Global CAR T-Cell Therapy Market 2024–2033

Reports Description

As per the current market research conducted by the CMI Team, the global CAR T-Cell Therapy Market is expected to record a CAGR of 18.1% from 2024 to 2033. In 2024, the market size is projected to reach a valuation of USD 3,324.6 Million. By 2033, the valuation is anticipated to reach USD 14,859.1 Million.

United States Rate of New Cancers by Age Group

Source: According to U.S. Cancer Statistics

The CAR T-cell therapy market encompasses the development, commercialization, and utilization of chimeric antigen receptor (CAR) T-cell immunotherapy treatments for cancer. This innovative approach involves modifying a patient’s T-cells to recognize and attack cancer cells expressing specific antigens.

CAR T-cell therapy has demonstrated remarkable efficacy in treating hematologic malignancies, including leukemia and lymphoma, with several products receiving regulatory approval.

The market is characterized by ongoing research and development efforts to expand indications, improve treatment outcomes, and overcome challenges related to manufacturing, safety, and access, underscoring its transformative potential in oncology care.

CAR T-Cell Therapy Market – Significant Growth Factors

The CAR T-Cell Therapy Market presents significant growth opportunities due to several factors:

• Clinical Success and Regulatory Approvals: The clinical success of CAR T-cell therapies in treating hematologic malignancies, coupled with regulatory approvals from agencies like the FDA and EMA, drive market growth. Positive clinical trial results and regulatory endorsements bolster confidence in the safety and efficacy of CAR T-cell therapies, stimulating investment and adoption.

• Advancements in Immunotherapy: Continuous advancements in immunotherapy, including CAR T-cell therapy, contribute to market expansion. Innovations in CAR construct design, target antigen selection, and manufacturing technologies enhance treatment efficacy, broaden the therapeutic potential, and drive interest from both biopharmaceutical companies and academic institutions.

• Increasing Cancer Incidence: The rising incidence of cancer worldwide, particularly hematologic malignancies such as leukemia and lymphoma, fuels demand for effective treatments like CAR T-cell therapy. As cancer rates continue to climb, there is a growing need for novel therapies capable of achieving durable responses and improving patient outcomes.

• Strategic Collaborations and Partnerships: Collaborations between biopharmaceutical companies, academic institutions, and research organizations accelerate CAR T-cell therapy development and commercialization. Strategic partnerships facilitate access to complementary expertise, resources, and infrastructure, driving innovation, reducing development timelines, and expanding market reach.

• Expansion into Solid Tumor Indications: Opportunities exist for CAR T-cell therapy to expand beyond hematologic malignancies into solid tumor indications. Advances in CAR design, target identification, and tumor microenvironment modulation present avenues for overcoming challenges associated with solid tumors, unlocking new therapeutic possibilities and expanding the addressable market.

• Personalized Medicine and Biomarker Development: CAR T-cell therapy offers opportunities for personalized medicine approaches and biomarker development. Tailoring treatments to individual patients based on disease characteristics, genetic profiles, and biomarker expression enhances treatment efficacy and safety, while biomarker discovery facilitates patient selection, response prediction, and treatment optimization, driving precision oncology advancements within the CAR T-cell therapy market.

CAR T-Cell Therapy Market – Mergers and Acquisitions

The CAR T-Cell Therapy Market has seen several mergers and acquisitions in recent years, with companies seeking to expand their market presence and leverage synergies to improve their product offerings and profitability. Some notable examples of mergers and acquisitions in the CAR T-Cell Therapy Market include:

• In 2023, Bristol-Myers Squibb obtained manufacturing and marketing approval for an additional indication for Abecma (idecabtagene vicleucel), a BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma who have undergone at least two prior therapies, including specific agents.

• In 2023, 2seventy Bio, Inc. and JW Therapeutics announced plans to expand their strategic alliance by including up to two additional candidates from the 2seventy portfolio. These candidates will focus on solid tumor indications using T-cell receptor (TCR) technology and autoimmune disease utilizing a CAR T-cell approach.

• In 2022, Autolus Therapeutics plc has partnered with Cardinal Health Inc. to facilitate the launch and commercialization of its CAR T-cell therapies in the United States, contingent upon FDA approval.

