South Korean companies are making waves in the botulinum toxin or botulinum neurotoxin market, also known as “Botox”. In February, Hugel, a South Korean botulinum toxin manufacturer, received approval from the U.S. Food and Drug Administration (FDA). This approval comes at a time when many domestic botulinum toxin companies are experiencing strong growth in the Asia-Pacific region and Europe. Hugel’s approval paves the way for increased competition among South Korean Botox suppliers, so-called “K-Botox” companies, in the U.S., by far the largest botulinum toxin market in the world.
In February, Hugel received product approval from the FDA for 50 units and 100 units of its botulinum toxin “Botulax (the brand name in the US: Letybo)”. The company applied for its FDA product approval in 2021, and after three years of refinements, the final authorization was granted. Hugel plans to launch Letybo in the States mid-year.
With this milestone, Hugel became the first and only South Korean company that has market approvals in all three major aesthetic markets – U.S., Europe, and China. Botulax is the second South Korean Botox to enter the U.S. market, after Daewoong Pharmaceutical’s (Daewoong’s) Nabota (the brand name in the US: Jeuveau). Daewoong started local sales of Nabota through its global partner Evolus, after the FDA approval in 2019. Daewoong’s Botox sales last year were about $1.09 million (147 billion won), accounting for 74.9% of Daewoong’s total exports.
There will be growing competition between the two South Korean firms when Botulax is launched. Attention is now focusing on how Nabota’s 11% share of the States’ beauty toxin market is affected by the introduction of Botulax.
The U.S. market is more than 30 times the size of South Korea’s, which is why South Korean Botox manufacturers are looking to enter the huge market. According to global market research firm Fortune Business Insights, the U.S. botulinum toxin market was valued at $4.74 billion (about 6.4 trillion won) last year. It is expected to grow to $6.68 billion (about 9 trillion won) by 2030. South Korean botulinum toxin market is only worth about $148.34 (about 200 billion won) per year. “The domestic Botox market has limited growth due to cutthroat competition and limited demand, which is why domestic companies are trying to expand overseas businesses and the therapeutic utility of botulinum toxin,” said a pharmaceutical industry insider.
However, obtaining approval from the FDA is a challenging process, so is entering the U.S. market. Medytox, a major player in the South Korean botulinum toxin market, experienced this difficulty when it applied for approval of “MT10109L” at the end of last year but received a rejection notice from the FDA this year. The reason cited was the absence of a specific verification test report. Only four botulinum toxins have been approved by the FDA so far since AbbVie’s “BOTOX” in 1989 - Supernus’s “MYOBLOC” in 2000, Merz’s “XEOMIN®” in 2010, Daewoong’s “Jeuveau” in 2019, and Hugel’s “Letybo” in 2024. Medytox plans to reapply after completing the documents.
South Korean pharmaceutical firms are also actively pursuing entry into the Chinese botulinum toxin market, which is estimated to be valued at about $111.24 million (about 1.5 trillion won). Hugel with a product license secured in 2020 is the only South Korean company that made its entry into the Chinese market.
Daewoong and Huons BioPharma are poised to follow suit as the next entrants into the Chinese market. Daewoong applied for marketing approval of Nabota, to China’s National Medical Products Administration (NMPA) in 2021 and is currently awaiting the outcome. Huons Biopharma is gearing up to apply for the license through its Chinese partner, iMeiK Technology. Additionally, CKD Bio and Inibi have commenced pivotal Phase III trials in China. Despite previous setbacks, Medytox is getting set for another attempt to penetrate the Chinese market. After withdrawing its 2018 “Meditoxin” registration application to China’s NMPA, the company is working on re-entering the Chinese market with its next-generation botulinum toxin, “Neuronox”.
With South Korean suppliers of botulinum toxin products experiencing a surge in sales last year and the latest Hugel’s FDA approval, exchange-traded funds (ETFs) featuring “K-Botox” companies have emerged in the stock market. NH-Amundi Asset Management is reportedly preparing to launch the “HANARO K-Beauty ETF” next month, which will include medical aesthetics companies as well as bio companies involved in beauty injections, such as Hugel. Furthermore, Shinhan Asset Management’s “SOL Medical Device Materials & Equipment (464610),” which comprises Hugel, Medytox, and Daewoong, has seen a 2% growth rate over the past month.
