Botulinum share in domestic market is 93%

Last year's production and import of botulinum toxins was ￦213.5 billion

No.1 production amount of Meditoxin ↓14% year-on-year, 3 types of license cancellation ￦82.2 billion

Production results of new products such as Liztox and Rientox

Among domestically produced and imported botulinum toxin preparations, products developed by Korean companies accounted for more than 90%.

 

Following Medytox, Hugel, and Daewoong Pharmaceutical, Huons Global and Pharma Research joined.

 

The three types of Meditoxin, whose license was decided to be canceled, recorded ￦82.2 billion in production last year.

 

According to the MFDS on the 7th, the domestically produced and imported botulinum toxin formulation last year was ￦213.5 billion.

 

It decreased by 0.3% from ￦214.2 billion in 2018, but increased 2.5 times in 4 years from ￦85.5 billion in 2015.

 

This is the result of a survey of products that reported production and import performance to the MFDS.

 

For imported products, an exchange rate of ￦1,200 per dollar was applied.

 

The botulinum toxin formulations registered last year's production and import records are a total of 10 products including Meditoxin, Botulax, Nabota, Innotox, Botox, Xeomin, Liztox, Rientox, Coretox, and Dysport.

 

A domestic company, Medytox, has three products, including Meditoxin, Innotex, and Coretox, and the remaining companies are selling one product each.

 

Yearly Botulinum Toxin Production Performance (Unit: ￦million, Source: the MFDS)

Among the total production and import of botulinum toxin products, the proportion of products from domestic companies overwhelmed the imported products.

 

The production of botulinum toxin preparations of domestic companies such as Meditoxin, Botulax, Nabota, Innotox, Liztox, Rientox, and Coretox last year was ￦198.5 billion, accounting for 92.2% of the total.

 

The proportion of domestically developed botulinum toxin production decreased slightly from 95.2% in 2018, but considering that Allergan and Ipsen entered generic maraket, the share of over 90% is an unusually high proportion.

 

Some of the products produced by domestic companies are sold in overseas markets, but even if exports are excluded, they dominate the original imported products.

 

Market share of domestically produced botulinum toxins by year (Unit: %, Source: the MFDS)

Not only existing companies such as Medytox, Hugel, and Daewoong Pharmaceutical, but also Huons Global and Pharma Research Bio recently jumped into the botulinum toxin market as generics and made results.

 

Production performance of Meditoxin was ￦104.1 billion last year, accounting for nearly half of the total production and imports, but decreased by 13.9% from ￦120.8 billion in 2018.

 

However, Innotox and Coretox, generics for Meditoxin, are recording high growth with production values of ￦10.5 billion and ￦2.5 billion respectively last year.

 

In the case of Meditoxin, the license was canceled in June due to the suspicion of manipulating documents, except for 200 units out of the four doses of 50, 100, 150, and 200 units.

 

Last year's production of the three products that were canceled last year amounted to ￦82.2 billion, or 78.9% of the production of Meditoxin.

 

While the court cited an application for suspension of execution of the three types of Meditoxin's license cancellation, collection, and disposal orders last month, it became possible to sell even the main lawsuit.

 

If sales are finally banned, it is expected that a significant loss in sales will be inevitable for Medytox.

 

Botulinum toxin production and import performance by item (Unit: ￦million, %, Source: the MFDS)

Production performance of Hugel's Botulex increased 5.4% from ￦55.7 billion in 2018 to ￦58.7 billion last year, while production performance of Nabota by Daewoong last year decreased 26.9% from the previous year.

 

Huons Global recorded ￦5.8 billion in production of Liztox, a botulinum toxin drug developed last year.

 

After recording production of ￦2.3 billion for the first time in 2016, it has increased every year, including ￦3.2 billion in 2017 and ￦3.5 billion in 2018.

 

Huons Global received a license for export under the brand name Hutox in October 2016, and then received an official license under the product name Liztox in April 2018.

 

Phamar Reserch BIO’s “Rientox” recorded the first production performance of ￦4.1 billion last year.

 

Phamar Reserch BIO is a company that changed its name after BioC&D, a bio company, was acquired by Phamar Reserch Product in January 2018.

 

It obtained a permit for export in February of last year, and although it has not yet been released in Korea, it seems that sales have occurred in overseas markets.

 

Allergan's Botox imports last year stood at ￦7.3 billion, up 69.2% from the previous year, but it was far short of domestically developed products.

 

The report of Xeomin by Mertz and Dysport by Ipsen also posted only ￦6.2 billion and ￦1.6 billion last year.