As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.
Biologics growth is pushing sterile injectable manufacturing infrastructure, with CMOs CDMOs building out to meet demand.
According to BioSpace conversations at recent conferences, biologics, biosimilars, GLP-1s and some advanced therapies are increasing demand for sterile injectable drug products. In addition, the global market for prefilled syringes is expanding, driven in part by the higher prevalence of chronic illnesses and a growing trend toward self-injection.
In most recent headlines, PCI Pharma Services announced in May the addition of sterile fill/finish and drug-device delivery combination capabilities to U.S. sites as part of a $1 billion global expansion program.
Changing market dynamics
There are two market trends developing in parallel, said Dr. Klaus Dörre, head of commercial at BAG Health Care, a German contract manufacturer. The first is the increasing utilization of device-based biologics such as prefilled syringes and cartridges, mostly fueled by GLP-1 drugs or biologics used outside the hospital setting.
“At the same time, we see a growing need for flexible manufacturing of smaller, more specialized injectable products,” Dörre said. “Innovative therapies for defined patient groups, regional supply strategies and the evolving biosimilar framework are all contributing to a market where agility and right-sized manufacturing capacity become increasingly important.”
The injectable demand and customer requirements for a robust, consistent supplier have underscored the expansion of German CDMO Adragos Pharma. Manufacturing sites operate in locations such as Germany, France, Switzerland and in Japan and the hope is to have additional sites as well, said Business Development Director Tobias Schlögl.
BioConnection, a Netherlands-based CMO that focuses on fill & finish services, is massively growing as well, according to Business Development Manager Alexandre Isabel. The client trend is biomolecules, with customers also asking for fill & finish for gene therapy.
Tech developments spur changes
It appears the trend of prefilled syringes composing a substantial portion of the injectables packaging market over the last 10 years won’t change.
A rise in autoinjectors, an injectable preferred by patients over traditional or prefilled syringes, explains the demand. Autoinjectors have user-friendly designs that mitigate the possibility of needlestick injuries and partial doses, and they can be created with a constant or variable dose, making them ideal for gradual increases.
About half of the autoinjector products marketed have been approved since 2017, underscoring this type of packaging is set to become even more popular in the future. In addition, the global prefilled syringe market is projected to expand from $9.4 billion in 2026 to $20.3 billion by 2035.
The biologics boom is forcing a reckoning in sterile manufacturing. CMOs and CDMOs are expanding fill-finish, lyophilization and prefilled syringe capacity because the market is demanding more flexibility, more device-based delivery and more resilient supply.
