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
TABLE OF CONTENTS
1. REPORT OVERVIEW
- 1.1. Statement of the Report
- 1.2. Executive Summary
- 1.3. Introduction
2. CAR-T CELL THERAPY: TECHNOLOGY DEVELOPMENT
- 2.1. 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
- 14.7. 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
- 14.24. Carina Biotech
- 14.25. CARsgen Therapeutics
- 14.26. Cartesian Therapeutics
- TABLE 14.19: Cartesian's Growing Product Pipeline
- 14.27. CARTherics Pty Ltd.
- 14.28. Cellectis
- 14.28.1. Product Candidates
- TABLE 14.20: Cellectis' Products in Development
- 14.29. CellPoint BV
- 14.30. Celularity, Inc.
- 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.
- 14.35. 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.
- 17.38. CytoSeek
- 14.38.1. Technology
- 14.38.2. Pipeline
- 14.39. Cytovia Therapeutics
- 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
- 14.53. Janssen Biotech, Inc.
- 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.
- 14.83. 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