CAR-T Cell Therapy Market Size, Share & Industry Analysis, By Drug Type (Axicabtagene Ciloleucel (Yescarta), Brexucabtagene Autoleucel (Tecartus), Ciltacabtagene Autoleucel (Carvykti), Idecabtagene Vicleucel (Abecma), Lisocabtagene Maraleucel (Breyanzi), Tisagenlecleucel (Kymriah), and Others), By Indication (Acute Lymphoblastic Leukemia, Non-Hodgkin Lymphoma, and Multiple Myeloma), By End-user (Hospitals and Oncology Treatment Centers), and Regional Forecast, 2024-2032

The global CAR-T cell therapy market size was valued at USD 4.38 billion in 2023, and is projected to grow from USD 6.37 billion in 2024 to USD 16.35 billion by 2032, exhibiting a CAGR of 12.5% during the forecast period.

CAR-T cell therapy, which stands for chimeric antigen receptor-T cell therapy, is a type of immunotherapy that involves modifying specialized T-cells, a component of the immune system, to target and eliminate cancer cells specifically. The increasing incidence of cancer in the population and the growing healthcare burden associated with this disease are anticipated to drive the need for innovative therapies and strategies to manage and treat these conditions.

• According to the statistics published by Globocan in 2020, the total number of newly diagnosed cancer cases worldwide was 19,292,789, while the number of deaths due to cancer was 9,958,133.

Furthermore, the market is expected to experience growth as a result of the increasing number of clinical trials and research & development initiatives undertaken by market players to create innovative therapies and more efficient drugs for chimeric antigen receptor T-cell therapy.

The impact of the COVID-19 pandemic on CAR-T cell therapy resulted in slower growth in 2020. The pandemic resulted in a low diagnosis rate of blood cancer, primarily due to several factors that created challenges in the healthcare system. Firstly, the pandemic decreased routine medical check-ups and screening procedures, as many hospitals and clinics postponed non-essential appointments and tests to minimize the risk of transmission of COVID-19 infection.

• For instance, according to the report of the Leukemia & Lymphoma Society in 2019-2020, an estimated combined total of 178,520 people in the U.S. were diagnosed with leukemia, lymphoma, or myeloma in 2020.

Secondly, the pandemic disrupted supply chains and made it difficult for healthcare providers to access the necessary equipment and materials for diagnosing blood cancer such as blood tests and imaging tools. Additionally, similarities between blood cancer and COVID-19 symptoms, such as fatigue, fever, and shortness of breath, complicated the diagnosis process. Due to these overlapping symptoms, individuals witnessed difficulties in recognizing the need for diagnostic testing for blood cancer, which led to further delays in diagnosis.

Despite these challenges, the market continued to grow at a slower pace in 2021, driven by increasing awareness and acceptance of the therapy and a growing number of approved indications.

CAR-T Cell Therapy Market Trends

Increasing Pipeline Candidates and Clinical Trials for Innovative Drugs Therapies

The rising prevalence of cancer among the population has led to increasing demand for effective drugs and treatment options. This demand prompted market players and research organizations to develop and launch innovative therapies to address the various types and stages of cancer. One such therapy that has gained attention is CAR-T cell therapy.

The increasing focus and robust efforts of key players operating in the market to introduce and develop novel therapies for the unmet demand of the rising patient population are expected to drive the demand for CAR-T cell therapy. This is particularly significant given the potential benefits of chimeric antigen receptor T-cell therapy, such as personalized treatment options and targeted cancer cell destruction, which can minimize side effects.

• In March 2023, there were 443 pipeline candidates for chimeric antigen receptor T-cell therapy listed on ClinicalTrials.gov, while only 12 clinical trials were investigating this type of treatment in 2012.

In addition, several market players are undergoing partnerships for the development of CAR-T cell therapy involving the treatment of cancer.

• For instance, in February 2024, BioNTech SE, an immunotherapy company and Autolus Therapeutics plc, a biopharmaceutical company, formed a partnership aimed at advancing both companies' autologous CAR-T programs toward commercialization, pending regulatory approvals.

Furthermore, research institutes and market players actively participate in annual conferences to showcase their clinical trial outcomes and collaborate to develop cutting-edge chimeric antigen receptor T-cell therapies. This collaborative effort among industry leaders and researchers is crucial for advancing the field and improving the effectiveness and accessibility of CAR-T therapy for patients.

