Local pharmaceutical companies are actively advancing to overseas markets. A total of 209 pharmaceutical companies expanded their businesses, such as establishing subsidiaries or plants, in 2018. The number increased by four-folds from that of 2016.
Notably, data showed that local companies had been actively entering the U.S. and Europe over the past two years.
According to the “2019 Pharmaceutical Industry DATA BOOK,” recently published by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, local companies established 23 plants, 144 subsidiaries, 19 marketing branches, and 23 research facilities abroad in 2018.
The report also showed that 209 pharmaceutical companies had operations abroad, four times higher than the 45 companies that had overseas operations in 2016.
By region, Asia and North America saw the most active advances by 108 and 54 companies, respectively, followed by the EU (28 companies). The data showed that while companies focused on Asia and the Middle East in 2016, companies focused their entry into main markets such as North America and Europe in 2018.
The report also showed that sales approval cases in the U.S. are expanding. In 2016, only two items – Celltrion’s autoimmune disease biosimilar Inflectra and SK Chemicals’ hemophilia treatment Afstyla -- were approved by the FDA.
However, the number of drug approvals quadrupled to eight cases this year. They are Samsung Bioepis Ontruzant (anticancer biosimilar), Eticovo and Hadlima (autoimmune disease biosimilar), Daewoong Pharmaceutical’s Jeuveau (botulinum toxin strain), SK Biopharmaceutical’s Sunosi (excessive sleepiness treatment), Xcorpi (epilepsy treatment), Celltrion’s Linezolid (antibiotic generic), and SK Chemicals’ SID710 (dementia treatment) received approval this year.
Exports were also steadily increasing. In 2018, total exports of raw materials, finished drugs and quasi-drugs amounted to $5.1 billion (6.5 trillion won). The amount is a sharp increase from the exports in 2016 and 2017 ($3.4 billion and $4.4 billion).
By country, exports to the United States were the highest at $ 502 million, followed by Germany ($ 460.6 million) and Japan ($455.8 million). Shipments to North America and Europe, including the U.S., Germany, and the Netherlands, increased significantly.
The increase in numbers is attributed to the significant increase in exports from Celltrion and Samsung Biologics' biosimilar products.
Among the top 10 export companies in 2018, Celltrion's exports were the highest, with 713.5 billion won ($616.6 million), followed by Samsung Biologics at 307.9 billion won.
The exports of domestic fillers and botulinum toxin preparations also increased significantly.
LG Chem, which developed the lgyvoire filler, took third place with an export value of 247.9 billion won. At the same time, Hugel and Medytox, which focus on botulinum toxin and fillers, also ranked among the top 10 companies with the exports of 182.4 billion and 133.3 billion won, respectively.