Product Code: GDHC034POA
GlobalData has released its new Opportunity Analyzer report, "OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update". The NASH market is currently deserted and awaits its first NASH-specific therapy. With novel mechanism of action awaiting approval such as: Genfit's PPAR agonist, GFT505 and Intercept Pharmaceuticals/Dainippon Sumitomo Pharma's FXR agonist, Obeticholic Acid. These compounds will race to be the first approved therapy thus claiming first in class.
- Overview of NASH, including epidemiology, etiology, symptoms, diagnosis, pathology and disease management.
- Analysis of the current and future market competition in the global NASH therapeutics market.
- Pipeline analysis: comprehensive data split across Phase II/IIb, emerging trends and mechanisms of action under development, including: oral Proliferator Activated Receptor alpha, delta (PPARa,d) agonist, oral Farnesoid X Receptor (FXR) agonist, subcutaneous Lysyl Oxidase-Like 2 (LOXL2) inhibitor and subcutaneous Glucagon-like Peptide-1 (GLP-1) agonist.
- Annualized NASH therapeutics market forecast, annual cost of therapy and treatment usage pattern data from 2012-2017.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
- Key topics covered include strategic clinical and commercial benchmarking assessment of the pipeline and standard of care, market outlook, R&D strategies, and unmet needs for the NASH therapeutics market.
Reasons to buy
Develop business strategies and perform superior market quantification analysis by -
- Understanding the trends shaping and driving the global NASH Therapeutics market.
- Understanding treatment preferences of physicians in disease state and across treatment flow.
- Accessing market sizing, forecasts and quantified growth opportunities in the global NASH Therapeutics market till 2017.
- Quantifying patient population in the global NASH Therapeutics market to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape by
- Performing benchmarking analysis and growth opportunities against currently marketed products.
- Identifying market entry points based on safety, efficacy, and pricing parameters.
- Assessing competitiveness of products in market by understanding the strength and weakness of current competition.
- Develop and design your in-licensing and out-licensing strategies by
- Taking a comprehensive look of at the disease pipeline and identifying most promising paradigm shifting products.
- Assessing strength of pipeline based on first in class and lifecycle management of products.
- Analyze the potential impact of novel oral therapies such as Genfit's GFT505 on the NASH treatment paradigm.
- Track drug sales in the global NASH Therapeutics market from 2012 to 2017.
- Identify the 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 the best opportunities for consolidation, investments and strategic partnerships.
- What's the next big thing in the global NASH Therapeutics market landscape? Identify, understand, and capitalize.
Table of Contents
1. Table of Contents
- 1.1. List of Tables
- 1.2. List of Figures
- 2.1. Catalyst
- 2.2. Related Reports
3. Disease Overview
- 3.1. Etiology and Pathophysiology
- 3.1.1. Etiology
- 3.1.2. Pathophysiology
- 3.2. Symptoms
- 4.1. Disease Background
- 4.2. Risk Factors and Comorbidities
- 4.2.1. Increased age is associated with a worsened disease progression, prognosis, and mortality
- 4.2.2. Being a male is an independent risk factor in morbidly obese NASH cases
- 4.2.3. Metabolic conditions, such as type 2 diabetes, considerably increase the risk of NASH
- 4.3. Global Trends
- 4.4. Forecast Methodology
- 4.4.1. Sources Used
- 4.4.2. Forecast Assumptions and Methods
- 4.4.3. Sources Not Used
- 4.5. Epidemiology Forecast of NASH (2012-2022)
- 4.5.1. Total Prevalent Cases of NASH
- 4.5.2. Age-Specific Prevalent Cases of NASH
- 4.5.3. Sex-Specific Prevalent Cases of NASH
- 4.5.4. Age-Standardized Prevalence of NASH
- 4.6. Discussion
- 4.6.1. Conclusions on Epidemiological Trends
- 4.6.2. Limitations of the Analysis
- 4.6.3. Strengths of the Analysis
5. Current Treatment Options
- 5.1. Overview
- 5.2. Product Profiles - Major Off-Label Brands
- 5.2.1. Vitamin E (numerous generics)
- 5.2.2. Pioglitazone (Actos)
6. Unmet Needs Assessment and Opportunity Analysis