• In September 2022, CARsgenTherapeutics Co., Ltd showcased the presentation on the North America phase 2 clinical trial of zevorcabtagene autoleucel (CT 053). The study was designed to assess the safety & efficacy of this treatment in patients with relapsed and refractory multiple myeloma in North America.


• In February 2021, Caribou Biosciences, Inc. and AbbVie collaborated and entered into a license agreement to research and develop chimeric antigen receptor T cell therapeutics.

Thus, rising cancer patient population, increasing partnerships, and collaborations among research organizations and market players to develop innovative and more effective chimeric antigen receptor T-cell therapies with increasing number of ongoing clinical trials are expected to spur market growth during the forecast period.

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CAR-T Cell Therapy Market Growth Factors

Rising Prevalence of Hematological Cancer to Surge the Demand for CAR-T Cell Therapy

One of the most critical drivers that positively impact the CAR-T cell therapy market growth is the extensive increase in the global prevalence of cancer. Along with this, the increasing availability of Patient Assistance Programs (PAPs) is driving the adoption of this therapy. Furthermore, governments worldwide are taking measures to raise awareness about cancer, further contributing to the market growth.

• The International Agency for Research on Cancer (IARC) projected that the worldwide burden of cancer is set to increase significantly by 2040. The estimated number of new cancer cases is expected to rise to 27.5 million by 2040, while the number of cancer-related deaths is projected to reach 16.3 million worldwide by 2040.


• According to the statistics published by the American Cancer Society, Inc., there is a projected increase of over 60.0% in the global burden of cancer, with an expected rise from 18.1 million new cases in 2018 to 29.4 million cases by 2040.

The increasing awareness among the general population regarding various blood cancers owing to the rising number of initiatives carried out by different government bodies, healthcare agencies, and market players is resulting in a high diagnosis and treatment rate among the population.

Along with these, the expanding healthcare expenditure and the growing prevalence of non-hodgkin's lymphoma in both developed and developing countries are additional factors likely to drive the demand for CAR-T cell therapy.

• The American Society of Hematology reported in November 2022 that Non-Hodgkin's Lymphoma (NHL) was among the top 5 to 9 most prevalent types of cancer worldwide, with an estimated 544,000 new cases and 260,000 cancer-related deaths.

Furthermore, due to the rising prevalence of different types of blood cancer, researchers from different institutions are focusing more on the development of CAR-T cell therapy to treat all types of blood cancer. Researchers are also incorporating new approaches such as CRISPR, a gene-editing technology for making changes in the protein that relies on the surface of stem cells and CAR-T cells.

As a result of these factors, the market players' increasing emphasis on creating and introducing new drugs and therapies to treat these conditions is expected to be an upsurge in the demand and adoption of these novel drugs in the market over the forecast period.

RESTRAINING FACTORS

High Treatment Cost of the Expensive Drugs is Limiting the Adoption of the Therapy

Over the past decade, the industry witnessed notable developments in chimeric antigen receptor T-cell therapy, among others. However, certain limitations, such as the higher cost of chimeric antigen receptor T-cell therapy drugs and higher out-of-pocket spending, limit the market growth. The higher cost of drugs, owing to their numerous benefits and various costs involved in their development and approvals is a restraining factor limiting the adoption of these drugs.

• According to the article published in the National Library of Medicine in October 2022, the cost of acquiring a CAR T-cell therapy infusion typically falls within the range of USD 373,000 to USD 475,000, not considering additional procedures or expenses related to healthcare facilities.


• For instance, Novartis, the manufacturer of Kymriah, stated that the cost of one treatment cycle for this chimeric antigen receptor T cell therapy is USD 475,000. Kymriah has also been approved to treat relapsed or refractory large B-cell lymphoma in adults who have undergone two or more prior therapies.

Another challenge for this novel cancer therapy is that the treatment is restricted to heavily pretreated patients. To qualify for tisagenlecleucel or axicabtagene ciloleucel treatment, patients must have undergone at least two lines of systemic therapies and have relapsed or shown resistance to those treatments. However, certain patients undergoing multiple treatments for their condition may be too weakened to handle the severe side effects associated with chimeric antigen receptor T-cells. Consequently, this further reduces the number of eligible patients for these therapies.

Therefore, the limited eligibility criteria for chimeric antigen receptor T-cell therapy, coupled with the high out-of-pocket costs involved, is creating a growing discrepancy between the number of patients who could benefit from this treatment and those who can access it. Consequently, this disparity is expected to impede the widespread adoption of CAR-T therapy.

