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The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.
The latest research from GlobalData has revealed that more than two-thirds (69%) of contract manufacturing organizations (CMOs) high-containment facilities are based in the top five European Union countries (5EU-France, Germany, Italy, Spain, and the United Kingdom) and Switzerland.
“As is to be expected, the 5EU, as well as Switzerland, house the most small-molecule API facilities with containment in Europe,” said Adam Bradbury, PharmSource analyst at GlobalData, in an Aug. 8, 2019 press release. “Most of these belong to dedicated CMOs [contract manufacturing organizations], which only perform contract manufacturing rather than also marketing their own products.”
Manufacturing requirements for highly potent drug substances is becoming more routine as a result of the rising proportion of biologics and complex entering the drug development pipeline. These complex ingredients are useful in fields such as oncology; however, their appropriate handling requires very special equipment, facilities, and skill levels.
“The manufacture of chemical APIs has become lucrative due to its growing complexity, using materials that are poorly soluble or require containment, which makes their handling more difficult,” continued Bradbury. “Approximately half of oncology drug candidates in Phase III and pre-registration are small molecules. This highlights that small-molecule cytotoxic oncology will play a major role in upcoming approvals and is good news for small-molecule CMOs as small-molecule drugs tend to be outsourced more than biologics.”