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

EXECUTIVE SUMMARY
 
CAR-T cell therapy is a remarkably promising treatment for cancer patients. This emerging treatment represents one of the biggest breakthroughs since the introduction of chemotherapy. 
 
In 2017, the world witnessed a historic CAR-T cell therapy approval when on August 30, 2017, Tisagenlecleucel (Kymriah) was approved by U.S. FDA for the treatment of children and young adults with acute lymphoblastic leukemia (ALL). On May 1, 2018, FDA approved Kymriah for a second indication (diffuse large B-cell lymphoma). By October 18, 2017, the FDA granted approval for Yescarta for treating patients with relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) and other rare large B-cell lymphomas. Other notable approvals for CAR-T cell therapy products have also been achieved.
 
In August 2018, Kymriah and Yescarta secured approval in Europe, indicating the willingness of European regulators to usher in a new age of regenerative medicine. Novartis’ Kymriah was given marketing authorization in the EU for the treatment of blood cancers, including B-cell acute lymphoblastic leukaemia (ALL) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Gilead/Kite Pharma’s Yescarta was authorized as a treatment for adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL). Health Canada approved Kymriah as the first CAR-T therapy in Canada and the Therapeutic Goods Administration (TGA) approved it as the first CAR-T therapy in Australia.
 
What is CAR-T Cell Therapy? 
 

Chimeric antigen receptors (CARs) are genetically engineered cells that are developed in the laboratory and infused into a patient to help in detecting and fighting cancer. The protein constructs stimulate anti-cancer T-cells, which in turn boost a patient’s immune system. CAR-T cell therapy is defined as a type of immunotherapy that teaches T cells to recognize and destroy cancer.
CAR-T 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.”
 
How Does CAR-T Cell Therapy Work?
 
T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of our immune system and they 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 used to genetically engineer the T-cells to produce chimeric antigen receptors (CARs) on their surface. These receptors are synthetic and do not exist naturally. Once infused into the patient, these CARs enable the T-cells recognize and get attached to an antigen (specific protein) on the tumor cell leading to the destruction of the tumor.
 
Like all cancer therapies, CAR-T cell therapy can also cause a number of side effects. However, all these side effects can be managed with standard supportive therapies including steroids. The widespread research activities, worldwide clinical trials and treatments in a limited number of U.S. hospitals have created a robust CAR T-cell market. This billion dollar market and projected growth would have been not possible without the remarkable efficacy of Kymriah and Yescarta in treating several types of blood cancers.
 
Market for CAR-T Cell Therapy
 
CAR-T cell therapy has swept the biotech industry by storm in recent years, creating hope that it could welcome in a new age of cancer treatment. However, the remarkable success stories have come from targeting CD19, which is now considered an antigen that holds the key to a limited range of blood cancers. Presently, this hematological arena is a highly competitive therapy space that is being shared between among leading CAR-T companies.
 
Scientists, investors and developers invariably agree that the key to longer-term success in this space depends on solving two major problems: identifying antigens other than CD19 that can be targeted with CAR-T therapy with strong efficacy and going beyond liquid cancers into solid tumor indications. CAR-T cell products to deal with solid tumors will undoubtedly offer a larger market potential.
 
However, it is not an easy task to identify the antigens found on the cells of solid tumors. There are reasons why CD19 is the most common target. It is seen solely on B cells, whose destruction via CAR-T therapy offers a straightforward route for treating B-cell leukemias and lymphomas. At the same time, loss of the body’s B cells is not particularly problematical, because their antibody-producing function can be reinstated by injecting intravenous immunoglobulin (IVIG) to patients.
 
Currently, the only two non-CD19-directed CAR-T therapies are those that target CD22 in B-cell malignancies and B-cell maturation antigen (BCMA) in multiple myeloma. CD22 is structurally analogous to CD19, while BCMA is an antigen expressed on plasma cells, whose functional loss can also be replaced with IVIG.
 
The problem with solid tumors is that there is little evidence of CAR-T being able to overcome the numerous difficulties that exist for these to be targeted efficiently. However, both academic and commercial groups are racing against time to identify the antigens on solid tumor cells and develop suitable CAR-T cells, because it represents large market potential.
There are several reasons which make solid tumors difficult to treat using CAR-T cell therapies. Globally, solid tumors outnumber the hematological tumors by 10 to one. In 2015, Novartis and PENN reported that their CART-meso failed to show any effect in patients with mesothelioma, ovarian cancer and pancreatic cancer. Moreover, there was very poor persistence of CAR-T cells in the patients.
 
The difficulty with solid tumors is that they are usually surrounded by a hostile, immuno-suppressive microenvironment. This environment presents many inhibitory factors that prevent CAR-T cells from reaching them. A typical CAR-T approach will not have success under these conditions. For this reason, Juno and Novartis are engaging in constructing CAR-T cells with novel designs that incorporate additional elements to boost activity within this setting. Currently, these products are in preclinical development.
 
Driving Forces for the CAR-T Therapy Market
 

With growing demand for CAR-T therapies, CAR-T companies are proliferating. Growing numbers of these companies are supported by:

 • Increasing investment flowing into CAR-T cell research
 • Landmark approvals of CAR-T cell therapies by the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA)
 • Major acquisitions within the CAR-T industry
 • Large IPOs within the CAR-T industry
 
As mentioned, 2017 was the first year that the U.S. FDA approved a CAR-T cell therapy, approving Kymriah in August 2017 and Yescarta in October 2017. Novartis produced Kymriah, a CAR-T therapy used to treat leukemia, while Gilead/Kite Pharma developed Yescarta, a CAR-T therapy for patients with lymphomas. Approvals for these products are now spreading globally, with authorizations permitted by the EU, Canada, and Australia, among others. The approval of these early CAR-T cell therapies has opened the gates for many other types of cell and gene therapies to claim respect, both from regulators, as well as from the broader scientific and medical communities. 
CAR-T funding is also on the rise. At first the trend was subtle, but the tide swelled as CAR-T therapies like Kymriah and Yescarta reached the marketplace and created a CAR-T funding craze. CAR-T start-ups have been richly funded by investors eager to get into this trending area of regenerative medicine. Following IPOs by CAR-T players Kite Pharma, Bellicum, Juno Therapeutis and Cellectis totaling over $750 million, CAR-T developer Autolus announced a $150 million IPO.
This has bought the total value of recent CAR-T initial public offerings (IPO’s) to nearly $1 billion.
 
