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Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024 - Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market

Published By :

GBI Research

Published Date : Dec 2018

Category :

Therapeutic Area

No. of Pages : 112 Pages

Non-alcoholic steatohepatitis (NASH) is the severe form of non-alcoholic fatty liver disease (NAFLD), characterized by a buildup of fat in the liver. Globally, the NAFLD prevalence rate is estimated to be around 25% and a significant proportion of these people are progressing to NASH.

The disease is more frequently progressive and may lead to cirrhosis with complications of hepatocellular carcinoma, liver failure and liver-related death or the requirement of liver transplantation, which is not always feasible. NASH is a major global healthcare problem as the number of NASH patients is increasing.

NASH has been gradually rising in the Asia-Pacific region, owing to the growing prevalence of diabetes, obesity and metabolic syndromes, an aging population and increasingly Westernized lifestyles. Increasing risk factors will result in more people living with the condition and drive revenue growth. Patients with NAFLD and NASH are at increased risk of mortality as well as liver, cardiovascular and malignancy-related death.

The poor long-term prognosis associated with NASH in particular has created a pressing need for improved therapeutic options. At present, there is no approved drug to treat NASH. Lifestyle modification is the initial approach to managing patients with NASH, and then pharmacological treatments such as vitamin E and pioglitazone are recommended as first-line drugs for biopsy-proven NASH.

Significant unmet need exists for NASH-specific products that can treat patients with the condition. NASH-specific therapies, namely selonsertib, elafibranor, Ocaliva and saroglitazar, are in the pipeline for NASH.

Scope

  • The NASH Asia-Pacific market will be valued at $102.6m in 2024, growing from $33.7m in 2017 at a CAGR of 17.2%.
  • How will the approval of NASH-specific therapies affect the market?
  • The NASH market has cheap, generic, off-label drugs, making it a particularly difficult market to penetrate. What are the main barriers a new therapy faces when entering the NASH market?
  • How will the annual cost of therapy and market size vary between the five assessed Asia-Pacific markets?
  • How will changes in risk factors such as population age, obesity, type 2 diabetes, NAFLD, metabolic syndrome and lifestyle influence the market?
  • The pipeline for NASH therapies is quite diverse with a range of molecule types and molecular targets.
  • Which molecular targets appear most frequently in the pipeline?
  • How have the late-stage therapies performed in clinical trials?
  • The level of unmet need in the NASH market is significantly high. Will the pipeline drugs fulfill these unmet needs?
  • Various drivers and barriers will influence the market over the forecast period.
  • Licensing deals are the most common form of strategic alliance in NASH, with total deal values ranging from under $10m to over $300m.
  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key licensing deals?

Reasons to buy

This report will enable you to:

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the NASH market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the NASH pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict NASH market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the NASH deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 12
2.4.1 Etiology 12
2.4.2 Pathophysiology 12
2.5 Diagnosis 16
2.5.1 Non-invasive Tests 17
2.6 Disease Classification 18
2.7 Prognosis 20
2.8 Co-morbidities 20
2.9 Treatment Options and Treatment Algorithm 20
2.9.1 Treatment Options 20
2.9.2 Treatment Algorithm 23
2.9.3 Non-pharmacological Treatments 25

3 Marketed Products 27
3.1 Overview 27
3.1.1 Vitamin E 27
3.1.2 Pentoxifylline 27
3.1.3 Pioglitazone 28
3.2 Comparative Efficacy and Safety of Marketed Products 29

4 Pipeline Analysis 32
4.1 Overview 32
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 32
4.3 Pipeline by Molecular Target 34
4.4 Promising Pipeline Candidates 35
4.4.1 Selonsertib - Gilead 35
4.4.2 Elafibrinor - Genfit 37
4.4.3 Saroglitazar - Zydus 39
4.4.4 Ocaliva (obeticholic acid) - Intercept Pharmaceuticals 40
4.4.5 Cenicriviroc - Allergan 42
4.4.6 Aramchol - Galmed 44
4.5 Comparative Efficacy and Safety of Pipeline Products 44
4.6 Product Competitiveness Framework 46