- 6.1. Overview
- 6.2. Unmet Needs Analysis
- 6.2.1. Lack of Approved Therapies
- 6.2.2. Identification of Biomarkers for Early Diagnosis and Endpoints
- 6.2.3. Physician Awareness Due to Understanding of Pathophysiology
- 6.3. Opportunity Analysis
- 6.3.1. Therapies with Targeted MOA to NASH
- 6.3.2. Better Models to Understand Drug Efficacy
- 6.3.3. Future Tool to Measure Fibrosis in NASH Patients
7. R&D Strategies
- 7.1. Overview
- 7.1.1. Understanding Multiple Factors of NASH
- 7.1.2. Potential for a Personalized Approach
- 7.2. Clinical Trial Design
- 7.2.1. Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed
- 7.2.2. Patient Recruitment Issues
- 7.2.3. Appropriate Endpoints
- 7.2.4. Clinical Regulatory Guidelines
8. Pipeline Assessment
- 8.1. Overview
- 8.2. Promising Drugs in Clinical Development
- 8.2.1. GFT505
- 8.2.2. Obeticholic Acid (INT-747)
- 8.2.3. Simtuzumab (Formerly GS-6624)
- 8.2.4. Liraglutide (Victoza)
- 8.3. Innovative Early-Stage Approaches
- 8.3.1. Targeting Cytokines
9. Pipeline Valuation Analysis
- 9.1. Clinical Benchmark of Key Pipeline Drugs
- 9.2. Commercial Benchmark of Key Pipeline Drugs
- 9.3. Competitive Assessment
- 9.4. Top-Line Five-Year Forecast
- 10.1. Bibliography
- 10.2. Abbreviations
- 10.3. Methodology
- 10.4. Forecasting Methodology
- 10.4.1. Diagnosed NASH Patients
- 10.4.2. Percent Drug-Treated Patients
- 10.4.3. Drugs Included in Each Therapeutic Class
- 10.4.4. Launch Dates
- 10.4.5. General Pricing Assumptions
- 10.4.6. Individual Off-Label Drug Assumptions
- 10.4.7. Pricing of Pipeline Agents
- 10.5. Physicians and Specialists Included in this Study
- 10.6. About the Authors
- 10.6.1. Author
- 10.6.2. Epidemiologist
- 10.6.3. Global Head of Healthcare
- 10.7. About GlobalData
- 10.8. Disclaimer
List of Tables
- Table 1: Symptoms of NASH
- Table 2: Risk Factors and Comorbidities for NASH
- Table 3: Reported Prevalence of NASH in the US and 5EU
- Table 4: Reported Prevalence of NAFLD in the US and 5EU
- Table 5: 6MM, Sources of Prevalence Data Used in the NASH Epidemiological Forecast
- Table 6: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, Men and Women, N, Selected Years, 2012-2022
- Table 7: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N (Row %), 2012
- Table 8: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, By Sex, N (Row %), 2012
- Table 9: Off-Label Treatments for NASH
- Table 10: Product Profile - Vitamin E
- Table 11: Vitamin E SWOT Analysis in NASH, 2013
- Table 12: Product Profile - Pioglitazone
- Table 13: Pioglitazone SWOT Analysis in NASH, 2013
- Table 14: Overall Unmet Needs in NASH - Current Level of Attainment
- Table 15: Current Clinical Trial Design of Key Pipeline Drugs for NASH, 2013
- Table 16: NASH - Mid-Late-Stage Pipeline, 2013
- Table 17: Product Profile - GFT505
- Table 18: GFT505 SWOT Analysis, 2013
- Table 19: Product Profile - Obeticholic Acid (INT-747)
- Table 20: Obeticholic Acid (INT-747) SWOT Analysis, 2013
- Table 21: Product Profile - Simtuzumab
- Table 22: Simtuzumab SWOT Analysis, 2013
- Table 23: Product Profile - Liraglutide
- Table 24: Liraglutide Safety Profile from the LEAD Program
- Table 25: Liraglutide SWOT Analysis, 2013
- Table 26: Early-Stage Pipeline Products in NASH, 2013
- Table 27: Clinical Benchmark of Key Pipeline Drugs for NASH, 2013
- Table 28: Commercial Benchmark of Key Pipeline Drugs for NASH, 2013
- Table 29: Top-Line Sales Forecasts ($m) for NASH, 2012-2017
- Table 30: Key Events Impacting Sales for NASH, 2017
- Table 31: NASH Market: US and 5EU - Drivers and Barriers, 2012-2017
- Table 32: Key Launch Dates
List of Figures
- Figure 1: Two-Hit and Multiple-Hits Theories in NASH
- Figure 2: Distinct-Hit Pathogenesis in NASH
- Figure 3: Stages of Liver Disease
- Figure 4: 5EU, Prevalence of NAFLD and Obesity, Ages ≥20 Years, Men and Women, %
- Figure 5: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, Men and Women, N, Selected Years, 2012-2022
- Figure 6: 6MM, Prevalent Cases of NASH, By Age*, Men and Women, N, 2012
- Figure 7: 6MM, Prevalent Cases of NASH, Ages ≥20 Years, By Sex, N, 2012
- Figure 8: Liver Biopsy to Confirm NASH
- Figure 9: Competitive Assessment of Mid-Stage Pipeline Agents in NASH, 2012-2017
- Figure 10: Global Sales for NASH by Region, 2012-2017