In today’s evolving pharmaceutical environment, the fill‐finish segment stands out as a critical linchpin connecting drug development with successful patient delivery. Driven by seismic shifts in global health trends, an evolving therapeutic landscape, and breakthroughs in manufacturing technology, fill‐finish outsourcing is undergoing a transformation unlike any seen before. 

With the COVID-19 pandemic having not only reshaped supply chains but also accelerated the adoption of innovative technologies, companies worldwide are now leaning heavily on contract development and manufacturing organizations (CDMOs) to meet the surging demand for life-saving therapies. This article explores the key trends, challenges, and opportunities in fill‐finish outsourcing, providing insights into how industry leaders are adapting to a market characterized by both unprecedented growth and increasingly complex requirements.

Global Health Trends and the Surge in Demand

The last few years have seen an extraordinary upsurge in the need for fill‐finish services. Early in the COVID-19 pandemic, global demand for vaccines and therapeutics skyrocketed as manufacturers raced to produce billions of doses of medications. Yet, even as COVID-related therapies begin to wane, another wave of demand has emerged. In particular, the explosion in GLP-1 products has further accelerated the need for high-quality fill‐finish capacity.

As Nithin Stephen, director of commercial development at Resilience, explained, “The demand for fill and finish services has surged significantly in recent years, driven by global health trends. Just as the COVID-19 pandemic led to a sharp increase in demand for fill and finish capacity for vaccines and therapeutics, the explosive demand for GLP-1 products in the past two to three years has further accelerated the need for these services. Key drivers of this growth in demand have been Novo Nordisk and Eli Lilly as they are the two main players in the GLP-1 market.”

This surge is not merely a reflection of immediate public health crises but also underscores a broader shift toward biologics and advanced therapeutics. As the industry moves away from traditional small molecules and embraces more complex biologics, gene therapies, and mRNA-based treatments, the need for sophisticated, scalable, and compliant fill‐finish operations becomes paramount.

The Outsourcing Imperative: Leveraging CDMO Expertise

The rapidly evolving therapeutic landscape has placed enormous pressure on pharmaceutical companies to innovate faster yet manage risks effectively. With the increasing complexity of drug formulations and the critical importance of sterility and precision, many organizations are choosing to outsource their fill‐finish operations to CDMOs that have already invested in state-of-the-art technology and specialized expertise. This outsourcing strategy allows companies to focus on their core competencies, such as drug discovery and clinical development, while relying on trusted partners to ensure product integrity and regulatory compliance.

Shawn Cain, senior vice president of development and manufacturing at PCI Pharma Services and general manager of PCI Bedford, highlighted this critical shift. “These varying demands, together with technological advancements including automation, isolators, robotics, and single-use systems, have enhanced efficiency by reducing manufacturing product loss, mitigating contamination risks, and increasing production flexibility,” he said. “Furthermore, outsourcing trends continue to drive growth, with pharmaceutical companies leveraging CDMOs to access state-of-the-art fill and finish capabilities without the need for significant capital investment to deliver their life-changing therapies.”

This strategic move toward outsourcing is not just a cost-saving measure—it represents a fundamental change in how pharmaceutical companies manage risk, ensure quality, and speed up time-to-market for innovative therapies. By collaborating closely with specialized partners, companies can better navigate the complexities of modern manufacturing while keeping pace with rapidly evolving regulatory standards. 

Technological Advancements Redefining Fill‐Finish Capabilities

Modern fill‐finish operations have witnessed transformative advancements over the past decade. The integration of automation, robotics, and single-use systems has dramatically reshaped the landscape, allowing manufacturers to achieve higher throughput and reduce downtime while maintaining stringent quality standards. These innovations have become essential in managing the dual demands of high-volume blockbuster drugs alongside therapies for orphan diseases, which often require smaller, more customized batch sizes.

Automation and robotics, for instance, have reduced manual handling, which in turn minimizes the risk of contamination—a critical factor when dealing with sterile injectable products. Similarly, isolators and Restricted Access Barrier Systems (RABS) have become invaluable in maintaining aseptic conditions, ensuring that even the most complex biologics are processed in an environment that meets or exceeds global regulatory standards.

In an era when patient-centricity is paramount, the evolution of drug delivery systems further underscores the importance of technological progress. Advanced drug-device combination products—such as autoinjectors and prefilled syringes—are now being introduced earlier in the clinical trial phases. These innovations not only support the development of user-friendly, at-home therapies but also play a pivotal role in ensuring that the final product meets real-world usability standards.

Balancing Diverse Market Demands

One of the most significant challenges facing fill‐finish service providers today is balancing the disparate needs of blockbuster therapeutics with those of niche, orphan disease products. On one hand, there is a growing demand for high-volume production capabilities to support widely used treatments like vaccines and biologics; on the other, personalized medicine and gene therapies require agile, small-batch production solutions.

