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Nonalcoholic Steatohepatitis (NASH) also known as silent disease is a type of fatty liver disease, which mainly affects people with diabetes and obesity. Symptoms of NASH are found among all demographics (from children to adults); however, they are more prevalent in younger people. Corner stage of cirrhosis is a form of NASH that can be reversed with proper medication. Moreover, most of the NASH specific pharmaceutical solution are in clinical trial phase . Additionally, the absence of efficient diagnostic technologies acts as a major hurdle for the research of NASH therapeutics. Nevertheless, the emergence of novel biomarker technologies and improvements in liver biopsy technologies are expected to bring about an evolution in the diagnosis of NASH and other fatty liver diseases. Global non-alcoholic Steatohepatitis market is expected to garner $1693.2 million by 2020 growing at a CAGR of 25.6% during 2014-2020.

Increase in cycles of clinical trials and their success rate has increased the probability of industries receiving commercial approval for NASH therapeutics by the end of 2017. The market growth is restricted by factors such as NASHs complex and enigmatic physiological structure and inefficient diagnostics technology; these factors could also prolong the commercialization process for NASH therapeutics. Nevertheless, certain key players competing in the market are conducting extensive research on NASH therapeutics and are receiving positive results from clinical trials. The results of a recent clinical trial conducted by Genfit satisfied concerns of the EMA (European Medicines Agency), regarding the efficacy and safety of GFT5o5 as therapeutics for NASH. The EMA finally recommended that the development of GFT5o5 as a therapeutic drug progress to Phase III of the clinical trial. Additionally, Dainippon Sumitomo Pharma (DSP), a partner of Intercept Pharmaceuticals, initiated a phase 2 clinical trial to test thesafety and efficacy of one daily dose of OCA in 200 adult NASH patients. The trial is expected to be completed in the first half of 2016.

Geographically, the NASH therapeutics market is segmented into North America, Europe, Asia-Pacific and LAMEA. Geographical analysis of NASH therapeutics is conducted with reference to research and commercialization. North America, which has the highest number of research initiatives concerning NASH, holds nearly half of the global market share. It is also one of the regions with the most cases of NASH and other non-alcoholic fatty liver diseases. European countries are equally contributing to the growth of the NASH therapeutics market in terms of research and commercialization; however, failure to comply with regulations and decreased number of research initiatives causes them to be relegated to the second place in this market. With regard to developing economies, Asia-Pacific region is one of the fastest growing markets for NASH therapeutics and is expected to have a double digit growth rate during the analysis period. The chief reason behind this growth is the high prevalence of diabetes and obesity and the growing number of people afflicted with these conditions- a number which is expected to increase up to 30 fold by 2030. Furthermore, the exorbitant price of the physical therapeutics currently used to treat fatty liver diseases is raising the demand for pharmaceutical therapies as they are comparatively economical.

nonalcoholic

KEY BENEFITS

  • Various opportunities for non alcoholic fatty liver disease therapeutics present in developed as well as developing economies are thoroughly assessed
  • Substitute treatments and their potential impact on NASH therapeutics are strategically quantified in the report
  • Opportunities from a business perspective latent in the Asia-Pacific region are brought to light
  • Market dimensions of diagnostic techniques used in NASH monitoring provide a clear outline of the NASH therapeutics research market
  • Geography-wise segmentation of clinical trials is conducted to provide strategic intelligence to the stakeholder
  • Pipeline analysis for the key NASH therapeutics under clinical research provides market intelligence needed for commercialization
  • Detailed analysis of market dynamics provides intelligence about market competencies according to segments
  • In depth analysis of key players operating in the fatty liver disease therapeutics market is conducted according to regions
  • Drivers and factors limiting market expansion are studied in detail
  • Comprehensive and quantitative data about changing market trends, competition and opportunities in NASH market is provided in the report
  • SWOT analysis of companies would help stakeholders make strategic decisions
  • Deep dive analysis of key market players and strategies adopted by them would provide valuable information regarding the top contenders in the market

KEY DELIVERABLES

Global Non-alcoholic Steatohepatitis market is categorized into pipeline therapeutic types and geography.

MARKET BY THERAPEUTICS

  • GFT505
  • Obeticholic Acid (INT-747)
  • Simtuzumab and Liraglutide (Victoza)
  • Vitamin E
  • Pioglitazone
  • Placebo

MARKET BY GEOGRAPHY

  • North America NASH drugs market
    • GFT505
    • Obeticholic Acid (INT-747)
    • Simtuzumab and Liraglutide (Victoza)
    • Vitamin E
    • Pioglitazone
    • Placebo
  • Europe NASH drugs market
    • GFT505
    • Obeticholic Acid (INT-747)
    • Simtuzumab and Liraglutide (Victoza)
    • Vitamin E
    • Pioglitazone
    • Placebo
  • Asia-Pacific NASH drugs market
    • GFT505
    • Obeticholic Acid (INT-747)
    • Simtuzumab and Liraglutide (Victoza)
    • Vitamin E
    • Pioglitazone
    • Placebo
  • LAMEA NASH drugs market
    • GFT505
    • Obeticholic Acid (INT-747)
    • Simtuzumab and Liraglutide (Victoza)
    • Vitamin E
    • Pioglitazone
    • Placebo
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Title/ Chapter Name

