ISCT Global Regulatory Report

Developed by ISCT in partnership with Citeline, the Global Regulatory Report provides an overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), approved products, covering cell, genetically modified cell and gene therapies.

THIRD GLOBAL REGULATORY REPORT: 2024 H1

Highlights:

  • 2848 therapies in the global pipeline (–3.8% decrease from H2 2023)
  • 85 products are under regulatory review globally of which 8 products are in pre-registration phase and 77 products are in Phase III clinical trials
  • 99 products approved globally (–50% decrease from H2 2023) of which 3 producs received their first approvals:
    • Amtagvi (Lifileucel)
    • CT-053 (Zevorcabtagene Autoleucel)
    • Beqvez (fidanacogene elaparvovec)
  • Key Global Legislative/Framework Changes by British Pharmacopoeia, EMA, ICH, NIH,
    and US FDA

READ THE FULL REPORT

REPORT ARCHIVES

2023 Archive

Read all regulatory reports from 2023.

The International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective therapies to improve patients' lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory, and Commercialization. Through strong relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprised of over 4,000 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation. For more information about the organization, visit ISCT.

Citeline (formerly Pharma Intelligence) powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial, and regulatory related-decisions and create real-world opportunities for growth.

Our global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts and more. For more information on one of the world’s most trusted life science partners, visit Citeline.