CAR-T cell therapy is a remarkably promising treatment for cancer patients. This emerging treatment is one of the biggest breakthroughs since the introduction of chemotherapy. CAR-T is a type of immunotherapy where doctors collect immune cells from a patient, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells and infuse them back into the patient. The infused cells get multiplied and stay in the body as “living drugs.”
In the past, significant successes were made possible by chemotherapy and radiation by killing cancer cells. However, the effects were not permanent. Now, CAR-T cells are providing a compelling alternative.
T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of the immune system and they play a key role in directing the immune response and killing cells infected by pathogens.
The purpose of this report is to describe the current status of chimeric antigen receptor T-cells (CAR-T cells), the related patent landscape, funding, deals, research, applications, technologies, the details of the two marketed CAR-T cell products, and the ongoing and late stage clinical trials.
The widespread research activities, worldwide clinical trials and approved treatments (Kymriah and Yescarta) have created a robust CAR-T cell therapy market. This billion dollar market size and its strong growth would not be possible without the remarkable efficacy of Kymriah and Yescarta in treating several types of blood cancers. CAR-T cell therapy has swept the biotech industry by storm, attracting new market participants at a rapid pace.
The main objectives of this report are to provide the reader with the following details:
- Currently available CAR-T cell therapy products and the treatable indications.
- The late-stage CAR-T product candidates.
- Number of clinical trials focusing on CAR-T cells targeting solid tumors.
- New designs and concepts of CAR-T cells.
- Funding for CAR-T cell-based research.
- Key patents filed in recent years.
- Number of clinical trials involving CAR-T cells.
- Advantages of CAR-T cell therapy over other immunotherapies and chemotherapies.
- Number of companies contributing to CAR-T cell therapy market and their product candidates.
Key questions answered in this report are:
- What are CAR-T cells?
- What are the various indications for CAR-T cell therapies?
- Which cancers are treated by the currently available Kymriah and Yescarta?
- What is the timeline for the development of CAR-T cell therapy?
- How are autologous and allogeneic CAR-T cells manufactured?
- What is the structure of a CAR-T cell?
- What are first generation, second generation, third generation and fourth generation CAR-T cells?
- What is the mechanism of action of CAR-T cells?
- What is the future of CAR-T cell therapy with the arrival of new models and concepts?
- What are the target antigens in CAR-T cell therapy?
- What are the target antigens in solid tumors?
- What is the price structure of CAR-T products?
- How many medical facilities are currently offering CAR-T cell therapy?
- How many patent applications have been filed?
- How many deals, partnerships and collaborations have been signed in recent years?
- What is the funding landscape in the CAR-T space?
- How many clinical trials are actively conducted in the CAR-T space?
- Which clinical trials are run by biotech companies?
- Which clinical trials are conducted by academicia?
- How do Tisagenlecleucel (Kymriah) and Axicabtagene ciloleucel (Yescarta) bring about the death of cancer cells in hematological malignancies?
- What is the total cost of treating a patient with CAR-T cell therapy?
- How much relief is provided by insurance companies to the patients?
- What are the strengths and weaknesses of the CAR-T cell therapy industry?
- What is the global market for CAR-T cells?
- What is the global market for CAR-T cells by geography?
- What is the market for CAR-T cells by target antigen?
- How many companies are involved in developing CAR-T cell therapies and what product/technologies are they developing?
