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Takeda Aims for U.S. Approval to Sell Dengue Vaccine, Eyes $2 Billion Market

The company seeks entry into the U.S. vaccine market with dengue vaccine approval, after success in Southeast Asia and Europe
Japan
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Takeda Pharmaceutical is seeking U.S. regulatory approval to sell its dengue fever vaccine, positioning itself as the first Japanese company to enter the American vaccine market, Nikkei reported. The move follows the vaccine’s approval in Southeast Asia and Europe, where it has gained recognition for its effectiveness and safety in children aged four and older. Takeda anticipates that global sales could reach $2 billion annually.

The dengue vaccine market is growing, as global warming expands the regions where the mosquito-borne virus can spread. With nearly 400 million infections annually worldwide, according to the World Health Organization, the demand for effective prevention is significant.

Takeda previously sought U.S. approval but withdrew its application. Now, the company is re-engaging with the U.S. Food and Drug Administration, though details regarding the filing and production are still being finalized.

As the global vaccine market is dominated by U.S. and European companies like Pfizer and Moderna, Takeda aims to strengthen its competitive position by expanding its vaccine offerings beyond dengue. Success in the U.S. could bolster Takeda’s vaccine development pipeline, helping Japan improve its standing in the global pharmaceutical landscape.

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