Visiongain has published a new report entitled CAR-T Therapy Market Report 2024-2034: Forecasts by Indication (Diffuse Large B-Cell Lymphoma (DLBCL), Acute Lymphoblastic Leukaemia (ALL), Follicular Lymphoma, Multiple Myeloma (MM), Others), by Type (Abecma, Yescarta, Kymriah, Tecartus, Others), by Target Antigens (CD19/CD22, BCMA, Others), by Patient (Children, Adults, Seniors), by End-users (Hospitals, Specialty Clinics, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.
The global CAR-T Therapy market is estimated at US$1,482.2 million in 2024 and is projected to grow at a CAGR of 35.9% during the forecast period 2024-2034.
Increasing Research and Development to Enhance Treatment with CAR-T Cell Therapy
Scientists are always coming up with new ways to make CAR T-cells that are more successful at fighting a larger variety of malignancies, including solid tumours for which CAR T-cell therapy is still being investigated. Research is still being done to address some of the drawbacks of CAR T-cell treatment, including high costs, limited persistence, and possible adverse effects. Research and development is looking into using CAR T-cell therapy to treat autoimmune illnesses in addition to cancer.
There has been a boom in research and development on this subject. This includes continuous research into new targets, which produces a large pool of possible treatments. The research and development of CAR T-cell therapies are progressing faster because of strategic partnerships forged by biotech firms, academic institutions, and even the biggest pharmaceutical companies. There have been rumours of around 260 such partnerships created in 2023 alone. Working together makes it possible to pool resources and knowledge, which expedites the process of getting breakthrough therapies to patients. For example, the European Commission approved Bristol Myers Squibb's CD19-directed CAR T-cell treatment, Breyanzi, in May 2023. Adult patients with diffuse large B-cell lymphoma may benefit from the therapy. Also, Ginkgo Bioworks and the Wisconsin Alumni Research Foundation (WARF) partnered in April 2023 to create next-generation GD2 CAR T-cell therapies.
The goal of the research is to increase the safety and efficacy of CAR T-cell treatments. This includes lowering the possibility of potentially fatal adverse effects and enhancing CAR T-cell persistence in the body, which will enable patients to experience remissions that endure longer. Improved patient outcomes and a wider pool of prospective patients are the results of better medicines, which propel market expansion. In order to increase CAR T-cell therapy's efficacy and reach and make it a more appealing therapeutic choice for a larger variety of malignancies, continued research and development are essential. As more healthcare providers use CAR T-cell therapy and more patients become eligible for it, this promotes market expansion.
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How will this Report Benefit you?
Visiongain’s 337-page report provides 117 tables and 192 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the CAR-T therapy market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for CAR-T Therapy. Get financial analysis of the overall market and different segments including type, process, upstream, downstream, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing CAR-T Therapy market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.
What are the Current Market Drivers?
Rising Cancer Incidence
A novel kind of immunotherapy called CAR-T cell therapy has completely changed the way some cancers are treated. Because of its potential for treating solid tumors and its efficacy in treating hematologic malignancies, CAR-T treatment has seen tremendous expansion in the market. With rising incidence rates, cancer remains a serious worldwide health concern. Globally, the prevalence of cancer is rising due to a number of variables, including aging populations, changing lifestyles, environmental concerns, and better diagnostic techniques. It has demonstrated amazing efficacy in the treatment of specific blood malignancies, including certain forms of lymphoma and acute lymphoblastic leukemia, particularly when all other therapies have failed. The treatment includes taking the patient's T-cells, genetically modifying them to produce chimeric antigen receptors (CARs), which bind to particular proteins on cancer cells, and then reintroducing the altered CAR-T cells into the patient.
The World Health Organization (WHO) projects that the number of cancer cases worldwide will rise from 20 million in 2023 to 28.4 million in 2040, an increase of over 50%. An important factor driving the market for CAR-T cell treatment is the rise in leukemia prevalence. The disease known as leukemia, which is defined by the unchecked growth of aberrant white blood cells, has seen a significant increase in cases in recent years. According to the Leukemia & Lymphoma Society (LLS) predictions, around 59,610 Americans had a leukemia diagnosis in 2023 (Source: LLS Blood Cancer Statistics). Furthermore, leukemia is still a devastating disease; according to LLS predictions, the disease will be responsible for 23,710 deaths in the US in 2023. Numerous causes, including genetic predispositions, environmental exposures, and changes in lifestyle, can be related to this rise. One innovative immunotherapy that has gained popularity as a possible treatment for leukemia is CAR-T cell therapy. By modifying a patient's T cells to express CARs, this therapeutic strategy improves the patient's ability to identify and eradicate cancer cells.
