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嵌合抗原受體T細胞 (CAR-T細胞) 療法

Chimeric Antigen Receptor Cell Therapy

出版商 GlobalData 商品編碼 815395
出版日期 內容資訊 英文 108 Pages
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嵌合抗原受體T細胞 (CAR-T細胞) 療法 Chimeric Antigen Receptor Cell Therapy
出版日期: 2019年02月28日內容資訊: 英文 108 Pages
簡介

嵌合抗原受體T細胞 (CAR-T細胞) 療法是用癌症免疫療法 (IO)的方法之一,近幾年急速普及。以前已知關於其功效高,不過,製造工程的複雜度、成本高、毒性強等成為普及的障礙。現在,開發同種異體CAR-T細胞「裝甲化」細胞,聯合治療等新的有效利用方法,改善效率和克服問題點。

本報告提供全球CAR-T細胞療法的最新臨床實驗趨勢調查,治療方法的概要和到目前為止的開發成果,主要8個國家(8MM:法國,德國,義大利,西班牙,英國,美國,日本,中國)的法規環境,及推動CAR-T療法時的主要課題,今後的技術開發、市場部署的方向性,腫瘤治療專家的見解等資訊彙整,為您概述為以下內容。

第1章 序論

第2章 摘要整理

第3章 簡介

  • CAR-T細胞療法的作用機制
  • CAR-T細胞產品的發展歷史
  • 已認證的CAR-T細胞產品
  • CAR-T細胞療法:臨床實驗最後階段的開發中產品
  • CAR-T細胞療法:臨床試驗前的產品

第4章 CAR-T細胞的相關法規

  • 全球主要國家 (8MM) 的,CAR-T細胞療法的相關法規
  • CAR-T細胞療法的相關法規:美國的情況
  • CAR-T細胞療法的相關法規:歐洲各國的情況
  • CAR-T細胞療法的相關法規:日本的情況
  • CAR-T細胞療法的相關法規:中國的情況

第5章 CAR-T細胞療法的課題

  • 在價格方面的問題
  • 有毒性
  • 製造工程
  • 抗性

第6章 CAR-T細胞療法的未來方向性

  • 同類移植CAR-T細胞療法
  • 裝甲化 (armored) CAR-T細胞
  • 雙重標的CAR-T細胞療法
  • CAR-T細胞的聯合治療
  • CAR自然殺手細胞
  • 固體腫瘤CAR-T細胞療法

第7章 附錄

目錄
Product Code: GDHCHT022

Chimeric Antigen Receptor (CAR) cell therapy is an Immuno-Oncology (IO) approach that has gained increasing momentum in the past few years. Despite having demonstrated impressive efficacy in terms of response rates, CAR-T cell therapies are faced with several issues. Complex manufacturing leads to delayed patient access, high toxicity requires constant patient monitoring, and high cost of production means therapies are costing close to $0.5M.

Many new methods are being tested to improve CAR cell efficacy and overcome these challenges, in a broad range of indications Allogeneic CAR cell therapies may reduce manufacturing delays; however these are likely to be associated with additional toxicities versus autologous cells, and may demonstrate lower persistence.

Combinatorial approaches may improve CAR cell therapy efficacy and prevent resistance, but no single strategy stands out as the most promising. 'Armored' CARs, CARs in combination with other immunotherapies, and dual-targeting CARs may be some of the ways in which CARs can be enhanced, however there are concerns that these may drive up cost of already very costly therapies.

CAR cell therapies are still very new, and specific guidance for regulation is not available on a global scale. Improved regulatory guidance may enhance integration of CAR cell therapies as developers feel more confident in their strategic approaches.

There is global consensus that cell therapies should be regulated in a different way to small molecules or other less complex biologic therapies, however, to date, CAR cell-specific guidance exists only in Europe. Nevertheless, the European, American, Japanese, and Chinese healthcare regulatory agencies all appreciate that cell therapies have huge therapeutic potential, and accelerated pathways for approval of cell therapies are in place in these markets.

Currently, two CAR-T cell products are approved in the US and EU, Gilead Sciences' Yescarta for diffuse large B-cell lymphoma (DLBCL) and Novartis' Kymriah for acute lymphocytic leukemia and DLBCL, while several late-stage candidates are being developed for a broad range of blood cancers and solid tumors.

The "Chimeric Antigen Receptor Cell Therapy", report provides an overview of the approved and late-stage pipeline CAR cell therapy landscape (including pre-clinical and Phase I CAR-NK cells), as well as a summary of key regulation processes in place in the 8MM (France, Germany, Italy, Spain, UK, US, Japan, China). Key challenges faced by CAR cell therapies are summarized, as well as expected future development trends for the field.

Scope

Components of the slide deck include primary and secondary research -

  • Quotes from eight US- and 5EU-based key opinion leaders, payers, and researchers
  • Quotes from three Japan-based key opinion leaders
  • Summary of CAR-cell therapy mechanism of action and history of development
  • Overview of late-stage CAR cell pipeline and two marketed products
  • Outline of regulatory pathways in place for CAR cell therapies across the 8MM, challenges that currently face CAR cell therapies, and future directions for CAR cell therapies
  • Call-outs of key information and details
  • Insight from GlobalData's specialist oncology analysts.

Reasons to buy

  • Develop business strategies by understanding the challenges facing CAR cell therapies.
  • Design development strategies by understanding innovative development strategies likely to improve CAR cell therapy perceptions and uptake in the future.
  • Be acquainted with regulatory processes relevant to CAR cell therapies across the US, 5EU, Japan and China.
  • Develop strategies by understanding expert perceptions of currently approved CAR cell therapies, challenges facing CAR cell therapies, and future directions of CAR cell therapy.

Table of Contents

1. Preface

  • 1.1 Related Reports
  • 1.2 Upcoming Reports
  • 1.3 Abbreviations

2. Executive Summary

3. Introduction

  • 3.1 Chimeric Antigen Receptor Cell Therapy Mechanism of Action
  • 3.2 History of Development of CAR Cell Products
  • 3.3 Approved CAR-T Cell Products
  • 3.4 Late-stage Pipeline CAR-T Cell Therapies
  • 3.5 Preclinical Development of CAR Cell Products

4. Regulatory Pathways for CAR Cell Therapy

  • 4.1 CAR Cell Therapy Regulation Overview in the 8MM
  • 4.2 US CAR Cell Therapy Regulation
  • 4.3 EU CAR Cell Therapy Regulation
  • 4.4 Japan CAR Cell Therapy Regulation
  • 4.5 China CAR Cell Therapy Regulation

5. Challenges for CAR Cell Therapy

  • 5.1 Pricing Issues
  • 5.2 Toxicity
  • 5.3 Manufacturing
  • 5.4 Resistance

6. Future Directions for CAR Cell Therapy

  • 6.1 Allogeneic CAR Cell Therapies
  • 6.2 Armored CARs
  • 6.3 Dual Targeting CAR Cell Therapies
  • 6.4 CAR Cell Therapy Combinations
  • 6.5 CAR Natural Killer Cells
  • 6.6 CAR Cell Therapies for Solid Tumors

7. Appendix

  • 7.1 Primary Research
  • 7.2 Sources
  • 7.3 About the Authors
  • 7.4 About GlobalData
  • 7.5 Contact Us
  • 7.6 Disclaimer
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