The contract development and manufacturing organization (CDMO) sector has moved from supporting act to co-star. In many therapeutic areas – and particularly in sterile injectables and complex modalities – CDMOs now rival, and sometimes surpass, pharma sponsors in operational reach and technical breadth.
The shift reflects a convergence of forces: the rise of biologics and long-acting injectables, the continued aftershocks of COVID-19 on supply chains and regulatory expectations, the policy push toward onshoring, and the growing centrality of patient-centric delivery formats such as prefilled syringes, pens, autoinjectors, and wearables.
As a result, outsourcing is no longer merely a capacity release valve; it is a strategic lever for speed, resilience, and access to specialized experience. The global CDMO market is projected to grow steadily this decade; estimates vary by methodology, but reputable sources peg 2024/2025 market size well into the hundreds of billions with high-single- to low-double-digit CAGR through 2030. That growth is propelled by the simple fact that modern pipelines require capabilities few sponsors maintain in-house, at the scale and quality regulators and patients expect.
From my vantage point at PCI, the industry is at an inflection point. Winning in this new era demands three things in combination: a quality mindset that is genuinely non-negotiable; a service model that enables faster, better decisions; and an operating system that delivers agility without sacrificing scale. The prize is not abstract. It is measured in therapies launched on time, shortages avoided, and patients living better, longer lives.
The macro forces reshaping the market
Oral solid dose medicines remain essential, but the broad application of small molecules have largely been exhausted. The spotlight has shifted decisively toward biologics and injectable formats, with GLP-1 receptor agonists offering the clearest example. Originally developed for type 2 diabetes, GLP-1s are now transforming obesity care and are being investigated for a range of cardiometabolic and even neurodegenerative conditions. Prescription volumes have risen at an extraordinary pace – around 38% annually from 2022 to 2024 – and forecasts suggest global sales could exceed $100 billion by 2030. That trajectory is creating sustained pressure on sterile capacity, device assembly, and the supply of components. Even with oral GLP-1 candidates progressing through pipelines, demand for advanced fill-finish and device capabilities will remain high for years to come.
Layered onto this is the long shadow of COVID-19, which forced an unprecedented expansion in sterile manufacturing and exposed vulnerabilities in glass, rubber, and equipment. Five years on, those lessons continue to shape regulatory scrutiny, procurement strategies, and client expectations around resilience and surge capacity. What was once a crisis response has become embedded as a structural requirement: sponsors and regulators now assume redundancy and agility must be built into every supply chain.
Alongside these pressures, patient-centricity has emerged as a defining principle of therapy design. The evidence base for safe self-administration is robust, and delivery platforms such as pens, autoinjectors, and on-body systems are now firmly established. For patients, this means greater independence and convenience; for manufacturers, it means heightened expectations around device integration, usability, and reliability. The result is a rapidly growing device market, with autoinjectors alone forecasted to expand at a CAGR in the mid-teens through 2030, reflecting the momentum behind home-based care.
Geopolitics is another accelerant. Policy signals are clear: governments want greater control over critical medicine supply. The U.S. BioSecure Act, though still evolving, has already triggered contingency planning among large sponsors, with the explicit goal of reducing reliance on overseas production by the early 2030s. That shift is driving investment back into North America and Europe, rewarding CDMOs that can provide regionally redundant capacity and supply-chain resilience.
Finally, the funding environment is reshaping how drugs are developed. Drug development has always been a billion-dollar, decade-long, high-risk journey. In today’s tighter capital cycles, companies have less freedom to pursue multiple indications in parallel as hedges against failure. Increasingly, investment is concentrated on the single, most promising pathway. That reality magnifies the importance of CDMOs that can de-risk scale-up, safeguard timelines, and present data in ways that support rapid, confident decision-making.
What separates good from great: quality, service, and agility-at-scale
In sterile manufacturing, quality is the bedrock. Recent years have seen a number of high-profile enforcement actions and observation trends tied to aseptic controls, data integrity, and contamination risks. The U.S. FDA issued 190 warning letters to drug and biologics manufacturers in FY2024, with more than a hundred triggered by inspection findings; aseptic operations and data integrity remain recurrent themes. For patients, payers, and sponsors, the tolerance for failure is shrinking, and rightly so.