Clinical trials involving B-cell acute lymphoblastic leukemia (ALL) and other hematological malignancies have shown extraordinary success, which has propelled CAR-T cell therapy to the forefront of cancer treatment. In light of this, the increase in leukemia cases has highlighted the critical need for sophisticated and tailored treatments as well as established CAR-T cell therapy as a game-changing and increasingly essential element in the ongoing fight against leukemia. Consequently, an increase in leukemia prevalence is anticipated to have a major impact on market expansion. The market for CAR-T cell therapy is anticipated to continue expanding in 2023 due to the approval of novel treatments, their expanding range of applications, and their rising use in a variety of cancer types. With incidence rates expected to continue rising and placing a burden on healthcare systems, cancer continues to be a major worldwide health concern that highlights the need for ongoing research, prevention, and early detection initiatives. The goals of ongoing clinical studies and research are to investigate the potential of CAR-T cell therapy for solid tumors and to enhance the safety, effectiveness, and accessibility of these treatments.
Growing Ongoing Clinical Trials and Regulatory Approvals
Clinical studies for CAR-T cell treatments are being conducted in increasing numbers. This shows a dedication to creating fresh, enhanced therapies for different types of cancer. Regulatory agencies are also approving these therapies more quickly because they understand how life-saving they may be for patients with few other options for treatment. Globally, 750 active CAR-T treatments are being developed as of 2023 (375 in the preclinical stage and 378 in the clinical phases). Compared to 2019, when there were over 245 CAR-T treatments under clinical development, this is an increase of more than 50%. As of right now (375 out of 1,191 active trials), CAR-T treatments continue to comprise 31% of the clinical pipeline in C>. Over 95% of the ongoing CAR-T trials are in oncology, and the great majority of them are in the early stages of clinical development (mostly Phase 1).
A large number of clinical trials are currently being conducted in the quickly developing field of CAR-T cell therapy. There were around 1200 experiments examining the use of CAR-T cells for the treatment of different malignancies registered on ClinicalTrials.gov alone in 2023. For instance, as of April 2023, six CAR T cell treatments have received approval, showing previously unheard-of levels of effectiveness in treating patients with multiple myeloma and B-cell cancers. However, side effects such as immune effector cell-associated neurotoxicity and cytokine release syndrome present serious obstacles to CAR T cell therapy. Following are some of the CAR-T therapy approved in 2023.
- In June 2023, the National Medical Products Administration approved CT103A, the third CAR-T-cell product for multiple myeloma (MM) treatment.
- In October 2023, the Central Drugs Standard Control Organization, India's version of the US Food and Drug Administration, approved NexCAR19, India's first CAR-T cell therapy. This approval was based on the results of two small clinical trials conducted in India in 64 people with advanced lymphoma or leukaemia.
- Researchers at the University of Maryland School of Medicine (UMSOM) engineered a new CAR T-cell therapy for multiple myeloma in 2023. This therapy selectively attacks cancer cells while sparing healthy cells, which could potentially reduce the likelihood of toxic side effects.
- Penn Medicine presented early results for the AT101, a CAR T cell therapy with a new binding mechanism, at ASH on December 9, 2023.
In order to guarantee patient safety, regulatory organizations such as the US Food and Drug Administration (FDA) are essential. There are strict guidelines governing the production of CAR T-cells, and new approvals can greatly impact the expansion of the market. The growing number of clinical trials, regulatory approvals, and ongoing R&D initiatives imply that CAR T-cell therapy will be a major part of cancer treatment in the future.
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Where are the Market Opportunities?
Expanding Target Indications
A major opportunity for the CAR-T cell therapy market is to expand target indications, which will spur growth and allow for a broader range of applications beyond hematologic malignancies. Research efforts are increasingly focused on expanding the use of CAR-T cell therapy to solid tumours despite the fact that the treatment initially demonstrated great efficacy in treating hematologic malignancies. Tumour microenvironment, tumour heterogeneity, and antigen expression patterns pose particular hurdles for solid tumours. Progress in this field is being driven, nevertheless, by developments in CAR-T cell engineering, which include the creation of innovative CAR designs, combination therapies, and methods to get beyond immunosuppressive mechanisms.
Major biopharmaceutical companies are continuing to invest extensively in this field as the race to produce viable CAR-T cell treatments for solid tumours heats up in 2023. For example, Novartis released encouraging preliminary data from its Phase 1/2 trial, which assessed lova-cel, a new CAR-T cell treatment candidate, in advanced solid tumours that expressed the mesothelin antigen at the beginning of 2023. A pivotal study is scheduled to begin in 2023 as part of the company's ongoing advancement of its MUC16-targeted CAR-T cell treatment for ovarian cancer. Further, the following are some of the players developing CAR-T cells for solid tumours.
