Consecutive drug launches will drive growth of NASH treatment in 7MM: GlobalData

• NASH market is expected to experience rapid growth, at a CAGR of 68.8% from 2019 to 2029
• Pharmacological treatments for non-alcoholic steatohepatitis (NASH) are predicted to launch in the seven major markets.
• Reimbursement issues and the dearth of validated NASH specific non-invasive tests (NITs) might serve as hindrances to its growth.

THD NewsDesk, London: In the coming decade, various pharmacological treatments for non-alcoholic steatohepatitis (NASH) are predicted to launch in the seven major markets. According to GlobalData, NASH market is expected to grow, given that there is no approved therapy for the indication as these products have higher prices than the current off-label treatments.

Mohammad Uddin, the Senior Pharma Analyst at GlobalData, says, “Currently, majority of physicians recommend lifestyle changes as the principal standard of care, particularly in those at early stages of their disease where mortality rates are low. If pharmacological intervention is used, treatment options include vitamin E and pioglitazone. However, many have disregarded the use due to observable adverse events associated with the therapies, such as cancer risks and lack of efficacy concerning the current regulatory requirements. Owing to the large population and current treatment use being infrequent, there is a significant opportunity for companies to introduce regulatory approved branded therapies into the market and garner high revenues.”

GlobalData’s research indicates that the market for NASH treatment in the 7MM will experience tremendous growth. The growth is expected to occur at a compound annual growth rate (CAGR) of 68.8% over ten years, from 2019 to 2029. The development is a result of the wide NASH population and introduction of approved therapies priced highly.

“As such, several therapies have either completed or entered Phase III clinical trials for NASH, including Intercept’s Ocaliva (obeticholic acid), AbbVie’s cenicrivivoc and Madrigal’s resmetirom, all of which have demonstrated effectiveness in NASH resolution or at least one stage of liver fibrosis improvement. FDA currently requires one of the two endpoints to be met while EMA has indicated both should be met, although this could be changed to follow that of the FDA.”

Moreover, the GlobalData’s report takes into account the impact of the FDA’s recent complete response letter (CRL) issued to Intercept’s Ocaliva (obeticholic acid) on the expected revenue generation of the compound.

Uddin continues, “Intercept resubmission of a new drug application for Ocaliva is expected, and if approved, will generate significant uptake since it will be the first therapy approved for the indication, although sales are likely to be slowed by the CRL considering some physicians will still hold a negative opinion of Ocaliva’s clinical profile. In response, developers of other pipeline therapies will be keen to leverage heightened efficacy results within their trials, with Novo Nordisk’s Ozempic (semaglutide) indicating considerably higher rates of NASH resolution compared to current Phase III therapies. At the same time, Inventiva’s lanifibranor has shown significant efficacy results in its Phase IIb trial.”

Uddin concludes, “Primary research conducted by GlobalData suggests efficacy profiles of therapies, specifically related to regulatory endpoints, will have a significant influence on the physician treatment choice and increase reimbursement rates, as indicated by payers. Therefore, therapies such as Ozempic and lanifibranor are expected to hold significant proportions of the NASH market by 2029.”

However, experts have foreseen certain impediments that are expected to hinder the rapid increase of the NASH market at the start of the forecast period. The obstacles include reimbursement issues and the dearth of validated NASH specific non-invasive tests (NITs). On the other hand, enhanced access to drugs and the introduction of NITs to facilitate the diagnosis and treatment response are expected to drive the growth of the NASH market. 

Source: Express Pharma