NASH Drugs Market 2015-2025

NASH Drugs Market 2015-2025

NASH or Non-Alcoholic Steatohepatitis refers to a chronic liver disorder characterized by accretion of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. In other words, it can be defined as significant steatohepatitis not caused due to alcohol, drugs, toxins, infectious agents or other identifiable exogenous causes. NASH is often accompanied with a high possibility of cirrhosis, a condition in which the liver functions are changed, leading to liver insufficiency. Although NASH has become quite common, there is still no clarity about the underlying cause of the disease. It is currently the third most common factor leading to liver transplants in the US. Estimated to affect around 2-5% of Americans, NASH has been cited as the next hepatitis C.

Given the rising prevalence of NASH, it has become all the more crucial to understand the pathophysiology of NASH in order to develop therapeutic interventions. Several options are being investigated to identify an efficient treatment regimen for NASH; these include lifestyle modifications, off-label therapies, natural products and combinations of these approaches. However, the diagnostic landscape for NASH is quite challenging; majority of the patients are asymptomatic and can only be detected by routine blood tests showing elevations in liver enzymes. At present, liver biopsy is being used as the only reliable way to diagnose NASH and detect the presence of fibrosis; however, very few patients choose to undergo liver biopsy because of its invasive nature.

Recognizing the huge unmet medical need, several companies are striving to establish an early foothold in the area. Investigators are also looking forward to exploiting the approach of personalized medicine in order to identify diagnostic biomarkers, prognostic biomarkers and therapeutic targets for the treatment of NASH on the basis of their pathogenic and clinical traits.

The ‘NASH Drugs Market, 2015-2025’ report provides a comprehensive study on the current landscape and the future outlook of the evolving pipeline of molecules in this area. With an expanding NAFLD and NASH population worldwide, there is a growing need for development of therapeutics in this disease area. NASH is gradually emerging as the leading cause of liver transplants. While the field has garnered interest of several companies, there are no approved therapies till date. It is important to stress that the development pipeline of NASH has several promising candidates that are likely to result in many commercial success stories in the foreseen future.

Amongst other elements, the report elaborates on the new diagnostic solutions being developed and the upcoming opportunities for different stakeholders. As pharmaceutical companies continue to initiate and expand their research programs in this area, one of the key objectives outlined for this report is to understand the future potential of the market. This is done by analyzing:

The epidemiology, patient population and staging of NASH in different geographies.
The NASH pipeline in terms of phase of development, type of molecule, route of administration and mechanism of action.
The likely evolution in the rate of diagnosis, drug treated patient population and the likely price of the drugs.
The associated constraints, in terms of undefined pathogenesis and the unavailability of non-invasive diagnostic tests, and the initiatives being carried out by the companies to overcome these.

The study provides a detailed scenario analysis to estimate the market forecast for the period till 2025. The research, analysis and insights presented in this report include potential sales of the drugs in late stages of development and expected to launch by 2025. Our opinions and insights, presented in this study, were influenced by the discussions that we conducted with experts in this area. These included senior representatives at BiOrion Technologies, Phenex Pharmaceuticals, Tobira Therapeutics, Verlyx Pharmaceuticals and Connexios.

All actual figures have been sourced and analyzed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.

1. During the course of our study, we identified over 50 molecules. Of these, two molecules (Lipaglyn by Zydus Cadila and OCA by Intercept Pharmaceuticals) are in phase 3 clinical studies. Nearly 37% of the pipeline is captured by molecules in phase 2 and 22% in phase 1. Additionally, 35% of the molecules are in preclinical/discovery phase, demonstrating the strong market potential of this field.

2. Amongst several companies expanding in this domain, Intercept Pharmaceuticals is expected to launch INT 747 in the US and EU5 countries in 2017/2018. Subsequently, Genfit (GFT505), Gilead Sciences (GS-6624), Conatus Pharmaceuticals (Emricasan), Galmed Pharmaceuticals (Aramchol) and Raptor Pharmaceuticals (RP103) are expected to complete the clinical trials of their respective molecules in the coming years, sustaining the growth momentum.