Peter Sölkner, managing director at Vetter, encapsulated this balancing act. “Fill and finish partners are now facing a need to balance evolving customer demands that require capacities supporting the coexistence of mega blockbusters and orphan disease drug products,” he said. “Another key driver is the continued growth of the home care sector leading to a rising demand for innovative drug delivery devices like autoinjectors and pens which allow patients to self-administer without a doctor being present.”

Sölkner added, “Pharma and biotech companies are developing new, innovative products with increasingly complex compounds and sometimes lack the proper capacity and capabilities to manage manufacturing in-house, which leads them to seek collaborative partnerships with pharmaceutical service providers. This is especially the case for challenging drug products which require specialized manufacturing knowledge that only certain CDMOs possess.”

This dual demand requires fill‐finish providers to maintain flexible operations and to continually invest in both capacity and technological innovation. The ability to swiftly pivot between large-scale production and the meticulous requirements of personalized therapies is emerging as a key competitive differentiator in the market.

Overcoming the COVID-19 Impact and Quality Challenges

While the early days of the COVID-19 pandemic drove a massive influx in fill‐finish demand, many expected that the subsequent decline in COVID-related therapies would lead to a contraction in overall market activity. However, the dramatic growth in GLP-1 products has more than offset any such decline, resulting in a sustained upward trend in demand. Moreover, the pandemic served as a crucible, exposing vulnerabilities in quality and capacity that have reshaped market expectations.

Quality issues experienced during the rapid scale-up of COVID-related projects have led to a market-wide shift toward higher-quality suppliers. Jon Best, director of biologics business development at AbbVie, reflected on this evolution.

“The decline in COVID-related therapies was expected to drive a decrease in total fill-finish demand. However, the tremendous growth in GLP-1 products seemed to have more than offset the COVID related decrease,” he said. “There has been a notable shift toward pre-filled syringes in terms of product format, though demand for liquid and lyophilized vials remains very high. More advanced and complex therapeutics will likely continue to drive this general growth. At AbbVie, we have noticed that past quality challenges during the volume and project runup during COVID has driven the market back toward higher quality suppliers. There have been significant inquiries for antibody-drug conjugate (ADC) fill-finish also, since there are only a handful of experienced ADC contract manufacturing organizations (CMOs) with isolator fill-finish technology, and experience in scale up and commercial launch.”

This renewed emphasis on quality has not only strengthened the credibility of CDMOs but has also reinforced the importance of stringent process controls and regulatory adherence. As companies demand ever-higher quality standards, fill‐finish providers are compelled to continuously upgrade their infrastructure and processes.

Addressing the Complexity of Modern Therapeutics

The modern therapeutic landscape is defined by an ever-growing portfolio of complex drug products—from biologics and gene therapies to mRNA-based vaccines and monoclonal antibodies. These therapies, which often involve intricate formulations and require advanced sterile processing, have fundamentally altered the demands placed on fill‐finish operations.

Frank Tagliaferri, chief scientific officer at Pace Life Sciences, noted the ongoing growth driven by these advanced therapies. “The demand for fill-finish continues to grow due to the rising number of biologics and gene therapy products being developed, predominantly for parenteral administration,” he said. “The increasing introduction of more convenient and user-friendly routes of administration for these products, such as semaglutides, has also significantly contributed to the demand for more manufacturing capacity.”

Similarly, Vincent Villegas, senior director of commercial operations and strategy at Jubilant Hollisterstier, emphasized the influence of the COVID-19 vaccine development legacy.

“The success of the mRNA-based COVID-19 vaccine and the increased use of biologics like monoclonal antibodies has drawn increased interest in therapeutic options involving fill-finish,” he said. “Manufacturers with experience developing the COVID-19 vaccine will have the infrastructure and technical know-how to produce safe and effective mRNA drugs for clinical and commercial use.”

The inherent complexity of modern therapies necessitates a robust and adaptive fill‐finish capability that can handle everything from high-volume production runs to the meticulous requirements of advanced, individualized treatments. The need for specialized expertise in aseptic processing and contamination control is more critical than ever, ensuring that even the most delicate formulations are manufactured to the highest standards of safety and efficacy.

From Service Provider to Strategic Partner

The relationship between pharmaceutical companies and their fill‐finish partners is evolving. No longer is the model purely transactional, with service providers functioning merely as external vendors. Instead, a growing number of companies are embracing a true partnership model—one that emphasizes collaborative problem-solving, shared expertise, and a mutual commitment to delivering the highest quality products to patients.

Tony Murray, director of business development operations at Selkirk, captured this paradigm shift. “We’ve seen a shift away from a service provider-only model to a partnership model, where the teams work together to ensure consistent and quality products are delivered to patients,” he said. “Drug innovators can leverage the skilled expertise of a fill and finish facility to effectively manufacture drug products, allowing their internal teams to focus on innovative challenges for new products.”

