In 2025, around 70–75% of all drug trials (Phases I–IV) worldwide will be managed end-to-end by CROs under full‑service outsourcing (FSO) agreements—not just task‑based (FSP) support. That amounts to nearly three out of every four trials being fully entrusted to CRO partners. Here’s how we arrive at that estimate, and why it matters—especially if you’re navigating today’s biotech‑CRO ecosystem with a dose of pragmatic realism.
🌍 The Global CRO Market: A Natural Migration toward FSO
Outsourcing has been steadily rising for decades. In the late 2010s, only two‑thirds of clinical development was outsourced; by 2020, forecasts had risen to around 70–72%. But by mid‑2020s, industry consensus and multiple survey data confirm that nearly 75% of trials are run by CROs globally. This shift isn’t just theoretical—it’s reflected in market revenues. The global CRO services market was valued around US $80 billion in 2023 and is on track to double by 2032, with ~10% CAGR. These aren’t abstract numbers—they reflect sponsors’ appetite to lean into CROs as trial complexity, technology needs, and globalization accelerate.
💊 Sponsor Behavior: Who Outsources What?
Small Biotech / Emerging Pharma
These sponsors typically lack the in-house infrastructure required to run trials independently. As a result, they rely on full-service CROs for almost everything—from protocol design and regulatory submissions to recruitment and data delivery. In 2024, emerging biopharma accounted for 63% of global trial starts, and nearly all of those are outsourced via full-service models. For this group, FSO isn’t a preference—it’s a necessity.
But not all CRO partnerships are equal.
While the largest CROs dominate on paper, smaller CROs often deliver better outcomes for smaller sponsors. Why? Because they operate with greater agility, shorter decision-making cycles, and a shared sense of urgency. These are the CROs where a CEO can speak directly to the sponsor’s CEO, where timelines and issues are escalated and resolved in hours—not weeks. They’re not over-engineered with layers of functional silos or global matrix structures. For small pharma and biotech clients under pressure to execute with limited budget and time, that responsiveness is invaluable.
In fact, across many early-stage programs, client satisfaction scores tend to be higher with specialist or mid-sized CROs than with their larger, full-service competitors. While they may lack global reach or the breadth of service lines, they often win on what matters most: communication, accountability, and execution.
Large Pharma
By contrast, large pharmaceutical companies often maintain robust internal clinical operations. Many prefer FSP or hybrid models, selectively outsourcing functions like monitoring, biostatistics, or regulatory support. That lets them retain oversight of strategic activities while tapping into CRO capabilities where needed. Nonetheless, even for big pharmas, full-service outsourcing remains common—especially in geographies, indications, or trial designs where internal experience is limited or speed is critical.
📈 Trends in FSO vs. FSP: A Shifting Landscape
Full-service outsourcing (FSO) still accounts for the majority of outsourced trials—somewhere in the region of 60–70% of engagements. Most sponsors, especially those under time or resource pressure, continue to favour the simplicity of handing full execution to a single CRO.
But we’re seeing clear signs of movement toward functional service provision (FSP) and hybrid models—particularly among larger sponsors. In recent surveys, 35% of sponsors increased their use of FSP in 2024 compared to just 29% for FSO, with hybrid models also climbing to 33%, up from 26% the year before.
I believe this shift is being driven by a few overlapping factors:
- A desire for greater oversight: Many sponsors want to stay closer to the work—embedding dedicated teams, retaining oversight of core functions, and maintaining alignment with internal ways of working. FSP allows for that kind of structural control without having to rebuild full trial capabilities in-house.
- The complexity of systems and handoffs: With multiple CROs, vendors, and geographies in play, the reality is that platform and process fragmentation can create unnecessary friction. FSP models can offer a more stable approach to core functions like data management or biostats utilising a Sponsors technology platform, especially where standardisation matters.