1. Report Overview
1.1 Statement of the Report
1.2 Executive Summary
2. History of CAR-T Cell Therapy
2.1 Timeline of CAR-T Cell Therapy Development
3. CAR-T Manufacturing Processes
3.1 Manufacturing Autologous CAR-T Cells
3.3 T-Cell Activation
3.3.1 Beads-Based T-Cell Activation
3.3.2 Antibody-Coated Magnetic Beads
3.3.3 Antibody-Coated Nanobeads
3.3.4 Expamer Technology
3.3.5 Activation with Anti-CD3 Antibodies
3.4 Genetic Modification of T-Cells
3.5 Expansion of CAR-T Cells
3.5.1 Expansion of CAR-T Cells using GE Bioreactors
3.5.2 Expansion of CAR-T Cells using G-Rex Bioreactors
3.5.3 Expansion of CAR-T Cells using Prodigy
3.5.4 Expansion of CAR-T Cells through Recursive AAPC Stimulation
3.6 Clinical CAR-T Cell Manufacturing Quality Checkpoints
3.6.1 Qualification of Manufacturing Facilities
3.6.2 Qualification of Ancillary Components
3.6.3 Qualification of Manufacturing Process
3.7 In-Process Testing and Release Testing of Cellular Products
3.8 Allogeneic CAR-T Cells
4. Structure of a CAR-T Cell
4.1 First Generation CAR-T Cells
4.2 Second Generation CAR-T Cells
4.3 Third Generation CAR-T Cells
4.4 Fourth Generation CAR-T Cells
4.5 Mechanism of Action
4.6 New CAR Models and Concepts
4.6.1 Truck CAR
4.6.2 Universal CAR
4.6.3 Self-driving CAR
4.6.4 Armored CAR
4.6.5 Self-destruct CAR
4.6.6 Conditional CAR
4.6.8 Dual CAR
4.6.9 Safety CAR (sCAR)
4.7 Basic Components of CAR
4.7.1 Common Deigns of CAR-T Constructs
18.104.22.168 Single Chain Fv Fragments (scFv)
22.214.171.124 4-1BB, CD28, OX40, FceRI? and CD3?
