AR-T cell therapy is a groundbreaking advancement in cancer treatment, offering remarkable promise for patients. This form of immunotherapy harnesses the power of the body's own immune cells, modifying them in a laboratory to enhance their ability to recognize and destroy cancer cells. Once infused back into the patient, these engineered cells multiply and persist in the body as "living drugs," continually working to fight the disease.
T-cells, a crucial component of the immune system, form the foundation of CAR-T therapy. These immune workhorses play a key role in directing immune responses and eliminating infected or abnormal cells. In CAR-T cell therapy, a patient's blood is drawn, and T-cells are separated out. Scientists then use a disarmed virus to genetically engineer these cells to express chimeric antigen receptors (CARs) on their surface. These CARs enable the T-cells to specifically target antigens found on cancer cells, leading to their destruction upon infusion back into the patient.
Global Regulatory Approvals
Since 2017, 13 CAR-T cell therapies have reached commercialization across multiple healthcare markets. Seven therapies have been approved by the U.S. FDA, after which approvals for them were issued in other major healthcare markets as well. These therapies include:
1. Kymriah (tisagenlecleucel)
2. Yescarta (axicabtagene ciloleucel)
3. Tecartus (brexucabtagene autoleucel)
4. Breyanzi (lisocabtagene maraleucel)
5. Abecma (idecabtagene vicleucel)
6. Carvykti (ciltacabtagene autoleucel)
7. Aucatzyl (obecabtagene autoleucel)
Beyond the U.S., four CAR-T therapies-Relma-cel, Fucaso, Yuanruida, and Zever-cel-have been approved by China's National Medical Products Administration (NMPA). Additionally, two therapies, NexCAR19 and Qartemi, have received approval from India's Central Drugs Standard Control Organisation (CDSCO).
Market Expansion and Industry Growth
These regulatory approvals mark a major milestone, solidifying the CAR-T market as a dominant force in biotech. Mergers and acquisitions have been particularly aggressive, demonstrating strong investor confidence. Celgene's acquisition of Juno Therapeutics for $9 billion underscored the industry's potential, followed by Bristol-Myers Squibb (BMS) acquiring Celgene for $74 billion. Another significant move was Gilead's acquisition of Kite Pharma for $11.9 billion, further strengthening its position in the space. Additionally, Astellas Pharma expanded its portfolio by purchasing Xyphos Biosciences for $665 million. These transactions highlight the increasing commitment from major pharmaceutical companies to invest in CAR-T technologies and shape the future of cancer treatment.
As CAR-T therapy continues to evolve, the industry faces key challenges, including improving gene-transfer efficiency and mitigating toxicity risks. Researchers are actively exploring CRISPR and electroporation technologies to enhance T-cell modification, while others develop "on-off" switches to regulate CAR-T activity.
One of the biggest hurdles remains the treatment of solid tumors, as clinical trials have shown lower response rates compared to blood cancers. Thus, a major focus is on identifying solid tumor-specific antigens to improve efficacy in these cancers.
Currently, nearly 75% of ongoing clinical trials and all marketed CAR-T therapies rely on autologous (patient-derived) cells. However, the next breakthrough lies in allogeneic CAR-T therapies-off-the-shelf solutions that could streamline manufacturing, reduce costs, and expand patient accessibility.
Global CAR-T Cell Therapy Market
The CAR-T cell therapy market has grown from early experimental treatments to a multi-billion-dollar industry with global reach. Early successes in blood cancers have paved the way for broader applications, with companies ranging from startups to biotech giants working to expand the field. As innovation continues, the future of CAR-T therapy holds immense potential to revolutionize cancer treatment worldwide.
This report aims to provide readers with the following insights:
An overview of CAR-T therapy, covering the structure and function of T cells, how they normally act on infected cells, and how they are "armed" with engineered receptors to target and destroy cancer cells.
A breakdown of chimeric antigen receptors (CARs), cancer cell antigens, CAR-T cell manufacturing, and the available CAR-T products, including autologous and allogeneic CAR-Ts.
A brief history of CAR-T therapy, highlighting its evolution from 1989 to the present, its transformative potential, and the accelerating activities within the CAR-T sector.
An examination of the manufacturing process and the costs associated with developing autologous and allogeneic CAR-T cell therapies.
An overview of cancer biomarkers or antigens targeted by CAR-T cells.
A detailed analysis of the global CAR-T patent landscape, including leading sponsors, inventors, and regions
An in-depth look at the rates, types, and trends for clinical trials involving CAR-T cells.
A review of the rates and types of CAR-T cell therapy scientific publications.
An overview of NIH grants awarded to support CAR-T cell therapy research.
A review of industry dealmaking and strategic partnerships within the CAR-T sector in 2024.
