South Korean Toxin Firms Have Diverged in U.S. Market
Daewoong and Hugel have expanded their American market presence while Medytox continues to face FDA approval delays.
Updated on Oct. 7, 2026 in Beauty
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South Korean pharmaceutical companies are seeing vastly different outcomes in the United States, which accounts for 60% of the global botulinum toxin market. While Daewoong Pharmaceutical and Hugel have successfully scaled operations, Medytox remains hindered by regulatory rejections and ongoing legal disputes.
Why it matters
The U.S. remains the world's most lucrative market for aesthetic injectables, leading South Korean firms to aggressively compete for share through direct sales models and pricing strategies. However, regulatory hurdles and intellectual property litigation continue to determine which firms can capture this multibillion-dollar opportunity.
The U.S. toxin market was valued at 5.4905 billion dollars in 2025 and is projected to reach 11.5311 billion dollars by 2033. Daewoong Pharmaceutical saw a 32% year-over-year sales increase, while Hugel offers its products at a 20-35% discount compared to Botox.
The players
Daewoong Pharmaceutical
A South Korean pharmaceutical company that has successfully captured 14% of the U.S. aesthetic toxin market since 2019.
Hugel
A South Korean firm that began direct sales of its toxin product Retibo in the U.S. via a local subsidiary in 2026.
Medytox
A developer of botulinum toxin products that has faced significant regulatory and legal setbacks in its efforts to enter the U.S. market.
The details
Daewoong Pharmaceutical utilizes distributor Evolus to provide products at 70% lower prices than luxury alternatives, while Hugel has transitioned to a direct sales subsidiary model. Medytox faces continued challenges after the FDA rejected its MT10109L application in February 2025 following a decade of legal friction.
Timeline
Daewoong Pharmaceutical entered the U.S. market in 2019.
Medytox applied for FDA approval of MT10109L in December 2023.
The FDA rejected the Medytox application in February 2025.
Hugel initiated direct U.S. sales in July 2026.
Daewoong plans to submit an IND application in Q4 2026.
Roadmap
The aggressive entry of South Korean firms into the American aesthetic market reflects a broader shift toward global competition in the injectable toxin sector. As companies like Daewoong and Hugel displace established premiums, the industry is seeing a move toward direct-to-market distribution models.
Consumers seeking aesthetic treatments may find more affordable options as firms like Daewoong and Hugel increase availability through competitive pricing strategies. These market changes influence which injectable brands are offered at local clinics and the overall cost of cosmetic procedures.
The takeaway
The botulinum toxin market is becoming increasingly crowded, forcing companies to prioritize efficient distribution and aggressive pricing to maintain relevance. Investors and consumers should monitor how regulatory success and intellectual property litigation shape future product availability.
What happens next
Daewoong Pharmaceutical is expected to submit an IND application in Q4 2026 and plans to begin clinical trials for therapeutic applications in Q1 2027, while Hugel aims to complete its full transition to a direct sales system by 2027.
Further reading
For more on the evolving aesthetic injectable landscape, visit our Beauty section.
Source note: This article includes information reported by 조선일보.
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