As the rapid expansion of biologics continues, today’s high‑concentration injectables, prefilled syringes and cartridges, as well as suspensions, present unique challenges for manufacturers. Increasingly complex therapeutics with smaller commercial volumes such as cell and gene therapies, and high value, low volume drugs, have shifted demand for parenteral drug development and manufacturing services.  

Today’s contract development and manufacturing organizations (CDMOs) must be capable of manufacturing small batch sizes, handling complex biologics, and using novel processing technologies. Additionally, manufacturers must address operational complexities, demanding contamination controls, and the need for highly specialized fill-finish expertise and equipment. 

CDMOs specializing in the parenteral and sterile fill-finish space share insight on the biggest challenges and opportunities facing parenteral and sterile drug product manufacturers, the technologies and capabilities needed in today’s market, and the trends expected to further drive growth.

Challenges and Opportunities

Anticipating demand is key for CDMOs. Keeping abreast of market changes and trends and investing in the right capabilities early puts them in a position to provide much-needed capacity.

The growing complexity of today’s therapeutics presents significant challenges for parenteral and sterile drug product manufacturers. Among them, high‑concentration biologics, establishing proper containment, particularly for controlled substance and injectables for oncology. Additionally escalating equipment costs are straining pharma supply chains. Conversely, these drug products also present opportunities for CDMOs such as expanding capabilities, adding technologies and creating much needed flexibility for clients.

Mary Evelyn Hudson, Director, New Business Development Lifecore Injectables CDMO, said, “High‑concentration biologics, sensitive molecules, and other advanced modalities require exceptionally tight control over processing conditions, including shear, oxygen, and light exposure throughout formulation and filling. At the same time, manufacturers continue to face persistent supply‑chain constraints. Lead times for critical components—such as stoppers, syringes, format parts, and specialized equipment—often extend six to twelve months.” 

Furthermore, rising costs compound the issue, as sponsors must be prepared to invest in specialized parts required for complex product handling, according to Hudson. “Yet these same forces create clear opportunities. Companies that have made the necessary investments in capability, flexibility, and technical depth are now well positioned to differentiate themselves,” said Hudson.

One of the biggest challenges in this space is the growing capacity crunch—especially for highly potent compounds, noted Benoite Angeline, Vice President, Marketing and Communications at Simtra.  “As pipelines shift toward more complex and targeted modalities, pharma companies need partners who can manage the technical demands of advanced therapeutics while mitigating risk, controlling cost, and ensuring supply reliability. At the same time, manufacturers must maintain rigorous cGMP and ISO standards and protect the stability of sensitive biologics—all while operating in an increasingly complex aseptic environment,” Angeline said.

Moreover, regulatory scrutiny continues to intensify around contamination control and sterility assurance, requiring manufacturers to demonstrate superior aseptic capabilities, according to Nick Buschur, President & CEO of Woodstock Sterile Solutions. “Also, market demand is increasingly bifurcated, manufacturers must handle both small clinical batches and large commercial volumes efficiently, requiring unprecedented operational flexibility,” said Buschur. 

“For Brand companies working on BFS programs, limited quantities or very expensive API for initial work requires a partner that can perform development and clinical batch manufacturing at small scale. For generic companies it’s leveraging economies of scale to drive efficiencies and lowest possible commercial COGS,” Buschur added.

This leads to opportunities, according to Buschur, “Where BFS technology’s inherent contamination advantages—forming, filling, and sealing in one continuous automated process with minimal human intervention—positions it perfectly as the industry prioritizes sterility assurance. Unit-dose delivery formats are gaining preference for patient safety and convenience, playing directly to BFS strengths.”

Meanwhile escalating equipment and component costs are the biggest challenges, according to Lee Karras, Executive Chairman of Halo Pharma. “Suppliers have taken advantage of the willingness of branded pharma companies (especially GLP-1s) to pay above market pricing for these items, whereas manufacturers of generic parenteral products cannot absorb these costs. It’s further straining generic pharma supply chains which will lead to more drug shortages,” Karras said.  

All products on shortage are generics and 90% are injectables, Karras noted. The biggest opportunity, according to Karras, is onshoring of manufacturing, however, there are no incentives for generics, which is where the supply issues exist.

As a CDMO with a diverse array of pharma customers, Brian Blagg, General Manager San Diego & Global Head of Technical Operations for PCI Pharma Services, added, “Among the most pressing challenges is continuously assessing our resources, equipment and manpower to maintain a best-possible balance of demand and capacity for both clinical and commercial products.” 

Most new equipment projects involve lengthy timelines. This extended timetable requires CDMOs to keep a close eye on market signals, and to invest early in emerging trends rather than at their peaks, according to Blagg. “This puts a premium on securing and incorporating ample capacity well ahead of anticipated demand, and engaging smart, reliable equipment vendors and service partners who share our commitment to uncompromising quality and supply chain continuity,” said Blagg.

Technologies and Capabilities 

To accommodate the increasing complexity of today’s therapeutics, CDMOs are investing in multi-product lines with isolator technology. Supporting next‑generation therapeutics requires modern, flexible, and highly controlled manufacturing platforms. Hudson of Lifecore Injectables CDMO, said, “Isolator‑based systems have become central to enabling sterile operations for biologics, vaccines, and other injectables. Multi‑format fill‑finish lines—capable of processing vials, prefilled syringes, and cartridges—allow manufacturers to adapt to diverse product requirements without sacrificing efficiency.” 

Additionally, flexibility in pumping technologies, including both peristaltic and rotary piston systems, is increasingly essential, according to Hudson. “The rise of auto‑injector programs also demands more sophisticated mechanical precision, such as accurate plunger placement and component alignment. Enhanced process controls are critical for protecting sensitive molecules, and many CDMOs are expanding in‑house analytical capabilities to accelerate batch release,” Hudson added.

