Expanding the promise of CAGTs through community-based care

With the potential to treat or even cure conditions for which patients once had no options, cell and gene therapies (CAGTs) are changing the way we approach many genetic diseases. The Alliance for Regenerative Medicine reports that 20 of the 30 largest biopharma companies are currently investing in CAGTs — a sector that received $11.1 billion in funding in 2025. In what it calls an “exceptional expansion,” Credence Research expects the market to grow to more than $146 billion by 2032. Physicians, too, see the field growing. When surveyed by McKesson, providers reported treating an average of 25 patients using CAGTs in 2025 compared to 17 in 2024. 

The reach of CAGT trials, however, is not expanding. According to McKesson, the number of qualified treatment centers (QTCs) in the U.S. stayed stagnant between 2024 and 2025. This lack of growth indicates that studies for these advanced therapies aren’t expanding beyond academic medical centers (AMCs), where CAGT studies have historically been concentrated.

Community settings: Essential to CAGT success

To develop safer therapies faster and serve even more patients, developers need to increase their reach by encouraging community hospitals, clinics, and providers to participate in CAGT research. 

Wider access for patients is, first and foremost, a matter of equity and inclusion. Research shows that most people eligible for chimeric antigen receptor (CAR) T-cell therapies do not receive them, suggesting that patients experience significant barriers to treatment. Among these barriers is geography. McKesson identified approximately 100 geographic markets in the U.S. with QTCs, often clustered around major cities. This means many Americans live hours from the closest option. One study found that eligible patients who lived between two and four hours from their nearest treatment center were 40% less likely to receive a CAR T-cell therapy than those who lived within two hours. In another study, only 7.3% of CAR T-cell therapy recipients lived in neighborhoods with a median income under $40,000, suggesting that the need to travel to and temporarily live near a CAR T-cell therapy center excludes people from lower socioeconomic backgrounds from participating.

In addition to better serving underrepresented patients, CAGT study site expansion will result in more comprehensive evidence generation, thanks to the capture of additional patient data. And community-based efforts will only become more important as the geographic areas surrounding AMCs reach study saturation and researchers need access to broader patient populations. Further, securing market share will make it financially viable for sponsors to continue developing advanced therapies that address critical and often unmet patient needs. Expanding into new geographic areas is one way that market share can be earned.

The path forward

We recognize that becoming a QTC or earning accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) may require a center, health system, or site to invest in additional infrastructure and staff training. And while it’s reasonable for CEOs to be cautious about such investments, CAGTs are among the most promising treatments under development today. Joining research efforts now will put community care at the forefront of bringing incredibly valuable therapies to the regions they serve.
We’ve also found that community-based health care centers often overestimate the investment required of them. For example, a large majority of CAGTs are administered either systemically or intramuscularly — two well-known routes — so many studies may not require specialized equipment or treatment spaces.

Bringing CAGTs to community settings will require advocacy from physicians within those systems and enthusiastic backing from their leadership. One example is Novant Health, which offers tumor-infiltrating lymphocyte (TIL) therapies with options previously only available at AMCs — the only program of its kind in Western North Carolina. Novant also offers FACT-accredited transplant, CAR-T, apheresis, and autologous therapy programs in Charlotte and the greater Greensboro area, helping the system attract new patients and grow its reputation for innovation.

Recent changes in regulation and accreditation are also helping remove barriers to community-based CAGT trials. For its part, the FDA recently lifted Risk Evaluation and Mitigation Strategies (REMS) requirements for some CAR T-cell therapies. These strict standards made it difficult to study advanced therapies in non-AMC settings. The shift suggests that the FDA believes CAR T-cell therapies can be safely administered in a wider range of settings. In another example, FACT recently released its Standards for Immune Effector Cells (IECs) in the Community Clinical Setting, a framework that considers the care models and limitations of community oncology programs and establishes a recognized approach for local IEC therapy administration.

The final key to fully capitalizing on the promise of CAGTs? Sponsors with vision who are willing to prioritize community settings for their studies. But developers don’t have to do this work alone. The Parexel CAGT team can support you in designing protocols that can be operationalized in a variety of settings and building community-based options into site selection strategy. We also offer resources such as our CAGT Training Academy, which prepares staff to perform with excellence across trials for advanced therapies. Our team of more than 30 cross-functional professionals includes medical directors and former regulators as well as experts in clinical logistics, CMC, oncology clinical operations, data management, translational medicine, and biostatistics.
 

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