Gene therapy expands beyond oncology — and brings new challenges

  • Home
  • Newsroom
  • Gene therapy expands beyond oncology — and brings new challenges
Gene therapy expands beyond oncology — and brings new challenges - Axcellant

Gene therapy expands beyond oncology — and brings new challenges

  1. maj 30, 2025

Gene therapies now account for most ATMP clinical trials, with a balanced distribution between in vivo and ex vivo approaches. Oncology remains dominant (38%), but there is increasing activity in metabolic (13%) and hematological (10%) areas.

Notably, in December 2023, the FDA approved Casgevy — the first CRISPR-based therapy — for sickle cell disease and beta-thalassemia. By Q3 2024, over half of newly initiated gene therapy trials targeted non-oncology indications.

Axcellant has extensive experience in this space, supporting clinical programs involving CAR-T cells, cancer vaccines, and stem cells. We help biotech teams manage the regulatory, logistical, and operational complexity behind these groundbreaking therapies.

Discover our capabilities in ATMP trial delivery.

Read more

Can AI Write Radiology Reports? A Study Suggests It Can — and Save Time Doing It

A recent publication in npj Digital Medicine explored the use of AI-generated radiology reports — and the results are worth…

Exploring Partnerships and Clinical Innovation in New York

The Axcellant team recently traveled to New York to meet with research partners and clinical collaborators from across the U.S.…

Nuclear Medicine Procedures in Clinical Research: Safety, Standards, and Regulatory Oversight

What Are Nuclear Medicine Procedures and How Are They Used in Clinical Trials? Nuclear medicine procedures (NMPs) are diagnostic and/or…