Global CAR-T Cell Therapy Market - 2025-2033

The global CAR-T cell therapy market reached US$ 4.8 billion in 2024 and is expected to reach US$ 20.4 billion by 2033, growing at a CAGR of 16.3% during the forecast period 2025-2033.

CAR-T cell therapy or Chimeric Antigen Receptor T-cell therapy, is an advanced type of immunotherapy used primarily in cancer treatment. It involves engineering a patient's own T cells, a type of immune cell by modifying them to express a chimeric antigen receptor (CAR) that allows these cells to recognize and attack specific cancer cells. CAR-T cell therapy has been particularly effective for certain blood cancers, such as acute lymphoblastic leukemia (ALL) and certain types of lymphoma. However, research is ongoing to adapt this approach for solid tumors, which have different challenges, like a more suppressive tumor microenvironment that can limit CAR-T cell effectiveness.

The demand for CAR-T cell therapy is growing rapidly, driven by its potential to treat advanced blood cancers and its ability to deliver personalized treatment outcomes. For instance, according to the American Society of Hematology, 71% of the participants in the research received a lymphoma diagnosis, 28% myeloma and 1% B-cell acute lymphoblastic leukemia. Most frequently, tisagenlecleucel (34%), lisocabtagene maraleucel (16%), axicabtagene ciloleucel (13%) and idecabtaene vicleucel (12%) were given to patients who qualified for CAR-T treatment. Overall, 76% of patients achieved remission and 33% experienced immune effector cell-associated neurotoxicity syndrome, a common side effect of CAR-T therapy.

Market Dynamics: Drivers & Restraints

High efficacy in hematological cancers

The high efficacy of CAR-T cell therapy in hematological cancers is significantly driving the market and is expected to drive the CAR-T cell therapy market over the forecast period. There is an increasing burden of hematological cancers which increases the demand for CAR-T cell therapy due to its remarkable efficacy in treating hematological cancers, especially in patients who have not responded to conventional therapies. CAR-T therapies have demonstrated high response rates and durability in blood cancers like acute lymphoblastic leukemia (ALL), various forms of lymphoma and multiple myeloma.

For instance, according to the American Society of Hematology, globally, the total number of hematological malignancy cases is projected to reach approximately 4,634,937 by 2030. The projected total number of hematological malignancy cases by 2030 across different levels of SDI are as follows: 1,113,313 cases in high-SDI areas, 1,004,403 cases in high-middle SDI areas, 475,496 cases in low-SDI areas, 795,475 cases in low-middle SDI areas, and 1,244,424 cases in middle-SDI areas.

Additionally, Gilead's Yescarta (axicabtagene ciloleucel) has shown a 52% complete remission rate in large B-cell lymphoma (LBCL) patients, offering a significant alternative for those who have relapsed after conventional chemotherapy. Breyanzi (lisocabtagene maraleucel) from Bristol Myers Squibb has demonstrated similar results, with overall response rates around 73% in LBCL. Thus, the high efficacy of CAR-T cell therapy significantly drives CAR-T cell therapy market growth.

High cost of therapy

The high cost of CAR-T cell therapy significantly hampers its market growth by limiting accessibility and affordability for patients and healthcare systems. The cost barrier restricts patient access, especially in countries without comprehensive reimbursement frameworks and limits the therapy's market penetration. In many regions, healthcare providers and insurers hesitate to cover CAR-T cell therapy due to the lack of long-term cost-benefit data, thus constraining its adoption despite clinical efficacy.

For instance, according to the National Institute of Health, the acquisition cost of CAR T-cell therapy is between $373,000 to $475,000 per infusion, excluding extra procedures and facility costs. Moreover, the therapies are usually performed in an inpatient environment since they require the infusion of modified T cells and consequent monitoring of the disease status, costing an additional $79,466 to $85,267. In the United States, an infusion of CAR T-cell therapy costs about $400,000.

Segment Analysis

The global CAR-T cell therapy market is segmented based on therapy type, drug type, target antigen, application and region.

Therapy Type:

The allogeneic CAR-T cell therapy segment is expected to dominate the global CAR-T cell therapy market share

The allogeneic CAR-T cell therapy segment holds a major portion of the CAR-T cell therapy market share and is expected to continue to hold a significant portion of the CAR-T cell therapy market share over the forecast period due to its potential to overcome the limitations of autologous (patient-specific) CAR-T cell treatments. Unlike autologous CAR-T, which requires extracting and modifying a patient's own T cells, allogeneic CAR-T uses "off-the-shelf" T cells from healthy donors.

For instance, according to a study conducted by the National Institute of Health (NIH), patients treated with allogeneic CAR-T cells had higher remission rates, less recurrence and more durable CAR-T survival than those receiving autologous products. Allogeneic CAR-T cells appeared to be a better option for patients with T-cell malignancies.

Since autologous CAR-T therapies require a personalized manufacturing process that takes several weeks, they aren't ideal for patients with aggressive cancers needing urgent intervention. Allogeneic CAR-T therapies offer pre-manufactured, readily available options, shortening the time from diagnosis to treatment. This immediacy benefits patients with rapidly progressing cancers who cannot wait for cell manufacturing.

