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PUBLISHER: BioInformant | PRODUCT CODE: 1493841

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PUBLISHER: BioInformant | PRODUCT CODE: 1493841

Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, and Trends, 2024

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EXECUTIVE SUMMARY

CAR-T cell therapy is a remarkably promising treatment for cancer patients. It is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as "living drugs."

T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of our immune system and play a key role in directing the immune response and killing cells infected by pathogens. In CAR-T cell therapy, blood is drawn from the patient and the T-cells are separated out. In the laboratory, a disarmed virus is then used to genetically engineer the T-cells to produce chimeric antigen receptors (CARs) on their surface. Once infused into the patient, these CARs enable the T-cells to recognize and attach to an antigen on the cancer cell, leading to its destruction.

Between 2017 and today, nine CAR-T products reached commercialization, and this number is estimated to reach double-digits by 2032. Of these, six are U.S.FDA-approved CAR-T cell therapies, each of which have received approvals in other major healthcare markets as well.

The six U.S. FDA approved products include:

  • 1. Kymriah (tisagenlecleucel)
  • 2. Yescarta (axicabtagene ciloleucel)
  • 3. Tecartus (brexucabtagene autoleucel)
  • 4. Breyanzi (lisocabtagene maraleucel)
  • 5. Abecma (idecabtagene vicleucel)
  • 6. Carvykti (Ciltacabtagene autoleucel)

In addition, two CAR-T therapies have received approval from the Chinese National Medical Products Administration (NMPA), Relma-cel and Yuanruida, and one CAR-T cell therapy has received approval from the Indian Central Drugs Standard Control Organisation (CDSCO), NexCAR19.

These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm. M&A activity has been particularly aggressive, with Celgene snagging Juno Therapeutics for $9 billion in 2018 and Bristol-Myers Squibb (BMS) acquiring Celgene for $74B by 2019. Gilead's acquisition of Kite Pharma for $11.9 billion also made waves, as did other transactions, such as Astellas Pharma's acquisition of Xyphos Biosciences and its CAR-T technology for $665 million.

The billion-dollar CAR-T cell therapy market would not have been possible without the remarkable efficacy of the early CAR-T therapies in treating several types of blood cancers. The next frontier for CAR-T cell therapies will be to apply them in the fight against solid tumors. All of the nine marketed CAR-T cell therapy products and nearly three-quarters (75%) of the ongoing clinical trials utilize an autologous treatment approach. Thus, the development of allogeneic CAR-T cell therapies will open critical market opportunities.

Another key issue is the "vein-to-vein" time or the time that elapses between apheresis and product delivery. Thus, CAR-T therapies are usually recommended for the end-stage patients who have exhausted all other treatment options. Another challenge encountered by CAR-T therapies is the reimbursement issues across the U.S. and Europe.

For the continued progress of CAR-T cell therapies, the industry is trying to mitigate these challenges. Several CAR-T players have started to use efficient gene-transfer tools to impregnate T cells with CARs, and there are numerous examples of partnerships to develop CRISPR and electroporation technologies to modify T cells. Some companies also use "on-off" switches that can turn off CAR-T cells to prevent toxicity. Thus far, the goal of achieving success with solid tumors remains elusive with clinical trials producing a low response rate. Thus, ongoing efforts within the CAR-T sector are focused on discovering effective solid tumor-specific antigens.

The purpose of this report is to describe the current state of CAR-T cell therapies, as well as the future of the CAR-T industry landscape at large. Importantly, it describes details of the CAR-T cell therapy products approved to date, as well as late-stage CAR-T clinical trials that could lead to near-term market approvals. Ranging from small start-ups to billion-dollar companies, CAR-T companies are now proliferating in all healthcare markets worldwide.

Key questions answered in this report include:

  • How many automated manufacturing systems are available within the global market?
  • What are the most targeted antigens for liquid and solid cancers?
  • What are anticipated developments within the CAR-T sector? What commercial opportunities and patient outcomes will they unlock?
  • How many CAR-T-related patent publications and granted patents were issued from 2012 to present?
  • Which two countries have the largest number of CAR-T patents?
  • Which 20 companies have filed the largest number of CAR-T patents?
  • Who are the top 20 CAR-T patent inventors?
  • How many clinical trials were registered between 2003 and present?
  • Which biomarker antigens dominate in the CAR-T clinical trial landscape?
  • Which are the most common indications addressed by clinical trials in the U.S. and China?
  • Who are the U.S., Chinese, and European companies involved in CAR-T-related clinical trials?
  • How many deals have been signed within the CAR-T sector within the past year?
  • What are promising CAR-T candidates that could soon reach commercialization?
  • How are CAR-T therapies reimbursed within the U.S. and Europe?
  • What is the current market size for CAR-T cell therapies by Geography, Product, and Indication?
  • What are the future market forecasts for CAR-T cell therapies by Geography, Product, and Indication?
  • What are the barriers, risks, and opportunities for growth within the global CAR-T industry?
  • Who are the major companies that are developing CAR-T cell therapies, what are their core technologies, and what products do they have under development?

This 329-page market report reveals:

  • Global CAR-T Cell Therapy Market Size, with Segmentation by Product, Geography, and Indication, including Future Market Size Forecasts through 2032
  • Detailed Coverage of the Approved CAR-T Products, including Regulatory Approvals, Pricing, Reimbursement, and Degree of Market Penetration
  • Clinical Trial Activity by Type, Geography, Phase, and Sponsor
  • Comprehensive CAR-T Patent Analysis, including Top Inventors, Patent Holders, Patent Types, Geographies, and Most Cited Patents
  • CAR-T Industry Mergers and Acquisitions, IPOs, and Financing Events
  • Strategic Partnerships, Alliances, and Co-commercialization Agreements within the CAR-T sector
  • Market Trends, Future Directions, and Emerging Opportunities
  • Profiles of Leading CAR-T Competitors Composing the Global Marketplace
  • And Much More