- In January 2023, Gilead Sciences and Xyphos Biosciences extended their partnership to use Xyphos' ACCELTM technology to develop more CAR-T cell treatments for solid cancers. Additionally, Gilead is anticipated to start Phase 1/2 research in 2023 to assess its PSMA-targeted CAR T-cell therapy for prostate cancer that has spread and is resistant to castration.
- In March 2023, patients with relapsed or refractory multiple myeloma, a solid tumour cancer, were given the opportunity to receive bb21217, a BCMA-targeted CAR-T cell treatment, as part of a Phase 1 research conducted by Bristol Myers Squibb. With intentions to start a pivotal phase in 2023, the business is also pursuing its PSMA-targeted CAR-T cell treatment for prostate cancer.
- Early in 2023, Janssen and Century Therapeutics reported encouraging preliminary results from their Phase 1 trial assessing CNS-101, an off-the-shelf CAR-T cell therapy candidate, in patients with advanced solid malignancies. Additionally, Phase 1/2 research assessing Janssen's GPC3-targeted CAR T-cell treatment for hepatocellular carcinoma (liver cancer) is anticipated to begin in 2023.
- A Phase 1 study is scheduled to begin in 2023 by Bristol Myers Squibb subsidiary Celgene, which is currently developing B7-H3-targeted CAR-T cell therapy for a range of solid cancers.
Furthermore, a number of smaller biotechnology businesses and academic institutions are working hard to investigate and create CAR-T cell therapies for solid tumours. In 2023, some of the most promising candidates will move on to clinical trials. The considerable interest and resources that major biopharmaceutical companies are devoting to bringing CAR-T cell treatments for solid tumours to market and potentially changing the therapy landscape for these difficult diseases are highlighted by these ongoing investments and clinical developments.
Increasing Adoption of CAR-T Cell Therapy in Emerging Markets
In emerging countries, biopharmaceutical companies are collaborating and forming partnerships with local companies and institutes to expedite the development, production, and distribution of CAR-T cell treatments. These partnerships can assist in resolving administrative and legal issues. In order to expedite the research and approval of CAR-T cell treatments, several emerging markets, like China and India, have put in place regulatory frameworks and guidelines. This could lead to increased investment and uptake.
Biopharmaceutical companies are stepping up their efforts in 2023 to leverage collaborations and strategic investments to boost the uptake of CAR-T cell treatments in emerging regions. The following are some noteworthy advancements and business expenditures in this field, particularly for 2023.
- Novartis announced plans to build a production facility for CAR-T cell treatment in Singapore at the beginning of 2023. This plant will cater to the Asia-Pacific region, which includes developing markets such as China and India. To further research and market CAR-T cell therapies in China, the business increased its partnership with Guangzhou Bio-Ree Cell Therapy Co., Ltd.
- Gilead Sciences and IndiaBioScience, an Indian biotechnology business, formed a strategic alliance in March 2023 to research and produce CAR-T cell treatments for the Indian market. The partnership intends to use Gilead's CAR-T cell therapy technology and IndiaBioScience's experience in cell therapy manufacturing to provide these medicines to patients in India.
- In early 2023, Bristol Myers Squibb announced plans to open a CAR-T cell therapy production facility in China, working with regional businesses. Additionally, it has been claimed that the company is in talks to introduce its CAR-T cell therapies to regulatory bodies in Brazil and other Latin American countries.
The investments above and collaborations underscore the increasing acknowledgment of the possibilities of CAR-T cell therapies in developing economies and the endeavours of biopharmaceutical corporations to get a foothold in these areas. Through creating manufacturing facilities, utilizing local expertise, and managing regulatory procedures, these firms seek to expand patients' access to these cutting-edge cancer medicines in developing economies.
Competitive Landscape
The major players operating in the CAR-T Therapy market are Gilead Sciences Inc., Novartis AG, Bristol-Myers Squibb, Johnson & Johnson Services, Inc., AbbVie Inc., Amgen Inc., BioNTech S.E., Bluebird bio Inc., Caribou Biosciences, Inc., GSK plc, CARsgen Therapeutics Holdings Limited, Pfizer Inc., Autolus Therapeutics, Intellia Therapeutics, and 2seventy bio, Inc. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.
Recent Developments
- In October 2023, Almac announced a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialize multiple CDx products. This partnership will leverage Almac's expertise in CDx development and commercialization with AstraZeneca's drug development pipeline.
- In February 2023, Roche and Janssen announced an expanded collaboration to develop and commercialize a wider range of CAR-T Therapy. This includes tests based on tissue, blood, next-generation sequencing, and digital pathology. This collaboration is expected to accelerate the development of personalized medicine solutions.
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To find more Visiongain research reports on the Pharma sector, click on the following links:
- Cell Therapy Technologies Market Report 2024-2034
- Stem Cell Therapy Contract Manufacturing Market Report 2023-2033
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