Non-Alcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2029

1.1 List of Tables
1.2 List of Figures

2.1 Sales Growth Expected to Correlate with Successive Drug Approvals
2.2 Combination Approaches Will Become a Key Strategy
2.3 Level of Unmet Need Remains Significant
2.4 Opportunity for Non-invasive Tests to Be at the Forefront of NASH Patient Diagnosis and Management
2.5 Innovative Pipeline Products Demonstrating High Levels of Effectiveness will Acquire Large Market Share
2.6 What Do Physicians Think?

3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports

4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification or Staging Systems

5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.3.1 Total Prevalence of NASH
5.3.2 Diagnosed Prevalence of NASH
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Sources Not Used
5.4.3 Forecast Assumptions and Methods
5.4.4 Total Prevalent Cases of NASH
5.4.5 Diagnosed Prevalent Cases of NASH
5.4.6 Diagnosed Prevalent Cases of NASH by Stage of Fibrosis
5.5 Epidemiological Forecast for NASH (2019-2029)
5.5.1 Total Prevalent Cases of NASH
5.5.2 Diagnosed Prevalent Cases of NASH
5.5.3 Age-Specific Diagnosed Prevalent Cases of NASH
5.5.4 Sex-Specific Diagnosed Prevalent Cases of NASH
5.5.5 Diagnosed Prevalent Cases of NASH by Stage of Fibrosis
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis

6.1 Overview
6.2 Diagnosis
6.3 Treatment
6.3.1 Vitamin E
6.3.2 Pioglitazone
6.4 Guidelines

7.1 Overview
7.2 Lack of Approved Therapies
7.3 Cost Efficient Non-Invasive Tests for Patient Monitoring and Potential Diagnosis
7.4 Understanding of NASH Pathophysiology
7.5 Cost-Effective Novel Therapies and Improved Access

8.1 Overview
8.1.1 Combination Therapies to Target Multiple Pathways
8.1.2 Differential Targeting of Early and Late-Stage NASH
8.2 Clinical Trials Design
8.2.1 Patient Selection
8.2.2 Clinically Meaningful Endpoints and Study Period
8.2.3 Uncertainty Surrounding Endpoints for Regulatory Submission
8.2.4 Employing Biomarkers to Measure Therapeutic Response

Table 1: NASH: Key Metrics in the 7MM
Table 2: NASH Clinical Research Network Histological Scoring System
Table 3: Risk Factors and Comorbidities for NASH
Table 4: Treatment Guidelines for NAFLD/NASH
Table 5: Recommendations for Pharmacological Therapies from Guidelines
Table 6: Comparison of Mechanisms of Action in Development for NASH, 2019-2029
Table 7: Innovative Early Stage Approaches for NASH, 2020
Table 8: Clinical Benchmark of Key Pipeline Drugs - NASH
Table 9: Commercial Benchmark of Key Pipeline Drugs - NASH
Table 10: Key Events Impacting Sales for NASH, 2019-2029
Table 11: NASH Market - Global Drivers and Barriers, 2019-2029
Table 12: Key Historical and Projected Launch Dates for NASH
Table 13: Key Historical and Projected Patent Expiry Dates for NASH
Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for NASH in 2019 and 2029
Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Vitamin E
Figure 3: Stages of Liver Disease
Figure 4: Pathways of Current and Pipeline NASH Therapeutics
Figure 5: 7MM, Total Prevalence of NASH (%), Both Sexes, All Ages, 2009?2029
Figure 6: 7MM, Diagnosed Prevalence of NASH (%), Both Sexes, All Ages, 2009?2029
Figure 7: 7MM, Sources Used for NASH Total Prevalence
Figure 8: 7MM, Sources Used for Obesity Prevalence
Figure 9: 7MM, Sources Used for the Diagnosed Prevalent Cases of NASH and Diagnosed Prevalent Cases of NASH by Stage of Fibrosis
Figure 10: 7MM, Total Prevalent Cases of NASH, Both Sexes, All Ages, 2019
Figure 11: 7MM, Diagnosed Prevalent Cases of NASH, Both Sexes, All Ages, 2019
Figure 12: 7MM, Age-Specific Diagnosed Prevalent Cases of NASH, Both Sexes, 2019
Figure 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of NASH, All Ages, 2019
Figure 14: 7MM, Diagnosed Prevalent Cases of NASH by Stage of Fibrosis, Both Sexes, All Ages, 2019
Figure 15: Unmet Needs and Opportunities in NASH
Figure 16: Overview of the Development Pipeline in NASH
Figure 17: Key Phase II/III Trials for Promising Pipeline Agents that the Publisher Expects Will Be Licensed for NASH in the 7MM During the Forecast Period
Figure 18: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Vitamin E
Figure 19: Global (7MM) Sales Forecast by Country for NASH in 2019 and 2029
Figure 20 presents the global sales forecast, by therapeutic class, for NASH in 2019 and 2029. Figure 20: Global (7MM) Sales Forecast by Class for NASH in 2019 and 2029
Figure 21: Sales Forecast by Class for NASH in the US in 2019 and 2029
Figure 22: Sales Forecast by Class for NASH in the 5EU in 2019 and 2029
Figure 23: Sales Forecast by Class for NASH in Japan in 2019 and 2029