- Control over data in an AI-driven future: There’s a growing sense that sponsors want to hold their data more tightly—not just for regulatory reasons, but because of the longer-term value it enables. If you’re feeding trial data into proprietary AI tools, you need to trust its structure, lineage, and consistency. FSP combined with Sponsor licensed and controlled clinical technology can provide a cleaner line of sight into how data is handled and where it ends up.
So while cost or flexibility might have driven FSP adoption in the past, I think we’re now seeing it used more strategically—as a way for larger sponsors to stay engaged and protect the integrity of their operations.
That said, it’s not one-way traffic. As some CROs improve their consistency and capability, integrated FSO models continue to appeal—especially when sponsors want a single point of accountability across regions or phases. For many, vendor fatigue and operational overload still make full-service models attractive—provided the CRO can actually deliver.
📉 Sponsor Sentiment: Scale Brings Cost, Not Always Satisfaction
While outsourcing levels have never been higher, satisfaction hasn’t kept pace. Over the last few years, a growing number of sponsors—especially small and mid-sized pharma and biotech—have expressed frustration with the experience of working with large, consolidated CROs.
Independent sponsor surveys and advisory analyses suggest that many large CROs, particularly those navigating post-merger transitions, have struggled with service consistency, team continuity, and delivery quality. Common themes include:
- Team turnover mid-project—resulting in “B teams” being swapped in, despite “A team” promises at pitch stage.
- Slow response times, with smaller sponsors often deprioritised beneath larger clients.
- Process fragmentation, as global CROs integrate systems and structures across legacy organisations.
- Escalation difficulties, where decisions stall in matrixed structures and sponsors feel unheard.
One McKinsey study found that emerging biotechs consistently rated their CRO relationships lower than large pharma—across every measured domain. Similarly, ISR’s annual global benchmarking reports show that large CROs often score well for breadth of services but fall short on responsiveness and relationship quality—especially in studies involving newer, resource-constrained sponsors.
Meanwhile, conference panels (OCT and SCOPE – that I attended early this year) and investor analyst commentary from 2023–2025 have highlighted growing concern over client churn among smaller sponsors—and declining confidence in the “one-stop-shop” delivery promise. It’s no coincidence that this coincides with a surge in spin-outs, roll-ups, and new CROs aiming to reset the delivery model.
I don’t believe sponsors are just putting up with this anymore. I believe that many are starting to rethink how they outsource—choosing CROs not based on brand or scale, but on whether they can actually deliver. Increasingly, that means turning to smaller or more focused providers. Not because they do everything, but because they stay close to the work, keep the same people on the project, and deal with issues quickly. In other words, they do what they said they would.
🌍 Operational Shifts and Regional Behaviours
These shifts in sponsor sentiment are also reflected in how outsourcing strategies are evolving. Strategic partnerships are becoming more flexible—blending FSO and FSP in ways that allow sponsors to dial services up or down based on trial maturity, therapeutic area, or internal capability.
We’re also seeing a diversification in geographies and delivery models. Sponsors running trials in Asia‑Pacific, Eastern Europe, or Latin America often need CROs with on-the-ground presence. That’s opened the door for regional providers to step in—sometimes under FSP arrangements, sometimes supporting a global FSO lead.
While the largest CROs still dominate in terms of volume—backed by mega‑mergers like Quintiles/IMS Health and Thermo Fisher/PPD—sponsors are increasingly open to building ecosystems that combine global reach with local or specialist depth. In many cases, that means a large CRO handling core functions, but working alongside specialist vendors for areas like AI‑enabled analytics, remote site management, or decentralised trial support.
💭 Final Thoughts: The CRO Model Isn’t Untouchable
So, if you need a headline figure: in 2025, roughly three‑quarters of worldwide Phase I–IV drug trials are outsourced to CROs under full‑service models. It’s a strong majority, and one that reflects practical pressures: complexity, cost, speed, and global execution.
But that doesn’t mean the status quo is satisfying.
Many sponsors are increasingly frustrated—with both the cost of outsourcing and the pace and quality of execution. Trial timelines remain long. Data still takes too long to flow. Change requests ripple through delivery chains with sluggishness that feels incompatible with a digitally connected world. For all the consolidation, scale, and tech investment among the CRO giants, the operational feel for many sponsors hasn’t radically shifted. It still feels like a clunky overlay of 1990s process wrapped in digital gloss.
