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.
CAR-T Cell Therapy Market
Since the first historic CAR-T approvals in 2017, the following CAR T-cell therapies have reached commercialization:
- Kymriah (tisagenlecleucel)
- Yescarta (axicabtagene ciloleucel)
- Tecartus (brexucabtagene autoleucel)
- Breyanzi (lisocabtagene maraleucel)
- Abecma (idecabtagene vicleucel)
Additionally, JW Therapeutics achieved NMPA approval of Relma-cel (relmacabtagene autoleucel) in China. This is the first CAR-T product independently developed in China and approved as a Category 1 biologics product, as well as the sixth approved CAR-T product globally.
In 2012, there were only 12 CAR-T clinical trials. Today, this number had surged to over 1,200. Based on CAR-T products in the clinical pipeline, the number of approved CAR-T cell therapies is projected to reach double digits within the next five years and over a 100 by 2035.
This growth in the number of trials has been fueled by the unprecedented 90% remission rate shown in acute lymphoblastic leukemia (ALL) patients treated with Kymriah. From 60% to 70% of the patients treated in the earliest clinical trials are now in remission for more than nine years, which is an unprecedented accomplishment. The earliest approvals of Kymriah and Yescarta have been infused into an astounding half million patients worldwide.
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 rapidly expanding area of regenerative medicine.
In aggregate, there has been an astonishing $100 billion of market capitalization from CAR-T companies in recent years. Financing rounds by CAR-T companies are approaching a total value of $4 billion, while CAR-T industry partnerships contribute 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.
This billion dollar 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.
Recently released, this 254-page report reveals:
- CAR-T market size determinations with segmentation by product, geography, and indication, as well as future forecasts through 2027
- Detailed coverage of the approved CAR-T products, including regulatory approvals, pricing, reimbursement, and 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
- Deal-making, strategic partnerships, and co-commercialization agreements within the CAR-T sector
- Little known market trends, future directions, and emerging opportunities
- Profiles of 62 leading CAR-T competitors composing the global marketplace
This 254-page global strategic report will position you to:
- 1. Capitalize on rapidly emerging trends
- 2. Optimize decision-making
- 4. Approach partners/investors for collaboration or funding
- 5. Implement an informed and advantageous business strategy in 2022
Although progressing at breakneck speed, developments within the field of CAR-T cell therapy are still early stage, positioning the market for remarkable expansion. Today is similar to the launch of the first chemotherapy treatments, when oncologists started treating patients with a single type of chemotherapy. Now, fifty years later, cancer patients are treated with over a hundred different chemotherapy agents. In the same way, we will soon have numerous CAR-T therapies available to treat liquid cancers, solid tumors, and autoimmune diseases, as well as inflammatory conditions.
With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.
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
- 2.3. Antigens Present on Hematological Cancer Cells
- 2.4. Tools for Inserting Receptor Genes into T Cells
- 2.5. Transforming T Cells into CAR-T Cells