Murray continued, “Additional capacity and new facilities were built during the pandemic, and companies focusing on multiple modalities (syringes, lyo, vials) will be key drivers for growth. Time and effort spent developing strong partnerships, rigorous quality expectations, and modality expertise simplifies the overall supply network. There also is a need to move through the clinical phases to succeed or fail faster, which is driving faster development cycles.”

This partnership model is especially beneficial in an era when speed-to-market is critical. By working closely with CDMOs, pharmaceutical companies can accelerate clinical development, rapidly iterate on product designs, and ensure that manufacturing processes are optimized well ahead of commercial launch. This collaborative approach not only reduces time and cost but also fosters innovation by leveraging the specialized technical expertise of fill‐finish partners.

Innovations in Patient-Centric Drug Delivery

As the focus on patient-centric care intensifies, so too does the need for innovative drug delivery solutions that enhance the patient experience. Traditional vial and syringe formats are increasingly being supplemented—or even replaced—by more user-friendly options such as pre-filled syringes, autoinjectors, and wearable devices. These novel drug-device combinations are designed with the end-user in mind, providing greater convenience, reducing the need for healthcare professional oversight, and ultimately empowering patients to manage their conditions more independently.

Chelsea Keeton, senior manager of marketing and public relations at Grand River Aseptic Manufacturing, elaborated on this trend. “The pharmaceutical landscape has shifted significantly towards biologics and biosimilars, with a greater emphasis on delivering positive patient experiences. Innovations in patient-centric drug delivery are rapidly evolving, particularly regarding subcutaneous (subQ) administration,” she said. “The focus on enhancing user experience is driving increased demand for fill-finish services involving pre-filled syringes and cartridges, often used in autoinjectors or wearable devices that patients can utilize outside of a medical setting. These products typically incorporate complex formulations and, like all sterile injectables, are subject to stringent regulatory requirements. As a result, there has been a growing demand for expert CDMO services that adhere to the latest regulatory guidelines, such as Annex 1.”

Keeton added, “It is crucial for experienced fill and finish manufacturers to implement advanced technologies and contamination prevention strategies to ensure the integrity of the products. Additionally, the rising trend towards personalized medicine—encompassing gene and cell therapies—has created a need for specialized fill and finish services that can accommodate smaller batch sizes and niche product specifications. These converging factors have contributed to a strong growth trajectory in the fill and finish services sector, reflecting the dynamic nature of the pharmaceutical industry.”

The shift towards patient-friendly designs is not merely a matter of aesthetics; it has significant implications for adherence, treatment outcomes, and overall healthcare costs. By offering products that are easier to use and less intimidating for patients, companies can improve compliance rates and ultimately deliver better clinical outcomes. In turn, this drives further demand for fill‐finish services that can produce these innovative formats at scale.

Responding to Regulatory and Quality Imperatives

In an industry where even minor deviations from quality standards can have significant consequences, adherence to strict regulatory guidelines is non-negotiable. The introduction of updated regulatory frameworks—such as the 2023 revision to the EU’s Good Manufacturing Practice (EU GMP) Annex 1 regulation—has underscored the need for advanced manufacturing technologies that minimize contamination risks and streamline production processes.

Ewelina Zielińska-Rosik, production division manager at Mabion Biologics CDMO, underscored the critical role of regulatory compliance in today’s fill‐finish landscape.

“Recently, the need for fill and finish services has skyrocketed due to the rise of biologics, vaccines, and ATMPs. As the pharma world pivots to biologic drugs, which are trickier to craft than the usual small molecules, the call for expert fill and finish services has intensified,” she said. “Unlike small molecules, biologics require highly specialized, sterile filling processes to maintain their safety and efficacy. The rise of monoclonal antibodies, gene therapies, and mRNA-based treatments has made expert fill and finish solutions essential to ensuring product integrity from production to patient delivery.”

She continued, “The COVID-19 pandemic further highlighted the critical role of these services, with global vaccine production requiring fast, scalable, and compliant filling solutions. At the same time, regulatory agencies have tightened quality expectations for biologics, making precision, sterility, and compliance non-negotiable. Pharma companies increasingly turn to specialized CDMOs with state-of-the-art facilities and expertise in aseptic filling to meet these evolving standards efficiently. As pharma companies continue outsourcing to experienced partners, fill and finish services remain a vital component in bringing next-generation therapies to market safely and efficiently.”

This regulatory evolution has forced both manufacturers and CDMOs to invest heavily in advanced technologies and rigorous process controls. The emphasis on quality and compliance not only protects patient safety but also serves as a competitive differentiator in a crowded marketplace. For pharmaceutical companies, partnering with fill‐finish providers that consistently meet—or exceed—regulatory standards is crucial for maintaining market credibility and ensuring long-term success.