TABLE OF CONTENTS

1. REPORT OVERVIEW

  • 1.2. Statement of the Report
  • 1.2. Executive Summary
  • 1.3. Introduction

2. CAR-T CELL THERAPY: TECHNOLOGY DEVELOPMENT

  • 2.1. CAR-T cell
  • 2.2. Evolution of CAR-T Development
    • 2.2.1. The CAR-T cell Family
      • 2.2.1.1. First Generation CARs
      • 2.2.1.2. The Second Generation CARs
      • 2.2.1.3. Third Generation CARs
      • 2.2.1.4. Fourth Generation CARs
      • 2.2.1.5. Fifth Generation CARs
      • 2.2.1.6. CAR Constructs in the FDA Approved CAR-T Cell Products
  • 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 Eight CAR-T Therapies Available in the Market: A Brief Overview
    • 2.6.1. Kymriah (tisagenlecleucel)
      • 2.6.1.1. Indication
      • 2.6.1.2. Product Description & Machanism of Action
      • 2.6.1.3. Manufacturing
      • 2.6.1.4. Dosage Composition
      • 2.6.1.5. Approval History
      • 2.6.1.6. Market
      • 2.6.1.7. Competition
    • 2.6.2. Yescarta (axicabtagene ciloleucel)
      • 2.6.2.1. Indication
      • 2.6.2.2. Product Description & Mechanism of Action
      • 2.6.2.3. Manufacturing Process of Yescarta
      • 2.6.2.4. Dosage Composition
      • 2.6.2.5. Approval History
      • 2.6.2.7. Sales Revenues
      • 2.6.2.8. Competitors
    • 2.6.3. Tecartus (brexucabtagene autoleucel)
      • 2.6.3.1. Indication
      • 2.6.3.2. Product Description & Mechanism of Action
      • 2.6.3.3. Tecartus Manufacturing Process
      • 2.6.3.4. Dosage Composition
      • 2.6.3.5. Approval History
      • 2.6.3.6. Sales Revenues
      • 2.6.3.7. Competitors
    • 2.6.4. Carvykti (ciltacabtagene autoleucel)
      • 2.6.4.1. Indication
      • 2.6.4.2. Product Description & Mechanism of Action
      • 2.6.4.3. Manufacturing Process of Carvykti
      • 2.6.4.4. Dosage & Composition
      • 2.6.4.5. Approval History
      • 2.6.4.6. Sales Revenues
      • 2.6.4.7. Competition
    • 2.6.5. Abecma (idecabtagene vicleucel)
      • 2.6.5.1. Indication
      • 2.6.5.2. Product Description and Mechanism of Action
      • 2.6.5.3. Manufacturing of Abecma
      • 2.6.5.4. Dosage & Composition
      • 2.6.5.5. Approval History
      • 2.6.5.6. Sales Revenues
      • 2.6.5.7. Competitors
    • 2.6.6. Breyanzi (lisocabtagene maraleucel)
      • 2.6.6.1. Indication
      • 2.6.6.2. Product Description & Mechanism of Action
      • 2.6.6.3. Manufacturing
      • 2.6.6.4. Breyanzi Dosage & Composition
      • 2.6.6.5. Approval History
      • 2.6.6.6. Sales Revenues
    • 2.6.7. Relma-cel (relmacabtagene autoleucel)
    • 2.6.8. NexCAR19 (Actalycabtagene autoleucel)
    • 2.6.9. Yuanruida (inaticabtagene autoleucel; CNCT19)
  • 2.7. Toxicities Associated with CAR-T Treatment

3. STRATEGIES FOR FUTURE CAR-T THERAPIES

  • 3.1. Switchable CARs (sCARs)
  • 3.2. Suicide Genes to Destroy CAR-T Cells in vivo
  • 3.3. Transient Transfection
  • 3.4. Affinity-Tuned CARs
  • 3.5. Armored CARs
  • 3.6. Shifts from Liquid Cancers to Solid Tumors
  • 3.7. Focus on Shortening Hospital Stay
  • 3.8. Focus on Discovering New Antigens
  • 3.9. Shifting from Autologous to Allogeneic CAR-T Therapies
  • 3.10. CAR-T for the Masses
  • 3.11. New in vivo CAR-T Approaches
  • 3.12. Combination with mRNA Vaccine
  • 3.13. Combination with Oncolytic Virus

4. MAJOR EVENTS DURING THE DEVELOPMENT OF CAR-T, 1989-2024

  • 4.1. CAR-T Development Timeline
  • 4.2. Top Ten Milestones Crossed by CAR-T Therapy
    • 4.2.1. First Pediatric Patient to Receive CAR-T Therapy
    • 4.2.2. CAR-T Granted Breakthrough Therapy Designation
    • 4.2.3. The Beginning of CAR-T Development to Combat Solid Cancers
    • 4.2.4. First CRISPR CAR-T Built
    • 4.2.5. The First Two CAR-T Approvals by FDA
    • 4.2.6. The First Two CAR-T Approvals by EMA
    • 4.2.7. Approval of Tecartus, Breyanzi and Abecma
    • 4.2.8. NMPA Approval of Relma-cel (Carteyva)
    • 4.2.9. Approval of Carvykti
    • 4.2.10. Approval of NexCAR19 (actalycabtagene autoleucel)
    • 4.2.11. Approval of Yuanruida (inaticabtagene autoleucel)
  • 4.3. Current Status of CAR-T Therapy Products
  • 4.4. The Upcoming CAR-T Stars
    • 4.4.1. ALLO-501
    • 4.4.2. CTX-110
    • 4.4.3. UCART19
    • 4.4.4. AUT01
    • 4.4.5. JCARH125
    • 4.4.6. PBCAR20A
    • 4.4.7. UCART123
    • 4.4.8. PRGN-3006
    • 4.4.9. UCART22
    • 4.4.10. UCARTCS1
  • 4.5. Cancer Population Addressed by CAR-T Therapy
  • 4.6. Advantages of CAR-T Cell Therapy
  • 4.7. Disadvantages of CAR-T Cell Therapy

