Korean toxin makers split as Daewoong and Hugel advance

The U.S. accounts for roughly 60% of the global botulinum toxin market. Grand View Research projects the U.S. market will grow from $5.49 billion in 2025 to $11.53 billion by 2033, a compound annual growth rate of 9.8%.

Daewoong entered the U.S. market in 2019 with Nabota, supplied by distributor Evolus at prices about 70% lower than premium competitors. The product captured 4% of the aesthetic toxin market in its first year and climbed to 14% by last year, placing it second only to Allergan's Botox. Daewoong's U.S. sales hit $266.3 million last year, up 32% from the prior year. Nabota has generated 1 trillion won in cumulative sales since its 2014 domestic launch, with exports accounting for 84% of last year's 228.8 billion won in total sales.

Now Daewoong is moving beyond aesthetics. The company seeks to position Nabota as a biologic similar to Botox and develop it as a biosimilar for therapeutic indications where Botox is approved. Its U.S. partner Ionis Biopharma is developing Nabota for blepharospasm, upper limb spasticity, and chronic migraines. Ionis will submit an investigational new drug application in the fourth quarter of this year and launch clinical trials in the first quarter of 2027.

Hugel is pursuing a different strategy: shifting to direct sales. The company launched Letibot through partner Benev last year and added its own U.S. subsidiary sales operation in July. By 2027, Hugel plans to convert Benev from a distributor to a contract sales organization and move to full direct sales, with Hugel's in-house team managing all customers.

Hugel is pricing Letibot 20% to 35% below Botox. The company expects direct sales to more than double revenue compared with the distributor model. Beyond Letibot, Hugel plans to launch the skin booster Ophuluxe V and the premium cosmetic Byryzn BR in the U.S. in 2027.

Medytox, by contrast, is stalled. The company out-licensed its liquid botulinum toxin formulation Innotox to Allergan in 2013, then pursued independent U.S. entry. In December 2023, it applied to the FDA for approval of MT10109L, but the FDA refused to file the application in February 2024, citing insufficient materials. Medytox said it would supplement its dossier and reapply, but has not done so for three years.

The company blamed delays on reselecting a contract research organization and additional verification processes. It now says supplementation of documents is in final stages, but has disclosed no specific reapplication timeline.

Medytox faces additional headwinds. A nine-year domestic dispute with Daewoong over botulinum toxin strain rights remains unresolved. In the U.S., the company lost a lawsuit against Hugel and is appealing.

When Medytox does enter the U.S. market, it will use a direct-sales subsidiary and lead with a type A liquid formulation that differs from its export products. But competitors have already built sales networks. A biotech analyst quoted in the report said Medytox will need "a strategy that is even more differentiated than what it currently puts forward" to compete.

Business information, not medical or legal advice. Verify regulatory status at FDA.gov.