Non-Alcoholic Steatohepatitis (NASH) – Opportunity Analysis and Forecasts to 2029
- Pages: 140
- Published: November 2020
- Report Code: GDHC113POA
Non-alcoholic steatohepatitis (NASH) is a common, often clinically silent liver disease characterized by the presence of steatosis (fatty liver), in addition to liver inflammation and damage. Unlike alcoholic liver disease, NASH occurs in those who drink little or no alcohol. NASH usually presents with few or no symptoms, and most people affected with the disease feel healthy and are unaware they have a problem. However, symptoms including fatigue, weight loss, and weakness emerge once the disease has progressed to a more advanced stage, like cirrhosis. NASH is suspected if elevated liver enzymes are detected during routine blood panels, but it is only definitively diagnosed when a liver biopsy is performed.
Both NASH and non-alcoholic fatty liver (NAFL) are histologically categorized under the umbrella of non-alcoholic fatty liver disease (NAFLD). NAFL is defined as the presence of a fatty liver with no evidence of hepatocellular injury or fibrosis, whereas NASH is defined as the presence of fatty liver and inflammation with evidence of hepatocyte injury, with or without fibrosis. NASH can progress to more advanced stages of liver disease including cirrhosis, liver failure, and in rare cases, liver cancer.
Key Questions Answered
How will the NASH therapeutic market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) will change from 2019–2029?
What NASH therapeutics are in clinical development?
How do the clinical and commercial attributes of NASH therapies in development compare with one another, and which will become market leaders?
What are the remaining unmet needs in NASH?
What drivers and barriers will affect NASH therapy sales in the 7MM over the forecast period?
Overview of current and future therapeutic approaches in treating NASH in patients with stages F2-F4.
Topline NASH market revenue from 2019-2029. 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, pipeline valuation analysis of the NASH market in the 7MM.
Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of pipeline products.
Analysis of the current and future market competition in the global NASH market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Over the 10-year forecast period, GlobalData estimates the sales for the NASH market to grow from $144.4M in 2019 to $27.2B in 2029 at a Compound Annual Growth Rate (CAGR) of 68.8% across the 7MM. At the end of 2029, the US will contribute around 94.3% of global sales, while the 5EU and Japan will account for around 4.5% and 1.2% of sales, respectively.
GlobalData expects the main drivers of growth during the forecast period to be the US launch of Intercept’s Ocaliva in 2021, Inventiva’s lanifibranor in 2025 and Novo Nordisk’s Ozempic in 2026. Ozempic is anticipated to have rapid growth and be the highest grossing therapy by 2029 in NASH.
Throughout the forecast period, cost of therapy and slow reimbursement rates will likely hinder uptake of certain therapies. GlobalData also expects finding an alternative to liver biopsy will remain a challenge for diagnosis and measuring treatment response, although novel non-invasive tests such as Genfit’s NIS-4 could become validated in hopes of boosting diagnosis rates throughout the period.
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Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 NASH: Executive Summary
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?
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and 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
5.4.2 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
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of the Analysis
5.6.3 Strengths of the Analysis
6 Current Treatment Options
6.3.1 Vitamin E
7 Unmet Needs and Opportunity Assessment
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 R&D Strategies
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
9 Pipeline Assessment
9.2 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
11.3.1 Forecasting Methodology
11.3.2 Diagnosed Patients
11.3.3 Percent Drug-Treated Patients
11.3.4 Drugs Included in Each Therapeutic Class
11.3.5 Launch and Patent Expiry Dates
11.3.6 General Pricing Assumptions
11.3.7 Individual Drug Assumptions
11.3.8 Generic Erosion
11.3.9 Pricing of Pipeline Agents
11.4 Primary Research – KOLs Interviewed for This Report
11.5 Primary Research – Prescriber Survey
11.6 About the Authors
11.6.2 Therapy Area Director
11.6.4 Managing Epidemiologist
11.6.5 Global Director of Therapy Analysis and Epidemiology
11.6.6 Global Head and EVP of Healthcare Operations and Strategy
11.7 About GlobalData
11.8 Contact Us
List of Tables
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
List of Figures
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, 20092029
Figure 6: 7MM, Diagnosed Prevalence of NASH (%), Both Sexes, All Ages, 20092029
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 GlobalData 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