Market Trends– category –
-
BioCentury Analyzes Commercialization Strategies for Gene-Edited Hematopoietic Stem Cell Therapies, Discussing Solutions for High Costs and Manufacturing Complexity
BioCentury USA Overview BioCentury published an analytical article focusing on commercialization strategies for companies developing gene-edited hematopoietic stem cell (HSC) therapies. The article discusses high treatment costs, manufac... -
Automated GMP Facility Launched, Supercharging Scalable Production for Off-the-Shelf Cell Therapies
Company Announcement / Specialized Media International Overview A new, state-of-the-art GMP facility dedicated to commercial-scale allogeneic cell therapy manufacturing has commenced operations. This facility leverages advanced automatio... -
FDA Issues Draft Guidance for Long-Term Follow-Up of Gene Therapies, Establishing Industry Standards for Safety and Efficacy
STAT News USA Overview The U.S. Food and Drug Administration (FDA) has released new draft guidance for the long-term safety and efficacy follow-up of approved gene therapy products. This guidance aims to establish industry standards for ... -
BioPharma Dive Features Real-World Evidence Analysis of Approved CAR-T Therapies, Unveiling New Insights into Subgroup Efficacy and Long-Term Safety
BioPharma Dive USA Overview BioPharma Dive published an in-depth analysis of post-market real-world data for approved CAR-T cell therapies. The article reveals novel insights into efficacy within specific patient subgroups and the long-t... -
Lonza Reports Robust Cell and Gene Therapy Sector Growth in H1 2026 Earnings, Driven by CDMO Contracts and Facility Utilization
Lonza Switzerland Overview Lonza announced strong growth in its cell and gene therapy division in the first half of 2026 earnings, propelled by an increase in new CDMO contracts and improved utilization of existing manufacturing faciliti... -
Catalent Enhances End-to-End Cell and Gene Therapy Services to Accelerate Market Entry of Novel Therapeutics
Catalent USA Overview Catalent has significantly bolstered its comprehensive, end-to-end service portfolio in the cell and gene therapy sector. This enhancement aims to accelerate the market entry of client therapies by providing seamles... -
BioPharma Dive Reports on Cell and Gene Therapy Manufacturing Frontlines: Viral Vector Supply Shortages and CDMO Market Soaring to $9.08 Billion by 2031
BioPharma Dive USA Overview BioPharma Dive analyzes key challenges and commercial opportunities in cell and gene therapy manufacturing, pinpointing viral vector production as the most severe supply constraint. Lonza is significantly expa... -
FDA Flags Unapproved Exosome Therapies, Citing Safety Concerns and International Regulatory Gaps
PLANEW Clinic South Korea Overview Exosome therapy is attracting significant attention for its regenerative potential, particularly in skin treatments, yet currently lacks U.S. FDA approval. The FDA has issued public safety warnings agai... -
CHOC Shapes Future of Pediatric Gene Therapy: Driving Early Intervention with CRISPR Editing and Strict Quality Control
Children's Hospital of Orange County (CHOC) Pediatrica USA Overview Rady Children's Health Orange County is focusing on in vivo gene replacement, ex vivo gene therapy (e.g., CAR T-cell therapy), and CRISPR-based genome editing to shape t... -
EU AI Act Extends High-Risk System Compliance Deadline to 2027, While Transparency Mandates Loom
Ethisphere Europe Overview The European Union has postponed the compliance deadline for standalone high-risk AI systems under its landmark AI Act, pushing it from August 2, 2026, to December 2, 2027. This extension, introduced via Regula...