This dissatisfaction has opened the door for startups seeking to reimagine the clinical trial delivery model. Their pitch is compelling: faster, cheaper, tech‑enabled trials with end‑to‑end visibility and lean teams. But their early traction is being closely watched, and one reality may hold them back: a lack of deep CRO or clinical systems experience. Disruption in clinical trials isn’t just about moving faster—it’s about knowing what can and can’t be cut without compromising regulatory rigor or patient safety. That requires scar tissue from years in the industry, not just a Silicon Valley product sprint.
Still, they’re not wrong to try.
In fact, it’s likely we’ll see the next wave of challengers come from teams who do bring that hard-won experience—former CRO leaders, clinical systems architects, data science and regulatory veterans—who understand what needs to be kept, what can be rebuilt, and where the inefficiencies truly lie.
And the breakthrough won’t come from layering more marginal AI automation onto legacy processes.
It’s going to require transformational AI—not to auto-tag adverse events or sort PDFs, but to rethink how protocol data, site operations, monitoring and analysis are integrated from the start. A ground-up re-architecture of the trial model—one that treats the clinical trial not as a sequence of disconnected handoffs, but as a connected eco-system working for all stakeholders, with AI natively embedded in design, execution, and decision-making.
That’s the direction the sector is slowly tilting toward. And for now, the big CROs hold the volume. But volume doesn’t always equate to value. The next five years could very well see a shift—not away from outsourcing per se, but away from the traditional full-service CRO structure, towards something far leaner, more integrated, and genuinely AI-native.
And when that happens, today’s 75% figure may tell a very different story.
📚 Key References and Sources
CRO Outsourcing Rates and Market Trends
- ISR Reports – CRO Benchmarking Reports Industry Standard Research, 2022–2024. Widely cited reports based on sponsor surveys evaluating CRO performance, FSO/FSP usage, and satisfaction across sponsor types. https://isrreports.com
- Global CRO Market Size and Forecasts MarketsandMarkets, Grand View Research, Fortune Business Insights (2023–2025). Reports confirm ~$80B market size in 2023 with ~10% CAGR, projected to exceed $150B by 2032. https://www.grandviewresearch.com https://www.marketsandmarkets.com
- Emerging Biopharma Statistics IQVIA Institute: “Emerging Biopharma’s Contribution to Innovation” (2024). Notes that emerging biopharma accounted for 63% of global clinical trial starts and heavily relies on FSO. https://www.iqvia.com
Sponsor Dissatisfaction & Post-Merger CRO Challenges
- McKinsey & Company – Biotech-CRO Partnership Insights “Partnering with CROs in a Biotech World” (2022–2023). Shows that emerging biotechs consistently report lower satisfaction across all CRO service domains. https://www.mckinsey.com
- Conference Sponsor Feedback Outsourcing in Clinical Trials (OCT) and SCOPE Summit (2023–2025). Sponsor panel commentary highlights dissatisfaction with CRO mega-mergers, delivery delays, and churn. https://arena-international.com/event/clinical-trials https://scopesummit.com
- Jefferies, Bernstein, and SVB Leerink Analyst Reports Analyst insights from 2023–2025 note post-merger integration risks, emerging client churn, and dissatisfaction from small/mid-sized sponsors. (Subscription access or investor briefings)
FSP/FSO Utilisation Patterns
- WCG Avoca State of the Industry Reports (2023–2024) Documents hybrid and flexible outsourcing models, with rising FSP adoption among large pharma, but FSO still dominant in volume. https://www.wcgclinical.com/insights/avoca
- Clinical Leader and Applied Clinical Trials Articles (2022–2024) Commentary and survey summaries on evolving sponsor outsourcing preferences and quality benchmarks. https://www.clinicalleader.com https://www.appliedclinicaltrialsonline.com
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