Furthermore, clients don’t outsource for a data dump; they outsource for expert judgment. They want to make complex decisions quickly and confidently: changeover strategies, lot sizes, tech-transfer timelines, regulatory mitigations, device options, and supplier substitutions. Fundamentally, it’s about transparency: understanding what’s available, when, and with what trade-offs. Decision-enablement platforms that expose live capacity, material status, and risk flags help teams move from endless email threads to action. Our proprietary digital supply chain management platform pci | bridge™ is designed for exactly this use case, reducing latency between evidence and decision.
The historical trade-off – boutique flexibility versus big-plant throughput – is increasingly untenable for sponsors. Programs may need an intimate development setting in early phase and then a rapid pivot into high-throughput device assembly at commercial launch. A decentralized network can offer both: client intimacy and prioritization at the site level, with the safety net of multi-regional capacity and harmonized quality systems.
Strategy in practice: where we’re investing (and why)
Thought leadership should translate into operating choices. The following areas illustrate how PCI – and, I would argue, the industry’s forward-leaning CDMOs – are preparing for the next decade.
1) End-to-end injectables and device integration.
Prefilled syringes and cartridges in the U.S. and EU; high-speed assembly for autoinjectors, safety syringes, pens, and on-body systems; and rigorous in-line vision and leak-test analytics. At peak rates, state-of-the-art lines can assemble 200+ finished devices per minute. That’s not an exaggeration; it’s essentially aerospace-grade systems engineering applied to drug delivery. Demand signals are unlikely to soften soon: GLP-1s alone are forecast to roughly triple in market value by 2030, and the autoinjector market is on a similar growth trajectory.
2) High-potency oral solid dose (OSD).
Potent small molecules remain critical, particularly in oncology. We built new capacity in the UK ahead of the curve – before the constraint was obvious – precisely because sponsors need reliable partners who won’t force “hard choices” between accounts. We’re evaluating complementary high-potent OSD capacity in the U.S. to mirror that philosophy regionally.
3) Lyophilization as a core competency.
Freeze-drying is equal parts science and craft. Scale matters, but so does process development – the cycle design, cake structure, residual moisture, and reconstitution performance that drive product stability and patient experience. Market demand for lyophilized products is projected to rise strongly over the decade as biologics and complex injectables proliferate, and as sponsors seek longer shelf life and cold-chain resilience.
4) Clinical trial supply (CTS) as a “window to the future.”
Managing thousands of trials globally gives a privileged view of what’s coming several years before commercial reality. Right now, antibody-drug conjugates (ADCs) are the standout example. Depending on the dataset, dozens of ADCs are in late-stage development, with hundreds in the broader pipeline; recent M&A underscores the strategic stakes as big pharma buys or partners for access. For CDMOs, the implication is clear: invest in targeted containment, conjugation-friendly workflows, and analytical depth, but tailor solutions to the true potency and risk classification of each program rather than defaulting everything to “most potent possible.”
5) Digital infrastructure that shortens time-to-decision.
Beyond MES/LIMS hygiene, sponsors increasingly expect real-time visibility across material availability, slotting, yield trends, deviation closure cadence, and device component inventory. A “single version of the truth” reduces friction across tech transfer, PPQ, and commercial ramp, and it’s where service excellence increasingly lives.
How we partner: talent, technology, and tri-partite integration
Complex therapies demand more than machines. They require a three-way fit between the drug (its formulation and critical quality attributes), the technology (lines, components, and software), and the people (scientists, engineers, and operators). That’s why we invest as much in process science and engineering talent as in hardware – and why we cultivate bi-directional partnerships with equipment and component suppliers. Early co-development and stress testing reveal failure modes before they become audit findings or, worse, market recalls.
On the bench-to-plant continuum, Phase 1/2 work is where a product is most vulnerable – every datapoint matters, and the right adjustments can be the difference between a dead end and a viable path. Phase 3 is industrialization rehearsal: can we reproducibly make this at scale, within the process window, with the right device integration and human-factors performance? That’s where CDMO problem-solving earns its keep.
