Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends, 2023

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.

Scientific progress within the field of cancer immunotherapy has led to seven CAR-T cell therapy approvals, including:

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

While Relma-cel has been approved by NMPA in China, all the other six therapies have been approved in the U.S. by the FDA.

These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm. This has driven CAR-T funding to staggering new heights. At first the trend was subtle, but the tide has swelled as CAR-T start-ups have been richly funded by investors eager to get into this expanding area of regenerative medicine. In total, there has been an astonishing $100 billion of market capitalization from CAR-T companies in recent years.

Financing rounds by CAR-T companies have approached $4 billion, while CAR-T industry partnerships have contributed an astounding $2 billion. M&A activity has been even more 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. Ranging from small start-ups to billion-dollar companies, CAR-T companies are proliferating in all healthcare markets worldwide.

This 321-page market report reveals:

Global CAR-T Cell Therapy Market Size, with Segmentation by Product, Geography, and Indication

Future Market Size Forecasts by Segment through 2030

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

1.1. 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 Cell Development
- 2.2.1. The CAR-T Cell Family
  - 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 Seven CAR-T Therapies Available in the Market: A Brief Overview
2.7. Toxicities Associated with CAR-T Treatment
2.8. Strategies for the Future of CAR-T Therapies
- 2.8.1. Switchable CARs (sCARs)
- 2.8.2. Suicide Genes to Destroy CAR-T Cells In Vivo
- 2.8.3. Transient Transfection
- 2.8.4. Affinity Tuned CARs
- 2.8.5. Armored CARs
- 2.8.6. Shift from Liquid Cancers to Solid Tumors
- 2.8.7. Focus on Shortening Hospital Stay
- 2.8.8. Focus on Discovering New Antigens
- 2.8.9. Shifting from Autologous to Allogeneic CAR-T Therapies
- 2.8.10. CAR-T for the Masses
- 2.8.11. New In Vivo CAR-T Approach
- 2.8.12. Combination with mRNA Vaccine
- 2.8.13. Combination with Oncolytic Virus
2.9. Direct Competion between Autologous CAR-T Therapies

3. CAR-T CELL THERAPY: PRODUCT DEVELOPMENT

3.1. History of Development of CAR-T Cells
3.2. Top Ten Milestones Crossed by CAR-T Therapy
- 3.2.1. First Pediatric Patient to Receive CAR-T Therapy
- 3.2.2. CAR-T Granted Breakthrough Therapy Designation
- 3.2.3. The Beginning of CAR-T Development to Combat Solid Cancers
- 3.2.4. First CRISPR CAR-T Built
- 3.2.5. The First Two CAR-T Approvals
- 3.2.6. EMA's Approval for Kymriah and Yescarta
- 3.2.7. Approval of Tecartus, Breyanzi and Abecma
- 3.2.8. NMPA Approval of Relma-cel (Carteyva)
- 3.2.9. Approval of Carvykti
3.3. Current Status of CAR-T Therapy Products
- 3.3.1. Kymriah (Tisagenlecleucel)
  - 3.3.1.1. Kymriah's Mechanism of Action
  - 3.3.1.2. Clinical Trials on Kymriah
- 3.3.2. Yescarta (Axicabtagene ciloleucel)
  - 3.3.2.1. Mechanism of Action
  - 3.3.2.2. Yeskarta on Clinical Trials
- 3.3.3. Tecartus (Brexucabtagene autoleucel)
  - 3.3.3.1. Tecartus Approvals
  - 3.3.3.2. Mechanism of Action
  - 3.3.3.3. Clinical Trials on Tecartus
- 3.3.4. Breyanzi (Lisocabtagene maraleucel)
- 3.3.5. Abecma (Idecabtagene vicleucel)
  - 3.3.5.1. Regulatory Approvals for Abecma
  - 3.3.5.2. Mechanism of Action
  - 3.3.5.3. Clinical Trials on Abecma
- 3.3.6. Relma-Cel (Relmacabtagene autoleucel)
- 3.3.7. Carvykti (Ciltacabtagene autoleucel)
  - 3.3.7.1. Regulatory Approvals for Carvykti
  - 3.3.7.2. Mechanism of Action
  - 3.3.7.3. Clinical Trials on Carvykti
3.4. Other Promising CAR-T Product Candidates
- 3.4.1. ALLO-501
- 3.4.2. CTX-110
- 3.4.3. UCART19
- 3.4.4. AUT01
- 3.4.5. JCARH125
- 3.4.6. PBCAR20A
- 3.4.7. UCART123
- 3.4.8. PRGN-3006
- 3.4.9. UCART22
- 3.4.10. UCARTCS1
3.5. Transformative Potential of CAR-T Therapy
3.6. Cancer Population Addressed by CAR-T Therapy
3.7. Advantages of CAR-T Cell Therapy
3.8. Disadvantages of CAR-T Therapy

4. SCALABLE MANUFACTURING OF CAR-T CELLS

4.1. The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
4.2. The Evolution of CAR-T Cell Manufacturing Platforms
- 4.2.1. Open vs. Closed Systems
- 4.2.2. Manual Processing vs. Automation
- 4.2.3. Autologous vs. Allogeneic Manufacturing
4.4. Operating Expenses in Autologous CAR-T Manufacturing
4.5. Operating Expenses in Allogeneic CAR-T Manufacturing

