INTRODUCTION

The global injectable drug delivery market is projected to reach $1.11 trillion in 2030, driven by the surge in chronic dis­eases, the growing adoption of biologics, and the desire for pa­tient-centric administration routes.¹ At the same time, therapeutic innovations like RNA-based platforms and gene therapies are testing the technical limits of conventional fill finish infrastructure.

What was once a system designed for large-volume vial fills must now accommodate prefilled syringes, autoinjectors, car­tridges, and small-batch, high-value therapies. These diverse for­mats require different container components, production volumes, processing speeds, and sterility considerations. Contract development and manufacturing organizations (CDMOs) are also facing rising expectations around regulatory compliance, op­erational sustainability, and early phase technical collaboration.

For manufacturers, this means designing facilities and teams that are fast, compliant, and flexible. That flexibility must extend across container types and fill volumes, through late-stage scale-up, and across development models. Meeting this challenge re­quires investment in automation, data systems, and isolator-based design, but it also demands something less tangi­ble: a shift in mindset. In this environment, the most effective CDMOs are those structured to solve, not just supply.

The following examines how evolving therapeutic modalities, delivery systems, and regulatory expectations are reshaping the fill finish landscape. It explores how CDMOs can adapt infrastruc­ture, sustainability practices, and early development engagement to meet rising complexity with confidence. Each section highlights the strategic decisions manufacturers must make to build flexible, future-ready operations that can support a broader range of ther­apies and delivery formats.

BRIDGING TOMORROW’S THERAPIES THROUGH FUTURE-READY FACILITIES

Adapting to today’s demands means designing infrastructure for what comes next. Demand is shifting away from uniform, high-volume runs toward a mix of personalized treatments, de­vice-integrated formats, such as autoinjectors or microneedle array patches (MAPs) and rapid turnarounds. This shift is driven primarily by evolving patient preferences for simplified, self-ad­ministered options, with added pressure from healthcare buyers who are prioritizing simpler delivery options that are easier and safer to use.

Emerging formats like prefilled syringes, wearable injectors, and MAPs require infrastructure that can handle a range of vol­umes, container types and sterility conditions without compromis­ing operational efficiency. Facilities built around a small number of dedicated lines for specific formats are no longer sufficient on their own. Those optimized exclusively for a single container type will struggle to keep pace with the growing diversity of delivery systems and the operational demands they bring.

To address this, CDMOs are investing in flexible fill lines, iso­lator-based designs and modular cleanroom suites that support multiple formats and rapid changeovers. These approaches en­able smoother transitions from development to commercial scale, support both large and small batch sizes and better position CDMOs to respond to future shifts in patient need, modality, or market urgency.

COMPLIANCE IS A COMPULSORY DESIGN ELEMENT

The revision of Annex 1 of the EU Good Manufacturing Practice (GMP) guidelines in 2022 marked a turning point in sterile facility design. Among its most significant updates was a reinforced em­phasis on contamination control through advanced technologies, including the use of isolators, restricted access barrier sys­tems (RABS), and automation to reduce human intervention in aseptic environ­ments. While such systems have been available for years, the revised guidance now effectively elevates them to baseline expectations for regulatory compliance in sterile manufacturing.

This is evident not only in regulatory language but in how biopharma compa­nies approach outsourcing partnerships. There is now a clear expectation that filling lines minimize operator intervention, data integrity systems are robust and equipment can be validated to meet rigorous global standards.

With this shift in regulatory expecta­tions, retrofitting legacy lines is increas­ingly seen as a short-term fix that may leave manufacturers unable to keep pace with evolving standards and competitive timelines. As facilities age, their risk of fail­ing to meet evolving compliance standards increases.² By contrast, greenfield builds provide an opportunity to embed compli­ance from the outset by incorporating the most modern, future-ready approaches to aseptic processing and facility design to stay ahead of evolving sterility standards.

For decision-makers assessing infra­structure strategy or outsourcing partner­ships, this underlines the importance of long-term regulatory alignment. Facilities designed with these expectations in mind are more likely to earn regulatory trust, streamline tech transfers, and maintain consistent performance as product and format complexity increases.