Descriptions of CAR-T therapies, including Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Relma-cel, Carvykti, NexCAR19, Yuanruida, Qartemi, Aucatzyl, Fucaso, and Zever-cel.
A review of reimbursement policies for CAR-T therapies in the U.S. and outcome-based reimbursement policies in Europe.
A global market analysis for CAR-T cell therapies by Geography, Product, and Indication.
Profiles of leading CAR-T cell therapy market competitors, including their novel products, emerging candidates, and proprietary technology platforms.
Key Questions Answered in This Report:
What are T cells, and how do they target and destroy infected cells and pathogens?
How are T cells armed with chimeric antigen receptors (CARs) to become CAR-T cells?
What do first-, second-, third-, fourth-, and fifth-generation CAR-T therapies refer to?
How are CAR genes inserted into T cells?
What are the features of the FDA-approved CAR-T therapies currently available?
What future developments are expected within the CAR-T sector?
Which new CAR-T products are anticipated to enter the market soon?
How many automated manufacturing systems are available for CAR-T production?
Which antigens are most commonly targeted in liquid and solid cancers?
What is the number of CAR-T-related patent publications and granted patents from 2012 to present?
Which countries hold the most CAR-T patents?
Which companies have filed the most CAR-T patents?
Who are the top CAR-T patent inventors?
How many CAR-T-related clinical trials have been registered from 2003 to the present?
Which biomarker antigens dominate the CAR-T clinical trial landscape?
How many CAR-T deals were signed in 2023-2024 and who entered into them?
What is the current market size for FDA-approved CAR-T therapies?
What promising CAR-T candidates are expected to reach commercialization soon?
How are CAR-T therapies reimbursed in the U.S. and Europe?
What is the market size for CAR-T therapies by geography, product, and indication?
Which major companies are developing CAR-T cell therapies?
This global strategic report will position you to:
1. Capitalize on rapidly emerging trends
2. Optimize decision-making
3. Reduce company risk
4. Approach partners/investors for collaboration or funding
5. Implement an informed and advantageous business strategy in 2025
With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without missing critical opportunities.
Companies and Organizations Mentioned:
2seventy bio
Abintus Bio, Inc.
AffyImmune Therapeutics, Inc.
Aleta BioTherapeutics
Allogene Therapeutics
Anixa Biosciences, Inc.
Arbele, Ltd.
Arcellx
Atara Biotherapeutics
Aurora BioPharma
Autolus Therapeutics plc
AvenCell Europe GmbH
Beam Therapeutics, Inc.
Bellicum Pharmaceuticals
BioNTech
Biosceptre
Bluebird bio
Bristol Myers Squibb/Celgene Corporation
Cabaletta Bio
Carina Biotech
CARsgen Therapeutics
Cartesian Therapeutics
CARTherics Pty Ltd.
CASI Pharmaceuticals
Cellectis
CellGenix (Owned by Sartorius)
Celularity, Inc.
Celyad Oncology
CRISPR Therapeutics
Curocell, Inc.
DiaCarta
Elicera Therapeutics AB
EXUMA Biotech
Fate Therapeutics
Galapagos NV
Gilead Sciences, Inc.
Gracell Biotechnologies
IASO Biotherapeutics
ImmPACT Bio
Immuneel Therapeutics, Pvt., Ltd.
ImmunoACT
Interius BioTherapeutics
Juventas Cell Therapy
JW Therapeutics
Kite Pharma (Gilead)
Kyverna Therapeutics
Legend Biotech
Leucid Bio
Lonza
Luminary Therapeutics, Inc.
Lyell Immunopharma, Inc.
March Biosciences
MaxCyte, Inc.
Miltenyi Biotec
Minerva Biotechnologies Corporation
Mustang Bio
Noile-Immune Biotech
Novartis AG
Oncternal Therapeutics
Oxford Biomedica plc
PeproMene Bio, Inc.
Poseida Therapeutics, Inc.
Precigen, Inc.
Prescient Therapeutics
ProMab Biotechnologies, Inc.
Sartorius
SOTIO Biotech BV
Syngene International, Ltd.
Synthekine
T-CURX
TC BioPharm
Umoja Biopharma
University of Pennsylvania
ViTToria Biotherapeutics
Vor Biopharma
Wugen
WuXi Advanced Therapies
Xenetic Biosciences
Xyphos Biosciences, Inc.
