How cell and gene therapy center expansion is reshaping patient access

A new report from Guidehouse and the Alliance for Regenerative Medicine explores how cell and gene therapy (CGT) delivery in the United States is evolving—and what it will take to sustain access as the market grows. 

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Cell and gene therapies are transforming treatment across oncology and rare diseases, but delivering these therapies at scale is becoming an increasingly complex challenge. Once limited to a small number of highly specialized academic medical centers, CGT delivery is undergoing a significant shift as clinical experience grows and the market matures. 

Early in the market, centralization was necessary. Providers needed specialized infrastructure, highly trained care teams, and tightly controlled processes to manage risk and ensure patient safety. While effective in supporting early launches, this model limited access and often required patients to travel across state lines to receive treatment at a select group of established centers. 

Today, that model is evolving. The CGT treatment network has expanded beyond its academic roots as clinical protocols have matured, training has become more standardized, and regulatory requirements have adapted. Community providers are playing a growing role, helping to extend access into new geographies and bringing treatment closer to where patients live. 

This expansion is already changing how patients experience care. Fewer patients now need to travel long distances for treatment, reducing logistical barriers such as time away from work, caregiver burden, and coordination challenges. At the same time, overall treatment volume has increased significantly, reflecting both broader adoption of approved therapies and continued growth in the pipeline. 

But a more distributed network introduces new complexities. As delivery expands across a wider range of sites, variation in experience, staffing, and operational processes can lead to inconsistencies in how therapies are administered. These differences can affect patient experience, create operational inefficiencies, and increase scrutiny from payers evaluating outcomes and total cost of care. Maintaining consistency across sites is becoming just as important as expanding access. 

The implications vary across stakeholders. For therapy developers, the shift toward a mixed delivery ecosystem requires a more proactive, deliberate approach to network design. Success depends on selecting the right mix of academic and community sites to deliver therapy, supporting those sites with adequate training and resources, and aligning on expectations for performance, quality, and patient support earlier in the launch process. 

For providers, the expanding role of community-based delivery presents both opportunity and pressure. While providers may be interested in adding this service line to their offerings, doing so requires significant investment in training, infrastructure, care coordination, and ongoing performance management. Organizations that have the resources to effectively build these capabilities will be better-positioned to capture growing demand. Others may need to pursue gradual capability improvements that build readiness to deliver these sophisticated therapies. 

For payers, a broader network of treatment centers increases both access and complexity. While the availability of more sites can improve patient convenience and reduce non-clinical barriers, it also expands the range of delivery settings that must be evaluated for cost, quality, and outcomes. As treatment volumes grow, payers are likely to place increasing emphasis on site-of-care management and consistent standards across providers, similar to how they’ve shifted imaging and outpatient surgery to community settings.  

Looking ahead, the next wave of CGTs is expected to further reshape the landscape. Therapies in late-stage development are targeting more prevalent and higher-volume conditions, including chronic and neurological diseases. These programs have the potential to significantly increase the number of eligible patients and create demand that exceeds the capacity of today’s delivery networks. 

As more therapies are developed, treatment delivery may become the primary constraint on market adoption. Without proactive planning, organizations risk encountering capacity bottlenecks that slow uptake, increase variability, and limit patient access—even as clinical innovation continues to advance. 

To prepare for this next phase, stakeholders will need to rethink how CGT delivery networks are designed and supported. This includes aligning on access and reimbursement requirements early, building integrated evidence and value strategies, investing in site readiness and enablement, and developing delivery models that can scale effectively across both academic and community settings. 

Our full report explores these trends in greater detail and outlines what it will take to sustain access in a more decentralized CGT delivery environment.