Pre-filled syringes (PFS) offer plenty of advantages for injectable drug formulations, but also have challenges ranging from sterile integrity requirements to packaging. Robert Fielders, Director, Engineering at Recipharm, presents the benefits that the PFS format gives the pharmaceutical industry and patients and provides advice to solve the common challenges associated with PFS filling and packaging.
The PFS format is increasingly being used for the administration of medicines, with benefits for dose accuracy, ease of use, and reduced patient risk. This is reflected in the rapid growth of the international PFS market, which is expected to be worth $6.5 billion by 2030, up from $3.6 billion in 2021.1
Multiple drivers are contributing to PFS market growth:
Growing Demand for Injectable Biologics and Biosimilars
The biologics market is set to be worth $900 billion by 2030.2 Demand for injectables has grown as a result of the rise in chronic conditions, such as autoimmune diseases or cancers. Biologics are often more selective than conventional medications in targeting the disease-modifying facets of human physiology. Many of these target the immune system, making them prime therapeutics to treat many immune-related chronic diseases. Biologics are often developed for parenteral administration to increase bioavailability as they are often broken down by oral administration. An injectable format that offers patient convenience benefits is highly desirable for treating chronic conditions, and can help therapies stand out in a competitive market.
Planning for Future Pandemics
The global COVID-19 vaccination programme to protect patients from potentially fatal virus symptoms required fast action from the pharmaceutical industry and from governments too. Although the vaccination campaign was highly successful, it flagged areas for improvement. At the time vaccine products needed to be manufactured and delivered efficiently and in high volume using vials to contain multiple doses. A disadvantage to this approach was the patient turnover time at vaccination centres. Each patient required a syringe to be prepared and filled from a vial, adding a cumulative time impact, which restricted the number of vaccinations that could be performed within a day.
There are lessons to be learnt from COVID-19 for future outbreaks or for seasonal flu vaccination programmes. In particular, there needs to be better infrastructure in place to speed up the administration of vaccines to the general public. Learning from the pandemic is crucial and an injectable format that can simplify the vaccine administration process can significantly speed up the turnover of patients, allowing more people to be vaccinated each day. Ready-prepared injectables, like PFSs, also have the potential to enable self-administered vaccination for tourists against tropical diseases.