These mergers and acquisitions helped companies expand their product offerings, improve their market presence, and capitalize on growth opportunities in the CAR T-Cell Therapy Market. The trend is expected to continue as companies seek to gain a competitive edge in the market.

COMPARATIVE ANALYSIS OF THE RELATED MARKET

CAR T-Cell Therapy Market – Significant Threats

The CAR T-Cell Therapy Market faces several significant threats that could impact its growth and profitability in the future. Some of these threats include:

• Safety Concerns and Adverse Events: CAR T-cell therapy can be associated with severe adverse events, including cytokine release syndrome (CRS) and neurotoxicity. Safety concerns pose a threat to patient acceptance, physician confidence, and regulatory approval, potentially limiting market adoption and hindering commercial success.

• High Cost of Treatment: The high cost of CAR T-cell therapy poses a significant barrier to widespread adoption and reimbursement. The complex manufacturing process, personalized nature of the treatment, and associated hospitalization and monitoring expenses contribute to the substantial financial burden on healthcare systems, payers, and patients, potentially restricting access and market penetration.

• Limited Indications and Patient Eligibility: CAR T-cell therapy is currently indicated for specific hematologic malignancies and patient populations, limiting its addressable market. Factors such as target antigen expression, disease stage, and patient comorbidities restrict eligibility and treatment options, potentially reducing the overall market size and revenue potential for CAR T-cell therapies.

• Manufacturing Challenges and Scalability: The complex and labor-intensive manufacturing process for CAR T-cell therapies presents challenges related to scalability, reproducibility, and cost-effectiveness. Manufacturing capacity constraints, supply chain disruptions, and variability in cell product quality may impact treatment availability, delay market entry, and hinder commercialization efforts, posing a threat to market growth and sustainability.

Category-Wise Insights:

By Drug Type

• Axicabtagene Ciloleucel: Axicabtagene ciloleucel is a CAR T-cell therapy approved for the treatment of certain types of non-Hodgkin lymphoma. Its approval marked a significant milestone in CAR T-cell therapy, demonstrating efficacy in relapsed or refractory lymphomas. Trends include increasing adoption in clinical practice, ongoing research to optimize treatment protocols, and efforts to broaden its indication to additional lymphoma subtypes.

• Tisagenlecleucel: Tisagenlecleucel, also known as Kymriah, is a CAR T-cell therapy approved for the treatment of certain pediatric and young adult patients with acute lymphoblastic leukemia and certain types of non-Hodgkin lymphoma. Trends include expanding indications, ongoing research into its long-term safety and efficacy, and efforts to improve manufacturing processes to enhance treatment accessibility and scalability.

• Brexucabtagene Autoleucel: Brexucabtagene autoleucel, also known as Tecartus, is a CAR T-cell therapy approved for the treatment of certain adults with relapsed or refractory mantle cell lymphoma. Trends include its recent approval as a novel treatment option for mantle cell lymphoma, ongoing clinical trials exploring its potential in other hematologic malignancies, and efforts to optimize patient selection criteria and management strategies.

• Others: The “Others” category encompasses various investigational CAR T-cell therapies targeting different cancer types and antigens. Trends include the diversification of CAR constructs, exploration of novel target antigens, and advancements in manufacturing technologies to improve treatment efficacy, safety, and accessibility. Ongoing research efforts aim to expand the therapeutic potential of CAR T-cell therapy across a broader range of cancers and patient populations.

By Indication

• Lymphoma: CAR T-cell therapy for lymphoma involves modifying a patient’s T-cells to target and destroy lymphoma cells expressing specific antigens. Trends include the development of CD19-targeted therapies like axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated high response rates and durable remissions in relapsed/refractory lymphomas. Ongoing research focuses on optimizing CAR constructs, exploring combination therapies, and addressing safety concerns to further improve outcomes in lymphoma patients.

• Acute Lymphocytic Leukemia (ALL): CAR T-cell therapy for acute lymphocytic leukemia (ALL) entails genetically modifying T-cells to recognize and eliminate leukemia cells expressing CD19. Trends in ALL treatment include the approval of tisagenlecleucel and Kymriah for pediatric and young adult patients with relapsed/refractory ALL, demonstrating significant efficacy and long-term remissions. Future directions involve expanding CAR T-cell therapy to adult ALL populations and investigating novel targets and combination strategies.

