The pre-filled syringe (PFS) market is growing fast. Valued at $4.5 billion in 2022, the global market is on track to be worth $5.53 billion by 2029, with a compound annual growth rate (CAGR) of 2.9 percent throughout the forecast period.¹ Packaging is set to have an important part to play in the sector’s success in 2024 and beyond.

Many innovations are expected to move into the mainstream of PFS packaging design to support improvements in a variety of areas. These include solutions to enhance useability for even more convenient self-administration by patients, initiatives to comply with legislation to address counterfeiting to boost patient safety, and new materials to support sustainability.

However, adopting new PFS packaging can be a challenge for many pharmaceutical companies, and for smaller drug developers in particular. The capital expenditure required to upgrade manufacturing lines, combined with potential uncertainty about selecting the right solutions for the needs of the treatment can make it daunting to harness new technology.

With this in mind, close partnerships with experts who specialize in PFS packaging will be crucial if pharmaceutical companies want to thrive in 2024 and beyond.

PFS revolutionizing self-administration

Traditionally, self-administering injectable medicines has been challenging for patients. From the inconvenience of manual syringe preparation to the risk of medication errors or contamination, these hurdles can significantly impact patient well-being.

Recognizing the importance of patient-centric solutions to make self-administration viable, the pharmaceutical industry has invested extensive research and development efforts into creating an optimal user experience in recent years. The PFS is one of the outcomes of this work.

PFS has vital advantages compared with the traditional vial and syringe. As the syringe comes already charged with a single dose of the drug product, under- or over-dosing is no longer a risk, making it safer and more convenient for the user. This makes PFS far more suitable than traditional syringes for self-administration by the patient in their own home, freeing them from the inconvenience of having to travel to the clinic.

The role of secondary packaging

However, for the PFS to live up to its full potential, the right packaging is vital to ensure patients have everything they need to administer their treatment correctly and safely.

More than just attractive wrapping or a means of storing and transporting the required doses of treatment, packaging has always been a key way to safeguard the integrity of medicines while also enhancing convenience for users and supporting patient compliance.

Safeguarding medicine integrity

Packaging adds value to PFS self-administration by optimizing safety across a number of areas:

•  Ensuring patient safety from criminal activity: Counterfeit drug products pose a significant threat to the sector, risking patient safety and undermining the integrity of the global supply chain. Seizures of counterfeit drugs in 2021 increased by 101% compare to the previous year.² With this in mind, pharmaceutical companies face a pressing need for robust solutions to combat counterfeit drugs. One way to do this, championed by many governments through legislation, is for unique identifiers to be added to drug product packaging to support improved serialization and prevent falsified medicines from entering the supply chain. Serialization has been a comprehensive means of ensuring the authenticity and traceability of pharmaceuticals throughout the supply chain, from the factory to the patient, for over a decade. Legal frameworks are in place in key markets, such as the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), phase II of which is now in force.

•  Optimizing stability and shelf life: Secondary packaging helps to protect the primary packaging—and, therefore, the product within—from breakage and exposure to the environment. In addition, with the advent of biologics—and their unique sensitivity to environmental factors—there is increased demand for temperature-controlled transit to ensure that the product remains stable until it reaches the patient. As a result, the global pharmaceutical cold-chain logistics market is estimated to grow by $11.6 billion from 2022 to 2027, with a CAGR of 9.51% during the forecast period.³ Any temperature excursions experienced by such products could shorten their shelf life, resulting in them being unviable or even dangerous by the time they reach patients. With this in mind, steps need to be taken to minimize the risk of temperature anomalies. Smart packaging can be used to monitor external temperatures for these therapies, helping to prevent temperature excursions. As a result, packaging can help ensure formulation stability and maximize the shelf life of a product even as it is transported long distances to reach the patient.

Supporting convenience

In addition, secondary packaging can support greater convenience and comfort for patients self-administering the medication in many ways, such as:

•  Boosting useability: By enabling efficient kitting processing—to include vital additional materials, such as swabs or replacement needles, usage instructions and other information—the right secondary packaging can support efforts to enhance the useability of the PFS. All this can help extend the number of injectable treatments that can be self-administered by patients.

•  Clear labelling and easy-to-read instructions: To prepare the PFS, inject themselves safely and comfortably, and dispose of the device afterwards, patients need clear, straightforward instructions in their language that they can understand and follow.

•  Enhancing safety for children and vulnerable demographics:  As the prevalence of self-administration of injectables rises, so does the risk that children may come into contact with drugs that may be hazardous to their health. Young children in particular, are curious about the world around them and use their hands and sense of taste to explore. Child-proof secondary packaging can prevent vulnerable young people from accessing potent products that are not intended for their unsupervised use.

Innovations supporting greater patient centricity and safety

However, these are not the only possible benefits of secondary packaging for PFS. The industry has increasingly recognized that packaging can do so much more to further enhance and refine the patient centricity of PFS treatments.

Thanks to advances in technology, innovations in secondary packaging are becoming mainstream and can be expected to be a key focus for new PFS products over the next 12 months.

Smart labels to enhance serialization and support compliance

Compliance with the increasingly stringent serialization regulations in the U.S. and the EU is a challenging prospect for many companies in the pharmaceutical industry. Companies need to be able to harmonize and integrate their data with those of their suppliers to support the traceability of each product unit. They need to find ways to further improve collaboration with supply chain partners while optimizing cost and time efficiencies.

