By Kate Hammeke, VP of Market Research, Industry Standard Research (ISR)
The long history and market dominance of oral dosage forms have made this category of drug product a good candidate for outsourced manufacturing. And, according to respondents* who participated in Industry Standard Research’s 2019 Oral Dosage Forms survey, there are no signs of oral-dose outsourcing letting up. In fact, across all sponsor groups, respondents predict increases in the proportion of oral-dose manufacturing that is outsourced. For clinical trial manufacturing, the increase averaged 6 percentage points, climbing from 54 percent to 60 percent outsourced, and for commercial manufacturing, the increase averaged 8 percentage points, rising from 57 percent to 65 percent outsourced.
Not only is the proportion of outsourcing predicted to increase, so is the number of oral-dose products in sponsors’ pipelines, which means that even if outsourcing percentages remained static, CMOs could anticipate increased demand because sponsors expect to have more oral-dose products in their portfolios five years from now. Some of the same characteristics that helped the oral dose earn its valued position in healthcare — ease of accurate dosing and patient-friendly delivery format — will continue to contribute to its popularity, but so will use of newer technologies such as modified release combined with advances in the dosage form, like multilayer tablets.