global nash market

Global NASH (Non-Alcoholic Steatohepatitis)Market: Trends and Opportunities (2015-2030)

September 2015

Scope of the ReportThe report titled “Global Non-Alcoholic Steatohepatitis (NASH) Market: Trends and Opportunities (2015-2030)”, analyzes the potential opportunities and significant trends in the global NASH market. The global NASH off label and NASH specific drug market size in terms of US$ and number of NASH patients has been provided for the period 2014 to 2030. The report provides market analysis of the global NASH market by country, treatment costs, players and drugs. The report provides detailed country analysis of the US, Europe and the Japan NASH market. Each country analysis includes the analysis of their respective pipeline drugs with projected market size both by value and volume, annual cost of treatment and penetration rate. The clinical pipeline assessment of the major NASH therapeutics is also provided in this report. The report identifies the key growth drivers, challenges and trends shaping and driving the global nonalcoholic steatohepatitis market. The report also provides understanding on the competitive landscape and the emerging players expected to gain significant market share in future. The report profiles key market players such as Gilead Sciences, Genfit, Galmed Pharmaceuticals and Galectin Therapeutics on the basis of attributes such as company overview, recent developments, strategies adopted by the market leaders to ensure growth, sustainability, financial overview and recent clinical developments.Country Coverage• United States• Europe• Japan

Company CoverageGenfitGalectin TherapeuticsGalmed PharmaceuticalsGilead Sciences

Global NASH Market Report

Executive SummaryNon-alcoholic steatohepatitis or NASH is a common, often “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. Symptoms of NASH are found among all demographics; however, they are more prevalent in younger people. NASH is a more aggressive form of NAFLD (Nonalcoholic Fatty Liver Disease), which often progresses to liver cirrhosis. NASH (non-alcoholic steatohepatitis) is a large, un-tapped market with no FDA approved therapeutics. Antioxidants, anti-diabetic medications, anti-obesity medications and antihyperlipidemics are some of the off-label products currently used by NASH patients. The NASH market has seen an increasing number of new players in the past two to three years. Global non-alcoholic steatohepatitis drug specific market is estimated to start growing by 2020 at a CAGR of 25.56% during 2020-2030, due to the projected product launches in 2020. Surge in cycles of clinical trials and their success rate has improved the probability of industries receiving commercial approval for NASH therapeutics by the end of 2020. 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. The NASH market growth is restricted by factors such as NASH’s unclear understanding of pathophysiology, inefficient diagnostics technology and stringent regulatory requirements; due to these challenges the commercialization process for NASH therapeutics is getting delayed. Despite of these challenges, certain key players such as Galmed Pharmaceuticals, Gilead Sciences, Novo Nordisk, Genfit, Intercept and Galectin Therapeutics are conducting extensive research on NASH therapeutics and are receiving positive results from clinical trials. But, the low diagnosis rates, low prescription rates and low treatment seeking rates continue to pose significant challenges for these emerging players.

Executive SummaryThe United States, which has the highest number of research initiatives concerning NASH, holds nearly half of the global market share. The chief reason behind this growth is the high prevalence of diabetes and obesity and the growing number of people suffering with these conditions. The US has the highest number 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. Germany has the highest market share among the other European Countries. Europe NASH market share has decreased due to decreased number of research initiatives and failure to comply with regulations. Asia-Pacific market is anticipated to show highest growth rate for the NASH therapeutics market due to increasing rate of obesity and metabolic disorders.

Global NASH Market Report

Global NASH Off-Label Drug Market by Value; 2012-2019E (US$ Billion)

Global NASH specific drug market is anticipated to report market value of US$........ billion in 2020 and it projected to grow at a CAGR of ……% over the period 2030 and is expected to reach market value of US$......... billion in 2030.

Global NASH Drug Market by Value; 2017E-2030E (US$ Billion)

The global NASH market is progressing very fast. Adult population (age 20-74 years) is major patient population. In 2014, the US adult population was ~441 million and out of which 167 million adults are suffering from non-alcoholic fatty liver disease.