• According to the article published in the MJH Life Sciences in April 2021, a recent analysis of real-world data revealed that the total cost of chimeric antigen receptor T-cell therapy surpasses USD 700,000 on average. In certain cases, it can even exceed USD 1 million.

Furthermore, CAR-T therapies are associated with higher research and development costs along with high production and administration costs. In addition, autologous CAR T-cells are costly to produce due to their patient-tailored nature. These are the several components that are limiting market growth.

One of the factors that could limit the market growth in emerging countries, such as Mexico, Saudi Arabia, and other African nations, is the inadequate awareness among the general population about various cancer conditions such as multiple myeloma, acute lymphoblastic leukemia, and non-Hodgkin's lymphoma. Furthermore, lack of reimbursement policies in these countries may also contribute to market limitations during the forecast period.

CAR-T Cell Therapy Market Segmentation Analysis

By Drug Type Analysis

Axicabtagene Ciloleucel (Yescarta) Segment Dominates due to Increasing Prevalence of Non-Hodgkin Lymphoma

On the basis of drug type, the market is segmented into axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), ciltacabtagene autoleucel (Carvykti), idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), tisagenlecleucel (Kymriah), and others.

Among drug types, the axicabtagene ciloleucel (Yescarta) segment dominated the market in 2023. The dominance was attributed to the increasing prevalence of non-Hodgkin lymphoma, increasing healthcare expenditure, and rising general awareness through various campaigns among the population, resulting in the growing demand for axicabtagene ciloleucel.

• For instance, the Lymphoma Action in September 2022 conducted various awareness campaigns in September, including World Lymphoma Awareness Day on 15^th September among the general population in the U.K.

Axicabtagene ciloleucel is indicated for the treatment of two forms of non-Hodgkin lymphoma that is used when initial treatment has proven ineffective or if the cancer has resurfaced within a year of the initial treatment for large B-cell lymphoma, and for follicular lymphoma when the cancer has been unresponsive to at least two different types of treatment.

Furthermore, the rising number of drug approvals and launches of new drug products is contributing to the growth of the ciltacabtagene autoleucel segment globally.

• In February 2022, Janssen Global Services, LLC, a division of Johnson & Johnson, reported the U.S. Food and Drug Administration (FDA) granted approval for Carvykti for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM) in adults.

The growth of the others segment is expected to be driven by collaborations among industry players as well as increasing research and development activities in chimeric antigen receptor T-cell therapy to meet the growing demand for innovative drugs among the patient population.

• In November 2022, Caribou Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for CB-011. The CB-011 is a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune cloaking.

Thus, the rising demand for these drugs owing to better potential advantages over various cancer therapies and increasing research & development activities among the global market players propels the segmental share in the market.

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By Indication Analysis 

Increasing Incidence of Non-Hodgkin Lymphoma and Rising Approvals of New Products by Regulatory Agencies Aided in Segment Growth

In terms of indication, the market is segmented into acute lymphoblastic leukemia, non-Hodgkin lymphoma, and multiple myeloma.

Non-Hodgkin lymphoma dominated the market in 2023, primarily due to the rising incidence of this condition among the population. This is further fueled by the rising number of initiatives to raise awareness about these conditions, resulting in a growing diagnosis rate and an increased demand for therapeutic products. Furthermore, an increasing number of regulatory approvals for the treatment of Non-Hodgkin lymphoma is one of the factors contributing to segment growth.

• For instance, in October 2023, ImmunoACT announced that it received an approval from the Central Drugs Standard Control Organization for its CAR-T cell therapy for treating relapsed/refractory B-cell lymphomas and leukaemia.


• According to the estimated statistics published by the American Cancer Society, Inc. in 2023, Non-Hodgkin Lymphoma (NHL) is expected to be diagnosed in approximately 80,550 individuals, comprising 44,880 males and 35,670 females, including adults and children.

The multiple myeloma segment is expected to grow at a higher CAGR during the forecast period. This growth can be attributed to the increasing focus of key players in the pharmaceutical industry to develop and introduce new drugs to treat this condition.

• For instance, in January 2022, Bristol-Myers Squibb Company announced that Abecma, a chimeric antigen receptor T-cell immunotherapy directed toward B-cell Maturation Antigen (BCMA), approved by Japan's Ministry of Health, Labour and Welfare for treating adult patients with relapsed or refractory (R/R) multiple myeloma.

