Cell and gene therapy manufacturing is shifting from scientific feasibility toward industrialization, with industry leaders emphasizing process consolidation, closed workflows, and digital quality systems to enable scalable, reproducible production. Insights from the Advanced Therapies USA conference highlighted that sustainable CGT commercialization depends on manufacturability at scale, with a US$40 million grant program and single-workflow bioreactor data demonstrating practical steps toward that goal.
SK pharmteco commits $100 million to expand its viral vector business across U.S. and European sites, while Minaris joins CIRM's Industry Resource Partner Program to provide end-to-end cell and gene therapy manufacturing capabilities to funded innovators. Both moves strengthen manufacturing infrastructure for advanced therapies.
The FDA issued reforms on January 11, 2026, loosening chemistry, manufacturing, and control requirements for cell and gene therapy products to advance innovation and accommodate the unique complexity of these treatments.
More than 16,000 dermatology trials were completed, ongoing, or planned by the end of 2025, with the Asia-Pacific region experiencing a nearly five-fold increase over the past decade. The field now accounts for around 8,000 trials in Asia-Pacific alone, matching North America and Europe combined.
Drug discovery outsourcing, preparative chromatography, and Latin America point-of-care diagnostics markets are forecast to grow at CAGRs between 7.5% and 8.2% through 2031, driven by biologics expansion and chronic disease prevalence.
Federal regulators unveiled a new regulatory approach to accelerate approval of personalized genetic treatments for rare, life-threatening conditions, allowing smaller studies when traditional large-scale trials aren't practical while maintaining post-market safety oversight.
