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

  • ID: 4720218
  • Report
  • Region: Asia Pacific
  • 112 Days
  • GBI Research
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FEATURED COMPANIES

  • Allergan
  • Galmed
  • Genfit
  • Gilead
  • Intercept Pharmaceuticals
  • Zydus
  • MORE

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.

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.
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FEATURED COMPANIES

  • Allergan
  • Galmed
  • Genfit
  • Gilead
  • Intercept Pharmaceuticals
  • Zydus
  • MORE

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

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

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

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

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

6 Multi-scenario Forecast
6.1 Geographical Markets
6.2 Asia-Pacific Market
6.3 India
6.3.1 Treatment Usage Patterns
6.3.2 Annual Cost of Therapy
6.3.3 Market Size
6.4 China
6.4.1 Treatment Usage Patterns
6.4.2 Annual Cost of Therapy
6.4.3 Market Size
6.5 Australia
6.5.1 Treatment Usage Patterns
6.5.2 Annual Cost of Therapy
6.5.3 Market Size
6.6 South Korea
6.6.1 Treatment Usage Patterns
6.6.2 Annual Cost of Therapy
6.6.3 Market Size
6.7 Japan
6.7.1 Treatment Usage Patterns
6.7.2 Annual Cost of Therapy
6.7.3 Market Size

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

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

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

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

List of Figures
Figure 1: Pathophysiology of Hepatic Steatosis
Figure 2: Factors Contributing to Development of NASH from Steatotic Liver
Figure 3: Diagnostic Flow Chart for NASH
Figure 4: Stages of NASH Progression
Figure 5: Treatment Options in NASH (Potential Therapeutic Targets)
Figure 6: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for NASH Treatment, 2018
Figure 7: NASH Therapeutics Market, Global, Pipeline, 2018
Figure 8 NASH Therapeutics Market, Global, Pipeline by Molecular Target, 2018
Figure 9: NASH Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2018
Figure 10: NASH Therapeutics Market, APAC, Selonsertib Forecast ($m), 2023-2024
Figure 11: NASH Therapeutics Market, APAC, Elafibrinor Forecast ($m), 2023-2024
Figure 12: NASH Therapeutics Market, APAC, Saroglitazar Forecast ($m), 2020-2024
Figure 13: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for NASH Treatment, 2018
Figure 14: NASH Therapeutics Market, Competitor Matrix for NASH Marketed and Pipeline Products, 2018
Figure 15: NASH Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2017
Figure 16: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2007-2017
Figure 17: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2007-2017
Figure 18: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type, 2007-2017
Figure 19: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target, 2007-2017
Figure 20: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Type, 2007-2017
Figure 21: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Target, 2007-2017
Figure 22: NASH Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, 2007-2017
Figure 23: NASH Therapeutics Market, Global, Clinical Trial Duration by Molecular Target, 2007-2017
Figure 24: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 25: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target
Figure 26: NASH Therapeutics Market, APAC, Treatment Patterns (million), 2017-2024
Figure 27: NASH Therapeutics Market, APAC, Market Size ($m), 2017-2024
Figure 28: NASH Therapeutics Market, India, Treatment Usage Patterns (million), 2017-2024
Figure 29: NASH Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024
Figure 30: NASH Therapeutics Market, India, Market Size ($m), 2017-2024
Figure 31: NASH Therapeutics Market, China, Treatment Usage Patterns (millions), 2017-2024
Figure 32: NASH Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024
Figure 33: NASH Therapeutics Market, China, Market Size ($m), 2017-2024
Figure 34: NASH Therapeutics Market, Australia, Treatment Usage Patterns (million), 2017-2024
Figure 35: NASH Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024
Figure 36: NASH Therapeutics Market, Australia, Market Size ($m), 2017-2024
Figure 37: NASH Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2017-2024
Figure 38: NASH Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024
Figure 39: NASH Therapeutics Market, South Korea, Market Size ($m), 2017-2024
Figure 40: NASH Therapeutics Market, Japan, Treatment Usage Patterns (millions), 2017-2024
Figure 41: NASH Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024
Figure 42: NASH Therapeutics Market, Japan, Market Size ($m), 2017-2024
Figure 43: NASH Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2018
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
Figure 45: NASH Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018
Figure 46: NASH Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018
Figure 47: NASH Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018
Figure 48: NASH Therapeutics Market, Global, Co-development Deals by Region, 2007-2018
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
Figure 50: NASH Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018
Figure 51: NASH Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2007-2018
Figure 52: NASH Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018

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  • Allergan
  • Galmed
  • Genfit
  • Gilead
  • Intercept Pharmaceuticals
  • Zydus
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