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030

Global NASH Market: Country Analysis

Japan NASH Therapeutics Market by Value; 2023E-2030E (US$ Billion)

The US NASH Off-Label Drugs Market by Value; 2012-2017E (US$ Million)

Europe NASH Market by Value; 2012-2019E (US$ Million)

2012 2013 2014 2015 2016 2017 2018 2019 2012 2013 2014 2015 2016 2017 2018 2019

2023 2024 2025 2026 2027 2028 2029 2030

Table of Contents: Global NASH Market1. Executive Summary 2. Introduction2.1 Diagnosis2.2 Symptoms2.3 Causes2.4 Treatment2.5 Patient Population2.6 Disease Progression

3. Global NASH Market: An Analysis 3.1 Global NASH Market Overview3.1.1 Global NAFLD Population3.1.2 Global NASH Population3.1.3 Global NASH Market by Prevalence Rate3.1.4 Global NASH Diagnosed Cases 3.2 Global NASH Market by Therapeutics3.1.1 Global NASH Off-Label Drugs Market by Value3.1.2 Global NASH Off-Label Drugs Market Share by Region3.1.3 Global NASH Specific Drugs Market by Value3.2.4 Global GFT505 Market: Sizing & GrowthGFT505 Estimated ValuationGFT505 Market by Value3.2.2 Global Aramchol Market: Sizing & GrowthAramchol Market by ValueAramchol Market by Patient Volume3.2.3 Global GR-MD-02 Market: Sizing & GrowthGR-MD-02 Estimated ValuationGR-MD-02 Market by Value

4. Country Analysis 4.1 The US NASH Market Overview4.1.4 The US NAFLD Population4.1.5 The US NASH Population4.1.6 The US NASH Prevalence Rate4.1.7 The US NASH Diagnosed Cases4.1.8 The US NASH Treatment Rate 4.2 The US NASH Market by Therapeutics4.2.1 The US NASH Off-Label Drugs Market by Value4.2.2 The US NASH Specific Drugs Market by Value4.2.3 The US Aramchol Market: Sizing & GrowthThe US Aramchol Market by ValueThe US Aramchol Market by Patient VolumeThe US Aramchol Penetration RateAramchol Cost of Treatment in the US4.2.4 The US GFT505 Market by Value4.2.5 The US GR-MD-02 Market: Sizing & GrowthGR-MD-02 Market by ValueGR-MD-02 Market by Patient VolumeGR-MD-02 Cost of Treatment in the US 4.3 Europe NASH Market Overview4.3.1 Europe NAFLD Population4.3.2 Europe NASH Population4.3.3 Europe NASH Prevalence Rate4.3.4 Europe NASH Diagnosed Cases4.3.5 Europe NASH Treatment Rate

Table of Contents: Global NASH Market

4.4 Europe NASH Market by Therapeutics4.4.1 Europe NASH Off-Label Drugs Market by Value4.4.2 Europe NASH Off-Label Drugs Market Share by Region4.4.3 Europe NASH Specific Drugs Market by Value4.4.4 Europe Aramchol Market: Sizing & GrowthEurope Aramchol Market by ValueEurope Aramchol Market by Patient VolumeEurope Aramchol Penetration RateAramchol Cost of Treatment in Europe4.4.5 Europe NASH GFT505 Market by Value 4.5 Japan NASH Market Overview4.5.1 Japan NASH Therapeutics Market by Value 5. Clinical Pipeline Analysis of NASH Drugs 5.1 Aramchol (Galmed)5.1.1 Chemical Structure5.1.2 Route of Administration5.1.3 Mechanism of Action5.1.4 Clinical Timeline 5.2 GFT505 (GENFIT)5.2.1 Chemical Structure5.2.2 Route of Administration5.2.3 Mechanism of Action5.2.4 Clinical Timeline5.2.5 Benefits


5.3 Obeticholic acid or OCA (Intercept)5.3.1 Chemical Structure5.3.2 Route of Administration5.3.3 Mechanism of action5.3.4 Clinical TimelineOCA Future Plan5.3.5 Benefits 5.4 Cenicriviroc or CVC (Tobira Therapeutics)5.4.1 Chemical Structure5.4.2 Route of Administration5.4.3 Mechanism of Action5.4.4 Clinical Timeline 5.5 RP103: Delayed-Release Cysteamine Bitartrate (Raptor)5.5.1 Chemical Structure5.5.2 Route of Administration5.5.3 Mechanism of Action5.5.4 Clinical Timeline 5.6 Emricasan (Conatus Pharmaceuticals)5.7 Simtuzumab (GS-6624) (Gilead)5.8 GR-MD-02 (Galectin Therapeutics)5.9 LJPC-1010 for NASH (La Jolla Pharmaceutical Company)5.10 SHP626/LUM002 (Shire/Lumena’s)