3. Lack of competent diagnostic tests has led to a poor diagnosis rate and management of NASH so far. Liver biopsy is currently the gold standard to validate the presence of NASH. We believe that merely 5% - 10% of the total patients suffering from the disease are actually being diagnosed in the US and the EU 5 countries. In addition to developments of tests to diagnose NASH, many small and mid-sized firms are now developing companion diagnostics alongside their NASH drug candidates.

4. The market is fragmented with several start-ups actively involved in this area. Examples (in alphabetical order) include Cerenis Therapeutics, DS Biopharma, Galectin Therapeutics, Immuron, Islet Sciences, Matinas BioPharma, Metabolic Solutions, Naia Pharmaceuticals, Nimbus Therapeutics, Verva Pharmaceuticals, ViroBay and Zafgen.

5. The overall market is likely to be influenced by several parameters such as diagnosis rate, drug penetration and the likely price of the drugs. We expect the market to witness an aggressive growth rate of close to 90%, emerging as a multi-billion dollar market by 2025. However, with successful reimbursement practices and launch in wider markets, the overall opportunity could be much higher.

Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
3.1. Context and Background
3.2. The Concept of NASH
3.3. Target Patient Population
3.4. Pathogenesis of NASH
3.5. Epidemiology
3.6. Animal Models for NASH
3.7. Clinical Trial Designs and End Points
3.8. Regulatory Initiatives
4.1. Context and Background
4.2. Treatment Options for NASH
4.2.1. General Recommendations
4.2.2. Pharmacological Interventions
4.2.3. Natural Products for the Treatment of NASH
4.3. Diagnostic Solutions
5.1. Chapter Overview
5.2. Key Growth Drivers
5.2.1. Growing Worldwide Prevalence of Obesity and Diabetes
5.2.2. Increase in Research and Development Initiatives
5.2.3. Promising Late Stage Molecules
5.3. Challenges
5.3.1. Lack of Understanding of Pathophysiology of NASH
5.3.2. Incompetent Diagnostic Tools for NASH
6.1. Context and Background
6.2. Pipeline of Drugs
6.3. Pipeline Analysis
6.3.1. Distribution by Phase of Development
6.3.2. Distribution by Type of Molecule
6.3.3. Distribution by Route of Administration
7.1. Context and Background
7.2. Lipaglyn, Saroglitazar (ZYH1), Zydus-Cadila
7.2.1. Drug Overview
7.2.2. Background
7.2.3. Mechanism of Action
7.2.4. Development Status
7.2.5. Key Clinical Trial Results
7.2.6. Patent Portfolio
7.3. INT-747 (Obeticholic acid (OCA))/ DSP-1747, Intercept Pharmaceuticals
7.3.1. Drug Overview
7.3.2. Background
7.3.3. Mechanism of Action
7.3.4. Development Status
7.3.5. Key Clinical Trial Results
7.3.6. Manufacturing
7.3.7. Patent Portfolio
7.3.8. Collaborations
7.4. Emricasan (IDN-6556), Conatus Pharmaceuticals
7.4.1. Drug Overview
7.4.2. Mechanism of Action
7.4.3. Development Status
7.4.4. Key Clinical Trial Results
7.4.5. Manufacturing
7.4.6. Collaborations
7.5. GFT505, Genfit
7.5.1. Drug Overview
7.5.2. Background
7.5.3. Mechanism of Action
