Pharmaceutical packaging is a multifaceted segment, providing essential protection for the important and sensitive materials housed within, while also delivering key information and advertising to patients. According to market research, the pharmaceutical packaging sector is expected to grow at a compound annual rate of 7.4% between 2022 and 2031, reaching an estimated $178.8 billion by the end of the forecast period (1).
Factors driving the growth of the pharmaceutical packaging market include a developing preference for single-dose packaging formats, a rise in drug development in general, and the growth of e-Commerce (1). Obviously, the COVID‑19 pandemic has impacted the whole bio/pharma industry, but given the rapid approval of the therapies to tackle the virus, such as the messenger RNA (mRNA) vaccines, drug packaging very quickly became a priority issue.
Pandemic impact
“During the pandemic, new drug categories and more precisely mRNA drugs entered the market in record-breaking time,” confirms Andreas Reisse, executive vice-president of SCHOTT Pharma. “The new drugs played a key role in the fight against COVID-19. As complete game-changers, they also affect the drug containment solutions, which have to withstand the specific requirements, such as ultra-cold storage temperatures.”
Furthermore, packaging companies had to surmount the challenge of providing drug containment solutions rapidly to ensure the vaccines could be rolled out in a suitably quick timescale. To this point, Stefan Verheyden, global vice-president of the Gx Biological Solutions Team, Gerresheimer, explains that it was necessary to quickly free-up capacity and utilize the intense cooperation with customers to be able to provide the required capacities to the market.
For Patrick Ferguson, managing director, Tjoapack US, COVID-19 provided the industry with an opportunity to accelerate the regulatory approval process in certain aspects, allowing products to reach the market more quickly, yet also demonstrated some shortcomings. “On the downside,” he says, “[accelerated approvals] have further contributed to the observed supply chain challenges.”
“The disruption the pandemic has caused to global supply chains has magnified shortcomings that have existed for years,” agrees Rich Quelch, global head of marketing, Origin. “The solution is creating a more resilient, collaborative, and networked operation moving forwards.”
Increasing sustainability
“One of the most important and current trends is sustainability,” specifies Verheyden. “Even during the development of drug delivery devices and packaging solutions, customers pay attention to how sustainability is integrated in the packaging ecosystem.” As a company, Gerresheimer has set itself sustainability targets, such as cutting carbon dioxide (CO2) emission by half by 2030, Verheyden notes. The new strategy, based on three pillars, sets targets that are to be achieved within a tight timeframe.
“Pharma, as one of the largest global industries, is both part of the problem and the solution when it comes to minimizing the adverse effects of climate change,” adds Quelch. “Pharmaceutical waste continues to be a huge problem, so to eliminate non-biodegradable and single-use plastics from the supply chain, more research is taking place around bio-based PET [polyethylene terephthalate]. It’s made from ethylene derived from sugarcane which has a negative carbon footprint, using CO2 and releasing oxygen when cultivated.” Additionally, Quelch points out that research is currently being performed on a pioneering technology that can convert PET waste back to virgin-grade material for re-use.
“Cutting-edge manufacturing methods like 3D visualization and printing are also helping to reduce waste by eliminating the need for multiple prototype designs,” Quelch says. Utilizing a knowledge-based design or taking a quality-by-design (QbD) approach can help to improve sustainability and reduce waste, he explains. “By designing a product’s primary and secondary packaging well from the outset (including investing ample resources into the process), manufacturers can reduce the amount of materials used and wasted, test new eco materials, ensure safety compliance and efficacy, and benefit from cheaper transportation costs,” Quelch surmises.
The challenge of biologics
Drug development pipelines are becoming increasingly saturated with biological drugs, stresses Reisse. “These [drugs] are typically highly sensitive and are oftentimes filled in low-fill dosages under 1 mL,” he notes. “Subsequently, these types of drugs require high-end containment solutions, which protect the sensitive formulations from unwanted drug/container interactions.”
The highly complex and sensitive biologic formulations also have the potential of contamination via leachables, Reisse continues. “In such cases, unique product development, such as EVERIC care vials that feature a special inner coating for protection, provide a suitable solution to minimize the risk of drug-container interaction,” he says. SCHOTT’s EVERIC care vials feature an inner single-layer plasma-impulse chemical vapor deposition barrier coating with hydrophobic surface, which allows for low leachable levels especially in the alkaline pH range.
