Cell and gene therapy report: How leading health systems are operationalizing the next era of medicine

The advanced therapies market is entering a period of rapid expansion, with the cell and gene therapy (CGT) pipeline projected to reach 85 products by 2032 and total market value anticipated to exceed $90 billion by 2034. Despite this growth, health system infrastructure, reimbursement models, and operational frameworks have not matured at the same pace.

Findings from a Vizient survey of hospitals and health systems reveal that organizations are strongly committed to expanding CGT programs, but face persistent financial, operational, and contracting challenges that threaten scalability.

Health systems are transitioning CGT from high-complexity, niche services into foundational clinical programs. However, success will depend on advancing standardization across financial models, contracting strategies, data infrastructure, and workforce planning.

Adoption is growing but is still concentrated at low volumes

CGT utilization remains concentrated at relatively low volumes across most organizations, reinforcing that the market is still in an early scaling phase.

• Cell therapy: Most organizations administer less than 100 treatments per year, with the largest cluster (31%) providing 51–100 annually.
• Gene therapy: Lower volume overall; most (70%) administer 0–10 treatments per year, with only 2% administering greater than 50 treatments per year.

While cell therapy programs have established a foothold, gene therapy remains nascent, with limited patient throughput and evolving operational requirements. As pipeline approvals accelerate, these low-volume programs will face pressure to rapidly scale capacity, coordination, and expertise.

Action steps:

• Prepare for rapid volume acceleration, particularly in gene therapy
• Evaluate whether current financial and operational infrastructure can scale 2-3x without disruption
• Begin strategic planning for pipeline-driven demand increases

Alignment is strong but execution remains a challenge

Survey responses indicate strong alignment across pharmacy, oncology, finance, and executive leadership, positioning CGT as a core strategic priority and foundational service line over the next 1-3 years. Across respondents:

• 89% plan to expand cell therapy management/dispensing in the next 1-3 years.
• 83% plan to expand gene therapy management.
• 88% say CGT is a cornerstone of broader innovation strategy.
• 88% report that non-pharmacy stakeholders (finance, service-line leaders) view CGT as a key strategic growth lever.

However, alignment alone does not translate to readiness. Many organizations lack the standardized operating models required to support sustained growth. Respondents noted the following top challenges and learning priorities when assessing whether to invest in a CGT program:

• Growing complexity of contracting, sometimes taking years
• Urgent need for integrated data systems
• Concern about access and limited distribution models
• Desire for best practices on sustainability, workforce planning, and program scaling
• Interest in examples of GMP in-house engineered cell therapy programs
• Questions about gene therapy tracking, outcomes, accreditation pathways, and future pipeline planning

Action steps:

• Move from strategic alignment to defined operating models
• Establish enterprise-wide CGT governance structures
• Align executive, finance, pharmacy, and clinical leadership on standardized workflows and financial metrics

Care delivery models are evolving, but fragmented

While programs are expanding, operational maturity is uneven. Most organizations administer CGTs in hospital-based outpatient infusion centers (39%) or inpatient units (37%), often using hybrid care models that shift patients between settings based on toxicity risk and reimbursement considerations. Although inpatient and outpatient administration are roughly split among respondents, comments indicate a greater shift to outpatient in the future. Cell processing approaches vary, with organizations divided among fully integrated, partially integrated, and outsourced models.

Despite increasing investment in specialized CGT roles, infrastructure development remains largely reactive, a strategy that threatens to create inefficiencies that could complicate scaling efforts—particularly as therapies move beyond oncology.

Logistics and transport

Organizations are split evenly, with 52% relying upon third-party logistics. Most organizations are required to use the manufacturer’s exclusive contracted distributor rather than selecting from a variety of 3PL partners.

Action steps:

• Standardize care pathways across inpatient and outpatient settings
• Evaluate long-term strategy for in-house vs. outsourced processing
• Assess logistics dependencies and opportunities for greater control

Financial and reimbursement models are misaligned, creating systemic risk

Despite the high cost and complexity of CGTs, financial and reimbursement models have not sufficiently evolved to support sustainable program growth. Organizations are navigating both underdeveloped internal financial structures and prolonged, variable reimbursement timelines—creating compounded risk.

