Lee Buckler
The cell and gene therapy sector is reaching a pivotal maturation point in 2026, with several regulatory approvals already pending in the United States and Europe, and many more submissions expected throughout the year. While a handful of therapies are projected to achieve blockbuster status, significant challenges remain in expanding patient access.
CAR-T therapies, for example, are still estimated to reach only a fraction of eligible patients, largely due to limited referrals and the concentration of treatments within specialized centers. A key development to watch will be the sector’s ability to expand delivery into community healthcare settings. Improving accessibility at this level will be critical to increasing market penetration, strengthening investor confidence, and unlocking the next phase of growth for cell and gene therapies.