Delamination control is another technological advancement that is interesting for biologics, Reisse confirms. Despite the fact that delamination is rare and occurs under certain circumstances, there is still a potential risk for patients. By way of example of a solution to this risk, Reisse refers to a delamination controlled forming process used by SCHOTT, which means that the company can offer vials with a high chemical stability and homogenous surface near the bottom heel area.
Further exciting innovations in packaging for biologics is a trend to watch out for in Quelch’s opinion. “Fluoropolymers—which don’t use any leachable or degradable stabilizing additives—are increasingly being used to form a resistant barrier to eliminate biodegradation issues. So too are cyclic olefin plastics (very rigid thermoplastics), which are intrinsically very inert, composed of just carbon and hydrogen,” he says. “These next-generation packaging materials, amongst others, are helping to deliver the next generation of medicines.”
“Newly developed biological drugs require containers, syringes, and devices that are tailored to the drug and its molecular properties,” concurs Verheyden. A way to help the customer overcome the specific challenges encountered with packaging of biological drugs is to employ a guide, such as Gerresheimer’s ‘g guide’, which can lead the customer to the most suitable solution within the respective therapeutic class or disease area, he states.
Although these new, small-batch, biological medicines represent an exciting era for pharma, there is also a potential pitfall in the supply chain, which will be inherently more complex than the traditional medicines, Quelch warns.
A disrupted supply chain
Supply chain challenges are one of the most disruptive issues, in a negative way, for the pharma industry, reveals Ferguson. “The supply chain challenges are negatively impacting the packaging industry both upstream and down,” he notes. “Price increases, delayed delivery, and material shortages at all levels of the supply chain are impacting the industry daily.”
It is not all doom and gloom, however, as a trend that has been apparent for Ferguson has been an increasing uptick in the adoption of a packaging outsourcing model by drug manufacturers in the United States when compared with historical rates. “This [trend] has created opportunities for organizations such as Tjoapack,” he explains. “Most recently, there have been more opportunities tied to the COVID-19 pandemic, providing some sizeable packaging opportunities as part of the testing or treatment of the disease.”
Numerous factors have challenged existing supply processes, such as the pandemic, the war in Ukraine, and the shortage of shipping containers, Reisse points out. “As a result, pharma companies can benefit from a packaging supplier with a true global footprint,” he says.
Yet, Reisse also believes that in the future, the trend of localization (versus globalization) will potentially have a significant impact on containment and drug delivery solutions. “While the industry has highly structured processes, the recent global developments (both social and political) have taken a toll on the supply chains,” he specifies. “In consequence, the industry is shifting towards more regional approaches to overcome those challenges.”
Flexible primary packaging
“From a fill and finish perspective, we are witnessing the industry shifting towards ready-to-use (RTU) solutions,” Reisse reveals. “These [solutions] allow pharma companies to focus on their core competencies of developing and filling valuable medications.” A particular benefit of RTU solutions is that pharma companies can simply start the filling process straight away as the washing and sterilization steps are done by the packaging company, he adds.
Verheyden concurs that the trend for RTU primary packaging is continuing to rise, with a clear move from customers choosing this solution for their packaging needs. “RTU drives flexibility and efficiency, while in parallel it offers a substantial impact on total cost of ownership in filling activities,” he says.
“Over the next years, it is likely we will see a move to pharma companies using RTU solutions in mass scale with high demands for vials, syringes, and cartridges,” continues Reisse. “This is a natural step in simplifying the filling process for pharma companies and offering more flexibility when filling different medications or switching from one containment solution to another.”
Technological aides for quality and safety
Quality requirements for packaging have also increased, asserts Verheyden, but more advanced inspections technologies and the use of artificial intelligence (AI) has enabled progression. “Through AI, the glass manufacturing process of the syringe barrels can be monitored, and recommended actions are displayed to the plant operator,” he says.
