Pharma companies in Japan are still working to bring their first COVID-19 indigenous vaccine, though the pandemic has already completed two years in various parts of the world. As a result, any further delay in the launch of indigenous COVID-19 vaccines will impact domestic market potential, says GlobalData, a leading data and analytics company.

According to GlobalData’s Pharma Intelligence Center, 10 indigenous COVID-19 vaccines are being developed in Japan. Shionogi & Co. (subunit vaccine), Daiichi Sankyo Co. (mRNA vaccine), KM Biologics Co. (inactivated vaccine), and AnGes Inc. (DNA vaccine) are in Phase III. In addition, AnGes Inc. has two COVID-19 vaccines in Phase III.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Japan has already fully vaccinated almost 79% of its population. As a result, it will be challenging to recruit local subjects for the ongoing trials. However, it can further extend the Phase III trials timelines. Furthermore, looking at the vaccination rate, companies developing new vaccines are now more inclined towards COVID-19 booster vaccine market.”

Recently, Daiichi Sankyo commenced Phase I/II/III trial for COVID-19 booster in Japan. Moreover, Shionogi had requested the Ministry of Health, Labor and Welfare (MHLW) to obtain third-shot approval for its COVID-19 vaccine only with data from its booster trial. However, MHLW indicated that booster trial data alone are not enough to get approval for use in third vaccinations.

Notably, most of the indigenous COVID-19 vaccines in Phase III are undergoing clinical development in Japan. In December 2021, only Shionogi’s COVID-19 vaccine S-268019 had initiated a global Phase III trial and initiated recruitment in Vietnam as part of the global trial. S-268019 is expected to reach US$67m in 2027 as per GlobalData’s Pharma Intelligence Center consensus forecast of sales.

Khadayate concludes: “Shionogi is expected to be the front runner in launching the first indigenous COVID-19 vaccine with expected approval in H2’2022. Japanese players are currently focusing domestic market. However, they should work on clinical development strategies for other markets to improve sales potential. Furthermore, the COVID-19 pandemic is highly unpredictable with the emergence of new variants. Therefore, there are still many opportunities for new vaccines in different parts of the world, where supply is still an issue and new vaccines can help improve the overall supply situation.”