For much of the past decade, the UK’s position in cell and gene therapy (CGT) has been framed primarily around scientific leadership — world-class academic research, early clinical innovation, and a strong translational base. But as advanced therapies move closer to routine clinical use, the factors shaping global competitiveness are beginning to change. The question is no longer just where the best science originates, but where complex, personalized therapies can be manufactured reliably, affordably, and at scale.
New industry data suggest the UK is starting to make progress on that front. Incremental gains in automation, digital manufacturing systems, and policy alignment are beginning to ease some of the cost, variability, and delivery constraints that have historically limited CGTs. At the same time, investment volatility and intensifying global competition mean those advantages remain fragile.
It is within this tension — between operational momentum and financial pressure — that the UK’s next phase in CGT is taking shape. Rather than a story of breakthrough science alone, it is increasingly a test of whether manufacturing efficiency, regulatory flexibility, and health-system pragmatism can translate promise into sustainable patient access.
Clinical trial momentum and ecosystem data
UK clinical trial activity offers a window into the sector’s operational capacity and underlying strength. New data from CGT Catapult show that the number of ongoing advanced therapy trials in the UK continued to grow in 2025, reaching 193, with 56 percent classified as early-stage. Roughly 80 percent of these were commercially sponsored, reflecting both the scale and complexity of running these studies, as well as the capital intensity required to bring advanced therapies from concept to clinical evaluation.
In 2025, UK ATMP trials hit a 7-year high, accounting for over half of all such trials in Europe, which is a very visible sign of ecosystem health and readiness.
—Philip Simister, OBN
In a global environment where many companies are narrowing pipelines and cutting costs, the persistence of early-stage activity suggests the UK retains the specialist sites, clinical expertise, and delivery infrastructure needed to support advanced modalities — even amid financial and operational pressures.
“In 2025, UK ATMP trials hit a 7-year high, accounting for over half of all such trials in Europe, which is a very visible sign of ecosystem health and readiness,” Philip Simister, Head of Science and Entrepreneur Advocate at OBN, told DDN. “These data coincide with the government’s recent series of regulatory announcements including a fast-track notification for certain eligible lower-risk drugs, 14-day assessments for new medicines going into Phase 1, and a goal to cut overall time to clinical trials by up to 90 days. This new, efficient framework for access to the clinic promises international competitiveness.”
From trial to approval
The UK’s clinical trial strength is increasingly translating into real-world patient access. As of 2025, close to 20 advanced therapy medicinal products (ATMPs) have been authorized for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), including gene-edited and CAR-T therapies such as Casgevy, Tofersen, and obe-cel.
A clear example is Autolus Therapeutics’ CAR-T therapy obe-cel, approved by the National Institute for Health and Care Excellence (NICE) in November 2025 for adults aged 26 and over living with relapsed or refractory B-cell acute lymphoblastic leukaemia. In clinical trials, 77 percent of patients achieved remission, with half showing no detectable cancer after three and a half years, and an average survival benefit of 15.6 months.
The journey of obe-cel — researched, developed, and manufactured entirely in the UK — exemplifies the sector’s ability to combine academic discovery, clinical testing, regulatory approval, and domestic manufacturing into a pathway that delivers tangible patient benefit.
Automation has become a necessity
Manufacturing has long been the rate-limiting step for CGT, with manual processes driving high costs, long turnaround times, and batch-to-batch variability. According to the BioIndustry Association’s latest report, UK-based technology providers are now showing that automation can materially improve efficiency and throughput. The UK has successfully scaled manufacturing from small academic centers to large, purpose-built facilities, now employing over 2,000 staff in dedicated manufacturing roles.
Companies including Autolomous, Cellular Origins, eXmoor Pharma and Sartorius are deploying digital quality systems, robotic handling, and single-use platforms to reduce labor intensity and accelerate batch release. In some cases, automation has shortened release timelines by as much as 86 percent, the report notes.
