In this context, Gilead Sciences (via its Kite Pharma subsidiary) and Arcellx Inc. have formed one of the most strategically impactful alliances in the CAR-T ecosystem. Their lead investigational product, anito-cel (formerly known as CART-ddBCMA), represents a new generation of CAR T-cell therapy targeting BCMA with enhanced safety and durability of response.

Challenge:

Despite remarkable success in hematologic malignancies, CAR T-cell therapies have faced three key limitations:

• Safety risks such as cytokine release syndrome (CRS) and neurotoxicity.
• Manufacturing delays associated with autologous CAR T production, leading to treatment bottlenecks.
• Short duration of remission, especially in patients with advanced or refractory myeloma.
  

Patients who relapse after prior CAR-T treatments often have limited options, creating a clinical and commercial need for safer, longer-lasting, and more scalable CAR T-cell products.

Solution:

Arcellx's proprietary ARC-SparX platform introduced a modular CAR design that allows precise activation of engineered T cells only in the presence of a matching antigen-binding“SparX” protein. This innovation provides:

• Improved safety control (reduces off-tumor toxicity and cytokine storms).
• Flexible reactivation (enables re-dosing for sustained therapeutic effects).
• Simplified manufacturing with enhanced cell viability.
  

Gilead Sciences, leveraging its commercial and regulatory infrastructure, partnered with Arcellx in December 2022, investing over USD 225 million upfront and later expanding the deal to USD 1.25 billion to co-develop and co-commercialize anito-cel globally.

Implementation:

The collaboration moved rapidly through the clinical development phase.

• In November 2024, Gilead and Arcellx presented updated Phase 2 trial data at the American Society of Hematology (ASH) Annual Meeting.
• 95% overall response rate (ORR) and 62% complete or stringent complete response (CR/sCR) were reported among 58 patients with RRMM.
• Median follow-up: 10.3 months.
• Safety profile: No delayed neurotoxicity, reduced cytokine release incidents compared to earlier CAR T versions.

Manufacturing efficiency also improved, with turnaround times reduced by nearly 30%, enhancing patient access.

Results:

These outcomes place anito-cel among the most promising next-generation CAR T therapies in development. Analysts from Fierce Biotech and Evaluate Vantage noted that the therapy could“outperform Carvykti” (Johnson & Johnson/Legend Biotech) in long-term safety and consistency.

Impact:

• Clinical Impact:
  The partnership established a model for collaborative innovation between a global biopharma leader and a specialized CAR T developer. The therapy's performance reinforces the viability of BCMA as a target antigen and demonstrates how modular CAR designs can mitigate toxicity risks.
• Market Impact:
  The case has shifted investor focus toward second-generation CAR platforms, accelerating funding for companies working on tunable and allogeneic CARs. It directly supports Statifacts' market projection of the BCMA segment's 46% CAGR and validates the trend of next-gen cell therapy scaling.
• Regulatory & Commercial Outlook:
  Gilead is expected to file for FDA submission in late 2025, with EU and APAC filings following soon after. This expansion could reshape market competition and pricing dynamics, creating pressure on legacy products like Kymriah and Abecma.
  

Key Takeaways:

• Strategic Partnerships Accelerate Innovation:
  Collaborations between niche innovators (Arcellx) and established players (Gilead) can bridge technical and regulatory gaps in complex biologics
• BCMA Target Validity Strengthened:
  Consistent efficacy across trials reinforces BCMA as a long-term growth engine in the CAR T landscape.
• Patient Accessibility & Manufacturing Optimization Are Core Growth Drivers:
  The focus has shifted from“curing cancer” in isolated cases to scaling therapies efficiently for real-world application.
  
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  CAR T-Cell Therapy Market Dynamics

  Market Driver

  • Growing demand for personalized cancer treatments:
    

  The personalized cancer treatment goal is to improve tumor response while minimizing therapy side effects, resulting in improved patient care and quality of life. Personalized medicines chemotherapy

  Market Restraint

  • Side effects of CAR T-cell therapy:
    

  The most common side effect of CAR T-cell therapy is called cytokine release syndrome or CRS. It can affect up to 9 in 10 CAR T-cell patients. CAR T-cell therapies are associated with unique adverse events (AEs), including cytokine release syndrome (CRS) and neurologic events. It also includes side effects like low blood counts, infection risk, low B-cell count, allergic reactions, and tumor lysis treatment. Infection risk includes symptoms like generally feeling unwell, tummy pain, being sick, discharge coming from it, redness or pain around the central line, extreme tiredness, feeling breathless, a cough or chest, shivering, or a high temperature.

