Overview: CMC / GxP regulatory compliance — context, definitions, and current market posture.
What is CMC / GxP regulatory compliance?
CMC/GxP regulatory compliance in gene therapy refers to the stringent quality and safety standards governing product development and manufacturing. CMC (Chemistry, Manufacturing & Controls) ensures every batch meets defined criteria for identity, purity, potency, and consistency through documented process controls, quality attribute monitoring, and robust analytical testing. GxP (“Good X Practices”)—including GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice)—provides a comprehensive framework for manufacturing, clinical trials, and laboratory operations. Together, they form the foundation for FDA, EMA, and global approval pathways, ensuring therapies are safe, effective, and reliably produced.
Market snapshot
Current projections indicate the global gene therapy market is expected to reach an estimated $68 billion by 2033, reflecting a base-case Compound Annual Growth Rate (CAGR) of 21.2% from 2025. Within this, the CAR-T therapy market segment alone is forecast to achieve $21.5 billion by 2033. This growth is underpinned by a burgeoning clinical pipeline, with 1,420 active gene therapy clinical trials in 2025, projected to surpass 2,100 by 2033. Oncology represents the dominant therapeutic area, accounting for 64% of global gene therapy trials.
Regulatory notes
Next: See the Biopharma & Life Sciences guide or the full 2025–2033 report for forecasts and detailed methodology.
