The contract pharmaceutical packaging market is growing, and quickly. In this article, Dexter Tjoa, CEO of Tjoapack will explore the challenges facing pharmaceutical companies as a result of recent industry trends and will explain how expert support from CPO partners is crucial to shaping the future of their drug product supply chain.
The global pharmaceutical market was estimated to be worth $1,573 billion in 2023 and projected to at a compound annual growth rate (CAGR) of 6.15% from 2024 to 2034 [1]. This growth is fuelled by an aging population and advances in available treatments, which have considerably impacted the global pharmaceutical industry.
However, the pharmaceutical sector faces several challenges that could impact the secondary packaging and presentation of finished drug doses. These challenges include compliance with requirements to prevent counterfeiting and support product quality to optimise patient safety.
For a growing number of pharmaceutical companies, the answer to tackling these obstacles effectively is to work with an expert contract packaging organization (CPO). These are companies that specialize in packaging and labelling pharmaceutical products on behalf of pharmaceutical companies. More drug developers than ever before are harnessing these experts’ specialist insights, dedicated infrastructure and capacity to deliver secondary packaging design and packaging services to help them prepare their drug products for the future.
The pharmaceutical contract packaging market is expanding at a fast rate. The market was valued at $17.06 billion in 2024 and is projected to grow to $43.46 billion by 2034, expanding at a CAGR of 9.8% throughout the forecast period [2].
The pharmaceutical industry faces mounting packaging challenges
The design of secondary pharmaceutical packaging is being impacted by a number of key market challenges:
Serialisation to safeguard against counterfeiting
This is necessary to address the significant risk to patient safety posed by counterfeit drugs, which account for 13.6% of medicines in low- and middle-income countries [3], with this percentage rising to 19.1% for antimalarials [4]. Governments are mandating serialization on all drug units to combat this issue. Digitalization and innovative track and trace solutions are now crucial to meet serialization regulations and ensure end-to-end visibility across the supply chain. By assigning a serial number to each dose and pack, companies can track their movement and comply with U.S. and E.U. regulations.
In the E.U., serial numbers must be entered into the EMVO database so pharmacies can verify products at the point of dispensing. This system is intended to prevent counterfeit drugs and enable rapid traceability. Digitalization also helps companies monitor temperature readings in real time, minimizing the risk of unsafe temperature excursions. Pharmaceutical companies must adapt their secondary packaging and logistics to comply with these regulations, particularly for entry into the U.S. and E.U. markets, while also maintaining optimal manufacturing efficiency.
Chain of custody for patient safety
Beyond counterfeiting, patient safety is also threatened by issues within the drug product’s chain of custody. This is especially true for temperature-sensitive drugs like biologics, which require specific storage and transport temperatures. To ensure product safety, companies must implement methods to monitor temperature and environmental conditions throughout the transportation process.
Enhancing the patient experience
Secondary packaging is increasingly required to enhance patient experience and support self-administration. In the case of prefilled syringe (PFS) drug products, efficient kitting is needed more and more to include additional materials like swabs, replacement needles, usage instructions and informative content. This improves PFS usability, expanding the range of injectable treatments patients can self-administer.
Improving guidance for patients when administering treatments is also important. Clear labelling and easily understandable instructions are crucial for patients to prepare, inject and safely dispose of PFS and similar spent drug devices. Providing straightforward guidance in the patient’s language ensures a seamless self-administration process. With the rise of self administration, the risk of children encountering hazardous drugs increases. Child-proof secondary packaging is essential, preventing unsupervised access and ensuring safety.
Secondary packaging is changing
To ensure that patients have what they need for safe and accurate treatment, drug products
must have the right packaging. Recent innovations in secondary packaging can help pharmaceutical companies meet the changing needs of the market:
Kitting advances for patient convenience
Suitable secondary packaging facilitates efficient kitting, enabling the inclusion of extra materials, such as swabs, replacement needles (particularly useful for PFS) and usage instructions. This improves the usability of treatments like injectables and expands the range of treatments patients can self-administer.
Ongoing developments in kit packaging and associated manufacturing equipment are focused on making PFS more user-friendly, especially for vulnerable patients. Alternative ergonomic grips can be included in kits to provide different options for patients, particularly older individuals who may have issues with manual dexterity.
Improvements in smart labelling for safety, information and convenience
Clear labelling and easy-to-understand instructions are essential for patients to prepare, inject and safely dispose of PFS, as well as to administer oral solid dose (OSD) and other drug types.
Kitting innovations help provide this additional information and support in the patient’s language without affecting manufacturing productivity or cost-effectiveness.
Smart labels for serialization and temperature control
Smart labels with radio-frequency identification (RFID) or near-field communication (NFC) technology are increasingly being considered to support serialization requirements for PFS, OSD and other drug types. These labels provide more robust information than traditional labels, including unique identifiers and serialization data that are critical for regulatory compliance and facilitate seamless scanning during transport. Smart labels can potentially harmonize data systems across the pharmaceutical supply chain, aligning serialization compliance with operational efficiency.
In addition, smart labels can potentially help pharmaceutical companies that manufacture temperature-sensitive drug products, such as biologics, by allowing real-time monitoring of temperature conditions during product transport. Processor cores within these labels can enable data transmission to a central database, which allows for the identification and disposal of units with temperature excursions. This system helps with understanding the root cause of excursions and can prevent them from happening in the future.
