Global CAR-T Cell Therapy Market – Market Size, Forecasts, Trials & Trends
CAR-T cell therapy is a remarkably promising treatment for cancer patients. This emerging treatment is the biggest breakthrough since the introduction of chemotherapy. Already two products (Kymriah and Yescarta) have been approved by the U.S. FDA and European EMA for different cancer indications.
What is CAR-T Cell Therapy?
Chimeric antigen receptors (CARs) are genetically engineered cells that are developed in the laboratory and infused into a patient to help in detecting and fighting cancer. The protein constructs stimulate anti-cancer T-cells, which in turn boost a patient’s immune system. CAR-T cell therapy is defined as a type of immunotherapy that teaches T cells to recognize and destroy cancer.
CAR-T is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as “living drugs.”
How Does CAR-T Cell Therapy Work?
T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of our immune system and they play a key role in directing the immune response and killing cells infected by pathogens. In CAR-T cell therapy, blood is drawn from the patient and the T-cells are separated out. In the laboratory, a disarmed virus is used to genetically engineer the T-cells to produce chimeric antigen receptors (CARs) on their surface. These receptors are synthetic and do not exist naturally. Once infused into the patient, these CARs enable the T-cells recognize and get attached to an antigen (specific protein) on the tumor cell leading to the destruction of the tumor.
Two CAR-T products are available in the market. The first one, Kymriah (Tisagenlecleucel) by Novartis, was approved by U.S. FDA in August 2017. It was approved to be used in children and adults with ALL. On May 1, 2018, FDA approved Kymriah for a second indication (diffuse large B-cell lymphoma). The second CAR-T product, Yescarta (Axicabtagene ciloleucel) by Kite Pharmaceuticals, was approved by FDA in October 2017 for patients with lymphoma.
In August 2018, both Kymriah and Yescarta secured approval in Europe, indicating the willingness of European regulators to usher in a new age of regenerative medicine. In September 2018, Health Canada approved Kymriah as the first CAR-T therapy to receive regulatory approval in Canada.
Like all cancer therapies, CAR-T cell therapy can also cause a number of side effects. However, all these side effects can be managed with standard supportive therapies including steroids. The widespread research activities, worldwide clinical trials and treatments in a limited number of U.S. hospitals have created a robust CAR T-cell market with an estimated CAGR of 6.3% per year. This billion dollar market and projected growth would have been not possible without the remarkable efficacy of Kymriah and Yescarta in treating several types of blood cancers.
Market for CAR-T Cell Therapy
CAR-T cell therapy has swept the biotech industry by storm in recent years, creating hope that it could welcome in a new age of cancer treatment. However, the remarkable success stories have come from targeting CD19, which is now considered an antigen that holds the key to a limited range of blood cancers. Presently, this hematological arena is a highly competitive therapy space that is being shared between among leading CAR-T companies.
Scientists, investors and developers invariably agree that the key to longer-term success in this space depends on solving two major problems: identifying antigens other than CD19 that can be targeted with CAR-T therapy with strong efficacy and going beyond liquid cancers into solid tumor indications. CAR-T cell products to deal with solid tumors will undoubtedly offer a larger market potential.
However, it is not an easy task to identify the antigens found on the cells of solid tumors. There are reasons why CD19 is the most common target. It is seen solely on B cells, whose destruction via CAR-T therapy offers a straightforward route for treating B-cell leukemias and lymphomas. At the same time, loss of the body’s B cells is not particularly problematical, because their antibody-producing function can be reinstated by injecting intravenous immunoglobulin (IVIG) to patients.
Currently, the only two non-CD19-directed CAR-T therapies are those that target CD22 in B-cell malignancies and B-cell maturation antigen (BCMA) in multiple myeloma. CD22 is structurally analogous to CD19, while BCMA is an antigen expressed on plasma cells, whose functional loss can also be replaced with IVIG.
The problem with solid tumors is that there is little evidence of CAR-T being able to overcome the numerous difficulties that exist for these to be targeted efficiently. However, both academic and commercial groups are racing against time to identify the antigens on solid tumor cells and develop suitable CAR-T cells, because it represents large market potential.
There are several reasons which make solid tumors difficult to treat using CAR-T cell therapies. Globally, solid tumors outnumber the hematological tumors by 10 to one. In 2015, Novartis and PENN reported that their CART-meso failed to show any effect in patients with mesothelioma, ovarian cancer and pancreatic cancer. Moreover, there was very poor persistence of CAR-T cells in the patients.
The difficulty with solid tumors is that they are usually surrounded by a hostile, immuno-suppressive microenvironment. This environment presents many inhibitory factors that prevent CAR-T cells from reaching them. A typical CAR-T approach will not have success under these conditions. For this reason, Juno and Novartis are engaging in constructing CAR-T cells with novel designs that incorporate additional elements to boost activity within this setting. Currently, these products are in preclinical development.
Driving Forces for the CAR-T Therapy Market
With growing demand for CAR-T therapies, CAR-T companies are proliferating. Growing numbers of these companies are supported by:
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