CAR-T Industry Deal-Making
The CAR-T industry has also witnessed aggressive deal-making in recent years. Celgene snagged Juno Therapeutics for a shocking $9 billion in January 2018 and Gilead acquired Kite Pharma for an astounding $11.9 billion in August 2017. After $20 billion of market capitalization from the CAR-T companies in 2018, the CAR-T market has continued to gain momentum.
There have also been more than a dozen CAR-T deals between pharmaceutical companies and academic institutions, with the best known being the partnership between Novartis and the University of Pennsylvania (UPenn). When Kymriah™ because the first CAR-T cell therapy to be approved in the U.S. in August 2017, it resulted from a 5-year collaboration between UPenn and Novartis.
 
CAR-T financing rounds have also proliferated. In one major example, Celularity raised $250 million in February 2018 to support development of placental-derived products, including T-cells that will be immune advantaged because of their derivation from the placenta. Celularity is looking to burst a major bottleneck in the industry by deriving T-cells from a single (allogeneic) cell line, potentially positioning itself to slash the price point for CAR-T treatments. In other significant example, London-based CAR-T start-up Allogene Therapeutics entered into an asset contribution deal with Pfizer in April 2018, as well as announced a $300 million Series A round.
 
To better understand and compete within the rapidly expanding CAR-T marketplace, claim this global strategic report to learn the identities and strategies of leading market competitors, access market size data accompanied by market segmentation and forecasts, review clinical trial activity within the sector, assess CAR-T market approvals by region, and importantly, evaluate industry deal-making, emerging technologies, and future directions for the industry at large. 
  

 1. REPORT OVERVIEW 11
 1.1 Statement of the Report 11
 1.2 Executive Summary 13
 1.3 INTRODUCTION 15
 2. SIXTY YEAR HISTORY OF CAR-T CELL THERAPY 17
 2.1 Timeline of CAR-T Cell Therapy Development 18
 
 3. CAR-T MANUFACTURING PROCESSES 19
 
3.1 Manufacturing Autologous CAR-T Cells 19
 3.2 T-Cell Source 19
 3.3 T-Cell Activation 20
 3.3.1 Beads-Based T-Cell Activation 21
 3.3.2 Antibody-Coated Magnetic Beads 21
 3.3.3 Antibody-Coated Nanobeads 21
 3.3.4 Expamer Technology 21
 3.3.5 Activation with Anti-CD3 Antibodies 22
 3.4 Genetic Modification of T-Cells 22
 3.5 Expansion of CAR-T Cells 23
 3.5.1 Expansion of CAR-T Cells using GE Bioreactors 23
 3.5.2 Expansion of CAR-T Cells using G-Rex Bioreactors 23
 3.5.3 Expansion of CAR-T Cells using Prodigy 24
 3.5.4 Expansion of CAR-T Cells through Recursive AAPC Stimulation 24
 3.6 Clinical CAR-T Cell Manufacturing Quality Checkpoints 24
 3.6.1 Qualification of Manufacturing Facilities 24
 3.6.2 Qualification of Ancillary Components 25
 3.6.3 Qualification of Manufacturing Process 25
 3.7 In-Process Testing and Release Testing of Cellular Products 26
 3.8 Allogeneic CAR-T Cells 26
 
 4. STRUCTURE OF A CAR-T CELL 28
 4.1 First Generation CAR-T Cells 28
 4.2 Second Generation CAR-T Cells 29
 4.3 Third Generation CAR-T Cells 30
 4.4 Fourth Generation CAR-T Cells 30
 4.5 Mechanism of Action 32
 4.6 New CAR Models and Concepts 33
 4.6.1 Truck CAR 33
 4.6.2 Universal CAR 33
 4.6.3 Self-driving CAR 33
 4.6.4 Armored CAR 34
 4.6.5 Self-destruct CAR 34
 4.6.6 Conditional CAR 34
 4.6.7 TanCAR 34
 4.6.8 Dual CAR 35
 4.6.9 Safety CAR (sCAR) 35
 4.7 Basic Components of CAR 36
 4.7.1 Common Deigns of CAR-T Constructs 36
 4.7.1.1 Single Chain Fv Fragments (scFv) 37
 4.7.1.2 4-1BB, CD28, OX40, FcεRIγ and CD3ξ 38
 4.7.1.3 Vectors for Transfection 38
 
 5. NUMBER OF CAR-T COMPANIES, THEIR RECENT ACTIVITIES 39
 
5.1 Geographical Distribution of CAR-T Cell Therapeutic Companies 39
 5.2 Immunocellular Therapy Companies by Cell Type 40
 5.3 Market Leaders in CAR-T Cell Therapy and their Recent Activities 41
 5.3.1 AbbVie 41
 5.3.2 Allogene Therapeutics 41
 5.3.3 Amgen 42
 5.3.4 Agios Pharmaceutical 42
 5.3.5 Atara Biotherapeutics 42
 5.3.6 Autolus Limited 42
 5.3.7 Bellicum Pharmaceuticals 43
 5.3.8 bluebird bio 43
 5.3.9 Calibr 43
 5.3.10 Carina Biotech 43
 5.3.11 CARsgen Therapeutics 44
 5.3.12 Celgene Corporation 44
 5.3.13 Cellectis 44
 5.3.14 Cell Medica 44
 5.3.15 Cell Design Labs 45
 5.3.16 Celularity 45
 5.3.17 Celyad 45
 5.3.18 Fate Therapeutics 45
 5.3.19 Fortress Bio 46
 5.3.20 Gilead Sciences 46
 5.3.21 Janssen Biotech 46
 5.3.22 Juno Therapeutics 46
 5.3.23 JW Therapeutics 47
 5.3.24 Kite Pharma 47
 5.3.25 Medisix Therapeutics 47
 5.3.26 Mustang Bio 47
 5.3.27 Nanjing Legend Biotech 48
 5.3.28 Novartis 48
 5.3.29 Pfizer 48
 5.3.30 Precision Biosciences 48
 5.3.31 Posedia Therapeutics 49
 5.3.32 Shire 49
 5.3.33 Sorrento Therapeutics 49
 5.3.34 Ziopharm 49
 
