세계의 CAR-T 세포 치료 시장은 2024년에 48억 달러로 평가되었고, 2033년까지는 204억 달러에 이를 것으로 예측되며, 예측 기간 중 2025년부터 2033년까지 CAGR 16.3%로 성장할 전망입니다.
CAR-T 세포 치료 또는 키메라 항원 수용체 T 세포 치료는 주로 암 치료에 사용되는 고급 면역 요법의 일종입니다. 이 치료법에서는 면역세포의 일종인 환자 자신의 T세포를 키메라 항원 수용체(CAR)를 발현하도록 개조함으로써 이러한 세포가 특정 암세포를 인식하고 공격할 수 있도록 합니다. CAR-T 세포 치료는 급성 림프모구성 백혈병(ALL)과 특정 림프종과 같은 특정 혈액암에 특히 효과적입니다. 그러나, CAR-T 세포의 효능을 제한할 수 있는 보다 억제적인 종양 미세환경 등, 다른 과제를 가지는 고형암에 이 접근법을 적응시키기 위한 연구가 진행중입니다.
CAR-T 세포 치료 수요는 진행된 혈액암을 치료할 가능성과 맞춤 치료 결과를 가져오는 능력에 의해 급속히 성장하고 있습니다. 예를 들어, 미국 혈액 학회에 따르면 연구 참가자의 71%가 림프종, 28%가 골수종, 1%가 B 세포성 급성 림프아구성 백혈병으로 진단되었습니다. CAR-T 세포 치료를 받은 환자에게는 티사겐 레클로이셀(34%), 리소카부타젠 말라레클로이셀(16%), 액시카부타젠 실로로이셀(13%), 이데카부타젠 비클로이셀(12%)이 투여되었습니다. 전반적으로, 환자의 76%가 관해를 달성했고, 33%가 CAR-T 세포 치료의 일반적인 부작용인 면역 효과기 세포 관련 신경독성 증후군을 경험했습니다.
촉진요인 및 억제요인
혈액암에서 높은 효능
혈액암에서 CAR-T 세포 치료의 높은 효능이 시장을 크게 견인하고 있어 예측 기간 중에도 CAR-T 세포 치료 시장을 견인할 것으로 예상됩니다. 혈액암, 특히 종래의 치료법에 반응하지 않은 환자에 대한 CAR-T 세포 치료의 현저한 효능에 의해 CAR-T 세포 치료 수요를 증가시키는 혈액암의 부담이 증가하고 있습니다. CAR-T 세포 치료는 급성 림프아구성 백혈병(ALL), 각종 림프종, 다발성 골수종 등의 혈액암에서 높은 주효율과 지속성을 나타냅니다.
예를 들어, 미국 혈액학회에 따르면 세계 혈액학적 악성 종양의 총 환자 수는 2030년까지 약 463만 4,937명에 이를 것으로 예측됩니다. 2030년까지 예측되는 혈액학적 악성 종양의 총 환자 수는 SDI 수준별로 다음과 같습니다. : 고SDI 지역에서는 111만 3,313례, 고중 SDI 지역에서는 100만 4,403례, 저 SDI 지역에서는 47만 5,496례, 저중 SDI 지역에서는 79만 5,472례, 중 SDI 지역에서는 124만 4424례입니다.
또한, Gilead의 Yescarta(axicabtagene ciloleucel)는 대세포형 B 세포 림프종(LBCL) 환자에서 52%의 완전한 관해율을 나타내며, 기존의 화학 치료 후 재발한 환자에게 중요한 선택을 제공합니다. Bristol Myers Squibb의 Breyanzi(lisocabtagene maraleucel)도 비슷한 결과를 보였으며, LBCL의 전주 효율은 약 73%였습니다. 따라서 CAR-T 세포 치료의 높은 효능은 CAR-T 세포 치료 시장의 성장을 크게 뒷받침하고 있습니다.
높은 치료비
CAR-T 세포 치료의 높은 가격은 환자 및 헬스케어 시스템에 대한 접근성과 가용성을 제한함으로써 CAR-T 세포 치료 시장의 성장을 현저하게 억제합니다. 특히 종합적인 상환 프레임워크가 없는 국가에서는 비용 장애가 환자의 접근을 제한하고 치료법 시장 침투를 제한합니다. 많은 지역에서 장기적인 비용 효과적인 데이터가 없기 때문에 의료 서비스 제공업체와 보험 회사는 CAR-T 세포 치료의 보험 적용을 망설이고 있으며 임상 효능에도 불구하고 도입이 제한됩니다.
예를 들어, 미국 국립 위생 연구소에 따르면 CAR-T 세포 치료의 취득 비용은 추가 치료 및 시설 비용을 제외하고 한 번의 주입 당 373,000 달러에서 475,000 달러입니다. 또한, CAR-T 세포 치료은 개조된 T 세포의 주입 및 이에 따른 병리학의 모니터링이 필요하기 때문에 일반적으로 입원 환경에서 실시되며, 7만 9,466달러에서 8만 5,267달러의 추가 비용이 듭니다. 미국에서는 CAR-T 세포 치료 링거는 약 40만 달러가 소요됩니다.
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.
The global CAR-T cell therapy market is segmented based on therapy type, drug type, target antigen, application and region.
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.
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.
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
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.
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.
Target Audience 2024
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