LONDON—According to recently released research by data and analytics company GlobalData, the European contract manufacturing organization (CMO) industry has invested heavily in containment capabilities, and approximately 69 percent of CMO high-containment facilities in Europe can be found in Switzerland and the five major European markets (5EU) of France, Germany, Italy, Spain and the United Kingdom.
“As is to be expected, the 5EU, as well as Switzerland, house the most small-molecule active pharmaceutical ingredient (API) facilities with containment in Europe,” said Adam Bradbury, an analyst at GlobalData. “Most of these belong to dedicated CMOs, which only perform contract manufacturing rather than also marketing their own products.”
The handling of drug substances classed as highly potent or cytotoxic is increasingly commonplace for drug manufacturers due to the continuing growth of the oncology drug pipeline. Manufacturing these drugs is complex, requiring special equipment, facility layout and expertise.
Continued Bradbury: “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.”
Around 60 percent of highly potent APIs (HPAPIs) in the pipeline are being trialed for oncology, making this therapy area a strong indicator of pipeline HPAPI activity, says GlobalData, adding that this is also a good predictor of future commercial-scale manufacturing demand for containment substances.
“Approximately half of oncology drug candidates in Phase 3 and pre-registration are small molecules,” Bradbury concluded. “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.”