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

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?

Scope

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.

Key Highlights

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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Companies mentioned

Intercept Pharmaceuticals

AbbVie/Allergan

Galmed Pharmaceuticals

Galectin Therapeutics

Madrigal Pharmaceuticals

Inventiva Pharma

Novo Nordisk

NGM Biopharmaceuticals Inc

Bristol Myers Squibb

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 Introduction

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 Epidemiology

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

9.1 Overview

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

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

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

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analysts

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

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

11.9 Disclaimer

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, 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 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

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