OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026 - Product Image

OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026

  • ID: 4370601
  • Drug Pipelines
  • 171 pages
  • GlobalData
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FEATURED COMPANIES

  • Allergan Plc
  • Conatus Pharmaceuticals
  • Galmed Pharmaceuticals
  • Gilead Sciences
  • Intercept Pharmaceuticals
  • Novartis
  • MORE
OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026

Summary

Nonalcoholic steatohepatitis (NASH) (ICD-10-CM = K75.81) is a condition that develops as a subgroup of nonalcoholic fatty liver disease (NAFLD) when excessive fat buildup is accompanied by liver cell injury and inflammation. NAFLD is defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver. Progression of this condition to NASH dramatically increases the risk of cirrhosis, liver failure, and hepatocellular carcinoma, and it is therefore a potentially fatal condition.

It is estimated that the 2016 sales for the nonalcoholic steatohepatitis (NASH) market at approximately $618m across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. Over the course of the 10-year forecast period, the NASH market will grow at a Compound Annual Growth Rate (CAGR) of 45.0% across the 7MM.

The US and Japanese markets are both anticipated to grow significantly, recording CAGRs of 48.1% and 50.7%, respectively, while the 5EU will record a CAGR of 30.6%. At the end of 2026, the US will contribute around 88% of global sales, while the 5EU and Japan will account for around 10% and 2% of sales, respectively. The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of NASH in the region, as well as the launch of more pipeline agents in this region.

Major drivers of growth in the NASH market include -
  • The growing rate of obesity and diabetes globally, leading to an increase in the number of NASH cases.
  • The launches of multiple late-stage pipeline products, which will transform the market from one dominated by the use of off-label generics to a burgeoning, competitive space.
The report "OpportunityAnalyzer: NASH - Opportunity Analysis and Forecasts to 2026" analyzes the nuances of the NASH treatment landscape and provides detailed insights into the market dynamics of this highly competitive space. The analysis also includes the evaluation of the commercial and clinical profiles of the late-stage pipeline candidates, and their sales forecasts for the NASH indication over the 2016-2026 time periods.

In particular, this report provides the following -
  • Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global NASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Companies mentioned in this report: Gilead Sciences, Intercept Pharmaceuticals, Genfit SA, Allergan Plc, Galectin Therapeutics, Galmed Pharmaceuticals, Inventiva Pharma, Novo Nordisk, Conatus Pharmaceuticals, Novartis, Immuron Limited, Cirius Therapeutics.

Scope
  • Overview of NASH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline NASH market revenue from 2016-2026. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting NASH therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global NASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to Buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global NASH therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NASH therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify 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 maximum opportunities for consolidations, investments, and strategic partnerships.
READ MORE
Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • Allergan Plc
  • Conatus Pharmaceuticals
  • Galmed Pharmaceuticals
  • Gilead Sciences
  • Intercept Pharmaceuticals
  • Novartis
  • MORE
1.1 List of Tables
1.2 List of Figures

2. Executive Summary
2.1 Mid-Forecast Surge in Sales for NASH
2.2 Manufacturers Are Employing Strategies to Improve Diagnostics while Advancing Drug Development
2.3 Vast Unmet Needs Exist in the NASH Market
2.4 Opportunities Abound for Tools that Support Accurate Diagnosis
2.5 Launches of Novel Pipeline Products Will Revolutionize the NASH Treatment Landscape
2.6 What Do the Physicians Think?