 6. TUMOR-ASSOCIATED TARGET ANTIGENS 50
 
6.1 Antigens on Solid Tumors 50
 6.1.1 Epidermal Growth Factor Receptor (EGFR) 51
 6.1.2 Epidermal Growth Factor Receptor Variant III (EGFRvIII) 51
 6.1.3 Human Epidermal Growth Factor Receptor-2 (HER2) 51
 6.1.4 Mesothelin (MSLN) 51
 6.1.5 Prostate-Specific Membrane Antigen (PSMA) 52
 6.1.6 Disialoganglioside 2 (GD2) 52
 6.1.7 Interleukin-13Rα2 (IL13Rα2) 52
 6.1.8 Glypican-3 (GPC3) 52
 6.1.9 Carbonic Anhydrase IX (CAIX) 53
 6.1.10 L1 Cell Adhesion Molecule (L1-CAM) 53
 6.1.11 Cancer Antigen 125 (CA125) (MUC16) 53
 6.1.12 Prominin-1 (CD133) 53
 6.1.13 Fibroblast Protein-α (FAP-α) 54
 6.1.14 Cancer/Testis Antigen 1B (CTAG1B) 54
 6.1.15 Mucin 1 (MUC1) 54
 6.1.16 Folate Receptor-α (FR-α) 54
 6.2 CAR-T Targets in Hematologic Malignancies 54
 6.2.1 CD19 55
 6.2.2 CD20 55
 6.2.3 CD22 56
 6.2.4 ROR1 56
 6.2.5 CD30 56
 6.2.6 CD138 56
 6.2.7 CD123 57
 6.2.8 NKG2D-L 57
 6.2.9 BCMA 57
 6.2.10 CD174 57
 6.3 CAR-T Cell Trials Targeting CD19 57
 6.3.1 Positive CR Rates in CD19 Targeted Studies in Hematological Malignancies 58
 6.3.2 Outcome of CAR-T Cell Therapy Trials Targeting Antigens other than CD19 59
 6.3.3 Targets other than CD19 in Hematological Cancers 60
 6.3.4 CD30 vs. BCMA Targets for Multiple Myeloma 61
 6.4 CAR-T Cell Therapy for Solid Tumors 62
 6.4.1 CAR-T Cell Targets in Solid Malignancies 63
 
 7. TARGET DISEASES FOR CAR-T CELL THERAPY 65
 
7.1 Acute Lymphoblastic Leukemia (ALL) 65
 7.2 Chronic lymphocytic leukemia (CLL) 66
 7.3 Non-Hodgkin lymphoma 66
 7.4 Acute myeloid leukemia (AML) 67
 7.5 Neuroblastoma 67
 7.6 Multiple myeloma (MM) 68
 
 8. PRICING AND PAYMENT MODELS FOR CAR-T THERAPIES 69
 8.1 Controversies over CAR-T Pricing 69
 8.2 Hospital Mark-up Costs for Kymriah and Yescarta 70
 8.3 Cost Effectiveness of Tisagenlecleucel and Axicabtagene 71
 8.4 Value-Based Price Benchmarks 72
 8.5 Unit Prices Needed to Reach Cost-Effectiveness Thresholds 73
 8.6 Alternate Payment Strategies 73
 
 9. MEDICAL FACILITIES OFFERING CAR-T THERAPIES 74
 
9.1 CAR-T Recommended in Europe 76
 9.2 CAR-T Cell Therapy in Chinese Hospital 76
 9.3 Canada Joins the CAR-T Club 77
 
 10. CAR-T THERAPY PATENT LANDSCAPE 78
 
10.1 Number of CAR-T Cell Patents, 2013-2018 78
 10.2 CAR-T Patent Types 79
 10.3 A Brief Snapshot of CAR-T Patent Landscape 80
 10.3.1 Patents for Anti-CD19 CAR-T 80
 10.3.2 Patents for Anti-BCMA CAR-T 80
 10.3.3 Patents for Regulatable CAR-T 81
 10.3.4 Patents for CAR-T for Solid Tumors 81
 10.4 Major CAR-T Patent Applicants 82
 
 11. DEALS, FUNDINGS, PARTNERSHIPS AND COLLABORATIONS 83
 
11.1 Funding for CAR-T 83
 11.2 CAR-T Deals 83
 11.3 Initial Public Offering (IPO) 85
 11.4 Key CAR-T Technology Deals 85
 11.4.1 Deal between Juno Therapeutics and Eureka for a Fully Human ScFv Binding Domain 86
 11.4.2 Acquisition of Stage Cell Therapeutics by Juno Therapeutics 86
 11.4.3 Collaboration between Juno Therapeutics and Editas Medicine 87
 11.4.5 Kite and Alpine in Research and License Agreement 87
 11.4.6 Johnson & Johnson Gets PiggyBac Technology from Transposagen 87
 11.4.7 Johnson & Johnson and Posedia in a Technology Deal 87
 11.4.8 Partnership between Baxalta and Precision Biosciences 88
 11.4.9 Novartis, Intellia and Caribou 88
 11.4.10 Trends in Oncology Licensing, Joint Venture and Research Deals 88
 
 12. THE LANDSCAPE OF CAR-T CELL THERAPY CLINICAL TRIALS 90
 
12.1 The Surge in Number of CAR-T Clinical Trials 90
 12.2 Percentage (%) of Total CAR-T Clinical Trials by Target 91
 12.3 Research Focus on CAR-T Trials by Indication 92
 12.4 Clinical Trials using CAR-T Cells by Country as of 2018 93
 12.5 CAR-T Clinical Trials to Watch 93
 12.6 CAR-T Projects with Commercial Licensees 94
 12.7 Clinical CAR-T Constructs with Sole Involvement from Academicia 96
 12.8 Anti-CD19 CAR-T Studies 97
 12.9 CAR-T Studies in Multiple Myeloma and Acute Myeloid Leukemia 100
 11.10 CAR-T Cell Therapy for Solid Tumors 101
 12.11 Studies of CAR-T Projects Transfected using mRNA Electroporation 103
 12.12 CAR-T Projects Incorporating Suicide Genes 103
 12.13 Early Stage CAR-T Assets 104
 12.14 Anti-CD22 CAR-T Projects 105
 12.15 Cytokine Release Syndrome (CRS) with CART19 Therapy 106
 12.16 CAR-T Therapy Pipeline Distribution by Indication 106
 12.17 CAR-T Therapy Pipeline Distribution by Target Antigen 108
 12.18 Distribution of CAR-T Clinical Trials in China 109
 12.18.1 CD19-Directed CAR-T Clinical Trials in China 109
 12.18.2 Chinese Trials Targeting Non-CD19 Antigens 111
 12.18.3 Chinese Trials on Solid Tumors 111
 12.18.4 Chinese Trials Using Fourth Generation CAR Constructs 113
 12.18.5 Clinical Stage CAR-T Projects in China 113
 