And Many More
TABLE OF CONTENTS
1. REPORT OVERVIEW
1.1. Statement of the Report
1.2. Executive Summary
1.3. Introduction
2. CAR-T CELL THERAPY: TECHNOLOGY DEVELOPMENT
2.1. An Overview of CAR-T cell Therapy
2.2. Evolution of CAR-T Development
2.2.1. CAR-T cell Therapy Technology Progression
2.2.1.1. First Generation CARs
2.2.1.2. Second Generation CARs
2.2.1.3. Third Generation CARs
2.2.1.4. Fourth Generation CARs
2.2.1.5. Fifth Generation CARs
2.3. Antigens Present on Hematological Malignant Cells
2.4. Tools for Inserting Receptor Genes into T cells
2.5. Transforming T cells into CAR-T cells
2.6. The 13 CAR-T Therapies Available Globally: A Brief Overview
2.6.1. Kymriah (tisagenlecleucel)
2.6.1.1. Manufacturing
2.6.1.2. Indication
2.6.1.3. Dosage Composition
2.6.1.4. Approval History of Kymriah
2.6.1.5. Sales Revenue
2.6.2. Yescarta (axicabtagene ciloleucel)
2.6.2.1. Manufacturing of Yescarta
2.6.2.2. Indication
2.6.2.3. Dosage Composition
2.6.2.4. Approval History of Yescarta
2.6.2.5. Sales Revenue
2.6.3. Tecartus (brexucabtagene autoleucel)
2.6.3.1. Manufacturing of Tecartus
2.6.3.2. Indication
2.6.3.3. Dosage Composition
2.6.3.4. Approval History of Tecartus
2.6.3.5. Sales Revenue
2.6.4. Breyanzi (lysocabtagene maraleucel)
2.6.4.1. Manufacturing of Breyanzi
2.6.4.2. Indication
2.6.4.3. Dosage Composition
2.6.4.4. Approval History of Breyanzi
2.6.4.5. Sales Revenue
2.6.5. Abecma (idecabtagene vicleucel)
2.6.5.1. Manufacturing of Abecma
2.6.5.2. Indications
2.6.5.3. Dosage Composition
2.6.5.4. Approval History of Abecma
2.6.5.5. Sales Revenue
2.6.6. Relma-cel (relmacabtagene autoleucel)
2.6.7. Carvykti (ciltacabtagene autoleucel)
2.6.7.1. Manufacturing of Carvykti
2.6.7.2. Indications
2.6.7.3. Dosage
2.6.7.4. Approval History of Carvykti
2.6.7.5. Sales Revenue
2.6.8. Fucaso (equecabtagene autoleucel)
2.6.8.1. Dosage & Overall Response Rate
2.6.9. NexCAR19 (actalycabtagene autoleucel)
2.6.10. Yuanruida (inaticabtagene autoleucel)
2.6.11. Zevor-cel (zevorcabtagene autoleucel)
2.6.12. Qartemi (varnimcabtagene autoleucel)
2.6.12.1. Indication & Dosage
2.6.12.2. Product Description & Mechanism of Action
2.6.12.3. Manufacture
2.6.13. Aucatzyl (obecabtagene autoleucel)
2.6.13.1. Manufacturing
2.6.13.2. Indication & Dosage
2.6.13.3. Approval
2.6.13.4. Wholesale Price
2.7. Cost of CAR-T Therapy around the World
2.8. Toxicities Associated with CAR-T Treatment
3. STRATEGIES FOR FUTURE CAR-T THERAPIES
3.1. Switchable CARs (sCARs/Universal CARs)
3.1.1. Switchable CAR-Ts in the Clinic
3.1.2. Suicide Genes
3.1.3. Transient Transfection
3.2. Affinity-Tuned CARs
3.3. Armored CARs
3.4. Shift from Liquid Cancers to Solid Cancers
3.5. Focus on Shortening Hospital Stay
3.6. Focus on Discovering New Antigens
3.7. CAR-T for the Masses
3.8. New In Vivo CAR-T Approaches
3.9. Combination with mRNA Vaccine
3.10. Combination with Oncolytic Virus
4. MAJOR EVENTS DURING THE DEVELOPMENT OF CAR-T, 1989-2024
4.1. Major 15 Milestones Crossed by CAR-T cell Therapy
4.1.1. First CAR Developed by Zelig Eshhar (1993)
4.1.2. Development of First Generation CAR-T (1993)
4.1.3. First Effective CAR-T Cells Developed (2002)
4.1.4. Second Generation CARs Developed (2003)
4.1.5. Recipe for CD19 CARs Published (2009)
4.1.6. Coley Award Given for CAR-T Cell Therapy (2012)
4.1.7. Results for CAR-T Leukemia Published (2013)
4.1.8. Cancer Immunotherapy Voted "Breakthrough of the Year" (2013)
4.1.9. FDA Designates CARs a "Breakthrough" Therapy (2014)
4.1.10. Mesothelin-Directed CARs Developed (2014)
4.1.11. Armored CARs Developed (2015)
4.1.12. CRISPR CARs Built (2017)
4.1.13. First CAR-T Crosses Regulatory Finish Line (August 30, 2017)