6. Market Dynamics 6.1 Growth Drivers


6.1.1 Increasing Rate of Obesity6.1.2 Growing Diabetes Population 6.1.3 Poor Efficacy of Marketed Drug6.1.4 Vast Unmet Needs in the NASH Market6.1.5 Prevalence of Metabolic Syndrome 6.2 Challenges6.2.1 Lack of a Reliable Method for Diagnosis6.2.2 Unclear Understanding of the Pathophysiology of NASH6.2.3 Slow Drug Development 6.3 Market Trends6.3.1 Strong Research and Development Effort by Companies6.3.2 Opportunities for Biomarkers 7. Competitive Landscape 8. Company Profiles8.1 Galmed Pharmaceuticals8.1.1 Business Overview8.1.2 Development Pipeline8.1.3 Financial Overview8.1.4 Business Strategy 8.2 Genfit8.2.1 Business Overview8.2.2 Development Pipeline8.2.3 Financial Overview8.2.4 Business Strategy


8.3 Galectin Therapeutics8.3.1 Business Overview8.3.2 Development Pipeline8.3.3 Financial Overview8.3.4 Business Strategy 8.4 Gilead Sciences8.4.1 Business Overview8.4.2 Development Pipeline8.4.3 Financial Overview8.4.4 Business Strategy About UsDisclaimer


Figure 1: Diagnostic and Treatment Algorithm for NASHFigure 2: Liver Biopsy ProcedureFigure 3: Liver Disease ContinuumFigure 4: Microscopic View of Fatty liver Disease ProgressionFigure 5: Multi-Hit HypothesisFigure 6: Odds Ratio of Various Factors Related in Developing CVDFigure 7: Cardiovascular Risk Associated with NASHFigure 8: NASH Addressable Market; 2014Figure 9: Global NAFLD Population; 2015-2035E (In Million)Figure 10: Global NASH Population; 2015-2035E (In Million)Figure 11: Global Prevalence of NASH; 2014 (In %)Figure 12: Global NASH (pre-fibrotic and early-stage fibrosis) Diagnosed Cases; 2015-2035E (In Million)Figure 13: Global NASH Off-Label Drug Market by Value; 2012-2019E (US$ Billion)Figure 14: Global NASH Off-Label Drugs Market Share by Region; 2012-2017EFigure 15: Global NASH Drug Market by Value; 2017E-2030E (US$ Billion)Figure 16: GFT505 Estimated Valuation; (US$ Million)Figure 17: GFT505 Market by Value; 2020E-2030E (US$ Million)Figure 18: Aramchol Market by Value; 2021E-2035E (US$ Million)Figure 19: Aramchol Market by Patient Volume; 2021E-2035E (in 000s)Figure 20: GR-MD-02 Market by Value; 2021E-2030E (US$ Million)Figure 21: The US NAFLD Population; 2015-2035E (In Million)Figure 22: The US NASH Population; 2015-2035E (In Million)Figure 23: The US NASH Pre-Fibrotic and Early Stage Fibrosis Cases; 2015-2035E (In Million)Figure 24: NASH Prevalence Rate in the US; 2014 (In %)Figure 25: Prevalence Rate of NASH in the US; 2021E-2028E (In %)Figure 26: The US NASH Diagnosed Cases; 2015-2035E (In Million)Figure 27: Diagnosis Rate of NASH in the US; 2021E-2028E (In %)Figure 28: Treatment Rate of NASH in the US; 2021E-2028E (In %)Figure 29: The US NASH Off-Label Drugs Market by Value; 2012-2017E (US$ Million)