 13. CAR-T CELL PRODUCTS IN THE MARKET 115
 
13.1 Tisagenlecleucel (Kymriah) 115
 13.1.1 Evidences Supporting Effectiveness of Tisagenlecleucel (Kymriah) 116
 13.1.2 Medical Necessities for Tisagenlecleucel (Kymriah) 117
 13.1.3 Overall Remission Rates in Patients Treated with Kymriah 117
 13.1.4 Overall Event-Free Survival Rate with Tisagenlecleucel (Kymriah) 118
 13.1.5 Key Adverse Events in ELIANA Trial 119
 13.1.6 Key Adverse Events in JULIET Trial 119
 13.1.7 Budget Impact for Tisagenlecleucel 120
 13.1.8 Overall Adverse Events with Tisagenlecleucel 121
 13.1.9 Per-Patient Potential Budget Impact of Tisagenlecleucel 122
 13.2 Axicabtagene Ciloleucel (Yescarta) 122
 13.2.1 Evidences to Support the Effectiveness of Axicabtagene Ciloleucel 123
 13.2.2 Medical Necessities for Axicabtagene Ciloleucel (Yescarta) 123
 13.2.3 Clinical Benefits of Axicabtagene Ciloleucel (Yescarta) 124
 13.2.4 Objective Response Rates (ORR) for Axicabtagene Ciloleucel 124
 13.2.5 CRR for Axicabtagene Ciloleucel 125
 13.2.6 Adverse Events in ZUMA-Trial 125
 13.2.7 Base-Case Results 126
 13.2.8 Value-Based Benchmark Prices 126
 13.2.9 Per-Patient Budget Impact of Axicabtagene Ciloleucel 127
 13.2.10 Unit Cost for Healthcare Utilization in CAR-T Therapy 128
 13.2.10.1 Costs Associated with Adverse Events 128
 
 14. INSURANCE COVERAGE FOR CAR-T THERAPY 130
 
14.2 Coverage Policies for Tisagenlecleucel – B-ALL Patients 130
 14.2 Coverage for Stem Cell Transplantation (SCT) – B-Cell ALL Patients 130
 14.3 Coverage for Axicabtagene Ciloleucel – B-Cell NHL Patients 131
 14.4 Coverage for Stem Cell Plantation (SCT) in B-Cell NHL Patients 131
 14.5 Insurance Coverage by Medicare and Medicaid 132
 
 15. COMMERCIAL THREATS FOR CAR-T INDUSTRY 133
 
15.1 Competition in a Narrow Field 133
 15.2 Competition from other Technologies 133
 15.3 Threat from TCRs 133
 15.4 Threat of Litigation 133
 
 16. CHALLENGES TO OVERCOME 134
 
16.1 Lack of Persistence 134
 16.2 Inadequate Activation 134
 16.3 Transfection Method 134
 16.4 Humanized Binding Domains 134
 16.5 Antigen Escape 135
 16.6 Lineage Switching 135
 16.7 Lack of Safety 135
 16.8 Benefits of CAR-T Cell Therapy 135
 16.9 CAR-T Cell Therapy: Only the Beginning of the Story 135
 16.10 A New Standard 136
 
 17. MARKET ANALYSIS 137
 
17.1 Global Market for CAR-T Therapy by Geography 138
 17.2 Global Market for CAR-T Therapy by Country 139
 17.3 Global Market for CAR-T Cell Therapy by Targeted Antigens 141
 17.4 Competitive Landscape 141
 
 18. COMPANY PROFILES 143
 
18.1 AbbVie Inc. 143
 18.1.1 Collaboration with Calibr 143
 18.2 Adaptimmune Therapeutics PLC 144
 18.2.1 Pipeline 144
 18.3 Amgen, Inc. 145
 18.3.1 Amgen’s Collaboration with Kite Pharma 146
 18.3.2 Amgen’s Collaboration with MD Anderson Cancer Center 146
 18.4 Atara Biotherapeutics, Inc. 146
 18.4.1 Technology 147
 18.4.2 Atara tab-cel™ 148
 18.4.3 Atara ATA188 148
 18.4.4 Atara ATA230 148
 18.5 Aurora Biopharma, Inc. 149
 18.5.1 CAR-T for Glioblastoma 149
 18.6 Autolus Therapeutics PLC 149
 18.6.1 Technology 150
 18.7 Bellicum Pharmaceuticals, Inc. 150
 18.7.1 GoCAR Technology 150
 18.7.2 BPX-501 151
 18.7.3 BPX-601 151
 18.7.4 BPX-701 151
 18.8 BioAtla LLC 152
 18.8.1 Conditionally Active Biologics (CABs) 152
 18.8.2 Agreement with Pfizer 152
 18.8.3 Agreement with Sinobioway 153
 18.9 bluebird bio 153
 18.9.1 Technology 153
 18.10 Carina Biotech 154
 18.10.1 Technology 154
 18.11 CARsgen Therapeutics, Ltd. 155
 18.12 CARTherics 156
 18.13 Cellectis 156
 18.13.1 Products 157
 18.14 Celularity 157
 18.15 Celyad SA 158
 18.16 Creative Biolabs 159
 18.17 DiaCarta, Inc. 161
 18.17.1 Personalized CAR-T Immunotherapy Platform 161
 18.18 Endocyte, Inc. 162
 18.18.1 LU-PSMA-617 162
 18.18.2 Adaptor-Controlled CAR-T Therapy 162
 18.19 F1 Oncology, Inc. 163
 18.19.1 Conditionally Active Biologics (CAB) Technology 163
 18.20 Fate Therapeutics Inc. 164
 18.21 Humanigen, Inc. 165
 18.21.1 Ifabotuzumab 165
 18.22 Immune Therapeutics, Inc. 166
 18.22.1 CAR-T from Immune Therapeutics 166
 18.23 Intrexon, Corp. 167
 18.24 Juno Therapeutics, Inc. 168
 18.25 Kite Pharma, Inc. 169
 18.25.1 Product 169
 18.25.1.1 Yescarta (Axicabtagene ciloleucel) 169
 18.26 Lion TCR Pte Ltd. 170
 18.26.1 Technology 170
 18.26.1.2 Virus-Related Cancers 170
 18.27 MaxCyte, Inc. 171
 18.27.1 CARMA Platform 171
 18.28 Mesoblast, Ltd. 172
 18.28.1 Partnership with Cartherics 172
 18.29 Minerva Biotechnologies Corp. 173
 18.29.1 Solid Tumor Cancer Portfolio 173
 18.29.2 Antibody Therapeutic for MUC1* Positive Cancers 173
 18.29.3 Anti-Metastasis Antibody 174
 18.29.4 MUC1* 174
 18.30 Mustang Bio, Inc. 175
 18.31 Novartis AG 176
 18.31.1 Kymriah (Tisagenlecleucel) 176
 18.32 Oxford BioMedica PLC. 177
 18.32.1 LentiVector Platform 177
 18.33 PeproMene Bio Inc. 178
 18.33.1 BAFFR R CAR-Cell 179
 18.34 Pfizer, Inc. 179
 18.34.1 Asset Contribution Agreement with Allogene Therapeutics 180
 18.35 Posedia Therapeutics Inc. 180
 18.36 Precision Biosciences, Inc. 181
 18.36.1 Precision Biosciences’ Cancer Immunotherapy 181
 18.37 ProMab Biotechnologies Inc. 181
 18.38 Servier Oncology 183
 18.39 Sorrento Therapeutics, Inc. 184
 18.40 TC Biopharm Ltd. 184
 18.40.1 ImmuniCAR 185
 18.40.2 OmniCAR 185
 18.40.3 OmnImmune 185
 18.41 Tessa Therapeutics Pte Ltd. 185
 18.41.1 TT10 EBVSTs 186
 18.41.2 TT12 Armored HPVSTs 186
 18.41.3 TT14 GPC3-CAR VSTs 186
 18.41.4 TT16 HER2-CAR VSTs 186
 18.42 TILT Biotherapeutics Ltd. 187
 18.42.1 Technology 187
 18.43 Tmunity Therapeutics Inc. 188
 18.43.1 Technology 188
 18.44 TrakCel Ltd. 189
 18.45 Xyphos 189
 18.45.1 ConvertibleCAR Technology 189
 18.46 ZIOPHARM Oncology, Inc. 190
 18.46.1 IL-12 Platform 191
 18.46.2 Sleeping Beauty 191
  


