Packaging is a critical component of pharmaceuticals, protecting the integrity, safety, and efficacy of essential treatments throughout the supply chain and providing tools for product traceability.
Tjoapack
As a result, the pharmaceutical packaging market is projected to grow from $110.55 billion in 2024 to $176.94 billion by 2032 at a compound annual growth rate (CAGR) of 6.06%.
However, as the biopharmaceutical industry continues to evolve — with innovative products and changing regulations — packaging innovators must find new ways to adapt to maintain compliance, meet product demands and cater to patient needs.
In this article James Bury, director technology at Tjoapack examines the increasing need for innovative solutions in pharmaceutical packaging, emphasising cutting-edge approaches and emerging technologies that address changing packaging requirements.
Driving the demand for packaging innovation
The pharmaceutical industry is under constant transformation, with the following trends driving the demand for innovation in drug packaging manufacturing, processes and products:
1. The increasing prevalence of biologic drug products
Biologic drug products are becoming more prevalent to better cater to unmet medical needs, including chronic and rare disease indications. In 2023, biologics accounted for 31% of the 55 new molecular entities (NMEs) approved by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
Unlike traditional small-molecule therapeutics, biologic materials are highly sensitive, demanding strict and controlled environments, such as temperature and humidity, throughout development, manufacturing, and supply. This sensitivity also means biologic drug products rely on parenteral administration and must be manufactured in sterile environments. An excursion from the required conditions could shorten the product's shelf life. As a result, appropriate packaging solutions and processes, effective monitoring, and cold-chain logistics must be in place to ensure drug product viability upon receipt by the healthcare professional or patient.
2. Safeguarding drug products throughout supply
Biopharmaceutical supply chains are prone to several risks. These include:
- Drug counterfeiting: In 2023, The US Drug Enforcement Administration (DEA) confiscated 80 million counterfeit pills laced with fentanyl — 2,300 times greater compared to 2017 — along with nearly 12,000 pounds of pure fentanyl powder. Drugs containing fentanyl elicit therapeutic effects with lower drug quantities. This prevalence of counterfeit drugs poses a severe threat to patient safety and compromises the integrity of the global supply chain. Biopharmaceutical companies must introduce robust solutions to combat the proliferation of counterfeit drugs.
- Tampering: The circulation of substandard and falsified medicines significantly threatens public health. The World Health Organization (WHO) estimates that around 10.5% of medicines worldwide are substandard or falsified. These medicines can include repackaged products with inferior ingredients or altered labels and serial numbers to disguise the true origin of a product. Patients who consume these counterfeit therapies may not receive the necessary medical treatment or could be exposed to harmful products, both of which could potentially lead to serious health consequences. Moreover, pharmaceutical companies' reputations can be severely damaged if their brand names are associated with ineffective or harmful counterfeit products.
3. Maintaining compliance with regulations
Regulations are continuously implemented and revised to ensure the biopharmaceutical industry maintains the highest safety standards throughout all processes, from development to supply.
An example is the introduction of the Drug Quality and Security Act (DQSA), enacted in November 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), details steps organisations must follow to develop systems and processes to achieve interoperable, end-to-end electronic traceability of drug products at the package level. Originally given a 10-year implementation period, companies must introduce strategies to meet the DQSA before the recently extended deadline of November 27, 2024. Failure to comply could result in lengthy delays, significantly impacting patient accessibility to critical treatments.
4. Meeting sustainability objectives
Governments worldwide are implementing stringent measures to address climate emergencies to reduce carbon emissions and minimise waste.
The European Union (EU) proposes that all packaging must be recyclable and any plastic components should comprise a minimum percentage of recycled material obtained from post-consumer plastic waste by January 1, 2030.
However, introducing recyclable materials into pharmaceutical packaging is challenging, with multifaceted considerations spanning drug product compatibility, durability and regulatory approval. The proposal does take this into account, with packaging directly in contact with medicinal products and contact-sensitive packaging of medical devices gaining exemption from the proposal until 1st January 2035. Companies must find innovative and sustainable packaging solutions to meet these sustainability initiatives.
Enhancing biologic manufacturing and distribution with packaging innovation
Packaging solutions that consider patient and product needs are crucial to ensuring product viability and patient convenience. As a result, one solution the biopharmaceutical industry is moving toward is pre-filled syringes (PFS). Patients can self-administer PFS, increasing usability, adherence and convenience. With the increasing frequency of treatments targeting rare and chronic diseases, there is a growing need for drug products in smaller volumes. PFS excels in handling such smaller volumes and can accommodate a diverse range of dosage solutions. In the realm of biopharmaceutical packaging, anticipated innovations in PFS design are poised to make a significant impact, driving advancements in various fields.
Biologic products are sensitive in nature and prone to aggregations and degradation, which can impact safety and efficacy. Therefore, biologics require a controlled environment and temperature (cold chain) throughout supply to ensure that they remain stable and efficacious upon receipt by the patient.
Secondary packaging is critical to protect the primary packaging and drug product when delivered to the patient or individual. In addition, when transporting temperature-sensitive products, smart packaging can be integrated to monitor the external temperature of the packaged therapies throughout transit. This helps to reduce temperature excursions; the organisation would also be notified if a temperature excursion occurs. This ensures that products remain stable throughout distribution and maximises the shelf life of products.
