CAR T-Cell Design and Evolution
Chimeric antigen receptors (CARs, also known as chimeric immunoreceptors, chimeric T-cell receptors, artificial T-cell receptors or CAR-T) are engineered receptors that graft an arbitrary specificity onto an immune effector cell (T-cell). Typically, these receptors are used to graft the specificity of a monoclonal antibody onto a T-cell, with transfer of their coding sequence facilitated by retroviral vectors. The receptors are called chimeric because they are composed of parts from different sources.
FDA Product Approvals
There are two chimeric antigen receptor T-cell (CAR T) therapies currently approved by the U.S. FDA.
1. On Aug. 30, 2017, Novartis announced that the U.S. FDA had approved Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
2. On Oct. 18, 2017, the U.S. FDA approved Yescarta (axicabtagene ciloleucel) (Kite Pharma Inc.), a cell-based gene therapy, for the treatment of adult patients with relapsed or refractory large Bcell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, highgrade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for
the treatment of patients with primary central nervous system lymphoma. It is a CD19-directed genetically modified autologous T-cell immunotherapy.
It has been estimated that the global market for CAR T-cell therapies, as defined in the reports market segmentation, was valued at $REDACTED million in 2017 and $REDACTED million in 2018. By the end of the forecast period in 2023, it is predicted that the global market will have increased in value to $REDACTED billion,representing a compound annual growth rate (CAGR) of REDACTED%.
Analysis of the global CAR T-cell therapy market shows that North America is by far the largest geographic region in terms of revenue with an estimated REDACTED% global share. The European market is the second largest regional market with an estimated REDACTED% global share and Asia-Pacific has a very small REDACTED% share of the global market in 2018."
The key objectives of this study are to:
- Review the historical development of CAR T-cell technology.
- Discuss the principles of chimeric antigen receptor design.
- Understand the mechanisms of action associated with CAR T-cell immunotherapy.
- Highlight the ongoing clinical and non-clinical advancements in the field of CAR T-cell therapy.
- Access the side effects, disadvantages and limitations of existing CAR T-cell technologies.
- Examine the current marketed drugs, including development activities and details of patent expirations.
- Determine the production methods for CAR T-cells.
- Review the range of joint ventures, collaborations, license and research agreements currently focused on CAR T-cell technology.
- Review of the regulatory requirements.
- Review the global CAR T-cell therapy market dynamics.
- Survey the key players involved in the development of therapeutics for CAR T-cell immunotherapy and provide company profiles.
By purchasing this study, the reader will gain:
- An improved understanding of the current state and future of this exciting, new and innovative technology.
- The latest information on the leading companies engaged in developing this technology, clinical trials being conducted, a review of the status of their intellectual property, product pipelines and insight into their proprietary technologies.
- The role and influence of individual countries relating to the development of CAR T-cell therapy and the number of CAR T-cell trials in the U.S. versus China and other countries.
- Knowledge of the market potential for the CAR T-cell therapy market and anticipated development of the market.
- The analysis includes the use of charts and graphs measuring product growth and trends within the marketplace. In addition, an analysis of the incidence and mortality associated with cancers and the target market helps provide the reader with a deeper understanding of the possibilities for future treatment and avenues for possible R&D budgets. Company-specific information, including sales figures, product pipeline status and R&D trends, is provided throughout the report.
- 31 data tables and 41 additional tables
- An overview of global market for current research & developments status of Chimeric Antigen Receptor (CAR) T-cell therapy
- Analyses of global market trends, with data from 2017, estimates for 2018, and projections of compound annual growth rates (CAGRs) through 2023
- Understand market dynamics of CAR T-Cell therapy, along with the growth driving factors, restraints and future scope
- Information on competitor initiatives, research and development status of CAR T-cell therapy
- Comprehensive company profiles of major players in the market including, Amgen, Avacta Life Sciences Ltd., Bluebird Bio Inc., Novartis Ag, Servier Laboratories, Takeda Pharmaceuticals, and Transgene SA"
Table of Contents
Chapter 1 Introduction
Scope of the Report
Methodology and Information Sources
Primary Data and Information Gathering
Secondary Data and Information Gathering
Market Share Analysis and Market Forecast
Related BCC Research Reports
Chapter 2 Summary and Highlights
CAR T-Cell Design and Evolution
FDA Product Approvals
Clinical Applications of CAR T-Cell Therapy
CARs for Tumors of the Hematopoietic and Lymphoid Tissues
CAR T-Cell Therapy for Solid Tumors
Barriers to Research and Product Development
Chapter 3 Introduction to Chimeric Antigen Receptor (CAR) T-Cell Therapy
A Brief History of CAR T-Cell Therapy Development
Cluster of Differentiation
Adoptive Cell Transfer (ACT) Technologies
Tumor-Infiltrating Lymphocytes (TILs)
T-Cell Receptors (TCRs)
Chimeric Antigen Receptors (CARs)
Chapter 4 Current Production Methods, Latest Technological Advances and Future Direction
Production of CAR T-Cells
Stage 1: Leukapheresis and T-Cell Isolation
Stage 2: T-Cell Activation, Transduction and Modification of CAR T-Cells
Stage 3: Expanding Modified CAR T-Cells
Overcoming CAR T-Cell Manufacturing Challenges
Latest Advances in Production Processes
Closed, Automated Production Systems
End-to-End Production Systems and Solutions
Key Technologies Used in the Manufacturing Stage
Chapter 5 Clinical Trial Analysis of CAR T-Cells and Related Technologies
Clinical Trials Being Conducted Globally
Distribution of CAR T-Cell Trials in the U.S.
