Technological advancements, global market dynamics, and patient-centric approaches are all factors driving the transformation of the parenteral drug market.
Parenteral drug administration has witnessed significant advancements and transformations in recent years. This critical method of drug delivery plays a pivotal role in delivering therapeutic agents directly into the bloodstream, offering rapid and effective therapeutic outcomes. The parenteral drug market has been evolving dynamically, driven by technological innovations, increasing prevalence of chronic diseases with preference for at home treatment, and a growing demand for more targeted and efficient drug delivery systems.
Key Trends Shaping the Parenteral Drug Market
1. Biologics and Biosimilars: A Dominant Force
One of the most prominent trends in the parenteral drug market is the rising prominence of biologics and biosimilars. In a recent report by Mordor Intelligence, it is estimated that the biologics market size will be USD $429.5 billion in 2024 and is expected to reach $601.26 billion by 2029, growing at a CAGR of 6.96% during the forecast five-year period (2024-2029).
With their ability to target specific disease pathways with increased efficacy, biologics have gained traction. Furthermore, the market is also being driven by growing capital investment from key players in research and development of these innovative therapies, the rise in the burden of chronic diseases and the loss of patent exclusivity of leading biologic drugs. As the patent exclusivity of many biologics expires, the market is witnessing a surge in biosimilars—biologically similar versions of already approved reference biologics. The parenteral route remains crucial for the administration of these complex molecules, further fueling the demand for parenteral drug delivery systems.
2. Rise of Self-Administration Devices
The demand for self-administration devices has witnessed a notable upsurge in recent years, driven by the growing preference for home-based healthcare solutions. Advanced drug delivery devices such as auto-injectors, pen injectors, and wearable injectors offer patients greater convenience, accuracy, and control over their treatment regimens. The trend is particularly evident in the management of chronic conditions such as diabetes and rheumatoid arthritis. As these devices become more user-friendly and technologically sophisticated, they are expected to dominate the parenteral drug market, contributing to increased patient adherence, reduced healthcare costs, and improved therapeutic outcomes.
3. Focus on Patient-Centricity
Patient-centricity has become a key focus in the pharmaceutical industry, influencing drug development strategies and the design of advanced drug delivery packaging. Tailoring drug product delivery to meet patient needs, preferences, and lifestyles is gaining significance. In the parenteral drug market, this translates into the development of products that reduce the frequency of injections, minimize pain and discomfort, and enhance overall patient experience. Manufacturers are investing in research and development to create formulations that align with patient preferences, alongside focusing on Human Factors Engineering earlier in the development process for optimizing usability, minimizing user errors, and enhancing overall safety, efficacy, and adherence to gain improved outcomes.
4. Breakthroughs for Specialty and Orphan Drugs
The parenteral drug market is witnessing a significant move towards addressing the unmet medical needs of people living with rare diseases and developing specialty and orphan drug therapies. Drug modalities such as siRNAs and ASOs are often designed to treat rare diseases or conditions with limited patient populations and require specialized formulations and delivery systems. The parenteral route is frequently chosen for these drugs due to its ability to provide precise dosing, targeted delivery, and rapid onset of action.
With high-value drug products such as those for rare diseases, eliminating or reducing drug product loss is vital. Utilizing a prefilled syringe dosage form eliminates the waste caused by overfilling vials, which can be as high as 15 to 25 percent. This is not the case with a prefilled syringe format, as the design, components (including stopper), and functionality improve dosing control, thereby significantly reducing drug product waste. Combined with utilizing advanced robotic aseptic prefilled syringe filling technologies, which deliver minimal line losses as low as 50mL, these technologies provide a significant increase in available drug product for the patient population.
5. Environmental Sustainability
Environmental sustainability is emerging as a critical consideration in the pharmaceutical industry, including the parenteral drug market. Efforts to reduce the environmental impact of drug manufacturing and disposal are gaining momentum. The development of environmentally friendly packaging materials is becoming a focal point for biopharmaceutical companies. As stakeholders recognize the importance of sustainable practices, the integration of eco-friendly initiatives is expected to shape the future landscape of parenteral drug development.
6. Globalization of Parenteral Drug Manufacturing
The parenteral drug market has witnessed a change in manufacturing dynamics, with a growing trend towards globalization. Contract development and manufacturing organizations (CDMOs) play a vital role in this trend, offering time and cost efficiencies together with scalable solutions to biopharmaceutical companies. Outsourcing manufacturing processes allows companies to focus on research, development, and commercialization, accelerating the overall drug development timeline. Additionally, globalization allows access to a diverse pool of expertise, fostering innovation and collaboration in the parenteral drug space.
Meeting the Demand for Scalable Parenteral Solutions
In response to the evolving biologics industry landscape and as part of PCI Pharma Services’ global strategy to increase our sterile fill-finish (SFF) and parenteral packaging capabilities to alleviate the global capacity shortage for sterile drug manufacturing and advanced drug delivery packaging, we continue to invest and grow our service offerings through investment in new facilities, state-of-the-art technology, and our people.
