Korean botulinum toxin makers tap overseas therapeutic market

Botulax [Courtesy of Hugel]

South Korean botulinum toxin makers are going beyond the beauty market and expanding their presence in the therapeutic market as they hope to leverage the rising exports of domestically produced botulinum toxin products.

According to multiple industry sources on Thursday, Korean botulinum toxin makers, including Daewoong Pharmaceutical Co., Medytox Inc., and Huons BioPharma Co., are expanding their production facilities as the toxin market, in which they have a competitive edge, continues to grow steadily.

According to global market research firm Grand View Research, the global toxin market is projected to grow by an annual average of 11.5 percent to $15.4 billion in 2030 from $6.4 billion in 2022.

Toxin exports are also on the rise. According to the Korea Customs Service, outbound shipments of toxins stood at $251.9 million in the first 9 months of this year, up 16.5 percent from the same period a year ago. Annual exports are expected to reach an all-time high this year and surpass last year’s $296.3 million.

Notably, sales of Daewoong Pharmaceutical’s Nabota hit 75.3 billion won ($55.6 million) in the first six months of this year, up 11.6 percent from the same period a year ago. Annual sales of Nabota are projected to reach an all-time high this year, surpassing last year’s 142 billion won.

Nabota’s overseas sales more than doubled to 109.9 billion won in 2022 from 49.2 billion won in 2021. Overseas sales accounted for 62.9 billion won out of the entire sales of 75.3 billion won in the first half of this year.

Daewoong Pharmaceutical is now eyeing the therapeutic market for Nabota with its partner, AEON Biopharma Inc.

In Korea, the beauty toxin market accounts for 90 percent of the entire toxin market, but global therapeutic toxins took up 53 percent of the entire toxin market in 2022.

AEON Biopharma obtained a patent related to the treatment of migraines for Nabota in the United States in September, securing exclusive rights in this field in the region until 2041.

In line with the increased global sales, Daewoong Pharmaceutical is focusing on expanding its facilities.

The company plans to invest a total of 100 billion won by next year to build its third Nabota factory in Hwaseong, Gyeonggi Province, which will have the capacity to produce 13 million vials per year.

The company’s annual production capacity is expected to hit 18 million vials when adding the 5 million production capacity of the first and second factories.

Global sales for other toxin makers are also on the rise.

Hugel Inc. saw its toxin-related sales increase by 46.8 percent from 109.5 billion won in 2020 to 160.7 billion won in 2022.

Sales reached 73.4 billion won in the first half of this year, up 8.8 percent from the same period a year ago.

Hugel’s upbeat sales are led by overseas demand. The company applied for product approval for its flagship product, Botulax, from the U.S. Food and Drug Administration in September, aiming to enter the top three global toxin markets and hit 1 trillion won in annual sales by 2025.

Hugel plans to raise the current 60 percent level of overseas sales to 80 percent by 2025.

The company is also building a third factory with the goal of starting operations in 2024. Once the construction of its third factory is completed, Hugel will be able to produce 13.72 million vials of finished products annually, or 2.4 times the current level of 5.72 million vials.

Meanwhile, Medytox is preparing for the application of a U.S. product approval for an injectable toxin preparation, MT10109, which has completed a third-phase clinical trial in the United States.

Medytox’s sales soared 45.2 percent to 94.7 billion won in 2022 from 65.2 billion won in 2020. Its first-half sales came to 44.5 billion won, up 4.7 percent from the same period last year.

Medytox plans to enhance its market dominance by producing a large volume of new products, including Newlux. Its third facility is expected to have the capacity to produce 600 billion won worth of botulinum toxin finished products annually.