Detailed market knowledge and an experienced CMO are still critical to successfully developing a biopharmaceutical or biosimilar according to Cobra Biologics.
Outsourcing-pharma.com spoke with commercial director Julian Hanak who said that an experienced contract manufacturing organisation (CMO) - and detailed analysis of the market - can reduce the risks involved in developing biologics.
“Drug development is a high attrition rate process. It’s very expensive to do, it’s highly regulated and it’s slow. What you don’t want is failures doing the basics, making the molecule, testing the molecule and shipping the molecule around.”
However – while experienced CMOs in the US and Europe still dominate – the growth of the Asian contracting sector is starting to alter market dynamics according to Hanak.
“There are two sorts of companies [Asian CMOs]. There are companies… that are actually buying organisations in the western world and then there are those whose manufacturing assets are actually in the developing world,” he said, highlighting the BRIC nations as a particular.
“There was a perception in the past that you couldn’t get quality from going outside developed western markets and I think that myth has been dispelled now. “
The challenges that Asian CMOs now face in attracting customers – and hence the advantage Western manufactures retain – are more related to distance, language and project oversight Hanak continued.
Nevertheless – there are still opportunities for experienced Western CMOs as regional markets begin to open up.
“In terms of contract manufacturing, a lot of the technology and the expertise resides in Western and developed nations, so a lot of the more difficult to manufacture products at least start life and get launched from facilities in the Western world,” Hanak said, even if they are likely to be transferred elsewhere at the end of their lifecycles.