Chemical Information Services, June 2014

According to the World Health Organization, 1.3 million people die each year from unsafe injection practices, including needle-sticks, blood born-pathogens, and reuse, sharing and unsafe disposal of syringes.

As more parenteral drugs come on the market— driven by the increase in biological drugs that must be injected into the body — it is important that improved safety measures accompany these medications. Technology is playing a part in improving injectable drug safety with the introduction of retractable safety syringes to prevent needle-sticks and pre-filled syringes—with or without retractable needles—to improve patient safety and compliance and reduce the likelihood of contamination at the injection site.

According to Visiongain’s report “Pre-Filled Syringes: World Market Outlooks 2011-2021,” pre-filled syringes represent one of the fastest growing markets in drug delivery and packaging, with total revenues in the market expected to reach $5.5B by 2025. This is in addition to offering one of the highest growth potentials in the biopharmaceutical industry, with 20% CAGR over the past five years. There is good reason for this growth as pre-filled syringes are arguably a win for all. They offer improved safety for the patient by mitigating dosage errors, healthcare providers have faster access to injectable medications in pre-measured doses, and manufacturers save money through reduced overfill wastage that occurs with vials. In addition to the healthcare benefits, pre-filled syringes also offer marketing differentiation for drug makers.

On average, regulatory scores among CMOs that offer pre-filled syringes were a point higher than the general CMO benchmark for regulatory, 75% vs. 74%.

Twenty CMOs included in Nice Insight’s annual research offer services for pre-filled syringes. We reviewed how the market perceives these brands with respect to the six outsourcing drivers and learned that their strengths lie in regulatory and productivity categories, which were ranked respectively third and fourth, in order of importance by buyers of CMO services.On average, regulatory scores among CMOs that offer pre-filled syringes were a point higher than the general CMO benchmark for regulatory, 75% vs. 74%. This bodes well for drug innovators concerned about the regulatory challenges that accompany the transition from vials to cartridges. And fortunately for outsourcers, sixteen of the twenty CMOs that offer pre-filled syringes also provide regulatory support. Productivity was the second highest scoring category for CMOs offering pre-filled syringes. Again, we found the average score among these CMOs to be one percentage point higher than the general CMO benchmark for productivity, 74% vs. 73%.Quality and reliability, which traditionally hold the first and second place rankings among buyers of outsourced services and tied for third place with respect to the scores among pre-filled syringe CMOs, were additional areas where these CMOs received higher scores than the typical, broader benchmarks. The average among the pre-filled syringe subset was 73% for quality, two percentage points higher than the CMO benchmark of 71%. There was also a single percentage point increase in the reliability benchmark between CMOs offering pre-filled syringe services and the broader grouping, 73% vs. 72% respectively.

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Innovation often holds sixth place among the outsourcing drivers when ranked by survey respondents, but when viewed from the perspective of CMO performance perceptions, it was ranked one place higher—in fifth. With an averaged score of 72% among CMOs that offer pre-filled syringes, the innovation score was the same as the broader CMO benchmark (72%). The pre-filled syringe subset also averaged the same score for affordability as the mainstream CMO benchmark, each at 69%. Affordability tends to be the lowest scoring category regardless of groupings (CMOs, CROs, and service or technology related subsets), which should not come as a surprise since drug innovators are consistently facing cost pressures and the overarching goal of reducing drug development expense.

In this instance, however, poor affordability may be a misconception of sorts, as pre-filled syringes have proven to be cost effective for several reasons, including the increased durability of plastic-base pre-filled cartridges over traditional glass products that may crack or break, as well as the reduced overfill when compared to vials. The logistics associated with distributing pre-filled syringes offer some cost benefit over traditional vials as well. For example, pre-filled syringes weigh less and take up less space, which saves on both shipping and storage. In addition to cost efficiencies for drug developers, patients save money by self-administering drugs instead of traveling to a doctor’s office or infusion center—another area where the pre-filled technology proves to be a win for all.