List Of Tables

INDEX OF FIGURES

FIGURE 1.1: Diagrammatic Representation of the Binding of CAR-T with Antigen of Malignant Cell 16
FIGURE 3.1: Stages from Apheresis to Patient Administration of CAR-T Cells 19
FIGURE 3.2: The Process of CAR-T Cell Manufacturing 20
FIGURE 4.1: Building a CAR-T Cell and its Binding to Tumor Antigen 28
FIGURE 4.2: First Generation CAR-T Cells 29
FIGURE 4.3: Second Generation CAR-T Cells 29
FIGURE 4.4: Third Generation CAR-T Cells 30
FIGURE 4.5: Fourth Generation CAR-T Cells 31
FIGURE 4.6: Recognition and Killing of Tumor Cell by CAR-T Cell 32
FIGURE 4.7: New CAR Models and Concepts 35
FIGURE 4.8: Components of a Chimeric Antigen Receptor 36
FIGURE 4.9: Schematic Representation of scFv Fragment 37
FIGURE 5.1: Global Distribution of CAR-T Cell Therapeutic Companies 40
FIGURE 5.2: Number of Immunocellular Therapy Companies by Cell Type 41
FIGURE 6.1: Percent (%) Share of CAR-T Cell Trials Targeting CD19 58
FIGURE 6.2: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Targeting CD19 59
FIGURE 6.3: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Except CD19 60
FIGURE 6.4: Most Frequent CAR-T Cell Targets in Liquid Malignancies (Except CD19) 61
FIGURE 6.5: Trend in Number of CAR-T Cell Therapy Clinical Trials: CD30 vs. BCMA 62
FIGURE 6.6: Clinical Outcome of CAR-T Cell Therapy Trials in Solid Malignancies 63
FIGURE 6.7: Most Frequent CAR-T Cell Targets in Solid Malignancies 64
FIGURE 10.1: Number of CAR-T Cell Patents, 2013-2018 78
FIGURE 10.2: Major CAR-T Patent Applicants 82
FIGURE 11.1: Licensing, Joint Venture and Research Only Oncology Deals from 2013-2017 89
FIGURE 12.1: Number of Initiated CAR-T Cell Therapy Clinical Trials, 2007-2017 90
FIGURE 12.2: Percentage (%) of Total CAR-T Clinical Trials by Target 91
FIGURE 12.3: Research Focus on CAR-T Trials by Indication 92
FIGURE 12.4: Engineered CD19-CAR-T Cell Targeting CD19 Antigen on the Malignant Cell 97
FIGURE 12.5: CAR-T Cells Targeting Solid Tumor Antigen 101
FIGURE 12.6: CAR-T Therapy Pipeline Distribution by Indication 107
FIGURE 12.7: CAR-T Therapy Pipeline Distribution by Target Antigen 108
FIGURE 17.1: Global Market for CAR-T Cell Therapies, 2018-2023 137
FIGURE 17.2: Global Market for CAR-T Therapy by Geography, 2024 138
FIGURE 17.3: Global Market for CAR-T Therapy by Country, 2024 140
FIGURE 17.4: Global Market for CAR-T Cell Therapies by Targeted Antigen, 2018 141

1. REPORT OVERVIEW 11
1.1 Statement of the Report 11
1.2 Executive Summary 13
1.3 INTRODUCTION 15
2. SIXTY YEAR HISTORY OF CAR-T CELL THERAPY 17
2.1 Timeline of CAR-T Cell Therapy Development 18

3. CAR-T MANUFACTURING PROCESSES 19
3.1 Manufacturing Autologous CAR-T Cells 19
3.2 T-Cell Source 19
3.3 T-Cell Activation 20
3.3.1 Beads-Based T-Cell Activation 21
3.3.2 Antibody-Coated Magnetic Beads 21
3.3.3 Antibody-Coated Nanobeads 21
3.3.4 Expamer Technology 21
3.3.5 Activation with Anti-CD3 Antibodies 22
3.4 Genetic Modification of T-Cells 22
3.5 Expansion of CAR-T Cells 23
3.5.1 Expansion of CAR-T Cells using GE Bioreactors 23
3.5.2 Expansion of CAR-T Cells using G-Rex Bioreactors 23
3.5.3 Expansion of CAR-T Cells using Prodigy 24
3.5.4 Expansion of CAR-T Cells through Recursive AAPC Stimulation 24
3.6 Clinical CAR-T Cell Manufacturing Quality Checkpoints 24
3.6.1 Qualification of Manufacturing Facilities 24
3.6.2 Qualification of Ancillary Components 25
3.6.3 Qualification of Manufacturing Process 25
3.7 In-Process Testing and Release Testing of Cellular Products 26
3.8 Allogeneic CAR-T Cells 26

4. STRUCTURE OF A CAR-T CELL 28
4.1 First Generation CAR-T Cells 28
4.2 Second Generation CAR-T Cells 29
4.3 Third Generation CAR-T Cells 30
4.4 Fourth Generation CAR-T Cells 30
4.5 Mechanism of Action 32
4.6 New CAR Models and Concepts 33
4.6.1 Truck CAR 33
4.6.2 Universal CAR 33
4.6.3 Self-driving CAR 33
4.6.4 Armored CAR 34
4.6.5 Self-destruct CAR 34
4.6.6 Conditional CAR 34
4.6.7 TanCAR 34
4.6.8 Dual CAR 35
4.6.9 Safety CAR (sCAR) 35
4.7 Basic Components of CAR 36
4.7.1 Common Deigns of CAR-T Constructs 36
4.7.1.1 Single Chain Fv Fragments (scFv) 37
4.7.1.2 4-1BB, CD28, OX40, FcεRIγ and CD3ξ 38
4.7.1.3 Vectors for Transfection 38

