Overcoming the Challenges in Bringing Cell & Gene Therapies to Market

As cell and gene therapies (CGTs) continue to enter the market, treatment centers have become the primary gatekeepers to patient access. Capacity limitations, operational burden, financial exposure, and increasing competition from both other approved therapies and ongoing clinical trials are forcing centers to be increasingly selective in what they adopt and sustain.

In this four-part blog series, we will address four major challenge areas manufacturers face in bringing cell and gene therapies to market, and the best practices to follow in overcoming them. Challenges and solutions discussed include:

1. Treatment Center Capacity Constraints
2. Operational Complexity and Workflow Burden
3. Financial Concerns and Reimbursement Exposure
4. Market Competition: Commercial and Clinical Trials

Challenge 1 – Addressing Treatment Center Capacity Constraints

The facts are clear. Treatment centers are facing significant demand:

• As of June 30, 2025 there were 4,469 cell and gene therapy (CGT) products in pre-clinical or clinical development. (1)
• A compounded growth rate of 24% from 2026 through 2035 is anticipated for CGT products. (2)
• 48 FDA-approved commercialized CGT products are being served by treatment centers.

Other constraining factors to consider:

• Treatment center availability is restrained by them having only so many beds, ICU capacity and procedural slots for CGT products.
• There can be limited availability of trained nursing, pharmacy and care coordination staff.
• The desired treatment center may not have the ability to scale capacity in parallel with the overall CGT pipeline growth.
• There is a constant stream of clinical trials competing for treatment center capacity.

So how do you best navigate this challenge of limited treatment center capacity? 

Planning for CGT therapy throughout product administration and follow-up is necessary and complex. Having a qualified treatment center that meets your process criteria and can support your clinical trial, and potentially, your commercialization, is a must. Yet, treatment centers with the qualified processes, staff and support systems to support CGT products are few and far between. Therefore, locating potential treatment centers that have the necessary stakeholder support, can collect the cells as required and treat the patients as needed for your product to work, is a critical initial step in your product planning. Once these factors are addressed, capacity and timing come into play along with differentiating you from competitors vying for the same centers.

Accurately predicting capacity of your targeted treatment center(s) when your CGT therapy is ready for clinical trial, or has been approved by the FDA for commercial delivery, is complicated by patient desire to be treated at a specific center based on their reputation, location or both. However, as you develop your plan, there are ways to improve your case to make you an acceptable partner.

• Forecasting – Forecasting can be tricky. You can forecast your demand for slots at the treatment center early, ensuring you have the necessary site resources to best support patient volume for your therapy, but you must also balance this patient demand with product availability. Forecasts for product allocation need to address this demand management, particularly in launch situations when product may not be produced at scale quickly enough, resulting in patient waiting lists.
• Care Pathway Design – Keeping in mind that treatment centers ae often exhausted with various conflicting processes and technology, design your ecosystem to best accommodate their existing practices to result in a more sustainable product delivery and customer experience. Pursue the possibility of using an outpatient or hybrid model for therapy administration to reduce the burden on inpatient beds.
• Staffing Support – Recognizing the burden on treatment center staff is important to maintaining a strong partnership. You should avoid conflicts with existing workflows so that the treatment center can continue running smoothly. Providing patient support to navigate treatment center resources as well as educational resources for staff to help them engage patients more effectively, will make you a better partner. Deploying amenable logistics throughout patient eligibility identification to product ordering and monitoring, will be attractive to treatment centers stretched too thin.
• Technology – Connect technology enabled resources and services through platforms putting accessible information in one place that can integrate into the existing treatment center workflows. The platforms need to underpin the entire product delivery process and be user-friendly. For example, if someone forgets their password, they need a clear process to get it reset in a timely manner. This technology approach will greatly ease the burden on the treatment center.

Last but not least, optimize your relationship with treatment center stakeholders

Physical restraints are not the only limiting factor in selecting qualified treatment centers. The roles treatment center stakeholders play in keeping your product process in alignment cannot be overstated. When planning you should:

1. Identify the treatment center stakeholders who can partner with you to ensure issues that arise are effectively identified and aligned to internal roles and responsibilities.
2. Distinguish those stakeholders enabling clinical trials who will also be involved with FDA approved product delivery so that existing processes can continue to support the product in commercialization.
3. Engage the stakeholders early in your planning process to solidify your ongoing partnership.

By understanding the role your stakeholders play in your process, and engaging with them early and throughout your partnership, will only serve to solidify your relationship and strengthen your product delivery process.

Look for our next blog in this series, where we will address the challenges associated with operational complexity and workflow burden.

Want guidance with your upcoming CGT project? Contact our team at Nuvera to leverage our deep treatment experience capabilities with allogenic and autologous therapies.

See our Case Example on CGT Therapy: Designing an End-to-End Therapy Order Management Process – Nuvera

1 BioSpace: Cell And Gene Therapy Clinical Trials Market Accelerates from USD 12.47Billion in 2025 to USD 45.31 Billion by 2034, December 3, 2026. https://www.biospace.com/press-releases/cell-and-gene-therapy-clinical-trials-market-accelerates-from-usd-12-47-billion-in-2025-to-usd-45-31-billion-by-2034

2 Towards Healthcare: Cell and Gene Therapy Market Size to Hit US$232.22billion by 2035, updated 19 January 2026. https://www.towardshealthcare.com/insights/cell-and-gene-therapy-market, accessed February 18, 2026.