126.96.36.199 Vectors for Transfection
5. Number of CAR-T Companies, their Recent Activities
5.1 Geographical Distribution of CAR-T Cell Therapeutic Companies
5.2 Immunocellular Therapy Companies by Cell Type
5.3 Market Leaders in CAR-T Cell Therapy and their Recent Activities
5.3.2 Allogene Therapeutics
5.3.4 Agios Pharmaceutical
5.3.5 Atara Biotherapeutics
5.3.6 Autolus Limited
5.3.7 Bellicum Pharmaceuticals
5.3.8 bluebird bio
5.3.10 Carina Biotech
5.3.11 CARsgen Therapeutics
5.3.12 Celgene Corporation
5.3.14 Cell Medica
5.3.15 Cell Design Labs
5.3.18 Fate Therapeutics
5.3.19 Fortress Bio
5.3.20 Gilead Sciences
5.3.21 Janssen Biotech
5.3.22 Juno Therapeutics
5.3.23 JW Therapeutics
5.3.24 Kite Pharma
5.3.25 Medisix Therapeutics
5.3.26 Mustang Bio
5.3.27 Nanjing Legend Biotech
5.3.30 Precision Biosciences
5.3.31 Posedia Therapeutics
5.3.33 Sorrento Therapeutics
6. Tumor-Associated Target Antigens
6.1 Antigens on Solid Tumors
6.1.1 Epidermal Growth Factor Receptor (EGFR)
6.1.2 Epidermal Growth Factor Receptor Variant III (EGFRvIII)
6.1.3 Human Epidermal Growth Factor Receptor-2 (HER2)
6.1.4 Mesothelin (MSLN)
6.1.5 Prostate-Specific Membrane Antigen (PSMA)
6.1.6 Disialoganglioside 2 (GD2)
6.1.7 Interleukin-13Ra2 (IL13Ra2)
6.1.8 Glypican-3 (GPC3)
6.1.9 Carbonic Anhydrase IX (CAIX)
6.1.10 L1 Cell Adhesion Molecule (L1-CAM)
6.1.11 Cancer Antigen 125 (CA125) (MUC16)
6.1.12 Prominin-1 (CD133)
6.1.13 Fibroblast Protein-a (FAP-a)
6.1.14 Cancer/Testis Antigen 1B (CTAG1B)
6.1.15 Mucin 1 (MUC1)
6.1.16 Folate Receptor-a (FR-a)
6.2 CAR-T Targets in Hematologic Malignancies
6.3 CAR-T Cell Trials Targeting CD19
6.3.1 Positive CR Rates in CD19 Targeted Studies in Hematological Malignancies
6.3.2 Outcome of CAR-T Cell Therapy Trials Targeting Antigens other than CD19
6.3.3 Targets other than CD19 in Hematological Cancers
6.3.4 CD30 vs. BCMA Targets for Multiple Myeloma
6.4 CAR-T Cell Therapy for Solid Tumors
6.4.1 CAR-T Cell Targets in Solid Malignancies
7. Target Diseases for CAR-T Cell Therapy
7.1 Acute Lymphoblastic Leukemia (ALL)
7.2 Chronic lymphocytic leukemia (CLL)
7.3 Non-Hodgkin lymphoma
7.4 Acute myeloid leukemia (AML)
7.6 Multiple myeloma (MM)
8. Pricing and Payment Models for CAR-T Therapies
8.1 Controversies over CAR-T Pricing
8.2 Hospital Mark-up Costs for Kymriah and Yescarta
8.3 Cost Effectiveness of Tisagenlecleucel and Axicabtagene
8.4 Value-Based Price Benchmarks
8.5 Unit Prices Needed to Reach Cost-Effectiveness Thresholds
8.6 Alternate Payment Strategies
9. Medical Facilities Offering CAR-T Therapies
9.1 CAR-T Recommended in Europe
9.2 CAR-T Cell Therapy in Chinese Hospital
9.3 Canada Joins the CAR-T Club
10. CAR-T Therapy Patent Landscape
10.1 Number of CAR-T Cell Patents, 2013-2018
10.2 CAR-T Patent Types
10.3 A Brief Snapshot of CAR-T Patent Landscape
10.3.1 Patents for Anti-CD19 CAR-T
10.3.2 Patents for Anti-BCMA CAR-T
10.3.3 Patents for Regulatable CAR-T
10.3.4 Patents for CAR-T for Solid Tumors
10.4 Major CAR-T Patent Applicants
11. Deals, Fundings, Partnerships and Collaborations
11.1 Funding for CAR-T
11.2 CAR-T Deals
11.3 Initial Public Offering (IPO)
11.4 Key CAR-T Technology Deals
11.4.1 Deal between Juno Therapeutics and Eureka for a Fully Human ScFv Binding Domain
11.4.2 Acquisition of Stage Cell Therapeutics by Juno Therapeutics
