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Published Date: 2016-04-15Number of Pages: 65

Nonalcoholic Steatohepatitis Therapeutics Market (Obeticholic Acid, Aramchol, Saroglitazar, and Elafibranor) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 - 2025

Global Nonalcoholic Steatohepatitis (NASH) Market: Snapshot 

Nonalcoholic Steatohepatitis (NASH), a syndrome found in non-alcoholic patients, causes damage to liver that is histologically akin to alcoholic hepatitis. NASH results from fat in the liver, along with inflammation. Symptoms in NASH usually do not show, but it can be severe and lead to cirrhosis, which is permanent damage to the liver. 

Those suffering from obesity, dyslipidemia, and glucose intolerance are most likely to have nonalcoholic steatohepatitis (NASH). Most patients are asymptomatic and biopsy is essential to confirm the diagnosis. Treatment mainly entails elimination of causes and risk factors.  

Driving the growth in the global market for nonalcoholic steatohepatitis therapeutics is the rising instances of obesity and diabetes. Another factor boosting the market is the thrust on research and development. In fact, a noticeable trend in the market has been the focus on developing novel therapeutics for the curing NASH by big biopharmaceutical manufacturing companies. Propelled by such factors, the global market for nonalcoholic steatohepatitis therapeutics is slated to expand at a robust 10.7% CAGR between 2015 and 2025 to attain a value of US$20.27 bn by 2025. 

Elafibranor Drug Holds a Sway over Market by Dint of being Most Advanced 

The cause for nonalcoholic steatohepatitis (NASH) is unclear and research is being carried out to find effective treatments. At present, treatment of NASH focuses on controlling some of the medical conditions associated with it such as diabetes and obesity and monitoring for advancement. As with nonalcoholic fatty liver disease, people with NASH should be vaccinated against hepatitis A and B if they are not immune already. 

Depending upon the type of drug, the global market for nonalcoholic steatohepatitis (NASH) can be segregated into potential phase III candidates such as Saroglitazar, Obeticholic acid (OCA), Aramchol, and Elafibranor. There are others too in the Phase I and Phase II clinical trials. Among the different types of drugs Elafibranor is predicted to hold maximum share in the market and also exhibit maximum growth rate. This is because Elafibranor is the most advanced drug in this category. It is followed by Obeticholic Acid (OCA) in the market. 

Currently, Intercept Pharmaceuticals, in collaboration with DSP, is developing obeticholic acid for commercialization in the United States and European countries. This drug is anticipated to receive commercial approval by the end 2017. 

Developing Nations Power Growth in Asia Pacific Market 

While the prevalence of nonalcoholic steatohepatitis (NASH) is growing across the globe, it is the developed regions of Europe and North America that are seeing maximum instances on account of increasing occurrence of lifestyle related conditions such as obesity and diabetes. In North America particularly, the rate of obesity has almost doubled in children. Obesity also leads to diabetes and high blood cholesterol, which can aggravate health issues of those suffering from NASH. 

In Europe, nonalcoholic steatohepatitis (NASH) is most prevalent in the countries of Spain, Germany, Italy, France and, the U.K. Developing economies, especially in Asia-Pacific are considered high growth markets for nonalcoholic steatohepatitis (NASH) therapeutics and are forecasted to grow at double digits in the foreseeable future. This is because of the alarming increase in nonalcoholic fatty liver diseases in countries of Korea, China, and Japan. 

Some of the prominent names operating in the global market for nonalcoholic steatohepatitis (NASH) are Astazeneca Plc., Intercept Pharmaceuticals Inc., Galmed Pharmaceuticals Ltd., GENFIT SA, Gilead Sciences, Inc., Zydus Cadila, Immuron Ltd., Conatus Pharmaceuticals, and Tobira Therapeutics, Inc. 