• Others: In addition to lymphoma and ALL, CAR T-cell therapy is being explored for various other indications, including chronic lymphocytic leukemia (CLL), multiple myeloma, and solid tumors. While challenges remain in identifying suitable antigens and overcoming tumor heterogeneity, ongoing research efforts aim to expand the therapeutic potential of CAR T-cell therapy across a broader range of hematologic malignancies and solid tumor types, driving innovation and clinical advancement in the field.

By Target Antigen

• CD19-targeted Therapies: CD19-targeted CAR T-cell therapies are designed to recognize and eliminate cancer cells expressing the CD19 antigen, primarily used in treating B-cell malignancies such as leukemia and lymphoma. Trends include optimization of CAR constructs for enhanced efficacy and durability, development of combination therapies to overcome resistance mechanisms, and exploration of CD19-targeted therapies in solid tumor indications.

• CD22-targeted Therapies: CD22-targeted CAR T-cell therapies target the CD22 antigen expressed on B-cell malignancies, offering an alternative treatment option for patients who may not respond to CD19-targeted therapies. Trends include the investigation of dual-targeting CAR constructs targeting both CD19 and CD22 antigens, as well as the development of next-generation CAR designs to improve tumor cell recognition and CAR T-cell persistence.

• BCMA-targeted Therapies: BCMA-targeted CAR T-cell therapies target the B-cell maturation antigen (BCMA), predominantly used in the treatment of multiple myeloma. Trends include the optimization of BCMA-targeted CAR constructs to enhance tumor specificity and reduce off-target effects, as well as the exploration of combination therapies incorporating BCMA-targeted CAR T-cell therapy with other agents such as immunomodulatory drugs and monoclonal antibodies to improve treatment outcomes.

• EGFRvIII-targeted Therapies: EGFRvIII-targeted CAR T-cell therapies are designed to target the EGFRvIII variant expressed on tumor cells, primarily in glioblastoma multiforme (GBM). Trends include the development of novel CAR constructs with improved tumor penetration and persistence, investigation of combination therapies with standard-of-care treatments such as radiation and chemotherapy, and exploration of EGFRvIII-targeted therapies in other solid tumor indications.

• HER2-targeted Therapies: HER2-targeted CAR T-cell therapies target the human epidermal growth factor receptor 2 (HER2), commonly overexpressed in breast cancer and other solid tumors. Trends include the refinement of HER2-targeted CAR designs to minimize on-target off-tumor toxicities, exploration of combination therapies with HER2-targeted monoclonal antibodies and tyrosine kinase inhibitors, and investigation of HER2-targeted therapies in HER2-positive solid tumor indications beyond breast cancer.

• Mesothelin-targeted Therapies: Mesothelin-targeted CAR T-cell therapies aim to target mesothelin, a cell surface antigen overexpressed in various solid tumors, including mesothelioma and pancreatic cancer. Trends include the optimization of CAR constructs for improved tumor targeting and trafficking, the development of bispecific CAR designs targeting both mesothelin and other antigens and the exploration of combination therapies with checkpoint inhibitors and chemotherapy to enhance treatment efficacy in mesothelin-positive malignancies.

• Others: Other CAR T-cell therapies target a variety of antigens expressed on cancer cells, including prostate-specific membrane antigen (PSMA) in prostate cancer, CD20 in B-cell malignancies, and NY-ESO-1 in solid tumors. Trends include the development of novel CAR constructs targeting rare or specific antigens, exploration of allogeneic CAR T-cell therapies, and investigation of combinatorial approaches to overcome antigen escape and treatment resistance.

By End User

• Academic Medical Centers: Academic medical centers serve as hubs for CAR T-cell therapy research, development, and clinical trials. Trends include collaboration with industry partners, technology transfer initiatives, and training programs for healthcare professionals.

• Hospitals: Hospitals play a crucial role in providing CAR T-cell therapy to patients. Trends include the establishment of specialized CAR T-cell therapy centers within hospitals, the adoption of advanced treatment protocols, and the integration of supportive care services.

• Outpatient Clinics: Outpatient clinics offer CAR T-cell therapy in ambulatory settings, providing convenient access to treatment. Trends include the expansion of outpatient CAR T-cell therapy programs, implementation of telemedicine for follow-up care, and optimization of patient scheduling and logistics.

