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Nonalcoholic Steatohepatitis Therapeutics - Pipeline Assessment and Market Forecasts to 2017

Published By :

GlobalData

Published Date : Dec 2010

Category :

Therapeutic Area

No. of Pages : 66 Pages


GlobalData, the industry analysis specialist, has released its new report, “Non-alcoholic Steatohepatitis (NASH) - Pipeline Assessment and Market Forecasts to 2017”. The report is an essential source of information and analysis on the global NASH market. The report identifies the key trends shaping and driving the global NASH market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global NASH sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts. 

GlobalData estimated that the Nonalcoholic Steatohepatitis (NASH) market was worth $0.5 billion in 2009. The major reason for the limited market revenues is that there is no approved drug for the treatment of NASH. NASH is a disease with an unrecognized cause but with emerging importance. It is an aggressive form of NAFLD (Non-Alcoholic Fatty Liver Disease), which often progresses to liver cirrhosis. Since NASH is strongly associated with metabolic syndromes, the increased prevalence of diabetes, obesity and hyperlipidemia are considered to be important reasons for an increased incidence and prevalence of NASH. Antioxidants, anti-diabetes medications, anti-obesity medications and anti-hyperlipidemics are some of the off-label products currently used by NASH patients. The modest growth forecast is primarily attributed to a weak pipeline landscape. The fact that low diagnosis rates, low prescription rates and low treatment seeking rates continue to pose significant challenges for prospective market entrants, the market landscape in future is expected to be devoid of any significant dynamism. Overall, between 2009 and 2017, the NASH market is expected to grow at a CAGR (Compounded Annual Growth Rate) of 16% to reach $1.65 billion by 2017, mainly driven by the increasing incidence and prevalence of NASH due to an increase in the incidence of metabolic syndrome and increased awareness among patients and physicians, which are expected to lead to improvements in diagnosis and treatment rates 

Scope

The report provides information on the key drivers and challenges of the NASH market. Its scope includes:

  • Annualized global NASH market revenues data from 2001 to 2009, forecast for eight years to 2017.
  • Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends. Pipeline candidates fall under major therapeutic classes such as antioxidants, pan-caspase inhibitors and GLP-1 agonists.
  • Analysis of the current and future competition in the global NASH market. Key market players covered are Amylin/Lilly, Enzo Biochem, Raptor Pharmaceuticals, Gilead Sciences and Axcan Pharma.
  • Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide a qualitative analysis of its implications.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the NASH therapeutics market
Reasons to buy 

The report will enhance your decision making capability. It will allow 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 market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments and companies likely to impact the global NASH market in 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.
  • What’s the next big thing in the global NASH market landscape? - Identify, understand and capitalize.
Table of Contents

1 Table of Contents 3

1.1 List of Tables 5
1.2 List of Figures 5

2 Nonalcoholic Steatohepatitis: Introduction 6
2.1 Disease Overview 6
2.2 Signs and Symptoms 9
2.3 Diagnosis 10
2.3.1 Ultrasonography 10
2.3.2 Computed Tomography 10
2.3.3 Magnetic Resonance Imaging 10
2.3.4 Liver function tests 11
2.3.5 Liver Biopsy 11
2.4 Trends in Diagnosis of NASH 11
2.5 Prevention 12
2.6 Treatment 13
2.7 Trends in Treatment of NASH 15
2.8 Epidemiology 15
2.9 GlobalData Pipeline Report Guidance 17

3 Nonalcoholic Steatohepatitis: Market Characterization 18
3.1 Nonalcoholic Steatohepatitis Disease Market Size 18
3.2 Nonalcoholic Steatohepatitis Market Forecast and CAGR 19
3.3 Drivers and Barriers for the Nonalcoholic Steatohepatitis Disease Market 20
3.3.1 Drivers for the NASH Market 20
3.3.2 Barriers for the NASH Market 21
3.4 Opportunity and Unmet Need 22
3.5 Key Takeaway 23

4 Nonalcoholic Steatohepatitis Market : Competitive Assessment 24
4.1 Overview 24
4.2 Strategic Competitor Assessment 24
4.3 Product Profile for the Major Off-label Marketed Products in the Nonalcoholic Steatohepatitis Market 25
4.3.1 Antioxidants 25
4.3.2 Anti-diabetes Medications 26
4.3.3 Anti-obesity Medications 27
4.3.4 Antifibrotic Medications 28
4.4 Key Takeaway 28

5 Nonalcoholic Steatohepatitis Market : Pipeline Assessment 29
5.1 Overview 29
5.2 Strategic Pipeline Assessment 29
5.2.1 Technology Trends Analytic Framework 29
5.3 Nonalcoholic Steatohepatitis Therapeutics Promising Drugs under Clinical Development 31
5.4 Molecule Profile for Promising Drugs under Clinical Development 33
5.4.1 Byetta (exenatide) 33
5.4.2 GS 9450 (LB84451) 34
5.4.3 High-Dose Ursodesoxycholic Acid (HD-UDCA) 36
5.4.4 DR Cysteamine (delayed release cysteamine bitartrate) 37
5.4.5 EGS21 (beta glucosylceramide formulation) 38
5.5 Nonalcoholic Steatohepatitis Market Pipeline by Mechanism of Action 40
5.6 Nonalcoholic Steatohepatitis Pipeline by Clinical Phases of Development 41
5.6.1 Nonalcoholic Steatohepatitis Therapeutics Phase III Clinical Pipeline 41
5.6.2 Nonalcoholic Steatohepatitis Therapeutics Phase II Clinical Pipeline 42
5.6.3 Nonalcoholic Steatohepatitis Therapeutics Phase I Pipeline 43
5.6.4 Nonalcoholic Steatohepatitis Therapeutics Preclinical Pipeline 43
5.6.5 Nonalcoholic Steatohepatitis Therapeutics Discovery Phase Pipeline 43
5.7 Key Takeaway 43

