Survey Report: Non Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) Drug Development Pipeline Review, 2018

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This report provides an overview of the non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players active in this space, and also features data for dormant and discontinued projects.

NAFLD and NASH represent considerable burdens for healthcare systems, particularly in developed countries where NAFLD is the most common liver disorder.

NAFLD is strongly related to insulin resistance and is therefore often treated by therapeutics originally intended for use in diabetes mellitus. Up to 80% of obese people have NAFLD, which is usually asymptomatic or mildly symptomatic.

NASH is a severe form of NAFLD. It presents as a swelled or inflamed liver and may result in cirrhosis and consequent liver failure. As populations age the incidence of NASH is likely to rise and become a major healthcare concern for western systems.

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Scope

- Which companies are the most active within the pipeline for NAFLD and NASH therapeutics?
- Which pharmaceutical approaches are most prominent at each stage of the pipeline and within each indication?
- To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?
- What are the most important R&D milestones and data publications to have happened within this field?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication
- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication, and a comprehensive picture of recent updates and milestones for each
- Analyze the companies, institutions and universities currently operating in the pipeline, and the products being fielded by each of these
- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

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Table of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 5
1.2 List of Figures 8
2 Introduction 9
2.1 Gastrointestinal Report Coverage 9
2.2 Non-Alcoholic Steatohepatitis (NASH) - Overview 9
2.3 Non Alcoholic Fatty Liver Disease (NAFLD) - Overview 9
3 Therapeutics Development 10
3.1 Non-Alcoholic Steatohepatitis (NASH) 10
3.2 Non Alcoholic Fatty Liver Disease (NAFLD) 29
4 Therapeutics Assessment 37
4.1 Non-Alcoholic Steatohepatitis (NASH) 37
4.2 Non Alcoholic Fatty Liver Disease (NAFLD) 48
5 Companies Involved in Therapeutics Development 58
5.1 Non-Alcoholic Steatohepatitis (NASH) 58
5.2 Non Alcoholic Fatty Liver Disease (NAFLD) 103
6 Dormant Projects 124
6.1 Non-Alcoholic Steatohepatitis (NASH) 124
6.2 Non Alcoholic Fatty Liver Disease (NAFLD) 127

Non-Alcoholic Steatohepatitis (NASH) Drugs Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2016 - 2025

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Non-alcoholic steatohepatitis or NASH is a common term for “silent” liver disease. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware that they have a liver problem. Nevertheless, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to work properly.
There are two main types of fatty liver disease: alcohol-related fatty liver disease and non-alcoholic fatty liver disease (NAFLD). NASH is also associated with lysosomal acid lipase deficiency. Patients with only steatosis but no fibrosis can progress to NASH.

NASH itself can remain asymptomatic for years, or it can progress to cirrhosis and hepatocellular carcinoma. Risk factors such as insulin resistance related to obesity are central to the pathogenesis of NASH. Methods to diagnose NASH include MRI, CT or X-rays, however, only liver biopsy is reliable. There are no approved NASH drugs available in the market, but they are expected to enter the market by 2020. The potential NASH drug candidate include Elafirbranor, OCA, CVC and Aramchol. Currently, off-label drugs and therapies are employed to counter the progression of NASH.

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The global NASH drugs market is expected to experience robust growth post the launch of NASH therapeutic drugs, primarily due to increasing patient base, rise in obese population, increasing number of people suffering from type-2 diabetes coupled with increasing healthcare expenditure. However, the market growth is hindered by the unavailability of effective biomarkers, high cost of drugs and undefined pathogenesis.

The report “Global NASH Drugs Market: Industry Analysis & Outlook (2016-2020)” analyzes the development of this market, with focus on the US and Europe markets. The major trends, growth drivers as well as issues being faced by the market are discussed in detail in this report. The four major players: Genfit SA, Intercept Pharmaceuticals, Inc., Tobira Therapeutics Inc. and Galmed Pharmaceuticals Ltd. are being profiled along with their key financials and strategies for growth. The report contains a comprehensive analysis of the global NASH market along with the study of the regional markets.

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Diagnosis And Monitoring Of Non-alcoholic Steatohepatitis (NASH) Biomarkers Global Market Over The Period 2017 - 2024

ResearchMoz presents this most up-to-date research on "Diagnosis And Monitoring Of Non-alcoholic Steatohepatitis (NASH) Biomarkers Global Market Over The Period 2017 - 2024".