11.4.3 Collaboration between Juno Therapeutics and Editas Medicine
11.4.5 Kite and Alpine in Research and License Agreement
11.4.6 Johnson & Johnson Gets PiggyBac Technology from Transposagen
11.4.7 Johnson & Johnson and Posedia in a Technology Deal
11.4.8 Partnership between Baxalta and Precision Biosciences
11.4.9 Novartis, Intellia and Caribou
11.4.10 Trends in Oncology Licensing, Joint Venture and Research Deals
12. The Landscape of CAR-T Cell Therapy Clinical Trials
12.1 The Surge in Number of CAR-T Clinical Trials
12.2 Percentage (%) of Total CAR-T Clinical Trials by Target
12.3 Research Focus on CAR-T Trials by Indication
12.4 Clinical Trials using CAR-T Cells by Country as of 2018
12.5 CAR-T Clinical Trials to Watch
12.6 CAR-T Projects with Commercial Licensees
12.7 Clinical CAR-T Constructs with Sole Involvement from Academicia
12.8 Anti-CD19 CAR-T Studies
12.9 CAR-T Studies in Multiple Myeloma and Acute Myeloid Leukemia
11.10 CAR-T Cell Therapy for Solid Tumors
12.11 Studies of CAR-T Projects Transfected using mRNA Electroporation
12.12 CAR-T Projects Incorporating Suicide Genes
12.13 Early Stage CAR-T Assets
12.14 Anti-CD22 CAR-T Projects
12.15 Cytokine Release Syndrome (CRS) with CART19 Therapy
12.16 CAR-T Therapy Pipeline Distribution by Indication
12.17 CAR-T Therapy Pipeline Distribution by Target Antigen
12.18 Distribution of CAR-T Clinical Trials in China
12.18.1 CD19-Directed CAR-T Clinical Trials in China
12.18.2 Chinese Trials Targeting Non-CD19 Antigens
12.18.3 Chinese Trials on Solid Tumors
12.18.4 Chinese Trials Using Fourth Generation CAR Constructs
12.18.5 Clinical Stage CAR-T Projects in China
13. CAR-T Cell Products in the Market
13.1 Tisagenlecleucel (Kymriah)
13.1.1 Evidences Supporting Effectiveness of Tisagenlecleucel (Kymriah)
13.1.2 Medical Necessities for Tisagenlecleucel (Kymriah)
13.1.3 Overall Remission Rates in Patients Treated with Kymriah
13.1.4 Overall Event-Free Survival Rate with Tisagenlecleucel (Kymriah)
13.1.5 Key Adverse Events in ELIANA Trial
13.1.6 Key Adverse Events in JULIET Trial
13.1.7 Budget Impact for Tisagenlecleucel
13.1.8 Overall Adverse Events with Tisagenlecleucel
13.1.9 Per-Patient Potential Budget Impact of Tisagenlecleucel
13.2 Axicabtagene Ciloleucel (Yescarta)
13.2.1 Evidences to Support the Effectiveness of Axicabtagene Ciloleucel
13.2.2 Medical Necessities for Axicabtagene Ciloleucel (Yescarta)
13.2.3 Clinical Benefits of Axicabtagene Ciloleucel (Yescarta)
13.2.4 Objective Response Rates (ORR) for Axicabtagene Ciloleucel
13.2.5 CRR for Axicabtagene Ciloleucel
13.2.6 Adverse Events in ZUMA-Trial
13.2.7 Base-Case Results
13.2.8 Value-Based Benchmark Prices
13.2.9 Per-Patient Budget Impact of Axicabtagene Ciloleucel
13.2.10 Unit Cost for Healthcare Utilization in CAR-T Therapy
188.8.131.52 Costs Associated with Adverse Events
14. Insurance Coverage for CAR-T Therapy
14.2 Coverage Policies for Tisagenlecleucel - B-ALL Patients
14.2 Coverage for Stem Cell Transplantation (SCT) - B-Cell ALL Patients
14.3 Coverage for Axicabtagene Ciloleucel - B-Cell NHL Patients
14.4 Coverage for Stem Cell Plantation (SCT) in B-Cell NHL Patients
14.5 Insurance Coverage by Medicare and Medicaid
15. Commercial Threats For CAR-T Industry
15.1 Competition in a Narrow Field
15.2 Competition from other Technologies
15.3 Threat from TCRs
15.4 Threat of Litigation
