Current Research & Development Status of Chimeric Antigen Receptor (CAR) T-Cell Therapy
Report Scope:
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.
Report Includes:
- 37 data tables and 55 additional tables
- An updated review of the global market for chimeric antigen receptor (CAR) T-cell therapy with emphasis on the current research and development status
- Analyses of the global market trends, with historic data from 2018-2020, estimates for 2021 and 2022, and projections of compound annual growth rates (CAGRs) through 2026
- Evaluation and forecast the overall CAR T-Cell therapy market size in dollar value terms, and corresponding market share analysis by product, application, technology and region
- Highlights of the market potential for the CAR T-cell therapy market, opportunities and trends estimating current and future demand, and impact of COVID-19 on the progress of this market
- Assessment of current marketed drugs, including development activities, R&D activities and anticipated developments, along with a look into the patent expirations within the industry
- Latest information on the major stakeholders of global CAR T-Cell therapy market, along with a review of their intellectual property status, product innovations, technological advancements, and research collaborations and business consolidations
- Insight into the current competitive environment, recent mergers and acquisitions, license agreements, and company revenue share analysis of the key players involved in the development of therapeutics for CAR T-cell therapy
- Descriptive company profiles of the leading industry players, including AstraZeneca, Bristol Myers Squibb, Gilead Sciences, Novartis AG, F. Hoffmann-La Roche and Takeda Pharmaceutical Co., Ltd.
- Chapter 1 Introduction
- Scope of This Report
- What's New in this Update?
- Methodology and Information Sources
- Primary Data and Information Gathering
- Secondary Data and Information Gathering
- Market Share Analysis and Market Forecast
- Analyst's Credentials
- BCC Custom Research
- Related BCC Research Reports
- Chapter 2 Summary and Highlights
- CAR T-Cell Design and Evolution
- FDA Product Approvals
- Market Analysis
- 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
- Clinical Trials
- Chapter 3 Introduction to Chimeric Antigen Receptor (CAR) T-Cell Therapy
- Introduction
- A Brief History of CAR T-Cell Therapy Development
- Antigens
- Exogenous Antigens
- Endogenous Antigens
- Autoantigens
- Tumor Antigens
- Cluster of Differentiation
- Lymphocytes
- B Cells
- T Cells
- Adoptive Cell Transfer (ACT) Technologies
- Tumor-Infiltrating Lymphocytes (TILs)
- T-Cell Receptors (TCRs)
- Chimeric Antigen Receptors (CARs)
- Chapter 4 Impact of COVID-19 on the Market
- Overview
- Outlook
- Chapter 5 Market Dynamics
- Market Dynamics
- Selected Drivers of the Global CAR T-Cell Market
- Trends
- Selected Restraints of the Global CAR T-Cell Market
- Chapter 6 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 7 Clinical Trials on CAR T Cells and Related Technologies
- Introduction
- 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 8 Cancer Demographics: A Global Summary
- Cancer: The Disease
- Epidemiology by Cancer Type/Site
- Global Cancer Incidence
- Global Cancer Prevalence, 2020
- Global Cancer Mortality Overview
- Cancer Epidemiology by Region
- Europe
- North America
- Asia-Pacific
- Rest of the World
- 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 9 Global CAR T-Cell Market Analysis
- Introduction
- Global CAR T-Cell Market
- Yescarta
- Tecartus
- Kymriah
- Breyanzi
- Abecma
- Chapter 10 Regional Analysis
- North America
- Europe
- Asia-Pacific
- Rest of the World
- Chapter 11 Regulatory and Legislative Requirements
- North America
- United States
- Canada
- Europe
- Mutual Recognition Procedure (MRP)
- Decentralized Procedure (DCP)
- Centralized Procedure (CP)
- Asia-Pacific
- Japan
- China
- India
- South Korea
- Central and South America
- Brazil
- Argentina
- Mexico
- Middle East and Africa
- South Africa
- Saudi Arabia
- Published Guidelines on Production and Testing of Cell-Based Therapies
- Chapter 12 Patent Review/New Developments
- Introduction
- 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
- Amgen
- Avacta Life Sciences Ltd.
- Bellicum Pharmaceuticals Inc.
- Bluebird Bio
- Celgene Corp.
- Cellectis
- Celyad SA
- Editas Medicine Inc.
- Eureka Therapeutics Inc.
- Gilead Sciences Inc.