5. CAR-T TARGET ANTIGENS

5.1. CAR-T Target Antigens on Hematalogical Malignancies
5.2. CAR-T Target Antigens on Solid Tumors
5.3. Common Antigens Targeted by CAR-T Cells in Clinical Trials
- 5.3.1. Cluster of Differentiation 19 (CD19)
- 5.3.2. Mesothelin
- 5.3.3. B-Cell Maturation Agent (BCMA)
- 5.3.4. GD2
- 5.3.5. Glypican-3 (GPC3)
- 5.3.6. Cluster Differentiation-22 (CD22)

6. CAR-T PATENT LANDSCAPE

6.1. Geographical Origin of CAR-T Patent Applications
6.2. Top Ten CAR-T Patent Jurisdictions
6.3. Affiliations of CAR-T Patent Applicants
6.4. Top 20 Companies in CAR-T Patent Landscape
6.5. Top 20 Research Centers in CAR-T Patent Landscape
6.6. Top Ten CAR-T Inventors
6.7. Top Five CAR-T Patents with Most Family Members
6.8. Top Five CAR-T Patents with Most Inventors in Co-Authorship
6.9. Top Five Patents with Most Co-Applicants
6.10. Top 5 CAR-T Patents with Most Co-Applicants

7. CAR-T CLINICAL TRIAL LANDSCAPE

7.1. Most Addressed Indications in Clinical Trials
7.2. Current Focus of Ongoing Clinical Trials
7.3. Countries with Most Clinical Trials
7.4. Phase of Clinical Trial Studies
7.5. CAR-T Clinical Trials for Hematalogical Malignancies
7.6. Simultaneous Targets by One CAR-T
7.7. CAR-T Generations Used in Clinical Trials
7.8. CAR-T Clinical Trials Focusing on Solid Tumors
7.9. CAR-T Targeted Biomarkers in Clinical Trials
7.10. CAR-T Targeted Biomarkers in the U.S. Clinical Trials
7.11. CAR-T Targeted Biomarkers in Chinese Clinical Trials
7.12. CAR-T Targeted Indications in the U.S. Clinical Trials
7.13. Indications Addressed by CAR-T Clinical Trials in China
7.14. Hematological Malignancies v.s. Solid Cancers in CAR-T Clinical Trials
7.15. CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
7.16. CAR-T Clinical Trial Sponsor Companies & Institutions in China
7.17. CAR-T Clinical Trial Sponsor Companies & Institutions in other Countries
7.18. Improved CAR-T Constructs in Clinical Trials
- 7.18.1. CAR-T with PD1Fc
- 7.18.2. CAR-T with Truncated with EGFR (EGFRt)
- 7.18.3. CAR-T with IL7 and CCL19
- 7.18.4. CAR-T with PD1/CD28 Switch Receptor
- 7.18.5. CAR-T with PD1 shRNA Expressing Cassette
- 7.18.6. CAR-T with CTLA-4/PD-1 Antibody
- 7.18.7. CAR-T with PD-1 Antibodies
7.19. Distribution of CAR-T Trials by Type of SeFv Used
7.20. Distribution of CAR-T Clinical Trials by Type of Vectors Used

8. PUBLISHED CAR-T SCIENTIFIC PAPERS IN PUBMED.GOV & NIH FUNDING

8.1. PubMed.gov Published Papers on the Five Generation of CARs
8.2. PubMed.gov Papers Published on Autologous and Allogeneic CAR-Ts
8.3. Published CAR-T PubMed Papers on Solid & Liquid Cancers
8.4. NIH Funding for CAR-T Research in 2022

9. DEALS IN CAR-T THERAPY SPACE

9.1. Most Recent CAR-T Deals
- 9.1.1. Autolus Therapeutics/Bristol Myers Squibb
- 9.1.2. ArsenalBio/Genentech
- 9.1.3. Chugai Pharmaceutical/Noile Immune Biotech
- 9.1.4. Roche/Poseida Therapeutics
- 9.1.5. Oxford Biomedica/Undisclosed U.S. Company
- 9.1.6. Immatics/Bristol Myers Squibb
- 9.1.7. Galapagos/CellPoint/AboundBio
- 9.1.8. Coeptis/University of Pittsburgh
- 9.1.9. Pregene/CellPont
- 9.1.10. Intellia/Kyverna
9.2. Funding for CAR-T Therapy in H1 2022
- 9.2.1. Neukio Bio
- 9.2.2. Arsenal Biosciences
- 9.2.3. Eyestem
- 9.2.4. Legend Biotech
- 9.2.5. Immuneel Therapeutics
- 9.2.6. Tessa Therapeutics
- 9.2.7. Elicera Therapeutics
- 9.2.8. Inceptor Bio
- 9.2.9. AvenCell Therapeutics
- 9.2.10. Ucello Theraputics
- 9.2.11. Kyverna Therapeutics

