stages of Liver Disease 17
Figure 4: The Multiple Hits Theory in NASH 19
Figure 5: Major Drug Targets for NASH Treatment 21
Figure 6: 5EU, Total Prevalence of NAFLD and Obesity (%), Ages ?20 Years, Both Sexes 28
Figure 7: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages ?4 Years, Selected Years, 2016-2026 43
Figure 8: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, 2016 45
Figure 9: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages ?4 Years, 2016 47
Figure 10: 7MM, Age-Standardized Total Prevalence of NASH, Ages ?4 Years, 2016 48
Figure 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages ?4 Years, Selected Years, 2016-2026 50
Figure 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages ?4 Years, N, 2016 51
Figure 13: NASH - Phase II?III Pipeline, 2017 92
Figure 14: Competitive Assessment of Late-Stage Pipeline Agents in NASH 141
Figure 15: Global Sales for NASH by Region, 2016-2026 144
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