- 2.6. The Five CAR-T Therapies Crossing the Finishing Line
- 2.7. Toxicities Associated with CAR-T Treatment
- 2.8. The Future of CAR-T Cell Therapy
- 2.8.1. Transition from Liquid Cancers to Solid Tumors
- 2.8.2. Reduction in the Length of Hospital Stay
- 2.8.3. Discovery of New Target Antigens
- 2.8.4. Shifting from Autologous to Allogeneic CAR-T Therapy
- 2.8.5. CAR-T for the Masses
- 2.9. Advantages of CAR-T Therapy
- 2.10. Disadvantages of CAR-T Therapy
- 2.11. CAR-T Therapy Expansion in 2021 and Beyond
- 2.11.1. Direct Competition among the Autologous CAR-T Therapies
- 2.11.2. Allogeneic CD19 CAR-Ts: Current Status
- 2.11.3. B-Cell Maturation Antigen (BCMA) CAR-Ts
- 2.11.4. Other CAR-T Targets and Technologies
3. CAR-T CELL THERAPY: PRODUCT DEVELOPMENT
- 3.1. Current Status of CAR-T Therapy Products
- 3.2. Prospective CAR-T Product Candidates
- 3.3. Transformative Potential of CAR-T Therapy
- 3.4. Small Patient Population & Huge Clinical Trial Landscape
4. MANUFACTURE OF CAR-T CELLS
- 4.1. Automation in CAR-T Manufacturing
- 4.2. Operating Expenses in Autologous CAR-T Manufacturing
- 4.3. Operating Expenses in Allogeneic CAR-T Manufacturing
5. CAR-T TARGET ANTIGENS: A BRIEF OVERVIEW
- 5.1. CAR-T Target Antigens on Hematological Cancers
- 5.2. CAR-T Target Antigens on Solid Tumors
- 5.3. Common Antigens Targeted by CAR-T Cells
- 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 Cell Patent Applicants
- 6.3.1. Top 20 Companies in CAR-T Patent Landscape
- 6.3.2. Top 20 Research Centers in CAR-T Patent Landscape
- 6.3.3. Top 20 CAR-T Cell Inventors
- 6.3.4. Top Five CAR-T Patents with Most Family Members
- 6.3.5. Top Five CAR-T Patents with Most Inventors in Co-Authorship
- 6.3.6. Top Five Patents with Most Co-Applicants
- 6.3.7. Top Five CAR-T Patents with Most Citations Received
7. GLOBAL CAR-T CLINICAL TRIALS: AN OVERVIEW
- 7.1. CAR-T Targeted Biomarkers in Clinical Trials
- 7.1.1. CAR-T Targeted Biomarkers in U.S. Clinical Trials
- 7.1.2. CAR-T Targeted Biomarkers in Chinese Clinical Trials
- 7.1.3. CAR-T Targeted Biomarkers in other Countries
- 7.2. CAR-T Targeted Indications in the U.S. Clinical Trials
- 7.3. Indications Addressed by CAR-T Clinical Trials in China
- 7.4. Percent Share of Indications Addressed by the Ongoing CAR-T Clinical Trials
- 7.5. Phase of CAR-T Clinical Trials
- 7.6. CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
- 7.7. CAR-T Clinical Trial Sponsor Companies and Institutions in China
- 7.8. CAR-T Clinical Trial Sponsor Companies and Institutions in other Countries
- 7.9. Ongoing Clinical Trials with Improved CAR-T Constructs
- 7.9.1. CAR-T with PD1Fc
- 7.9.2. CAR-T with Truncated EGFR (EGFRt)
- 7.9.3. CAR-T with IL7 and CCL19
- 7.9.4. CAR-T with PD1/CD28 Switch-Receptor
- 7.9.5. CAR-T with PD1 shRNA-expressing cassette
- 7.9.6. CAR-T with CTLA-4/PD-1 Antibody
- 7.9.7. CAR-T with PD-1 Antibodies
- 7.10. Geographic Distribution of CAR-T Clinical Trials
- 7.11. Distribution of CAR-T Clinical Trials by Type of CAR Generations
- 7.12. Distribution of CAR-T Clinical Trials by Type of ScFv Used
- 7.13. Distribution of CAR-T Clinical Trials by Type of Vectors Used
8. PUBLISHED SCIENTIFIC PAPERS & NIH GRANTS
- 8.1. Number of Published Papers
- 8.2. NIH Funding for CAR-T Research
9. DEALS IN CAR-T THERAPY SPACE
- 9.1. Most Recent CAR-T Deals
- 9.1.1. Dr. Reddy's Laboratories/Shenzhen Pregene Biopharma
- 9.1.2. Abbvie/Caribou Biosciences
- 9.1.3. Gilead/Tango Therapeutics
- 9.1.4. Kite/Teneobio
- 9.1.5. Fate/Janssen
- 9.1.6. Juno/Oxford Biomedica
- 9.1.7. Allogene/MaxCyte
- 9.1.8. Applied DNA Sciences, Inc.