10. REIMBURSEMENT FOR CAR-T THERAPIES

10.1. Potential Barriers to CAR-T Treatments
- 10.1.1. Patient Barriers
- 10.1.2. Limited Number of Treatment Centers
- 10.1.3. Travel, Lodging & Meal Expenses
- 10.1.4. Utilization Management Policies
- 10.1.5. Out-of-Pocket Costs
- 10.1.6. Geography
- 10.1.7. Logistics of Follow-Up
- 10.1.8. Reimbursement Uncertainty
10.2. Manufacturer Challenges
- 10.2.1. Lingering Manufacturing Issues
- 10.2.2. Difficulties with Scaling Up
10.3. CAR-T Reimbursement Updated for FY 2023 IPPS Final Rule
- 10.3.1. Payment Changes for CAR-T Cases
- 10.3.2. High-Cost Outlier Payments
10.4. Use of 2021 Data to Establish Payment
- 10.4.1. Adjustment for Clinical Trial Cases
- 10.4.2. Product NTAP Decisions
10.5. Reimbursement for CAR-T Therapy in Europe
- 10.5.1. Cost Components of Pre- and Post-CAR-T Cell Therapy
- 10.5.2. Average Total Costs Pre- and Post CAR-T Cell Administration in E.U.
10.6. Outcomes-Based Reimbursement for CAR-T Therapies in Europe
- 10.6.1. France
- 10.6.2. Germany
- 10.6.3. Italy
- 10.6.4. Spain
- 10.6.5. Reimbursement for CAR-T Therapies in U.K.
10.7. CAR-T Cell Treated Patients Registered in EBMT Registry

11. BLOOD CANCERS: INCDENCE AND AVAILABLE TREATMENTS

11.1. Lymphoma
- 11.1.1. Hodgkin Lymphoma (HL)
- 11.1.2. Non-Hodgkin Lymphoma (NHL)
- 11.1.3. Difuse Large B Cell Lymphoma (DLBCL)
- 11.1.4. Follicular Lymphoma (FL)
11.2. Leukemia
- 11.2.1. Types of Leukemia
  - 11.2.1.1. Acute Myeloid Leukemia (AML)
  - 11.2.1.2. Acute Lymphoblastic Leukemia (ALL)
  - 11.2.1.3. Chronic Myeloid Leukemia (CML)
  - 11.2.1.4. Chronic Lymphocytic Leukemia (CLL)
  - 11.2.1.5. Multiple Myeloma (MM)
11.3. Treatment Options for Blood Cancers
- 11.3.1. Chemotherapy
- 11.3.2. Radiation Therapy
- 11.3.3. Targeted Therapy
- 11.3.4. Stem Cell Transplantation
- 11.3.5. Immunotherapy
  - 11.3.5.1. Monoclonal Antibodies (mAbs)
- 11.3.6. Adoptive Cell Transfer Therapy/T Cell Transfer Therapy
11.4. The Staggering Cost of Cancer Therapies

12. MARKET ANALYSIS

12.1. Global Market for CAR-T Cell Therapy by Product
12.2. Global Market for CAR-T Therapy by Geography
12.3. Global Market for CAR-T Therapy by Indication

13. BARRIERS & STRATEGIES FOR SUCCESS IN CAR-T 2.0 MARKET PLACE

13.1. Barriers to CAR-T 2.0 Commercial Success
13.2. Capacity Constraints
13.3. Competition among Manufacturers
13.4. Competition from other Treatments
13.5. Market Development Strategies for CAR-T 2.0
- 13.5.1. Effective Physician Education
- 13.5.2. Logistical Excellence
- 13.5.3. Evidence Generation

