[Edaily Reporter KIM SUNG-JIN ] #Daewoong Pharmaceutical has begun the process of seeking formal approval for its botulinum toxin “Nabota” (DWP450) in the Japanese market. Given Japan’s regulatory framework, which permits the use of such products only under a doctor’s prescription, the company has been selling the product in Japan without formal approval until now; analysts suggest that it is now seeking official product approval to facilitate more aggressive marketing and promotional activities.

Among domestic toxin manufacturers, #Meditox has already thrown its hat into the ring in 2024 and begun clinical trials in Japan for its toxin product, “MT010109L.” The Japanese botulinum toxin market is estimated to be worth approximately 1 trillion won, making it a massive market—more than two to three times the size of the domestic market. As leading domestic botulinum toxin companies accelerate their expansion into overseas markets, competition is intensifying.

From “Unofficial Sales” to Formal Approval… A Shift in Strategy for the Japanese Market

According to a U.S. clinical trial information website on the 27th, Daewoong Pharmaceutical recently registered a Phase 3 clinical trial plan for Nabota’s entry into

the

Japanese

market

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This clinical trial aims to evaluate the efficacy and safety of DWP450 in 120 Japanese adults with moderate to severe glabellar wrinkles. Participants will be randomly assigned to either the DWP450 treatment group or the placebo group, and the trial will be conducted as a double-blind study so that neither the patients nor the investigators know which treatment is being administered. The full-scale clinical trial is scheduled to begin in January 2027 and is expected to be completed by December 2028.

Japan has a unique regulatory framework under the Named Patient Program (NPP), authorized by the Ministry of Health, Labor and Welfare, which allows for the supply and use of products without formal approval, provided they are prescribed by a physician. Through this system—commonly referred to as “medication certification”—individual physicians can order and prescribe products that have been certified overseas. Major South Korean botulinum toxin companies, including Daewoong Pharmaceutical, Medytox, and #Hugel, have been selling their products in the Japanese market through this method.

Regarding this, a Daewoong Pharmaceutical official explained, “We have been selling products in small quantities in the Japanese market.”

However, there is a drawback: without formal product approval, it is difficult to establish a local supply chain or conduct active marketing and promotional activities. In essence, product approval is essential for a full-scale market push.

According to Fortune Business Insights, the Japanese botulinum toxin market is estimated to reach approximately $770 million (about 1 trillion won) by 2026, accounting for about 6% of the global market. Considering that data from Japan’s Yano Research Institute in 2023 estimated the market size at around 600 billion won, it appears that significant growth is occurring in a short period of time. Even from a global perspective, Japan is considered one of the top five markets worldwide, following the United States, China, and Brazil.

Growing into a 1 Trillion Won Market… Japan’s Market in the Spotlight

Daewoong Pharmaceutical’s move to seek formal approval for Nabota in the Japanese market is seen as part of its strategy to expand into overseas markets. While Nabota has established partnerships in 80 countries—including the United States (Jeuveau) and Europe (Nuceiva)—and has obtained approval in 69 countries, it has not yet officially entered the Japanese market.

In fact, Daewoong Pharmaceutical has been significantly increasing the proportion of its revenue derived from Nabota exports in recent years. In the second quarter of this year, Daewoong Pharmaceutical’s Nabota export revenue reached 94.1 billion won, a staggering 54.3% increase compared to the same period last year. This figure also represents a 108.2% increase compared to the second quarter of 2024 (45.2 billion won), two years ago.

As Daewoong Pharmaceutical accelerates its push into the Japanese market, competition with Medytox—considered its domestic rival—is expected to intensify. Medytox had already signed a contract with a global contract research organization (CRO) in 2024 and begun preliminary work to apply for local clinical trials.

A Medytox official stated, “We are currently in Phase 3 clinical trials and are aiming for official product launch in 2028, following marketing authorization.”

To date, only two products—AbbVie’s Botox from the U.S. and Merz’s Xeomin—have received formal marketing authorization in the Japanese botulinum toxin market, fueling growing expectations that Korean latecomers could rapidly expand their market share if they successfully clear the regulatory hurdle.

Despite the market’s large size and rapid growth, analysts suggest that the reason Korean companies have been relatively slow to pursue formal approval is that it is not easy to meet the standards set by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

An industry official explained, “Korean pharmaceutical companies have been knocking on the door of the Japanese market for a long time, but there have been many failures,” adding, “Furthermore, the existence of a system that allows products to be sold even without obtaining product approval likely played a role.”

As Price Competition Intensifies, the Need for Marketing Grows

Although domestic botulinum toxin companies have been selling products without formal approval for a long time, it appears they have recently revised their strategies in response to shifting market conditions in Japan. Hugel, for instance, has been selling products in the Japanese market since 2012, and Medytox established a local subsidiary in 2015 and has been conducting business there for over 10 years.

A source in the botulinum toxin industry said, “As competition in the Japanese market has intensified recently, price competition is becoming increasingly fierce,” adding, “Consequently, the need for aggressive promotional and marketing activities is also growing.”

Consequently, it appears that each company is adopting a differentiated approach to targeting the Japanese market. In particular, Hugel, which entered the Japanese market early on, is reported to be in a relatively comfortable position after quickly securing market share by targeting large chain clinics.

A Hugel official explained, “We are implementing an optimal market entry strategy for Retivo that takes into account the regulatory requirements and market characteristics of each country.”