  Market Opportunity

  • Advancement in biotechnology and genetic engineering:
    

  Some benefits of advancement in biotechnology

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  CAR T-Cell Therapy Market Scope

  Report Attribute	Key Statistics
  Market Size in 2024	USD 5.51 Billion
  Market Size in 2025	USD 7.64 Billion
  Market Size in 2031	USD 54.61 Billion
  Market Size by 2034	USD 146.55 Billion
  CAGR 2025-2034	38.83%
  Leading Region in 2024	North America
  Fastest Growing Region	Asia Pacific
  Base Year	2024
  Historical Year	2021 - 2023
  Forecast Period	2025 to 2034
  Quantitative units	Revenue in USD million and CAGR from 2025 to 2034
  Report coverage	Revenue forecast, company ranking, competitive landscape, growth factors, and trends
  Segments Covered	By Target Antigen, By Indication / Disease Type, By Type of Therapy, By Technology / Vector Used, By Manufacturing/Delivery Method, By End User, and By Region
  Regional analysis	North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa
  Leading Players	Johnson & Johnson Services Inc., ALLOGENE THERAPEUTICS, Lonza, Aurora Biopharma, Cartesian Therapeutics Inc., Novartis, Bristol-Myers Squibb company, Gilead Sciences, Curocell Inc, JW Therapeutics, and Others.

  
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  CAR T-Cell Therapy Market Segmentation

  Target Antigen Insights

  How CD19 Segment Leads the CAR T-Cell Therapy Market?

  The CD19 segment led the market in 2024. CD19 CAR T cell therapy

  The BCMA (B-cell Maturation Antigen) segment is expected to grow at a significant CAGR over the projected period. B-cell maturation antigen (BCMA) is one of the promising targets for immunotherapy in the management of relapsed/refractory multiple myeloma. Engagement of T-cells to malignant cells expressing B-cell maturation antigen (BCMA) leads to selective, redirected lysis of MM cells. BCMA, by its ligand, increases survival and long-lived plasma cells that contribute to MM development.

  Indication/Disease Type Insights

  How Hematologic Malignancies Dominated the CAR T-Cell Therapy Market?

  The hematologic malignancies segment dominated the market in 2024. CAR-T cell therapy represents a major breakthrough in cancer treatment, and it has achieved unprecedented success in hematological malignancies. CAR T-cell has become a powerful treatment option in B-cell and plasma cell malignancies, and many patients have benefited from its use. The CAR-T cell therapy has been used predominantly in the treatment of hematological malignancies, including lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, and multiple myeloma.

  The solid tumors

  Technology/Vector Used Insights

  How Viral Vectors Segment Dominated the CAR T-Cell Therapy Market?

  The viral vectors segment dominated the market in 2024, due to its proven clinical efficacy, high gene transfer efficiency, and durable CAR expression, all of which are critical for successful treatment outcomes. All currently approved CAR T-cell therapies rely on lentiviral or retroviral vectors, benefiting from well-established manufacturing infrastructure and regulatory familiarity. These vectors enable stable integration of the CAR gene into T cells, ensuring long-term therapeutic effects, especially in hematologic cancers. Despite emerging alternatives like non-viral delivery and gene editing, challenges such as transient expression and scalability issues keep viral vectors as the preferred choice.

  The dual and multiple antigen targeting CAR T-cell segment is expected to grow fastest over the forecast period, driven by their ability to address several key limitations of single-antigen CARs. These include reducing relapse from antigen escape (when a tumor loses or downregulates the target antigen), improving recognition of heterogeneous tumor cell populations, and enhancing specificity to reduce off-tumor toxicity. The heightened therapeutic potential makes them more attractive in both hematologic malignancies and solid tumors, especially when single-antigen approaches have failed or have limited durability.

  Manufacturing/Delivery Method

  Which Manufacturing/Delivery Method Leads the CAR T-Cell Therapy Market?

  The centralized manufacturing segment led the market in 2024. CAR T-cell therapy is delivered systematically and intravenously. Central line insertion of a catheter. This is the most common method of infusion of CAR-T cells to systemic circulation after ex vivo manufacturing. This is the classic method of CAR-T cells administration to cancers within the human body is through intravenous (IV) central line infusion. Centralized manufacturing, where patient cells are collected at clinics or hospitals and shipped to a central GMP facility for processing, vector transduction, quality assurance, and then shipped back, offers economies of scale, tighter quality control, and regulatory alignment that make it the default model for commercial CAR T products.

  The in vivo CAR T cell therapy segment is expected to grow at the fastest CAGR over the projected period. In vivo CAR T cell therapy has the benefit of both CAR T cell therapy and antibody drugs, which show rapid and constant anti-cancer efficacy and are suitable for patients with rapidly progressive diseases. In vivo CAR-T gene therapies can overcome the challenges faced by autologous and allogeneic treatments. During in vivo exposure, patients engage in activities where they gradually approach trauma-related memories, feelings, and situations that are avoided because of the trauma.