14. CAR-T COMPANIES: AN OVERVIEW

14.1. Abintus Bio, Inc.
14.2. Adicet Bio
- 14.2.1. Gamma Delta T Cells
- 14.2.2. Proprietary Cell Platform Process
- 14.2.3. Pipeline
14.3. AffyImmune Therapeutics, Inc.
- 14.3.1. Affinity-Tuned CARs
- 14.3.2. Real-Time CAR-T Cell Monitoring
14.4. Alaunos Therapeutics, Inc.
14.5. Aleta BioTherapeutics
- 14.5.1. Aleta's CAR-T Engager Pipeline
14.6. Allogene Therapeutics
- 14.6.1. AlloCAR-T
14.7. Anixa Biosciences, Inc.
14.8. Appia Bio
14.9. Arbele Ltd.
- 14.9.1. AI-CAR-T/NK Cell Platform
14.10. Arcellx
- 14.10.1. D-Domain Technology
- 14.10.2. ddCAR
- 14.10.3. ARC-SparX
14.11. Artiva Biotherapeutics
- 14.11.1. Artiva's AlloNK Platform
- 14.11.2. Artiva's CAR-NK Platform
14.12. Atara Biotherapeutics
- 14.12.1. Technology
- 14.12.2. Atara's Robust Pipeline
14.13. Aurora BioPharma
14.14. Autolus Therapeutics plc
- 14.14.1. Technology
- 14.14.2. CAR-T Cell Production
- 14.14.3. Manufacturing
- 14.14.4. Autolus' Therapies in Development
- 14.14.5. obe-cel
14.15. AvenCell Europe GmbH
- 14.15.1. AvenCell's Proprietary Platforms
- 14.15.2. UniCAR
- 14.15.3. RevCAR
- 14.15.4. TCE
- 14.15.5. AvenCell's Clinical and Preclinical Pipeline
14.16. Aavocyte, Inc.
- 14.16.1. AAVOT Technology
- 14.16.2. Indications for AAVOT Therapy
14.17. Beam Therapeutics, Inc.
- 14.17.1. Base Editing Technology
14.18. Bellicum Pharmaceuticals
- 14.18.1. GoCAR Technology
- 14.18.2. CaspaCIDe Safety Switch
14.19. BioNTech
- 14.19.1. BioNTech's Engineered Cell Therapies
- 14.9.2. BNT211
- 14.19.3. BNT212
14.20. Biosceptre
- 14.20.1. nfP2X7
- 14.20.2. Biosceptre's Product Pipeline
14.21. bluebird bio
- 14.21.1. CAR-T Collaborations
- 14.21.2. Collaboration with Celgene
- 14.21.3. Collaboration with Bristol Myers Squibb
- 14.21.4. Collaboration with TC BioPharm
- 14.21.5. Collaboration with Inhibrx
- 14.21.6. Collaboration with PsiOxus
14.22. Bristol Myers Squibb/Celgene Corp.
- 14.22.1. Products
  - 14.22.1.1. ABECMA (idecabtagene vicleucel)
  - 14.22.1.2. Breyanzi (lisocabtagene maraleucel)
14.23. Cabaletta Bio
- 14.23.1. CAAR Technology
14.24. Carina Biotech
14.25. CARsgen Therapeutics
14.26. Cartesian Therapeutics
- TABLE 14.19: Cartesian's Growing Product Pipeline
14.27. CARTherics Pty Ltd.
- 14.27.1. Technology
14.28. Cellectis
- 14.28.1. Product Candidates
- TABLE 14.20: Cellectis' Products in Development
14.29. CellPoint BV
14.30. Celularity, Inc.
- 14.30.1. P CAR-T
14.31. Celyad Oncology
- 14.31.1. Technologies
- 14.31.2. All-In-One Vector Approach
- 14.31.3. Pipeline
14.32. Century Therapeutics, Inc.
- 14.32.1. Century's Approach
- 14.32.2. Gene Editing Technology
- 14.32.3. Proprietary Allo-Evasion Technology
- 14.32.4. CAR and Protein Engineering
- 14.32.5. Common Engineered iPSC Progenitors
- 14.32.6. Streamlined Manufacturing
- 14.32.7. Century's Pipeline Overview
14.33. Clade Therapeutics
14.34. Coeptis Therapeutics, Inc.
- 14.34.1. SNAP CAR-T
14.35. Creative Biolabs
- 14.35.1. CAR-T Therapy Development
- 14.35.2. Biomarker Identification and Selection
- 14.35.3. scFv Generation
- 14.35.4. CAR-T Gene Packaging & Delivery
- 14.35.5. Replication-Competent Virus Testing Service
- 14.35.6. CAR Cell In Vitro Assay Service
- 14.35.7. CAR-T Preclinical In Vivo Assay
- 14.35.8. IND Development for CAR-T Cell Therapy
- 14.35.9. GMP Production for CAR-T Products
- 14.35.10. CAR-T Clinical Trials