Robotic Isolator Aseptic Filling Technologies
Complementing our expert sterile fill-finish and lyophilization capabilities at our North American and European sites, and to provide an end-to-end clinical solution for aseptic drug manufacture and packaging from a single site, PCI has invested in state-of-the-art gloveless robotic sterile filling technology platforms at our clinical facility in San Diego, California.
Utilizing the latest advancements of Cytiva Microcell and SA25 technologies, we deliver flexible aseptic fill-finish solutions for both small and larger-scale clinical production runs across a variety of dosage forms including vials, syringes, and cartridges for use in auto-injectors, helping to meet our clients’ scalable aseptic manufacturing needs, delivering products to patients safely and efficiently. Our investment in multiple robotic technologies provides a scalable solution for our clients, meeting clinical requirements from smaller preclinical/Phase I trials and beyond.
Precise, programmable robotic functions cover all aspects of the Microcell and SA25 filling process, including isolator leakage tests, VHP sterilization of the filling chamber, filling into the container closure system (CCS) of choice, capping and batch delivery. The advanced robotic platforms are compatible with ready-to-use (RTU) containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a sterility assured drug product.
At PCI Pharma Services, clients have immediate access to our robotic SFF capacity. In addition, with clinical packaging, labeling, and distribution activities also located at the San Diego site, this not only provides for a streamlined supply chain, mitigating risk, but also provides clients with an accelerated solution to get their drug candidates to patients.
Increased High Volume Vial Filling and Lyophilization Isolator Capacity
With a $100 million investment we are enhancing our integrated development to commercialization sterile fill-finish offering with a new 50,000-square-foot commercial scale facility at our Bedford, New Hampshire, campus. This facility will provide increased capacity using Annex 1 compliant state-the-art isolator technology including high speed, large volume vial filling and twin lyophilization lines complete with automatic loading and unloading systems.
Processing batch sizes up to 300,000 vials at a rate of 400vpm provides much needed large-scale capacity for our client partners in the filling of their life-changing biologics, mABs, oligonucleotides, proteins, and peptide drug products. The facility will be operational early 2025 with capacity reservation available immediately to secure sterile supply chains.
Advanced Drug Delivery Packaging Expansion
Complementing the continued growth and investment across our sterile manufacturing network, we continue to expand our European, North American and UK Centers of Excellence for clinical and commercial packaging. These state-of-the-art facilities are equipped with advanced drug delivery packaging technologies for the assembly and labeling of vials, cartridges, standard prefilled syringes, advanced safety syringes, auto-injector and pen devices complete with integrated top-open cartoning and in-line serialization.
Most recently, we announced an investment of $150 million in a new 200,000-square-foot facility at our Rockford, Illinois, site to meet the growing biologic market need of specialized assembly and packaging for injectable drug-device combination products. With over 20 dedicated suites, the new facility will support the assembly and packaging of vials, prefilled syringes, auto-injectors, on-body injectors, and pen-cartridges such as those for oncology treatments and autoimmune diseases.
Sustainable Packaging by Design
PCI has implemented state-of-the-art software to analyze the sustainable factors of pharmaceutical packaging down to individual components. By having a complete view of which specific elements of packaging are contributing most to a package’s carbon footprint, clients can make more informed decisions. Sometimes small changes can have a compounding impact. For example, this software revealed that when changing from a plastic tray to a molded, paper fiber tray, global warming impact is reduced by 50%. Whatever sustainability approach companies choose, it does not have to involve a complete package redesign or other drastic changes. Together with our client partners, PCI works to develop the most appropriate solution that aligns to goals and budget.
Seamless Solutions to Secure Supply Chains
Recent events have put a spotlight on the need for secure and nimble supply chains. Biopharmaceutical companies seek service providers that can provide robust integrated solutions to support their drug products throughout their development lifecycle to commercialization, mitigating the need to transfer between suppliers therefore reducing supply chain complexity and risk.
At PCI, ensuring continuity of supply of life-changing medicines is our highest priority. As a truly 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 assembly and packaging solutions for sterile injectables allows for ultimate knowledge sharing and communication between teams to ensure the drug product packaging is optimized for the product, patient, and production.
With in-house laboratories we provide a range of packaging and analytical services to support client’s development, clinical and commercial supply of medicines globally. From product ID testing, method transfer, release and stability testing to auto-injector system testing with ISO 11608 functional tests such as cap removal force, activation force, extended needle length, dose accuracy, injection time, and lockout force, we ensure your life-changing therapy meets regulatory guidelines and is safe for patient use.
Conclusion
The parenteral drug market is undergoing a transformative phase, driven by a confluence of factors ranging from technological advancements to global market dynamics and patient-centric approaches. Biologics, technological innovations in drug delivery systems, and the emphasis on patient experience are reshaping the landscape. As the industry continues to evolve, biopharmaceutical companies and their partnering CDMO(s) must remain agile to navigate the complexities of the market and capitalize on emerging opportunities. With a focus on innovation, collaboration, and sustainability, the future of parenteral drug administration holds promise for improved therapeutic outcomes and enhanced patient care.
The Evolving Landscape of Parenteral Drug Administration: Market Trends Shaping the Future with Jeff Clement, Executive Director, Technical Sales – Development and Manufacturing at PCI Pharma Services | as seen in Contract Pharma | March 2024.
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