16. Challenges to Overcome
16.1 Lack of Persistence
16.2 Inadequate Activation
16.3 Transfection Method
16.4 Humanized Binding Domains
16.5 Antigen Escape
16.6 Lineage Switching
16.7 Lack of Safety
16.8 Benefits of CAR-T Cell Therapy
16.9 CAR-T Cell Therapy: Only the Beginning of the Story
16.10 A New Standard
17. Market Analysis
17.1 Global Market for CAR-T Therapy by Geography
17.2 Global Market for CAR-T Therapy by Country
17.3 Global Market for CAR-T Cell Therapy by Targeted Antigens
17.4 Competitive Landscape
18. Company Profiles
18.1 AbbVie Inc.
18.1.1 Collaboration with Calibr
18.2 Adaptimmune Therapeutics PLC
18.3 Amgen, Inc.
18.3.1 Amgen’s Collaboration with Kite Pharma
18.3.2 Amgen’s Collaboration with MD Anderson Cancer Center
18.4 Atara Biotherapeutics, Inc.
18.4.2 Atara tab-cel™
18.4.3 Atara ATA188
18.4.4 Atara ATA230
18.5 Aurora Biopharma, Inc.
18.5.1 CAR-T for Glioblastoma
18.6 Autolus Therapeutics PLC
18.7 Bellicum Pharmaceuticals, Inc.
18.7.1 GoCAR Technology
18.8 BioAtla LLC
18.8.1 Conditionally Active Biologics (CABs)
18.8.2 Agreement with Pfizer
18.8.3 Agreement with Sinobioway
18.9 bluebird bio
18.10 Carina Biotech
18.11 CARsgen Therapeutics, Ltd.
18.15 Celyad SA
18.16 Creative Biolabs
18.17 DiaCarta, Inc.
18.17.1 Personalized CAR-T Immunotherapy Platform
18.18 Endocyte, Inc.
18.18.2 Adaptor-Controlled CAR-T Therapy
18.19 F1 Oncology, Inc.
18.19.1 Conditionally Active Biologics (CAB) Technology
18.20 Fate Therapeutics Inc.
18.21 Humanigen, Inc.
18.22 Immune Therapeutics, Inc.
18.22.1 CAR-T from Immune Therapeutics
18.23 Intrexon, Corp.
18.24 Juno Therapeutics, Inc.
18.25 Kite Pharma, Inc.
184.108.40.206 Yescarta (Axicabtagene ciloleucel)
18.26 Lion TCR Pte Ltd.
220.127.116.11 Virus-Related Cancers
18.27 MaxCyte, Inc.
18.27.1 CARMA Platform
18.28 Mesoblast, Ltd.
18.28.1 Partnership with Cartherics
18.29 Minerva Biotechnologies Corp.
18.29.1 Solid Tumor Cancer Portfolio
18.29.2 Antibody Therapeutic for MUC1* Positive Cancers
18.29.3 Anti-Metastasis Antibody
18.30 Mustang Bio, Inc.
18.31 Novartis AG
18.31.1 Kymriah (Tisagenlecleucel)
18.32 Oxford BioMedica PLC.
18.32.1 LentiVector Platform
18.33 PeproMene Bio Inc.
18.33.1 BAFFR R CAR-Cell
18.34 Pfizer, Inc.
18.34.1 Asset Contribution Agreement with Allogene Therapeutics
18.35 Posedia Therapeutics Inc.
18.36 Precision Biosciences, Inc.
18.36.1 Precision Biosciences’ Cancer Immunotherapy
18.37 ProMab Biotechnologies Inc.
18.38 Servier Oncology
18.39 Sorrento Therapeutics, Inc.
18.40 TC Biopharm Ltd.
18.41 Tessa Therapeutics Pte Ltd.
18.41.1 TT10 EBVSTs
18.41.2 TT12 Armored HPVSTs
18.41.3 TT14 GPC3-CAR VSTs
18.41.4 TT16 HER2-CAR VSTs
18.42 TILT Biotherapeutics Ltd.
18.43 Tmunity Therapeutics Inc.
18.44 TrakCel Ltd.
18.45.1 ConvertibleCAR Technology
18.46 ZIOPHARM Oncology, Inc.
18.46.1 IL-12 Platform
18.46.2 Sleeping Beauty
Index of Figures
Figure 1.1: Diagram of the Binding of CAR-T with Antigen of Malignant Cell
Figure 3.1: Stages from Apheresis to Patient Administration of CAR-T Cells
Figure 3.2: The Process of CAR-T Cell Manufacturing
Figure 4.1: Building a CAR-T Cell and its Binding to Tumor Antigen
Figure 4.2: First Generation CAR-T Cells
Figure 4.3: Second Generation CAR-T Cells
Figure 4.4: Third Generation CAR-T Cells
Figure 4.5: Fourth Generation CAR-T Cells
Figure 4.6: Recognition and Killing of Tumor Cell by CAR-T Cell