SUSTAINABILITY IS A SHARED RESPONSIBILITY

The growing emphasis on early align­ment is mirrored in another area of ex­panding industry focus: sustainability. Drug developers are facing increasing pressure to account for the environmental footprint of their supply chains, from the materials used to the ways energy, water, and waste are managed during produc­tion.

This focus is prompting re-evaluation of how facilities are built and operated. Design choices that once prioritized throughput or footprint are now being re­assessed for their impact on resource effi­ciency. Technologies such as isolators can reduce the frequency of cleaning cycles and limit waste generation, while thought­ful process design can minimize batch loss and disposable consumption.

As regulatory and market expecta­tions continue to evolve, sustainability is becoming a strategic advantage. CDMOs that embed these considerations into their operations early are better positioned to align with client goals while also support­ing the lifecycle needs of increasingly com­plex therapies. By reducing material usage, optimizing line cleaning require­ments and enhancing energy and water efficiency, sustainability-oriented design helps improve operational efficiency and ensure manufacturing remains adaptable and cost-effective as therapies become more personalized and formats more di­verse.

HEALTHIER TOMORROWS ARE BUILT ON TODAY’S COLLABORATION

Many of the downstream challenges in injectable drug manufacturing originate from early decisions made without ade­quate input from those responsible for scale-up. Formulations that appear prom­ising in small-scale trials may behave un­predictably at larger volumes. Container materials, filling equipment, or facility lim­itations can introduce friction or delays, es­pecially when not factored in from the start.

As therapies become more complex and timelines more compressed, CDMOs are expected to participate earlier and contribute technical foresight, helping de­velopers avoid late-stage surprises. This includes evaluating how formulations will perform at scale, identifying material or equipment incompatibilities and under­standing how design decisions may affect throughput or product loss.

The modern CDMO role now extends beyond production. Leading partners are expected to contribute to formulation risk assessments, advise on container closure selection, validate compatibility with fill lines, and assess scale-up viability. These inputs help drug developers avoid mis­steps and make decisions that support long-term manufacturability.

Successful tech transfer depends on early alignment between teams, timelines, and technical expectations. It is not a hand-off, but a continuous collaboration. When that collaboration begins early, manufacturers are better positioned to de­liver a process that is robust and aligned with the goals of the overall development program.

WHAT IT TAKES TO DELIVER TOMORROW’S INJECTABLE INNOVATION

The demands facing injectable drug manufacturing are more dynamic than ever. Infrastructure must accommodate a broader spectrum of delivery formats, reg­ulatory expectations continue to elevate standards for contamination control and sustainability has become a core consid­eration rather than a secondary goal. Across every stage of development and production, alignment between stakehold­ers is essential.

Long-term success depends on de­signing flexible facilities that support di­verse modalities, embedding compliance and sustainability from the outset and fos­tering collaboration early in the develop­ment process to reduce risk and enable scalability.

These priorities are reflected in man­ufacturing approaches that prioritize ver­satility and responsiveness across technical, regulatory and environmental domains. As injectable therapies continue to diversify and evolve, these capabilities will become even more critical to ensuring safe, timely and effective delivery to pa­tients around the world.

Ultimately, the path forward lies in de­liberate coordination. Facilities, technolo­gies and partnerships must work in unison to support today’s therapies and prepare for those yet to come.

REFERENCES

1. Injectable Drug Delivery Devices Mar­ket – Growth (Size, Share), Segments, Regions, Competition & Trends Overview, Mordor Intelligence
2. Aging Facilities: An FDA Perspective, U.S. Food & Drug Administration

Tommy Schornak is Senior Vice President, Injectables at Kindeva Drug Delivery, where he leads the strategic growth and operational excellence of our global sterile injectables platform. With over 17 years of experience in pharmaceutical manufacturing and site leadership, he has worked across some of the industry’s most complex CDMO environments — driving large-scale operations, leading high-impact teams, and delivering critical therapies to market. At Kindeva, he is focused on advancing injectable capabilities that support our customers’ commercial success and public health impact. From capacity expansion to continuous improvement, he is committed to fostering innovation, ensuring quality, and enabling long-term, scalable partnerships.