Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics

Compton,Joe;

Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics

Published on: February 6, 2025

Pharmaceutical Technology, Pharmaceutical Technology, JanuaryFebruary 2025, Volume 49, Issue 1

Pages: 23–25

Rapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.

The global biologics market is currently experiencing considerable growth, and it is set for even greater expansion in the near future. In 2022, the market was valued at $461.74 billion and is projected to reach $817.48 billion by 2032, growing at a compound annual growth rate (CAGR) of 8.5% (1). This growth is fueled by several factors, including an aging global population, increasing prevalence of chronic diseases, and advancements in biotechnology, including innovations in monoclonal antibodies and cell and gene therapies. In recent years, supportive regulatory frameworks in many countries have also helped accelerate the development and approval of biologics.

Current and future market trends in biologics packaging

The expansion of the biologics space has influenced growth in the packaging market, with continued innovation and favorable market conditions bound to propel this area’s further expansion. The following are some of the key trends driving this market:

More Hot Topics in Packaging for 2025

Phamaceutical Technology® 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.

PharmTech: What drug modalities is the market most focused on?

Mark Staiger (Schott): The market is heavily focusing on 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]. Personalized medicines are gaining traction, with companies like BioNTech making substantial progress.

Stefan Verheyden (Gerresheimer): Almost half of newly approved drugs by FDA, EMA [European Medicines Agency] or other regulatory authorities are biologics. Depending on the therapeutic area and the route of administration, biologic drugs present several challenges to effective delivery, including the potential for elevated viscosity with increased concentration, larger volumes, and the sensitive nature of the biomolecules. The pharmaceutical primary packaging and the 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 that, while ensuring patients’ safety.

PharmTech: 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 in the pharma industry. For the majority of our biologic customers, we still see injectables as the preferred route of administration. A clear trend toward drug delivery devices that enable home treatment, such as 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, and ready-to-use (RTU) manufacturing. The number of biologics is steadily increasing, necessitating injectable formats. There is a continuous rise in demand for prefillable syringes (PFS), with a shift from vials to PFS and new approvals driving this trend.

PharmTech: Pharma companies seem to be transforming when it comes to packaging. What trends have you observed in areas including automation, smart packaging, regulatory compliance, and maintaining sterility?

Verheyden (Gerresheimer): We see a clear trend in the industry toward deploying RTU or what Gerresheimer calls ‘ready-to-fill’ (RTF) formats in vials and cartridges, as we did some years ago with syringes. RTU/RTF packaging, like any pharmaceutical packaging, must meet rigorous standards. Pharma companies can mitigate the risk of contamination, maintain the highest quality, and thus ensure patient safety when deploying RTU/RTF packaging. And they 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 very important aspects for the whole industry. This includes primary packing and drug delivery systems like Gerresheimer is offering today. We have been using artificial intelligence (AI) technology in our own Gx G3 inspection systems for quality control for a number of years already, and we are constantly upgrading our automation and smart factory capabilities. Connected ‘smart’ packaging is certainly a very interesting trend in the industry and Gerresheimer offers a number of innovative solutions in this field.

Staiger (Schott): Automation is enhancing efficiency and reducing human error in packaging processes. Maintaining sterility is critical, especially with the rise of complex biologics and personalized medicines.

PharmTech: What major learnings from 2024 are going to help shape the year ahead?

Verheyden (Gerresheimer): The rise of biologics will drive change in the industry. Beside the big pharma players, there are now a number of new, smaller players in the market with highly sophisticated drugs in the pipeline. We have one of the broadest portfolios in the industry: containment solutions in glass and plastics, as well as drug delivery devices, including our own intellectual property (IP) devices. And we amended our portfolio even further with the acquisition of Bormioli Pharma.

Staiger (Schott): The industry has learned the importance of supply chain resilience and localization to mitigate disruptions. There is a stronger emphasis on sustainability and eco-friendly packaging solutions. The need for digital transformation and data-driven decision-making has been highlighted, driving investments in AI and machine learning.

— Patrick Lavery

Increased demand for biosimilars and biobetters. Biosimilars are expected to gain significant market share due to their lower cost than original biologics. The biosimilar market in the United States has experienced rapid growth, with 61 biosimilars approved across 17 unique biological molecules as of September 2024, and the global biosimilar market is estimated to reach $43.8 billion by the end of 2024 (2,3). Biobetters, which offer improved efficacy or safety profiles compared to original treatments, are also emerging as a promising trend. The biobetters market worldwide was valued at $65.7 billion in 2024 and is projected to reach $113.78 billion by 2031, growing at a CAGR of 8.2% (4). This rising demand is driving the need for specialized packaging solutions that ensure the stability of these products so that their efficacy is protected. By collaborating with experienced packaging partners, biosimilar and biobetter developers can leverage packaging as a strategic tool to enhance product differentiation, patient convenience, and overall success in this market.