5. NUMBER OF CAR-T COMPANIES, THEIR RECENT ACTIVITIES 39
5.1 Geographical Distribution of CAR-T Cell Therapeutic Companies 39
5.2 Immunocellular Therapy Companies by Cell Type 40
5.3 Market Leaders in CAR-T Cell Therapy and their Recent Activities 41
5.3.1 AbbVie 41
5.3.2 Allogene Therapeutics 41
5.3.3 Amgen 42
5.3.4 Agios Pharmaceutical 42
5.3.5 Atara Biotherapeutics 42
5.3.6 Autolus Limited 42
5.3.7 Bellicum Pharmaceuticals 43
5.3.8 bluebird bio 43
5.3.9 Calibr 43
5.3.10 Carina Biotech 43
5.3.11 CARsgen Therapeutics 44
5.3.12 Celgene Corporation 44
5.3.13 Cellectis 44
5.3.14 Cell Medica 44
5.3.15 Cell Design Labs 45
5.3.16 Celularity 45
5.3.17 Celyad 45
5.3.18 Fate Therapeutics 45
5.3.19 Fortress Bio 46
5.3.20 Gilead Sciences 46
5.3.21 Janssen Biotech 46
5.3.22 Juno Therapeutics 46
5.3.23 JW Therapeutics 47
5.3.24 Kite Pharma 47
5.3.25 Medisix Therapeutics 47
5.3.26 Mustang Bio 47
5.3.27 Nanjing Legend Biotech 48
5.3.28 Novartis 48
5.3.29 Pfizer 48
5.3.30 Precision Biosciences 48
5.3.31 Posedia Therapeutics 49
5.3.32 Shire 49
5.3.33 Sorrento Therapeutics 49
5.3.34 Ziopharm 49

6. TUMOR-ASSOCIATED TARGET ANTIGENS 50
6.1 Antigens on Solid Tumors 50
6.1.1 Epidermal Growth Factor Receptor (EGFR) 51
6.1.2 Epidermal Growth Factor Receptor Variant III (EGFRvIII) 51
6.1.3 Human Epidermal Growth Factor Receptor-2 (HER2) 51
6.1.4 Mesothelin (MSLN) 51
6.1.5 Prostate-Specific Membrane Antigen (PSMA) 52
6.1.6 Disialoganglioside 2 (GD2) 52
6.1.7 Interleukin-13Rα2 (IL13Rα2) 52
6.1.8 Glypican-3 (GPC3) 52
6.1.9 Carbonic Anhydrase IX (CAIX) 53
6.1.10 L1 Cell Adhesion Molecule (L1-CAM) 53
6.1.11 Cancer Antigen 125 (CA125) (MUC16) 53
6.1.12 Prominin-1 (CD133) 53
6.1.13 Fibroblast Protein-α (FAP-α) 54
6.1.14 Cancer/Testis Antigen 1B (CTAG1B) 54
6.1.15 Mucin 1 (MUC1) 54
6.1.16 Folate Receptor-α (FR-α) 54
6.2 CAR-T Targets in Hematologic Malignancies 54
6.2.1 CD19 55
6.2.2 CD20 55
6.2.3 CD22 56
6.2.4 ROR1 56
6.2.5 CD30 56
6.2.6 CD138 56
6.2.7 CD123 57
6.2.8 NKG2D-L 57
6.2.9 BCMA 57
6.2.10 CD174 57
6.3 CAR-T Cell Trials Targeting CD19 57
6.3.1 Positive CR Rates in CD19 Targeted Studies in Hematological Malignancies 58
6.3.2 Outcome of CAR-T Cell Therapy Trials Targeting Antigens other than CD19 59
6.3.3 Targets other than CD19 in Hematological Cancers 60
6.3.4 CD30 vs. BCMA Targets for Multiple Myeloma 61
6.4 CAR-T Cell Therapy for Solid Tumors 62
6.4.1 CAR-T Cell Targets in Solid Malignancies 63

7. TARGET DISEASES FOR CAR-T CELL THERAPY 65
7.1 Acute Lymphoblastic Leukemia (ALL) 65
7.2 Chronic lymphocytic leukemia (CLL) 66
7.3 Non-Hodgkin lymphoma 66
7.4 Acute myeloid leukemia (AML) 67
7.5 Neuroblastoma 67
7.6 Multiple myeloma (MM) 68

8. PRICING AND PAYMENT MODELS FOR CAR-T THERAPIES 69
8.1 Controversies over CAR-T Pricing 69
8.2 Hospital Mark-up Costs for Kymriah and Yescarta 70
8.3 Cost Effectiveness of Tisagenlecleucel and Axicabtagene 71
8.4 Value-Based Price Benchmarks 72
8.5 Unit Prices Needed to Reach Cost-Effectiveness Thresholds 73
8.6 Alternate Payment Strategies 73

9. MEDICAL FACILITIES OFFERING CAR-T THERAPIES 74
9.1 CAR-T Recommended in Europe 76
9.2 CAR-T Cell Therapy in Chinese Hospital 76
9.3 Canada Joins the CAR-T Club 77

10. CAR-T THERAPY PATENT LANDSCAPE 78
10.1 Number of CAR-T Cell Patents, 2013-2018 78
10.2 CAR-T Patent Types 79
10.3 A Brief Snapshot of CAR-T Patent Landscape 80
10.3.1 Patents for Anti-CD19 CAR-T 80
10.3.2 Patents for Anti-BCMA CAR-T 80
10.3.3 Patents for Regulatable CAR-T 81
10.3.4 Patents for CAR-T for Solid Tumors 81
10.4 Major CAR-T Patent Applicants 82

11. DEALS, FUNDINGS, PARTNERSHIPS AND COLLABORATIONS 83
11.1 Funding for CAR-T 83
11.2 CAR-T Deals 83
11.3 Initial Public Offering (IPO) 85
11.4 Key CAR-T Technology Deals 85
11.4.1 Deal between Juno Therapeutics and Eureka for a Fully Human ScFv Binding Domain 86
11.4.2 Acquisition of Stage Cell Therapeutics by Juno Therapeutics 86
11.4.3 Collaboration between Juno Therapeutics and Editas Medicine 87
11.4.5 Kite and Alpine in Research and License Agreement 87
11.4.6 Johnson & Johnson Gets PiggyBac Technology from Transposagen 87
11.4.7 Johnson & Johnson and Posedia in a Technology Deal 87
11.4.8 Partnership between Baxalta and Precision Biosciences 88
11.4.9 Novartis, Intellia and Caribou 88
11.4.10 Trends in Oncology Licensing, Joint Venture and Research Deals 88