Distribution of CAR T-Cell Clinical Trials in China
Chapter 6 Incidence, Prevalence and Mortality Statistics for Cancer: A Global Summary
Cancer: The Disease
Cancer: A Statistical Analysis of the Disease Incidence and Prevalence
Incidence and Prevalence Rates for Major Cancer Types
Global Regional Patterns of Cancer
Latin and Central America
Middle East and Africa
Global Cancer Burden and Worldwide Cancer Risk Factors
Tobacco Use and Statistics
Alcohol Abuse and Cancer Statistics
Obesity and Cancer Statistics
Infectious Diseases and Cancer
Inherited Genes: Diseases and Cancer
Sun, Ultraviolet Radiation and Cancer
Hormones and Cancer
Chapter 7 Global CAR T-Cell Market Analysis
Global CAR T-Cell Market
Regional CAR T-Cell Market Analysis: North America
Regional CAR T-Cell Market Analysis: Europe
Regional CAR T-Cell Market Analysis: Asia-Pacific
Regional CAR T-Cell Market Analysis: Central and Latin America
Regional CAR T-Cell Market Analysis: Middle East and Africa
Global CAR T-Cell Market Share Analysis
Selected Drivers of the Global CAR T-Cell Market
Selected Restraints of the Global CAR T-Cell Market
Chapter 8 Regulatory and Legislative Requirements for CAR T-Cell and Related Technologies
Mutual Recognition Procedure (MRP)
Decentralized Procedure (DCP)
Centralized Procedure (CP)
Central and South America
Middle East and Africa
Published Guidelines on Production and Testing of Cell-Based Therapies
Chapter 9 Patent Review/New Developments for Chimeric Antigen Receptors (CARs)
Complexities of the Patents and Patent Applications for Biotechnology and Pharmaceutical Companies
Anticipated Increase in Patent Litigation on Customized Patient Treatments
Company Specific Intellectual Property and Patent Information
Avacta Life Sciences Ltd.
Bellicum Pharmaceuticals Inc.
Editas Medicine Inc.
Eureka Therapeutics Inc.
Gilead Sciences Inc.
iCell Gene Therapeutics
Juno Therapeutics Inc. (A Celgene Company)
Mustang Bio Inc.
Chapter 10 Company Profiles
AVACTA LIFE SCIENCES LTD.
EDITAS MEDICINE INC.
EUREKA THERAPEUTICS INC.
FORMULA PHARMACEUTICALS INC.
F. HOFFMAN LA ROCHE AG
ICELL GENE THERAPEUTICS
JUNO THERAPEUTICS INC. (A CELGENE COMPANY)
KITE PHARMA INC. (A SUBSIDIARY OF GILEAD SCIENCES INC.)
MUSTANG BIO INC.
SHIRE PHARMACEUTICALS INC.
Chapter 11 Appendix A
Company Addresses and Contact Details
Chapter 12 Appendix B
Government Regulatory Agencies and Professional Organizations
Chapter 13 Appendix C
Commonly Used Acronyms Associated with CAR T-Cell Therapy
Chapter 14 Appendix D
Recent Patent Applications Filed Related to CAR T-Cell Therapy
Chapter 15 Appendix E
CAR T-Cell and CD19 Clinical Trials in China
List of Table
List of Tables
Summary Table A : Global CAR T-Cell Market, by Region, Through 2023
Summary Table B : Global CAR T-Cell Market, by Product, Through 2023
Table 1 : Tumor-Associated Antigens of CAR T-Cell Targets
Table 2 : List of Relevant Human Clusters of Differentiation
Table 3 : Classification of Natural Killer T-Cells
Table 4 : Summary Classification of Tumors of the Hematopoietic and Lymphoid Tissues
Table 5 : Tumor-Associated Antigens of CAR T-Cell Target
Table 6 : Supplementary Components in CAR T-Cell Manufacture
Table 7 : Technologies Used in the Selection, Isolation and Enrichment of Cells During the Manufacture of CAR T-Cells
Table 8 : Technologies Used in the Activation and Simulation of Cells During the Manufacture of CAR T-Cells
Table 9 : Technologies Used in the Gene Transfer and Delivery of Cells During the Manufacture of CAR T-Cells
Table 10 : Gene Transfer and Gene Delivery Technologies Developed by Poseida Therapeutics Inc.