6 Nonalcoholic Steatohepatitis Market : Implications for Future Market Competition 44

7 Nonalcoholic Steatohepatitis Disease Market : Future Players in the Nonalcoholic Steatohepatitis Market 45

7.1 Introduction 45
7.2 Raptor Pharmaceuticals 45
7.2.1 Company Overview 45
7.2.2 Gastroenterology Disease Portfolio 46
7.2.3 Nonalcoholic Steatohepatitis Product Portfolio 46
7.3 Gilead Sciences 47
7.3.1 Company Overview 47
7.3.2 Gastroenterology Disease Portfolio 50
7.3.3 Nonalcoholic Steatohepatitis Product Portfolio 50
7.4 Axcan Pharma 51
7.4.1 Company Overview 51
7.4.2 Gastroenterology Portfolio 52
7.4.3 Nonalcoholic Steatohepatitis Product Portfolio 53
7.5 Eli Lilly and Company 55
7.5.1 Company Overview 55
7.5.2 Gastroenterology Portfolio 55
7.5.3 Nonalcoholic Steatohepatitis Product Portfolio 55
7.6 Enzo Biochem 57
7.6.1 Company Overview 57
7.6.2 Gastroenterology Portfolio 58
7.6.3 Nonalcoholic Steatohepatitis Product Portfolio 58

8 Nonalcoholic Steatohepatitis Market : Appendix 60
8.1 Market Definitions 60
8.2 Abbreviations 60
8.3 Research Methodology 61
8.3.1 Coverage 62
8.3.2 Secondary Research 62
8.3.3 Forecasting 62
8.3.4 Primary Research 64
8.3.5 Expert Panels 65
8.4 Contact Us 65
8.5 Disclaimer 65
8.6 Sources 65

List of Table


Table 1: Grading and Staging of Nonalcoholic Steatohepatitis 9
Table 2: Therapeutic Options For the Treatment of Nonalcoholic Steatohepatitis 13
Table 3: Nonalcoholic Steatohepatitis Therapeutics Market, Global, Prevalence of Liver Abnormalities Among Obese, Diabetic and General Population (%), 2010 16
Table 4: Nonalcoholic Steatohepatitis Therapeutics Market, Global, Prevalence of Parameters (%) of Metabolic Syndromes in NASH, 2010 16
Table 5: NASH Therapeutics, Global, Revenues ($m), 2001 2009 19
Table 6: NASH Therapeutics, Global, Revenues Forecast ($m), 2009 2017 20
Table 7: NASH Therapeutics Most Promising Drugs Under Clinical Development, 2010 31
Table 8: NASH Therapeutics, Phase III Clinical Pipeline, 2010 41
Table 9: NASH Therapeutics, Phase II Clinical Pipeline, 2010 42
Table 10: NASH Therapeutics, Phase I Pipeline, 2010 43
Table 11: NASH Therapeutics, Preclinical Pipeline, 2010 43
Table 12: NASH Therapeutics, Discovery Pipeline, 2010 43
Table 13: Raptor Pharmaceuticals Pipeline Products, 2010 46
Table 14: Gilead Sciences Pipeline Products, 2010 50
Table 15: Axcan Pharma Marketed Products, 2010 52
Table 16: Axcan Pharma Pipeline Products, 2010 53
Table 17: Eli Lilly and Company Pipeline Products, 2010 55
Table 18: Enzo Biochem Pipeline Products, 2010 58

List of Chart


Figure 1: Nonalcoholic Steatohepatitis Therapeutics Market, Two-Hit Hypothesis of Disease Pathogenesis 6
Figure 2: Mechanisms Leading to Liver Steatosis 7
Figure 3: Factors Contributing to the Development of NASH from a Steatotic Liver 8
Figure 4: Risk Factors Associated with Nonalcoholic Steatohepatitis 12
Figure 5: Treatment Targets for NASH, 2010 14
Figure 6: NASH Therapeutics, Global, Revenue ($m) 20012009 19
Figure 7: NASH Therapeutics, Global, Revenues Forecast ($m), 20092017 20
Figure 8: Opportunity and Unmet Need in the NASH, 2010 23
Figure 9: Strategic Competitor Assessment of the Major Marketed (Off-Label) Products for NASH, 2010 25
Figure 10: Technology Trends Analytic Framework of NASH Pipeline, 2010 30
Figure 11: Technology Trends Analytic Framework of the NASH Pipeline - Description, 2010 30
Figure 12: NASH Therapeutics, Global, Clinical Pipeline by Mechanism of Action (%), 2010 40
Figure 13: NASH Therapeutics, Global, Pipeline by Phase of Clinical Development (%), 2010 41
Figure 14: Implications for Future Market Competition in the NASH Market, 2010 44
Figure 15: NASH Therapeutics Market, Global, Clinical Pipeline by Company, Number of Molecules, 2010 45
Figure 16: GlobalData Market Forecasting Model 64

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