  End User Insights

  What Made the Hospitals Dominate the CAR T-Cell Therapy Market?

  The hospitals segment dominated the market share in 2024. One of the main benefits of CAR T cell therapy is the short treatment time needed, administered with a single infusion that may need at most two weeks of inpatient care, and then it's done. During the CAR T-cell therapy, we will receive the full course of treatment on an outpatient basis rather than being admitted to the hospital for 10 to 14 days. Administering CAR T therapy requires specialized infrastructure, including cell collection (apheresis) units, cryopreservation equipment, and intensive care capabilities to manage potentially life-threatening side effects like cytokine release syndrome (CRS) and neurotoxicity. In addition, hospitals must have trained multidisciplinary teams, including hematologists, immunologists, and ICU staff, along with the necessary accreditations (such as FACT certification) to deliver CAR T therapies safely and in compliance with regulatory standards.

  • According to a report, Mayo Clinic has been one of the top cancer centers in the country for many years. In the United States, Mayo Clinic is also consistently rated the top hospital. They specialize in and offer all the available CAR T cell therapies, and also have many clinical trials and CAR T-cell treatment. Source: Mayo Clinic
    

  The contract development and manufacturing organization (CDMO) segment is expected to grow at a significant CAGR from 2025 to 2034. The benefits of collaborating with a cell therapy CDMO include scalability, speed to market, access to technical expertise without cost efficiencies, and overhead costs. Companies are signing supply agreements with CDMOs, building internal manufacturing capabilities, and enhancing manufacturing processes and efficiency by exploring new technologies. Cell therapy CDMO provides analytical and process development expertise to improve and scale up CAR-T cell manufacturing, supporting at every stage.

  Regional Insights

  North America CAR T-Cell Therapy Market

  North America dominated the global market in 2024 due to the robust product pipeline with regulatory approvals, increasing shift towards targeted treatments, rising cases of cancer malignancies across the population, improved in-hospital infrastructure, strong clinical pipeline, suitable reimbursement, regulatory approvals, rising demand for personalized medicine, and expanding applications in the region. The growing prevalence of cancer and strong investments in R&D are contributing to this growth. The strong presence of strict regulations and their approvals for novel therapies is fueling this growth.

  The U.S. dominates the regional market due to its robust biopharmaceutical

  Asia Pacific CAR T-Cell Therapy Market

  Asia Pacific is expected to grow at the fastest CAGR during the forecast period because of the increased R&D investments, technological innovations, increasing cancer incidences, growing demand for effective cancer treatments, growing cancer prevalence, increasing senior population, growing prevalence of rate of many diseases, including lymphoma and multiple myeloma, and heightened awareness of treatment options. The strong government & regulatory support for the pharmaceutical industry and R&D are fueling innovations and developments of comprehensive CAR T-cell Therapies. The market is further seeking growth with factors like increasing investments in genetic engineering and demand for personalized medicines.

  Country-Level Investments & Funding for CAR T-Cell Therapy Industry:

  • United States - The U.S. has been a pioneer in CAR T-cell therapy development, with substantial investments from both government agencies like the National Institutes of Health (NIH) and private companies. The FDA has approved several CAR T therapies, and the U.S. market continues to lead in both clinical trials and commercial applications.
  • China - China has invested heavily in CAR T-cell therapy, with over $2.37 billion allocated in 2021 to support research and development. The country now surpasses the U.S. in the number of CAR T therapy clinical trials registered, focusing extensively on the CD19 target.
  • Japan - Japan's government has committed approximately $260 million over four years to support capital investment and human resource development for contract development and manufacturing organizations (CDMOs) of regenerative medicine products, including CAR T-cell therapies.
  • France - Allogenica received a €2.5 million grant from the French government's France 2030 program to support the industrialization of its universal CAR-T therapies for blood cancers. This funding aims to reduce production costs and enhance treatment availability.
  • Sweden - Elicera Therapeutics was awarded €2.5 million in funding from the European Innovation Council (EIC) Accelerator Programme to finance a clinical Phase I/II trial of its CAR T-cell therapy, ELC-301, for B-cell lymphoma.
    

