The UK life sciences sector contributes £94 billion to the economy each year, but it faces increasing global competition, alongside internal challenges such as low numbers of NHS clinical trials, and slow regulatory approval processes. Here, Professor Alejandro Frangi outlines how in silico technologies – Artificial Intelligence and other computer-based approaches for virtual product development and testing – can maintain the UK’s leadership in life sciences innovation and clinical trials, enhance patient outcomes, and reduce development costs for lifesaving new medicines and medical devices.

• The financial cost of traditional drug and medical device development pathways is rising, threatening the longevity of the UK life sciences sector.
• In silico technologies can make the process more efficient, boosting growth while improving outcomes for patients.
• Policy support for regulatory sciences needs to go further and faster if the country is to secure a first-move advantage.

The UK’s life sciences ecosystem is robust, supported by prestigious academic institutions and a sophisticated biopharmaceutical sector, responsible for 140,000 high-value jobs. Despite this strong grounding, evidence suggests a concerning erosion of the UK’s competitive edge in global healthcare innovation, with low numbers of NHS clinical trials and protracted regulatory approval timelines signalling a critical point for the sector.

This regulatory friction creates a situation where only 71% of health technology firms aspire to launch within the NHS, citing its processes as major growth barriers and leading two-thirds of innovators to postpone UK market entry. The UK commands just 3% of the global market, sits outside the larger EU regulatory market, and ranks 28th out of 30 European countries in medical device trade balance (a £3.2 billion deficit), with a similarly poor performance in pharmaceuticals, where trade has been in deficit for nine of the last ten years.

Globally, the healthcare innovation landscape is reshaping, creating challenges and opportunities for regulatory transformation. Healthcare costs are projected to rise by 40% by 2030, coinciding with an increase in the complexity of precision medicines and medical devices. Environmental sustainability pressures and the digital transformation of healthcare delivery further complicate matters. More positively, the UK’s post-Brexit regulatory autonomy presents a timely opportunity to streamline processes and establish an innovative regulatory framework. Against this backdrop, the imperative for strategic reform becomes clear.

Strategic case for in silico technologies

In silico technologies (ISTs) encompass computational methods such as AI, machine learning, and mechanistic modelling. These methods create detailed mathematical representations of biological and physical systems, enabling the creation of ‘virtual laboratories’ for testing new medicines and medical devices through computer simulations, and modelling how diseases and other health conditions might progress in different patient populations. ISTs allow us to explore and validate healthcare innovations in the digital realm first, where comprehensive testing can accelerate innovation while maintaining or improving safety standards.

The current pathway for bringing medical innovations to patients is risky and inefficient. Only 30% of complex medical devices and 5% of drugs entering development ever reach patients, with failure costs burdening our healthcare system. Meanwhile, each year, approximately one million UK patients participate in clinical trials, yet 41% of device trial participants and 68% of pharmaceutical trial participants are exposed to interventions that never reach market approval.

This represents not just financial waste but missed opportunities for improving patient care and maintaining UK global competitiveness in life sciences. ISTs offer a more ethical approach, enabling comprehensive safety and efficacy assessment before human exposure, reducing reliance on animal testing, and fundamentally transforming clinical research and patient protection. There is also strong potential for better quality products; more equitable consideration of underserved social groups such as children, ethnic minorities, and pregnant women in product development; and more personalised care. This could potentially generate significant savings for the NHS in reduced medical failures.

The financial burden of traditional development pathways is unsustainable, costing £1.8 billion and taking 14-16 years on average for pharmaceuticals, and £410 million and 13 years for complex medical devices. ISTs can greatly reduce these figures by enabling earlier virtual testing and optimising regulatory pathways. Crucially, ISTs can be used holistically, with data collected from clinical trials used to inform models aiding drug discovery and screening, and vice-versa. This efficiency gain is crucial for maintaining the UK’s global life sciences leader position and ensuring faster access to innovative treatments. In multi-billion-pound global markets, the potential to bring more products to revenue, and bring medicines and devices to market up to 2 years earlier through faster delivery of in-patent development stages, will clearly be a boon for UK business, if first-mover advantages can be gained.