- iCell Gene Therapeutics
- Juno Therapeutics Inc. (A Celgene Co.)
- Mustang Bio Inc.
- Noile-Immune Biotech
- Novartis AG
- Chapter 13 Global Competitive Market Landscape
- Global CAR T-Cell Market Share Analysis
- Market Share Analysis
- Product Launches
- Strategic Initiatives
- Mergers and Acquisitions
- Chapter 14 Company Profiles
- ABBVIE INC.
- AMGEN
- ASTRAZENECA
- AVACTA LIFE SCIENCES LTD.
- BELLICUM PHAMACEUTICALS
- BLUEBIRD BIO
- BRISTOL MYERS SQUIBB
- CELLECTIS
- CELYAD SA
- EDITAS MEDICINE INC.
- EUREKA THERAPEUTICS INC.
- FORMULA PHARMACEUTICALS INC.
- GILEAD SCIENCES
- F. HOFFMAN-LA ROCHE AG
- ICELL GENE THERAPEUTICS
- MUSTANG BIO INC.
- NOILE-IMMUNE BIOTECH
- NOVARTIS AG
- PROTHERAGEN INC.
- PURETECH HEALTH
- SERVIER LABORATORIES
- TAKEDA PHARMACEUTICALS
- TRANSGENE SA
- Chapter 15 Appendix A
- Company Contact Details
- Chapter 16 Appendix B
- Government Regulatory Agencies and Professional Organizations
- Chapter 17 Appendix C
- Commonly Used Acronyms Associated with CAR T-Cell Therapy
- Chapter 18 Appendix D
- Recent Patent Applications Filed Related to CAR T-Cell Therapy
- Chapter 19 Appendix E
- CAR T-Cell and CD19 Clinical Trials in China
- List of Tables
- Summary Table A : Global CAR T-Cell Market, by Region, Through 2026
- Summary Table B : Global CAR T-Cell Market, by Product, Through 2026
- 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 : Reported COVID-19 Confirmed Cases and Deaths, by Country, October 22, 2021
- Table 7 : Supplementary Components in CAR T-Cell Manufacture
- Table 8 : Technologies Used in the Selection, Isolation and Enrichment of Cells During the Manufacture of CAR T Cells
- Table 9 : Technologies Used in the Activation and Simulation of Cells During the Manufacture of CAR T Cells
- Table 10 : Technologies Used in the Gene Transfer and Delivery of Cells During the Manufacture of CAR T Cells
- Table 11 : Gene Transfer and Gene Delivery Technologies Developed by Poseida Therapeutics Inc.
- Table 12 : Technologies Used in the Expansion and Culture of Cells During the Manufacture of CAR T Cells
- Table 13 : Technologies Used in the Formulation of Cells During the Manufacture of CAR T Cells
- Table 14 : Technologies Used in the Cryopreservation of Cells During the Manufacture of CAR T Cells
- Table 15 : Technologies Used in the Thawing of Cells During the Manufacture of CAR T Cells
- Table 16 : Emerging CAR T-Cell Therapy Clinical Trials, by Company
- Table 17 : Global CAR T-Cell Clinical Trial Activity, by Study Location/Region, as of Oct. 2021
- Table 18 : Clinical Trials on CD19 Directed CAR T-Cells in the U.S.