5. SCALABLE MANUFACTURING OF CAR-T CELLS

  • 5.1. The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
  • 5.2. The Evolution of CAR-T Cell Manufacturing Platforms
    • 5.2.1. Open vs. Closed Systems
    • 5.2.2. Manual Processing vs. Automation
    • 5.2.3. Autologous vs. Allogeneic CAR-T Manufacturing
    • 5.2.4. Operating Expenses in Allogeneic CAR-T Manufacturing
    • 5.2.5. Operating Expenses in Allogeneic CAR-T Manufacturing

6. CAR-T TARGET ANTIGENS

  • 6.1. CAR-T Target Antigens in Hematological Cancers
  • 6.2. CAR-T Target Antigens on Solid Tumors
  • 6.3. Common Antigens Targeted by CAR-T Cells in Clinical Trials
    • 6.3.1. Cluster Differentiation 19 (CD19)
    • 6.3.2. Mesothelin
    • 6.3.3. Beta Cell Maturation Agent (BCMA)
    • 6.3.4. GD2
    • 6.3.5. Glypican-3 (GPC3)
    • 6.3.6. Cluster Differentiation-22 (CD22)

7. CAR-T PATENT LANDSCAPE

  • 7.1. Geographical Distribution of CAR-T Patents
  • 7.2. Top Ten Applicants of CAR-T Patents
  • 7.3. Top Ten Inventors of CAR-T Patents
  • 7.4. Top Ten Owners of CAR-T Patents
  • 7.5. Legal Status of CAR-T Patents

8. CAR-T CLINICAL TRIAL LANDSCAPE

  • 8.1. Most Addressed Indications in Clinical Trials
  • 8.2. Current Focus of Ongoing Clinical Trials
  • 8.3. Clinical Trial by Country
  • 8.4. Phase of Studies
  • 8.5. CAR-T Clinical Trials by Funding Type
  • 8.6. Types of Hematological Malignancies Addressed in Clinical Trials
  • 8.7. Simultaneous Targets by one CAR-T
  • 8.8. CAR-T Generation Types used in Clinical Trials
  • 8.9. CAR-T Clinical Trials Focusing on Solid Cancers
  • 8.10. Distribution of CAR-T Trials by Type of SeFv Used
  • 8.11. Distribution of CAR-T Trials by Type of Vectors Used
  • 8.12. Geographical Distribution of CAR-T Studies in Solid Tumors
    • 8.12.1. CAR-T Solid Tumor Clinical Trials by Phase of Study
    • 8.12.2. Funding Types in CAR-T Solid Tumor Clinical Trials
    • 8.12.3. Solid Tumor Types in Clinical Trials
  • 8.13. CAR-T Targeted Biomarkers in Clinical Trials
    • 8.13.1. CAR-T Targeted Indications in the U.S. Clinical Trials
    • 8.13.2. Indications Addressed by CAR-T Clinical Trials in China
    • 8.13.3. Liquid Cancers vs. Solid Cancers in CAR-T Clinical Trials
    • 8.13.4. CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
    • 8.13.5. CAR-T Clinical Trial Sponsor Companies and Institutions in China
    • 8.13.6. CAR-T Trial Sponsor Companies and Institutions in Other Countries
  • 8.14. Improved CAR-T Constructs in Clinical Trials
    • 8.14.1. CAR-T with PD1Fc
    • 8.14.2. CAR-T with Truncated EFGR
    • 8.14.3. CAR-T with IL7 and CCL 19
    • 8.14.4. CAR-T with PD1/CD28 Switch Receptor
    • 8.14.5. CAR-T with PD1 shRNA Expressing Cassette
    • 8.14.6. CAR-T with CTLA-4/PD-1 Antibody
    • 8.14.7. CAR-T with PD-1 Antibodies

9. PUBLISHED CAR-T SCIENTIFIC PAPERS IN PUBMED.GOV

  • 9.1. PubMed.gov Papers on Autologous and Allogeneic CAR-T Therapies
  • 9.2. PubMed.gov Papers on CAR-T for Liquid vs. Solid Cancers, 2013-March 2024
  • 9.3. PubMed Papers on the Five Generation of CARs
  • 9.4. NIH Funding for CAR-T Research

10. CAR-T FUNDING LANDSCAPE

  • 10.1. Venture Capital Funding in CAR-T Sector, 2014-March 2024
    • 10.1.1. Venture Capital Funding for CAR-T Companies by Year, 2014-March 2024
  • 10.2. IPO Funding in Invested in CAR-T Companies, 2014-March 2024
  • 10.3. CAR-T Licensing Deals
  • 10.4. CAR-T Collaboration Deals
  • 10.5. CAR-T Merger and Acquisition (M&A) Deals, 2015-March 2024
  • 10.6. Overview of CAR-T Funding

11. COST OF CAR-T TREATMENT AND REIMBURSEMENT

  • 11.1. New Payment Models
    • 11.1.1. List Price of approved CAR-Ts
    • 11.1.2. Component Cost in addition to Treatment Acquisition Cost
    • 11.1.3. Adverse Event Costs (AEs)
  • 11.2. Reimbursement in the U.S. for CAR-T Therapy
    • 11.2.1. Policy Changes for FY 2024
  • 11.3. Cost of CAR-T Therapies in Europe
    • 11.3.1. Cost Components and Resource Use
    • 11.3.2. Average Total Component Costs for CAR-T Therapy in Former EU-5 and NL
    • 11.3.3. Reimbursement for CAR-T Therapies in Europe
    • 11.3.4. Innovative Reimbursement Schemes in Europe
  • 11.4. Cost & Reimbursement for CAR-T Therapy in Asia
    • 11.4.1. Cost & Reimbursement for CAR-T in Japan
    • 11.4.2. Cost & Reimbursement for CAR-T Therapy in South Korea
    • 11.4.3. Cost & Reimbursement for CAR-T Therapy in Malaysia
    • 11.4.4. Cost & Reimbursement for CAR-T Therapy in Singapore
    • 11.4.5. Cost & Reimbursement for CAR-T Therapy in China
    • 11.4.6. Cost of CAR-T Therapy in India

