Hospitals and clinics are scrambling to keep pace as cell and gene therapies (CGTs) push into new disease areas. The 2026 Cell and Gene Therapy Report from InspiroGene by McKesson lays out the new battleground: not scientific discovery, but the grind of getting these treatments to patients who qualify.
Mapping the U.S. clinical trial scene, the report finds a tight cluster of expertise. Just 236 sites handle half of all CGT trial activity. More than half of oncology trials run through the top 50 institutions. This centralization makes it tough to expand access as CGTs move into fields like autoimmune disease and ophthalmology. The American Journal of Health-System Pharmacy points to more than geography: insurance rules, care infrastructure, and economic barriers mean two patients with the same diagnosis can face wildly different odds of getting therapy.
The federal CMMI model for Medicaid access to cell and gene therapy initially focused on two FDA-approved treatments for sickle cell disease—Casgevy and Lyfgenia—using advance discounts and outcomes-based agreements.
New specialties hit a wall on readiness
Autoimmune and eye diseases are now the fastest-growing non-oncology targets for CGTs. Autoimmune pipeline activity jumped 38% in the past year, with lupus and systemic sclerosis leading the charge. Yet most rheumatologists and ophthalmologists surveyed admit they are barely prepared for the coming wave of advanced therapies expected within five years.
Oncologists have nearly doubled their annual CGT patient load since 2024, from 17 to 32. Confidence in the curative potential runs high: 97% of oncologists, all surveyed rheumatologists, and 96% of ophthalmologists see CGTs as the best shot for some patients. Still, two-thirds of oncologists expect care to stay locked in specialist centers. Gene therapy reimbursement remains stuck on single-case agreements in three-quarters of cases.
AI steps in to break the logjam
This year, the report spotlights a cross-industry roundtable on AI’s role in closing access gaps. AI-driven tools are being tested to speed up patient identification and smooth out onboarding for treatment centers. Prior authorization approvals could move faster, too. The roundtable’s bottom line: if AI is rolled out effectively, CAR-T access could jump from 2 in 10 eligible patients to 6 in 10. Industry reviews now describe AI as a workhorse for finding therapeutic targets, designing therapies, picking patients, and planning development. These steps cut the time to match patients and sharpen clinical programs, as detailed in a 2026 market assessment.
Joe DePinto, who leads Cell, Gene and Advanced Therapies at McKesson, doesn’t mince words: “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.” The report calls out the need for a full ecosystem overhaul. That means changing how patients are found and referred, how providers gear up, how payers reimburse, and how centers deliver care.
In October 2025, AstraZeneca signed a deal worth up to $555 million with Algen Biotechnologies to develop gene therapies using AI platforms, signaling that AI is now a core part of commercial CGT development strategies.
Similar themes show up in recent coverage of new CAR T cell therapy guidelines for autoimmune disease. Even as clinical promise grows, readiness and infrastructure keep lagging.
Operational overhaul, not new science, is the hurdle
The 2026 Cell and Gene Therapy Report spells it out: science is running ahead of the system’s ability to deliver. The next leap depends on whether the industry can break old habits and put AI-driven solutions to work. Unless payers, providers, and centers move fast, too many patients will keep missing out. The data points to one conclusion: operational change now matters as much as scientific progress.