3. Introduction
3.1 Catalyst
3.2 Related Reports

4. Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Disease Staging
4.3 Symptoms

5. Epidemiology
5.1 Risk Factors and Comorbidities
5.2 Global Trends
5.2.1 US
5.2.2 5EU
5.2.3 Japan
5.3 Forecast Methodology
5.3.1 Sources Used Tables
5.3.2 Forecast Assumptions and Methods
5.3.3 Sources Not Used
5.4 Epidemiological Forecast for NASH (2016-2026)
5.4.1 Total Prevalent Cases of NASH
5.4.2 Age-Specific Total Prevalent Cases of NASH
5.4.3 Sex-Specific Total Prevalent Cases of NASH
5.4.4 Age-Standardized Prevalence of NASH
5.4.5 Diagnosed Prevalent Cases of NASH
5.4.6 Diagnosed Prevalent Cases of NASH by Comorbid Disorder
5.5 Discussion
5.5.1 Epidemiological Forecast Insight
5.5.2 Limitations of the Analysis
5.5.3 Strengths of the Analysis

6. Current Treatment Options
6.1 Overview
6.2 Diagnosis
6.3 Treatment Guidelines and Leading Prescribed Drugs
6.4 Product Profiles
6.4.1 Vitamin E
6.4.2 Pentoxifylline
6.4.3 Pioglitazone

7. Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.2 Unmet Needs Analysis
7.2.1 Approved Therapies
7.2.2 Identification of Biomarkers for Early Diagnosis and Clinical Endpoint Determination
7.2.3 Physician Awareness
7.2.4 Understanding Disease Pathophysiology and Characterizing the Disease
7.2.5 Understanding the Impact and Burden of NASH on Healthcare Service

8. R&D Strategies
8.1 Overview
8.1.1 NASH-Specific Drugs with Multiple Physiological Targets
8.1.2 Combination Therapies
8.2 Clinical Trial Design
8.2.1 Differences in Diagnosis, Monitoring, and Sensitive Imaging Techniques Are Needed
8.2.2 Patient Recruitment Issues
8.2.3 Appropriate Endpoints
8.2.4 Clinical Regulatory Guidelines

9. Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.2.1 Ocaliva (Obeticholic Acid)
9.2.2 Elafibranor (GFT505)
9.2.3 Aramchol
9.2.4 Cenicriviroc
9.2.5 Emricasan
9.2.6 IMM-124E
9.2.7 Selonsertib (GS-4997)
9.2.8 IVA337
9.2.9 GR-MD-02
9.2.10 Semaglutide (NN9931)
9.2.11 MSDC-0602K
9.3 Innovative Early-Stage Approaches

10. Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top Line 10-Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan

11. Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Total Prevalent Cases of NASH
11.4.2 Diagnosed Prevalent Cases of NASH
11.4.3 Patient Segmentation
11.4.4 Percent Drug-Treated Patients
11.4.5 Launch Dates for Pipeline Drugs
11.4.6 General Pricing Assumptions
11.5 Physicians and Specialists Included in this Study
11.6 About the Authors
11.6.1 Analyst
11.6.2 Directors
11.6.3 Epidemiologist
11.6.4 Global Director of Therapy Analysis and Epidemiology
11.6.5 Global Head and EVP of Healthcare Operations and Strategy
11.7 About
11.8 Contact Us
11.9 Disclaimer