14.36. CRISPR Therapeutics
- 14.36.1. CRISPR/Cas9 Immuno-Oncology Cell Therapy
- 14.36.2. CRISPR/Cas9 Allogeneic CAR-T Design
14.37. Curocell, Inc.
- 17.37.1. OVIS Technology
17.38. CytoSeek
- 14.38.1. Technology
- 14.38.2. Pipeline
14.39. Cytovia Therapeutics
- 14.39.1. Technology
14.40. DiaCarta
- 14.40.1. Personalized CAR-T Immunotherapy Platform
14.41. Elicera Therapeutics AB
- 14.41.1. iTANK CAR-T Technology
- 14.41.2. Elicera's Product Pipeline
14.42. Eureka Therapeutics, Inc.
- 14.42.1. Technology
  - 14.42.1.1. E-ALPHA Phage Display Platform
  - 14.42.1.2. ARTEMIS Cell Receptor Platform
- 14.42.2. Eureka's Product Pipeline
14.43. EXUMA Biotech Corp.
- 14.43.1. TMR CAR-T Technology
14.44. Fate Therapeutics, Inc.
14.45. Gilead Sciences, Inc.
- 14.45.1. CAR-T Products
  - 14.45.1.1. TECARTUS (Brexucabtagene autoleucel)
  - 14.45.1.2. Yescarta (Axicabtagene ciloleucel)
- 14.45.2. CAR-T Programs
14.46. Gracell Biotechnologies
- 14.46.1. FasTCAR
- 14.46.2. TruUCAR
- 14.46.3. SMART CART
- 14.46.4. Gracell's Clinical Pipeline
14.47. IASO Biotherapeutics
- 14.47.1. Technology Platforms
  - 14.47.1.1. Fully Human Antibody Discovery Platform (IMARS)
  - 14.47.1.2. High-Throughput Screening Platform for CAR-T Candidates
  - 14.47.1.3. Universal CAR-T Technology Platform
  - 14.47.1.4. Manufacturing Technology Platform
- 14.47.2. IASO's Diverse Product Pipeline
14.48. iCell Gene Therapeutics
- 14.48.1. CARvac Platform
- 14.48.2. T-Cell Targeted CARs
- 14.48.3. Non-Gene Edited Universal CARs
- 14.48.4. C-TPS1
- 14.48.5. Compound CARs
- 14.48.5. Pipeline
14.49. ImmPACT Bio
- 14.49.1. Technologies
  - 14.49.1.1. Dual-Targeted CAR-T Cell Therapy
  - 14.49.1.2. ICAR Dual Targeting Technology
  - 14.49.1.3. TGF-B CARS Targeting TME
14.50. Immuneel Therapeutics, Pvt. Ltd.
14.51. Inceptor Bio
- 14.51.1. Inceptor's Technology Platforms
14.52. Interius BioTherapeutics
- 14.52.1. Core Technology
14.53. Janssen Biotech, Inc.
- 14.53.1. JNJ-4528
14.54. JW Therapeutics
- 14.54.1. Relma-cel (JWCAR029)
14.55. Kite Pharma (Gilead)
- 14.55.1. Kite's Technology
- 14.55.2. Kite's Marketed Therapies
  - 14.55.2.1. Yescarta (Axicabtagene ciloleucel)
  - 14.55.2.2. Tecartus (Brexucabtagene autoleucel)
- 14.55.3. Kite's Pipeline Cancer Therapies
14.56. Kuur Therapeutics
- 14.56.1. Kuur's Product Candidates
14.57. Kyverna Therapeutics
- 14.57.1. CAR-T Cells
  - 14.57.1.1. SynNotch CAR-T Cells
  - 14.57.1.2. SynReg T Cells
14.58. Legend Biotech
- 14.58.1. LCAR-B38M/JNJ-4528
14.59. Leucid Bio
- 14.59.1. Leucid's Science
- 14.59.2. Leucid's Product Pipeline
14.60. Luminary Therapeutics, Inc.
- 14.60.1. BAFF CAR-T
- 14.60.2. Universal Receptor
- 14.60.3. Luminary Therapeutics' Pipeline
14.61. Lyell Immunopharma, Inc.
- 14.61.1. Technologies
  - 14.61.1.1. Gen-R Technology
  - 14.61.1.2. Epi-R Technology
14.62. MaxCyte, Inc.
- 14.62.1. ExPERT Technology Platform
  - 14.62.1.1. ATx
  - 14.62.1.2. GTx
  - 14.62.1.3. STx
  - 14.62.1.4. VLx
14.63. Minerva Biotechnologies Corporation
- 14.63.1. Autologous huMNC2-CAR44
14.64. Mnemo Therapeutics
- 14.64.1. Mnemo's Approach
  - 14.64.1.1. Mnemo's 1XX CAR
14.65. Mustang Bio
14.66. Neukio Biotherapeutics
- 14.66.1. iPSC-CAR-NK Technology
14.67. NKarta, Inc.
- 14.67.1. Technology
- 14.67.2. NKarta's Pipeline
14.68. Noile-Immune Biotech
- 14.68.1. PRIME Technology
14.69. Novartis AG
