INNOVATION
There have been several recent innovations in prefilled syringes. For example:
- Restricted access barrier systems have had one of the biggest impacts on the sterility assurance of prefilled syringes.
- Electron-beam sterilization tunnels for the aseptic transfer of prefilled syringe tubs provide benefits by delivering high
throughput and high levels of sterility assurance.
- Nondestructive control and inspection advances, coupled with improved cold-chain management, are of great advantage to minimize
the waste of highcost biologic APIs.
- Enhanced readability of fluid levels and accuracy of fluid draw helps ensure appropriate dosing.
Despite the advances made thus far, there is still room for further improvement. There has been an increase in the requirements
for documented processing and control of the glass syringe throughout manufacture including: tube processing, forming machines
(including closedloop controls), ammonium sulfate treatment, coating and annealing controls, leachable and extractable analysis,
dimensional and cosmetic inspection, needle assembly control, water-for-injection washing, siliconization, shield assembly,
and nesting. The systems that support the timely availability of this data will need to evolve and improve to support the
requirements of pharmaceutical and biotech companies.
As drugs evolve to more targeted applications, manufacturing flexibility will be crucial. From a CMO's perspective, innovative
equipment that supports this flexibility and optimization (e.g., equipment that can handle multiple safety shield vendors
with minimal change parts) will be important. Another improvement that would be welcomed is easy interchangeability in fill
and inspection equipment for glass and plastic syringes, which would increase efficiency and provide more flexibility.
Specifically for biologics, a siliconization process or suitable substitute is needed that has zero to minimal impact on the
biological material. New tools for funnel forming, combined with lower forming temperatures, currently provide the lowest
tungsten content, but alternates are needed, as this would improve stability by eliminating the potentially detrimental tungsten–protein
interaction. Further understanding of product–container interactions is also required to ensure hydrolytic resistance of the
syringe to prevent delamination, an issue in recent product recalls seen in the market.
PREFILLED-SYRINGE MARKET DYNAMICS
To understand prefilled syringe growth, we look to external expertise from companies such as IMS and Frost and Sullivan. These
sources generally agree that the US market is growing at twice the speed of the European market. According to IMS data on
prefilled syringes and pens (IMS MIDAS injectables data 2003–2009), the share of total injectable volume is roughly the same
in the US and Europe (top five countries) at 20% and 18%, respectively. The market for prefilled syringes has been growing
at 10% and 5.5% in the US and the European Union, respectively, from 2003 to 2009. At the same time, the overall injectable
volume (excluding vaccines) has been growing at 6% in the US and 2.5% in Europe.
Both regions have expressed the same desire to have readytouse delivery systems, such as prefilled syringes, widely incorporated
into healthcare systems. However, economic uncertainty and related budgetary austerity measures are in place in both the US
and Europe, and it is not immediately clear what impact, if any, these factors will have on the adoption rate of prefilled
syringes or other preferred methods of drug delivery.
The world market outlook from 2010 to 2025 shows a range of therapeutic agents—vaccines, insulins, analogs, and other biologicals—driving
growth in the injectable and prefilled syringes sector. Important innovations will include advances in liquid formulation
technology that enable protein drugs to be stable, as well as liquid prefilled packages and developments that enable the simple
and cost-effective production of lyophilized formulations.
In the author's opinion, several factors will converge that ultimately impact the prefilled syringe market:
- The trend towards development of longer acting therapies will reduce the volume of prefilled syringes required.
- Scarce economic healthcare resources may contribute to a slowing rate of adoption of readytouse delivery systems. Prioritizing
relevant therapies in these delivery systems will also increase.
- Innovation and technical requirements relative to the potential for glass incompatibility with biologics could result in a
volume shift between glass and plastic, without an expansion of the overall market.
- Legislation will be an important driver in the demand for prefilled syringes, and it will be interesting to see what effect
EU laws designed to reduce needlestick injuries have on the availability, pricing, and share of doses delivered in prefilled
syringes.
n Lastly, in Europe, glass syringes are considered to be a pharmaceutical component of the prefilled syringe, whereas the
US FDA mainly regulates prefilled syringes under pharma product regulations. As such, for Europe, the glass supplier is the
starting point in the production chain. It will be interesting to see what future developments hold for the glass-syringe
suppliers, and whether this leads to shared responsibility with pharmaceutical companies for a drug's integrity and efficacy.
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