On the other hand, increasing strategic initiatives by government health bodies across the globe along with the rising prevalence of these conditions, is leading to an increasing focus of the key market players to develop and introduce novel and effective therapies for the treatment, further augmenting the demand for these drugs.

By End-user Analysis

Increasing Inpatient Admissions will Augment the Hospitals Segment Growth

On the basis of end-user, the market is segmented into hospitals and oncology treatment centers.

The hospitals segment dominated with the maximum market share in 2023 and is estimated to register a higher CAGR during the forecast period. The chimeric antigen receptor T-cell therapy is a highly specialized form of treatment that requires close collaboration between different healthcare professionals, including hematologists, oncologists, and immunologists. This collaboration is best facilitated in a hospital setting, where patients can receive comprehensive and integrated care from a multidisciplinary team.

Additionally, in certain instances, patients may need to be hospitalized for a duration of 7 to 10 days to enable healthcare providers to closely monitor their treatment response and effectively address any potential side effects that may occur.

• According to the statistics published by the Leukemia & Lymphoma Society in 2021, the number of individuals diagnosed with leukemia, lymphoma, or myeloma in the U.S. is a combined total of 186,400.

The oncology treatment centers segment is expected to grow primarily due to the availability of various treatment options, and the increasing number of oncology centers in developing nations is one of the major reasons contributing to the overall growth of the segment.

• According to the report published by the Kite Pharma, Inc., there are 110 authorized treatment centers located across the U.S. for the treatment of chimeric antigen receptor T-cell therapy

REGIONAL INSIGHTS

Geographically, the global market is studied across North America, Europe, Asia Pacific, and the Rest of the World.

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North America holds the highest CAR-T cell therapy market share and generated a revenue of USD 3.01 billion in 2023. The region is anticipated to dominate the market over the forecast period as well, owing to the growing prevalence of hematologic cancer along with a higher diagnosis and treatment rate. Moreover, the presence of adequate reimbursement for inpatient hospital stays encourages the adoption of novel and advanced treatment in the key countries in the region.

• According to the article published in the Avalere Health in September 2022, for the fiscal year 2022, hospitalizations involving Chimeric Antigen Receptor T-cell treatment are categorized under MS-DRG 018, with a base reimbursement rate of USD 246,955.

Additionally, the region's growth is attributed to technological advancements in the field, partnerships between key industry players for receiving regulatory approvals and new product launches.

• For instance, in February 2024, Kelonia Therapeutics and Astellas Pharma Inc. announced their research partnership and signed a license agreement for the development of new immuno-oncology therapeutics. As a part of this agreement, both companies will develop novel in vivo CAR-T cell therapies for the treatment of cancer.


• Similarly, in June 2022, Bristol-Myers Squibb Company declared that lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy directed at CD19, was granted approval by the U.S. Food and Drug Administration (FDA) for treating Large B-Cell Lymphoma (LBCL) in adults, including Diffuse Large B-Cell Lymphoma (DLBCL).

Europe accounted for a substantial share of the market. Increasing collaboration between the market players to launch novel drug therapy, rising research and development activities, and rising government funding are expected to boost the market growth in Europe over the projected period.

• For instance, in June 2022, Elicera Therapeutics AB received a grant of USD 3.0 million from the European Innovation Council (EIC) Accelerator Programme. This funding will cover the costs of Elicera's clinical phase I/II study of their CAR T-cell therapy, ELC-301, which is intended to treat B-cell lymphoma.

The Asia Pacific market is projected to grow at the highest CAGR during the forecast timeframe owing to the rising clinical trials, rising awareness among the patient population regarding new and recent treatments, and emphasis of the key market players on receiving approvals from the regulatory bodies for marketing and distribution of their products in the region is fueling the market growth in this region

• For instance, in February 2022, JW Therapeutics (Shanghai) Co., Ltd. granted clearance for an Investigational New Drug (IND) by the National Medical Products Administration (NMPA) of China. This clearance allows the company to conduct a pivotal clinical trial for relmacabtagene autoleucel, its autologous chimeric antigen receptor T-cell immunotherapy product targeting CD19, in the treatment of large B-cell lymphoma.

Further, the market in the rest of the world is expected to grow during the forecast period. The improving healthcare infrastructure and increasing collaboration and partnerships among the key market players to expand its geographical reach, among others, are a few factors augmenting the market growth in the region.