Autolomous’ digital manufacturing platform reduced quality assurance review times by 65 percent, saving the equivalent of 100 full-time employee days. Cellular Origins’ robotic cell-handling systems cut labor requirements by a factor of 16 and reduced costs by 51 percent, while Sartorius reported a 45 percent reduction in cost of goods through automated platforms.
Despite these headline gains, experts caution that the economic impact varies by therapy type. Sean Werner, Chief Technology Officer of Cell Processing at BioLife Solutions, told DDN that allogeneic products are more likely to realize per-unit cost reductions sooner, while autologous therapies may continue to face higher production costs due to their individualized nature. “As these systems become more turn-key, we should be able to recognize reductions in infrastructure and staffing costs though.”
Supporting growth amid uncertainty
While automation and digitalization are improving manufacturing efficiency, the UK’s CGT sector continues to navigate financial and regulatory pressures. Venture funding has been volatile, with total capital flowing into UK CGT peaking at £3.7 billion in 2021, before contracting sharply. Preliminary 2025 data showed that only £0.3 billion was raised by mid-November. Despite this, the UK retained its position as Europe’s leading national biotech market, accounting for 30 percent of all European venture financing in 2025.
This volatility is not unique to the UK. Marco Hogenboom, Global Head of Personalized Supply Chain at Cencora World Courier, told DDN that 2025 was a difficult year globally, as capital shifted away from long-horizon biotech programmes. “Sentiment may improve in 2026, but the ecosystem can’t rely on ventures alone. The biggest policy unlock is reducing adoption friction such as affordability, infrastructure, and delivery, making the UK a clearer 'go' decision for investors and innovators.”
Policy initiatives are increasingly aimed at mitigating funding gaps and enabling sustained growth. The 2025 Mansion House Accord, for example, will direct roughly 10 percent of pension fund investments — around £50 billion (approximately $68.3 billion) — into start-ups, infrastructure, and private equity, offering a potential long-term source of capital for high-growth sectors such as advanced therapies.
However, while the 2025 Mansion House Accord signals political intent, some industry voices argue it may not go far enough. Simister noted that UK pension funds currently invest “historically extremely low” levels into domestic private innovation, and that the Accord’s voluntary minimum of 5 percent remains conservative. More ambitious and mandated allocations, he suggested, could stabilize capital flows into contract development and manufacturing organizations and infrastructure, ultimately easing cost pressures for emerging biotechs.
Regulatory and reimbursement frameworks are also evolving to support scale-up and patient access. The MHRA’s decentralized manufacturing framework allows therapies to be produced closer to patients, reducing logistics complexity, shortening “vein-to-vein” time for therapies that require rapid turnaround, and helping address capacity bottlenecks in supply chains.
NICE’s updated commercial framework increased the net budget impact threshold from £20 million to £40 million for the first three years post-launch and introduced indication-based pricing, giving flexibility to commission therapies differently depending on clinical benefit. The Innovative Licensing and Access Pathway (ILAP) was also relaunched, offering developers an integrated route to engage with regulators, health technology assessment bodies, and the NHS to maximize adoption chances.
Together, these financial and policy measures are helping to de-risk pipelines, attract international partners, and support clinical translation, reinforcing the UK’s position as a trusted location for advanced therapy development and manufacturing — even amid a competitive global market and capital constraints.
Converting resilience into acceleration
The UK’s CGT ecosystem shows that scientific leadership alone is no longer enough. Clinical progress, operational efficiency, and supportive policy must work together to deliver therapies at scale, at a cost the NHS can sustain, and in a timeframe that benefits patients.
Despite a challenging investment environment, the combination of automation, digital platforms, regulatory flexibility, and targeted funding initiatives provides a foundation for sustained growth. Early-stage clinical trial momentum, recent approvals such as obe-cel, and expanding manufacturing capacity signal that the UK has the infrastructure and expertise to support complex, next-generation therapies.
The sector’s ability to convert resilience into acceleration will depend on continued investment, increased manufacturing capability, and clear regulatory pathways that enable therapies to reach patients efficiently. If these elements come together, the UK could solidify its position as a global hub for advanced therapy development and manufacturing, attracting international partnerships while delivering faster access to life-changing treatments.
