PUBLISHER: BioInformant | PRODUCT CODE: 1609195
PUBLISHER: BioInformant | PRODUCT CODE: 1609195
CAR-T cell therapy is a remarkably promising treatment for cancer patients. It is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to identify and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as "living drugs."
The backbone of CAR-T therapy is T-cells, which are essential to the immune system's ability to direct immune responses and eliminate cells infected by pathogens. For CAR-T therapy, blood is drawn from the patient, and T-cells are isolated. These cells are then genetically engineered in the laboratory using a modified virus, which enables the T-cells to produce chimeric antigen receptors (CARs) on their surface. Once reintroduced into the patient's body, these CARs allow the T-cells to recognize and bind to specific antigens on cancer cells, leading to their destruction.
From 2017 to today, 11 CAR-T products have reached commercialization. Of these, seven are U.S. FDA-approved CAR-T cell therapies, each of which have received approvals in other major healthcare markets as well.
Additionally, two CAR-T therapies have been approved by the Chinese National Medical Products Administration (NMPA): Relma-cel and Yuanruida. Two CAR-T therapies have also been approved by the Indian Central Drugs Standard Control Organisation (CDSCO): NexCAR19 and Qartemi.
These approvals highlight the rapid growth of the CAR-T market, which is having a significant impact on the biotech industry. Mergers and acquisitions have been particularly active, with Celgene acquiring Juno Therapeutics for $9 billion in 2018, and Bristol-Myers Squibb (BMS) purchasing Celgene for $74 billion by 2019. Gilead's $11.9 billion acquisition of Kite Pharma also made headlines.
The billion-dollar CAR-T cell therapy market owes much of its success to the early therapies' impressive effectiveness in treating blood cancers. However, the next major challenge for CAR-T therapies will be expanding their use to treat solid tumors. Currently, all nine marketed CAR-T products, along with nearly 75% of ongoing clinical trials, utilize an autologous approach (using the patient's own cells). Developing allogeneic CAR-T therapies-using donor cells-will open up critical market opportunities.
Another hurdle for CAR-T therapies is the "vein-to-vein" time-the time between apheresis (the process of collecting the T-cells) and the delivery of the final product. This process can be lengthy, so CAR-T therapies are typically recommended for end-stage patients who have exhausted other treatment options. Additionally, reimbursement remains a significant challenge in the U.S. and Europe.
The industry is working to overcome these challenges. Several CAR-T companies are using advanced gene-transfer techniques to introduce CARs into T-cells more efficiently. Partnerships are also emerging to develop CRISPR and electroporation technologies to enhance T-cell modification. Additionally, some companies are incorporating "on-off" switches in CAR-T cells to prevent toxicity. Despite progress, achieving success with solid tumors has proven difficult, with clinical trials so far showing low response rates. The focus now is on identifying effective antigens specific to solid tumors.
This report provides detailed analysis of the current state of CAR-T cell therapies and the broader CAR-T industry landscape. It highlights approved CAR-T therapies and late-stage clinical trials that could reach commercialization soon. CAR-T companies, ranging from small startups to billion-dollar giants, are now proliferating in all major healthcare markets worldwide.