Strong growth for injectable drug product market 

Fueled by chronic diseases, an aging population, the rising demand of vaccines and technological advances in injectable delivery systems, the global injectable drug-delivery market is projected to grow at a 10.2% compound annual growth rate (CAGR) between 2022 and 2032 reaching $1.040 trillion (1). The World Health Organization reports that diabetes was responsible for 1.5 million fatalities in 2019 (2) and as such, the demand for insulin and GLP-1 receptor agonists is on the rise for early treatment and medication, thus driving the growth in injectable packaging, especially in user-friendly drug-delivery methods such as prefilled syringe and auto-injector dosage forms.   

These self-injectable drug products provide the most adaptable device with a high precision of drug delivery and ease of use for the patient. Due to their complex nature, these biologic drug products require specialized packaging to ensure their safety, stability, and efficacy, meaning biopharmaceutical companies must also evaluate product and patient packaging needs while keeping an eye on the impact of packaging design on profitability and speed to market. 

Product Packaging Considerations 

1. Product Protection  

The primary function of pharmaceutical packaging is to protect the drug product from damage and/or degradation due to external factors, such as moisture, light, temperature, and physical damage during shipping and handling. For injectable drug products, this can be considerable given heightened drug-product thermal stability requirements with often cold / ultra-cold storage and distribution conditions a necessity, together with specialist frozen packaging processes. 

Traditionally manual frozen packaging has been the industry method of choice and is typically aligned to clinical or small-volume niche drug products.  However, with the latest advancements in technology, automated processing at low temperatures can now facilitate larger commercial-scale volumes, providing increased operational efficiencies, reducing quality and safety risks with accelerated speed to clinic during clinical development, and thereafter, product launch and commercialization. 

When processing temperature-sensitive drug products and packaging in cold/ultra cold conditions, consideration needs to be given to label adhesives and printing inks, which can be impacted by the low temperatures. Thought also needs to be given to active / passive shipping solutions to guarantee product protection during distribution to the end-user.  

2. Compatibility—Safe and Inert Primary Packaging 

With the primary goal to develop high-quality, safe, and efficacious medicines to improve patients’ lives, during the drug-development process, it is important for packaging materials to be carefully selected to ensure compatibility with the product and to identify any potential for product contamination that could affect product stability or efficacy. Therefore, the most critical aspect of primary packaging is for it to be as inert as possible, so that it does not react with, add to, absorb, or allow external factors to change a drug product’s established safety, strength, quality, stability or purity characteristics. The material must be chemically stable and not generate extractables or leachables (E&L), delaminate, or undergo other changes upon contact with the drug product.  

A combination of risk assessment and analytical testing will determine the potential of contamination. If outsourcing the sterile filling and packaging of your injectable drug product, an experienced contract development and manufacturing organization (CDMO) that has worked with a broad range of drug products will have historical documentation of E&L studies and be able to provide guidance and share their expert advice. 

Patient Packaging Considerations 

1. Patient-Centric Design 

Patient-centric design of injectable drug products not only facilitates drug administration but supports patients’ adherence to a treatment regimen. By listening to patient pain points, obtaining feedback from clinical trials and human factor testing, and then modifying packaging presentations to meet patient needs is vital to helping them live with and manage their disease.  

In the biotech space, the ever-evolving area of drug-delivery systems often triggers the need for more sophisticated packaging, with patient centricity being key when dealing with self-administration of products delivered by different presentation forms, including vials, prefilled syringes, and auto-injectors.  The packaging of these therapies, particularly when thinking about scale-up for commercial launch, may require a technology forward and often bespoke packaging solution. For example, some auto-injectors now include wraparound devices aimed at improving dexterity and grip of the patient.   

2. Child-Resistant / Senior Friendly  

A prominent factor in packaging design is the development of child-resistant packaging addressing global regulations and reducing the incidence of unintentional child poisoning.    However, when developing child-resistant packaging, one of the greatest challenges is designing a closure that both prevents children from gaining access to harmful substances, without limiting the ability of senior patients to take their medication. Increasing population age, combined with the growing trend for home care, is directing the focus of child-resistant packaging simultaneously onto the accessibility needs of older patients.  

Production Packaging Considerations 

1. Package Design for Manufacturability  

Early consultation between clinical and commercial stakeholder groups is important. Packaging design is a critical area of importance, so early consideration of manufacturability is encouraged. Considering package design earlier in the drug-development process can lead to both cost and time efficiencies as the cost of mistakes can be considerable and delay product launch milestones. Ensuring that design and operational teams work together and applying a design for manufacture philosophy, the teams will understand the impact of design on packaging operations earlier in the process, delivering a streamlined and longer-term efficient solution.  

A common challenge arises when a biopharma company has its pack designed by a third-party design agency, which may fit the end-user specification and sponsor’s branding requirements, but then does not fit on the packaging equipment itself when it comes to commercial manufacture at the selected CDMO. A designed pack that is not optimized for the packaging process equipment will result in unnecessary upfront capital costs, modifications to existing equipment, and higher labor and commercialization costs, ultimately resulting in higher manufacturing costs and lowering commercial revenues. 

2. Late-Stage Customization 

Utilizing late-stage customization for global market supply of valuable injectable drug products, such as prefilled syringes, auto-injectors, or drug–device combination products, allows for a streamlined production process of bulk drug products, which then can packed into final presentation and tailored to country / regional requirements closer to distribution.   

Late-stage customization offers flexibility in meeting diverse market demands, regulatory compliance, and patient preferences. This approach can reduce costs and minimize inventory, thereby enhancing supply-chain efficiency and agility. 

Global Integrated CDMO Solutions   

At PCI Pharma Services, ensuring life-changing therapies reach those who need them most is our highest priority. As an integrated global CDMO, we are manufacturing, packaging, and supply-chain experts, harnessing our experience and expertise to deliver seamless solutions with the ultimate aim of improving the lives of patients. 

Providing expert sterile fill–finish and lyophilization solutions from development to commercialization, together with integrated custom packaging solutions for sterile injectables, allows for ultimate knowledge sharing and communication between teams to ensure packaging is optimized for the product, patient, and production. 

PCI’s pharmaceutical packaging design department provides an innovative and value-added service to our clients. The dedicated team of in-house design specialists deliver insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions. Using three-dimensional modelling, we are able to facilitate rapid prototype design to support patient and physician focus groups providing vital insight to patient usability and acceptability and also in support of regulatory filings, expediting responses, and enabling true speed to market. 

Meeting the growing needs of our clients for their life-changing biological drug products, PCI continues to invest in both our manufacturing and packaging capacities and capabilities.  Over the next 12-18 months, we are investing over $150 million to expand upon our global sterile fill–finish and lyophilization manufacturing capabilities together with our clinical and commercial biotech packaging service offering for injectable drug-delivery device–combination products.   

These investments reflect the outlook and the market opportunity that the company envisages for the future of injectable drug products. As a leading global CDMO, we not only want to meet growing demand for scalable biologic manufacturing and packaging, but through innovative value-add solutions, we aim to exceed customer expectations, delivering flexibility and excellence in all that we do to accelerate the development and commercialization of life-changing therapies. 

References 

1. Reports and Data, “Pharma and Healthcare – Injectable Drug Delivery Market,” April 2023. 

2. World Health Organization, “Diabetes.”