- 14.69.1. The Pioneers of CAR-T Cell & Gene Therapy
- 14.69.2. Approval of Kymriah (tisagenlecleucel)
14.70. Oncternal Therapeutics
- 14.70.1. Oncternal's Product Pipeline
14.71. Orna Therapeutics
- 14.71.1. oRNA Circular RNA
- 14.71.2. oRNA's Pipeline Products
14.72. Oxford Biomedica plc
- 14.72.1. LentiVector Platform
- 14.72.2. LentiStable Platform
- 14.72.3. Adeno-Associated Virus (AAV) Platform
- 14.72.4. TRiP System
14.73. PeproMene Bio, Inc.
- 14.73.1. BAFFR CAR-T Cells
- 14.73.2. Bispecific T Cell Engager (BiTE)
- 14.73.3. CAR NK Cells
14.74. Poseida Therapeutics, Inc.
- 14.74.1. Platforms
  - 14.74.1.1. piggyBac
  - 14.74.1.2. Cas-CLOVER
  - 14.74.1.3. Gene Delivery
  - 14.74.1.4. TSCM Cells
- 14.74.2. Pipeline Products
  - 14.74.2.1. P-BCMA-ALL01
  - 14.74.2.2. P-MUC1C-ALL01
  - 14.74.2.3. P-PSMA-ALL01
  - 14.74.2.4. Dual CAR Allogeneic Programs
  - 14.74.2.5. P-PSMA-101
14.75. Precigen, Inc.
- 14.75.1. Therapeutic Platforms
  - 14.75.1.1. UltraCAR-T
  - 14.75.1.2. AdenoVerse Immunotherapy
  - 14.75.1.3. ActoBiotics
  - 14.75.1.4. Multifunctional Therapeutics
- 14.75.2. Technology Platforms
  - 14.75.2.1. UltraVector
  - 14.75.2.2. Sleeping Beauty System
  - 14.75.2.3. AdenoVerse
  - 14.75.2.4. UltraPorator
  - 14.75.2.5. RheoSwitch
- 14.75.3. Precigen's Pipeline
14.76. Precision Biosciences
- 14.76.1. ARCUS Genome Editing
- 14.76.2. Precision's CAR-T Immunotherapy Pipeline
14.77. Prescient Therapeutics
- 14.77.1. Technology
  - 14.77.1.1. OmniCAR
  - 14.77.1.2. CellPryme-M
  - 14.77.1.3. PTX-100
  - 14.77.1.4. PTX-200
14.78. ProMab Biotechnologies, Inc.
- 14.78.1. Products
- 14.78.2. Services
  - 14.78.2.1. Cell Line Engineering Services
  - 14.78.2.2. Custom CAR-T Cell Development
  - 14.78.2.3. Custom CAR-NK Cell Development
  - 14.78.2.4. Custom CAR-Macrophage Cell Development
  - 14.78.2.5. Custom Gamma Delta T Cell Development
- 14.78.3. Lentivirus Production
- 14.78.4. mRNA-Lipid Nanoparticle Gene Delivery
- 14.78.5. Cancer Stem Cell Line Services
14.79. Quell Therapeutics, Ltd.
- 14.79.1. Quell's Platform
14.80. Sorrento Therapeutics, Inc.
- 14.80.1. DAR-T (Dimeric Antigen Receptor T Cell)
14.81. SOTIO Biotech, A.S.
- 14.81.1. SOTIO's Pipeline
14.82. Syngene International, Ltd.
- 14.82.1. CAR-T Services
14.83. Synthekine
- 14.83.1. STK-009 + SYNCAR-001
14.84. TC BioPharm
- 14.84.1. Gamma Delta T Cells
- 14.84.2. Cell Banks
- 14.84.3. Co-Stim CAR-T
- 14.84.4. TC BioPharm's Product Pipeline
- 14.84.5. Omnlmmune
- 14.84.6. CAR-T Programs
14.85. T-CURX
- 14.85.1. CARAMBA Project
- 14.85.2. imSAVAR Project
14.86. Tessa Therapeutics, Ltd.
14.87. Tmunity Therapeutics
- 14.87.1. Technology
- 14.87.2. Pipeline
14.88. Umoja Biopharma
- 14.88.1. Umoja's Core Technology Platforms
  - 14.88.1.1. VivoVec in vivo Gene Delivery
  - 14.88.1.2. RACR/CAR in vivo Cell Programming
  - 14.88.1.3. TumorTag (Universal CAR Tumor Targeting)
14.89. Vor Biopharma
- 14.89.1. Vor Biopharma's Ap[proach
- 14.89.2. Vor's Platform
- 14.89.3. Vor's Pipeline
14.90. Wugen
14.91. WuXi Advanced Therapies
- 14.91.1. Closed-Process CAR-T Platform
14.92. Xenetic Biosciences
- 14.92.1. The DNase Platform Technology
- 14.92.2. XCART Personalized CAR-T Platform Technology
- 14.92.3. PolyXen PSA Technology Platform
14.93. Xyphos Biosciences, Inc.
- 14.93.1. ACCEL & UDC Technology
- 14.93.2. convertibleCAR
- 14.93.3. Univeral Donor Cells