- 9.1.9. Cellectis/Servier
- 9.1.10. Cell Therapies, Pvt. Ltd
- 9.1.11. Astellas/Adaptimmune
- 9.1.12. Astellas/Xyphos
- 9.1.13. Carisma Therapeutics, Inc./NYU Langone Health
10. MARKETED CAR-T PRODUCTS
- 10.1. Kymriah (Tisagenlecleucel)
- 10.1.1. Mechanism of Action
- 10.1.2. Dosing
- 10.1.3. Safety and Efficacy of Kymriah
- 10.1.4. Kymriah's Cost
- 10.1.5. Current Sales of Kymriah
- 10.2. Yescarta (Axicabtagene ciloleucel)
- 10.2.1. Mechanism of Action
- 10.2.3. Dosing
- 10.2.4. Safety and Efficacy of Yescarta
- 10.2.5. Manufacturing Network
- 10.2.6. Current sales of Yescarta
- 10.2.7. Sales of Kymriah and Yescarta: A Comparison
- 10.3. Tecartus (Brexucabtagene autoleucel)
- 10.3.1. Mechanism of Action
- 10.3.2. Dosing
- 10.3.3. Safety and Efficacy of Tecartus
- 10.4. Breyanzi (Lisocabtagene maraleucel)
- 10.4.1. Mechanism of Action
- 10.4.2. Dosing
- 10.4.3. Safety and Efficacy of Breyanzi
- 10.4.4. Efficacy, Safety and Composition of Approved CAR-T Products
- 10.5. Abecma (Idecabtagene vicleucel/Ide-Cel)
- 10.5.1. Health Canada's Conditional Approval
- 10.5.2. EMA's Conditional Marketing Authorization
- 10.5.3. Selected BCMA-Targeted Multiple Myeloma Therapies
- 10.6. Other Promising CAR-T Product Candidates
- 10.6.1. ALLO-501
- 10.6.2. CTX110
- 10.6.3. UCART19
- 10.6.3. AUTO1
- 10.6.4. JCARH125
- 10.6.5. LCAR-B38M
- 10.6.6. PBCAR20A
- 10.6.7. UCART123
- 10.6.8. PRGN-3006
- 10.6.9. UCART22
- 10.6.10. UCARTCS1
11. REIMBURSEMENT FOR CAR-T THERAPIES
- 11.1. Hospital Reimbursement in the U.S. for CAR-T Therapy
- 11.2. Outcomes-Based Reimbursement for CAR-T Therapies in EU5 Countries
- 11.2.1. France
- 11.2.2. Germany
- 11.2.3. Italy
- 11.2.4. Spain
- 11.2.5. U.K.
12. BLOOD CANCERS: TECHNOLOGIES AND TREATMENTS
- 12.1. Lymphoma
- 12.1.1. Hodgkin Lymphoma (HL)
- 12.1.2. Non-Hodgkin Lymphoma (NHL)
- 12.1.2.1. Diffuse Large B Cell Lymphoma (DLBCL)
- 12.1.2.2. Follicular Lymphoma (FL)
- 12.2. Leukemia
- 12.2.1. Types of Leukemia
- 12.2.1.1. Acute Myeloid Leukemia (AML)
- 12.2.1.2. Acute Lymphoblastic Leukemia (ALL)
- 12.2.1.3. Chronic Myeloid Leukemia (CML)
- 12.2.1.4. Chronic Lymphocytic Leukemia (CLL)
- 12.3. Multiple Myeloma (MM)
- 12.4. Treatment Options for Blood Cancers
- 12.4.1. Chemotherapy
- 12.4.2. Radiation Therapy
- 12.4.3. Targeted Therapy
- 12.4.4. Stem Cell Transplantation
- 12.4.5. Immunotherapy
- 12.4.5.1. Monoclonal Antibodies (mAbs)
- 12.4.5.2. Immune Check-point Inhibitors
- 12.4.5.3. Adoptive Cell Transfer Therapy/T-Cell Transfer Therapy
- 12.5. The Staggering Cost of Cancer Therapy
13. CAR-T CELL THERAPY MARKET ANALYSIS
- 13.1. Global Market for CAR-T Cell Therapy by Product
- 13.2. Global Market for CAR-T Therapy by Geography
- 13.3. Global Market for CAR-T Therapy by Indication
- 13.4. Companies at the Forefront of CAR-T Market
- 13.5. Barriers and Strategies for Success in CAR-T 2.0 Market Place
- 13.5.1. Barriers to CAR-T 2.0 Commercial Success
- 13.5.1.1. Capacity constraints
- 13.5.1.2. Competition among Manufacturers
- 13.5.1.3. Competition from other Treatments
- 13.5.2. Market Development Strategies for CAR-T 2.0
- 13.5.2.1. Effective Physician Education
- 13.5.2.2. Logistical Excellence
- 13.5.2.3. Evidence Generation
14. CAR-T COMPANY PROFILES
- 14.1. Aleta BioTherapeutics
- 14.2. Allogene Therapeutics
- 14.2.1. AlloCAR-T Therapy
- 14.3. Anixa Biosciences, Inc.
