Driven by improved device designs, a maturing supply chain infrastructure and broad acceptance of inherent patient and caregiver benefits, prefilled syringes will continue to grow at a double digit rate, climbing to four and three quarter billion units worldwide in 2016, according to the latest estimates from Greystone Research Associates.
Drug developers seeking to package their injectable formulations in prefilled devices need an understanding of the unique technology and business factors defining this sector. The prefilled syringe ecosystem has evolved to consist of several segments that include syringe component suppliers, syringe manufacturers, and contract filling companies. Within these layers are specialty service providers that include formulation technology developers, device designers, and physical properties testing. For small-to–mid size companies, many of these functions are outsourced. Because of the complexity of this ecosystem relative to vial packaging, the decision to develop an injectable for administration with a prefilled device is being made earlier in the drug development cycle, as product managers and marketers understand the need to take full advantage of combination product opportunities.
In what has amounted to a period of technology consolidation and horizontal integration, prefilled syringe suppliers have been refining their product offerings over the past 24 months, making important improvements in device compatibility and manufacturability. This period has been marked by key innovations in the areas of glass coatings and coating application, device markings and management (anti-counterfeiting, bar coding/traceability), and ready-to-fill packaging.
While glass prefilled syringes account for the vast majority of currently-marketed commercial products, the development of plastic prefillable syringes based on materials such as cyclic olefin copolymers (COCs), is an important trend to watch. While non-glass prefilled syringes continue to be refined, beyond the occasional exception such as Tercica’s somatuline depot for the treatment of acromegaly, their use is still limited to niche areas such as emergency medicine and drug reconstitution. We expect plastic PFS to being to make inroads for selected therapeutic drug classes.
As prefilled syringes have proliferated, the need to protect caregivers from cross contamination via needlestick injuries and to comply with government regulations has been primarily accomplished through the use of post-fill-and-finish add-on devices that allow the user to disable the needle after the injection event. These first-generation safety components, while mitigating the risk of inadvertent contact with a used needle, do not eliminate it. New second- and third-generation devices specifically aimed at addressing the safety issue as it pertains to prefillable syringes go beyond first-generation approaches, in many cases providing passive (no user action required) post-injection protection from contaminated needles. Unilife’s Unifill ready-to-fill safety syringe is the most advanced device in this segment.
More information on the growth of prefilled syringes can be found in a new and comprehensive report, researched and prepared by Greystone Research Associates. Prefillable Syringes to 2016: Devices, Therapeutics, Players, Markets and Prospects examines prefilled syringe market segments and product data, analyzes important therapeutic segments and examines key regulatory, economic and competitive factors that represent potential barriers to commercial success.
Greystone Research Associates (GreystoneAssociates.org) is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.