Personalized therapies. Advancements in genomics and proteomics are enabling the development of personalized biologics tailored to each patient’s genetic makeup. These treatments cater to niche patient groups with specific genetic or molecular markers, resulting in smaller batch sizes and increased complexity. Manufacturing and packaging need to adapt to handle smaller production runs efficiently, while logistics and supply chain management become more intricate due to diverse product variations. This is why these innovative therapies require flexible packaging and tailored solutions to accommodate diverse formats, fill volumes, and delivery devices to match specific patient needs. Packaging partners help biopharma companies use packaging as a strategic tool to support the successful development of personalized therapies.
Diversification of formulation approaches for a patient-centric approach. Traditionally, biologics are often administered through injections, which can be inconvenient and painful for patients. To address this issue, researchers have been working on oral solid dosage (OSD) biologic formulations. They can be easily self-administered at home, eliminating the need for frequent visits to healthcare facilities for injections, saving time and reducing healthcare costs. Patients can take oral biologics anytime, anywhere, making integrating medication into their daily routines easier. OSD biologics can be designed with specialized delivery systems that protect the drug from degradation in the digestive system and enhance its absorption into the bloodstream. They can also be formulated for controlled release, delivering the medication gradually over time. This can lead to improved efficacy and reduced dosage frequency, helping minimize side effects and maintain a consistent therapeutic effect.
However, as the digestive system is a hostile environment for many biologics, not all are suitable for oral delivery. For those formulations, pre-filled syringes (PFS) and autoinjectors offer a user-friendly, safe, and convenient way of administration.
Rise of biologics self-administration. The development of PFS and autoinjectors has simplified the injection process, making it easier for patients to self-administer biologics at home. Autoinjectors are designed for intuitive use, often requiring a single step to deliver the medication. This eliminates the complexity of traditional injections, which involve multiple steps like preparing the syringe, measuring the dose, and administering the injections. Autoinjectors feature ergonomic designs and clear instructions, making them easy to handle and operate, even for patients with limited dexterity or those unfamiliar with injections. The needle is hidden from view, and the injection is automated, which eliminates hesitation and anticipation that can contribute to needle-related anxiety and fear for patients uncomfortable with needles. Autoinjectors empower patients to self-administer their medication at home, reducing reliance on healthcare professionals and increasing independence.

Biologics development and packaging challenges and strategies

The complex nature of biologics, especially in OSD forms, PFS, and autoinjectors, presents unique challenges in their development, packaging, distribution, and delivery. Thankfully, ongoing innovations pave the way for more cost-effective production and patient-friendly administration, helping overcome these hurdles:

Biologics must remain stable during transport and storage, which is challenging due to their sensitivity to temperature, humidity, and light. Using materials with improved barrier properties, compatibility, and stability can enhance biologics’ performance and shelf life.
As PFS and autoinjectors require piercing the skin and bypassing the body’s natural defense systems, they must remain sterile right up to the point of administration to safeguard patient health.
Delivery systems face the same patient safety risks as other drug formats, especially regarding counterfeiting and tampering. Counterfeit drugs pose a danger to patients and undermine the security of the entire pharmaceutical supply chain. Regulations are in place to combat these threats, and packaging must adhere to these standards.

This is where secondary packaging comes in, providing additional protection and maximizing patient safety. In addition to aesthetics and helping with storage and transportation needs, secondary packaging helps preserve medicine integrity, enhance user convenience, and promote compliance and adherence. The right secondary packaging can include extra items like alcohol swabs, replacement needles, and clear instructions, making the process smoother for patients. With more people self-administering medications at home, child-resistant packaging becomes crucial to prevent accidental exposure and protect vulnerable patient groups, such as children or people with additional needs. Packaging partners, such as contract packaging organizations (CPOs) offering comprehensive services encompassing every aspect of the packaging process, can help ensure that biologics are safe and effective when administered.

Cost-effective biologics packaging solutions

The complexity of production and need for specialized facilities and equipment contribute to the current high cost of biologics. Working with a specialist CPO with experience in biologics offers advantages especially with diverse delivery methods. Specialized CPOs have expertise and infrastructure to handle biologics with care, ensuring integrity and efficacy. They can provide packaging solutions for biologics like pre-filled syringes, vials, and autoinjectors with appropriate temperature control and protection measures. CPOs are also well-versed in regulatory requirements and have established quality systems to ensure compliance, reducing risk of regulatory hurdles or delays. They can provide comprehensive validation documentation and support for packaging processes to ensure traceability and accountability.

Specialist CPOs also tend to stay abreast of all of the latest innovations in biologics packaging, such as drug delivery systems, and connected packaging technologies. Leveraging the knowledge of partners with expertise in innovative solutions can significantly reduce the cost of life-saving biologics, making them more accessible to healthcare systems as well as patients.

References

1. Ghosh, S. Biologics Market (2022 to 2032). FMI–Future Market Insights, October 2022.
2. Samsung Bioepis. Biosimilar Market Dynamics; 7th edition; Samsung Bioepis, September 2024.
3. Jha, S. N. Biosimilar Market Outlook (2024 to 2034). Fact.MR, June 2024.
4. Persistence Market Research. Biobetters Market Size, Share, and Growth Forecast for 2024–2031. Persistence Market Research, September 2024.

About the author

Joe Compton is senior director, Business Development and Alliance Management, TPU (Tjoapack US).

Article details

Pharmaceutical Technology®
Vol. 49, No. 1
January/February 2025
Pages: 23–25

Citation

When referring to this article, please cite it as Compton, J. Meeting Secondary Packaging Challenges of Innovative Delivery Systems for Biologics. Pharmaceutical Technology 2025 49 (1).

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