7.5.4. Development Status
7.5.5. Key Clinical Trial Results
7.5.6. Patent Portfolio
7.5.7. Collaborations
7.6. Cenicriviroc (CVC), Tobira Therapeutics
7.6.1. Drug Overview
7.6.2. Background
7.6.3. Mechanism of Action
7.6.4. Development Status
7.6.5. Key Clinical Trial Results
7.6.6. Manufacturing
7.6.7. Collaborations
7.7. Aramchol, Galmed Pharmaceuticals
7.7.1. Drug Overview
7.7.2. Mechanism of Action
7.7.3. Development Status
7.7.4. Key Clinical Trial Results
7.7.5. Manufacturing
7.7.6. Patent Portfolio
7.7.7. Collaborations
7.8. Simtuzumab (GS-6624), Gilead Sciences
7.8.1. Drug Overview
7.8.2. Background
7.8.3. Mechanism of Action
7.8.4. Development Status
7.8.5. Key Clinical Trial Results
7.8.6. Manufacturing
7.8.7. Patent Portfolio
7.8.8. Collaborations
7.9. Procysbi (RP103), Raptor Pharmaceuticals
7.9.1. Drug Overview
7.9.2. Background
7.9.3. Mechanism of Action
7.9.4. Development Status
7.9.5. Key Clinical Trial Results
7.9.6. Patent Portfolio
7.9.7. Collaborations
7.10. Remogliflozin etabonate (Remo), Islet Sciences / BHV Pharma
7.10.1. Drug Overview
7.10.2. Background
7.10.3. Mechanism of Action
7.10.4. Development Status
7.10.5. Key Clinical Trial Results
7.10.6. Manufacturing
7.10.7. Collaborations
8.1. Chapter Overview
8.2. Important Parameters and Key Assumptions
8.2.1. Target Patient Population
8.2.2. Diagnosis Rate
8.2.3. Drug Penetration Rate
8.2.4. Price of the Drug
8.3. Scenario Analysis: Description and Methodology
8.4. Overall NASH Market, 2015-2025
9.1. Chapter Overview
9.2. Conatus Pharmaceuticals
9.2.1. Company Overview
9.2.2. Financial Performance
9.2.3. NASH Drugs Portfolio
9.2.4. Partnerships
9.2.5. Future Outlook
9.3. Galmed Pharmaceuticals
9.3.1. Company Overview
9.3.2. Financial Performance
9.3.3. NASH Drugs Portfolio
9.3.4. Partnerships
9.3.5. Future Outlook
9.5. Genfit
9.5.1. Company Overview
9.5.2. Financial Performance
9.5.3. NASH Drugs Portfolio
9.5.4. Partnerships
9.5.5. Future Outlook
9.6. Gilead Sciences
9.6.1. Company Overview
9.6.2. Financial Performance
9.6.3. NASH Drugs Portfolio
9.6.4. Partnerships
9.6.5. Future Outlook
9.7. Intercept Pharmaceuticals
9.7.1. Company Overview
9.7.2. Financial Performance
9.7.3. NASH Drugs Portfolio
9.7.4. Partnerships
9.7.5. Future Outlook
9.8. Novo Nordisk
9.8.1. Company Overview
9.8.2. Financial Performance
9.8.3. NASH Drugs Portfolio
9.8.4. Future Outlook
9.9. Raptor Pharmaceuticals
9.9.1. Company Overview
9.9.2. Financial Performance
9.9.3. NASH Drugs Portfolio
9.9.4. Partnerships
9.9.5. Future Outlook
9.10. Zydus Cadila
9.10.1. Company Overview
9.10.2. Financial Performance
9.10.3. NASH Drugs Portfolio
10.1. NASH: Emerging As the Next Epidemic
10.2. Lifestyle Interventions: A Solution To Reduce Severity of the Disease
10.3. Diagnosis of Nash Remains a Challenge
10.4. With a High Unmet Need; Nash is Anticipated To Be a Multi-Billion Market
11.1. Chapter Overview
11.2. BiOrion Technologies (Herman Steen, CEO)
11.3. Phenex Pharmaceuticals (Dr. Claus Kremoser, CEO)
