Marcelo Cruz, director of Business Development and Marketing at Tjoapack discusses the rising market of biologics and how it is affecting packaging.
Over the past few years, one of the key trends in the pharmaceutical industry has been the rise of biologics. As this exciting sector grows, it is having a significant impact on the wider pharma space, including the packaging market.
Biologics an engine of growth
The biopharma space is playing an ever greater role in the success of the pharmaceutical industry. Global sales of biopharma treatments hit a high of $300 billion this year, rising at an annual rate of 12%, and they show no signs of losing momentum any time soon. This impressive performance is feeding into the wider pharma boom, with the industry as a whole expected to reach a value of $1.5 trillion by 2023.
The increasing demand for biopharmaceuticals in recent years is a result of the growing use of monoclonal antibodies for treating a wide range of chronic diseases, from auto-immune conditions, to cancer, to diabetes. Ageing populations in North America and Europe, as well as poor diet and environmental pollution in a number of emerging economies, are driving a major increase in diagnoses of such illnesses, meaning we can expect the prescriptions of biologic treatments to also increase as we move forward.
Driving drug delivery trends
The new demand for biologics isn’t affecting only biopharma companies, though. Its success is having a knock-on effect on other areas of the pharmaceutical space, driving new trends in drug delivery which, in turn, impacts on the packaging arena.
The biologics boom has led to a similar increase in the popularity of parenteral delivery in particular. In fact, as a result of the growing use of biopharma treatments, the injectables sector is forecast to be worth $624.5 billion worldwide by the end of next year – double its value in 2016.
There is a simple reason why growth in the biologics sector and growth in injectable delivery go hand in hand in this way. For many biopharma treatments, the only currently effective delivery mechanism is injection. As such, the success of the former necessarily drives the success of the latter
Injecting patient-centricity into biologics
However, traditional injectable dosage forms have a key drawback – they are not the easiest for patients to use.
Useability is a key challenge for injectable drug developers. Patients need to be able to administer the drugs themselves easily, outside of the clinical environment, and ensure they take their treatment at the right frequency and dose.
As such, an easy-to-use drug can maximise the effectiveness of the treatment and, in doing so, can relieve pressure on healthcare systems by minimising the need for chronic patients to be seen by doctors.
With this in mind, it is necessary for drug companies to consider injectable options to make their biologic treatments as patient-centric as possible. A host of companies have invested considerable time and funding in developing new delivery systems designed to support easier self-administered injections at home and even on the go.
A major step forward in delivering solution to this conundrum is the pre-filled syringe. As the name suggests, they come ready-filled with exactly the right amount of treatment for a single dose, allowing patients to administer their medication themselves without having to measure anything out. In doing so, they save patients time and safeguard against the consequences of over- or under-dosing.
Harnessing the power of pre-filled syringes can help drug companies improve patient-centricity to stay ahead of the competition. However, adopting pre-filled injectables does pose challenges when it comes to production and packaging that need to be overcome if manufacturers want to maintain the highest level of efficiency.
Pre-filled packaging challenges
Pre-filled injectable products have highly complex requirements when it comes to producing and packaging those manufacturers need to bear in mind for their production lines. Pre-filled syringes in particular require a clean environment throughout the production and packaging process in order to protect the health and wellbeing of the patients using them. Equipment and standard operating procedures capable of maintaining the highest sanitary standards through the entire manufacturing process are vital.
In addition, it is often the case that manufacturers must follow extra safety precautions when handling pre-filled biologic treatments throughout the production process. This is because the products involved are generally more complex than those in other dosage media. As such, they often require unique handling to cater for temperature parameters, exposure to oxygen and so on to ensure both the safety and efficacy of the product.
On top of this, pre-filled syringes often have a higher number of components that need to be included in final kits. A syringe may be accompanied by a staked needle, for instance, a loose needle, or even a safety device, depending on the nature of the treatment it contains. This device may feature a finger flange, or simply have a backstop. The only components that consistently feature are the plunger rod and label. Manufacturers may need to include other inserts, such as alcohol pads for sterilizing the skin prior to administration, or information leaflets in the secondary packaging to provide patients with guidance on using the syringe. Hence when it comes to packaging pre-filled syringes it’s not a one size fits all solution.
All of these complex requirements present a major challenge for manufacturers. Many don’t have the capabilities or the flexibility in-house to adapt their production lines to address these issues.
Outsourcing to overcome obstacles
In light of these complex packaging requirements, many manufacturers are rethinking their operations to ensure they are able to meet demand for pre-filled injectables. More and more, they are turning to outsourcing as a solution.
Traditionally, packaging has been considered a small rather insignificant part of the pharmaceutical production process. As a result, companies have often outsourced it to contract development and manufacturing organisations (CDMOs) bundled in a broader end-to-end service.
Increasingly, however, CDMOs do not have the specialised processing capabilities or the line capacity to meet the complex packaging needs of products such as pre-filled injectable treatments. To fill this gap companies are turning to specialist contract packaging organisations (CPOs) that can support drug companies in meeting the needs of their customers while reducing cost and enhancing production efficiency.
CPOs are uniquely placed to provide the industry with support. They have comprehensive expert knowledge about the injectables market, the regulatory environment and the unique processing needs of injectables. In addition, due to the nature of their role in the supply chain, they can offer the flexibility and the capacity to meet every customer’s needs. As a result, they can develop a customised packaging service that can add real value to customers, benefiting their business over the long term.
Whatever the specific kitting requirements of the prefilled biopharma treatment, CPOs will be able to provide a packaging service solution that maximises efficiency and output while also delivering optimum quality control. Meaning their relationships with customers is starting to move beyond simple transactional services, towards becoming an integral strategic partner that can help pharma companies deliver even better products for patients.
Ensuring chain of custody
CPOs are not only capable of providing support in scaling up the packaging process for pre-filled syringe products, they can provide other key benefits to deliver even more value for customers, as well as for end-users.
In particular, biologic therapeutics have special handling requirements that mean stringent chain- of-custody integrity must be ensured throughout the transport process from the end of the production line all the way to where the patient takes possession of the packaged product.
CPOs are well placed to provide manufacturers with this support and to tailor their offering to account for differing market requirements. Whether drug companies require vial labelling, re-labelling or over-labelling, serialisation for single or multipacks, or even inventory control, CPOs can help, providing customers with the solutions they need. Moreover, they can deliver cold-chain packaging and storage support, to help companies maximise their products’ shelf-life and protect the health of patients.
Collaboration key to continued biologics growth
Given their unique benefits when it comes to treating serious chronic diseases like cancer, it is not surprising that biologic treatments are slated to enjoy incredible growth well into the next decade.
To ensure it meets predicted growth the industry needs to ensure its treatments continue to be safe and meet the administration needs of users. Packaging is central to achieving this goal, provided the right solutions are used for the needs of the medicine.
With this in mind, it is crucial that drug companies collaborate with experts in injectables packaging. By working with CPOs, companies can ensure they benefit from specialist knowledge about handling the complexities of injectable biologic treatments and enjoy innovative supply chain management support, enhancing efficiency and maintaining regulatory compliance. As a result, they can be confident their drugs will continue to offer patients the best possible experience well into the future.