5 Clinical Trial Analysis 48
5.1 Failure Rate 48
5.1.1 Overall Failure Rate 48
5.1.2 Failure Rate by Phase and Molecule Type 50
5.1.3 Failure Rate by Phase and Molecular Target 51
5.2 Clinical Trial Size 52
5.2.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 52
5.2.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 54
5.3 Clinical Trial Duration 55
5.3.1 Clinical Trial Duration by Molecule Type 55
5.3.2 Clinical Trial Duration by Molecular Target 57
5.4 Summary of Clinical Trial Metrics 58

6 Multi-scenario Forecast 59
6.1 Geographical Markets 59
6.2 Asia-Pacific Market 59
6.3 India 61
6.3.1 Treatment Usage Patterns 61
6.3.2 Annual Cost of Therapy 62
6.3.3 Market Size 63
6.4 China 64
6.4.1 Treatment Usage Patterns 64
6.4.2 Annual Cost of Therapy 65
6.4.3 Market Size 67
6.5 Australia 67
6.5.1 Treatment Usage Patterns 67
6.5.2 Annual Cost of Therapy 69
6.5.3 Market Size 71
6.6 South Korea 72
6.6.1 Treatment Usage Patterns 72
6.6.2 Annual Cost of Therapy 73
6.6.3 Market Size 74
6.7 Japan 75
6.7.1 Treatment Usage Patterns 75
6.7.2 Annual Cost of Therapy 75
6.7.3 Market Size 77

7 Drivers and Barriers 78
7.1 Drivers 78
7.1.1 Rising Awareness and Growing Prevalence of the Disease 78
7.1.2 Launch of NASH-Specific Therapies 78
7.1.3 Advancements in Diagnostic Procedures for NASH 78
7.1.4 Increasing Awareness and Diversified Healthcare Reform 79
7.2 Barriers 79
7.2.1 Delayed Diagnosis Due to Complex Pathophysiology 79
7.2.2 Low Diagnosis and Treatment Rate 79
7.2.3 High Cost Therapies May Lead to Reimbursement issues 80

8 Deals and Strategic Consolidations 81
8.1 Licensing Deals 81
8.1.1 Deals by Region and Value 81
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 82
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 83
8.1.4 Key Licensing Deals 85
8.2 Co-development Deals 87
8.2.1 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 88
8.2.2 Deal Value by Stage of Development, Molecule Type, and Molecular Target 89
8.2.3 Key Co-development Deals 91

9 Appendix 93
9.1 All Pipeline Drugs by Stage of Development 93
9.1.1 Discovery 93
9.1.2 Preclinical 95
9.1.3 IND/CTA-filed 98
9.1.4 Phase I 99
9.1.5 Phase II 100
9.1.6 Phase III 101
9.2 Summary of Multi-scenario Market Forecasts to 2024 101
9.2.1 Asia-Pacific 101
9.2.2 India 102
9.2.3 China 102
9.2.4 Australia 103
9.2.5 South Korea 103
9.2.6 Japan 104
9.3 Bibliography 104
9.4 Abbreviations 107
9.5 Research Methodology 108
9.5.1 Secondary Research 109
9.5.2 Marketed Product Profiles 109
9.5.3 Late-Stage Pipeline Candidates 110
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 110
9.5.5 Product Competitiveness Framework 110
9.5.6 Pipeline Analysis 110
9.5.7 Forecasting Model 111
9.5.8 Deals Data Analysis 112
9.6 Contact Us 112
9.7 Disclaimer 112

