The 2026 Cell and Gene Therapy Report, released by InspiroGene, highlights significant advancements in cell and gene therapies (CGTs) while addressing patient access challenges across the healthcare ecosystem. As the report enters its third year, it emphasizes the need for the medical community to adapt in order to deliver these therapies effectively to patients in need.
“Cell and gene therapy is advancing at an extraordinary pace, but commercial patient access to these therapies needs to move as quickly as scientific progress,” stated Joe DePinto, head of Cell, Gene and Advanced Therapies at McKesson. The report gathers insights from providers, payers, manufacturers, industry experts, and patients, and this year, it introduces perspectives from rheumatologists and ophthalmologists. It also delves deeper into payer viewpoints and explores the potential role of artificial intelligence in improving the patient journey.
CGTs are now expanding beyond oncology, with autoimmune diseases like lupus and systemic sclerosis emerging as fast-growing sectors, boasting a 38% increase from the previous year. Ophthalmology is also becoming a significant area for CGT development. However, professionals in both fields report they are only minimally to moderately prepared for the anticipated changes in the next two to five years.
For the first time, the report provides a detailed mapping of CGT clinical trial activity in the U.S. There are 2,198 sites that have engaged in CGT trials, but just 236 of these sites are responsible for half of the total trial activity. The oncology sector remains foundational, with 464 trials spread across 1,074 sites, and a significant concentration of expertise retained at a select few institutions.
A new addition to this year’s report is a roundtable focused on how AI could address existing gaps in patient access to CGTs. Experts believe that AI-driven tools could enhance patient identification, streamline treatment center onboarding, and expedite prior authorization approvals. The roundtable participants indicated that such innovations could potentially increase access to CAR-T therapies from approximately 20% of eligible patients to 60%.
“The opportunity ahead is not only to bring more breakthrough therapies to market, but to build a system capable of getting these therapies to the patients who need them,” DePinto concluded.
