Cell and gene therapy companies must move beyond "beautiful science" and embrace industrialized, scalable, and digitally integrated manufacturing and commercial models to succeed in 2026.
Regulatory, payer, and investor expectations in 2026 favor companies that demonstrate robust CMC, manufacturability, long-term safety, and clear economic value rather than innovation alone.
Key themes at BIO 2026 include manufacturing scalability, AI‑driven process optimization, and broader access beyond specialist centers, with a strong focus on rare diseases and CAR-T.
Sources:
BIO 2026: Cell and gene therapy sector must break the mold to thrive
Regulatory dynamics and clinical progress in early 2026
Manufacturing the Future: How Technology Is Scaling Cell and ...
2026 cell and gene therapy predictions | Cellgenetherapyreview.com
Gene Therapy and Cell Therapy Industry Trends: First Half ...
8 Things to Do at BIO International Convention 2026
Cell & Gene Therapy in 2026: The Year the Field Grew Up - LinkedIn
BIO International Convention 2026 - Barcelona - Biocat
Scaling advanced therapies | Deloitte Insights
Industry Insights: Long-term follow-up data and clinical ...
Transformative Cell & Gene Therapy Summit 2026
Evolving and Integrating Technologies Across the Cell and Gene ...