OSD and PFS packaging seals to protect vulnerable populations and address tampering
Child-proof secondary packaging is increasingly being considered to prevent unsupervised access and ensure safety. This includes innovations in secondary packaging seals and closures that are difficult for children to open.
The use of blister packs is also expanding to protect patients from tampering. Blister packs have been mandated in the EU for prescription medicines since February 2019. Upcoming innovations aim to improve these devices, ensuring any alterations are visible to patients and streamlining installation during filling and packaging.
The power of expert contract packaging support
The considerable capital investments required for equipment and installation can make adopting new packaging innovations overwhelming for many pharmaceutical companies. To overcome this, these companies are increasingly establishing strategic partnerships with specialized CPOs. Partnerships with such organizations enable pharmaceutical companies to leverage the latest packaging innovations without substantial individual investments, potentially reshaping the industry for enhanced efficiency and improved patient experiences.
CPOs, equipped with the necessary infrastructure and resources, play a key role in facilitating the industry’s early, efficient and effective access to innovations that support the launch of patient-centric and complex dosage forms. Their expertise eliminates the need for pharmaceutical companies to invest in specialized equipment, ensuring compliance with stringent regulatory standards and guaranteeing the delivery of safe, high-quality products to patients.
For example, for pharmaceutical companies seeking to package large volumes of PFS drug products, working with a CPO with dedicated sterile infrastructure eliminates the need for pharmaceutical companies to invest in equipment themselves. This ensures compliance with rigorous regulatory standards, such as Annex 1 of the EU Guidelines for Good Manufacturing Practice, and guarantees the delivery of safe, high-quality and convenient products to patients[5].
Furthermore, CPOs offer valuable insights into specific packaging requirements and provide the flexibility and capacity to develop customized packaging solutions, adding tangible value for customers and fostering lasting partnerships. The collaboration extends beyond operational efficiencies, with CPOs contributing to branding and product promotion by assisting in the creation of packaging designs that resonate with target audiences. This collaborative approach effectively communicates product benefits, ensuring that pharmaceutical innovations stand out in the competitive marketplace.
CPOs in action
Tjoapack is one CPO that is helping to shape the future of the pharmaceutical supply chain for drug developers with complex secondary packaging needs. With sites in Europe and North America, it can meet a wide range of contract packaging needs for oral solids, injectables and custom solutions.
For over 35 years, it has supported customers in supplying 42 markets worldwide, helping them overcome fast-changing market needs and successfully addressing a range of unique challenges:
Compliance with U.S. serialization regulations
A customer approached Tjoapack to develop a packaging solution for launching its product in the U.S. market. The company needed an evaluation of its current packaging and the design of a new solution that complies with the applicable specifications and regulations for the U.S. – in particular, those relating to serialization.
Additionally, Tjoapack was tasked with securing the logistics and supply chain for the client, who had an established network and solution that could not be altered.
To adapt to the customer’s supply chain, Tjoapack designed a custom shipper (tertiary packaging) and procured the materials to secure the customer’s current supply chain. Tjoapack also designed two different packaging solutions:
- Matching the exact current E.U. solution and providing the flexibility of having different leaflet options with multiple language requirements.
- A specific carton for the client that supported serialization and aggregation.
Postponement packaging solutions to support patient-centric supply to China
The customer needed support with patient-centric packaging of small volumes of products to facilitate their expansion into the Chinese market. The packaged drugs needed to comply with local labeling regulations – including translation of instructions into Chinese. The labels also needed to be laid out in a patient-centric manner that was clear and easy for patients to read and follow.
Tjoapack addressed this issue by performing postponement packaging for the customer, receiving blank blisters from the customer’s manufacturing site and localizing them for the Chinese market when they were ready to be shipped. The low product volumes presented an additional logistical challenge, complicating tertiary packaging and the overall preparation for transportation.
Tjoapack developed a solution to carton 10 printed blisters per pack to ensure product integrity, optimizing the process for low-volume orders. This approach addressed the logistical challenges posed by the small quantities and ensured the product was safely prepared for transportation. All market-specific requirements, including the use of Chinese language on the blister captions, were successfully met. As a result, the product entered the Chinese market smoothly, and the solution was subsequently adopted for all postponement packaging projects.
Listen to this PharmaSource podcast interview with Dexter Tjoa
Time to shape your future with an expert CPO partner
Pharmaceutical companies must continue to adapt to evolving patient needs and preferences, such as the demand for more user-friendly and self-administration-compatible products, to ensure they remain competitive in an increasingly crowded pharmaceutical market. Adaptation of this nature often requires substantial capital investment, which can be daunting for companies. But it doesn’t have to be this way, provided drug developers have the support of the right CPO for their needs.
Leveraging CPOs’ ready-made infrastructure, in-house expertise and partnerships with leading suppliers, pharmaceutical companies can feel confident they have the power and the capability to stay on top of changing market requirements. As a result, they, their innovations and end- patients can thrive into the future.
To find out more about how Tjoapack can meet your contract secondary packaging needs,
contact our experts.
References
[1] Global Pharmaceutical Market Companies, Trends and Developments, Towards Healthcare
[2] Pharmaceutical Contract Packaging Market Size and Volume Worldwide
[3] Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low-
and Middle-Income Countries
[4]WHO
[5] Annex 1
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