Embracing Innovation to Meet the Future Packaging Needs of a Growing Biologics PFS Market

The pre-filled syringe (PFS) market is growing rapidly, driven by the rising need for innovative biologics and a desire for self-administration treatment options offering greater convenience. This increased demand for PFS is fuelling innovation in mainstream packaging design to support advancements aiding both useability and patient safety.   

However, supporting the PFS packaging needs of the expanding biologics market comes with many challenges. These include carefully selecting the right packaging solutions for each project and potentially committing considerable capital expenditure to upgrade manufacturing lines. As a result, adopting new PFS packaging and harnessing new technologies could be a daunting task, particularly for smaller biologics developers. 

In this article, Geert Vleugels, General Manager NL, Tjoapack, examines the driving forces behind PFS packaging innovations and highlights the need for partnerships with packaging experts to provide more patient-centric and safe therapies to patients. 

The Rising Demand for PFS in the Biologics Space 

Over the past decade, the injection market has rapidly evolved, with demand for PFS, as opposed to traditional syringes, steadily increasing over several years. Between 2022 and 2023, the global PFS market expanded from $6.39 billion to $7.29 billion at a compound annual growth rate (CAGR) of 14.0%. By 2027, this market is anticipated to reach a value of $12.19 billion, with a CAGR of 13.7%. 

Two key areas are driving the rising demand for PFS drug delivery: 

1. The expanding biologics market  

Since their introduction, biologics have continued to transform a wide variety of therapeutic areas, including dermatology, immunology, endocrinology, ophthalmology and oncology. With a growing demand for innovative therapies and the rising burden of chronic diseases, biologics now constitute approximately 44.7% of the drug development pipeline. This percentage is predicted to continue to grow, with the global biologics market size expected to rise from $348.03 billion in 2022 to $620.31 billion in 2032, at a CAGR of 6%. 

The loss of patent exclusivity of the leading biologic drugs is also fuelling the expansion of the biosimilars markets. As of December 2022, the U.S. FDA has approved 40 biosimilars. With many blockbuster biologics set to come off patent by 2030 — including AbbVie’s anti-inflammatory treatment Humira and Merck & Co.’s top-selling cancer medicine Keytruda — the biosimilars market is also expected to rapidly expand.  

Due to their sensitive nature, biologics are typically administered parenterally and not orally to avoid the harsh conditions of the gastrointestinal tract and first-pass metabolism. As a result, most biologics are still delivered via injection. Consequently, the biopharma industry is seeing greater demand for new packaging solutions for injectables.  

2. A need for self-administration options 

Treatment options enabling self-administration can help improve patients' well-being by giving them the confidence to manage their health and freeing them from the inconvenience of frequent travel to the clinic.  

However, self-administering injectable medicines has not always been easy for patients, with difficulties involved in manual syringe preparation and the potential risk of contamination or other errors.  

The pharmaceutical industry has invested extensive research and development (R&D) efforts to create an optimal user experience and realise the potential of self-administration.  

One outcome of R&D efforts in the pharmaceutical industry has been the PFS. This revolutionary device comes already charged with a single dose of the drug product, helping to prevent under- or over-dosing, and ensuring both patient safety and convenience. 

Drug developers have increasingly harnessed PFS in the delivery of a wide variety of biologics. Research on the global PFS drug molecules market indicates that among drug classes, vaccines will lead the market with a projected rev­enue of over $23 billion by the end of 2027 while insulin will have a higher growth rate. With this rising demand, PFS have consequently become the primary alternative to multi-vial solutions for biologics, as well as small molecule drugs. 

Secondary Packaging Supporting the Rising PFS Need for Biologics 

Packaging has always been essential in safeguarding the integrity of medicines while enhancing ease of use and supporting compliance. It is vital for biologics leveraging PFS to have the right packaging to ensure safe and correct administration for patients and to enable this delivery system to live up to its full potential.  

By embracing packaging innovations, drug developers and manufacturers can overcome future challenges to continue to meet patients’ PFS needs with agility and flexibility. As we look to the future, meeting the needs of biologics relying on PFS will require further advances in technology in the secondary packaging space in several ways: 

Protecting the Stability of Sensitive Biologics 

With rising numbers of biologics in the pipeline, developers and manufacturers must ensure their secondary PFS packaging protects against breakage of the primary packaging and prevents the potential exposure of these sensitive drugs to the environment. Many biologics, including vaccines, require temperature-controlled transit to ensure the product remains stable, safe and efficacious until it reaches the patient.  

As we look to the future, biologics producers will embrace technologies such as smart labels containing radio-frequency identification (RFID) or near-field communication (NFC) to minimise the risk of temperature anomalies. These innovative technologies can be added to product packaging to monitor the conditions and temperatures each product unit experiences in real time as it is transported through the supply chain. With processor cores that enable real-time monitoring of the temperature near the product unit, smart labels can send the data to nearby receivers to be fed to a central database.  