12. THE LANDSCAPE OF CAR-T CELL THERAPY CLINICAL TRIALS 90
12.1 The Surge in Number of CAR-T Clinical Trials 90
12.2 Percentage (%) of Total CAR-T Clinical Trials by Target 91
12.3 Research Focus on CAR-T Trials by Indication 92
12.4 Clinical Trials using CAR-T Cells by Country as of 2018 93
12.5 CAR-T Clinical Trials to Watch 93
12.6 CAR-T Projects with Commercial Licensees 94
12.7 Clinical CAR-T Constructs with Sole Involvement from Academicia 96
12.8 Anti-CD19 CAR-T Studies 97
12.9 CAR-T Studies in Multiple Myeloma and Acute Myeloid Leukemia 100
11.10 CAR-T Cell Therapy for Solid Tumors 101
12.11 Studies of CAR-T Projects Transfected using mRNA Electroporation 103
12.12 CAR-T Projects Incorporating Suicide Genes 103
12.13 Early Stage CAR-T Assets 104
12.14 Anti-CD22 CAR-T Projects 105
12.15 Cytokine Release Syndrome (CRS) with CART19 Therapy 106
12.16 CAR-T Therapy Pipeline Distribution by Indication 106
12.17 CAR-T Therapy Pipeline Distribution by Target Antigen 108
12.18 Distribution of CAR-T Clinical Trials in China 109
12.18.1 CD19-Directed CAR-T Clinical Trials in China 109
12.18.2 Chinese Trials Targeting Non-CD19 Antigens 111
12.18.3 Chinese Trials on Solid Tumors 111
12.18.4 Chinese Trials Using Fourth Generation CAR Constructs 113
12.18.5 Clinical Stage CAR-T Projects in China 113

13. CAR-T CELL PRODUCTS IN THE MARKET 115
13.1 Tisagenlecleucel (Kymriah) 115
13.1.1 Evidences Supporting Effectiveness of Tisagenlecleucel (Kymriah) 116
13.1.2 Medical Necessities for Tisagenlecleucel (Kymriah) 117
13.1.3 Overall Remission Rates in Patients Treated with Kymriah 117
13.1.4 Overall Event-Free Survival Rate with Tisagenlecleucel (Kymriah) 118
13.1.5 Key Adverse Events in ELIANA Trial 119
13.1.6 Key Adverse Events in JULIET Trial 119
13.1.7 Budget Impact for Tisagenlecleucel 120
13.1.8 Overall Adverse Events with Tisagenlecleucel 121
13.1.9 Per-Patient Potential Budget Impact of Tisagenlecleucel 122
13.2 Axicabtagene Ciloleucel (Yescarta) 122
13.2.1 Evidences to Support the Effectiveness of Axicabtagene Ciloleucel 123
13.2.2 Medical Necessities for Axicabtagene Ciloleucel (Yescarta) 123
13.2.3 Clinical Benefits of Axicabtagene Ciloleucel (Yescarta) 124
13.2.4 Objective Response Rates (ORR) for Axicabtagene Ciloleucel 124
13.2.5 CRR for Axicabtagene Ciloleucel 125
13.2.6 Adverse Events in ZUMA-Trial 125
13.2.7 Base-Case Results 126
13.2.8 Value-Based Benchmark Prices 126
13.2.9 Per-Patient Budget Impact of Axicabtagene Ciloleucel 127
13.2.10 Unit Cost for Healthcare Utilization in CAR-T Therapy 128
13.2.10.1 Costs Associated with Adverse Events 128

14. INSURANCE COVERAGE FOR CAR-T THERAPY 130
14.2 Coverage Policies for Tisagenlecleucel – B-ALL Patients 130
14.2 Coverage for Stem Cell Transplantation (SCT) – B-Cell ALL Patients 130
14.3 Coverage for Axicabtagene Ciloleucel – B-Cell NHL Patients 131
14.4 Coverage for Stem Cell Plantation (SCT) in B-Cell NHL Patients 131
14.5 Insurance Coverage by Medicare and Medicaid 132

15. COMMERCIAL THREATS FOR CAR-T INDUSTRY 133
15.1 Competition in a Narrow Field 133
15.2 Competition from other Technologies 133
15.3 Threat from TCRs 133
15.4 Threat of Litigation 133

16. CHALLENGES TO OVERCOME 134
16.1 Lack of Persistence 134
16.2 Inadequate Activation 134
16.3 Transfection Method 134
16.4 Humanized Binding Domains 134
16.5 Antigen Escape 135
16.6 Lineage Switching 135
16.7 Lack of Safety 135
16.8 Benefits of CAR-T Cell Therapy 135
16.9 CAR-T Cell Therapy: Only the Beginning of the Story 135
16.10 A New Standard 136

17. MARKET ANALYSIS 137
17.1 Global Market for CAR-T Therapy by Geography 138
17.2 Global Market for CAR-T Therapy by Country 139
17.3 Global Market for CAR-T Cell Therapy by Targeted Antigens 141
17.4 Competitive Landscape 141

