The global CAR-T Cell Therapy Market is estimated to be USD 482.2 Million in 2019, expected to grow at CAGR of 34.5% during the forecast period. In the recent years, cancer has become one the major cause of deaths worldwide and companies are coming up with various conventional and cytotoxic immunotherapies in the market. Keeping into consideration the complex behavior of tumors and the involvement of varied genetic and cellular factors in tumorigenesis and metastasis, companies are focusing on developing new treatments which would focus on targeting tumors at both genetic and cellular level.
Chimeric Antigen Receptor (CAR) T cell therapy is one such novel therapeutic treatment which comprises reengineering cancer patient's white blood cells (WBC) to fight the malignant cells by recognizing them. During this therapy, the person’s T cells are extracted, preciously reformed and then inserted again to the person's body where the restructured cell multiply and target cancer cells. Currently, CAR-T cell therapy is recognized as vastly effective in patients with blood cancer or hematologic cancer specifically for acute lymphoblastic leukemia (ALL) and non?Hodgkin lymphomas.
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The commercial scenario in the CAR-T cell therapy industry is very dynamic and the key players are competing among each other to gain access to the major markets in U.S. and Europe. Companies are trying to secure the treatment centers to increase the patients access to their treatments. For instance, in 2018 Novartis announced its 33 certified centers in the U.S. and Gilead announced its 28 authorized centers for treating the patients. Companies are also coming up with new developments in this space. For instance, it is anticipated that Celgene will file for FDA approval of two more CAR-Ts lisocabtagene maraleucel in lymphoma by end of 2019 and bb2121 (idecabtagene vicleucel) in myeloma in 2020.
Biotech and pharma companies are also focusing on mergers, acquisitions and partnerships to gain an edge over competitors in this market. Celgene Corporation acquired Juno Therapeutics, Inc. for approximately USD 9 billion in 2018. Further Bristol-Myers Squibb completed its acquisition of Celgene in November 2019. Similarly, in Feb 2018 Gilead Sciences Inc. partnered with Sangamo Therapeutics Inc. for its gene-editing technology to develop cancer treatment and it is estimated that the deal was worth USD 3 billion.
Other factors which are expected to enhance the market growth include increasing number of patients presenting a failure response to alternative therapies and growing occurrence of cancer cases across the globe. High cancer cases are anticipated to increase the demand for reliable and effective therapeutic treatment approach for enhancement of quality of person’s life. However, there are certain factors which are posing as challenge in this market. For instance, the manufacturing process of CAR-T cells is very complex, and the companies also have logistics challenge. There has also been a high rate of positive results of this therapy, however there are significant number of responding patients relapsed several months after the therapy. Another major challenge is the cost of the treatment and the reimbursement of this therapy. Due to complex procedures the cost of the treatment is very high and there is no specific package available by the healthcare insurance companies for these treatments.
In 2019, CAR-T therapies are estimated to be the highly significant market as being such flattering as well as the relevant theme for researchers and investors. CAR-T is at the leading stage of cellular therapies, with additional methodologies with its similar challenges and promises. It is expected to remark the new insights and products on the viable capability as more patients are treated in a commercial setting. Such therapies are estimated to generate a vast revolution in the oncology sector, complementary to the ongoing breakthrough of immuno-oncology.
The Global CAR-T Cell Therapy Market is segmented on the basis of target antigen, Indication and geography.
By Target Antigen
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On the basis of target antigen, the market is further segmented by CD19/CD22, BCMA (B-Cell Maturation Antigen) and Others (MUC16, L1CAM, ROR1, EGFRvIII, PSCA, NKR-2, IL13R?2 etc). CD19/CD22 target antigens are estimated to hold the largest market share and are estimated to have a market size of approximately 5 billion by 2026. This is due to the fact that majority of the companies were able to get their antigens approved and have commercialized them since 2017.
On the other hand, the B-cell maturation antigen are estimated to grow at a faster CAGR during the forecast period. However, the market for antigen for solid tumors such as MUC16, ROR1, L1CAM and others are expected to overtake the CD19/CD22 antigens and are expected to have a market size of approximately around USD 7 billion by 2030.
On the basis of indications, the market for CAR-T Cell therapy is further segmented into Diffuse Large B-Cell Lymphoma (DLBCL), Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), Follicular Lymphoma (FL) and Others. It is estimated that the market for DLBCL has the highest market share and is estimated to grow at a CAGR of 22.9% during the forecast period. The market for Multiple myeloma is also expected to grow at a faster pace reaching approximately USD 2.1 billion by 2026. The first therapy approved was in pediatrics and/or young adults Acute Lymphoblastic leukaemia (ALL), an ailment with a high unmet need where CAR-T indicated high effectiveness, nonetheless, which represents a very small patient population.
In terms of geography, U.S. was estimated to dominate the global CAR-T Cell Therapy Market. Increasing research and developments programs as well as ongoing regulatory approvals are factors attributed to the augmented market growth for CAR-T cell therapy. For instance, Kymriah (a Novartis product) has cleared the USFDA approval in August 2017 for the treatment of patients suffering from acute lymphoblastic leukemia. Moreover, according to an industry report, key players such as Novartis and Kite are the first to reach the US market and are anticipating focusing on expanding the number of academic centers that can provide appropriate cancer treatments in 2019. The market for U.S. DLBCL antigen is estimated to reach approximately USD500 million by 2026.
The U.S. market is closely followed by Europe which is estimated to grow at a CAGR during the forecast period. With the recommended approvals of Kymriah and Yescarta by the European Medicines Agencies (EMA), the market is anticipated to gain a boost. These therapies are also the first products in the EMA’s latest PRIME program. With the approvals of the therapies, Gilead has initiated the construction of its new plant in Amsterdam and Novartis has tied-up in an agreement with Fraunhofer Institute for Cell Therapy in Leipzig. Similarly, Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kymriah which is the first and only regulatory approved CAR-T therapy in Asia. Novartis along with Foundation for Biomedical Research and Innovation (FBRI) will manufacture Kymirah at Kobe. This approval will in-turn give a push to the market in the Asia Pacific region.
Major biotech and pharma companies are focusing on methodologies of securing the end goal to manage position in the market and are associated with mergers and acquisitions, key joint efforts, and novel item advancement to pick up profit share in the business. Some major key players in the global market includes Bluebird Bio (US), Celgene Corporation (US), Gilead Sciences, Inc. (US), Cellectis (France), Servier Laboratories (France), Pfizer Inc. (US), Mereck KGaA (Germany), Amgen Inc. (US), Intellia Therapeutics (US), Novartis International AG (Swiss), Caribou Biosciences, Inc. (US), Celyad (Belgium), Bellicum Pharmaceuticals, Inc. (US), Noile-Immune Biotech (Japan), Nanjing Legend Biotechnology Co., Ltd. (China), Johnson & Johnson (US), Sangamo Therapeutics, Inc. (US) among others.