The Industry’s Response to the Changing Market Needs of Cell and Gene Therapy

Overview

The advanced therapy industry is evolving fast. Following years of rapid growth, the cell and gene therapy sector is now entering a phase of reflection and recalibration. This piece explores how companies, regulators, and investors are responding to shifting market needs and what it means for the next wave of innovation.

 

The Industry’s Response to the Changing Market Needs of Cell and Gene Therapy

The 28th AMC (ATMP Manufacturing Community) Technical Meeting brought together experts, innovators, and leaders from across the advanced therapy sector to explore a timely question: how is the industry responding to the changing market needs of cell and gene therapy (CGT)?

Over the past five years, the CGT sector has experienced extraordinary growth. Dozens of therapies have advanced from discovery into clinical stages, and some have reached commercialisation. Yet this period of rapid expansion is now being followed by a phase of strategic recalibration, driven by funding pressures, operational challenges, and the evolving regulatory landscape.

This recalibration is not a sign of stagnation but rather a moment of maturity for the field. The conversations within the community now reflect a more grounded understanding of what it takes to move from scientific promise to scalable impact. It is a period marked not by retreat, but by refinement.

 

A Market Under Pressure but Still Full of Potential

Data shared during the meeting illustrated the challenge clearly. After record levels of investment in 2020 and 2021, funding in CGT has fallen sharply, back to levels last seen in 2013. The downturn has affected both private and public investment across the biotech ecosystem, including AI-enabled biopharma.

However, it’s important to note that the mood in the room was one of learning and adjustment, not pessimism. As one delegate put it, “It’s not about the dip itself; it’s about what we do next to drive the next upswing.”

That focus on learning was central to every discussion, with three key themes standing out. The sentiment across the sector was that challenge often precedes reinvention. In fact, many speakers suggested that this period of pressure could become a defining catalyst for smarter, more sustainable growth.

 

1. Start with the End in Mind

Speakers repeatedly returned to one principle: successful CGT development depends on thinking commercially and operationally from day one.

The complexity of scaling to GMP manufacture remains one of the biggest hurdles, both technically and financially. As one session noted, “Start with the end in mind because scaling to GMP is where your costs skyrocket.”

This mindset shift is leading many companies to reframe their development strategies. Rather than rushing to generate proof-of-concept data, they are prioritising process design, cost of goods, and manufacturability earlier in the pipeline. This approach helps prevent late stage bottlenecks and ensures therapies can be produced at a scale and price point that healthcare systems can realistically adopt. Ensuring affordability for healthcare systems is certainly mission critical.

What emerged clearly was the growing recognition that scientific innovation must go hand in hand with operational excellence. The most successful organisations are those that treat manufacturing and commercial readiness not as endpoints, but as integral parts of discovery itself. By embedding scalability thinking early, companies position themselves to move faster and more efficiently when opportunities arise.

 

2. Evolving Regulation and the Role of the MHRA

Regulation is evolving just as fast as the science itself. Experts working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) shared how the agency is moving toward a more collaborative, forward-facing approach to support innovation.

Discussions covered the development of new decentralised manufacturing frameworks, designed to make “vein-to-vein” delivery more achievable and improve how advanced therapies reach patients. This more adaptive model of regulation is essential for enabling faster translation from lab to clinic whilst maintaining safety and compliance.

This shift toward partnership-driven regulation could accelerate both development and adoption across the UK’s healthcare system, because it creates a more agile and collaborative ecosystem - one where regulators, industry, and healthcare providers can co-design solutions that address real-world needs faster, reduce compliance bottlenecks, and build earlier trust in innovation.

The MHRA’s approach reflects a broader trend across the life sciences sector: a move from transactional oversight to proactive partnership. When regulators and innovators work in tandem, it not only accelerates access for patients but also reinforces the UK’s position as a global leader in translational medicine.

 

3. Investment Is About People, Not Just Science

Another major theme was the evolving nature of investment strategy in advanced therapies. The sector’s funding correction is forcing a rethink of how companies attract and retain backers.

Investors no longer fund science alone; they invest in the people who invest in you.

Having a credible board, proven leadership, and a strategic team with a track record of success are now seen as vital indicators of future performance. Investors are increasingly drawn to companies that combine exceptional science with strong governance and commercial understanding.

This shift towards valuing leadership capability reflects a deeper truth: transformative science is only as strong as the strategy that carries it forward. The next generation of CGT companies will likely be built by multidisciplinary teams - those who can connect the dots between discovery, regulation, commercialisation, and patient outcomes.

 

4. The Scale of Innovation Remains Remarkable

Despite these challenges, the level of activity in advanced therapies remains extraordinary. According to data shared by Boyds, there are now:
• 4,469 therapies in development globally, ranging from preclinical to pre-registration
• 2,210 gene therapies in development, including CAR-T and other modified cell therapies
• 962 non-genetically modified cell therapies in progress
• 143 approved therapies worldwide, including 36 gene, 36 RNA, and 71 non-genetically modified cell therapies

This scale of innovation demonstrates that the science continues to advance at pace. The challenge now lies in aligning that innovation with sustainable investment and delivery models.

It is clear, that scientific ambition remains undiminished. The question facing the sector is how to translate that momentum into long-term impact. Success will depend on forging new partnerships, leveraging manufacturing innovation, and maintaining an unwavering focus on patient access and outcomes.

 

Learning from the Past to Build the Future

The meeting underscored that reflection, collaboration, and adaptability are now central to the CGT journey. As the market adjusts, the sector’s ability to evolve operationally, commercially, and culturally will determine how quickly it rebounds.

The UK’s advanced therapy ecosystem has the expertise, infrastructure, and ambition to lead globally. But success will depend on connecting science with the right people, partners, and processes from the lab bench to the boardroom.

As the industry continues to mature, it is becoming increasingly clear that resilience will be its defining strength. Those who can balance innovation with pragmatism - and vision with execution - will not only shape the next wave of advanced therapies but also redefine what sustainable innovation looks like for the decade ahead.