UK ‘gaining pace’ with early-stage trials for advanced therapies

UK ATMP clinical trials continue to hold strong, representing 57 percent of all European trials in 2025, according to new data.

The Cell and Gene Therapy Catapult’s (CGT Catapult) UK 2025 Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database found that last year in the UK 193 ongoing trials focused on advanced therapies, “with 56 percent being early-stage trials, and 80 percent being commercially sponsored”.

Dr Jacqueline Barry, Chief Clinical Officer, CGT Catapult told EPR that the number of ATMP trials conducted in the EU in 2025 reinforces the nation’s position “as one of the world’s leading locations for advanced therapy development [and] … aligns with the UK Government’s ambition to increase the number of commercial clinical trials conducted domestically. The expanding trial portfolio is expected to translate into more therapies progressing into later‑stage development and, ultimately, improved access for patients to life‑changing treatments.”

Like most trials in 2024, over 80 percent of ATMP clinical trials investigated gene therapies in 2025, CGT Catapult noted.

This aligns with research by GlobalData showing that “oncology-focused CGT deals remain heavily skewed toward early R&D and gene-modified cell therapies”. In total, 35 percent of studies focused on oncology indications last year, CGT Catapult explained.

Irena Maragkou, Senior Healthcare Researcher at GlobalData, said: “As therapeutic CGT approvals increase, and the CGT market is expected to grow at a rate of 34.2 percent by 2031, companies must simultaneously prepare for sector-specific challenges such as regulatory complexity and manufacturing scalability. Therefore, biotech companies need to be strategic in investing in differentiated technologies and build execution capabilities to deliver clinical and commercial impact.”

Hannah Hans, Head of Pharma Strategic Intelligence at GlobalData, anticipates that globally in 2026, “strong drug pipelines and breakthrough clinical catalysts will drive the sector”.

For cell and gene therapies (CGTs) specifically, there is no approved therapy and only one product in a phase III trial for respiratory diseases, GlobalData noted. However, “ongoing research and development efforts within the wider CGT space” hold promise for future success in the space.

Matthew Durdy, Chief Executive, CGT Catapult, said: “With a supportive regulator and recent updates such as the increase to the NICE thresholds, the UK is well-positioned to benefit from the health and economic benefits of advanced therapy clinical trials.”

Pertinent to UK trials generally, MHRA is piloting a Route B notification scheme to help sponsors ready themselves for the new modifications process changes in clinical trial regulation expected this year.