Application:

The multiple myeloma segment is expected to dominate the global CAR-T cell therapy market share

The multiple myeloma segment holds a major portion of the CAR-T cell therapy market share and is expected to continue to hold a significant portion of the market share over the forecast period. CAR-T cell therapy is increasingly used for treating multiple myeloma, especially for patients with relapsed or refractory cases. Multiple myeloma, a cancer of plasma cells, has shown responsiveness to CAR-T treatments targeting specific antigens found on cancer cells.

The success of BCMA-targeted CAR-T therapies is driving research and development in multiple myeloma, encouraging companies to invest in further CAR-T innovations for this condition. For instance, in October 2024, Aurigene Oncology Limited released the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study - India's first trial for a novel autologous BCMA-directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma.

The expanding FDA approvals for CAR-T in multiple myeloma treatment highlight its growing importance in this cancer type, with increasing patient access as more CAR-T products become available. For instance, in April 2024, the U.S. Food and Drug Administration (FDA) approved the CAR T-cell therapies ciltacabtagene autoleucel (cilta-cel; Carvykti) and idecabtagene vicleucel (ide-cel; Abecma) for earlier treatment of adults with multiple myeloma. Before these approvals, patients had to receive at least four lines of treatment before they were eligible for CAR T-cell therapy.

The non-Hodgkin lymphoma segment is the fastest-growing segment in the CAR-T cell therapy market

The non-Hodgkin lymphoma segment is expected to be the fastest-growing segment in the CAR-T cell therapy market over the forecast period. CAR-T cell therapy is showing strong promise for treating non-Hodgkin lymphoma, a type of blood cancer that often becomes resistant to traditional treatments like chemotherapy and radiation. This therapy targets specific proteins in lymphoma cells, allowing for a focused and effective attack by the patient's immune cells.

For instance, in May 2024, Bristol Myers Squibb cleared the U.S. Food and Drug Administration (FDA) approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR-T cell therapy available to treat the broadest array of B-cell malignancies.

Geographical Analysis

North America is expected to hold a significant position in the global CAR-T cell therapy market

North America region is expected to hold the largest share in CAR-T cell therapy market over the forecast period. According to the Leukemia & Lymphoma Society, approximately every 3 minutes, one person in the US is diagnosed with leukemia, lymphoma or myeloma. An estimated combined total of 187,740 people in the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2024. New cases of leukemia, lymphoma and myeloma are expected to account for 9.4 percent of the estimated 2,001,140 new cancer cases that will be diagnosed in the US in 2024. This rising prevalence of hematological cancers is boosting the demand for CAR-T cell therapy in the region, especially in the United States.

North America, particularly the United States is home to many of the world's leading biotech and pharmaceutical companies that are at the forefront of CAR-T cell therapy research. Major players such as Gilead Sciences, Novartis and Bristol Myers Squibb have established significant R&D facilities in the region, focusing on developing and refining CAR-T cell therapies.

For instance, in March 2024, Bristol Myers Squibb released that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Asia Pacific is growing at the fastest pace in the CAR-T cell therapy market

The Asia Pacific region is experiencing the fastest growth in the CAR-T cell therapy market. Hematological cancer rates are rising sharply in the APAC region, particularly blood cancers such as leukemia, lymphoma, and multiple myeloma, which are treatable with CAR-T therapies.

For instance, countries like China and India are seeing an increase in the incidence of hematologic cancers due to changing lifestyles, aging populations, and increased awareness. According to Shalby Hospitals, Inc., for every 5 minutes, someone in India is diagnosed with blood cancer, and an estimated 70,000 people die every year because of blood cancer, contributing to an increasing demand for innovative therapies like CAR-T cell therapy.

The regulatory environment in APAC is evolving rapidly, allowing faster approval and adoption of CAR-T therapies. China's National Medical Products Administration (NMPA) approved the first domestic CAR-T therapy, Kymriah (tisagenlecleucel), in 2019 for B-cell acute lymphoblastic leukemia (ALL) and later expanded approval to lymphoma treatments. Other countries in the region, such as Japan and South Korea, are following similar paths to introduce CAR-T therapies into their healthcare systems, making the market more accessible

Competitive Landscape

The major global players in the CAR-T cell therapy market include Novartis AG, Gilead Sciences, Inc., Bristol Myers Squibb Company, Johnson & Johnson, Autolus Therapeutics, Pfizer Inc., BioNTech SE., Merck KGaA, Allogene Therapeutics, Atara Biotherapeutics, Inc. and among others.

Emerging Players

The emerging players in the CAR-T cell therapy market include AstraZeneca, Eli Lilly and Company, JW Therapeutics, and among others.

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• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global CAR-T cell therapy market report delivers a detailed analysis with 70 key tables, more than 73 visually impactful figures, and 169 pages of expert insights, providing a complete view of the market landscape.

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