First described in 1980, nonalcoholic steatohepatitis (NASH) (ICD-10-CM = K75.81) is a condition that develops as a subgroup of nonalcoholic fatty liver disease (NAFLD) when excessive fat buildup is accompanied by liver cell injury and inflammation. NAFLD is defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver. Progression of this condition to NASH dramatically increases the risk of cirrhosis, liver failure, and hepatocellular carcinoma, and is therefore a potentially fatal condition .
Currently, the NASH market has no approved therapies and is dependent on off-label agents that only offer sub-optimal safety and efficacy outcomes to patients. GlobalData estimates the 2016 sales for the NASH market at approximately $618m across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. It is expected that eleven pipeline agents will be launched during the forecast period, which extends up to 2026.
GlobalData believes that most of the pipeline drugs in late-stage development for NASH are superior to the standard of care, vitamin E, and other off-label therapies in terms of their clinical and commercial profiles. The initial uptake of the drugs will be slow, due to their high cost and reimbursement issues. However, towards the end of the forecast period, it is expected that these drugs will displace current treatments, driven by the launch of biomarkers. These biomarkers will work in multiple ways, by identifying the target patient pool and by predicting treatment outcomes, both essential in demonstrating the pharmaco-economic value of the new agents to payers.
Due to their different mechanisms of action, it is also expected that each of the pipeline drugs will have a place in treating a specific segment of the heterogeneous patient population, so the NASH market is likely to be highly fragmented, with each drug garnering a small share of the total market. By 2026, the vast majority of global sales for NASH treatments will come from drugs that are currently in the pipeline. Among these drugs, Gilead’s selonsertib, Intercept’s Ocaliva, and Genfit’s elafibranor will be the highest revenue earners, accounting for around 29%, 22%, and 21% of 2026 global sales for the pipeline drugs, respectively.
In this webinar, GlobalData’s Managing Analyst covering Immunolgy, Dr. Lakshmi Dharmarajan, will share insights pulled from GlobalData’s Opportunity Analyzer: NASH – Opportunity Analysis and Forecast to 2026 report. Dr. Dharmarajan will outline and review the current NASH treatment landscape, discuss unmet needs and opportunities, and present a comprehensive analysis of NASH pipeline drugs. Dr. Christopher Pace, GlobalData’s Director covering Infectious Diseases, will moderate a Q&A session following the presentation.
Join this webinar to increase your knowledge of the current state of the NASH market and what can be expected in this exciting therapeutic area in the future.
Lakshmi Dharmarajan
Managing Analyst, Immunology
Lakshmi Dharmarajan, PhD, PPM, is a Managing Analyst in the Immunology team at GlobalData in Boston, where she provides strategic and market insights in the form of syndicated reports and consulting projects to pharma and healthcare clients. She received her Ph.D. in an interdisciplinary Biochemistry program from Virginia Tech, VA. As part of her dissertation, Lakshmi completed a research fellowship investigating the structure and function of enzymes regulating glucose metabolism in humans. She subsequently obtained a professional master’s (PPM) degree in Bioscience Management from the Keck Graduate Institute, CA. During this time, she worked on several short-term consulting projects with companies like Eli Lilly, GE Healthcare and Veracyte. Prior to this, Lakshmi obtained a BS in Biotechnology from Haldia Institute of Technology in India.
Christopher J. Pace
Director, Infectious Diseases
Christopher J. Pace, PhD is the Director of Infectious Diseases at GlobalData in Boston, where he oversees the infectious diseases portfolio of syndicated market research reports. Since joining GlobalData in 2013, Dr. Pace has extensively researched and provided in-depth analysis and commentary on a wide range of topics within the infectious diseases space and across the pharmaceutical and healthcare industries, with areas of expertise including hepatitis C and HIV therapeutics, vaccine R&D and immunization policy (specifically dengue, meningococcal disease, and hepatitis B), and market access strategies for antibiotics. Dr. Pace holds a PhD in Chemistry from Boston College and a BS in Chemistry from Fairfield University.
- Learn how GlobalData expects the NASH market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) to change over the 2016–2026 forecast period.
- Gain insight on the most promising late-stage pipeline drugs in NASH.
- See how the clinical and commercial attributes of late-stage pipeline therapies compare with one another and against existing treatment options for NASH.
- Identify the unmet needs in NASH treatment management and key opportunities.
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