Regulatory scrutiny has tightened across sterile operations post-pandemic. Public warning letters highlight recurring themes: inadequate aseptic practices, environmental monitoring gaps, weak data integrity controls, or poor CAPA effectiveness. No CDMO, however sophisticated, is immune to drift; the only durable stance is one of humility, continuous improvement, and openness with clients. Transparency about issues, options, and timelines is how trust is built – and how programs stay on track when experiments don’t yield the hoped-for results.
Policy-driven onshoring is real, but so is the global nature of science and supply. The BioSecure Act has already pushed large pharma to draft contingencies and re-map critical paths. We expect sustained investment in U.S. and EU capacity – particularly for sterile fill-finish and device integration – alongside selective expansion in Asia. The latter is essential for clinical supply, proximity to patients, and long-term commercial access, but it requires nuance: Asia is not a monolith; regulatory and geopolitical realities are diverse and dynamic. The winners will be those who balance regional redundancy with thoughtful market entry.
What’s next: complex modalities, niche scale, and culture
The next wave of therapies will test the CDMO model in new ways. Antibody–drug conjugates (ADCs) exemplify the challenge: they are highly specific, extremely potent, and operationally complex. Market forecasts vary, but consensus points to strong double-digit growth through 2030, with an expanding late-stage pipeline driving demand. The task for CDMOs is to design facilities and workflows that can manage conjugation-capable materials, advanced containment, and sophisticated analytics – while avoiding the kind of over-engineering that inflates costs and makes niche programs commercially unviable.
Not every pipeline success will be a blockbuster, and in fact many will never require more than a few thousand vials annually. Rare disease therapies and small-volume oncology products demand a “small is beautiful” mindset: cost-effective, flexible capacity that can scale down as effectively as it scales up. Achieving this balance – serving ultra-niche programs without compromising the responsiveness required for global launches – will distinguish the most adaptable networks from the rest.
Beyond injectables, oral technologies are also entering a new era. Targeted protein degraders (TPDs), for example, represent one of the most promising small-molecule modalities in oncology and immunology. Unlike traditional inhibitors, TPDs work by harnessing the body’s own protein-disposal machinery, effectively tagging disease-causing proteins for destruction. Many candidates are being developed in oral solid dose form, which raises new challenges in formulation, stability, and bioavailability – but also creates opportunities for CDMOs to bring together high-potency expertise, advanced analytics, and patient-friendly delivery in a single package.
Ultimately, though, technology and scale are only part of the equation. Machines do not serve patients – people do. That is why culture matters. Many of PCI’s acquisitions have been founder-led businesses where service was the defining competitive advantage. Preserving that entrepreneurial reflex is deliberate: it keeps us accountable, ensures speed, and helps every client – whether a major pharma sponsor or an emerging biotech – feel like a true partner rather than a purchase order.
Bringing it back to the patient
For me, this topic isn’t purely theoretical. My wife is insulin-dependent and also lives with the aftermath of a heart attack and bypass surgery. Every day she follows a complex regimen – some thirty medications across morning and night – that stands between stability and risk. Insulin is immediately life-critical: without it, an insulin-dependent patient’s health can deteriorate in a matter of days. The other medicines may not carry the same urgency, but they determine the difference between basic survival and real quality of life. When drug shortages hit, or a batch fails because basic aseptic discipline slipped, someone’s spouse, parent, or child pays the price.
That is why quality is non-negotiable. That is why service – decision-enablement, transparency, responsiveness – matters. And that is why the CDMO operating model must pair agility with scale, not trade one for the other.
Closing argument
The next decade of pharma will be defined by patient-centric delivery, complex modalities, and a policy environment that rewards resilience. CDMOs sit at the center of that transformation. Our job is to anticipate what’s coming, invest ahead of need, and make hard things look deceptively simple for our partners. At PCI, that means decentralized sites with harmonized quality, deep device and lyophilization expertise, digital tools that shorten time-to-decision, and a culture that treats every program like someone’s life depends on it – because it does.
If we hold that line – quality first, service as the differentiator, agility at scale – then the question will not be whether CDMOs can rise to the moment. It will be how far and how fast we can help this industry deliver.
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