Only a small proportion of organizations (12%) maintain a dedicated CGT budget. Fifty-eight percent embed CGT within broader service-line budgets, 25% rely on case-by-case financial decisions, 3% don’t have a clear budget structure, and 2% were unsure. This fragmented approach limits visibility into true program costs and reduces the ability to proactively manage financial performance as volumes scale.

Reimbursement delays create cash flow pressure

Reimbursement delays are common across payers, with many organizations reporting payment cycles exceeding 90-180 days. Some organizations even reported delays exceeding 12 months, introducing significant working capital strain.

Payment adequacy varies by payer

Health system respondents indicated that Medicare and Medicaid reimbursement—particularly inpatient—frequently fails to cover the total cost of care, creating structural margin pressure. In a recent New England Journal of Medicine article, leaders from the Centers for Medicare & Medicaid Services Innovation Center discussed potential opportunities to improve the access to expensive gene therapies, signaling a willingness to address some of the gaps providers are observing.

• Commercial inpatient: 71% sufficient
• Commercial outpatient: 88% sufficient
• Medicare/Medicaid inpatient: 33% sufficient
• Medicare/Medicaid outpatient: 67% sufficient

Financial risk preparedness remains limited

Organizations also report that financial credit limits—rather than payer reimbursement—are increasingly influencing the timing and feasibility of delivering ultra-high-cost therapies.

• 27% maintain CGT-specific cash reserves
• 32% acknowledge reimbursement variability impacts access
• 29% factor credit ratings into CGT planning

Action steps:

• Integrate financial planning and reimbursement strategy into a unified CGT program
• Model cash flow under extended reimbursement timelines and variable payment terms
• Establish CGT-specific financial tracking, reserves, and risk mitigation strategies
• Strengthen payer contracting approaches and explore alternative payment models to address delays and coverage gaps

Contracting complexity is a major challenge

Contracting for CGT is emerging as one of the most resource-intensive—and least standardized—components of program administration. Survey responses point to a structural imbalance between manufacturers and providers, with organizations shouldering significant administrative burden to secure access, negotiate terms, and meet evolving requirements.

• Only 3% of respondents report no challenges with manufacturer access or onboarding
• Contracting timelines frequently exceed six months

These dynamics are increasingly unsustainable as the CGT pipeline expands. Without shared frameworks, standardized terms, or collaborative negotiation approaches, contracting complexity may become a primary constraint on program growth.

Contracting challenges and uncertainty are widespread

Respondents cite access restrictions, cost terms, and data use agreements as the most common contracting challenges. Confidence in contract clarity remains low, particularly around liability, data security responsibilities, and product failure scenarios.

Most contracts require significant administrative effort, with 56% reporting more than 20 FTE hours per product—impacting timelines and process efficiency.

Notably, uncertainty around data use agreements and data-handling responsibilities highlights the growing intersection between contracting complexity and broader data governance challenges. Of the survey respondents, only 34% agree that contracts clearly assign data-handling responsibilities, and 43% say they have negotiated sufficient liability protections.

Procurement processes are still maturing

Most (72%) health systems have defined procurement processes in place; however, qualitative feedback indicates many of these processes remain in development. As organizations move from early adoption to scaling, procurement workflows will need to evolve from ad hoc coordination to repeatable, enterprise-level processes.

Infrastructure requirements are expanding alongside contracting demands

Respondents also report broader infrastructure implications tied to contracting and product requirements, with 39% anticipating additional storage capacity needs to meet manufacturer specifications. Qualitative comments indicate growing infrastructure demands, including increased freezer capacity, development of dedicated CAR-T laboratories, and expansion of space to support rising clinical trial activity. These investments reflect the downstream impact of manufacturer requirements, which extend beyond contracts into physical and operational infrastructure.

Action steps:

• Treat contracting as a core capability, not an administrative function
• Centralize expertise and develop standardized templates and playbooks
• Explore collaborative contracting strategies to reduce duplication of effort
• Align contracting, procurement, and infrastructure planning to avoid reactive investment