Chapter: 1 NTRODUCTION

1.1 Key Benefits
1.2 Key Market Segment
1.3 Key Audiences

1.3.1 Research Methodology
1.3.2 Primary Research
1.3.3 Secondary Research
1.3.4 Analyst tools and models

Chapter: 2 EXECUTIVE SUMMARY

Chapter: 3 MARKET BEYOND: WHAT TO EXPECT BY 2025

3.1 Moderate growth scenario
3.2 Rapid growth scenario
3.3 Diminishing growth scenario

Chapter: 4 MARKET OVERVIEW

4.1 Market Definition and Scope
4.2 Key Findings

4.2.1 Top Factors Impacting Global Non-alcoholic Steatohepatitis Market
4.2.2 Top Investment Pockets

4.3 Impeding opportunities for NASH
4.4 Incongruity about preventative role of Fructose
4.5 Dos and Don’ts For Nonalcoholic Fatty Liver Disease Patients

4.5.1 Alcohol Intake
4.5.2 Use of statin
4.5.3 Use of Hepatotoxic Drugs
4.5.4 Vaccination for Hepatitis A and B

4.6 Prevalence of nonalcoholic fatty liver disease in Asia-Pacific Region

4.6.1 Prevalence of NAFLD in China
4.6.2 Prevalence of NAFLD in India
4.6.3 Prevalence of NAFLD in Japan
4.6.4 Prevalence of NAFLD in Australia

4.7 Pipeline Therapeutics

4.7.1 Phase I
4.7.2 Phase II
4.7.3 Phase III

4.8 Diagnostic Techniques

4.8.1 Laboratory Evaluation
4.8.2 Imaging

4.8.2.1 Ultrasonography (US)
4.8.2.2 Computed Tomography (CT)
4.8.2.3 Magnetic Resonance Imaging (MRI) and Proton Magnetic Resonance Spectroscopy (MRS)
4.8.2.4 Transient Elastography

4.8.3 Liver Biopsy
4.8.4 Biomarker diagnostics

4.8.4.1 Common Biomarkers
4.8.4.2 Novel Biomarkers

4.9 Treatment Therapies

4.9.1 Pharmacologic therapy
4.9.2 Steatosis/insulin resistance
4.9.3 Anti-cytokines
4.9.4 Surgical Interventions

4.10 Clinical Trials
4.11 Market Dynamics

4.11.1 Drivers

4.11.1.1 Rampant rate of obesity and diabetes globally
4.11.1.2 Acceleration in initiatives for research and development activities

4.11.2 Restraints

4.11.2.1 Slower development of therapeutics for NASH
4.11.2.2 Blurred understanding of pathophysiology of NASH
4.11.2.3 Inefficient diagnostic technology for NASH

4.11.3 Opportunities

4.11.3.1 Biomarker technologies in diagnosis of NASH
4.11.3.2 Launches of novel therapeutic in 2017

Chapter: 5 GLOBAL NONALCOHOLIC STEATOHEPATITIS MARKET BY DRUG TYPES

5.1 GFT505

5.1.1 Competitive scenario
5.1.2 Market size and forecast

5.2 Obeticholic Acid (INT-747)

5.2.1 Competitive scenario
5.2.2 Market size and forecast

5.3 Simtuzumab and Liraglutide (Victoza)

5.3.1 Competitive scenario
5.3.2 Market size and forecast

5.4 Vitamin E

5.4.1 Competitive scenario
5.4.2 Market size and forecast

5.5 Poglitazone

5.5.1 Competitive scenario
5.5.2 Market size and forecast

5.6 Placebo

5.6.1 Market size and forecast

Chapter: 6 GLOBAL NONALCOHOLIC STEATOHEPATITIS MARKET (PIPELINE DRUG ANALYSIS)BY GEOGRAPHY, 2013-20206

6.1 North America

6.1.1 Market size and forecast by pipeline drug types

6.2 Europe

6.2.1 Market size and forecast by pipeline  drug types

6.3 Asia-Pacific

6.3.1 Market size and forecast by pipeline  drug types

6.4 LAMEA

6.4.1 Market size and forecast by pipeline  drug types

Chapter: 7 COMPANY PROFILES

7.1 Genfit

7.1.1 Overview
7.1.2 Company snapshot
7.1.3 Financial performance
7.1.4 Strategic moves and developments
7.1.5 SWOT analysis

7.2 Gilead Science

7.2.1 Overview
7.2.2 Company snapshot
7.2.3 Strategic moves and developments
7.2.4 SWOT analysis

7.3 Novo Nordisk

7.3.1 Overview
7.3.2 Company snapshot
7.3.3 Financial performance
7.3.4 Strategic moves and developments
7.3.5 SWOT analysis