INDEX OF FIGURES

FIGURE 2.1: The Basic Structure of a T cell
FIGURE 2.2: Binding of a T cell onto 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: Antigens Present on Normal & Cancer Cells
FIGURE 2.11: The Process of CAR-T Manufacturing
FIGURE 2.12: Preparation & Administration of CAR-T Therapy
FIGURE 3.1: The Five Generations of CARs
FIGURE 3.2: A Package of Kymriah
FIGURE 3.3: Yescarta in a Blood Bag
FIGURE 3.4: Tecartus in a Blood Bag
FIGURE 3.5: Abecma in a Blood Bag
FIGURE 3.6: Relma-cel in a Blood Bag
FIGURE 3.7: Carvykti in a Blood Bag
FIGURE 4.1: The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
FIGURE 4.2: G-Rex Bioreactors
FIGURE 4.3: CliniMACS Prodigy
FIGURE 4.4: Scaling Up of Allogeneic CAR-T Cells
FIGURE 4.5: Operating Expenses in Autologous CAR-T Manufacturing
FIGURE 4.6: Operating Expenses in Allogeneic CAR-T Manufacturing
FIGURE 5.1: CAR-T Global Distribution in Clinical Trials
FIGURE 6.1: CAR-T Patent Publications
FIGURE 6.2: Granted CAR-T Patents
FIGURE 6.3: Geographical Origin of CAR-T Patent Applications
FIGURE 6.4: Top Ten CAR-T Patent Jurisdictions
FIGURE 6.5: Affiliations of CAR-T Patent Applicants
FIGURE 7.1: Percent Share of CAR-T Clinical Trials by Phase
FIGURE 7.2: Percent Share of Hematological Malignancy Types in CAR-T Clinical Trials
FIGURE 7.3: Simultaneous Targets by One CAR-T
FIGURE 7.4: CAR-T Generations Used in Clinical Trials
FIGURE 7.5: % Share of Ten Major Solid Tumor Indications in CAR-T Clinical Trials
FIGURE 7.6: Hematological Malignancies v.s. Solid Cancers in CAR-T Clinical Trials
FIGURE 7.7: Distribution of CAR-T Clinical Trials by ScFv Used
FIGURE 7.8: Distribution of CAR-T Clinical Trials by Type of Vectors Used
FIGURE 8.1: Number of Published CAR-T Papers in PubMed.gov
FIGURE 8.2: Published PubMed Papers on the Five Generations of CAR-Ts
FIGURE 8.3: Published PubMed Papers, Autologous v.s Allogeneic CAR-Ts
FIGURE 8.4: Published CAR-T PubMed Papers on Solid & Liquid Cancers
FIGURE 10.1: CAR-T Cell Treated Patients Registered in EBMT Registry
FIGURE 11.1: Global Incidence of Blood Cancers & Death in 2020
FIGURE 11.2: Percent Distribution of New Leukemia Cases in the U.S. by Type
FIGURE 12.1: Estimated Global Market for CAR-T Therapy by Product, 2022-2030
FIGURE 12.2: Global Market for CAR-T by Geography, 2021-2030
FIGURE 12.3: Global Market for CAR-T Therapies by Indication, 2021-2030
FIGURE 14.1: Proprietary Cell Platform Process
FIGURE 14.2: Atara's Differentiated Approach to Allogeneic Cell Therapy
FIGURE 14.3: Schematic of P CAR-T with TCR-KO
FIGURE 14.4: All-In-One Vector Approach
FIGURE 14.5: Century's Approach in Developing Drug Product
FIGURE 14.6: Century's Precision Gene Editing Technology
FIGURE 14.7: Century's Allo-Evasion Technology
FIGURE 14.8: Century's CAR Engineering
FIGURE 14.9: Century's Common Engineered iPSC Progenitors
FIGURE 14.10: Difference between Donor-Derived and iPSC-Derived Cell Expansion
FIGURE 14.11: OVIS Technology
FIGURE 14.12: FasTCAR vs. Conventional CAR-T Manufacturing Process
FIGURE 14.13: Schematic of CD19/CD20 CAR-T Technology
FIGURE 14.14: Schematic of SynNotch CAR-T Cells Recognizing Target Cells
FIGURE 14.15: Schematic of Reprogrammed SynReg T Cells Targeting Disease Tissues
FIGURE 14.16: Schematic of BAFF CAR-T's Action
FIGURE 14.17: ATx
FIGURE 14.18: GTx
FIGURE 14.19: STx
FIGURE 14.20: MaxCyte VLx
FIGURE 14.21: NKarta's Engineered CAR-NK Cell
FIGURE 14.22: Mechanism of Action of BAFFR CAR-T Cells
FIGURE 14.23: Mechanism of Action of BAFF-R BiTE
FIGURE 14.24: PeproMene's CAR NK Cells
FIGURE 14.25: UltraCAR-T Cell
FIGURE 14.26: WuXi's Closed-Process CAR-T Platform
FIGURE 14.27: Convertible CAR Parts
FIGURE 14.28: Universal Donor Cells

