Primary packaging, such as vials, syringes, and cartridges, and their affiliated closures, play a vital role in ensuring the stability, and sterility, and thereby, the overall quality, efficacy and safety of a drug product. Moreover, the packaging bears the product label, which provides information related to the drug and, in certain cases, dosing instructions.[1] Pharmaceutical packaging is typically carried out under controlled conditions; specifically, for therapeutics that are designed for parenteral administration, fill / finish is carried out in sterile and aseptic environments. It is also crucial for innovators (or packaging service providers) to choose the appropriate, high quality primary packaging for their respective products; this is because the packaging material is in direct contact with the drug / therapy.[2] Building and maintaining the necessary expertise and infrastructure to support pharmacological fill / finish is a capital-intensive ordeal. Further, the growing complexity of modern pharmacological interventions, such as monoclonal antibodies, cell and gene therapies (which are typically produced in small batches) and the gradual (but imminent) shift to personalized therapies, has prompted drug developers to look for leaner manufacturing and packaging solutions. In this context, cost optimization is important and one of the available ways to save both time and capital is by bypassing manual processing and sterilization of primary packaging and switching to ready-to-use (RTU) formats.
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Pre-sterilized RTU container-closure systems have gradually become very popular and are widely used in the modern pharmaceutical industry. As indicated earlier, such components significantly simplify the overall fill / finish process, primarily by eliminating the need for several additional steps (such as washing, drying and sterilization), which were previously required to prepare primary containers for filling. In other words, using RTU components helps improve operational efficiencies.[3] In this context, it is worth highlighting that RTU packaging systems were in high demand during the COVID-19 pandemic, when novel vaccines and experimental therapies needed to be produced, and packaged for distribution in large quantities.[4] The surge in demand for appropriate packaging solutions in adequate quantities, is likely to persist, significantly adding to the opportunity for RTU package and affiliated closure developers / suppliers.
Presently, more than 150 pre-sterilized / RTU primary packaging systems, including cartridges, syringes and vials, as well as their respective closure systems are available worldwide. Majority (50%) of the pre-sterilized / RTU primary packaging systems are closures, followed by containers (34%) and container-closure systems (16%). It is worth highlighting that, of the total, 54 closures are suitable for use with vials, 19 are suitable for use with syringes and the remaining 5 are compatible with cartridges.
Amongst the primary packaging containers, vials and syringes emerged as the most common types of pre-sterilized / RTU containers manufactured by stakeholders engaged in this domain. This can be attributed to the fact that these containers are the most suitable for packaging of small volume of therapeutics, such as biologics, cell therapies, small molecules, vaccines and other potent products.
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Further, glass emerged as the most preferred fabrication material used for pre-sterilized / RTU containers. Of these, majority (83%) of the containers are made of type I borosilicate glass, followed by those fabricated using type II treated soda-lime glass (10%) and type III soda-lime glass (7%). This is followed by pre-sterilized / RTU containers fabricated using plastic (29%), primarily cyclic olefin polymer. Examples include (in alphabetical order) ClearVial (MedicoPack), Daikyo Crystal Zenith Insert Needle Syringe Systems (Daikyo Seiko), Daikyo Crystal Zenith Ready to Use Vials (Daikyo Seiko) and SCHOTT TopPac sensitive (SCHOTT).
Sterilization of primary packaging systems is considered to be an essential step in the overall healthcare manufacturing process as it deactivates various forms of contaminating agents (particularly referring to bacteria, fungi, protozoa and viruses). Majority (43%) of the pre-sterilized / RTU containers are sterilized using ethylene oxide, followed by those employing steam sterilization (34%).
Presently, close to 50 companies claim to be actively involved in the manufacturing of pre-sterilized / RTU primary packaging systems. The market landscape is highly fragmented, featuring a mix of small (less than 50 employees, 17%), mid-sized (51-500 employees, 37%), large (501-1,000 employees, 2%) and very large (more than 1,000 employees, 44%) companies. The pre-sterilized / RTU packaging manufacturers market is fragmented, featuring the presence of established players as well as new entrants, which are well distributed across different geographical regions. Examples of established players include (in decreasing order of experience) Gerresheimer (1864), Sartorius (1870), SCHOTT (1884), DWK Life Sciences (1887), SGD Pharma (1896) and Becton, Dickinson and Company (1897).
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