Non-Alcoholic Steatohepatitis (NASH) | Disease Landscape and Forecast | G7 | 2018

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.

Questions Answered:

• Prescribing medication off-label for NASH is common practice, given the lack of approved medications. How will the availability of the first novel branded NASHagents affect the prescribing landscape?
• Physicians, especially in the primary care environment, are not aware of the importance of diagnosis and treatment of NASH. Is their attitude expected to change over the forecast period? How will physicians’ lack of experience with NASH affect the uptake of novel medications?
• Diagnosis rates in the United States, EU5, and Japan remain exceptionally low due to the lack of noninvasive diagnostic tests. How will the availability of new noninvasive diagnostic tests for NASH (i.e., serum biomarkers or imaging) affect the diagnosis and treatment rates in the countries under study?

Scope:

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.