Sponsor Challenges When Outsourcing Sterile Injectables

By Kate Hammeke, VP of Market Research, Industry Standard Research (ISR) @ISRreports

Current demand for sterile injectable drug product manufacturing is fed by several dynamics. Biologic drugs in biopharmaceutical companies’ pipelines — roughly five on average among survey respondents — need to be delivered by injection due to molecule size. There are 3.6 small molecule compounds in development on average among respondents that will be sterile injectable formulations. Biopharma companies that have reduced internal manufacturing in order to focus on core competencies may no longer have internal expertise or capacity. Some biopharma companies have dedicated all internal capacity to existing marketed products, meaning either their new drugs or some portions of their portfolios will need to be outsourced in the future. Lastly, many new and virtual biopharma companies have no internal manufacturing and must outsource.