INDEX OF TABLES

TABLE 2.1: Potential CAR-T Targeted Antigens Present on Hematological Malignancies
TABLE 2.2: Key Differences between the available Vectors
TABLE 2.3: The Seven CAR-T Therapies Available in the Market: A Brief Overview
TABLE 2.3: (CONTINUED)
TABLE 2.3: (CONTINUED)
TABLE 2.4: Toxicities Associated with CAR-T Treatment
TABLE 2.5: Strategies for the Future of CAR-T Therapies
TABLE 2.6: A Short List of ongoing CAR-T Studies on Solid Tumors
TABLE 2.7: New Target Antigens and New Target Cancers
TABLE 2.8: A Non-Comprehensive List of Allogeneic CAR-T Companies
TABLE 3.1: History of Development of CAR-T Cell Therapy
TABLE 3.2: Approved CAR-T Products, their Developers and Indications
TABLE 3.3: Other Promising CAR-T Product Candidates
TABLE 3.4: Increased CAR-T Activity
TABLE 3.5: Very Small Patient Population Addressed by CAR-T Therapy
TABLE 5.1: CAR-T Target Antigens on Hematalogical Malignancies
TABLE 5.2: CAR-T Target Antigens on Solid Tumors
TABLE 6.1: Top 20 Companies in CAR-T Patent Landscape
TABLE 6.2: Top 20 Research Centers in CAR-T Patent Landscape
TABLE 6.3: Top Twenty CAR-T Inventors
TABLE 6.4: Top Five CAR-T Patents with Most Family Members
TABLE 6.5: Top Five CAR-T Patents with Most Inventors in Co-Authorship
TABLE 6.6: Top Five Patents with Most Co-Applicants
TABLE 6.7: Top 5 CAR-T Patents with Most Co-Applicants
TABLE 7.1: Number of CAR-T Clinical Trials by Country
TABLE 7.2: Percent Target Distribution of CAR-T Clinical Trials
TABLE 7.3: CAR-T Targeted Biomarkers in the U.S. Clinical Trials
TABLE 7.4: CAR-T Targeted Biomarkers in Chinese Clinical Trials
TABLE 7.5: CAR-T Targeted Indications in the U.S. Clinical Trials
TABLE 7.6: CAR-T Targeted Indications in the U.S. Clinical Trials
TABLE 7.7: CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
TABLE 7.7: (CONTINUED)
TABLE 7.8: CAR-T ClinicAl Trial Sponsor Companies & Institutions in China
TABLE 7.8: (CONTINUED)
TABLE 7.8: (CONTINUED)
TABLE 7.9: CAR-T Clinical Trial Sponsor Companies & Institutions in other Countries
TABLE 7.10: Clinical Trials of Fourth, Fifth and Gene Edited CAR-Ts
TABLE 7.10: (CONTINUED)
TABLE 7.10: (CONTINUED)
TABLE 7.10: (CONTINUED)
TABLE 7.10: (CONTINUED)
TABLE 8.1: A Short List of NIH Funding for CAR-T Research in 2022
TABLE 8.1: (CONTINUED)
TABLE 10.1: Hospital Reimbursement, Proposed & Final Rule FY 2022 and FY 2023
TABLE 10.2: List Prices of Kymriah and Yescarta in Europe
TABLE 10.3: Cost Components of Pre- and Post-CAR-T Cell Therapy, in E.U.
TABLE 10.4: Average Total Costs Pre- and Post CAR-T Cell Administration in E.U.
TABLE 10.5: Reimbursement for CAR-T Thrapies in France
TABLE 10.6: Reimbursement for CAR-T Therapies in Germany
TABLE 10.7: Reimbursement for CAR-T Therapies in Italy
TABLE 10.8: Reimbursement for CAR-T Therapies in Spain
TABLE 10.9: Reimbursement for CAR-T Therapies in U.K.
TABLE 11.1: Cost of Treating Blood Cancers
TABLE 12.1: Estimated Global Market for CAR-T Therapy by Product, 2021-2030
TABLE 12.2: Global Market for CAR-T by Geography, 2021-2030
TABLE 12.3: Global Market for CAR-T Therapies by Indication, 2021-2030
TABLE 14.1: Adicet's Broad Pipeline in Cancer
TABLE 14.2: AffyImmune's Affinity-Tuned Pipeline Products
TABLE 14.3: Alaunos' Advanced Platform Targeting Solid Tumors
TABLE 14.4: Aleta's CAR-T Engager Pipeline in High Unmet Need Indications
TABLE 14.5: Allogene's AlloCAR-T Pipeline
TABLE 14.6: Anixa's Product Pipeline
TABLE 14.7: Arbele's Product Pipeline
TABLE 14.8: Arcellx's Current Product Pipeline
TABLE 14.9: Artiva's NK Cell Therapy Pipeline for Cancer
TABLE 14.10: Atara's Robust Product Pipeline
TABLE 14.11: Autolus' Therapies in Development
TABLE 14.12: AvenCell's Clinical and Preclinical Pipeline
TABLE 14.13: Beam's Product Pipeline
TABLE 14.14: Bellicum's Pipeline of Investigational Immunotherapies
TABLE 14.15: Biosceptre's Product Pipeline
TABLE 14.16: Cabaletta's Autoimmune Therapy Candidates in Development
TABLE 14.17: Carina Biotech's Clinical Programs
TABLE 14.18: CARsgen's Product Pipeline
TABLE 14.21: Celyad's Diversified Pipeline
TABLE 14.22: Century's Pipeline Overview
TABLE 14.23: CRISPR Therapeutics' Immuno-Oncology Programs
TABLE 14.24: CytoSeek's Pipeline Product Candidates
TABLE 14.25: Cytovia's Product Pipeline
TABLE 14.26: Elicera's Product Portfolio
TABLE 14.27: Eureka's Product Pipeline
TABLE 14.28: EXUMA's Pipeline Assets
TABLE 14.29: Fate's Product Pipeline
TABLE 14.30: Gilead's Ongoing CAR-T Programs
TABLE 14.31: Gracell's Clinical Pipeline
TABLE 14.32: IASO's Diverse Product Pipeline
TABLE 14.33: iCell Gene's Product Pipeline
TABLE 14.34: ImmPACT Bio's Product Pipeline
TABLE 14.35: Inceptor's Diversified Cell Therapy Programs
TABLE 14.36: JW Therapeutics' Product Pipeline
TABLE 14.37: Kite's Pipeline Cancer Therapies
TABLE 14.38: Legend's Autologous Product Pipeline for Hematological Cancers
TABLE 14.39: Legend's Allogeneic Product Pipeline for Hematological & Solid Cancers
TABLE 14.40: Leucid's Product Pipeline
TABLE 14.41: Luminary's Product Pipeline
TABLE 14.42: Lyell's Diverse Pipeline Targeting Solid Tumor Cancers
TABLE 14.43: Minerva's Pipeline Products for Solid Tumors
TABLE 14.44: Mustang Bio's Five In Licensed CAR-T Programs
TABLE 14.45: NKarta's Product Pipeline
TABLE 14.46: Noile-Immune's PRIME-based Pipeline Products
TABLE 14.47: Oncternal's Product Pipeline
TABLE 14.48: oRNA's Pipeline Products
TABLE 14.49: Oxford Biomedica's CDMO Services Pipeline
TABLE 14.50: PeproMene's Product Pipeline
TABLE 14.51: Poseida's Allogeneic & Autologous Product Candidates
TABLE 14.52: Precigen's Pipeline
TABLE 14.53: Precision's CAR-T Immunotherapy Pipeline
TABLE 14.54: Quell's Pipeline
TABLE 14.55: SOTIO's Pipeline
TABLE 14.56: Tessa's Product Pipeline
TABLE 14.57: Tmunity's Product Pipeline
TABLE 14.58: Umoja's Product Pipeline
TABLE 14.59: Vor Biopharma's Product Pipeline against Blood Cancers
TABLE 14.60: Wugen's Product Pipeline
TABLE 14.61: Xenetic's Product Pipeline
TABLE 14.62: Xyphos' Product Pipeline