Zydus Lifesciences launched a first-in-class oral, non-statin lipid-lowering drug, bempedoic acid, under the brand name Bemdac, for the first time in India in May 2022. Considering bempedoic acid is a novel drug, multiple Indian pharma companies are expected to launch bempedoic acid under their brand names in the country. Against this backdrop, the bempedoic acid market in India will become crowded soon, says GlobalData, a leading data and analytics company.

Bempedoic acid helps lower cardiovascular risk in high or very high-risk atherosclerotic cardiovascular disease (ASCVD) patients as an add-on therapy to maximally tolerated statin and/or ezetimibe. Moreover, it has shown promising results in patients intolerant to statins and patients not responding to statins.

The focus on bempedoic acid by Indian pharma companies has increased drastically. Within eight days of the launch by Zydus Lifesciences, three companies Sun Pharma, Akum Drugs & Pharmaceuticals Ltd and Cadila Pharma have already announced plans to launch bempedoic acid in India.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Indian pharma companies are always looking to grab opportunities created by first in class drugs to meet the current unmet needs. Moreover, irrespective of great progress over the years in lipid-lowering treatments, there remains an unmet need for uncontrolled low-density lipoprotein cholesterol (LDL-c) levels, especially in patients with known ASCVD, familial hypercholesterolemia (FH), and those with multiple risk factors for cardiovascular disease.”

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of prevalent cases of dyslipidemia in India is estimated to grow at a CAGR of 1.9% from 691 million in 2021 to 737 million in 2025.

In February 2020, the FDA approved Esperion’s bempedoic acid under the brand name Nexletol and EMA approved it in April 2020 under the brand name Nilemdo. Notably, there are no generics available for bempedoic acid in the US or Europe. Furthermore, none of the Indian players have any partnership with Esperion for bempedoic acid.

Khadayate concludes: “Indian players can launch bempedoic acid in India as there is no valid product patent in India. Bempedoic acid has a huge potential in India, based on the overall dyslipidemia patient population and the patients with uncontrolled LDL-c levels. Moreover, affordable treatment will make it easy to access the therapy, which is crucial for the Indian market. The lipid-lowering drug market in India is crowded, with multiple generics available. For bempedoic acid, Indian pharma companies would be aiming to get the first mover advantage before it also becomes crowded.”