Figures & Tables: Global NASH Market

Figure 30: The US NASH Market by Value; 2019-2030E (US$ Billion)Figure 31: Aramchol Sales in the US; 2021E-2035E (US$ Million)Figure 32: Number of Patient Receiving Aramchol Treatment in the US; 2021E-2035E (in 000s)Figure 33: Aramchol Penetration Rate in the US; 2021E-2035EFigure 34: Aramchol Annual Cost of Treatment in the US; 2021E-2035E (US$ 000)Figure 35: GFT505 Net Sales in the North America; 2020E-2030E (US$ Million)Figure 36: GR-MD-02 Sales in the US; 2021E-2033E (US$ Billion)Figure 37: Number of Patient Receiving GR-MD-02 Treatment in the US; 2021E-2033E (in 000s)Figure 38: GR-MD-02 Annual Cost of Treatment in the US; 2021E-2035E (US$ 000s)Figure 39: Europe NAFLD Population; 2015-2035E (In Million)Figure 40: Europe NASH Population; 2015-2035E (In Million)Figure 41: Europe NASH Pre-Fibrotic & Early Fibrosis Cases; 2015-2035E (In Million)Figure 42: Prevalence of Rate of NASH in Europe; 2014 (In %)Figure 43: Prevalence of Rate of NASH in Europe; 2021E-2028E (In %)Figure 44: Europe NASH Diagnosed Cases; 2015-2035E (In Million)Figure 45: Diagnosis Rate of NASH in Europe; 2021E-2028E (In %)Figure 46: Treatment of Rate of NASH in Europe; 2021E-2028E (In %)Figure 47: Europe NASH Market by Value; 2012-2019E (US$ Million)Figure 48: Europe NASH Off-Label Drugs Market Share by Region; 2012Figure 49: Europe NASH Market by Value; 2021E-2030E (US$ Billion)Figure 50: Aramchol Net Sales in Europe; 2022E-2035E (US$ Million)Figure 51: Number of Patient Receiving Aramchol Treatment in Europe; 2021E-2035E (in 000s)Figure 52: Aramchol Penetration Rate in Europe; 2021E-2035E (In %)Figure 53: Aramchol Annual Cost of Treatment in Europe; 2021E-2035E (US$ 000)Figure 54: GFT505 Net Sales in Europe*; 2020E-2035E (US$ Million)Figure 55: Japan NASH Therapeutics Market by Value; 2023E-2030E (US$ Billion)Figure 56: Chemical Structure of AramcholFigure 57: Mechanism of Action SCD1Figure 58: Chemical Structure of GFT505


Figure 59: Chemical Structure of OCAFigure 60: Mechanism of Action of OCAFigure 61: Chemical Structure of CenicrivirocFigure 62: Mechanism of Action of CCR2/CCR5Figure 62: Chemical Structure of RP103 for NASHFigure 68: Caspase PathwaysFigure 69: Prevalence of Obesity among US Adults Aged 20-74 Years (In %)Figure 70: Global Diabetes Population Statistics; 2014 (In Million)Figure 71: Prevalence of Risk Factors among Adults with Metabolic Syndrome aged 20-79 years; 2013Figure 72: Genfit Net Sales; 2013-2017E (US$ Million)Figure 73: Galectin Net Revenue; 2015E-2023E (US$ Million)Figure 74: Galectin R&D Expenditure; 2015E-2023E (US$ Million)Figure 75: Galectin Cash Financing; 2015E-2023E (US$ Million)Figure 76: Gilead Sciences Net Sales; (US$ Billion) Table 1: Nonalcoholic Fatty Liver Disease and Related DefinitionTable 2: Comparison of NASH Diagnostic MethodsTable 3: Aramchol Composite AnalysisTable 4: GR-MD-02 in NASH Patients with Advanced Estimated ValuationsTable 5: Clinical Timeline of AramcholTable 6: ARREST StudyTable 7: Clinical timeline of CVCTable 8: Marketed Drugs for the treatment of NASHTable 9: Comparative Analysis of the Key Players; 2014Table 10: Comparative Analysis of Key Players Product PipelineTable 11: Comparative Analysis of Companies Developing NASH DrugTable 12: NASH Development Pipeline of Galmed PharmaceuticalsTable 13: Galmed Clinical NPV ModelTable 14: Galmed Financial Overview


Table 15: NASH Development Pipeline of Galmed Pharmaceuticals Table 16: Genfit Financial Overview; 2013-2014 (US$ Million)Table 17: NASH Development Pipeline of Galectin TherapeuticsTable 18: NASH Development Pipeline of Galmed Pharmaceuticals


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Title: Global NASH (Non-Alcoholic Steatohepatitis) Market: Trends and Opportunities (2015-2030)Published: September 2015Pages: 115Price: US$ 800 (Single-User License) : US$ 1600 (Corporate License)

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