List of Key Companies in CAR-T Cell Therapy Market

Gilead Sciences, Inc., to Lead the Market with a Strong Drug Product Portfolio

This highly fragmented market comprises a few players with a range of drug products, including prescription products. The increasing sales of the drug axicabtagene ciloleucel in the U.S. and the global market is one of the primary reasons contributing to the growing chimeric antigen receptor T-cell therapy market share of Gilead Sciences, Inc.

• According to the annual report of Gilead Sciences, Inc., in 2022, the company’s Yescarta drug product generated a revenue of USD 1,160.0 million and witnessed a growth of 66.9% compared to the previous year. The higher demand for Yescarta in R/R LBCL in the U.S. and Europe drives the growth.

Bristol-Myers Squibb Company is increasing its focus on approving and introducing products globally with strategic mergers and acquisitions. In addition, the company is placing a significant emphasis on developing its distribution network to meet the growing demand from the population, which is expected to strengthen its position in the market.

• According to the investor presentation of Bristol-Myers Squibb Company in 2022, the company predicted the Breyanzi drug product sales up to USD 3.0 billion by 2030.

The increasing number of pipeline candidates for the treatment of chimeric antigen receptors T-cell therapy is the result of the growing investment of other players in research & development activities aimed at developing novel drugs and therapies for the condition. These factors are expected to increase the chimeric antigen receptor T-cell therapy market share of these companies in the future.

• For instance, Aurora Biopharma, has its product candidate, AU-105, in a Phase II clinical trial, which involves the intravenous infusion of chimeric antigen receptor T-cell therapy cells targeting HER2 in patients with newly diagnosed glioblastoma. The company is expected to launch its chimeric antigen receptor T-cell therapy for Glioblastoma within the next five years, with potential annual revenues estimated to be over USD 1.0 billion.

LIST OF KEY COMPANIES PROFILED:

• Gilead Sciences, Inc. (U.S.)


• Novartis AG (Switzerland)


• Bristol-Myers Squibb Company (U.S.)


• Johnson & Johnson Services, Inc. (Janssen Global Services, LLC) (U.S.)


• Caribou Biosciences, Inc. (U.S.)


• CARsgenTherapeutics Co., Ltd (China)


• JW Therapeutics (Shanghai) Co., Ltd. (China)


• Cartesian Therapeutics, Inc. (U.S.)


• Aurora Biopharma (U.S.)

KEY INDUSTRY DEVELOPMENTS

• December 2023 - Max Healthcare introduced CAR-T cell therapy in Delhi-NCR in partnership with ImmunoACT for the treatment of lymphomas and leukemias.


• December 2022 - CARsgen Therapeutics Co., Ltd. and Shanghai Cancer Institute collaborated to create a new technology that can substantially enhance the antitumor capabilities of T cells. The CARsgen and Shanghai Cancer Institute research team developed CAR T cells that overexpressed Runx3 and discovered that Run-CAR-T cells exhibited persistent antitumor activity and better tumor control than conventional chimeric antigen receptor T-cell therapy.


• November 2022 - Caribou Biosciences, Inc. announced that its allogeneic anti-CD19 CAR-T cell therapy, CB-010, was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for relapsed or refractory large B cell lymphoma (LBCL) and fast track designation for relapsed or refractory B cell non-Hodgkin lymphoma.


• June 2022- The University of Ottawa, working on a clinical trial known as Canadian-Led Immunotherapies in Cancer-01 (CLIC-01), demonstrated encouraging outcomes for one of the initial Canadian-developed CAR-T cell therapies for cancer. The manufacturing process of this therapy is distinct, which provides the possibility of more affordable and fairer treatment options.


• December 2021 – The California Institute for Regenerative Medicine governing board approved the grant of USD 4.1 million to support the development of innovative chimeric antigen receptor T-cell therapy of scientists at the University of California San Diego School of Medicine, which could assist the team in bringing this promising cancer therapy from the laboratory to clinical use.


• December 2020 - Bayer AG and Atara Biotherapeutics, Inc. entered into an exclusive worldwide licensing agreement as well as a research, development, and manufacturing collaboration for mesothelin-directed CAR T-cell therapies aimed at treating solid tumors. The agreement covers the development of the ATA3271 candidate.

REPORT COVERAGE

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The report covers a detailed analysis and overview of the market. It focuses on key aspects such as competitive landscape, drug type, indication, end-user, and region. Besides this, it offers insights into the market drivers, market trends, market dynamics, and other key insights. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market in recent years.

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