11.4. Tobira Therapeutics (Laurent Fischer, CEO and Andrew McKibben, Director, Finance & Corporate Development)
11.5. Verlyx Pharma (Dr. Pierre Falardeau, CEO)
11.6. Connexios (Shobha Vijayaraghavan, VP Business Development)
Figure 3.1 Spectrum of Non Alcoholic Fatty Liver Disease
Figure 3.2 NAFLD: Classification
Figure 3.3 Chronology of the Pace of Research and Development for NASH
Figure 3.4 NAFLD and NASH: Pathogenesis
Figure 3.5 Prevalence of NASH
Figure 3.6 Prevalence of NASH in the US
Figure 3.7 Design and End-points for Clinical Trials of NASH
Figure 5.1 NASH Drugs Market: Key Market Drivers and Restraints
Figure 5.2 Rise in Overweight and Obesity Rate, 1980-2013
Figure 5.3 Diabetes: Worldwide Prevalence and Diagnosis (Million)
Figure 5.4 Diabetes: Prevalence by Regions /Countries (2014), Million
Figure 5.5 Diabetes: Diagnosed Cases by Regions /Countries (2014), Million
Figure 6.1 NASH Drugs: Distribution by Phase of Development
Figure 6.2 NASH Drugs: Distribution by Type of Molecule
Figure 6.3 NASH Drugs: Distribution by Route of Administration
Figure 7.1 Lipaglyn (Saroglitazar): Development Timeline
Figure 7.2 INT-747: Mechanism of Action
Figure 7.3 INT-747: Design of Phase III REGENERATE Trial
Figure 7.4 GFT505: Mechanism of Action
Figure 8.1 NASH Future Market Scenarios
Figure 8.2 Overall NASH Drugs Market, 2018 - 2025 (USD Million)
Figure 8.3 NASH Drugs Market: Distribution by Region, 2025 (USD Million)
Figure 8.4 Timeline: Launch of NASH Molecules
Figure 8.5 NASH Drugs Market: Indicative Distribution by Drugs: 2020, 2025
Figure 8.6 Market Scenarios, Comparative Positioning (USD Billion)
Figure 9.1 Conatus Pharmaceuticals: NASH Drugs Pipeline
Figure 9.2 Galmed Pharmaceuticals: NASH Drugs Pipeline
Figure 9.3 Genfit: Development History
Figure 9.4 Genfit: Revenues, 2010-2014 (EUR Million)
Figure 9.5 Genfit: Distribution of Revenues, 2014 (EUR Million)
Figure 9.6 Genfit: NASH Drugs Pipeline
Figure 9.7 Gilead Sciences: Net Revenues, 2010 – H1 2015 (USD Billion)
Figure 9.8 Gilead Sciences: Distribution of Revenues, 2014 (USD Million)
Figure 9.9 Gilead Sciences: NASH Drugs Pipeline
Figure 9.10 Intercept Pharmaceuticals: Revenues, 2011- H1 2015 (USD Million)
Figure 9.11 Intercept Pharmaceuticals: NASH Drugs Pipeline
Figure 9.12 Novo Nordisk Revenues, 2010 - H1 2015 (DKK Million)
Figure 9.13 Novo Nordisk Revenues: Distribution by Business Segment, 2014 (DKK Billion)
Figure 9.14 Novo Nordisk: NASH Drugs Pipeline
Figure 9.15 Raptor Pharmaceuticals: Revenues, 2013 - H1 2015 (USD Million)
Figure 9.16 Raptor Pharmaceuticals: NASH Drugs Pipeline
Figure 9.17 Zydus Cadila: Revenues, 2010-2014 (INR Billion)
Figure 9.18 Zydus Cadila: Revenues by Geographies, 2014 (INR Billion)
Figure 9.19 Zydus Cadila: NASH Drugs Pipeline
Figure 10.1 NASH Drugs Market (USD Million), 2018, 2020 and 2025
Table 3.1 Various Animal Models for the Study of NASH
Table 3.2 Important Definitions and Specifications for NASH Clinical Studies