Disruptive technologies, such as AI, are proving useful in the molding process as well, where many parameters can also be monitored, Verheyden continues. “In concrete terms, using AI can allow for the determination of, among other things, the remaining service lives of molding parts over their period of use and thus, instead of fixed replacement intervals, a precise prediction of lifespan can take place,” he notes. “Monitoring the molding process also makes it much easier to identify defects in a linked process.”
“There has been an increased focus on packaging line automation,” agrees Ferguson. “Equipment and solution providers have done an excellent job in developing various applications and solutions that range from dedicated lines for large commercial operations to highly flexible solutions for small-batch contract packaging operations.”
Additionally, the user is benefiting from some technological advances, such as quick response (QR) codes, which are being implemented on packaging to help with health literacy and patient compliance, states Quelch. “In the area of clinical trials, smart packaging (featuring RFID [radio frequency identification] tags) and wearable devices are promoting greater secure interaction between patient and doctor by using real-time data to monitor compliance, identify side effects faster, and improve health outcomes for both volunteers and, in the longer term, the wider community,” he says.
Technological progress is also helping with tracking and tracing of medicines. “Technological progress in the track-and-trace field are bringing ‘industry 4.0’ to the pharma industry and, most importantly, bringing its benefits to the fill-and-finish operations,” adds Reisse. “For example, using solutions such as SCHOTT Smart Container, it is possible to track and trace drug containment solutions on an individual basis, from production all the way to the end user. Among other benefits, this technology minimizes the risk of mix-ups on the filling line as each container is laser-marked with a data matrix code, which allows for distinct, single-container based traceability throughout the fill-and-finish process and beyond.”
The implementation of serialization, through the Drug Supply Chain Security Act in the US and the Falsified Medicines Directive in Europe, has been a hot topic for years and is generally well rooted in the industry now, explains Ferguson. “The regulations have separated contract packagers who chose to invest in serialization technologies from those who have not, resulting in more opportunities for the pharmaceutical companies such as Tjoapack, that chose to invest in the serialization technologies,” he says. “Keeping up with software and hardware upgrades is a challenge but necessary to stay current with industry expectations and requirements.”
Globally, the size of the fake medicines market is huge and growing, Quelch stresses. “Anti-counterfeiting is a cat and mouse game, which means continuous packaging improvements and advancements are needed to stay one step ahead,” he says. “RFID technology, using electromagnetic fields, is supporting anti-counterfeiting efforts by identifying tampering. Another key development is the application of thermochromic inks, used to print reactive temperature indicators on packaging, as will smart sensors that can detect changes in humidity, light, and temperature.”
Further advances in the field of anti-counterfeiting measures include digital watermarks that are invisible to the human eye and developments in holograms that are only visible behind each capsule or pill cavity on the back of the blister pack, Quelch continues. “Enhanced anti-counterfeiting methods, including cloud-based tracking and perennial encryption technologies, are extending the lifecycle of protection for manufacturers so frequent and costly overhauls are avoided,” he notes. “These methods are also making it easier to spot and eliminate weak links in supply chains that criminals are quick to exploit.”
Ferguson expects that there will be a continued focus on streamlining operations within the bio/pharma industry moving forwards with investments in automation and efficiency improvements. “These investments would also have a positive impact on product quality and delivery to the customer,” he says. “DSCSA will be fully implemented in the US in 2023, but the adaptation of a global serialization standard is needed to build a truly global system.”
Proactive packaging
As cost becomes an ever more pressing concern, Quelch believes that packaging will be an area where companies can unlock greater financial returns through driving efficiency, quality, and sustainability. “Traditionally, packaging has been an afterthought in the product design process. It starts with a ground-breaking idea, and once this is developed, attention turns to packaging,” he asserts. “However, this is an outdated approach that ignores the vital role packaging plays not just in the delivery stage of product development but in every stage, from conceptualization to dispensing by healthcare professionals or patients.”
Moreover, tackling the packaging too late in the development lifecycle will only serve to prevent companies from being able to take advantage of potential functional design features and could lead to costly mistakes, Quelch adds. “Taking a proactive approach to packaging not only helps avoid the costs associated with fixing future performance or functional problems but also delivers business benefits in improved products, patient satisfaction, and reputation,” he summarizes. “The result is an optimal product that puts user experience at the forefront of design, ensuring effortless patient experience and an improved bottom line for big pharma.”
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