- Table 19 : Examples of Clinical Trials on CD19-Directed CAR T Cells in China
- Table 20 : Examples of Clinical Trials on CAR T Cells Targeting Non-CD19 Antigens in China
- Table 21 : Examples of Clinical Trials on CAR T Cells for Solid Tumors in China
- Table 22 : Clinical Trials on CAR T Cells with Fourth-Generation CARs in China
- Table 23 : Global Cancer Incidence, by Cancer Type/Site, 2020
- Table 24 : Global Cancer Mortality, by Cancer Type/Site, 2020
- Table 25 : Estimated Number of New Cancer Cases in the U.S., by Cancer Type/Site and Sex, 2021
- Table 26 : Estimated Number of Cancer Deaths in the U.S., by Cancer Type/Site and Sex, 2021
- Table 27 : Global CAR T-Cell Market, by Product, 2026
- Table 28 : Global CAR T-Cell Market, by Region, Through 2026
- Table 29 : Global CAR T-Cell Market Share, by Region, 2021
- Table 30 : North American CAR T-Cell Market, Through 2026
- Table 31 : North American CAR T-Cell Market, by Product, Through 2026
- Table 32 : European CAR T-Cell Market, Through 2023
- Table 33 : European CAR T-Cell Market, by Product, Through 2026
- Table 34 : Asia-Pacific CAR T-Cell Market, Through 2023
- Table 35 : Asia-Pacific CAR T-Cell Market, by Product, Through 2026
- Table 36 : Rest of the World CAR T-Cell Market, Through 2020-2026
- Table 37 : Rest of the World CAR T-Cell Market, by Product, Through 2026
- Table 38 : Overview of Healthcare System in India
- Table 39 : Recent CAR T-Cell Therapy Patents and Patent Applications, 2020-2021
- Table 40 : Recent Bluebird Bio Patents and Patent Applications, 2010-Apr. 2021
- Table 41 : Recent Celgene Patents and Patent Applications, 2018-2021
- Table 42 : Recent Cellectis Patents and Patent Applications, 2018-2021
- Table 43 : Editas Medicine Patent Applications, 2010-2021
- Table 44 : Eureka Therapeutics Patent Applications, 2015-2021
- Table 45 : Kite Pharma’s (Gilead Sciences Subsidiary) Core Anticancer Technology: Yeda Research and Development Co., Ltd. Patents and Patent Applications, 1993-Apr. 2021
- Table 46 : iCell Gene Therapeutics Patent Applications
- Table 47 : Juno Therapeutics Inc. and Memorial Sloan Kettering Patents and Patent Applications
- Table 48 : Mustang Bio and City of Hope National Medical Center Patents and Patent Applications
- Table 49 : Noile-Immune Biotech Inc. Yamaguchi University Patent Applications
- Table 50 : Novartis AG and University of Pennsylvania Patents and Patent Applications, 2013-2021
- Table 51 : Global CAR T-Cell Market Share, by Company, 2021
- Table 52 : Global CAR T-Cell Therapy Market, by Company Revenue, 2018-2021
- Table 53 : New Product Launches in the CAR T-Cell Therapy Market
- Table 54 : New Strategic Initiatives in CAR T-Cell Therapy Market
- Table 55 : Mergers and Acquisitions in the CAR T-Cell Therapy Market, 2018-2021
- Table 56 : Regulatory Approvals in the CAR T-Cell Therapy Market, 2018-2021
- Table 57 : AbbVie Inc.: Marketed Products
- Table 58 : AbbVie Inc.: Net Revenue, 2017-2020
- Table 59 : AbbVie Inc.: Key Developments
- Table 60 : Amgen: Financials, 2014-2020
- Table 61 : Amgen: Financials, by Product, 2014-2020
- Table 62 : Avacta Group plc: Financials, 2015-2017
- Table 63 : Bellicum Pharmaceuticals Inc.: Financials, 2019 and 2020
- Table 64 : Bellicum Pharmaceuticals Inc.: Key Switch Technologies
- Table 65 : Bluebird Bio: Financials, 2018-2020
- Table 66 : Bluebird Bio: Key Developments
- Table 67 : Bristol-Myers Squibb: Net Revenue, 2017-2020
- Table 68 : Bristol-Myers Squibb: Key Cancer Biologics Product Portfolio
- Table 69 : Bristol-Myers Squibb: Key Developments
- Table 70 : Juno Therapeutics: Product Pipeline
- Table 71 : Editas Medicine Inc.: Financials, 2015-2020
- Table 72 : Editas Medicine Inc.: Key Developments
- Table 73 : Gilead Sciences: Financials, 2014-2020
- Table 74 : Gilead Sciences: Key CAR T-Cell Therapies
- Table 75 : Gilead Sciences: Individual Product Sales, 2018-2020
- Table 76 : Gilead Sciences: Product Pipeline
- Table 77 : F. Hoffman-La Roche: Financials, 2019 and 2020
- Table 78 : F. Hoffman-La Roche: Pharmaceutical Division Financials, 2019 and 2020
- Table 79 : F. Hoffman-La Roche: Total Revenue, by Geography, 2020