12. BLOOD CANCERS ADDRESSED BY CAR-T

  • 12.1. Acute Lymphoblastic Leukemia (ALL)
    • 12.1.1. Available Therapies
  • 12.2. Diffuse Large B-Cell Lymphoma (DLBCL)
    • 12.2.1. Available Therapies
  • 12.3. Mantle Cell Lymphoma (MCL)
    • 12.3.1. Available Therapies
  • 12.4. Multiple Myeloma (MM)
    • 12.4.1. Available Therapies
  • 12.5. Follicular Lymphoma
    • 12.5.1. Available Therapies
  • 12.6. The Staggering Cost of Blood Cancer Therapies

13. MARKET ANALYSIS

  • 13.1. Uptake of CAR-T Cell Therapy, 2017-2023
    • 13.1.1. Current Global Market for CAR-T Cell Therapy by Product
  • 13.2. Estimated Global Market for CAR-T Cell Therapy Products, 2024-2032
    • 13.2.1. Global Market for CAR-T Therapy by Geography
    • 13.2.2. Global Market for CAR-T Therapy by Indication
  • 13.3. Challenges & Opportunities for CAR-T Therapies in Blood Cancers
    • 13.3.1. Barriers to Access
    • 13.3.2. Targets other than CD19
    • 13.3.3. Resistance for CAR-T Therapy
    • 13.3.4. Manufacturing Time
    • 13.3.5. Autologous vs. Allogeneic CAR-Ts

