The global cell and gene therapy manufacturing market is expected to grow from $19.3 billion in 2024 to $146.2 billion by 2032, according to a Mar. 10 report from Credence Research.
This projection highlights the rapid expansion of the sector, driven by increased demand for advanced therapies, commercialization efforts, and improvements in automated manufacturing processes. The anticipated compound annual growth rate of 28.8% reflects optimism about the future of cell and gene therapies.
Credence Research found that North America currently leads the market with a 45% share of global revenue, followed by Europe at 30%. While Asia Pacific holds a smaller portion now, substantial growth is forecasted through 2032. Regulatory approvals are expected to drive further expansions in manufacturing capacity as more therapies approach potential approval. The Alliance for Regenerative Medicine recently identified 18 cell and gene therapies under review or likely to be filed with the Food and Drug Administration this year.
Some programs face regulatory challenges, such as uniQure’s Huntington’s disease gene therapy. Analysts say that the upcoming departure of Center for Biologics Evaluation and Research Director Vinay Prasad could ease regulatory pathways for new treatments after several controversial decisions during his tenure. Despite fluctuations in recent years, late-stage development pipelines suggest continued commercial demand for manufacturing capacity.
Industry leaders have commented on supply constraints within cell therapy production. "Similar to viral vector manufacturing, cell therapy capacity is scarce, and the trend of demand outstripping supply is projected to become more acute despite investments in additional capacity being made across the industry," John Chiminski, then CEO of Catalent, said on an earnings call in 2020. However, by 2023 some analysts questioned whether excess capacity existed in parts of the sector.
Companies are responding by expanding both internal and contract manufacturing capabilities. Johnson & Johnson announced plans to invest $1 billion in a new facility supporting its approved CAR T cell therapy Carvykti and other candidates with significant sales potential. OXB raised £60 million ($81 million) last year to expand its operations before acquiring a viral vector facility in North Carolina. Bio-Techne also plans to acquire Wilson Wolf Manufacturing following strong financial performance despite broader funding challenges.