Table of Contents

Chapter 1 Introduction
1.1 Report Description
1.2 Research Methodology
1.3 Market Segmentation
1.4 Assumptions

Chapter 2 Executive Summary
2.1 Global NASH Market, by Drug, 2025 (US$ Mn)

Chapter 3 Global Nonalcoholic Steatohepatitis (NASH) Therapeutics Market Overview 
3.1 Introduction
3.2 Epidemiology of Nonalcoholic Steatohepatitis (Qualitative Analysis)
     3.2.1 North America
     3.2.2 Europe
     3.2.3 Asia Pacific
     3.2.4 Rest of World
3.3 Diagnosis and Treatment of NASH (Qualitative Analysis)
3.4 Market Dynamics
     3.4.1 Drivers
     3.4.2 Restraints
     3.4.3 Opportunities

Chapter 4 Global Nonalcoholic Steatohepatitis (NASH) Therapeutics Market, By Drug Type, 2015 – 2025 (US$ Mn)
4.1 Overview
4.2 Potential Drug Candidates in Phase III
     4.2.1 Obeticholic Acid (OCA)
     4.2.2 Aramchol (arachidyl amido cholanoic acid)
     4.2.3 Saroglitazar
     4.2.4 Elafibranor
4.3 Pipeline Analysis
     4.3.1 Tabular Representation of Phase I and Phase II Clinical Trials (Qualitative Analysis)
4.4 Target Population By Geography: NASH Market 

Chapter 5 Recommendations

Chapter 6 Company Profiles
6.1 AstraZeneca plc
     6.1.1 Company Overview
     6.1.2 Financial Overview
     6.1.3 Product Pipeline
     6.1.4 Business Strategies
     6.1.5 Recent Developments
6.2 Intercept Pharmaceuticals Inc.
6.3 Galmed Pharmaceuticals
6.4 GENFIT SA 
6.5 Gilead Sciences Inc. 
6.6 Zydus Cadila 
6.7 Immuron Ltd. 
6.8 Conatus Pharmaceuticals 
6.9 Tobira Therapeutics Inc.
6.10 Others

Nonalcoholic fatty liver disease (NAFLD) is a disorder categorized by excess fat in the liver of people who drink little to no alcohol. No direct cause has yet been identified, however obesity and insulin resistance are believed to have major roles. Most often, NAFLD goes relatively undetected, as a liver can remain fatty without obstructing its function. Though, NAFLD can progress into a far more severe condition known as nonalcoholic steatohepatitis (NASH), a disease characterized by inflammation and irreversible cell death. NASH is a disease that advances over time. Over a period of ten years up to 20% of patients with NASH develop cirrhosis of the liver, and 10% die from the disease. At present, NASH is one of the leading causes of liver transplants in the U.S., with a considerable proportion of the general population currently suffering from the disease. NAFLD and NASH are both closely related to diabetes and obesity, and together are now considered as the leading cause of liver disease in Western countries. Thus, there is an urgent need for effective treatment options for these diseases. The need for treatment is expected to propel the growth of NASH therapeutics in coming years. 

The NASH market is segmented based on drug type which includes potential phase III candidates such as Obeticholic acid (OCA), Aramchol, Saroglitazar and Elafibranor. Moreover, the report provides a list of the candidates in Phase I and Phase II clinical trials. Based on the drug type, Elafibranor is expected to account for a major share of this market followed by Obeticholic Acid (OCA) market and the market for Elafibranor is expected to grow at the highest CAGR. 

The market overview section of the report demonstrates major market dynamics such as drivers, restraints, and opportunities that influence the current and future status of the industry. The market overview section includes epidemiology of Nonalcoholic steatohepatitis (NASH) by region, to provide a thorough analysis of the overall addressable global market for the NASH therapeutics. Moreover, the report provides qualitative information about diagnosis and treatment of NASH. 

The report also provides important recommendations for market players and new entrants. These recommendations would enable existing market players to expand their market shares and help new companies to establish their presence in the NASH market across different regions worldwide. The report concludes with the company profiles section, which includes key information about major players in the market such as financial overview, business strategies, and recent developments. 

Major players in this market are Astazeneca Plc (U.K.), Intercept Pharmaceuticals Inc. (U.S.), Galmed Pharmaceuticals Ltd. (Israel), GENFIT SA (France), Gilead Sciences, Inc. (U.S.), Zydus Cadila (India), Immuron Ltd. (Australia), Conatus Pharmaceuticals (U.S.), and Tobira Therapeutics, Inc. (U.S.). 

The Nonalcoholic Steatohepatitis (NASH) Therapeutics market has been segmented as follows: 

  • Global Nonalcoholic Steatohepatitis (NASH) Therapeutics Market, By Drug Type
    • Overview
    • Potential Drug Candidates in Phase III
    • Obeticholic Acid (OCA)
    • Aramchol (arachidyl amido cholanoic acid)
    • Saroglitazar
    • Elafibranor 


 
 
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