14. CAR-T COMPNIES: AN OVERVIEW

  • 14.1. 2seventy bio
    • 14.1.1. Abecma (idecabtagene vicleucel)
  • 14.2. Abintus Bio, Inc.
  • 14.3. AffyImmune Therapeutics, Inc.
    • 14.3.1. Affinity-Tuned CARs
      • 14.3.1.1. ICAM-1: AffyImmune's Target Antigen
      • 14.3.1.2. Targeted Indication
  • 14.4. Aleta BioTherapeutics
    • 14.4.1. Aleta's CAR-T Engager Pipeline
  • 14.5. Allogene Therapeutics
    • 14.5.1. AlloCAR-T
      • 14.5.1.1. Manufacturing of AlloCAR-T
  • 14.6. Anixa Biosciences, Inc.
  • 14.7. Arbele, Ltd.
    • 14.7.1. Advanced Cell Therapy
  • 14.8. Arcellx
    • 14.8.1. D-Domain Technology
    • 14.8.2. ddCAR Platform
    • 14.8.3. ARC-SparX Platform
  • 14.9. Atara Biotherapeutics
    • 14.9.1. Technology
    • 14.9.2. Allogeneic CAR-T Programs
  • 14.10. Aurora BioPharma
    • 14.10.1. HER2 Platform
  • 14.11. Autolus Therapeutics plc
    • 14.11.1. Technology
    • 14.11.2. CAR-T Cell Production
    • 14.11.3. Manufacturing
    • 14.11.4. Therapies in Development
      • 14.11.4.1. obe-cel
  • 14.12. AvenCell Europe GmbH
    • 14.12.1. Universal Switchable CAR
    • 14.12.2. Allogeneic Platform
    • 14.12.3. Clinical & Preclinical Pipeline Overview
  • 14.13. Beam Therapeutics, Inc.
    • 14.13.1. BEAM-201
  • 14.14. Bellicum Pharmaceuticals
    • 14.14.1. GoCAR Technology
    • 14.14.2. CaspaCIDe Safety Switch
  • 14.15. BioNTech
    • 14.15.1. BioNtech's Engineered Cell Therapies
    • 14.15.2. BN211
    • 14.15.3. BN212
  • 14.16. Biosceptre
    • 14.16.1. Biosceptre's Unique Target nf2X7
    • 14.16.2. BRiDGECAR Program
  • 14.17. Bluebird bio
    • 14.17.1. Blebird bio's CAR-T Collaborations
    • 14.17.2. Collaboration with BMS
    • 14.17.3. Collaboration with TC BioPharm
    • 14.17.4. Collaboration with Inhibrx
    • 14.17.5. Collaboration with PsiOxus
  • 14.18. Bristol Myers Squibb/Celgene Corporation
    • 14.18.1. Products
      • 14.18.1.1. Abecma (idecabtagene vicleucel)
      • 14.18.1.2. Breyanzi (lisocabtagene maraleucel)
  • 14.19. Cabaletta Bio
    • 14.19.1. CABA Platform
    • 14.19.2. Cabaletta's Pipeline
  • 14.20. Carina Biotech
  • 14.21. CARsgen Therapeutics
    • 14.21.1. CycloCAR-T
    • 14.21.2. THANK-uCAR
    • 14.21.3. LADAR
  • 14.22. Cartesian Therapeutics
    • 14.22.1. mRNA CAR-T Cell Program (RNA Armory)
    • 14.22.2. Pipeline
  • 14.23. CARTherics Pty Ltd.
    • 14.23.1. Autologous CAR-T Cells
  • 14.24. CASI Pharmaceuticals
    • 14.24.1. Yuanruida (inaticabtagene autoleucel; CNCT19)
  • 14.25. Cellectis
    • 14.25.1. TAL nucleases, or TALEN
    • 14.25.2. Gene Editing
    • 14.25.3. PulseAgile Technology
    • 14.25.4. Main Product Candidates
  • 14.26. Celularity, Inc.
    • 14.26.1. P CAR-T
  • 14.27. Celyad Oncology
    • 14.27.1. NKG2D-Based CAR-T Cells
    • 14.27.2. Multispecific CAR
    • 14.27.3. Short Hairpin RNA-based Platform
    • 14.27.4. CAR-T Therapy Development Services
    • 14.27.5. Biomarker Identification and Selection
    • 14.27.6. scFv Generation
    • 14.27.7. CAR-T Gene Packaging and Delivery
    • 14.27.8. Virus Testing Servive
    • 14.27.9. CAR Cell in vitro Assay Service
    • 14.27.10. CAR-T Preclinical in vivo Assay
    • 14.27.11. IND Development for CAR-T Cell Therapy
    • 14.27.12. GMP Production for CAR-T Products
    • 14.27.13. CAR-T Clinical Trial Services
  • 14.28. CRISPR Therapeutics
    • 14.28.1. CRISPR Therapeutics' Immuno-Oncology Programs
    • 14.28.2. CRISPR/Cas9-enabled Allogeneic CAR-T Design
  • 14.29. Curocell, Inc.
    • 14.29.1. OVIS Technology
  • 14.30. DiaCarta
    • 14.30.1. Personalized CAR-T Immunotherapy Platform
  • 14.31. Elicera Therapeutics AB
    • 14.31.1. iTANK CAR-T Technology
    • 14.31.2. Elicera's Product Pipeline
  • 14.32. EXUMA Biotech
    • 14.32.1. TMR CAR-T Technology
    • 14.32.2. CCT3 CAR-T
    • 14.32.3. rPOC SC CAR-TaNKs
    • 14.32.4. GCAR "in vivo Cell Therapy"
  • 14.33. Fate Therapeutics
    • 14.33.1. FT819
    • 14.33.2. FT825
  • 14.34. Galapagos NV
  • 14.35. Gilead Sciences, Inc.
    • 14.35.1. CAR-T Products
      • 14.35.1.1. Tecartus (brexucabtagene autoleucel)
      • 14.34.1.2. Yescarta (axicabtagene ciloleucel)
  • 14.36. Gracell Biotechnologies
    • 14.36.1. FasTCAR
    • 14.36.2. TruUCAR
    • 14.36.3. SMART CAR-T
    • 14.36.4. Gracell's Product Pipeline
  • 14.37. IASO Biotherapeutics
    • 14.37.1. Technology Platforms
    • 14.37.2. Fully Human Antibody Discovery Platform
    • 14.37.3. High-Throughput Screening Platform for CAR-T Candidates
    • 14.37.4. Universal CAR-T Technology Platform
    • 14.37.5. CAR-T Manufacturing Technology Platform
    • 14.37.6. IASO's Diverse Product Pipeline
