As the cell and gene therapy (CGT) sector moves toward standardised, accessible and globally scalable delivery models, for example, digital maturity will be critical to unlocking equitable patient access in emerging and established hubs alike.
Manufacturing Chemist (MC) caught up with Dr Matthew Lakelin (ML), Head of Consultancy Services and founder of TrakCel, to delve a little deeper.
MC: Looking back, what were the most significant industry shifts or developments in 2025?
ML: The defining trend of 2025 was the move from clinical proof-of-concept toward commercial readiness in the CGT market.
As of July 2025, 36 gene therapies, 36 RNA therapies and 71 non-genetically modified cell therapies have been approved.1
With more therapies approaching commercial launch, developers confronted the practical realities of scaling out highly individualised supply chains.
The year highlighted the limitations of the fragmented digital infrastructure inherited from early bespoke systems, drawing attention to issues such as inconsistent data structures, poor user experience and growing “portal fatigue” in treatment centres.
Regulators also signalled growing urgency around digital standardisation and traceability. Agencies began harmonising expectations for documentation, visibility and chain of identity and chain of custody management, prompting manufacturers to reassess their operational foundations.
Another key shift was the implementation of artificial intelligence (AI) across scheduling, logistics and planning.
Although still emerging, real-world pilots demonstrated how predictive tools could ease clinical burden and tighten delivery timelines, provided that data quality issues were addressed.
MC: What key trends defined your sector in 2025?
ML: The first defining CGT trend was the rise of standardisation as a strategic priority. The proliferation of bespoke portals has created inefficiencies that directly hinder large-scale supply.
In response, the industry increasingly embraced shared data models, common workflow structures and interoperable approaches as prerequisites for multisite, global delivery.
Secondly, AI-readiness emerged as a core differentiator. Organisations explored how predictive scheduling, early logistics risk detection and automation could improve orchestration, but also acknowledged that AI’s value is fundamentally limited without high-quality standardised data inputs.
Finally, distribution models diversified as more therapies moved toward outpatient and community based administration.
Operational demands shifted and stakeholders focused on planning for environments with lower digital maturity, variable staffing and inconsistent integration capabilities.
MC: Which changes in 2025 had the biggest impact on your business or customers?
ML: The most significant shifts were made in response to the experiences of healthcare providers and treatment centres.
Feedback from clinicians, particularly around multi-login workflows, fragmented portals and administrative burden, accelerated the industry’s focus on consolidating access points and simplifying the orchestration user experience.
Another high-impact change was the growing expectation for built-in compliance and global regulatory alignment.
As agencies prepared for a rise in CGT approvals, customers prioritised digital foundations that could support audit readiness, standardised documentation and traceability without extensive redevelopment.
Finally, the broader market slowdown in the US, paired with continued momentum in gene-editing therapies, created shifting demand profiles.
Companies became more selective with investments, seeking technologies that offered immediate operational value while remaining adaptable for future expansion into new regions, care settings and therapy types.
MC: What trends or challenges are you preparing for in 2026?
ML: One challenge we’re preparing for in 2026 will be supporting the rise of new CGT hubs outside traditional academic centres, particularly regions where digital infrastructure and regulatory familiarity are still developing.
As advanced therapies expand into community hospitals and outpatient clinics, variability in digital maturity is a major barrier to safe and consistent delivery.
Many of these sites lack integrated systems, making the case for standardised workflows, common data structures and simplified user experiences stronger than ever.
Another growing need is to ensure that digital tools are accessible to users with varying levels of experience.
In 2026, usability will become just as important as capability and systems must offer guided workflows, intuitive navigation and reduced login complexity to avoid overwhelming understaffed centres.
This feeds into the overarching challenge of creating an orchestration ecosystem in which patients in newer geographies can access advanced therapies without being disadvantaged by fragmented infrastructure.
MC: Where do you see the greatest opportunities or risks emerging in 2026?
ML: The biggest opportunity is the expansion of equitable access as CGTs move into emerging hubs and community settings.
With the right digital foundations, including standardised processes, interoperable data models and seamless integration with local systems, organisations can onboard new sites quickly and deliver therapies to patients who need them, closer to where they live.
However, the corresponding risk is deepening fragmentation if these hubs adopt bespoke or siloed solutions. Without shared standards, treatment centres may face increased administrative burden, inconsistent terminology and prolonged training.
These are issues that directly affect patient throughput and safety.
Harmonised regulatory expectations around data traceability can also help streamline global expansion, but centres lacking digital maturity may struggle to adapt, slowing therapy availability in precisely the regions that stand to benefit most.
In usability terms, multi-login workflows and unintuitive interfaces remain critical friction points unless proactively addressed.
MC: What innovations or shifts do you expect will shape the industry in the year ahead?
ML: The year ahead will be shaped by innovations designed to make CGTs more accessible across diverse geographies and care models.
One important shift will be the wider adoption of unified access frameworks; this will reduce the cognitive load on clinicians and enable emerging hubs to onboard therapies without navigating multiple complex portals.
Another key development is the evolution of standardised workflow blueprints. These configurable templates will enable new regions and clinics to deploy validated processes quickly while maintaining regulatory compliance and data integrity.
AI will also play a more prominent role in terms of reducing disparities in patient access. Predictive scheduling, logistics forecasting and automated guidance can help resource-limited sites to manage tightly timed supply chains with greater confidence.
However, AI can only reach its full potential when supported by interoperable, high-quality data structures, reinforcing the importance of standardisation.
Together, these innovations will help the industry to shift from isolated centres of excellence toward a more distributed, globally connected network wherein advanced therapies are accessible to patients regardless of location.
Reference
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