Meanwhile, Katie Falcone, Director of Technical Services, Integrated Systems at West Pharmaceutical Services, a provider of containment and delivery solutions for injectable medicines, said, “Modern biologics require highly precise, adaptable fill-finish technologies capable of tight control over headspace, plunger insertion, and dose accuracy. Manufacturers increasingly rely on platform-based strategies for component selection, enabling the use of pre-verified systems that reduce operational risk and streamline scaleup. In parallel, inline monitoring and early process ‑characterization tools are becoming essential for controlling variability and safeguarding overall product quality.”

Given the more stringent Annex 1 requirements and the ever-evolving therapeutics landscape, Brian Blagg of PCI Pharma Services said, “PCI is increasing investment in isolator technology across our network to align with next‑generation compliance standards and client expectations. Specifications concerning oxygen headspace limits, stopper placement accuracy, and other critical fill-finish parameters also continue to tighten, placing an emphasis on optimized performance for both existing and new filling equipment.”

Additionally, as batch complexity and volumes rise, advanced inspection systems are segueing from “nice to have” to “need to have,” according to Blagg. PCI is currently expanding its automated visual inspection capacity, allowing the company to maintain high throughput and ensure timely batch production without sacrificing mission-critical quality control.

Meanwhile, Lee Karras of Halo Pharma noted, the technologies and capabilities needed today include ready-to-use and multi-product lines vs older technology of dedicated lines for vials, syringes and cartridges, and that any new lines should be installed with full isolator technology for the highest degree of sterility assurance. Karras added, “Some products are suspensions so having recirculation technology integrated into the line is important.  GLP-1s require mostly cartridge and syringes plus an external device (autoinjector/pen system) which adds complexity.”

Adapting to the Current Manufacturing Environment

CDMOs are investing heavily in flexible, isolator‑based filling lines capable of handling multiple formats and a wide range of product complexities, according to Mary Evelyn Hudson of Lifecore. “Modular, scalable manufacturing suites are being developed to support both clinical and commercial volumes. Given persistent supply‑chain uncertainty, CDMOs are incorporating more robust planning and transparency into early project discussions. Some organizations are expanding in‑house analytical capabilities, reducing reliance on external laboratories and improving turnaround times,” said Hudson.

Leading CDMOs are investing in capacity expansion and technology advancement to meet surging demand while maintaining quality and delivery timelines, according to Nick Buschur of Woodstock Sterile Solutions. “The most successful CDMOS are offering seamless clinical-to-commercial capabilities within a single facility.  Operational flexibility is critical—the ability to handle small development batches alongside large commercial runs allows CDMOs to be true long-term partners rather than forcing clients to change manufacturers at scale-up,” said Buschur.

More CDMOs are seeking to implement fully integrated solutions that help pharma partners reduce the number of suppliers they have to manage, according to Brian Blagg of PCI Pharma Services. “PCI strives to support projects at various stages throughout their lifecycles – an “under one corporate roof” mindset that, for our pharma clients, reduces risk, shortens timelines and builds trust,” said Blagg.

At the same time, aligning regulatory expectations with diverse therapeutic modalities remains challenging, especially because RABS still make up a significant share of U.S. fill‑finish capacity, Blagg noted. “By applying strong ICH Q9 and Q10 risk‑management principles and embedding them within a fully integrated contamination control strategy, PCI can ensure consistent, compliant, and reliable outcomes—regardless of whether isolator or RABS technology is used. This approach, coupled with strategic investment in new isolator‑based fill‑finish equipment, ensures we continue to anticipate and address our clients’ evolving needs,” Blagg said.

Growth Drivers & Trends

Trends anticipated to further drive growth in the sterile fill-finish space include self-administered therapies and drug device combination products, long-acting therapies, complex biologics, and more resilient supply chains. 

“Innovation in long‑acting formulations and the shift toward self‑administration are increasing demand for sterile injectables, especially prefilled syringes and advanced delivery systems,” said Simtra’s Benoite Angeline. At the same time, complex biologics continue to accelerate growth. 

“Oncology remains a major driver, with ADCs and next‑generation constructs (like multi-specific and dual-payload ADCs) requiring highly specialized containment and analytical capabilities. RNA‑based therapies are also expanding, adding demand for facilities that can manage sensitive, temperature‑controlled products,” Angeline said. 

Meanwhile, supply chain resilience is another major catalyst according to Angeline. “Pharma companies are prioritizing localized, reliable manufacturing partners. The emergence of the first U.S. commercial‑scale ADC manufacturing capacity is expected to further boost domestic fill‑finish needs,” Angeline added.

Biologics will remain a dominant driver, and the rapid expansion of GLP‑1 therapeutics is expected to significantly increase demand for parenteral manufacturing, noted Hudson of Lifecore. Additionally, the shift toward at‑home administration is becoming more common. “Looking ahead, automation and AI‑enabled systems—from enhanced vision inspection to predictive analytics—are likely to become more prominent,” said Hudson.

Katie Falcone of West Pharmaceutical Services added, “Earlier adoption of fill- finish compatibility studies and scalability assessments during development will become more common as companies work to de-risk commercialization and accelerate timelines for combination product development.”

Additionally, supply chain resilience is becoming a strategic priority. According to Nick Buschur of Woodstock Sterile Solutions, this is driving sponsors to diversify manufacturing partners and favor North American capacity with proven scale, technology leadership, and that can deliver high quality with robust regulatory compliance records.  

As these trends continue to grow, sponsors are increasingly partnering with CDMOs that can provide high‑potency handling, development through to commercial manufacturing services, advanced automation, and flexible capacity.