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Cell and Gene Therapy Sponsors Must Overcome Unique Hurdles to Realize Promise to Patients

It's undeniable that the cell and gene therapies (CGT) market has shown robust growth yet, CGT faces a tumultuous path, from inception to commercialization. The number of products, product sales, and the sheer size of the market have all expanded. At BIO 2023, experts converged to discuss trends, prospects and major challenges for cell and gene therapy development.

Recent insight from key biotech decision-makers reveals intriguing CGT development trends. While many perceive CGT as a domain ripe for breakthroughs—a veritable "sweet spot"—the challenges of ushering new innovation to patients requires the industry to rethink how clinical trials are conducted.

The primary issue? The lack of precedent. Traditional drug development blueprints can't be mirrored for CGTs. This unique development journey often spirals into a cycle of "trial and error," draining resources and inflating costs. Then there's the challenge of sourcing and retaining patients for clinical trials—a critical yet oft-overlooked aspect of the research and development phase.

Six Major Hurdles in CGT Development

The survey revealed six pivotal challenges that if overcome could enhance CGT progress even further:

  1. Evidence generation
  2. Infrastructure and logistics supply chain
  3. Clinical trial implementation
  4. Extended long-term follow-up studies, sometimes spanning up to 15 years
  5. Engaging patients and medical stakeholders effectively
  6. The dauntingly high costs of the drugs

However, many biotech companies already boast solid foundations in core science and technology, leadership, and strategy. Their upcoming challenge? Translating this potential into mature business models for CGT, driving product differentiation, and adding unique value.

The Syneos CGT team is focused on creating novel clinical, medical, and business solutions to ensure novel genetic therapies reach patients and that sponsors achieve commercialization in the most efficient and effective way.  Our network of experts across multiple therapeutic areas and across the globe enable rapid delivery of targeted services with the aim to balance speed, risk, cost, and opportunity with the CGT market.

Digital Revolution in Healthcare

2023 healthcare trends emphasize the digital transformation sweeping across healthcare—a change that's refining how patients and healthcare professionals interact, consequently enhancing clinical trial patient recruitment.

The roles of healthcare leaders are rapidly transitioning from mere functional expertise to outcome-driven strategic masterminds. Not to be overlooked is the strategic shift in M&A focuses. Smaller entities and start-ups are now gravitating towards outsourcing for gaining experiential insights and making pivotal growth decisions. While the path for CGTs is fraught with challenges, with the right strategies, collaborations, and innovative solutions, there's still a bright future ahead.

Learn more about the evolving commercial market, including its changes and challenges, on the Syneos Health Insights Hub.


Abhi Gupta, Senior Vice President, Clinical Operations, Syneos Health

Wei Wang, Business Development Director, CGT, Syneos Health

Sam Wilson, Senior Vice President, Commercial Solutions, APAC, Syneos Health

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