Since 2017, 13 CAR-T cell therapies have reached commercialization across multiple markets. Seven therapies have been approved by the U.S. FDA, after which approvals for them were issued in other major markets as well. These include:
1. Kymriah (tisagenlecleucel)
2. Yescarta (axicabtagene ciloleucel)
3. Tecartus (brexucabtagene autoleucel)
4. Breyanzi (lisocabtagene maraleucel)
5. Abecma (idecabtagene vicleucel)
6. Carvykti (ciltacabtagene autoleucel)
7. Aucatzyl (obecabtagene autoleucel)
Beyond the U.S., four CAR-T therapies—Relma-cel, Fucaso, Yuanruida, and Zever-cel—have been approved by China’s National Medical Products Administration (NMPA).
Additionally, two therapies, NexCAR19 and Qartemi, have received approval from India’s Central Drugs Standard Control Organisation (CDSCO).
These regulatory approvals mark a major milestone, solidifying the CAR-T market as a dominant force. M&As have also been aggressive, demonstrating strong investor confidence. Celgene’s acquisition of Juno Therapeutics, Inc. for $9B underscored the industry’s potential, followed by Bristol Myers Squibb (BMS) acquiring Celgene for $74B.
Another big move was Gilead Sciences’s acquisition of Kite Pharma for $11.9B, further strengthening its position in the space. Additionally, Astellas Pharma expanded its portfolio by purchasing Xyphos Biosciences for $665 million. These transactions highlight an increasing commitment from major pharma companies to invest in CAR-T technologies.
As CAR-T therapy continues to evolve, the industry faces key challenges, including improving gene-transfer efficiency and mitigating toxicity risks. Researchers are actively exploring CRISPR and electroporation technologies to enhance T-cell modification, while others develop “on-off” switches to regulate CAR-T activity.
One of the biggest hurdles remains the treatment of solid tumors, as clinical trials have shown lower response rates compared to blood cancers. Thus, a major focus is on identifying solid tumor-specific antigens to improve efficacy in these cancers.
Currently, nearly 75% of ongoing clinical trials and all marketed CAR-T therapies rely on autologous (patient-derived) cells. However, the next breakthrough lies in allogeneic CAR-T therapies—off-the-shelf solutions that could streamline manufacturing, reduce costs, and expand patient accessibility.
In recent years, the CAR-T cell therapy market has grown from early experimental treatments to a multi-billion-dollar industry. Early successes in blood cancers have paved the way for broader applications, with companies ranging from startups to multinational giants working to expand the field.
To learn more about this rapidly evolving market, view the "Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials & Trends, 2025".
It reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with forecasts through 2032.
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