The Biggest Bottlenecks Holding Back Cell and Gene Therapy
Members of the 2026 Power List argue that manufacturing, infrastructure, reimbursement, and investment now pose the greatest challenges
Clinical Scorecard: The Biggest Bottlenecks Holding Back Cell and Gene Therapy
At a Glance
| Category | Detail |
|---|
| Condition | Cell and Gene Therapy |
| Key Mechanisms | Manufacturing capacity, clinical delivery, reimbursement, and system fragmentation. |
| Target Population | Patients with unmet medical needs requiring innovative therapies. |
| Care Setting | Clinical and manufacturing environments for advanced therapies. |
Key Highlights
- Limited patient access due to manufacturing and reimbursement constraints.
- Need for scalable manufacturing platforms and automation.
- Fragmentation across biology, manufacturing, and regulatory pathways creates inefficiencies.
- Investment in industrialization and standardized processes is essential.
- Access to capital is critical for early-stage development.
Guideline-Based Recommendations
Diagnosis
Management
- Invest in scalable manufacturing platforms and automation.
- Align academic innovators, manufacturers, regulators, and health systems.
Monitoring & Follow-up
Risks
- Manufacturing variability and complexity can delay therapy delivery.
- Insufficient therapeutic headroom may affect market adoption.
Patient & Prescribing Data
Patients requiring advanced therapies for complex conditions.
Therapies may offer long-lasting, potentially curative outcomes.
Clinical Best Practices
- Treat manufacturing and delivery as central scientific challenges.
- Standardize platforms and analytics without compromising therapy integrity.
- Integrate digitalization and closed-loop feedback in manufacturing.
Related Resources & Content
