Hugel, Inc. announced on March 4 that it has obtained product approval from the U.S. Food and Drug Administration (FDA) for its botulinum toxin product Letybo in 50-unit and 100-unit dosages on Feb. 29, local time. This FDA approval marks Hugel as the first and only company in South Korea, and the third globally, to enter all three major toxin markets: the United States, China, and Europe. To date, Letybo has been authorized in a total of 63 countries, rapidly expanding its global market presence.
The United States holds the largest botulinum toxin market in the world, accounting for over 50% of the total market. According to data from global market research firms such as Decision Resource Group and Boston Consulting Group, the market size is expected to nearly double from 3.25 trillion won in 2023 to 6.36 trillion won by 2031.
Hugel is finalizing its market entry strategy with the goal of launching the product in the middle of this year. Following its successful launch in Canada last year, which laid the foundation for North American expansion, the company anticipates accelerating its efforts to capture the U.S. market.