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非酒精性脂肪性肝炎 (NASH):盛行率、開發中的藥物、法律規章指南、市場機會分析:各地區

Non-Alcoholic SteatoHepatitis (NASH): An Analysis of Disease Prevalence, Drugs in development, Regulatory guidelines and Market opportunity in Various Geographies

出版商 MP Advisors 商品編碼 346132
出版日期 內容資訊 英文 65 Pages
商品交期: 最快1-2個工作天內
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非酒精性脂肪性肝炎 (NASH):盛行率、開發中的藥物、法律規章指南、市場機會分析:各地區 Non-Alcoholic SteatoHepatitis (NASH): An Analysis of Disease Prevalence, Drugs in development, Regulatory guidelines and Market opportunity in Various Geographies
出版日期: 2015年12月01日 內容資訊: 英文 65 Pages

C型肝炎的治療藥銷售額2014年超過100億美元,肝臟病的治療藥可能一鳴驚人。非酒精性脂肪性肝炎 (NASH) 預期也有同樣的高盈利。

本報告提供非酒精性脂肪性肝炎 (NASH) 治療藥的市場相關調查、NASH概要、有潛力的NASH治療藥、開發中的藥物狀況與開發企業、現有藥物對NASH的重新定位配合措施等彙整資料。

第1章 摘要整理

第2章 非酒精性脂肪性肝炎 (NASH) 概要

  • 在NASH治療中有潛力的標的
  • 開發平台藥物
  • 主要的里程碑
  • M&A/授權交易的推動因素
  • 市場機會預測

第3章 開發中的產品、競爭環境

  • 主要的NASH治療藥、開發企業
    • Obeticholic Acid:Intercept Pharmaceuticals/大日本住友製藥
    • Elafibranor:Genfit
    • Multiple programs:Gilead
    • Emricasan:Conatus Pharmaceuticals
    • Aramchol:Galmed Pharmaceuticals
    • Cenicriviroc:Tobira Therapeutics
    • IMM-124E:Immuron
    • GR-MD-02:Galectin Therapeutics
    • TD139:Galecto Biotech
    • SHP626:Shire
    • PXS4728A:Boehringer Ingelheim
  • 現有藥物對NASH的適應
    • Remogliflozin etabonate:Islet Sciences/BHV pharma
    • Lipaglyn (saroglitazar):Cadila Healthcare
    • Victoza (liraglutide):Novo Nordisk

第4章 NASH:病因、病原、診斷、目前治療方法

  • 原因、症狀、病理形成、診斷
  • 目前治療方法:含中藥

第5章 藥事上的途徑

  • 臨床試驗的課題
  • 有潛力的臨床試驗設計和試驗指標

第6章 附錄

Product Code: 4485

Sales of Hepatitis C drugs crossed ~$10bn in 2014 proving that treatments for liver disease could become mega-blockbusters and Non-Alcoholic SteatoHepatitis (NASH) is expected to be equally lucrative. Improved diagnosis rate and change in treatment guidelines along with defined clinical trials endpoint are the concerns for the emerging therapy. US FDA is expected to release guidelines for the clinical trial in CY16 and this should accelerate the development of the drugs targeting NASH.

NASH is the progressive form of Non-Alcoholic Fatty Liver Disease - NAFLD. While NASH can reverse itself, in many cases, the resulting liver scarring causes a patient's liver to harden and failure to work properly. It is estimated that NASH affects 2 to 5% of the US population. Other developed countries such as Europe and Japan also have similar or higher incidence of NASH disease. Due to the varying physical and metabolism traits across various geographies, development of drugs for NASH is facing difficulty. In Japan, the prevalence of NASH is rising although the population is not typically overweight. Countries like India and China with bigger population and changes in lifestyles face a greater risk of NASH along with other lifestyle diseases like Diabetes and Cardiovascular related complexities.

As per the US Association of Liver Disease, of those who develop NASH, ~15-25% will progress to end stage liver disease (ESLD) and hepatocellular carcinoma (HCC) over 10-20 years. Today, 1/3rd of Liver transplants and HCC are caused by NASH and the total cost burden of this on US is over ~$5 billion per year. Only new treatments in NASH could lead to a cut in this major cost burden along with improving quality of life.

Since a new innovation in NASH has been enlightened, the interest in companies developing drugs for NASH has also gone up. In Jan. 2015, Gilead Sciences (GILD) acquired Phenex Pharma's Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including nonalcoholic steatohepatitis (NASH) and other Liver Diseases. Merck-NGM Biopharma and Boehringer Ingelheim - Pharmaxis also entered into an exclusive agreement for the pipeline products which are being developed for NASH with a potential deal value of ~$450-600mn.

This report will provide detailed analysis on NASH disease and Drugs in development in broader pharma market. This report list all the drugs in clinical trial and their design and the population recruited, also tells about the pathways representing possible targets for the treatment of NASH.

Table of Contents

1. Executive Summary

2. Overview of NASH

  • 2.1. Possible targets for the treatment of NASH
  • 2.2. Drugs in the pipeline
  • 2.3. Key Milestones
  • 2.4. Drivers of M&A/ Licensing deals in NASH
  • 2.5. NASH disease market opportunity to 2025

3. Products in Development and Competitive Landscape

  • 3.1. Key Drugs/Companies Developing Drugs Against NASH
    • 3.1.1. Obeticholic Acid - Intercept Pharmaceuticals/ Dainippon Sumitomo
    • 3.1.2. Elafibranor - Genfit
    • 3.1.3. Multiple programs - Gilead
    • 3.1.4. Emricasan - Conatus Pharmaceuticals
    • 3.1.5. Aramchol - Galmed Pharmaceuticals
    • 3.1.6. Cenicriviroc - Tobira Therapeutics
    • 3.1.7. IMM-124E - Immuron
    • 3.1.8. GR-MD-02 - Galectin Therapeutics
    • 3.1.9. TD139 - Galecto Biotech
    • 3.1.10. SHP626 - Shire
    • 3.1.11. PXS4728A - Boehringer Ingelheim
  • 3.2. Repurposed Drugs for NASH
    • 3.2.1. Remogliflozin etabonate - Islet Sciences/BHV pharma
    • 3.2.2. Lipaglyn (saroglitazar) - Cadila Healthcare
    • 3.2.3. Victoza (liraglutide) - Novo Nordisk

4. NASH - Etiology, Pathogenesis, Diagnosis and Current Treatment

  • 4.1. Cause, Symptoms, Pathogenesis, Diagnosis
  • 4.2. Current treatment including Herbal Medicine

5. Regulatory Pathway

  • 5.1. Challenges in trials using endpoints to define clinically meaningful benefits
  • 5.2. Potential Clinical Trial Design for NASH and Endpoints

6. Annexure

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