OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026 Summary First described in 1980, 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. GlobalData estimates the 2016 sales for the 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 account for 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. Key Questions Answered - How will the NASH market landscape in the 7MM (US, France, Germany, Italy, Spain, UK and Japan) change from 2016-2026? - What are the most promising late-stage pipeline drugs in NASH? - How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options? - What are the greatest unmet needs in NASH? Will the pipeline drugs fulfil these needs of the market? - What are the biggest opportunities in the NASH landscape? 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.
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
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 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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