More Hot Topics in Packaging for 2025
BioPharm International® spoke with Mark Staiger, PhD, head of strategy at Schott Pharma, and Stefan Verheyden, global vice president, sales, pharma & biopharma solutions—injectables at Gerresheimer, about the outlook for pharma packaging in 2025.
BioPharm: Which drug modalities is the market most focused on?
Mark Staiger (Schott): GLP-1 agonists, [messenger] RNA-based drugs, and antibody-drug conjugates (ADCs). Significant investment and development are also seen in cell and gene therapies, CAR-Ts [chimeric antigen receptor T-cell therapies], and RNA [interference]. These new drugs place specific demands on pharmaceutical packaging, which we address by designing solutions to ensure that medicines are safe and easy to use for patients around the world.
Stefan Verheyden (Gerresheimer): Almost half of newly approved drugs by FDA, EMA [European Medicines Agency] or other authorities are biologics. Depending on the therapeutic area and route of administration, biologic drugs present several challenges to effective delivery, including potential for elevated viscosity with increased concentration, larger volumes, and the sensitive nature of the biomolecules. Pharmaceutical primary packaging and respective drug delivery devices must address these challenges and ensure drug stability through storage and transport as well as safe, precise drug delivery with patients’ comfort in mind. Our biologics customers often require smaller batch sizes and packaging solutions matching their high-end requirements, de-risking of fill/finish operations, and a significantly shortened time-to-market, all while ensuring patients’ safety.
BioPharm: What innovations or trends are you following when it comes to delivery formats?
Verheyden (Gerresheimer): Finding new, innovative routes of administration with patients’ comfort in mind is an ongoing topic. For the majority of our customers, we still see injectables as the preferred route of administration. A clear trend toward drug delivery devices that enable home treatment—pens, auto-injectors, or on-body drug delivery devices—is therefore noticeable.
Staiger (Schott): There is a noticeable shift toward subcutaneous administration, including large-volume injections. To meet customer needs and help the transition from hospital to homecare, we developed a 5.5 ml staked needle glass prefilled syringe for large-volume injections with autoinjectors, a 10 ml sterile cartridge for self-administration of large-volume biologics via on-body delivery systems, and partnered on infuse syringes enabling subcutaneous administration of volumes greater than 10m.
BioPharm: What are the impacts of automation, smart packaging, regulatory compliance, and maintaining sterility?
Verheyden (Gerresheimer): We see a clear trend toward deploying ready-to-use (RTU) or ready-to-fill (RTF) formats in vials and cartridges, as we did years ago with syringes. RTU/RTF packaging must meet rigorous standards. Pharma companies can mitigate risk of contamination, maintain highest quality, and ensure patient safety when deploying RTU/RTF packaging, and can rely on robust validation and seamless regulatory approval of the primary packaging through comprehensive documentation and data packages. Industrialization at scale and highly automated processes are important aspects for the industry. This includes primary packing and drug delivery systems like Gerresheimer is offering. We have been using artificial intelligence (AI) technology in our own Gx G3 inspection systems for quality control for years, and are constantly upgrading our automation and smart factory capabilities. Connected ‘smart’ packaging is a very interesting trend, and Gerresheimer offers innovative solutions.
Staiger (Schott): We’re observing a trend where pharma companies are increasingly adopting RTU solutions. These are particularly relevant as they reduce costs and optimize manufacturing processes. They enhance patient safety by minimizing contamination risks and offer flexibility and scalability for quicker adjustments to demands.
BioPharm: What did we learn in 2024? How will it shape 2025?
Verheyden (Gerresheimer): The rise of biologics will drive change. Beside the big pharma players, there are new, smaller players with sophisticated drugs in the pipeline. We have one of the broadest portfolios in the industry: containment solutions in glass and plastics, and drug delivery devices including our own intellectual property. We amended our portfolio further by acquiring Bormioli Pharma.
Staiger (Schott): We see a stronger focus on sustainability. In alignment with our customers, we’ve launched initiatives to reduce carbon emissions and drive circular packaging. Digital transformation is becoming more important as it enhances supply chain agility and improves traceability. We launched a polymer PFS that can include an RFID chip for digital drug traceability and inventory management in hospitals.
— Patrick Lavery
