Christy Eatmon, global subject matter expert, steriles, Thermo Fisher Scientific explores how to meet the growing demand for prefilled syringes.
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The pharmaceutical industry has always been resolutely focused on getting safe and effective therapies to patients in need and, with that, meeting a growing demand for therapeutics that are also easy to administer. Healthcare providers and patients alike are seeking more convenient methods to gain the positive outcomes experienced with medications historically delivered via less patient-friendly technologies, particularly those that require very frequent dosage or professional administration. Enabled by technological advancements, innovative drug delivery devices – such as prefilled syringes – are gaining increasing popularity.
Leading the way with prefilled syringes
The COVID-19 pandemic put a spotlight on prefilled syringes when a medical technology company switched their drug formulation from liquid vials to prefilled syringes, to help overcome the complexities of ultracold vaccine storage and administration. In tandem, the industry has seen a steady increase in biologic drug approvals, with the U.S. Food and Drug Administration (FDA) signing off on an average of 14 new biologic drugs each year since 2023. With the rise of popular GLP-1 medications delivered via sterile injectable technologies, such as Ozempic and Wegovy, pharmaceutical companies are prioritising bringing these weight loss medications to market in a self-injectable format that’s more accessible for consumers.
Today, the global prefilled syringe market is rapidly growing. According to a recent market analysis, it’s estimated to hit $9.71 billion in 2025 and to reach $16.44 billion by 2030, at a compound annual growth rate (CAGR) of 11.11%. In addition to a robust pipeline of biologic and biosimilar therapies, that growth is driven by technological advancements that allow pharmaceutical companies to manufacture highly concentrated biologics with reduced injection volume. These drug delivery formats allow for daily or weekly dosing, furthering the industry’s goal of creating patient-centric solutions.
With such high demand and key drivers behind today’s market, pharmaceutical companies must stay focused on supply chain management, regulatory considerations, cost, product safety and quality to continue meeting expectations and patient needs. Strategically choosing a partner to help bring technologies like prefilled syringes to market with a carefully coordinated approach can significantly accelerate the journey of delivering new medications to patients around the world.
Creating end-to-end efficiencies that improve manufacturing timelines
Choosing a contract development and manufacturing organisation (CDMO) partner with extensive experience, formulation development capabilities and manufacturing facilities where fill, automated inspection and device assembly happen under one roof can improve timelines and reduce costs. When both development and production happen in one facility, it’s significantly easier to transfer technology that supports filling, manufacturing, assembly and packaging. This way, pharmaceutical companies can maximise batch size, optimise cycle times by manufacturing concurrently, assemble and package per stock keeping unit (SKU) and streamline functional testing and packaging release.
Working with a CDMO also allows pharmaceutical companies to manage the ebbs and flows of global supply chains by leveraging demand planning and forecasting expertise. Not only do multiple production lines offer increased flexibility to adjust production according to demand, but pharmaceutical companies gain the ability to scale with limited additional investment. Additionally, many lines and facilities may use the same components, such as vials, stoppers, over seals and filters. Maintaining a stock of the most common materials increases efficiency and can decrease risk, not only in terms of process but also with potential supply chain challenges.
Utilising experience with a wide variety of componentry also reduces timeline and technical risk. It’s highly valuable for biotech and biopharma companies to partner with a CDMO able to provide end-to-end manufacturing within one network or even one site. Then, for example, a drug substance may be filled into syringes, inspected, packed and labelled all within the same facility – greatly improving efficiencies. Such a process flow can decrease timelines by eliminating shipments and driving better cross-functional collaboration, since filling and packaging occur within the same facility.
Improving yield and scaling for continued growth
Of the many factors at play when developing a new drug product, cost and development time remain the most significant – and require flexibility to account for adjustments at various points throughout the drug development process. When cost of production is the lead priority, for example, some companies may choose to produce vials first before tackling prefilled syringe production, requiring the right partner to guide them seamlessly through that transition. When time is the main driver, partnering with a CDMO that prioritises innovation – such as incorporating next-generation technologies like artificial intelligence (AI) into workflows – can help speed up the manufacturing process and accelerate overall timelines to patients. For example, a study conducted at a pharmaceutical manufacturing size in Monza, Italy, showed that combining human expertise with an AI model for vial particle inspection reduced the rejection rate by 84%. The same technology could be applied to the inspection of prefilled syringes.
Other technologies, especially those leveraging automation, are also being introduced to enhance sterile drug manufacturing. High-speed and fully automated aseptic fill-finish lines can help improve both yield and efficiency. Simultaneously, CDMOs are focused on problem-solving key pain points associated with injectables, to increase the rate of success for their partners. For example, innovative glass packaging can reduce breakage and glass particulate contamination that pose common challenges during fill-finish manufacturing. Additionally, partnering with both machine and component vendors has allowed specific studies to improve run rates and reduce defects or line stoppages that relate to machinability of components. Trials can be performed with a range of components to show which combination runs best with the line. These trials help to create recipes more effectively and reduce line stoppage due to glass breakage, tipped vials and so on.
The decades of experience and a global network a CDMO brings to the table can take life-changing therapies from formulation through commercialisation with less rework and fewer costly delays. Especially with all eyes on high-demand technologies like prefilled syringes, these end-to-end capabilities can be the essential element in helping remove barriers in the drug development process and get new medications to patients faster. Whether working with biologics or mRNA, or formats from vials to prefilled syringe or cartridge fill-finish, a CDMO can advise on and navigate the journey of the best sterile dosage format for a molecule’s specific needs.
Pharmaceutical companies often need partner support to meet the scale required to optimise line operations and grow throughout the product lifecycle. By choosing a collaborator early on in the process, pharmaceutical companies can stay focused on doing what they do best: bringing life-changing therapies to patients in need.