Product 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.
- 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.
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.
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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?
- 3.1 Catalyst
- 3.2 Related Reports
- 3.3 Upcoming Related Reports
4 Disease Overview
- 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 Current Treatment Options
- 6.1 Overview
- 6.2 Diagnosis
- 6.3 Treatment
- 6.3.1 Vitamin E
- 6.3.2 Pioglitazone
- 6.4 Guidelines
7 Unmet Needs and Opportunity Assessment
- 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 R&D Strategies
- 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
9 Pipeline Assessment
10 Pipeline Valuation Analysis
List of Tables
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 Pharmacolog
List of Figures
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