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キメラ抗原受容体T細胞 (CAR-T細胞) 療法

Chimeric Antigen Receptor Cell Therapy

発行 GlobalData 商品コード 815395
出版日 ページ情報 英文 108 Pages
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キメラ抗原受容体T細胞 (CAR-T細胞) 療法 Chimeric Antigen Receptor Cell Therapy
出版日: 2019年02月28日 ページ情報: 英文 108 Pages
概要

キメラ抗原受容体T細胞 (CAR-T細胞) 療法はがん免疫療法 (IO) のアプローチの一種で、近年になって急速に普及してきました。その効能の高さについては以前より知られていましたが、製造工程の複雑さやコストの高さ、毒性の強さなどが普及の障害となってきました。現在では、同種異系CAR-T細胞や「武装化」細胞、併用療法などの新たな活用法が開発され、効率の改善や問題点の克服が図られています。

当レポートでは、世界のCAR-T細胞療法の最新の治験動向について調査すると共に、治療法の概略や今日までの開発の成果、主要8ヶ国 (8MM:フランス、ドイツ、イタリア、スペイン、英国、米国、日本、中国) における規制環境や、CAR-T療法の推進に際しての主な課題、今後の技術開発・市場展開の方向性、腫瘍治療専門家の見解、といった情報を取りまとめてお届けいたします。

第1章 序論

第2章 エグゼクティブ・サマリー

第3章 イントロダクション

  • CAR-T細胞療法の作用機序
  • CAR-T細胞製品の開発の歴史
  • 認証済みのCAR-T細胞製品
  • CAR-T細胞療法:治験最終段階にあるパイプライン製品
  • CAR-T細胞療法:前臨床試験の製品

第4章 CAR-T細胞の関連規制

  • 世界の主要国 (8MM) における、CAR-T細胞療法の関連規制
  • CAR-T細胞療法の関連規制:米国の場合
  • CAR-T細胞療法の関連規制:欧州諸国の場合
  • CAR-T細胞療法の関連規制:日本の場合
  • CAR-T細胞療法の関連規制:中国の場合

第5章 CAR-T細胞療法の課題

  • 価格面での問題
  • 有毒性
  • 製造工程
  • 耐性

第6章 CAR-T細胞療法の将来的な方向性

  • 同種移植CAR-T細胞療法
  • 武装化 (armored) CAR-T細胞
  • 二重標的CAR-T細胞療法
  • CAR-T細胞との併用療法
  • CARナチュラルキラー細胞
  • 固形腫瘍向けCAR-T細胞療法

第7章 付録

目次
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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