About this white paper
Key topics covered in this resource
Advanced Therapy Medicinal Products (ATMPs) are reshaping modern medicine. Gene therapies, cell therapies, and tissue-engineered products are moving from experimental promise to commercial reality — and the regulatory, manufacturing, and commercial frameworks around them are evolving just as fast.
This white paper provides a comprehensive overview of the state of the art in ATMPs as of June 2026. It brings together the latest developments in EU regulation, breakthrough manufacturing technologies, updated quality standards, and the business strategies driving the sector forward. It is essential reading for ATMP developers, CDMOs, regulatory professionals, and life science executives navigating one of the fastest-moving fields in life sciences.
- ATMP developers and sponsors planning EU clinical trials or commercial launches
- CDMOs scaling cell and gene therapy manufacturing
- Regulatory affairs and quality leaders responsible for ATMP compliance
- Business development and market access teams shaping ATMP commercial strategy
What you'll learn
Key takeaways from this document
- How the EU regulatory landscape for ATMPs is evolving, including the new Biotech Act and updated GMP Part IV guidelines
- What breakthrough manufacturing innovations — from automated CAR-T platforms to digital twin technology — mean for ATMP production
- Why the EU HTA Regulation (in force since January 2025) is reshaping ATMP market access and reimbursement strategy
- How global ATMP and CDMO markets are growing, with projections reaching USD 245 billion by 2034
- What business development strategies — outcomes-based payment models, CDMO consolidation, automation — are key to commercial success
- How updated Ph. Eur. monographs and the new EMA guideline on investigational ATMPs affect clinical trial submissions
About the Author
QbD Group is a global life sciences consultancy supporting companies from idea to patient. With over 700 experts, QbD delivers regulatory, quality, and compliance services across pharma, biotech, medical devices, and diagnostics.
