Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024-Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market
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.
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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-
- 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-
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Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
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
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
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
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
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
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
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
9.1 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
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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.
- 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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