Otsuka's Bempedoic Acid: A New Hope for Japanese Hypercholesterolemia Market

Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for bempedoic acid, a novel treatment for hypercholesterolemia. This marks a significant milestone in the drug's development and has the potential to reshape the Japanese hypercholesterolemia market. This article explores the implications of Otsuka's submission and the prospects for bempedoic acid in the Japanese market.

Bempedoic acid, created by Esperion Therapeutics, Inc., boasts a unique mechanism of action that inhibits ATP citrate lyase in the liver, unlike statins that target HMG-CoA reductase. This novel approach offers potential benefits for patients with insufficient response to statins or statin intolerance. With promising Phase 3 trial results, showing a significant LDL-C reduction compared to placebo, bempedoic acid could provide a new treatment option for these patients.


The Japanese hypercholesterolemia market, valued at $4.5 billion in 2021, is expected to grow at a CAGR of 3.5% to $5.5 billion by 2028. This is lower than the global market size of $16.8 billion in 2021, which is projected to reach $25.5 billion by 2028, growing at a CAGR of 5.5%. The European market, valued at $7.3 billion in 2021, is expected to grow at a CAGR of 4.3% to $10.1 billion by 2028.

Otsuka's submission of an NDA for bempedoic acid in Japan positions the drug to compete in a growing market. However, Otsuka may face potential market barriers, such as pricing and reimbursement, as the Japanese healthcare system emphasizes cost-effectiveness. Otsuka will need to demonstrate the drug's value to secure favorable pricing and reimbursement terms from the Japanese government and insurance providers.

In conclusion, Otsuka's submission of a New Drug Application for bempedoic acid in Japan highlights the drug's potential as a novel treatment for hypercholesterolemia. With a unique mechanism of action and promising Phase 3 trial results, bempedoic acid could provide a new treatment option for patients with insufficient response to statins or statin intolerance. However, Otsuka must navigate potential market barriers, such as pricing and reimbursement, to successfully launch the drug in Japan's competitive hypercholesterolemia market.