Table 11 : Technologies Used in the Expansion and Culture of Cells During the Manufacture of CAR T-Cells
Table 12 : Technologies Used in the Formulation of Cells During the Manufacture of CAR T-Cells
Table 13 : Technologies Used in the Cryopreservation of Cells During the Manufacture of CAR T-Cells
Table 14 : Technologies Used in the Thawing of Cells During the Manufacture of CAR T-Cells
Table 15 : CAR T-Cell Clinical Trial Activity Globally, by Study Location/Region, as of April 26, 2018
Table 16 : Clinical Trials on CD19 Directed CAR T-Cells in the U.S., as of May 1, 2018
Table 17 : Examples of Clinical Trials on CD19-Directed CAR T-Cells in China
Table 18 : Examples of Clinical Trials on CAR T-Cells Targeting Non-CD19 Antigens in China
Table 19 : Examples of Clinical Trials on CAR T-Cells for Solid Tumors in China
Table 20 : Clinical Trials on CAR T-Cells with Fourth-Generation CARs in China
Table 21 : Summary Statistics (Global): Estimated Cancer Incidence, Mortality and Five-Year Prevalence, 2012
Table 22 : Global Estimated Cancer Incidence, Mortality and Five-Year Prevalence in Men and Women Combined, by Cancer Type, 2012
Table 23 : Global Estimated Cancer Incidence, Mortality and Five-Year Prevalence in Men, by Cancer Type, 2012
Table 24 : Global Estimated Cancer Incidence, Mortality and Five-Year Prevalence in Women, by Cancer Type, 2012
Table 25 : Estimated Number of New Cancer Cases by Sex in the United States, 2017
Table 26 : Estimated Number of Deaths from Cancer in the U.S., by Cancer Site and Sex, 2017
Table 27 : Global CAR T-Cell Market, by Product, 2023
Table 28 : Global CAR T-Cell Market, by Region, Through 2023
Table 29 : Global CAR T-Cell Market Shares, by Region, 2018
Table 30 : North American CAR T-Cell Market, Through 2023
Table 31 : European CAR T-Cell Market, Through 2023
Table 32 : Asia-Pacific CAR T-Cell Market, Through 2023
Table 33 : Central and Latin American CAR T-Cell Market, Through 2023
Table 34 : Middle East and African CAR T-Cell Market, Through 2023
Table 35 : Global CAR T-Cell Market Shares, by Company, 2018
Table 36 : Overview of Healthcare in India
Table 37 : Recent Bluebird Bio Patents and Patent Applications, 2010-April 2018
Table 38 : Editas Medicine Patent Applications, 2010-April 2018
Table 39 : Eureka Therapeutics Patent Applications, 2015-April 2018
Table 40 : Kite Pharmas Core Anticancer Technology: Yeda Research and Development Co. Ltd. Patents and Patent Applications, 1993-April 2018
Table 41 : iCell Gene Therapeutics Patent Applications
Table 42 : Juno Therapeutics Inc. and Memorial Sloan Kettering Patents and Patent Applications
Table 43 : Mustang Bio and City of Hope National Medical Center Patents and Patent Applications
Table 44 : Noile-Immune Biotech Inc. Yamaguchi University Patent Applications
Table 45 : Novartis AG and University of Pennsylvania Patents and Patent Applications, 2013-2018
Table 46 : Amgen Financials, 2014-2017
Table 47 : Amgen Financials, by Product, 2014-2017
Table 48 : Avacta Group PLC Financials, 2015-2017
Table 49 : Bellicum Pharmaceuticals Financials, 2014-2017
Table 50 : Bellicum Pharmaceuticals Key Switch Technologies
Table 51 : Bluebird Bio Financials, 2014-2017
Table 52 : Celgene Corp. Financials, 2014-2017
Table 53 : Editas Medicine Financials, 2015-2017
Table 54 : Gilead Sciences Financials, 2014-2017
Table 55 : Gilead Sciences Individual Product Sales, 2014-2017
Table 56 : Gilead Sciences Product Pipeline
Table 57 : F. Hoffman La Roche Financials, 2014-2017
Table 58 : F. Hoffman La Roche Pharmaceutical Division Financials, 2014-2017
Table 59 : F. Hoffman La Roche Pharmaceutical Division Oncology Product Sales, 2014-2017
Table 60 : iCell Gene Therapeutics Product Development Pipeline
Table 61 : Juno Therapeutics Financials, 2014-2016
Table 62 : Juno Therapeutics Product Pipeline
Table 63 : Novartis AG Revenues, by Segment, 2015-2017
Table 64 : Protheragen Enabling Technologies
Table 65 : Shire Pharmaceuticals Financials, 2015-2017
Table 66 : Takeda Pharmaceuticals Financials, 2014-2016