As the biopharmaceutical industry continues to advance, an example of smart packaging will be the introduction of smart labels which will also enable real-time monitoring. These labels contain core processors — such as radio frequency identification (RFID) chips or near-field communication (NFC) technology — that can track and send data to nearby receivers, which can then be fed into a central database. Tracking of temperature and environmental conditions encountered by each product unit in real-time throughout the supply chain ensures the integrity and safety of the pharmaceuticals. Alerted when a temperature excursion occurs, companies can use the data to understand better the root cause of an excursion to prevent reoccurrence.
Safeguarding drug products throughout the supply chain
It is critical to protect drug products throughout the supply chain to ensure they reach patients in the same condition they were shipped. Incorporating distinct identifiers on drug product packaging via serialisation can serve as a critical measure in safeguarding against the infiltration of falsified or counterfeit drug products into the supply chain. This method has been essential for over a decade, with legal frameworks in place to regulate this process.
The DSCSA serialisation measures will strengthen the FDA's ability to safeguard consumers from counterfeit, stolen or contaminated drugs, with enhanced detection and removal of potentially harmful drugs from the supply chain. Furthermore, the European Union's (EU) Falsified Medicines Directive (FMD) serves as a pivotal instrument in upholding the pharmaceutical supply chain's integrity within the region.
The integration of smart labels enhances serialised tracking throughout the supply chain. They carry more data than traditional labels, helping to meet the latest serialisation regulations.
Packaging innovators are also pioneering approaches to overcome drug product tampering, such as by applying tamper-evident seals on the outer packaging. This can be the use of blister packs, perforated caps, or foil stickers across secondary packaging. As of 9th February 2019, the EU requires most prescription medicines and certain over-the-counter drugs for human use to include an anti-tampering device on their exterior packaging. This eases the visibility of when tampering has occurred, as it is evident whether the packaging has been opened or altered since leaving the manufacturing site.
Pioneering sustainable packaging in the biopharmaceutical industry
Sustainability in packaging has emerged as a significant concern for the industry, driven by increasing awareness of the negative environmental effects of packaging materials. As packaging plays a critical role in ensuring drug product safety and efficacy, the biopharmaceutical industry is developing several strategies to better meet sustainability objectives, including:
- Eco-friendly materials: The use of biodegradable plastics, recycled paper and compostable materials are helping to reduce the environmental burden of drug product packaging.
- Reduced packaging: The optimisation of packaging designs can minimise the use of unnecessary packaging components while also driving cost savings.
- Postponement packaging: Responding to demand changes, companies can finalise products closer to the point of use, reducing waste, inventory costs and lost products.
- Improved distribution efficiency: By optimising transportation routes and delivery schedules, companies can reduce the environmental impact of their supply chains and improve product delivery times.
By integrating these technologies, the biopharmaceutical industry is moving closer to a circular economy and is contributing to the worldwide ambition of sustainability.
Continuous innovation with emerging technologies
To better meet stringent regulations, sustainability goals and drug product needs, packaging experts must continuously innovate and integrate advancing technologies to drive efficiency and ensure drug product safety and viability.
Blockchain-enhanced serialisation
Blockchain technologies hold promise for enhancing the security of biopharmaceutical supply chains. By providing the tools for tamper-proof digital record-keeping, a secure, transparent, and permanent record of all transactions within the supply network can be produced. Based on the Internet of Things (IoT), this blockchain-guided supply chain provides real-time tracking of individual drug packs' temperature and location by leveraging wireless sensors and GPS devices attached to the packaging. As a result, the integration of blockchain technologies promotes data visibility throughout supply, easing communication and ensuring product quality.
Artificial intelligence (AI) drives efficiency
In addition to transforming drug product discovery and development, AI has the potential to enhance pharmaceutical packaging workflows. For example, by integrating AI into production lines, predictive maintenance enables the rapid replacement of key components prior to failure, minimising production risks and delays. In addition, deep-learning AI models can provide a more robust inspection by adapting to changing environmental conditions like varying lighting intensities. This capability assists in augmenting packaging line speed, enhancing quality control, and ensuring precise product counts, ultimately optimising manufacturing processes.
Automation optimises packaging lines
Automated systems optimise supply chain management through enhanced track-and-trace. Monitoring and tracking inventory throughout storage and transportation reduces waste, improves operational efficiency and helps to prevent the entry of counterfeit medicines. Automation also minimises manual handling of products and their packaging, reducing human error and waste, and helping to ensure sterility of products.
The future of packaging
Packaging plays a critical role in protecting the integrity and efficacy of drug products throughout their journey from manufacturer to patient. As a result, biopharmaceutical companies must prioritise the role of packaging in drug product supply chains to guarantee safety, compliance, and uninterrupted supply.
Partnering with a specialised contract packaging organisation (CPO) can provide the support required to implement new packaging processes and strategies to meet changing regulatory requirements and evolving drug product needs while optimising packaging processes. With the experience, expertise and infrastructure for packaging innovation, a CPO can help customers harness emerging technologies to drive productivity and enhance serialisation.