Strategic CDMO Partnerships: A Key to Future Success

The growing complexity of modern therapeutics, coupled with the increasing regulatory demands, has led to a strategic shift in how pharmaceutical companies manage their manufacturing pipelines. By outsourcing fill‐finish operations to specialized CDMOs, companies are not only able to accelerate their product development cycles but also tap into a wealth of technical expertise and operational efficiencies.

Maeve McQuade, director of CDMO business development at August Bioservices, highlighted the strategic advantages of this model. 

“Pharmaceutical companies have increasingly shifted their strategy to partnering with CDMOs to bring new therapeutic treatments to market, allowing them to focus on their core competencies,” she said. “This shift has driven significant demand for specialized fill and finish services. Among the most sought-after capabilities are engineering and technical thought leadership to support the complex process control required for many new innovative drug delivery platforms. Additionally, integrated analytical capabilities are essential to properly characterize and control these advanced formulations, ensuring quality and regulatory compliance.”

By aligning with CDMOs that offer robust, scalable, and technologically advanced fill‐finish solutions, pharmaceutical companies can reduce the capital investment required for in-house facilities while accelerating time-to-market. This strategic partnership not only streamlines the manufacturing process but also fosters innovation—allowing drug developers to concentrate on pioneering new treatments and improving patient outcomes.

The Biotech Revolution and the Rise of Startups

Over the past few decades since the completion of the Human Genome Project in 2003—a turning point in biomedical research that opened the door to countless innovations in drug discovery and development—breakthroughs in genetics and molecular biology have given rise to thousands of biotech startups, each vying to develop the next breakthrough therapy. However, many of these startups lack the in-house capabilities required for large-scale manufacturing, particularly when it comes to the specialized needs of fill‐finish operations.  

Neal Higgins, program manager of commercial technical development at West Pharmaceutical Services, offered insight into this aspect of the market.  

“The completion of the Human Genome Project, led by an international team of scientists to map and sequence human DNA, stands as one of the most groundbreaking scientific achievements in history,” he said. “This milestone laid the groundwork for advances in biology and opened new possibilities for developing treatments for a wide range of diseases that were once considered untreatable. These breakthroughs led to the rise of thousands of biotech startups, many of which lacked the capacity for drug development, clinical trial materials, or commercial manufacturing. As a result, there has been a significant increase in demand for CDMOs. But biotech startups are only one piece of the jigsaw.”

Another driver behind increased demand for fill finish services, according to Higgins, is an ever-increasing demand for biologic molecules, many of which are injectable, as they demonstrate efficacy in treating various acute and chronic diseases. “In 2023,” he said, “there were over 6,000 injectables across Ph I/II/III of the clinical pipeline vs. ~3,000 injectables in 2017; of the ~6,000 injectables in pipeline in 2023, more than 80% were biologics, clearly demonstrating the trend in growth of biologics.”

Then there is the 2023 revision to the EU’s GMP Annex 1 regulation, which helped build demand for advanced technologies such as Restricted Access Barrier Systems (RABS) and isolators, robotics and single use systems, according to Higgins. “These technologies drive down contamination risks and improve efficiency, which ultimately reduces risk to the patient,” he said. “Not all companies are set up with these advanced technologies, so they naturally look to outsource their fill and finish to concentrate on their core competencies.”

Moving forward, the explosion of biotech startups, coupled with the impressive growth in injectable biologics, is transforming the fill‐finish market. With over 6,000 injectables now in the clinical pipeline—more than double the number seen just a few years ago—the demand for sophisticated fill‐finish services is not only strong but also set to increase further as more novel therapies reach the market.

Stevanato Group RTU Solutions 
Stevanato Group’s EZ-fill RTU solutions create a streamlined, agile and cost-effective fill-finish contract manufacturing process that meets both, industry needs and regulatory requirements. The EZ-fill platform offers a fully integrated pre-sterilized containment solution which includes vials, cartridges and syringes that are pre-washed, pre-siliconized (where applicable), pre-sterilized and ready to fill. EZ-fill solutions include:
• EZ-fill Vials and Cartridges are available in both nest and tray configurations with single and double steribags in compliance with ISO 21882 and ISO 21881.
• EZ-fill Cartridges can be supplied as pre-capped or uncapped and they come in a wide range of formats, from small volume (1.5ml, 2ml, 3ml) to large volume (5ml, 10ml, 20ml).
• EZ-fill Vials are available in various formats (2R,4R,6R,8R,10R,15R,20R,25R,30R,50R) and they can be provided in either standard or upside-down configurations.
The Nest-and-Tub configuration is compatible with multi-purpose fill-finish lines, while tray is compatible with a wide range of fill-finish processes, from manual to automatic, including high-speed lines. For more information visit: https://www.stevanatogroup.com/en/offering/drug-containment-solutions/ez-fill-platform/