Biologics growth is pushing sterile injectable manufacturing infrastructure, with contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) building out to meet demand, according to conversations at recent conferences reported by BioSpace on Aug. 3.
BioSpace reports that biologics, biosimilars, GLP-1s and some advanced therapies are increasing demand for sterile injectable drug products. The global market for prefilled syringes is also expanding, driven in part by the higher prevalence of chronic illnesses and a growing trend toward self-injection.
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. Dr. Klaus Dörre, head of commercial at BAG Health Care, said there are two market trends developing in parallel: “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.” Dörre added, “At the same time, we see a growing need for flexible manufacturing of smaller, more specialized injectable products. 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.”
German CDMO Adragos Pharma has expanded its operations with manufacturing sites in Germany, France, Switzerland and Japan; Business Development Director Tobias Schlögl said there are hopes to add additional sites as well. Alexandre Isabel, Business Development Manager at Netherlands-based CMO BioConnection—which focuses on fill & finish services—said that their company is experiencing significant growth due to client demand for biomolecules as well as requests for gene therapy fill & finish services.
Over the past decade prefilled syringes have composed a substantial portion of injectables packaging market share—a trend expected to continue. A rise in autoinjectors has contributed to this demand; these devices feature user-friendly designs that reduce needlestick injuries or partial doses while offering both constant or variable dosing options suitable for gradual increases.
About half of autoinjector products currently marketed have been approved since 2017; this type of packaging is expected to grow even more popular moving forward. The global prefilled syringe market is projected to expand from $9.4 billion in 2026 to $20.3 billion by 2035. The increase in biologic therapies continues driving CMOs’ and CDMOs’ expansion into fill-finish processes—including lyophilization—and greater flexibility with device-based delivery systems.