- 14.4. Arcellx, Inc.
- 14.4.1. Technology
- 14.4.2. CART-ddBCMA
- 14.5. Atara Biotherapeutics
- 14.5.1. Technology
- 14.5.2. Next-Generation CAR-T
- 14.6. Autolus Therapeutics, plc
- 14.7. Bellicum Pharmaceuticals, Inc.
- 14.7.1. GoCAR Technology
- 14.7.2. Bellicum's Pipeline
- 14.8. BioNTech
- 14.8.1. Collaborators
- 14.8.2. Services
- 14.8.3. Engineered Cell Therapies
- 14.8.4. CAR-T Programs
- 14.8.4.1. BNT211
- 14.8.4.2. BNT212
- 14.9. bluebird bio
- 14.9.1. CAR-T Collaborations
- 14.9.1.1. Collaboration with Celgene
- 14.9.1.2. Collaboration with Inhibrx
- 14.9.1.3. Collaboration with TC BioPharm
- 14.10. Cabaletta Bio
- 14.10.1. CAAR Technology
- 14.10.2. Cabaletta's Pipeline
- 14.11. Carina Biotech
- 14.11.1. New CAR-T Cells
- 14.11.2. CAR-T Access Technologies
- 14.11.2.1. Chemokine Receptor Mediation
- 14.11.2.2. Gel Formulation to Deliver CAR-T Cells
- 14.12. CARsgen Therapeutics
- 14.13. Cartesian Therapeutics, Inc.
- 14.13.1. Cartesian's Approach
- 14.14. CARTherics
- 14.15. Celgene Corporation
- 14.15.1. Lisocabtagene maraleucel (liso-cel)
- 14.16. Cellectis
- 14.16.1. Universal Chimeric Antigen Receptor T-Cells (UCARTs)
- 14.16.1.1. UCART 123
- 14.16.1.2. UCART22
- 14.16.1.3. UCARTCS1
- 14.16.1.4. UCART19
- 14.16.1.5. ALLO-501
- 14.16.1.6. ALLO-715
- 14.17. Celularity, Inc.
- 14.18. Celyad Oncology
- 14.18.1. TIM Technology
- 14.18.2. shRNA Technology
- 14.19. Creative Biolabs
- 14.19.1. CAR Construction and Production Platform
- 14.20. CRISPR Therapeutics
- 14.20.1. CRISPR/Cas9 Immuno-Oncology Cell Therapy
- 14.21. CytoSeek
- 14.21.1. Technology
- 14.21.2. Pipeline
- 14.22. Cytovia Therapeutics
- 14.23. DiaCarta, Inc.
- 14.23.1. Personalized CAR-T Immunotherapy Platform
- 14.24. Empirica Therapeutics
- 14.25. Eureka Therapeutics, Inc.
- 14.26. EXUMA Biotech Corp.
- 14.26.1. Logic Gate CAR-T Technology
- 14.26.2. Same-Day CAR-T Therapy
- 14.27. Fate Therapeutics, Inc.
- 14.28. Formula Pharmaceuticals, Inc.
