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OpportunityAnalyzer: NASH – Opportunity Analysis and Forecasts to 2026

First described in 1980, 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 .

GlobalData estimates the 2016 sales for the 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 account for 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.

Key Questions Answered

How will the NASH market landscape in the 7MM (US, France, Germany, Italy, Spain, UK and Japan) change from 2016–2026?

What are the most promising late-stage pipeline drugs in NASH?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the greatest unmet needs in NASH? Will the pipeline drugs fulfil these needs of the market?

What are the biggest opportunities in the NASH landscape?

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.

Companies mentioned

Gilead Sciences

Intercept Pharmaceuticals

Genfit SA

Allergan Plc

Galectin Therapeutics

Galmed Pharmaceuticals

Inventiva Pharma

Novo Nordisk

Conatus Pharmaceuticals

Novartis

Immuron Limited

Cirius Therapeutics

Table of Contents

Table of Contents

1 Table of Contents

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 GlobalData

11.8 Contact Us

11.9 Disclaimer

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

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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