- Table 80 : iCell Gene Therapeutics: Product Development Pipeline
- Table 81 : Mustang Bio Inc.: Research and Development Pipeline
- Table 82 : Novartis AG: Revenues, by Segment, 2019 and 2020
- Table 83 : Protheragen: Enabling Technologies
- Table 84 : PureTech Health: Immune System Pipeline
- Table 85 : Takeda Pharmaceuticals: Financials, 2014-2016
- Table 86 : Company Contact Details
- Table 87 : Government Regulatory Agencies and Professional Organizations Associated with CAR T-Cell Therapy
- Table 88 : Commonly Used Acronyms Associated with CAR T-Cell Therapy
- Table 89 : Recent Patent Applications Filed Related to CAR T-Cell Therapy
- Table 90 : CAR T-Cell and CD19 Clinical Trials in China
- List of Figures
- Summary Figure A : Global CAR T-Cell Market Share, by Region, 2021
- Summary Figure B : Global CAR T-Cell Market, by Product, 2018-2026
- Summary Figure C : Global CAR T-Cell Clinical Trials, by Phase, as of October 2021
- 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 Naïve 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 : Global CAR T-Cell Clinical Trial Activity, by Phase, as of Oct. 2021
- Figure 16 : Global CAR T-Cell Clinical Trial Activity, by Study Start Date and Phase, 2005-Oct. 2021
- Figure 17 : Distribution Map of CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of Oct. 2021
- Figure 18 : Distribution Map of CAR T-Cell Clinical Trial Activity in Europe, by Study Location/Country, as of Oct. 2021
- Figure 19 : Distribution Map of Phase I CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of Oct. 2021
- Figure 20 : Distribution Map of Phase II CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of Oct. 2021
- Figure 21 : Distribution Map of Phase III CAR T-Cell Clinical Trial Activity Globally, by Study Location/Country, as of Oct. 2021
- Figure 22 : Distribution Map of CAR T-Cell Clinical Trial Activity in the U.S., by Study Location, as of Oct. 2021
- Figure 23 : Distribution of CAR T-Cell Clinical Trials in China, South Korea and Taiwan, by Study Location/Region, as of Oct. 2021
- Figure 24 : CAR T-Cell Clinical Trials in China, by Study Start Date and Phase, 2006-Oct. 2021
- Figure 25 : Global Cancer Incidence, by Sex and Cancer Type/Site, 2020
- Figure 26 : Global Cancer Incidence, by Region, 2020
- Figure 27 : Global Cancer Incidence Trends, by Cancer Type/Site, 2020-2030
- Figure 28 : Global Cancer Prevalence by Cancer Type/Site and Sex, 2020
- Figure 29 : Global CAR T-Cell Market, by Product, 2018-2026
- Figure 30 : Global Market for Yescarta Cell Therapy, by Region, 2017-2021
- Figure 31 : Global Market Shares of Yescarta Cell Therapy, by Region, 2020
- Figure 32 : Global Market for Tecartus, by Region, 2020-2021
- Figure 33 : Global Market Shares of Tecartus, by Region, 2020
- Figure 34 : Global Market for Kymriah, by Region, 2017-2021
- Figure 35 : Global Market Shares of Kymriah, by Region, 2020
- Figure 36 : Global CAR T-Cell Market Share, by Region, 2021
- Figure 37 : Drug Discovery and Development Timeline
- Figure 38 : Mutual Recognition Procedure
- Figure 39 : Decentralized Procedure
- Figure 40 : Japanese Drug Funding/Reimbursement Approval Procedure
- Figure 41 : The Chinese Healthcare System
- Figure 42 : Argentina: Regulatory Drug Approval Procedure Standard Review 120-240 Business Days* for Approval**
- Figure 43 : Current Structure of the Health Care Sector in Saudi Arabia
- Figure 44 : Global CAR T-Cell Therapy Market Share, by Company, 2021
- Figure 45 : AbbVie Inc.: Revenue Share, by Country, 2020
- Figure 46 : Bellicum Pharmaceuticals Inc.: Product Pipeline
- Figure 47 : Bristol-Myers Squibb: Revenue Share, by Segment, 2020
- Figure 48 : Bristol-Myers Squibb: Revenue Share, by Region, 2020
- Figure 49 : Cellectis: Allogeneic CAR-T Pipeline
- Figure 50 : Eureka Therapeutics Inc.: Product Pipeline
- Figure 51 : Formula Pharmaceuticals Inc.: Product Pipeline
- Figure 52 : Kite Pharma Inc. (a Subsidiary of Gilead Sciences Inc.): CAR and TCR Pipeline
- Figure 53 : Noile-Immune Biotech: CAR Pipeline
- Figure 54 : Novartis AG: Sales Prediction for Kymriah
- Figure 55 : Protheragen: Product Pipeline