The pharmaceutical market for nonalcoholic steatohepatitis (NASH), a severe form of nonalcoholic fatty liver disease (NAFLD), has the potential to become lucrative owing to the current lack of approved agents and the disease’s large and growing prevalence. The body of evidence for the significant burden the disease places on healthcare systems is accumulating, particularly with respect to the increased risk of cardiovascular disease, liver failure, and NASH’s potential to quickly become the leading reason for liver transplantation. The lack of treatment options, the limited awareness of the disease, and its complications have kept diagnosis and treatment rates low. Despite guidelines recommending certain off-label medications, prescribing is usually limited to specialists caring for patients with more-advanced disease. However, as education increases, novel diagnostic tools are developed, and approved medical therapies become available, diagnosis and treatment rates will increase and drive growth of the market overall. Over the 2019-2029 study period the NASH market will see the launches of first therapies from a rich pipeline of emerging therapies, which will fuel an exponential market expansion.

Questions Answered:

  • What is the prevalence of NASH, and what is driving the growth of this indication?
  • How is NASH being managed? With no approved medications, how are physicians using available prescription medications off-label to treat the disease?
  • Which emerging therapy will gain the greatest share in the nascent branded therapy market?
  • Where will Intercept’s obeticholic acid, Madrigal’s resmetirom, Allergan’s cenicriviroc, and Novo Nordisk's semaglutide fit into the evolving NASH treatment paradigm?

Geographies:

United States, France, Germany, Italy, Spain, United Kingdom, Japan

Key companies mentioned:

Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Novo Nordisk, Allergan, Inventiva Pharma, Galectin Therapeutics, Galmed Pharmaceuticals, Viking Therapeutics, Cirius Therapeutics, NGM Bio, Novo Nordisk, Novartis, Gilead, Bristol-Myers Squibb, Enanta Pharmaceuticals

Key drugs covered:

Obeticholic acid, resmetirom (MGL-3196), cenicriviroc, belapectin (GR-MD-02), aramchol, VK-2809, MSDC-0602K, pegbelfermin (BMS-986036), aldafermin (NGM282), cilofexor, EDP-305, semaglutide, lanifibranor, tropifexor, firsocostat, vitamin E, pioglitazone

Table of contents

  • Non-Alcoholic Steatohepatitis - Landscape & Forecast - Disease Landscape & Forecast

Author(s): Dominika Rudnicka-Noulin, PhD, MSc; Joseph Granato, MPH

Dominika Rudnicka-Noulin, PhD, MSc is a senior business insights analyst in the Cardiovascular, Metabolic and Renal division at Decision Resources Group, specializing in cardiovascular diseases, with expertise in heart failure and acute coronary syndrome.

Prior to joining DRG, Dominika held a position of an associate editor at Nature Communications, working across a variety of therapy areas. Dominika also worked for three years as a Postdoctoral Research Associate on a joint project between Imperial College London and MedImmune aimed at developing more potent antibody-based drugs. Dominika gained her PhD at the Institut Pasteur in Paris, France where her work was funded by the European Commission Marie Skłodowska-Curie Actions

Joseph Granato joined Decision Resources Group in 2012 and previously worked on both Market Access and Global Market Access products.  Joseph is currently responsible for forecasting the prevalence and incidence of disease populations throughout the world.  He is also tasked with identifying at risk populations and developing new epidemiological methods used to predict overall population health.

He received his M.P.H. from Des Moines University where he worked on several population health projects including the delivery of continuing medical education on tick-borne diseases.  He also holds a B.S. in Animal Science from the University of Tennessee.  Prior to his time with DRG Joseph worked with the Monroe County Health Department on the surveillance of reportable diseases including Dengue Fever.