  • 14.38. ImmPACT Bio
    • 14.38.1. CD19/20 Bispecific CAR
    • 14.38.2. TGF-Beta
  • 14.39. Immuneel Therapeutics, Pvt., Ltd.
    • 14.39.1. Immuneel's R&D Roadmap
  • 14.40. ImmunoACT
    • 14.40.1. NexCAR19 (Actalycabtagene autoleucel)
  • 14.41. Interius BioTherapeutics
    • 14.41.1. Core Technology
  • 14.42. Juventas Cell Therapy
    • 14.42.1. Yuanruida (inaticabtagene autoleucel)
  • 14.43. JW Therapeutics
    • 14.43.1. Carteyva (relmacabtagene autoleucel; relma-cel)
  • 14.44. Kite Pharma (Gilead)
    • 14.44.1. Kite's Marketed CAR-T Products
      • 14.44.1.1. Yescarta (axicabtagene ciloleucel)
      • 14.44.1.2. Tecartus (brexucabtagene autoleucel)
    • 14.44.2. Kite's Pipeline Cancer Therapies
  • 14.45. Kyverna Therapeutics
    • 14.45.1. Kyverna's CAR-T Therapy for Autoimmune Diseases
  • 14.46. Legend Biotech
    • 14.46.1. Technology Platforms
      • 14.46.1.1. CAR-T
      • 14.46.1.2. CAR-Gamma-Delta T
      • 14.46.1.3. CAR-NK
      • 14.46.1.4. Non-Gene-Editing Universal CAR-T
    • 14.46.2. Product Pipeline
  • 14.47. Leucid Bio
    • 14.47.1. Leucid's Lateral CAR-Platform
    • 14.47.2. LEU011 - NKG2D CAR-T Cell Therapy
    • 14.47.3. T2, Gamma-Delta T-Cells for Off-The-Shelf Therapy
    • 14.47.4. T4 Immunotherapy
    • 14.47.5. Novel Manufacturing Platform
  • 14.48. Luminary Therapeutics, Inc.
    • 14.48.1. Allogeneic Gamma 2.0+ Platform
    • 14.48.2. Non-Viral Gene Modification Process
    • 14.48.3. Split Co-Stim Dual CAR
    • 14.48.4. Ligand-Based CAR to Target Three Antigens
    • 14.48.5. Product Pipeline
  • 14.49. Lyell Immunopharma, Inc.
    • 14.49.1. Technology
      • 14.49.1.1. Gen-R Technology
      • 14.49.1.2. Epi-R Technology
    • 14.49.2. Lyell's Product Pipeline
  • 14.50. March Biosciences
    • 14.50.1. MB-105
    • 14.50.2. March Biosciences' Pipeline
  • 14.51. MaxCyte, Inc.
    • 14.51.1. Technology: Flow Electroporation
    • 14.51.2. MaxCyte's Electroporation Systems
      • 14.51.2.1. ATx
      • 14.51.2.2. GTx
      • 14.51.2.3. STx
      • 14.51.2.4. VLx
  • 14.52. Minerva Biotechnologies Corporation
    • 14.52.1. CAR-T (huMNC2-CAR44)
  • 14.53. Mustang Bio
    • 14.53.1. Mustang's CAR-T Focus
  • 14.54. Noile-Immune Biotech
    • 14.54.1. PRIME CAR-T
  • 14.55. Novartis AG
    • 14.55.1. The Pioneer in CAR-T
    • 14.55.2. Kymriah (tisagenlecleucel)
    • 14.55.3. T-Charge Platform
      • 14.55.3.1. Phase I YTB323 Clinical Study
      • 14.55.3.2. Phase I PHE 885 Clinical Study
  • 14.56. Oncternal Therapeutics
    • 14.56.1. ONCT-808
  • 14.57. Oxford Biomedica plc
    • 14.57.1. LentiVector Platform
    • 14.57.2. inAAVate Platform
    • 14.57.3. CDMO Services
  • 14.58. PeproMene Bio, Inc.
    • 14.58.1. BAFFR CAR-T Cells
  • 14.59. Poseida Therapeutics, Inc.
    • 14.59.1. Poseida's Genetic Engineering Platforms
    • 14.59.2. PiggyBac Platform for Insertion
    • 14.59.3. Cas-CLOVER Platform for Editing
    • 14.59.4. Poseida's CAR-T Product Candidates
  • 14.60. Precigen, Inc.
    • 14.60.1. UltraCAR-T
    • 14.60.2. Sleeping Beauty System
    • 14.60.3. UltraPorator System
    • 14.60.4. Product Pipeline
  • 14.61. Prescient Therapeutics
    • 14.61.1. OmniCAR
    • 14.61.2. CellPryme
  • 14.62. ProMab Biotechnologies, Inc.
    • 14.62.1. ProMab's CAR-T Cells
    • 14.62.2. ProMab's Services
    • 14.62.3. ProMab's Preclinical and Clinical Study Services
  • 14.63. SOTIO Biotech BV
    • 14.63.1. BOXR Technology
    • 14.63.2. BOXR1030
  • 14.64. Syngene International, Ltd.
    • 14.64.1. CAR-T Services
  • 14.65. Synthekine
    • 14.65.1. STK-009 + SYNCAR-001
  • 14.66. TC BioPharm
    • 14.66.1. Gamma Delta T Cells
    • 14.66.2. Cell Banks
    • 14.66.3. Co-Stim CAR-T
    • 14.66.4. Product Pipeline
      • 14.66.4.1. OmnImmune
    • 14.66.5. CAR-T Programs
  • 14.67. T-CURX
    • 14.67.1. Technologies
  • 14.68. Umoja Biopharma
    • 14.68.1. Umoja's Technology Platforms
      • 14.68.1.1. VivoVec in vivo Gene Delivery
      • 14.68.1.2. RACR-Induced Cytotoxic Lymphocytes (iCIL)
      • 14.68.1.3. RACR/CAR: in vivo Cell Programming
      • 14.68.1.4. TumorTag: Universal CAR Tumor Targeting
  • 14.69. ViTToria Biotherapeutics
    • 14.69.1. Senza5
    • 14.69.2. VIPER-101
  • 14.70. Vor Biopharma
    • 14.70.1. Vor Biopharma's Approach
  • 14.71. Wugen
  • 14.72. WuXi Advanced Therapies
    • 14.72.1. WuXi's Closed Process CAR-T manufacturing
  • 14.73. Xenetic Biosciences
    • 14.73.1. DNase-based Oncology Platform
  • 14.74. Xyphos Biosciences, Inc.
    • 14.74.1. ACCEL & UDC Technology
    • 14.74.2. convertibleCAR
    • 14.74.3. Universal Donor Cells