Table 67 : Company Addresses and Contact Details
Table 68 : Government Regulatory Agencies and Professional Organizations Associated with CAR T-Cell Therapy
Table 69 : Commonly Used Acronyms Associated with CAR T-Cell Therapy
Table 70 : Recent Patent Applications Filed Related to CAR T-Cell Therapy
Table 71 : CAR T-Cell and CD19 Clinical Trials in China
List of Chart
List of Figures
Summary Figure A : Global CAR T-Cell Market Shares, by Region, 2018
Summary Figure B : Global CAR T-Cell Market, by Product, 2017-2023
Summary Figure C : Global CAR T-Cell Clinical Trials as of April 27, 2018, by Phase
Figure 1 : Historical Development of CAR T-Cell Therapy
Figure 2 : Cytotoxic T-Cell Activation and Action
Figure 3 : Overview of Signal Transduction Pathways Involved in Apoptosis
Figure 4 : Model for Th Differentiation from Nave CD4+ T Cells
Figure 5 : Diagram of Regulatory T-Cell, Effector T-Cells and Dendritic Cells Showing Putative Mechanisms of Suppression by Regulatory T-Cells
Figure 6 : Interactions and Cross Talk Between Different Subsets of NKT Cells and Other Immune Cells in TME
Figure 7 : Schematic of Adoptive Cell Transfer Therapies
Figure 8 : Structure and function of the TCR
Figure 9 : General Structure of a Chimeric Antigen Receptor
Figure 10 : CAR T-Cell Design
Figure 11 : CAR T-Cell Manufacture and Product Testing Process
Figure 12 : Sleeping Beauty (SB) Transposon System Mechanism Schematic
Figure 13 : piggyBac (PB) Transposon System Cut and Paste Mechanism Schematic
Figure 14 : CRISPR/Cas9 System Mechanism Schematic
Figure 15 : CAR T-Cell Clinical Trial Activity Globally, by Phase, as of April 27, 2018
Figure 16 : CAR T-Cell Clinical Trial Activity Globally, by Study Start Date and Phase, 2005-April 27, 2018
Figure 17 : Distribution Map of CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of April 26, 2018
Figure 18 : Distribution Map of CAR T-Cell Clinical Trial Activity in Europe, by Study Location/Country, as of April 26, 2018
Figure 19 : Distribution Map of Phase I CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of April 26, 2018
Figure 20 : Distribution Map of Phase II CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of April 26, 2018
Figure 21 : Distribution Map of Phase III CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of April 26, 2018
Figure 22 : CAR T-Cell Clinical Trials in the United States, by Study Start Date and Phase, 2006-April 30, 2018
Figure 23 : Distribution of CAR T-Cell Clinical Trials in China, by Study Location/Region, as of April 26, 2018
Figure 24 : CAR T-Cell Clinical Trials in China, by Study Start Date and Phase, 2006 Through April 30, 2018
Figure 25 : Estimated World Cancer Incidence in Men and Women Combined, by Major Site, 2012
Figure 26 : Global Estimated Cancer Incidence in Men, by Major Site, 2012
Figure 27 : Global Estimated Cancer Incidence in Women by Major Site, 2012
Figure 28 : Global CAR T-Cell Market, by Product, 2017-2023
Figure 29 : Global CAR T-Cell Market Shares, by Region, 2018
Figure 30 : Drug Discovery and Development Time Line
Figure 31 : Mutual Recognition Procedure
Figure 32 : Decentralized Procedure
Figure 33 : Japan Drug Funding/Reimbursement Approval Procedure
Figure 34 : The Chinese Healthcare System
Figure 35 : Argentina: Regulatory Drug Approval Procedure Standard Review 120-240 Business Days* for Approval**
Figure 36 : Current Structure of the Health Care Sector in Saudi Arabia
Figure 37 : Bellicum Pharmaceuticals Inc. Product Pipeline
Figure 38 : Cellectis Allogeneic CAR T Pipeline
Figure 39 : Eureka Therapeutics Product Pipeline
Figure 40 : Formula Pharmaceuticals Product Pipeline
Figure 41 : Kite Pharma Inc. (a Subsidiary of Gilead Sciences Inc.) CAR and TCR Pipeline
Figure 42 : Mustang Bio Research and Development Pipeline
Figure 43 : Noile-Immune Biotech CAR Pipeline
Figure 44 : Novartis Sales Prediction for Kymriah
Figure 45 : Protheragen Product Pipeline
Figure 46 : PureTech Health Immune System Pipeline
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