Report
US FDA’s Requirements on CAR-T Therapy
This report examines the U.S. FDA’s requirements for CAR-T therapy and the rapid growth of the global CAR-T market since the first products were launched in 2017. Driven by strong efficacy and favorable safety outcomes, the market is projected to grow from USD 4.4 billion in 2023 to USD 13.5 billion by 2029, representing a compound annual growth rate (CAGR) of 20%. Key approved therapies include Yescarta, Kymriah, Tecartus, Breyanzi, Abecma, and Carvykti, with major market players leading industry expansion. Yescarta and Kymriah have demonstrated particularly strong sales growth since launch. The United States remains the largest market, accounting for the majority of global sales. The report also highlights market growth drivers, ongoing research and development efforts, regulatory requir
