Spokespeople: Barry Robinson and Matthew Mellon at Phoenix Equity Partners

We are seeing a period of transformation in the clinical trials market, driven by demand for higher-quality trial execution. This shift is helping sponsors bring innovative therapies to market more quickly, with new models and technologies addressing persistent challenges such as slow patient recruitment and fragmented infrastructure. Multisite Research Organisations (MROs) ⁽¹⁾ are increasingly at the centre of this evolution.

Renewed confidence in Europe

After years of stagnation, the European clinical trials market is entering a new phase of growth, valued at $22 billion in 2024, and is projected to expand 7% annually through 2030. For much of the past decade, progress slowed due to fragmented regulation and uneven national investment in the infrastructure required to conduct trials effectively.

The picture is now changing. The EU Clinical Trials Regulation has streamlined approvals through a single application portal, while initiatives such as the Accelerating Clinical Trials in the EU (ACT EU) programme, alongside renewed national investment in clinical research infrastructure, are restoring stability and rebuilding investor confidence across the European market.

Meanwhile, the world’s largest clinical trials market, the US, is facing headwinds. FDA budget constraints alongside the Inflation Reduction Act, are encouraging pharmaceutical and biotech sponsors to diversify trial locations. Europe, with its improving regulatory framework and growing delivery capacity, is particularly well placed to benefit with recent private equity activity reflecting this renewed confidence.

Key players in the clinical trials market

In this evolving landscape, three types of players dominate. Public and academic institutions, independent single-site operators, and the rapidly growing MROs that manage networks of trial sites.

Although overall clinical trial volumes in Europe have remained largely flat in the last 5-10 years, MROs have grown quickly as they have taken more and more market share. The MRO market is projected to reach close to $2 billion by 2030, outperforming traditional operators in recruitment speed, patient retention, and data quality. At the network level, larger MROs bring additional advantages, from reduced administrative burden to offering pan-European coverage across multiple therapeutic areas. This blend of performance and scale makes MROs central to the ecosystem and prime investment targets.

Expanding into complex therapeutic areas

Historically, MROs thrived in high-volume trials, such as infectious diseases and vaccines, where their recruitment capabilities could be deployed at scale. Increasingly, however, they are expanding into more complex therapeutic areas, including oncology and CNS. These trials often involve smaller, harder-to-reach patient groups that have traditionally been concentrated in hospitals or academic centres.

By expanding patient databases, strengthening links with healthcare professionals, and investing in specialist expertise, MROs are gaining access to these harder-to-reach populations. As a result, they are becoming credible partners in highly complex trials. This evolution broadens their role in modern medicine and strengthens their long-term investment case, as sponsors seek partners able to deliver across both high-volume and specialist segments.

The increasing importance of technology-enabled studies

Alongside therapeutic innovation, technology is set to transform the clinical trials sector. There is an opportunity for AI to automate data input and reporting, accelerating processes such as patient recruitment and matching participants to appropriate trial requirements – tasks that are currently manual and time-consuming. Well-capitalised MROs are well positioned to lead this change. By embedding digital infrastructure and partnering with technology vendors, they can deliver faster recruitment and cleaner data.

Although adoption has historically been slow, due to the heavily regulated nature of drug development, technology is poised to become a defining feature of next-generation trials, further enhancing the MRO value proposition to sponsors.

The future belongs to scalable, connected networks

As clinical trials become more complex, global, and data-driven, the ability to operate as part of an integrated network will define success. Independent sites, while often highly capable locally, face growing challenges in technology investment, recruitment reach, and compliance overheads. MROs, by contrast, offer sponsors a scalable, tech-enabled solution that meets evolving expectations for speed, quality, and coverage.

Phoenix recently invested in FutureMeds, a UK-headquartered but pan-European MRO with 28 sites across seven countries, as we believe the future of clinical trials belongs to those who can combine patient access, operational excellence, and digital capability – where MROs, like FutureMeds, are leading the way.

“What differentiates the new generation of MROs is the ability to reach patients that traditional models struggle to engage, whilst offering sponsors a single, trusted partner across multiple countries. Our network at FutureMeds connects communities, clinicians and technology in a way that helps trials move faster and deliver better outcomes. We believe this integrated approach is essential to the next decade of clinical research.”

Dr Radek Janiak, Chief Executive Officer of FutureMeds

(1) MROs may also be referred to as Site Management Organisations (SMOs)