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

Description

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

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