Product Code: GBIHC487MR
Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024 - Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market
Non-Alcoholic Steato-Hepatitis (NASH) is the "silent" liver disease. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol, especially people who are middle-aged and overweight or obese. Non-Alcoholic Steato-Hepatitis (NASH) is an advanced form of Non-Alcoholic Fatty Liver Disease (NAFLD). Non-Alcoholic Fatty Liver Disease (NAFLD) is caused by accumulation of fat in the liver. When this also causes inflammation and damage to hepatic cells, it is known as Non-Alcoholic Steato-Hepatitis (NASH), which can lead to scarring of the liver.
Non-Alcoholic Fatty Liver Disease (NAFLD) has become the most common liver disease worldwide. Global prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) is estimated at 24%; the highest rates are in South America and the Middle East, followed by the US and Europe. Non-Alcoholic Fatty Liver Disease (NAFLD) is also an emerging problem in the Asia-Pacific region, where it is likely to increase in the future. Currently, the prevalence population of Non-Alcoholic Fatty Liver Disease (NAFLD) in Asia is around 25%, like many Western countries. Non-Alcoholic Steato-Hepatitis (NASH) is present in at least 20% of obese adults or children and in at least 5% of those who are overweight. The prevalence of Non-Alcoholic Steato-Hepatitis (NASH) in biopsy-proven Non-Alcoholic Fatty Liver Disease (NAFLD) patients is 63.5% in Asia.
The Asia-Pacific (APAC) Non-Alcoholic Steato-Hepatitis (NASH) market is forecast to grow at a compound annual growth rate (CAGR) of 17.2% from 2017 to 2024. Over the forecast period the prevalence of Non-Alcoholic Steato-Hepatitis (NASH) is expected to increase significantly across the APAC markets, in parallel with the increasing prevalence of associated risk factors such as obesity, type II diabetes (T2D), dyslipidemia and other metabolic conditions.
The rising prevalence population, together with the significant diagnostic advancements using ultrasound and biomarkers, improving health awareness, and increasing affordability and healthcare access, will increase diagnosis and the treatment-receiving population, driving demand and contributing to market growth.
- 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 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