Datamonitor Healthcare Strategy: Gene Therapy Commercialization – Opportunities and Barriers

Datamonitor Healthcare Strategy: Gene Therapy Commercialization – Opportunities and Barriers

  • October 2018 •
  • 144 pages •
  • Report ID: 5780145 •
  • Format: PDF
Overview
Commercialization of modern-day gene therapies is now a reality. Next-generation modalities such as chimeric antigen receptor T-cell (CAR- T) therapies are fully in launch mode in the US, with final approvals having also occurred in the EU. The first in vivo gene therapy for an inherited disease is also now available in the US. With a slew of gene therapies in the pipeline, across ex vivo and in vivo applications, and several indications including oncology and rare disorders, more treatments are advancing into later-stage development and onto potential regulatory approval over the next several years. Gene therapy developers can take advantage of a multitude manufacturing guidelines on gene therapy in the US and EU.