Non-alcoholic steatohepatitis (NASH) is liver disease which is categorized under the spectrum of non-alcoholic fatty liver disease (NAFLD). NASH is an advanced form of NAFLD where the liver inflammation occurs owing to fat deposition in liver. The fat accumulation may be induced by genetic abnormalities, metabolic dysfunction, drug induced damages, etc. Untreated and advanced NASH is one of the major reason for liver cirrhosis and sever liver damage such as liver failure. Presently three distinct method are used for diagnosis and monitoring of NASH, those are biopsy derived histopathology, imaging tools like transient elastography (TE), magnetic resonance imaging (MRI), etc., and in vitro diagnostic using biomarkers. As per the World Gastroenterology Organization It is estimated that around 20% to 30% of world population is affected with NAFLD.

Global Non-alcoholic Steatohepatitis Biomarker Market: Drivers and Trends

Increasing prevalence of NASH associated conditions like obesity and diabetes are expected to drive the growth of NASH biomarkers market. According to Deutsche Bank around 45 million people are anticipated to be affected by NASH in the U.S. and EU5 countries by 2025. Also there are many industry players investing on development of NASH therapeutic drugs, and most of them are in phase II or III of clinical trials. Their requirement of non-invasive diagnostic tools for monitoring their drug effectiveness is expected to drive the growth for NASH biomarkers market over the forecasted period. Biomarkers based NASH diagnostic tests are proposed to be at lower cost and non-invasive which is expected to make them a preferred tool for NASH diagnosis over invasive liver biopsy and costly imaging techniques. Ongoing research in discovery and development of novel NASH biomarkers is expected to drive the growth of NASH biomarkers market. However presently available NASH biomarkers are less accurate and have little efficacy which makes their usage limited. Also their results are overlapping with other metabolic disorders which is anticipated to restrain the growth of NASH biomarkers market.

Global Non-alcoholic Steatohepatitis Biomarker Market: Segmentation

Based on the marker type the global non-alcoholic steatohepatitis biomarkers market is segmented in to five segments viz. serum biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, oxidative stress biomarkers, and others. Serum biomarkers are expected to dominate the global NASH biomarkers market in the first half of the forecasted period. Owing to their indirect relation with NASH and other limitations they are expected to lose their market share in the second half of forecasted period. The Hepatic fibrosis markers are expected to grow exponentially over the forecasted period owing to their more accuracy and efficacy. This marker type segment is expected to hold the largest share of NASH biomarkers market by 2024. With expected launch of new diagnostic tools by Genfit SA and Exalenz Biosciences Ltd. the other markers segment is expected to have an exponential growth over the forecasted period.

Based on end-user, the global non-alcoholic steatohepatitis biomarkers market has been segmented into contract research organization (CRO) & pharmaceutical industry, academic research institutes, hospitals, and diagnostic laboratories. Owing to the requirement of non-invasive diagnostic tools for routine monitoring of drug therapy effectiveness during the clinical trial of drug candidates, the CRO & pharmaceutical industry end-user segment is expected to have a moderate growth over the forecasted period. However towards the end of forecasted period this segment is expected to be superseded by hospital and diagnostic laboratories end-user segment. With expected launch of companion diagnostic tests along with NASH therapeutic drugs the hospitals and diagnostic laboratories segments of end-user are expected to witness an exponential growth over forecasted period. The hospital end-user segment is expected to grow at CAGR of 36.6% while diagnostic laboratories segment is expected to grow at CAGR of 37.0% over the forecasted period.

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Global Non-alcoholic Steatohepatitis Biomarker Market: Regional Outlook

Geographically, the non-alcoholic steatohepatitis biomarkers market has been segmented into five regions: North America, Latin America, Europe, Asia Pacific and Middle East and Africa. These regions have been further segmented by marker type and end-user segments. The competition matrix section included in the report is likely to assist the existing players to increase their market shares and new companies to establish their presence in the global non-alcoholic steatohepatitis biomarkers market.

Key Players Mentioned in this Report are:

The report also profiles major players in the market based on various attributes such as company overview, financial overview, SWOT analysis, key business strategies, product portfolio, and recent developments. Key companies profiled in the report include One Way Liver S.L., BioPredictive S.A.S, Siemens Heathcare Pvt. Ltd. (now Siemens Healthineers), Genfit SA, Exalenz Biosciences Ltd., Quest Diagnostic Incorporated, Prometheus Laboratories Corp. (part of Nestle Health Sciences) and SNIBE diagnostics.

The global non-alcoholic steatohepatitis biomarkers market has been segmented as follows:

Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market, by Marker Type

• Serum Biomarkers
• Hepatic Fibrosis Biomarkers
• Apoptosis Biomarkers
• Oxidative Stress Biomarkers
• Others

Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market, by End-User

• Contract Research Organization(CRO) & Pharmaceutical Industry
• Academic Research Institutes
• Hospitals
• Diagnostic Laboratories

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