List of Table

Table 1: NAFLD Definitions and Phenotypes 10
Table 2: Major Symptoms of NASH 11
Table 3: Etiologies of NASH 12
Table 4: Histopathological Abnormalities in NASH 17
Table 5 NAFLD Activity Score and Staging System 20
Table 6: Therapeutic Management in NASH 24
Table 7: NASH Therapeutics Market, Global, Licensing Deals Valued $100m and Above, 2007-2018 86
Table 8: NASH Therapeutics Market, Global, Co-development Deals with Deal Value 10 and above, 2007-2018 92
Table 9: NASH Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 93
Table 10: NASH Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 95
Table 11: NASH Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2018 98
Table 12: NASH Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 99
Table 13: NASH Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 100
Table 14: NASH Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 101
Table 15: NASH Therapeutics Market, APAC, Market Forecast, 2017-2024 101
Table 16: NASH Therapeutics Market, India, Market Forecast, 2017-2024 102
Table 17: NASH Therapeutics Market, China, Market Forecast, 2017-2024 102
Table 18: NASH Therapeutics Market, Australia, Market Forecast, 2017-2024 103
Table 19: NASH Therapeutics Market, South Korea, Market Forecast, 2017-2024 103
Table 20: NASH Therapeutics Market, Japan, Market Forecast, 2017-2024 104

List of Chart

Figure 1: Pathophysiology of Hepatic Steatosis 13
Figure 2: Factors Contributing to Development of NASH from Steatotic Liver 15
Figure 3: Diagnostic Flow Chart for NASH 16
Figure 4: Stages of NASH Progression 19
Figure 5: Treatment Options in NASH (Potential Therapeutic Targets) 21
Figure 6: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for NASH Treatment, 2018 31
Figure 7: NASH Therapeutics Market, Global, Pipeline, 2018 33
Figure 8 NASH Therapeutics Market, Global, Pipeline by Molecular Target, 2018 34
Figure 9: NASH Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2018 35
Figure 10: NASH Therapeutics Market, APAC, Selonsertib Forecast ($m), 2023-2024 37
Figure 11: NASH Therapeutics Market, APAC, Elafibrinor Forecast ($m), 2023-2024 39
Figure 12: NASH Therapeutics Market, APAC, Saroglitazar Forecast ($m), 2020-2024 40
Figure 13: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for NASH Treatment, 2018 46
Figure 14: NASH Therapeutics Market, Competitor Matrix for NASH Marketed and Pipeline Products, 2018 47
Figure 15: NASH Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2017 49
Figure 16: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2007-2017 50
Figure 17: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2007-2017 51
Figure 18: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type, 2007-2017 52
Figure 19: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target, 2007-2017 53
Figure 20: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Type, 2007-2017 54
Figure 21: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Target, 2007-2017 55
Figure 22: NASH Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, 2007-2017 56
Figure 23: NASH Therapeutics Market, Global, Clinical Trial Duration by Molecular Target, 2007-2017 57
Figure 24: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type 58
Figure 25: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target 58
Figure 26: NASH Therapeutics Market, APAC, Treatment Patterns (million), 2017-2024 60
Figure 27: NASH Therapeutics Market, APAC, Market Size ($m), 2017-2024 61
Figure 28: NASH Therapeutics Market, India, Treatment Usage Patterns (million), 2017-2024 62
Figure 29: NASH Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 63
Figure 30: NASH Therapeutics Market, India, Market Size ($m), 2017-2024 64
Figure 31: NASH Therapeutics Market, China, Treatment Usage Patterns (millions), 2017-2024 65
Figure 32: NASH Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 66
Figure 33: NASH Therapeutics Market, China, Market Size ($m), 2017-2024 67
Figure 34: NASH Therapeutics Market, Australia, Treatment Usage Patterns (million), 2017-2024 68
Figure 35: NASH Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 70
Figure 36: NASH Therapeutics Market, Australia, Market Size ($m), 2017-2024 71
Figure 37: NASH Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2017-2024 72
Figure 38: NASH Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 73
Figure 39: NASH Therapeutics Market, South Korea, Market Size ($m), 2017-2024 74
Figure 40: NASH Therapeutics Market, Japan, Treatment Usage Patterns (millions), 2017-2024 75
Figure 41: NASH Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 76
Figure 42: NASH Therapeutics Market, Japan, Market Size ($m), 2017-2024 77
Figure 43: NASH Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2018 81
Figure 44: NASH Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 82
Figure 45: NASH Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 83
Figure 46: NASH Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018 84
Figure 47: NASH Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018 85
Figure 48: NASH Therapeutics Market, Global, Co-development Deals by Region, 2007-2018 87
Figure 49: NASH Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 88
Figure 50: NASH Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 89
Figure 51: NASH Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2007-2018 90
Figure 52: NASH Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018 91

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