Earlier this month, contract manufacturing organisation (CMO) Catalent told stakeholders that the high barriers to entry and increasing regulatory costs within the industry are making it harder for small players to compete.
UK-based aseptic manufacturer Symbiosis Pharmaceutical Services agreed barriers to entry are higher than ever and costs are on the rise but told in-Pharmatechnologist.com customers – especially biotechs – continue to contract both itself and other small CMOs.
“Bigger is likely to be better for large scale commercial volumes but for small, proof-of-concept studies required by biotechs, it’s all about the CMO being agile and quick in order to help accelerate development and meet increasingly tight timescales,” CEO Colin MacKay said.
“Cultural fit and relationships are also becoming increasingly important in the CMO selection process, as these factors can be critical in ensuring project success.”
As for the growing cost burden of regulatory oversight highlighted by Catalent, this is relative to the size of the organisation and its operations, MacKay continued, adding a small company’s inherent efficiency is often overlooked when assuming operational costs.
His views were mirrored by fellow CMO, Spain-based Idifarma which told us being smaller and nimbler can make products in a very efficient and agile manner.
“We are equipped and organised to handle very low-volume products so there are no small clients or products for us, and our aim is to provide the best service possible in each and every case,” said business development manager Manuel Leal Sánchez.
“The role of companies like Idifarma is valuable because we enable products to get into clinical trials quickly and safely within the regulatory guidance.”
And both firms added that going forward large, consolidated CMOs will operate alongside
“The market will continue to evolve and customers face the choice of big one-stop-shop service providers or electing to go with a smaller, specialist partner,” said Symbiosis’ MacKay. “Ultimately for clients, it’s about getting product delivery in the safest and quickest route they possibly can.”