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キメラ抗原受容体 (CAR) T細胞療法の現在の研究開発状況

Current Research & Developments Status of Chimeric Antigen Receptor (CAR) T-Cell Therapy

発行 BCC Research 商品コード 667514
出版日 ページ情報 英文 273 Pages
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キメラ抗原受容体 (CAR) T細胞療法の現在の研究開発状況 Current Research & Developments Status of Chimeric Antigen Receptor (CAR) T-Cell Therapy
出版日: 2018年07月24日 ページ情報: 英文 273 Pages
担当者のコメント
再生医療分野において注目を集め、市場の拡大が見込まれる、CAR-T細胞療法に着目した最新レポートが米国BCC Research社よりリリースされました。各国の規制トレンド、市場予測、新規参入企業及び製品開発動向など、当レポートで最新のトレンドを入手いただけます。試読可能ですので、是非お問い合わせください。
概要

世界のキメラ抗原受容体 (CAR) T細胞療法市場は、2018年の4億6,700米ドルから2023年までに29億米ドルへ拡大すると予測され、この間のCAGR (年間複合成長率) は44.1%が見込まれています。

当レポートでは、世界のキメラ抗原受容体 (CAR) T細胞療法市場について調査し、CAR T細胞技術の開発実績レビュー、CAR設計の原理についての議論、CAR T細胞免疫療法に関連した作用機序の把握、既存のCAR T細胞技術の副作用・デメリット・制限、現在の上市薬、規制要件のレビュー、世界のCAR T細胞療法市場ダイナミクスのレビュー、および主要企業のプロファイルなどをまとめています。

第1章 イントロダクション

第2章 サマリーとハイライト

第3章 キメラ抗原受容体 (CAR) T細胞療法のイントロダクション

  • イントロダクション
  • CAR T細胞療法開発のイントロダクション
  • 抗原
  • 差別化のクラスター
  • リンパ球
  • 養子免疫療法 (ACT) 技術

第4章 現在の製造方法、最新の技術進歩、および将来の方向性

  • CAR T細胞の製造
  • CAR T細胞の製造課題の克服
  • 製造工程における最新の進歩

第5章 CAR T細胞と関連技術の治験分析

  • イントロダクション
  • 世界で実施されている治験
  • 米国におけるCAR T細胞治験の分布
  • 中国におけるCAR T細胞治験の分布

第6章 癌の発症率・有病率・死亡率統計:世界のサマリー

  • 癌:疾患
  • 癌:疾患発症率・有病率の統計分析
  • 世界における癌の地域的パターン
  • 世界における癌の負担・世界的な癌リスク因子

第7章 世界のCAR T細胞市場分析

  • イントロダクション
  • 世界のCAR T細胞市場
  • 世界のCAR T細胞市場シェア分析
  • 市場ダイナミクス

第8章 CAR T細胞と関連技術の規制・法的要件

  • 北米
  • 欧州
  • アジア太平洋
  • 中南米
  • 中東・アフリカ
  • 製造・試験に関する出版ガイドライン

第9章 CARの特許レビュー/新規開発

  • イントロダクション
  • 企業別のIP (知的財産)・特許情報

第10章 企業プロファイル

  • AMGEN
  • AVACTA LIFE SCIENCES LTD.
  • BELLICUM PHAMACEUTICALS
  • BLUEBIRD BIO
  • CELGENE CORP.
  • CELLECTIS
  • CELYAD SA
  • EDITAS MEDICINE INC.
  • EUREKA THERAPEUTICS INC.
  • FORMULA PHARMACEUTICALS INC.
  • GILEAD SCIENCES
  • F. HOFFMAN LA ROCHE AG
  • ICELL GENE THERAPEUTICS
  • JUNO THERAPEUTICS INC. (A CELGENE COMPANY)
  • KITE PHARMA INC. (A SUBSIDIARY OF GILEAD SCIENCES INC.)
  • MEDIMMUNE LLC/ASTRAZENECA
  • MUSTANG BIO INC.
  • NOILE-IMMUNE BIOTECH
  • NOVARTIS AG
  • PROTHERAGEN INC.
  • PURETECH HEALTH
  • SERVIER LABORATORIES
  • SHIRE PHARMACEUTICALS INC.
  • TAKEDA PHARMACEUTICALS
  • TRANSGENE SA

第11章〜第15章 付録A〜付録E

図表

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 Pharma's 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 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 Naive 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
目次
Product Code: BIO162A

Highlights:

The global market for Chimeric Antigen Receptor (CAR) T-cell therapies will grow from nearly $467 million in 2018 to $2.9 billion by 2023 at a compound annual growth rate (CAGR) of 44.1% for the period of 2018-2023.

North American market for Chimeric Antigen Receptor (CAR) T-cell therapies will grow from $430 million in 2018 to nearly $2.5 billion by 2023 at a CAGR of 42.2% through 2023.

Asia-Pacific market for Chimeric Antigen Receptor (CAR) T-cell therapies will grow from $3.0 million in 2018 to $35.0 million by 2023 at a CAGR of 63.5% through 2023.

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:

  • 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
  • Analyst's Credentials
  • 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: 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

  • 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 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
    • Europe
    • North America
    • Asia-Pacific
    • 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

  • Introduction
  • 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
  • Market Dynamics
    • 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

  • 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 9: Patent Review/New Developments for Chimeric Antigen Receptors (CARs)

  • 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 Company)
    • Mustang Bio Inc.
    • Noile-Immune Biotech
    • Novartis AG

Chapter 10: Company Profiles

  • AMGEN
  • AVACTA LIFE SCIENCES LTD.
  • BELLICUM PHAMACEUTICALS
  • BLUEBIRD BIO
  • CELGENE CORP.
  • CELLECTIS
  • CELYAD SA
  • EDITAS MEDICINE INC.
  • EUREKA THERAPEUTICS INC.
  • FORMULA PHARMACEUTICALS INC.
  • GILEAD SCIENCES
  • F. HOFFMAN LA ROCHE AG
  • ICELL GENE THERAPEUTICS
  • JUNO THERAPEUTICS INC. (A CELGENE COMPANY)
  • KITE PHARMA INC. (A SUBSIDIARY OF GILEAD SCIENCES INC.)
  • MEDIMMUNE LLC/ASTRAZENECA
  • MUSTANG BIO INC.
  • NOILE-IMMUNE BIOTECH
  • NOVARTIS AG
  • PROTHERAGEN INC.
  • PURETECH HEALTH
  • SERVIER LABORATORIES
  • SHIRE PHARMACEUTICALS INC.
  • TAKEDA PHARMACEUTICALS
  • TRANSGENE SA

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
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