Contract research organizations (CROs) play a pivotal role in supporting pharma and biotech companies, especially as big data, AI and other new technologies continue to shape the drug development landscape. With 4,321 CROs operating in the US alone in 2024, the global CRO market is expected to grow from $92.27 billion in 2025 to $175.53 billion by 2032, reflecting a CAGR of 9.6%. This trajectory marks not only growth, but the evolution of the sector’s capabilities and strategic importance.
Sponsors need a CRO that has deep therapeutic expertise and regulatory knowledge, and that can accelerate drug development timelines without compromising on data quality or integrity. In many cases, sponsors are looking for specialists. Almost 8 in 10 pharma and biotech companies feel a ‘one-stop shop’ CRO model is no longer cost effective, with biotech companies, in particular, feeling that big CROs are failing to deliver.
CROs must elevate their performance. In today’s market, excellence isn’t optional. It is expected – and customers won’t tolerate less.
Rising complexity
In the past decade, trial complexity has increased by more than 10 percent and overall trial durations have increased by a third. These changes are driven by factors such as increased data inputs and evolving regulatory requirements. Turning complex clinical data into submission-ready evidence requires robust data collection, integration, and analysis. That said, the number of global companies with sufficient in-house expertise to meet this goal is limited. This talent gap is fuelling demand for CROs with the right mix of expertise in data management, biostatistics, and quality control. The right CRO can save between 6 and 11 weeks in the start-up phase of a clinical trial alone, so choosing the right partner is vital.
For example, in the rare disease space, a common obstacle is identifying eligible participants. Harnessing advanced statistical methods for trial design can help to overcome this obstacle by reducing the need for unfeasible large sample sizes. Bayesian trials using historical data, expert consensus, or both, to construct informative priors typically require substantially less participants than frequentist frameworks. However, utilizing these approaches effectively requires careful analysis and adjustment, which can only be delivered by specialists.
The evolving clinical trial landscape impacts more than just CROs; it is reshaping outsourcing strategies across pharma and biotech. While companies have historically been reluctant to share sensitive information with CROs, building long-term relationships with CROs as trusted strategic partners rather than simply service providers offers substantial benefits. Firstly, it allows CROs to build a better understanding of the aims and objectives of their partner, enabling a shift from reactive to proactive planning and risk mitigation. Strategic partners also enable feedback, learning and cycles of continuous development. In addition, when CROs are engaged early in the clinical trial life cycle, sponsors can make use of their geographical and regulatory knowledge more effectively.
Transparency at every stage of the process is key to success. Sponsor-CRO interactions built around the ‘I am the client you are my vendor’ framework invariably lead to breakdowns in communication, decreased quality and timeline disruption. With all stakeholders working together in partnership, there is increased knowledge of up and downstream activities, which in turn means teams can think more strategically and the study runs smoothly. In my experience, it is these relationships that reap the biggest benefits.
The clinical research sector is undergoing a profound evolution, and CROs must evolve with it. Faced with growing expectations for both operational agility and uncompromising quality, CROs must reimagine their roles. Success now hinges not on cost reduction, but on cultivating strategic alliances and recruiting – and maintaining – the right talent to deal with the increasing complexity of clinical trials.
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