INDEX OF FIGURES

  • FIGURE 2.1: The Basic Structure of a T cell
  • FIGURE 2.2: Binding of a T cell on to an Infected Cell
  • FIGURE 2.3: Components of a CAR-T cell
  • FIGURE 2.4: The Three Domains of a CAR
  • FIGURE 2.5: The first Generation CARs
  • FIGURE 2.6: Second Generation CARs
  • FIGURE 2.7: Third Generation CARs
  • FIGURE 2.8: Fourth Generation CARs
  • FIGURE 2.9: Fifth Generation CARs
  • FIGURE 2.10: CAR Constructs in the FDA Approved CAR-T Cell Products
  • FIGURE 2.11: Antigens Present on Normal and Cancer Cells
  • FIGURE 2.12: Preparation and Administration of CAR-T cell Therapy
  • FIGURE 2.13: Kymriah in Infusion Bag
  • FIGURE 2.14: Yescarta in Infusion Bag
  • FIGURE 2.15: Tecartus in Infusion Bag
  • FIGURE 2.16: Carvykti in Infusion Bag
  • FIGURE 2.17: Abecma in the Infusion Bag
  • FIGURE 2.18: Breyanzi in Package
  • FIGURE 2.19: Relma-cel Infusion Bag
  • FIGURE 3.1: Switchable CARs [sCARs; Universal CARs]
  • FIGURE 3.2: Action of Suicide Genes
  • FIGURE 3.3: Graphical Abstract for Transient Transfection
  • FIGURE 3.4: A Model of Armored CAR
  • FIGURE 4.1: The Five Generations of CARs
  • FIGURE 5.1: Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
  • FIGURE 5.2: G-Rex Bioreactors
  • FIGURE 5.3: CliniMACS Prodigy
  • FIGURE 5.4: Scaling Up of Allogeneic CAR-T Cells
  • FIGURE 5.5: Operating Expenses in Autologous CAR-T Manufacturing
  • FIGURE 5.6: Operating Expenses in Allogeneic CAR-T Manufacturing
  • FIGURE 6.1: CAR-T Target Antigens Evaluated in Clinical Trials
  • FIGURE 7.1: Number of CAR-T Patents Filed from 2000 to March 2024
  • FIGURE 8.1: CAR-T Clinical Trials by Phase of Study, March 2024
  • FIGURE 8.2: Types of Hematological Malignancies Addressed in Clinical Trials
  • FIGURE 8.3: Studies for Simultaneous Targets by One CAR-T
  • FIGURE 8.4: CAR-T Generation Types used in Clinical Trials
  • FIGURE 8.5: Distribution of CAR-T Trials by Type of SeFv Used
  • FIGURE 8.6: Distribution of CAR-T Trials by Type of Vectors Used
  • FIGURE 8.7: Solid Tumor Types in Clinical Trials, March 2024
  • FIGURE 8.8: Liquid Cancers vs. Solid Cancers in CAR-T Clinical Trials
  • FIGURE 9.1: Number of Published CAR-T Papers on PubMed.gov, 2000-March 2024
  • FIGURE 9.2: PubMed. Papers on Autologous vs. Allogeneic CAR-T Therapies, 2000-2024
  • FIGURE 9.3: PubMed Papers on CAR-T for Liquid vs. Solid Cancers, 2013-March 2024
  • FIGURE 9.4: PubMed Papers on the Five Generation of CARs
  • FIGURE 10.1: Venture Capital Funding for CAR-T Companies by Year, 2014-March 2024
  • FIGURE 10.2: IPO Invested in CAR-T Companies, 2014-March 2024
  • FIGURE 13.1: Uptake of CAR-T Doses, 2017-2023
  • FIGURE 13.2: Revenue Generation by CAR-T Therapy by Product, 2017-2023
  • FIGURE 13.3: Estimated Modest Growth of CAR-T Market by Product, 2023-2032
  • FIGURE 13.4: Global Market for CAR-T Products by Geography, 2023-2032
  • FIGURE 13.5: Global Market for CAR-T Therapies by Indication, 2024-2032
  • FIGURE 14.1: Atara's Approach to Allogeneic Cell Therapy
  • FIGURE 14.2: Illustration of CycloCAR-T
  • FIGURE 14.3: Illustration of THANK-uCAR-T
  • FIGURE 14.5: Schematic of Allogeneic P CAR-T with TCR KO
  • FIGURE 14.6: NKG2D-based CAR
  • FIGURE 14.7: Celyad's Multispecific CAR
  • FIGURE 14.8: CRISPR/Cas9-enabled Allogeneic CAR-T Design
  • FIGURE 14.9: FT819
  • FIGURE 14.10: FT825
  • FIGURE 14.11: FasTCAR vs. Conventional CAR-T Manufacturing Time
  • FIGURE 14.12: Action of TruUCAR
  • FIGURE 14.13: SMART CAR-T
  • FIGURE 14.14: CD19/CD20 CAR-T Technology
  • FIGURE 14.15: TGF-Beta Bispecific CAR Technology
  • FIGURE 14.16: Lateral CAR
  • FIGURE 14.17: T4 T-Cell
  • FIGURE 14.18: Split Co-Stim Dual CAR
  • FIGURE 14.19: Ligand-Based CAR to Target Three Antigens
  • FIGURE 14.20: Natural Killing of CAR-T Cells
  • FIGURE 14.21: ATx
  • FIGURE 14.22: GTx
  • FIGURE 14.23: STx
  • FIGURE 14.24: VLx
  • FIGURE 14.25: Features of PRIME CAR-T Cell Therapy
  • FIGURE 14.26: BAFFR CAR-T Cells
  • FIGURE 14.27: Poseida's PiggyBac Platform for Insertion
  • FIGURE 14.28: Poseida's Cas-CLOVER Platform for Editing
  • FIGURE 14.29: UltraCAR-T Cell
  • FIGURE 14.30: Precigen's Ultraporator System
  • FIGURE 14.31: Prescient's OmniCAR
  • FIGURE 14.32: VIPER-101, the Lead Program of ViTToria
  • FIGURE 14.33: WuXi's Closed Process CAR-T Platform
  • FIGURE 14.34: Convertible CAR Parts
  • FIGURE 14.35: Xyphos' Universal Donor Cells
  • INDEX OF TABLES
  • TABLE 2.1: Potential CAR-T Targeted Antigens Present on Hematological Malignant Cells
  • TABLE 2.2: Key Differences between the Available Vectors
  • TABLE 2.3: The Eight CAR-T Cell Therapies Available in the Market
  • TABLE 2.4: Toxicities Associated with CAR-T Treatment
  • TABLE 3.1: Strategies for Future CAR-T Therapies
  • TABLE 3.2: A Sample of CAR-T Studies on Solid Tumors
  • TABLE 3.3: New Target Antigens and New Target Cancers
  • TABLE 3.4: A sample of Allogeneic CAR-T Studies
  • TABLE 4.1: History of Development of CAR-T Cell Therapy
  • TABLE 4.2: Approved CAR-T Products, their Developers and Indications
  • TABLE 4.3: Upcoming CAR-T Stars
  • TABLE 4.4: Cancer Population Addresses by CAR-T Therapy
  • TABLE 6.1: CAR-T Target Antigens in Hematological Cancers
  • TABLE 6.2: Targeted Antigens involved in the Approved CAR-Ts
  • TABLE 7.1: Geographical Distribution of CAR-T Patents, March 2024