18. COMPANY PROFILES 143
18.1 AbbVie Inc. 143
18.1.1 Collaboration with Calibr 143
18.2 Adaptimmune Therapeutics PLC 144
18.2.1 Pipeline 144
18.3 Amgen, Inc. 145
18.3.1 Amgen’s Collaboration with Kite Pharma 146
18.3.2 Amgen’s Collaboration with MD Anderson Cancer Center 146
18.4 Atara Biotherapeutics, Inc. 146
18.4.1 Technology 147
18.4.2 Atara tab-cel™ 148
18.4.3 Atara ATA188 148
18.4.4 Atara ATA230 148
18.5 Aurora Biopharma, Inc. 149
18.5.1 CAR-T for Glioblastoma 149
18.6 Autolus Therapeutics PLC 149
18.6.1 Technology 150
18.7 Bellicum Pharmaceuticals, Inc. 150
18.7.1 GoCAR Technology 150
18.7.2 BPX-501 151
18.7.3 BPX-601 151
18.7.4 BPX-701 151
18.8 BioAtla LLC 152
18.8.1 Conditionally Active Biologics (CABs) 152
18.8.2 Agreement with Pfizer 152
18.8.3 Agreement with Sinobioway 153
18.9 bluebird bio 153
18.9.1 Technology 153
18.10 Carina Biotech 154
18.10.1 Technology 154
18.11 CARsgen Therapeutics, Ltd. 155
18.12 CARTherics 156
18.13 Cellectis 156
18.13.1 Products 157
18.14 Celularity 157
18.15 Celyad SA 158
18.16 Creative Biolabs 159
18.17 DiaCarta, Inc. 161
18.17.1 Personalized CAR-T Immunotherapy Platform 161
18.18 Endocyte, Inc. 162
18.18.1 LU-PSMA-617 162
18.18.2 Adaptor-Controlled CAR-T Therapy 162
18.19 F1 Oncology, Inc. 163
18.19.1 Conditionally Active Biologics (CAB) Technology 163
18.20 Fate Therapeutics Inc. 164
18.21 Humanigen, Inc. 165
18.21.1 Ifabotuzumab 165
18.22 Immune Therapeutics, Inc. 166
18.22.1 CAR-T from Immune Therapeutics 166
18.23 Intrexon, Corp. 167
18.24 Juno Therapeutics, Inc. 168
18.25 Kite Pharma, Inc. 169
18.25.1 Product 169
18.25.1.1 Yescarta (Axicabtagene ciloleucel) 169
18.26 Lion TCR Pte Ltd. 170
18.26.1 Technology 170
18.26.1.2 Virus-Related Cancers 170
18.27 MaxCyte, Inc. 171
18.27.1 CARMA Platform 171
18.28 Mesoblast, Ltd. 172
18.28.1 Partnership with Cartherics 172
18.29 Minerva Biotechnologies Corp. 173
18.29.1 Solid Tumor Cancer Portfolio 173
18.29.2 Antibody Therapeutic for MUC1* Positive Cancers 173
18.29.3 Anti-Metastasis Antibody 174
18.29.4 MUC1* 174
18.30 Mustang Bio, Inc. 175
18.31 Novartis AG 176
18.31.1 Kymriah (Tisagenlecleucel) 176
18.32 Oxford BioMedica PLC. 177
18.32.1 LentiVector Platform 177
18.33 PeproMene Bio Inc. 178
18.33.1 BAFFR R CAR-Cell 179
18.34 Pfizer, Inc. 179
18.34.1 Asset Contribution Agreement with Allogene Therapeutics 180
18.35 Posedia Therapeutics Inc. 180
18.36 Precision Biosciences, Inc. 181
18.36.1 Precision Biosciences’ Cancer Immunotherapy 181
18.37 ProMab Biotechnologies Inc. 181
18.38 Servier Oncology 183
18.39 Sorrento Therapeutics, Inc. 184
18.40 TC Biopharm Ltd. 184
18.40.1 ImmuniCAR 185
18.40.2 OmniCAR 185
18.40.3 OmnImmune 185
18.41 Tessa Therapeutics Pte Ltd. 185
18.41.1 TT10 EBVSTs 186
18.41.2 TT12 Armored HPVSTs 186
18.41.3 TT14 GPC3-CAR VSTs 186
18.41.4 TT16 HER2-CAR VSTs 186
18.42 TILT Biotherapeutics Ltd. 187
18.42.1 Technology 187
18.43 Tmunity Therapeutics Inc. 188
18.43.1 Technology 188
18.44 TrakCel Ltd. 189
18.45 Xyphos 189
18.45.1 ConvertibleCAR Technology 189
18.46 ZIOPHARM Oncology, Inc. 190
18.46.1 IL-12 Platform 191
18.46.2 Sleeping Beauty 191


List Of Figures

FIGURE 1.1: Diagram of the Binding of CAR-T with Antigen of Malignant Cell……………………16

FIGURE 3.1: Stages from Apheresis to Patient Administration of CAR-T Cells. 19

FIGURE 3.2: The Process of CAR-T Cell Manufacturing. 20

FIGURE 4.1: Building a CAR-T Cell and its Binding to Tumor Antigen. 28

FIGURE 4.2: First Generation CAR-T Cells. 29

FIGURE 4.3: Second Generation CAR-T Cells. 30

FIGURE 4.4: Third Generation CAR-T Cells. 30

FIGURE 4.5: Fourth Generation CAR-T Cells. 31

FIGURE 4.6: Recognition and Killing of Tumor Cell by CAR-T Cell 32

FIGURE 4.7: New CAR Models and Concepts. 35

FIGURE 4.8: Components of a Chimeric Antigen Receptor 36

FIGURE 4.9: Schematic Representation of scFv Fragment 37

FIGURE 5.1: Global Distribution of CAR-T Cell Therapeutic Companies. 40

FIGURE 5.2: Number of Immunocellular Therapy Companies by Cell Type. 41

FIGURE 6.1: Percent (%) Share of CAR-T Cell Trials Targeting CD19. 58

FIGURE 6.2: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Targeting CD19. 59

FIGURE 6.3: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Except CD19. 60

FIGURE 6.4: Most Frequent CAR-T Cell Targets in Liquid Malignancies (Except CD19) 61

FIGURE 6.5: Trend in Number of CAR-T Cell Therapy Clinical Trials: CD30 vs. BCMA. 62

FIGURE 6.6: Clinical Outcome of CAR-T Cell Therapy Trials in Solid Malignancies. 63

FIGURE 6.7: Most Frequent CAR-T Cell Targets in Solid Malignancies. 64

FIGURE 10.1: Number of CAR-T Cell Patents, 2013-2018. 78

FIGURE 10.2: Major CAR-T Patent Applicants. 82

FIGURE 11.1: Licensing, Joint Venture and Research Only Oncology Deals from 2013-2017. 89

FIGURE 12.1: Number of Initiated CAR-T Cell Therapy Clinical Trials, 2007-2017. 90

FIGURE 12.2: Percentage (%) of Total CAR-T Clinical Trials by Target 91

FIGURE 12.3: Research Focus on CAR-T Trials by Indication. 92

FIGURE 12.4: A Model Showing Engineered CD19-CAR-T Cell Targeting CD19 Antigen on the Malignant Cell 97

FIGURE 12.5: CAR-T Cells Targeting Solid Tumor Antigen. 100

FIGURE 12.6: CAR-T Therapy Pipeline Distribution by Indication. 106

FIGURE 12.7: CAR-T Therapy Pipeline Distribution by Target Antigen. 107

FIGURE 17.1: Global Market for CAR-T Cell Therapies, 2018-2024. 136

FIGURE 17.2: Global Market for CAR-T Therapy by Geography, 2024. 137

FIGURE 17.3: Global Market for CAR-T Therapy by Country, 2024. 139

FIGURE 17.4: Global Market for CAR-T Cell Therapies by Targeted Antigen, 2018. 140


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