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Nonalcoholic steatohepatitis (NASH) has the potential to be a large and lucrative market for pharmacotherapies owing to the lack of approved agents and the prevalence of the disease. The body of evidence for the financial costs of the disease is growing, particularly with respect to cardiovascular (CV) disease, liver failure, and the fact that NASH will quickly become the leading reason for liver transplantation. The lack of treatment options and the limited awareness of the disease and its complications haveresulted in low diagnosis and treatment rates. However, as education increases, novel diagnostic tools are developed, and new therapies are approved, diagnosis and treatment rates will increase, driving growth of the market overall. Currently, only off-label medications are available for NASH; they will sustain the small market over the first half of the 2017-2027 forecast period, until the anticipated approval and launch of the first wave of emerging therapies: Intercept Pharmaceutical’s obeticholic acid, Gilead’s selonsertib, Genfit’s elafibranor, and Allergan’s cenicriviroc. We anticipate gradual uptake of the new therapies, but if and when their long-term safety, liver-related benefits, and reductions in mortality are demonstrated later in the forecast period, their uptake will accelerate. These novel therapies will be able to command high prices owing to the innovation they provide for an indication without pharmacotherapeutic options. However, pricing strategies must take into account payers’ budgets and patients’ compliance owing to the relatively slow natural history of NASH and the need for long-term treatment.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 20 country-specific interviews with NASH thought leaders.
Epidemiology: Prevalent cases of NASH.
Emerging therapies: Phase II: 40 drugs; Phase III: 4 drugs; preregistration: 0 drugs; registered: 0 drugs. Coverage of select preclinical and Phase I products.
Key Companies: Intercept Therapeutics, Gilead, Genfit, Allergan, Galectin Therapeutics, Galmed Pharmaceuticals, Madrigal Pharmaceuticals, Viking Therapeutics, Immuron, NGM Bio, Novartis, Bristol-Myers Squibb, Conatus Pharmaceuticals.
Key Drugs: Obeticholic acid, selonsertib, elafibranor, cenicrivirox, GR-MD-02, Aramchol, MGL-3196, VK-2809, IMM-124E, NGM-282, tropifexor, BMS-986036, emricasan, vitamin E, ursodeoxycholic acid, pioglitazone, metformin, GLP-1 receptor agonists, SGLT inhibitors, statins.
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Andrew Frost is a Business Insights Analyst in Decision Resources Group’s Cardiovascular, Metabolic, Renal, and Hematologic Disorders team focusing on obesity and non-alcoholic steatohepatitis (NASH). In this role, he evaluates the latest primary and secondary research, as well as available commercial information, to forecast the potential of developmental drugs and provide insight on the various dynamics affecting relevant markets. Prior to joining DRG, Andrew worked as a Senior Drug Analyst at Citeline in the Cardiovascular and Metabolic Team. Andrew holds a BSc (Hons) degree in Pharmacology, awarded by King’s College London, and he has previously worked in the Immunopharmacology team at UCB.
Joseph Granato joined Decision Resources Group in 2012 and previously worked on both Market Access and Global Market Access ; Joseph is currently responsible for forecasting the prevalence and incidence of disease populations throughout the ; He is also tasked with identifying at risk populations and developing new epidemiological methods used to predict overall population health. He received his from Des Moines University where he worked on several population health projects including the delivery of continuing medical education on tick-borne ; He also holds a in Animal Science from the University of ; Prior to his time with DRG Joseph worked with the Monroe County Health Department on the surveillance of reportable diseases including Dengue Fever.