- 14.29. GEMoaB
- 14.29.1. UniCAR Platform
- 14.29.2. RevCAR Platform
- 14.29.3. GEMoaB's Pipeline
- 14.30. Gilead Sciences, Inc.
- 14.30.1. TECARTUS (Brexucabtagene autoleucel)
- 14.30.2. Yescarta (Axicabtagene ciloleucel)
- 14.30.3. Cell Therapy
- 14.31. Gracell Biotechnologies
- 14.31.1. Dual CAR
- 14.31.2. FasTCAR
- 14.31.3. TrUCAR
- 14.32. iCell Gene Therapeutics
- 14.32.1. iCell Platforms
- 14.32.1.1. CARvac
- 14.32.1.2. Non Gene Edited Universal CARs
- 14.32.1.3. C-TPS1
- 14.32.1.4. T-Cell Targeted CARs
- 14.32.1.5. Compound CARs
- 14.33. Janssen Biotech, Inc.
- 14.34. Juno Therapeutics
- 14.35. JW Therapeutics, Co., Ltd.
- 14.35.1. Relmacabtagene autoleucel (Relma-cel)
- 14.36. Kite Pharma, Inc.
- 14.36.1. Kite's Technologies (CAR-T & TCR)
- 14.36.2. Kite's Therapies
- 14.36.2.1. Yescarta (Axicabtagene ciloleucel)
- 14.36.2.2. Tecartus (Brexucabtagene autoleucel)
- 14.37. Kyverna Therapeutics
- 14.37.1. SynNotch CAR-T Platform
- 14.38. Lyell Immunopharma, Inc.
- 14.38.1. Technologies
- 14.38.2. Gen-R Technology
- 14.38.3. Epi-R Technology
- 14.39. MaxCyte, Inc.
- 14.39.1. CARMA Cell Therapies
- 14.39.2. Flow Electroporation Technology
- 14.40. Minerva Biotechnologies Corporation
- 14.41. Mnemo Therapeutics
- 14.41.1. Mnemo's Approach
- 14.42. Mustang Bio, Inc.
- 14.43. Nanjing Legend Biotechnology Co., Ltd.
- 14.43.1. LCAR-B38M/JNJ-4528
- 14.44. Noile-Immune Biotech
- 14.45. Novartis International, AG
- 14.45.1. Kymriah (Tisagenlecleucel)
- 14.46. Oxford Biomedica plc
- 14.47. PeproMene Bio, Inc.
- 14.47.1. BAFF-R CAR-T Cells
- 14.48. Poseida Therapeutics, Inc.
- 14.48.1. PiggyBac DNA Modification System
- 14.48.2. Autologous & Allogeneic Programs
- 14.48.2.1. P-BCMA-101
- 14.48.2.2. P-PSMA-101
- 14.48.2.3. P-BCMA-ALLO1
- 14.48.2.4. P-MUC1C-ALLO1
- 14.48.2.5. P-PSMA-ALLO1
- 14.49. Precigen, Inc.
- 14.50. Precision Biosciences
- 14.51. Prescient Therapeutics
- 14.51.1. OmniCAR Technology
- 14.52. ProMab Biotechnologies, Inc.
- 14.52.1. Custom CAR-T Cell Development
- 14.53. Protheragen
- 14.54. Sorrento Therapeutics, Inc.
- 14.55. Synthekine
- 14.55.1. STK-009 + SYNCAR-001
- 14.56. TC Biopharm
- 14.57. T-CURX
- 14.58. Tessa Therapeutics, Pvt. Ltd.
- 14.58.1. CD30 CAR-T Cells
- 14.58.2. Allogeneic CD30-CAR EBVSTs
- 14.59. Tmunity Therapeutics, Inc.
- 14.60. Wugen
- 14.61. Xyphos Biosciences, Inc.
- 14.61.1. Xyphos' Strategy
- 14.62. Ziopharm Oncology, Inc.
- 14.62.1. Non-Viral CAR-T Therapy
APPENDIX
- Appendix 1: Medical Centers offering CAR-T Therapies in the U.S.