The biggest challenges in cell and gene therapy

A decade ago, terms like ‘groundbreaking,’ ‘lifesaving’ and ‘transformative’ were frequently used within the context of cell and gene therapies — but almost always accompanied by the word ‘potential.’

Today, the industry has realized much of that potential. Cell and gene therapies have evolved from proof-of-concept to commercialized treatments, from science fiction to reality. Not only has the field delivered 43 FDA approvals, but it has also advanced therapies into broader indications and earlier treatment lines.

And yet, that word potential still looms large. Attend any CGT event and you can feel the palpable buzz of an industry on the cusp of more breakthroughs. To benchmark the sector’s progress in our inaugural print issue of Cell & Gene Therapy Review, we asked thought leaders a single question: What is the biggest challenge facing the CGT sector in 2025?

Although responses fall into slightly different buckets, most align at the same holy grail — integrating cell and gene therapies into mainstream medicine on a global scale.

Read challenges related to:

• Market and investment; technology and innovation (Part 1)
• Scalability, supply chain and manufacturing (Part 2)

• And definitely don’t miss: Thoughts from our editorial advisory board