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  Top Companies in CAR T-Cell Therapy Market

  • JW Therapeutics - JW Therapeutics focuses on developing, manufacturing, and commercializing innovative CAR-T cell therapies in China, including its lead product relma-cel targeting CD19 for B-cell malignancies.
  • Curocell Inc. - Curocell Inc. is advancing next-generation CAR-T cell therapies designed to overcome tumor microenvironment resistance, with its lead candidate CRC01 currently in clinical trials for relapsed or refractory B-cell lymphoma.
  • Gilead Sciences - Gilead Sciences, through its Kite Pharma subsidiary, offers FDA-approved CAR-T therapies such as Yescarta and Tecartus for various hematologic cancers, focusing on rapid manufacturing and global access.
  • Bristol-Myers Squibb Company - Bristol-Myers Squibb markets Breyanzi and Abecma, two CAR-T therapies targeting CD19 and BCMA, respectively, and continues to expand its pipeline in both hematologic and solid tumors.
  • Novartis - Novartis was the first to bring a CAR-T therapy to market with Kymriah, approved for pediatric and young adult acute lymphoblastic leukemia and adult diffuse large B-cell lymphoma, and is actively researching next-gen CAR platforms.
  • Cartesian Therapeutics, Inc. - Cartesian Therapeutics develops RNA-engineered cell therapies, including Descartes-11, a CAR-T product designed for autoimmune diseases and cancers with transient, non-viral CAR expression to improve safety.
  • Aurora Biopharma - Aurora Biopharma is focused on CAR-T therapies for solid tumors, developing novel CAR constructs that target tumor-associated antigens like HER2 in cancers such as glioblastoma and pancreatic cancer.
  • Lonza - Lonza is a leading global contract manufacturer offering end-to-end CAR-T cell therapy development and manufacturing services, supporting biotech and pharma companies with scalable and GMP-compliant production solutions.
  • ALLOGENE THERAPEUTICS - Allogene Therapeutics is pioneering allogeneic (off-the-shelf) CAR-T therapies using gene editing technologies to eliminate the need for patient-specific cell collection, with multiple programs in clinical development.
  • Johnson & Johnson Services, Inc. - Johnson & Johnson, through its Janssen division, is advancing CAR-T therapies, including Carvykti, a BCMA-directed treatment for multiple myeloma developed in partnership with Legend Biotech.

  Recent Developments

  • In January 2025, Qartemi, a global CAR T-cell therapy for adult B-cell Non-Hodgkin Lymphoma (B-NHL), was launched by Immuneel Therapeutics. This new therapy aims to address a critical gap in India's cancer immunotherapy landscape. Source: Express Pharma
  • In April 2025, the opening of South India's premier Centre of Excellence in CAR T-cell Therapy and Bone Marrow Transplantation at Smita Memorial Hospital in Thodupuzha, Idukki district, Kerala was announced by SunAct Cancer Institute and Smita Memorial Hospital. This partnership, formalized in March 2025, represents a significant stride in offering cost-effective, globally benchmarked cell and gene therapies to India, with a strong emphasis on pediatric care, precision oncology, and access to global clinical trials. Source: Healthcare Radius

    Segments Covered in the Report

    By Target Antigen

    • CD19
    • BCMA (B-cell Maturation Antigen)
    • CD22
    • GD2
    • HER2
    • GPC3
    • Others (e.g., EGFRvIII, CD7, CD123, mesothelin)
      

    By Indication / Disease Type

    • Hematologic Malignancies
      • Acute Lymphoblastic Leukemia (ALL)
      • Diffuse Large B-cell Lymphoma (DLBCL)
      • Mantle Cell Lymphoma (MCL)
      • Follicular Lymphoma (FL)
      • Multiple Myeloma (MM)
      • Chronic Lymphocytic Leukemia (CLL)
      • Hodgkin's Lymphoma
      • Other Non-Hodgkin Lymphomas (NHL)
    • Solid Tumors
      • Neuroblastoma
      • Glioblastoma
      • Breast Cancer
      • Pancreatic Cancer
      • Ovarian Cancer
      • Lung Cancer
      • Prostate Cancer
      • Colorectal Cancer
      • Others
        

    By Type of Therapy

    • Autologous CAR T-cell Therapy
    • Allogeneic CAR T-cell Therapy

    By Technology / Vector Used

    • Viral Vectors
      • Lentiviral vectors
      • Retroviral vectors
    • Non-viral Vectors
      • CRISPR/Cas9 gene editing
      • Transposons (Sleeping Beauty, PiggyBac)
      • mRNA electroporation
    • Armored CAR T-Cells (enhanced T-cell persistence/activity)
    • Dual/Multiple Antigen Targeting CAR T-Cells
    • Safety Switch-Equipped CAR T Cells

    By Manufacturing/Delivery Method

    • Point-of-Care Manufacturing
    • Centralized Manufacturing
    • In vivo CAR T therapy (emerging)
    • Off-the-shelf / Ready-to-use therapies

    By End User

    • Hospitals
    • Cancer Treatment Centers
    • Academic & Research Institutes
    • Specialty Clinics
    • Contract Development and Manufacturing Organization
      

    By Geography

    • North America
    • Europe
    • Asia-Pacific
    • Latin America
    • The Middle East and Africa
      
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