Table 3.3 Pre-fibrotic NAFLD/ NASH: Diagnostic Categories and Associated Histologic Lesions
Table 4.1 Recommended Nutritional Guidelines for NAFLD/ NASH
Table 4.2 Plant Extracts Used for the Treatment of NASH
Table 4.3 Polyherbal Medications for Management of NASH
Table 4.4 Phytochemicals for Treatment of NASH
Table 4.5 NASH: Non-invasive Imaging Diagnostic Methods
Table 6.1 NASH: Pipeline of Drugs
Table 7.1 NASH: Molecules in Late Stage of Development
Table 7.2 Saroglitazar: Clinical Trials
Table 7.3 Saroglitazar: Patent Portfolio
Table 7.4 FLINT Trial: Key Baseline Charcateristics
Table 7.5 INT-747: Research and Development Expenses
Table 7.6 INT-747: Patent Portfolio
Table 7.7 Emricasan: Phase 1 Clinical Trial Summary
Table 7.8 Emricasan: Clinical Trial Results
Table 7.9 GFT505: Clinical Trials
Table 7.10 CVC: Clinical Trials
Table 7.11 CVC: Patent Portfolio
Table 7.12 Aramchol: Clinical Trials
Table 7.13 Aramchol: Important Paramters of ARREST Study
Table 7.14 Aramchol: Completed Clinical Trials
Table 7.15 Simtuzumab: Clinical Trials
Table 7.16 Simtuzumab: Patent Portfolio
Table 7.17 RP103: Clinical Trials
Table 7.18 RP103: Treatment Regimen
Table 7.19 RP103: Patent Portfolio
Table 7.20 Remogliflozin etabonate: Clinical Development Overview
Table 7.21 Remogliflozin etabonate: Patent Portfolio
Table 8.1 Opportunity Analysis: Target Patient Population
Table 8.2 Opportunity Analysis: Diagnosis Rate
Table 8.3 Opportunity Analysis: Drug Penetration Rates
Table 8.4 Opportunity Analysis: Price of the Drug
Table 9.1 INT-747: Planned 2015 Milestones
Table 12.1 Rise in Overweight and Obesity Rate, 1980-2013
Table 12.2 Diabetes: Worldwide Prevalence and Diagnosis (Million)
Table 12.3 Diabetes: Prevalence by Regions/ Countries (2014), Million
Table 12.4 Diabetes: Diagnosed Cases by Regions/ Countries (2014), Million
Table 12.5 NASH Drugs: Distribution by Phase of Development
Table 12.6 NASH Drugs: Distribution by Type of Molecule
Table 12.7 NASH Drugs: Distribution by Route of Administration
Table 12.8 Overall NASH Drugs Market, 2018-2025 (USD Million)
Table 12.9 NASH Drugs Market: Indicative Distribution by Drugs: 2020, 2025
Table 12.10 Market Scenarios, Comparative Positioning (USD Billion)
Table 12.11 Genfit: Revenues, 2010-2014 (EUR Million)
Table 12.12 Genfit: Distribution of Revenues, 2014 (EUR Billion)
Table 12.13 Gilead Sciences: Net Revenues, 2010 – H1 2015 (USD Billion)
Table 12.14 Gilead Sciences: Distribution of Revenues, 2014 (USD Million)
Table 12.15 Intercept Pharmaceuticals: Revenues, 2011- H1 2015 (USD Million)
Table 12.16 Novo Nordisk Revenues, 2010 – H1 2015 (DKK Million)
Table 12.17 Novo Nordisk Revenues: Distribution by Business Segment, 2014 (DKK Billion)
Table 12.18 Raptor Pharmaceuticals: Revenues, 2013-H1 2015 (USD Million)
Table 12.19 Zydus Cadila: Revenues, 2010-2014 (INR Billion)
Table 12.20 Zydus Cadila: Revenues by Geographies, 2014 (INR Billion)
Table 12.21 Nash Drugs Market (USD Million), 2018, 2020, and 2015

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