  • TABLE 7.2: Top Ten Applicants for CAR-T Patents, March 2024
  • TABLE 7.3: Top Ten Inventors of CAR-T Patents, March 2024
  • TABLE 7.4: Top Ten Owners of CAR-T Patents, March 2024
  • TABLE 7.5: Legal Status of CAR-T Patent Applications, March 2024
  • TABLE 8.1: CAR-T Clinical Trials by Country, March 2024
  • TABLE 8.2: Number of CAR-T Clinical Trials by Funding Type, March 2024
  • TABLE 8.3: Clinical Trials Focusing on Solid Tumors by Country, March 2024
  • TABLE 8.4: CAR-T Solid Tumor Clinical Trials by Phase of Study, March 2024
  • TABLE 8.5: Funding Types in CAR-T Solid Tumor Clinical Trials, March 2024
  • TABLE 8.6: Percent Biomarker Distribution in CAR-T Clinical Trials
  • TABLE 8.7: CAR-T Targeted Indications in the U.S. Clinical Trials
  • TABLE 8.8: Indications Addressed by CAR-T Clinical Trials in China
  • TABLE 8.9: CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
  • TABLE 8.10: CAR-T Clinical Trial Sponsor Companies and Institutions in China
  • TABLE 8.11: CAR-T Clinical Trial Sponsor Companies and Institutions in Other Countries
  • TABLE 8.12: Clinical Trials of 4th, 5th gen. and Gene Edited CAR-Ts
  • TABLE 9.1: NIH Funding for CAR-T Research, 2024
  • TABLE 10.1: CAR-T Venture Capital Funding, 2014-March 2024
  • TABLE 10.2: IPO Invested in CAR-T Companies, 2014-March 2024
  • TABLE 10.3: CAR-T Licensing Deals, 2015-March 2024
  • TABLE 10.4: CAR-T Collaboration Deals Signed between 2013 and March 2024
  • TABLE 10.5: CAR-T Merger and Acquisition (M&A) Deals, 2015-March 2024
  • TABLE 10.6: Overview of CAR-T Funding, 2014-March 2024
  • TABLE 11.1: List Prices of CAR-T Cells
  • TABLE 11.2: Pre-, Peri-, and Post Infusion Unit Costs
  • TABLE 11.3: Adverse Events Rates and Unit Costs of Management
  • TABLE 11.4: Reimbursement for CAR-T Cases, FY 2023 vs. FY 2024
  • TABLE 11.5: Cost of CAR-T cell Products in the EU Countries
  • TABLE 11.6: Cost Components and Resource Use of Pre- and Post- CAR-T Cell Therapy
  • TABLE 11.7: Average Total Costs Pre- and Post- CAR-T Treatment in Former EU 5 and NL
  • TABLE 11.8: CAR-T Reimbursement Schemes in Europe
  • TABLE 12.1: FDA-Approved Therapies for R/R ALL Pediatric and Young Adult Patients
  • TABLE 12.2: FDA Approved Therapies for DLBCL
  • TABLE 12.3: FDA Approved Therapies for MCL
  • TABLE 12.4: FDA Approved Drugs for Multiple Myeloma
  • TABLE 12.5: FDA-Approved Drugs for Follicular Lymphoma
  • TABLE 12.6: Cost of Treating Blood Cancers
  • TABLE 13.1: Uptake of CAR-T Doses, 2017-2023
  • TABLE 13.2: Revenue Generation by CAR-T Therapy by Product, 2017-2023
  • TABLE 13.3: Estimated Modest Growth of CAR-T Cell Market by Product, 2023-2032
  • TABLE 13.4: Global Market for CAR-T Products by Geography, 2023-2032
  • TABLE 13.5: Global Market for CAR-T Therapies by Indication, 2024-2032
  • TABLE 14.1: AffyImmune's Affinity-Tuned Pipeline Products
  • TABLE 14.2: Aleta's CAR-T Engager Pipeline
  • TABLE 14.3: Allogene's AlloCAR-T Pipeline
  • TABLE 14.4: Anixa's CAR-T Pipeline
  • TABLE 14.5: Arbele's Advanced Cell Therapy Product Candidates
  • TABLE 14.6: ArcellX's Current Product Pipeline
  • TABLE 14.7: Atara's Product Pipeline
  • TABLE 14.8: Autolus' Therapies in Development
  • TABLE 14.9: Clinical & Preclinical Pipeline Overview
  • TABLE 14.10: Bellicum's Pipeline
  • TABLE 14.11: BRiDGECAR Program
  • TABLE 14.12: Cabaletta's Autoimmune Therapy Candidates in Development
  • TABLE 14.13: Carina's Clinical Programs
  • TABLE 14.14: CARsgen's Product Pipeline
  • TABLE 14.15: Cartesian's Product Pipeline
  • TABLE 14.16: Cellectis' Allogeneic CAR-T Cell Product Pipeline
  • TABLE 14.17: CRISPR Therapeutics' CAR-T Programs
  • TABLE 14.18: Elicera's Product Pipeline
  • TABLE 14.19: EXUMA's Pipeline Assets
  • TABLE 14.20: Galapagos' Oncology CAR-T Pipeline
  • TABLE 14.21: Gracell's Rich Product Pipeline
  • TABLE 14.22: IASO's Diverse Product Pipeline
  • TABLE 14.23: ImmPACT Bio's Product Pipeline
  • TABLE 14.24: Immuneels Product Pipeline
  • TABLE 14.25: JW Therapeutics' Product Pipeline
  • TABLE 14.26: Kite's Pipeline Cancer Therapies
  • TABLE 14.27: Product Pipeline to address Autoimmune Diseases
  • TABLE 14.28: Legend Biotech's Product Pipeline
  • TABLE 14.29: Leucid's Product Pipeline
  • TABLE 14.30: Luminary's Product Pipeline
  • TABLE 14.31: Lyell's Product Pipeline
  • TABLE 14.32: March Biosciences' Product Pipeline
  • TABLE 14.33: A Comparison Guide for MaxCyte's Elecroporation Systems
  • TABLE 14.34: Minerva's CAR-T Pipeline Products for Solid Tumors
  • TABLE 14.35: Mustang's CAR-T Product Candidates
  • TABLE 14.36: Noile-Immune's PRIME-Based Product Pipeline
  • TABLE 14.37: Oxford Biomedica's CDMO Services
  • TABLE 14.38: PeproMene's Product Pipeline
  • TABLE 14.39: Poseida's CAR-T Product Pipeline
  • TABLE 14.40: Precigen's UltraCAR-T Pipeline
  • TABLE 14.41: Prescient's CAR-T Pruct Pipeline
  • TABLE 14.42: ProMabs CAR-T Cells
  • TABLE 14.43: ProMab's Discovery Services Plans & Prices
  • TABLE 14.44: Synthekine's Pipeline with SYNCAR-001 + STK-009
  • TABLE 14.45: T-CURX' Product Candidates in Clinical Trials
  • TABLE 14.46: Umoja's Product Pipeline
  • TABLE 14.47: Vor Biopharma's Current Product Pipeline
  • TABLE 14.48: Wugen's Product Pipeline
  • TABLE 14.49: Xenetic's CAR-T Product Pipeline
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