7.4 Intercepts Pharmaceuticals

7.4.1 Overview
7.4.2 Company snapshot
7.4.3 Strategic moves and developments
7.4.4 SWOT analysis

7.5 Enzo Biochem, Inc.

7.5.1 Overview
7.5.2 Company snapshot
7.5.3 Financial performance
7.5.4 Strategic moves and developments
7.5.5 SWOT analysis

7.6 Raptor Pharmaceutical Corp.

7.6.1 Overview
7.6.2 Company snapshot
7.6.3 Financial performance
7.6.4 Strategic moves and developments
7.6.5 SWOT analysis

 

LIST OF TABLES

TABLE 1  Non-alcoholic steatohepatitis moderate growth scenario market revenue by geography, 2020-2025 ($million)
TABLE 2  Non-alcoholic steatohepatitis rapid growth scenario market revenue by geography, 2020-2025 ($million)
TABLE 3  Non-alcoholic steatohepatitis Diminishing growth scenario market revenue by geography, 2020-2025 ($million)
TABLE 4  Liver disease deaths in Australia (2012)
TABLE 5  Terminologies related to non alcoholic fatty liver diseases
TABLE 6  Therapies available for NASH/NAFLD
TABLE 7  Clinical trials initiated from 2012 for NASH therapeutics
TABLE 8  Global Nonalcoholic Steatohepatitis therapeutics market, by types, 2013-2020 ($ Million)
TABLE 9  Global GFT505 NASH therapeutics revenue by geography, 2013-2020, ($ millions)
TABLE 10  Global Obeticholic Acid NASH therapeutics market by geography, 2013-2020 ($ million)
TABLE 11  Key regional diabetes healthcare facts (2013)
TABLE 12  Global Simtuzumab and Liraglutide (Victoza) NASH therapeutics market by geography, 2013-2020 ($ million)
TABLE 13  Global vitamin E NASH therapeutics market by geography, 2013-2020 ($ million)
TABLE 14  List of key Pioglitazone brands available in the market
TABLE 15  Global Pioglitazone NASH therapeutics market by geography, 2013-2020 ($ million)
TABLE 16  Global Placebos NASH therapeutics market by geography, 2013-2020 ($ million)
TABLE 17  Global non-alcoholic Steatohepatitis market by geography, 2013-2020 ($million)
TABLE 18  North America NASH therapeutics market by therapeutics, 2013-2020 ($ million)
TABLE 19  european NASH therapeutics market by therapeutics, 2013-2020 ($ million)
TABLE 20  Asia-Pacific NASH therapeutics market by therapeutics, 2013-2020 ($ million)
TABLE 21  Prevalence of metabolic syndrome in Americas (2014)
TABLE 22  Prevalence of NAFLD in high risk populations in America (2014)
TABLE 23  LAMEA NASH therapeutics market by therapeutics, 2013-2020 ($ million)
TABLE 24  Expenses incurred in conducting clinical trials (2013)

 

LIST OF FIGURES

FIG. 1  Top factors impacting global non-alcoholic Steatohepatitis (2014-2020)
FIG. 2  Top investment pockets of NASH pipelines therapeutics, 2020, ($ million)
FIG. 3  Progression of Non-alcoholic fatty liver disease
FIG. 4  Number of incidences of Diabetes Globally, by geography (2000, 2011 & 2030)
FIG. 5  SWOT Analysis of Genfit
FIG. 6  SWOT Analysis of Gilead Science
FIG. 7  Business performance of Novo Nordisk by business units (2013)
FIG. 8  Market Share of Insulin unit by volume (Volume Mt)
FIG. 9  SWOT Analysis of Novo Nordisk
FIG. 10  SWOT Analysis of Intercepts Pharmaceuticals
FIG. 11  Business performance of Enzo Biochem, Inc. by segments (2013)
FIG. 12  Business performance of Enzo Biochem, Inc. by geography (2013)
FIG. 13  SWOT Analysis of Enzo Biochem, Inc.
FIG. 14  SWOT Analysis of Raptor Pharmaceutical Corp.

The growing inclination of pharmaceutical manufacturers towards the research and commercialization of nonalcoholic Steatohepatitis (NASH) therapeutics has strengthened the growth probability of the market. Various companies are actively participating in research and development. Genfit and Raptor Pharmaceutical Inc. are some of the leading participants in this industry. A recent clinical trial conducted by Genfit satisfied the concerns of the EMA (European Medicines Agency), regarding the efficacy and safety of GFT5o5 used as NASH therapeutics. The EMA has finally recommended that this drug progress to Phase III of the clinical trial for therapeutic development. Increase in the number of clinical trials and their success rate has increased the probability of receiving commercial approval for NASH therapeutics by the end of 2017. Since the market growth is restricted by restraints such as the complex physiological structure of NASH and inefficient diagnostics technology, the commercialization of NASH therapeutics might get delayed.

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