KATE HAMMEKE
Vice President of Market Research, Industry Standard Research, Raleigh, USA

Abstract

What drives successful outsourcing relationships between drug innovators and contract manufacturers? When it comes to small molecule drug substance manufacturing, a combination of company size and structure, internal needs, and external factors shape the criteria drug innovators use to choose their CDMO. Data from Industry Standard Research offers insight on CDMO selection metrics for outsourced API manufacturing over the past five years and ideas on why these metrics may have changed during that time.

INTRODUCTION
Persistent pressure to make medicines more affordable is one of the many reasons the practice of outsourcing manufacturing activities and services in the biopharmaceutical industry continues to evolve. Over the past thirty years, outsourcing has advanced from simple client-vendor relationships focused on identifying supply chain inefficiencies, improving operations, and reducing costs—which remain current outsourcing objectives—to true partnerships where accessing technologies and scientific expertise not possessed in house are the focus. Small molecule drug substance has one of the longest outsourcing histories, along with excipients and advanced intermediates, among biopharmaceutical products in part because of their long therapeutic history and relative lack of complexity compared to biologics. Industry Standard Research, a full-service market research company focused on the biopharmaceutical services industry, conducts annual benchmarking research to understand the preferences and practices of outsourcers as well as their experiences with specific CDMOs.

DISCUSSION

Methodology ...