Outsourcing Trends In Small Molecule API Manufacturing

By Kate Hammeke, Director of Marketing Intelligence, Nice Insight

Lately, much of the enthusiasm in drug development is centered around large molecule API / biologics. However, the vast majority of drugs on the market, and in development, have a chemical-based, small molecule active ingredient. Considering the dominance of this type of medicine on the market, it is not surprising that one-third of the CMOs included in Nice Insight offer commercial-scale small molecule API and advanced intermediates manufacturing, as compared to 20 percent that offer biologic API manufacturing.

Respondents to Nice Insight’s annual survey, who will outsource commercial scale manufacturing (25 percent), reported small molecule API manufacturing at a lower frequency than large molecule API or finished dosage forms (28 percent vs. 37 percent, respectively). However, this likely speaks to the many existing outsourcing relationships that are based on small molecule API manufacturing, as the survey inquires about new projects that will be outsourced in the next twelve to eighteen months.