Global market valuation was derived through revenue mapping and treatment volume analysis across CAR-T cell therapies, tumor-infiltrating lymphocytes (TIL), stem cell therapies, and emerging allogeneic platforms. The methodology included:
Identification of 50+ key manufacturers across North America, Europe, Asia-Pacific, and emerging markets, spanning large pharmaceutical companies, emerging biotechs, and specialized CDMOs
Product mapping across autologous cell therapies (patient-specific CAR-T, TCR-T), allogeneic cell therapies (donor-derived NK cells, iPSC-derived products), and stem cell therapies (mesenchymal stromal cells, hematopoietic stem cells, cord blood products)
Analysis of reported and modeled annual revenues specific to cell therapy portfolios, including approved therapies (Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti) and pipeline-stage products
Coverage of manufacturers and treatment centers representing 65-70% of global market share and patient volumes in 2024
Extrapolation using bottom-up (treatment-eligible patient volumes × therapy pricing by country/region, accounting for manufacturing success rates and vein-to-vein time) and top-down (manufacturer revenue validation, service provider capacity analysis) approaches to derive segment-specific valuations across oncology, cardiovascular, neurological, and orthopedic applications
FDA CBER Cellular & Gene Therapy Guidances
EMA Committee for Advanced Therapies (CAT) Scientific Recommendations
Alliance for Regenerative Medicine Sector Snapshots
ISCT Global (International Society for Cell & Gene Therapy) & Cytotherapy Journal
ASGCT (American Society of Gene & Cell Therapy)
NIH Regulatory Knowledge Guide for Cell and Gene Therapies