A Growing Number of Korean Firms Entering CDMO Market
With the European Medicines Agency (EMA) resuming on-site inspections after a hiatus caused by COVID-19, an increasing number of South Korean companies are entering the contract development and manufacturing market, which is expected to reach US$20 billion in 2026.
The EMA conducted production site inspections at Binex and Prestige Biologics early this month. The inspection is mandatory for drug product export to Europe and a pre-approval clinical trial in Europe.
The inspection at Binex was conducted at its biomedicine production facilities in Songdo. The company’s production facilities include those in Osong and Songdo with a total production capacity of 12,000 liters. Its clients include Boehringer Ingelheim, Genexine, Hanall Biopharma and PharmAbcine. The EMA visited Prestige Biologics’ facilities in Osong on Nov. 9 to 12.
South Korean contract development and manufacturing organizations are likely to accelerate their production with the inspections resumed. After the outbreak of the pandemic, most of them slowed down or halted their production facility operation with live streaming and recorded videos taking the place of on-site inspections. “Many foreign authorities in charge of drug approval switched to on-site inspections in the fourth quarter,” one of them said, adding, “Both approval and production will be accelerated as on-site inspections are more convenient than remote inspections needless to say.”
According to market research firms, the global market for contract development and manufacturing of biomedicines is expected to grow from US$12.8 billion to US$20.31 billion from this year to 2026. This is why more and more South Korean companies are focusing on this sector. Samsung Biologics is planning to increase its production capacity to 620,000 liters and raise its global market share to 50 percent by doubling the number of its plants to six. SK Bioscience and GC Labcell are also planning to expand their business in the sector.