Figure 4.7: New CAR Models and Concepts
Figure 4.8: Components of a Chimeric Antigen Receptor
Figure 4.9: Schematic Representation of scFv Fragment
Figure 5.1: Global Distribution of CAR-T Cell Therapeutic Companies
Figure 5.2: Number of Immunocellular Therapy Companies by Cell Type
Figure 6.1: Percent (%) Share of CAR-T Cell Trials Targeting CD19
Figure 6.2: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Targeting CD19
Figure 6.3: Outcome of CAR-T Cell Therapy Trials in Liquid Malignancies, Except CD19
Figure 6.4: Most Frequent CAR-T Cell Targets in Liquid Malignancies (Except CD19)
Figure 6.5: Trend in Number of CAR-T Cell Therapy Clinical Trials: CD30 vs. BCMA
Figure 6.6: Clinical Outcome of CAR-T Cell Therapy Trials in Solid Malignancies
Figure 6.7: Most Frequent CAR-T Cell Targets in Solid Malignancies
Figure 10.1: Number of CAR-T Cell Patents, 2013-2018
Figure 10.2: Major CAR-T Patent Applicants
Figure 11.1: Licensing, Joint Venture and Research Only Oncology Deals from 2013-2017
Figure 12.1: Number of Initiated CAR-T Cell Therapy Clinical Trials, 2007-2017
Figure 12.2: Percentage (%) of Total CAR-T Clinical Trials by Target
Figure 12.3: Research Focus on CAR-T Trials by Indication
Figure 12.4: A Model Showing Engineered CD19-CAR-T Cell Targeting CD19 Antigen on the Malignant Cell
Figure 12.5: CAR-T Cells Targeting Solid Tumor Antigen
Figure 12.6: CAR-T Therapy Pipeline Distribution by Indication
Figure 12.7: CAR-T Therapy Pipeline Distribution by Target Antigen
Figure 17.1: Global Market for CAR-T Cell Therapies, 2018-2024
Figure 17.2: Global Market for CAR-T Therapy by Geography, 2024
Figure 17.3: Global Market for CAR-T Therapy by Country, 2024
Figure 17.4: Global Market for CAR-T Cell Therapies by Targeted Antigen, 2018
- AbbVie Inc.
- Adaptimmune Therapeutics PLC
- Amgen, Inc.
- Atara Biotherapeutics, Inc.
- Aurora Biopharma, Inc.
- Autolus Therapeutics PLC
- Bellicum Pharmaceuticals, Inc.
- BioAtla LLC
- bluebird bio
- Carina Biotech
- CARsgen Therapeutics, Ltd.
- Celyad SA
- Creative Biolabs
- DiaCarta, Inc.
- Endocyte, Inc.
- F1 Oncology, Inc.
- Fate Therapeutics Inc.
- Humanigen, Inc.
- Immune Therapeutics, Inc.
- Intrexon, Corp.
- Juno Therapeutics, Inc.
- Kite Pharma, Inc.
- Lion TCR Pte Ltd.
- MaxCyte, Inc.
- Mesoblast, Ltd.
- Minerva Biotechnologies Corp.
- Mustang Bio, Inc.
- Novartis AG
- Oxford BioMedica PLC.
- PeproMene Bio Inc.
- Pfizer, Inc.
- Posedia Therapeutics Inc.
- Precision Biosciences, Inc.
- ProMab Biotechnologies Inc.
- Servier Oncology
- Sorrento Therapeutics, Inc.
- TC Biopharm Ltd.
- Tessa Therapeutics Pte Ltd.
- TILT Biotherapeutics Ltd.
- Tmunity Therapeutics Inc.
- TrakCel Ltd.
- ZIOPHARM Oncology, Inc.
The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.
- Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
- Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
- Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
- Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
- Product Launch Announcements (Trade Journals, Google News)
- Industry Events (Google News, Google Alerts, Press Releases)
- Company News (SEC Filings, Investor Publications, Historical Performance)
- Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
- Interviews with Stem Cell Industry Leaders
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