1.1 List of Tables
Table 1: NASH: Key Metrics in Seven Major Pharmaceutical Markets
Table 2: NASH Clinical Research Network Histological Scoring System
Table 3: Major symptoms of NASH
Table 4: Risk Factors and Comorbidities for NASH
Table 5: 7MM, Sources of Epidemiological Data Used to Forecast Total Prevalent Cases of NASH
Table 6: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of NASH
Table 7: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of NASH by Comorbid Disorder
Table 8: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages =4 Years, Select Years, 2016-2026
Table 9: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, N (Row %), 2016
Table 10: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages =4 Years, N (Row %), 2016
Table 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages =4 Years, Select Years, 2016-2026
Table 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages =4 Years, N (Row %), 2016
Table 13: Treatment Guidelines Available for NASH
Table 14: Off-Label Treatments for NASH
Table 15: Product Profile - Vitamin E
Table 16: Vitamin E SWOT Analysis in NASH
Table 17: Product Profile - Pentoxifylline
Table 18: Pentoxifylline SWOT Analysis
Table 19: Product Profile - Pioglitazone
Table 20: Pioglitazone SWOT Analysis in NASH
Table 21: Unmet Needs and Opportunities in NASH, 2017
Table 22: Phase III Clinical Trial Design of Key Pipeline Drugs for NASH
Table 23: Phase IIb Clinical Trial Design of Key Pipeline Drugs for NASH
Table 24: NASH - Late-Stage Pipeline, 2017
Table 25: Product Profile - Ocaliva
Table 26: Ocaliva SWOT Analysis
Table 27: Product Profile - Elafibranor (GFT505)
Table 28: Elafibranor (GFT505) SWOT Analysis
Table 29: Product Profile - Aramchol
Table 30: Aramchol SWOT Analysis
Table 31: Product Profile - Cenicriviroc
Table 32: Cenicriviroc SWOT Analysis
Table 33: Product Profile - Emricasan
Table 34: Emricasan SWOT Analysis
Table 35: Product Profile - IMM-124E
Table 36: IMM-124E SWOT Analysis
Table 37: Product Profile - Selonsertib
Table 38: Selonsertib SWOT Analysis
Table 39: Product Profile - IVA337
Table 40: IVA337 SWOT Analysis
Table 41: Product Profile - GR-MD-02
Table 42: GR-MD-02 SWOT Analysis
Table 43: Product Profile - Semaglutide
Table 44: Semaglutide SWOT Analysis
Table 45: Product Profile - MSDC-0602K
Table 46: MSDC-0602K SWOT Analysis
Table 47: Innovative Early-Stage Approaches in NASH
Table 48: Clinical Benchmark of Key Pipeline Drugs for NASH
Table 49: Clinical Benchmark of Key Pipeline Drugs for NASH (continued)
Table 50: Clinical Benchmark of Key Pipeline Drugs for NASH (continued)
Table 51: Clinical Benchmark of Key Pipeline Drugs for NASH (continued)
Table 52: Commercial Benchmark of Key Pipeline Drugs for NASH
Table 53: Commercial Benchmark of Key Pipeline Drugs for NASH (continued)
Table 54: Commercial Benchmark of Key Pipeline Drugs for NASH (continued)
Table 55: Commercial Benchmark of Key Pipeline Drugs for NASH (continued)
Table 56: Top Line Sales Forecasts ($m) for NASH, 2016-2026
Table 57: Key Events Impacting Sales for NASH, 2016-2026
Table 58: NASH Market: 7MM - Drivers and Barriers, 2016-2026
Table 59: Projected Launch Dates for Key Drugs in NASH Across the 7MM
Table 60: High-Prescribing Physicians Surveyed, by Country

1.2 List of Figures
Figure 1: Sales for NASH by Region, 2016-2026
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in NASH
Figure 3: Stages of Liver Disease
Figure 4: The Multiple Hits Theory in NASH
Figure 5: Major Drug Targets for NASH Treatment
Figure 6: 5EU, Total Prevalence of NAFLD and Obesity (%), Ages =20 Years, Both Sexes
Figure 7: 7MM, Total Prevalent Cases of NASH, Both Sexes, Ages =4 Years, Selected Years, 2016-2026
Figure 8: 7MM, Age-Specific Total Prevalent Cases of NASH, Both Sexes, 2016
Figure 9: 7MM, Sex-Specific Total Prevalent Cases of NASH, Ages =4 Years, 2016
Figure 10: 7MM, Age-Standardized Total Prevalence of NASH, Ages =4 Years, 2016
Figure 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, Ages =4 Years, Selected Years, 2016-2026
Figure 12: 7MM, Diagnosed Prevalent Cases of NASH, by Comorbid Disorder, Ages =4 Years, N, 2016
Figure 13: NASH - Phase II?III Pipeline, 2017
Figure 14: Competitive Assessment of Late-Stage Pipeline Agents in NASH
Figure 15: Global Sales for NASH by Region, 2016-2026
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  • Gilead Sciences
  • Intercept Pharmaceuticals
  • Genfit SA
  • Allergan Plc
  • Galectin Therapeutics
  • Galmed Pharmaceuticals
  • Inventiva Pharma
  • Novo Nordisk
  • Conatus Pharmaceuticals
  • Novartis
  • Immuron Limited
  • Cirius Therapeutics
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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