As a result, pharma companies leveraging smart labels will be able to identify any units that have experienced a temperature excursion for safe disposal. They also provide data allowing companies and their partners to understand the root cause of an excursion to prevent it from happening again in the future.  

Enhancing Patient Convenience and Useability 

Self-administration of biologics is an established therapeutic option for a wide variety of conditions, including rheumatologic, immunologic, neurologic, dermatologic, gastrointestinal, and endocrine diseases. As the demand for self-administration treatment options rises, secondary packaging will be integral in providing greater convenience and comfort for patients receiving biologic therapies. 

The right secondary packaging will support efforts to enhance the useability of the PFS by including vital additional materials, such as replacement needles or swabs, usage instructions and other information. For patients to prepare the PFS, inject themselves comfortably and safely, and then dispose of the device, the instructions included as part of the secondary packaging must be easy to read and understand.  

Looking ahead, further developments in kit packaging — and the manufacturing equipment to support kitting — could make self-administration with PFS even easier. Packaging alternative, more ergonomic PFS grips within a kit could for example provide more options for patients to help them find the right grip to administer their treatments effectively and with minimal discomfort.  

By enabling the inclusion of new components, accessories, and alternative grips, even patients with manual dexterity issues could see enhanced useability, helping them to feel more confident while giving them more independence and autonomy. 

Protecting Against Criminal Activity 

Counterfeit drug products pose a significant threat to patient safety and undermine global supply chain integrity. In 2021, seizures of counterfeit drugs increased by 101% from the previous year, resulting in a pressing need for more robust packaging solutions to prevent drug counterfeiting.  

Serialisation provides a comprehensive means of ensuring the traceability and authenticity of drug products throughout the supply chain. However, compliance with increasingly stringent serialisation regulations in the US and the EU is a challenging prospect for many companies in the pharmaceutical industry.  

Biologics developers and manufacturers will increasingly rely on smart labels to support serialisation while preventing falsified medicines from entering the supply chain. Carrying more information than traditional labels, smart labels support the latest serialisation regulatory requirements, furthering efforts to harmonise data systems across the pharmaceutical supply chain. They are also easier to scan during transport as they do not need to be near the reader.  

Preventing Tampering 

Tampering is another risk to patient safety and can involve falsifying the chain of custody of medication through the changing of labels or serial numbers or opening of packaging to change the product within it for a substandard alternative. It is estimated that 13.6% of medicines in low- and middle-income countries are substandard or falsified .  

Patients risk not receiving critical medications if they are tampered with. If patients become ill from consuming counterfeit medicines, the company’s reputation could also be at serious risk.  

Most prescription medicines and some over-the-counter drugs supplied in the EU are already required to have an anti-tampering device on their outer packaging and a unique identifier. These can be in the form of: 

• Blister packs for oral solid dose products 
• Perforated caps for liquid products 
• Foil stickers across secondary packaging closures  

With ongoing innovation focusing on finding new solutions to eliminate tampering that might not be immediately visible while making them more efficient to install throughout filling and packaging, biologic PFS will be safer for patients in the future.  

Facilitating Innovation Through Strategic Partnerships 

Harnessing new packaging technologies for the first time can be a daunting task, with significant capital expenditure needed to purchase and install new equipment. Due to the complexity involved, more biopharma companies are looking to CPOs for support in leveraging the latest packaging innovations. 

Forgoing the need to invest in equipment, biopharma companies can rely on CPOs with the infrastructure and capacity to fill and seal high volumes of PFS in a sterile environment. This also helps to ensure compliance with stringent regulatory requirements such as Annex 1 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 

Additionally, CPOs can offer biopharma manufacturers expert insight into the unique packaging needs of different products, leveraging their unique role in the supply chain. Providing value for their partners in the long term, CPOs can also ensure the flexibility and capacity needed to develop customised packaging services. 

By working together from the onset of a project, CPOs and manufacturers can combine their expertise to optimise cost and time efficiencies. A collaborative approach also promotes improved packaging design sustainability and can enable a streamlined time-to-market.  

The Future of Biologic Secondary Packaging 

In the rapidly growing biologic PFS market, packaging is set to play a vital role in the sector’s success for years to come. With many innovations anticipated in the PFS packaging space supporting improvements in useability, convenience of self-administration and safety, embracing advancements is more important than ever.  

Helping to overcome the challenges of adopting new PFS packaging, CPOs are enabling their customers to avoid the considerable capital expenditure needed to upgrade manufacturing lines while providing expert insight and efficiency. 

Close partnerships with experts who specialise in packaging will be crucial for pharmaceutical companies to thrive as we enter a new era of PFS therapeutics.