From a geographic perspective, the European Union (EU) s a highly diverse and heterogeneous market for recombinant protein manufacturing. As the EU continues to outpace the US in terms of the type and number of biosimilars that have received marketing authorization, the increasing activity surrounding biosimilars is having a secondary effect on the EU recombinant protein ecosystem.
As is the case in the U.S. the majority of suppliers in the region are captive – divisions, subsidiaries or business units of the labeling company. Not surprisingly, smaller labelers are most likely to contract for protein manufacturing services outside their own organization.
Top Level EU Recombinant Protein Manufacturers
Activity in biosimilars is also allowing selected companies who have several proteins in their manufacturing portfolio to enhance their manufacturing resumes. Since the shortest path to biosimilar approval lies in outsourcing not only the functional activity, but the knowledge base and existing art as well, biosimilar labelers in Europe are most often contacting with contact manufacturers with previous clients for the same API.
API Suppliers to Recombinant Protein Manufacturers in the EU