Marcelo Cruz, VP of business Development and Marketing at Tjoapack, explores the secondary innovations poised to revolutionise the patient centricity of PFSs over the next decade.
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The global prefilled syringe (PFS) market was worth $7.91 billion in 2023 and is expected to expand at a compound annual growth rate (CAGR) of 11.4% to reach $20.62 billion by 2032. Europe dominated the global market in 2023 with a share of 40.33%.
One of the key reasons behind the success of the PFS format is the improved patient experience it offers. Coming already charged with a single dose, the PFS allows patients the ability to administer a wide array of therapies themselves, in the comfort of the home, instead of requiring a professional in a clinical setting. As a result, PFSs enhance patient convenience and relieve a burden on healthcare providers’ limited human resources.
However, for the PFS market to continue to grow its market share over the next decade and beyond, further innovations will be needed to further enhance its patient centricity. Secondary packaging will be at the heart of this continued development, providing new ways to make PFS treatments more convenient for patients. Companies will need expert support to successfully integrate these packaging innovations so that they can continue to deliver the best possible treatments for vulnerable populations.
The challenge of patient centricity for injectable medicines
Historically, patients have faced significant challenges when self-administering injectable medications. Manual syringe preparation involves complexities that carry inherent risks of medication errors and contamination. Miscalculations during preparation can lead to compromised sterility or inaccurate dosages, potentially resulting in adverse reactions or undermining treatment efficacy. These issues emphasise the need for precision and safety in syringe preparation.
Recognising the need for patient-centric solutions to facilitate seamless self-administration, the pharmaceutical sector has invested substantial research and development resources into enhancing the user experience. The development of PFS represents a tangible outcome of these endeavours.
PFS offers significant advantages over the traditional vial and syringe approach. Prefilled syringes contain precisely measured single doses of medication, effectively mitigating the risks associated with under- or over-dosing. This feature ensures a safer and more convenient user experience, making PFS an optimal choice for patients who would otherwise need to visit a clinic for medication administration. By utilising PFS, patients can comfortably self-administer medication from the comfort of their own homes, eliminating the inconvenience of frequent clinic visits associated with traditional syringe methods.
Patient safety is a concern for PFS products, as much as it is for other formats. PFS must be able to ensure compliance with regulations designed to prevent drug counterfeiting and tampering. Drug counterfeiting poses a substantial threat to patient safety and the overall integrity of the global supply chain. Some 13.6% of medicines in low- and middle-income countries are estimated to be substandard or falsified. This statistic, coupled with a 19% surge in counterfeit drug seizures during 2023 compared to the preceding year highlight the urgent challenge confronting pharmaceutical companies.
Secondary packaging is key to overcoming these challenges and unlocking the potential of the PFS format in the future.
Secondary packaging at the core of future patient experience
To fully exploit the potential of PFS, suitable secondary packaging is vital. It guarantees patients have the necessary tools for accurate and secure treatment.
Beyond aesthetics or serving as a container for storage and transportation, packaging plays a key role in preserving medicine integrity, enhancing user convenience, and promoting adherence.
Maximising patient safety when administering PFSs
Packaging enhances the value of PFS self-administration by contributing to patient safety in several ways:
Tackling counterfeiting: Governments have implemented legal requirements for "serialisation" to combat drug counterfeiting. Unique identifiers on drug packaging prevent falsified medicines from entering the supply chain. Legislative frameworks like the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), phase II, establish the legal requirements for authenticity and traceability.
Maximising shelf life: Secondary packaging shields the primary packaging and the product from breakage and environmental exposure to ensure an optimal shelf life. New advancements in packaging design are crucial to maximising the stability and longevity of drug formulations. This is particularly important considering drug products may have to travel long distances across international borders, increasing the risk of breakage or temperature fluctuations.
Supporting convenience for patients
Secondary packaging also enhances convenience and comfort for self-administration by:
Boosting PFS user experience: The right secondary packaging facilitates efficient kitting, allowing for the inclusion of additional materials like swabs, replacement needles, usage instructions, and informative content. This improves PFS usability, expanding the range of injectable treatments that patients can self-administer.
Improving guidance for patients when administering treatments: Clear labelling and easily understandable instructions are crucial for patients to prepare, inject, and safely dispose of PFS. Providing straightforward guidance in the patient's language ensures a seamless self-administration process.
Optimising safety for vulnerable patient groups: With the rise of self-administration, the risk of children encountering hazardous drugs increases. Child-proof secondary packaging is essential, preventing unsupervised access and ensuring safety.
Expert support is key to harnessing new packaging technologies
Navigating the adoption of new packaging innovations can be overwhelming, especially considering the substantial capital investments required for equipment and installation. To address these challenges, more and more pharmaceutical companies are forming strategic partnerships with specialised Contract Packaging Organisations (CPOs).
These partnerships allow pharmaceutical companies to take advantage of the latest packaging innovations without having to make significant individual investments. These strategic alliances have the potential to reshape the industry, leading to enhanced efficiency and improved patient experiences.
Equipped with the necessary infrastructure and resources, CPOs play a pivotal role in supporting the industry's early, efficient, and effective access to innovations that facilitate the launch of patient-centric and complex dosage forms. Their expertise in meticulously filling and sealing large volumes of prefilled syringes (PFS) in sterile environments eliminates the need for pharmaceutical companies to invest in dedicated equipment themselves. This ensures compliance with rigorous regulatory standards, such as Annex 1 of the EU Guidelines for Good Manufacturing Practice, and guarantees the delivery of safe, high-quality and convenient products to patients.
Beyond providing instant access to appropriate infrastructure and capacity, CPOs offer pharmaceutical manufacturers valuable insights into the specific packaging requirements of their products. They provide flexibility and capacity to develop customised packaging solutions, adding tangible value for customers and establishing lasting partnerships.
Looking ahead
The PFS market, while poised for significant growth, faces future challenges. Companies must adapt to evolving patient needs and preferences, such as the demand for more user-friendly and self-administration-compatible products to ensure they remain competitive in an increasingly crowded pharmaceutical market.
Seamless coordination between the sponsor pharmaceutical company and packaging providers right from the initial stages of product development is key to successfully harnessing patient-centric packaging innovations. This alignment is imperative for a complex dosage form like a PFS, given its intricate secondary
By working together from the project’s inception, manufacturers and CPOs can combine their expertise to optimise not just packaging design, but also the manufacturing and packaging process. This can enhance cost-effectiveness and streamline time to market, all while providing patients with access to more patient-centric PFS products.