New developments in product packaging have the potential to provide a solution to these issues in 2024. Smart labels containing radio-frequency identification (RFID), or near-field communication (NFC) technology, can be added to pharmaceutical product packaging. These can carry more information than traditional labels, supporting the latest serialization regulatory requirements. Moreover, they are easier to scan during transport as they don’t need to be near the reader. Supporting efforts to harmonize data systems across the pharmaceutical supply chain, smart labels have the potential to reconcile serialization compliance requirements with efficiency. The industry will likely see more smart labels being used in PFS packaging in the future. 

New tamper-evident seals optimizing patient safety from counterfeiting

Linked to counterfeiting, tampering is another risk to patient safety. Tampering can encompass the opening of packaging to change the product within it for a substandard alternative, or the changing of labels or serial numbers to falsify the chain of custody of a medication. Some 13.6% of medicines in low- and middle-income countries are estimated to be substandard or falsified.⁴ The percentage increases to 19.1% for antimalarials.⁵ Patients risk not receiving life-saving medication and if they become ill from counterfeit therapies falsely marketed under a respected brand name, the company could find their reputation at serious risk.

Since February 2019, most prescription medicines and some over-the-counter medicines supplied in the EU are required to have an anti-tampering device on their outer packaging in addition to a unique identifier.⁶ These can be blister packs (for oral solid dose products), perforated caps on liquid products or foil stickers across secondary packaging closures to demonstrate they have not been opened.

Ongoing innovation in this area over the next 12 months and beyond will create new solutions to eliminate the possibility of these devices being altered without the change visible to patients, all while making them more efficient to install during filling and packaging.

Temperature-sensitive packaging to support cold chains

Advances such as smart labels will become more common over the next year or so to support pharmaceutical companies in monitoring the temperature and conditions experienced by each product unit in real time as it is transported through the supply chain.

Smart labels contain processor cores that enable real-time monitoring of the temperature near the product unit. These cores can then send the data to nearby receivers to be fed to a central database. This will enable companies and their logistics providers to identify any units that have experienced a temperature excursion so they can be disposed of safely. The system will even be able to provide data to support companies and their partners in understanding the root cause of an excursion so it can be prevented from happening in the future.

Kit innovations will support greater useability for vulnerable patients

Further developments in kit packaging—and the manufacturing equipment to support kitting—will allow the inclusion of new components and accessories to make PFS even easier to self-administer, even for patients with manual dexterity issues.

Alternative, more ergonomic PFS grips can be packaged within a kit, providing more options for patients to help them find the right grip to administer their treatments effectively and with minimal discomfort. Alternative grips will be particularly beneficial for older users with dexterity issues, helping them feel more confident about administering the treatment themselves and giving them more independence and autonomy.

The power of strategic partnerships

These are just some of the innovations in PFS secondary packaging that can be expected to become mainstream in 2024 and in the near future.

It can be daunting to harness new technologies for the first time. The capital expenditure required to purchase and install new equipment can be a significant hurdle for a pharmaceutical company operating on its own.

With this in mind, it is to be expected that increasing numbers of pharmaceutical companies will form strategic partnerships with expert contract packaging organizations (CPOs). In doing so, they will be able to harness the latest innovations in packaging to ensure the ongoing success of their therapies. Such relationships will shape the future of the industry, helping to deliver efficiency and better patient experiences.

CPOs are well equipped to help the industry adopt innovations supporting the launch of increasingly patient-centric and complex dosage forms. They already have the infrastructure and capacity to enable customers to carefully fill and seal high volumes of PFS in a sterile environment, meaning customers don’t need to invest in the equipment themselves. This ensures that companies remain compliant with stringent regulatory requirements—such as Annex 1 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use—while providing patients with safe, high-quality, and convenient products.⁷

More than this, CPOs’ unique role in the supply chain means they can offer pharmaceutical manufacturers expert insight into the unique packaging needs of their products. They can also provide the flexibility and the capacity needed to develop customized packaging services that can add real value for customers, benefiting their partners over the long term.
Partnerships between pharmaceutical companies and packaging providers can result in improved branding and promotion of products. CPOs can help companies create packaging designs that resonate with their target audience, effectively communicating product benefits to help them stand out in the marketplace.

Time to find the right partner

Success for any pharmaceutical product depends on effective coordination between the pharmaceutical company and packaging providers from the very early stages of product development. For a dosage form as complex as a PFS—with its complicated secondary packaging needs—this early collaboration is even more crucial, especially if companies want to benefit from new patient convenience and supply chain security advances in 2024.

By working together from the beginning of a project, manufacturers and CPOs can combine their expertise to optimize the cost- and time-efficiency as well as the sustainability of packaging designs and streamline time-to-market. If more companies take this approach in 2024, increasing numbers of patients will benefit from the performance of new treatments—enhanced by more effective packaging solutions—faster than ever before.

References
1. https://www.marketreportsworld.com/TOC/23793024
2. https://www.psi-inc.org/incident-trends
3. https://finance.yahoo.com/news/cold-chain-logistics-market-pharmaceuticals-000000427.html
4. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2696509
5. https://www.who.int/features/factfiles/malaria/en/
6. https://www.ema.europa.eu/en/news/new-safety-features-medicines-sold-eu
7. https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf