Cell and gene therapy integration: Strategies for health systems

The cell and gene therapy market landscape: Why health systems must act now 

The cell and gene therapy market is experiencing unprecedented growth. Since the first FDA-approved CAR-T therapy in 2017, the number of approved CGTs has grown by 31 products, with many more in the pipeline. Industry forecasts project a compound annual growth rate (CAGR) of approximately 18% from 2025 to 2034,² signaling sustained momentum in this space.

Oncology has been the primary driver of CGT expansion, but therapies are increasingly addressing non-oncology conditions such as autoimmune diseases, hemophilia, and degenerative disorders.³ Regulatory changes are also enabling greater access, such as the removal of Risk Evaluation and Mitigation Strategies (REMS) for certain CAR-T therapies, which allows treatments to potentially move from academic medical centers to community settings.⁴

This evolution highlights the importance for health systems to prepare now. By prioritizing CGT readiness, organizations can position themselves to deliver life-changing care, overcome operational barriers, and establish leadership in this transformative field as the healthcare landscape continues to shift toward these advanced therapies. 

Building a cell and gene therapy program: Three strategic steps

1. Securing stakeholder buy-in: Making the case for cell and gene therapies

One of the first and most critical steps in implementing a CGT program is gaining leadership support. According to Lori Stover, “The first key aspect was getting buy-in from administration. It’s not just about presenting the financial case, but also about helping leadership see the bigger picture—how these therapies can fundamentally change patient outcomes and position the health system as a leader in innovative care. When we framed the discussion around the long-term value for patients and the organization, it became much easier to get everyone aligned and excited about the opportunity.” 

At Allegheny Health Network, Stover and her team highlighted how CGTs could enhance the health system’s competitive edge and improve patient outcomes. By demonstrating the potential for curative treatments and reduced long-term costs, they secured the necessary resources to launch their program. This foundational step enabled Allegheny Health Network to establish a successful CGT program in 2019. 

2. Cross-departmental collaboration: Aligning stakeholders for success 

The operational complexities of CGTs require seamless coordination across multiple departments, including pharmacy, nursing, finance, managed care contracting, and IT. Both Stover and Konkol emphasized the importance of creating structured processes to align stakeholders.

At Froedtert ThedaCare, Konkol’s team established regular multidisciplinary meetings involving more than 40 stakeholders to ensure alignment on workflows, infrastructure, and patient care protocols. Pharmacy leadership played a pivotal role in these efforts, particularly in addressing challenges such as procurement, electronic medical record (EMR) integration, and chain-of-custody requirements for autologous therapies.

Justin Konkol shared, “One of the biggest challenges is ensuring that every stakeholder understands the unique complexities of CGTs and how their role contributes to the success of the program. Building that shared understanding across departments has been key to driving collaboration and achieving consistent results.”

Managed care contracting also emerged as a critical area for collaboration. Health systems must establish agreements with payers to address reimbursement challenges and mitigate financial risks. Stover shared that her team worked closely with managed care partners to negotiate single-case agreements and carve-outs, ensuring financial sustainability for their CGT program. 

3. Scaling CGT programs: A phased approach

Scaling CGT programs is a challenge, especially as therapies expand beyond oncology into other therapeutic areas. Both Stover and Konkol agreed that starting small and scaling strategically is the most effective approach.

At Froedtert ThedaCare, the oncology department served as the foundation for their CGT program, leveraging existing resources like financial liaisons and new patient coordinators. Konkol explained that his team is now developing a “coordination center” consisting of a pharmacy specialist, an advanced nurse clinician, and a program manager to support future growth in other service lines.

Similarly, Stover highlighted that Allegheny Health Network began with a single institution equipped with a cellular therapy lab. By centralizing operations and building expertise at one location, they laid the groundwork for gradual expansion to additional sites. This phased approach allowed them to refine their processes and address challenges incrementally. 

Framework for sustainable cell and gene therapy adoption

The experiences of early adopters like Allegheny Health Network and Froedtert ThedaCare suggest a systematic and multidisciplinary approach to integrating CGTs. Health systems can take the following steps to build sustainable frameworks:

1. Assess organizational readiness: Conduct a comprehensive evaluation of infrastructure, staffing, financial modeling, and payer relationships to identify gaps and opportunities.
2. Engage stakeholders early and often: Establish cross-departmental teams that include pharmacy, nursing, finance, managed care contracting, and administration to ensure alignment and buy-in.
3. Start small and scale strategically: Focus initial efforts on one site or therapeutic area to build expertise and refine workflows before expanding system-wide. 

Preparing your health system for the future of cell and gene therapy 

The evolution of the cell and gene therapy (CGT) landscape signals a shift toward treating broader patient populations and addressing non-oncology conditions. For health systems, this transition requires proactive investments in infrastructure, education, and collaboration to remain agile and prepared for emerging opportunities. 

Success in CGT adoption hinges on fostering partnerships across the healthcare ecosystem. Manufacturers, payers, and stakeholders within the health system must align to share best practices and lessons learned, enabling collective progress in integrating transformative therapies. 

Organizations that act decisively to integrate CGTs into their care models stand to achieve more than improved patient outcomes. By building the necessary capabilities now, they position themselves as leaders in a rapidly evolving field, where innovation and collaboration define success. 

This article is based on a panel discussion at Accelerate Pharmacy Solutions’ 2025 Health Systems National Summit. Cencora's Accelerate Pharmacy Solutions works with health system pharmacy leaders across specialty drug management, revenue cycle optimization, and patient access programs. For more information, visit Accelerate Pharmacy Solutions.

References 

¹Molecular Therapy. “Three decades of clinical gene therapy: From experimental technologies to viable treatments.” Accessed February 2021. https://www.sciencedirect.com/science/article/pii/S1525001621000137?via%3Dihub  
²Precedence Research. “Cell and Gene Therapy Market Size and Forecast 2025 to 2034.” Accessed August 2025. https://www.precedenceresearch.com/cell-and-gene-therapy-market
 
³FDA. “Approved Cellular and Gene Therapy Products.” Accessed October 2025. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
 
⁴FDA.  “FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies.” Accessed October 2025.  https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

This article is for informational purposes only. Readers should consult with counsel before acting on this information, which may not reflect current guidance and is subject to change.