Digital transformation and future readiness

The UK needs to act, yet only 35% of life sciences and health technology organisations have mature computer modelling capabilities, and just 15% are fully integrating ISTs with real-world data across product lifecycles. This gap presents both a challenge and an opportunity for UK policymakers in digital health innovation. By investing in these technologies now and building a networked national capability, we can position ourselves at the forefront of this transformation.

The Government’s establishment of seven Centres of Excellence for Regulatory Science and Innovation (CERSIs) demonstrates policymakers’ recognition of regulatory science as a cornerstone for future economic growth and healthcare innovation. While this £7 million investment represents a positive first step in positioning Britain as a global leader in regulatory innovation, it follows the US’ commitment of $50 million each year to five equivalent CERSIs in 2023-2028. It is clear that efforts in the UK must go further and faster.

The University of Manchester headquartered UK Centre of Excellence on In-Silico Regulatory Science and Innovation (UK CEiRSI) combines scientific advances from key universities into a single platform to engage industry and regulators. It exemplifies the powerful multiplier effect of government seed funding. With an initial £1 million from UK Research and Innovation, UK CEiRSI has already leveraged an additional £1.2 million in partner contributions, and engaged industry leaders, academic institutions, and regulatory bodies. This initiative demonstrates the public and private sectors’ support to UK regulatory innovation leadership, building on our globally competitive foundations as a leading science nation with a coordinated national IST initiative that can harness the UK’s large and diverse population health datasets.

By pioneering computational modelling, simulation, and AI-driven approaches to medical product development, the CERSIs are strategically positioned to revolutionise the £300 billion global clinical trials market. In establishing this network, the government has positioned the UK to capture a significant share of this growing market while accelerating access to life-saving innovations.

Taking the opportunity

A scaled investment approach, matching international competitors, would cement the UK’s competitive advantage. The current foundation provides a compelling case for increased long-term funding, ensuring Britain maintains its edge in the global race for regulatory innovation leadership. To capitalise on these opportunities, data must be harnessed as a healthcare asset to drive innovation, including ensuring that full secondary and tertiary data is captured and deployed.

The Regulatory Horizons Council should commission a report on the transformative potential of ISTs as a novel form of digital regulatory evidence in the life sciences. This report should evaluate the growth trajectory, regulatory implications, and healthcare impact of these technologies for the UK.

To ensure the UK captures a first-mover advantage in validating computational evidence for faster, safer product approvals, the Medicines and Health Regulatory Agency (MHRA), alongside other regulators, should be empowered with dedicated CERSI liaison teams. By providing additional insights and early evidence, ISTs can help avoid regulatory failure and contribute to unloading regulatory functions, improving the predictability and overall delivery of the MHRA’s statutory functions for the provision of scientific advice, standard and expedited authorisation pathways, and clinical trial approval processes.

The new Regulatory Innovation Office has a role in coordinating this, given its remit to support AI and digital in healthcare. Sovereign data partnerships between industry and academia should be facilitated through targeted incentives, establishing the UK as the trusted gateway for accelerated medical innovation and safeguarding our competitive edge.

The UK CEiRSI is poised to supercharge regulatory pathways, NHS evaluations of innovative technologies, and healthcare funding decisions. By leveraging the UK’s unparalleled NHS Real World Data, and building on the recently announced Health Data Research Service and Sub-National Regional Secure Data Environments, it can amplify the impact of these national assets. UK CEiRSI will fast-track patient benefits, derisk innovations, scale UK businesses, and cement the UK’s leadership in real-world evidence generation—all while driving the transformation to a digitally enabled health service.

Through the Department for Science, Innovation and Technology (DSIT), further investment should be ringfenced for UK CEiRSI technologies, with a mandate to position the UK as the premier destination for next-generation medical product development.

These recommendations will ultimately help position the UK’s regulatory science leadership on the global stage, facilitated through strategic international partnerships, enabling UK standards to shape worldwide practices, and subsequently protecting our innovation pipeline.

In silico technologies are not just an evolution in R&D methodology, but a strategic imperative for maintaining UK leadership in life sciences. By embracing ISTs, the UK can enhance patient safety, reduce development costs, and secure its position as a global leader in healthcare innovation. This transformation represents more than just technological advancement; it’s about creating a more efficient, ethical, and sustainable healthcare innovation ecosystem that better serves patients, while strengthening the UK’s position as a global leader in life sciences innovation.