• Others: Other end users of CAR T-cell therapy may include specialty cancer centers, infusion centers, and home healthcare providers. Trends in this segment include the development of decentralized treatment models, patient-centered care approaches, and innovative reimbursement strategies.

Report Scope

CAR T-Cell Therapy Market – Regional Analysis

The CAR T-Cell Therapy Market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. Here is a brief overview of each region:

• North America: In North America, a significant trend in the CAR T-cell therapy market is the rapid adoption of novel therapies and technologies, driven by robust research infrastructure, strong regulatory frameworks, and high healthcare expenditure. Additionally, collaborations between academia, industry, and healthcare institutions foster innovation and accelerate the translation of research into clinical practice, positioning North America as a leading market for CAR T-cell therapy development and commercialization.

• Europe: In Europe, an emerging trend in the CAR T-cell therapy market is the increasing focus on healthcare sustainability and cost-effectiveness. Healthcare systems across Europe are exploring innovative reimbursement models, value-based pricing strategies, and health technology assessments to ensure equitable access to CAR T-cell therapies while managing budgetary constraints. Additionally, cross-border collaborations and regulatory harmonization efforts facilitate market entry and streamline commercialization pathways for CAR T-cell therapies in the region.

• Asia-Pacific: In the Asia-Pacific region, a notable trend in the CAR T-cell therapy market is the growing investment in healthcare infrastructure and oncology research. Countries like China, Japan, and South Korea are making significant strides in CAR T-cell therapy development, fueled by government support, academic partnerships, and investment from biopharmaceutical companies. Moreover, rising cancer incidence rates and increasing patient awareness drive demand for innovative cancer treatments, positioning Asia-Pacific as a promising market for CAR T-cell therapy expansion.

• LAMEA: In the LAMEA (Latin America, Middle East, and Africa) region, a key trend in the CAR T-cell therapy market is the focus on improving healthcare access and infrastructure. Despite challenges such as limited healthcare resources and regulatory hurdles, countries in LAMEA are investing in oncology care, building specialized treatment centers, and forging partnerships with international stakeholders to address unmet medical needs. Additionally, initiatives to enhance clinical trial participation and increase awareness about CAR T-cell therapy contribute to market growth and development in the region.

Competitive Landscape – CAR T-Cell Therapy Market

The CAR T-Cell Therapy Market is highly competitive, with a large number of manufacturers and retailers operating globally. Some of the key players in the market include:

• Novartis AG
• Gilead Sciences Inc. (Kite Pharma)
• Bristol Myers Squibb (Celgene Corporation)
• Johnson & Johnson (Janssen Pharmaceuticals)
• Bluebird Bio Inc.
• Pfizer Inc. (Kite Pharma)
• Cellectis SA
• Sorrento Therapeutics Inc.
• Legend Biotech Corporation
• Fate Therapeutics Inc.
• Precision Biosciences Inc.
• Atara Biotherapeutics Inc.
• TCR2 Therapeutics Inc.
• CARsgen Therapeutics Ltd.
• Allogene Therapeutics Inc.
• Others

These companies operate in the market through various strategies such as product innovation, mergers and acquisitions, and partnerships.

New players entering the CAR T-cell therapy market are leveraging innovation and development to establish their presence. Companies like Allogene Therapeutics and Poseida Therapeutics are pioneering novel approaches to CAR T-cell therapy, such as allogeneic platforms and genome engineering techniques.

Conversely, key players dominating the market include Novartis AG, Gilead Sciences (Kite Pharma), and Bristol Myers Squibb (Celgene Corporation), renowned for their extensive experience, robust clinical pipelines, and commercial success with approved CAR T-cell therapies, solidifying their positions as industry leaders through strategic acquisitions and partnerships.

The CAR T-Cell Therapy Market is segmented as follows:

By Drug type

• Axicabtagene Ciloleucel
• Tisagenlecleucel
• Brexucabtagene Autoleucel
• Others

By Indication

• Lymphoma
• Acute Lymphocytic Leukemia
• Others

By Target Antigen

• CD19-targeted Therapies
• CD22-targeted Therapies
• BCMA-targeted Therapies
• EGFRvIII-targeted Therapies
• HER2-targeted Therapies
• Mesothelin-targeted Therapies
• Others

By End User

• Academic Medical Centers
• Hospitals
• Outpatient Clinics
• Others

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America