表紙:キメラ抗原受容体 (CAR-T) 細胞療法:市場機会・パイプライン製品・競争情報 (2020年)
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キメラ抗原受容体 (CAR-T) 細胞療法:市場機会・パイプライン製品・競争情報 (2020年)

Chimeric Antigen Receptor (CAR-T) Cell Therapy - Market Opportunity, Pipeline & Competitive Intelligence 2020

出版日: | 発行: Mellalta Meets LLP | ページ情報: 英文 1,083 Pages | 納期: 即納可能 即納可能とは

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キメラ抗原受容体 (CAR-T) 細胞療法:市場機会・パイプライン製品・競争情報 (2020年)
出版日: 2021年06月22日
発行: Mellalta Meets LLP
ページ情報: 英文 1,083 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 目次
概要

近年、キメラ抗原受容体 (CAR-T) 細胞療法に関する研究開発が進み、安全性・有効性が向上するとともに、投資家からの関心が高まっています。現在、何千件もの細胞・遺伝子治療のパイプライン製品が治験・上市の途上にあり、FDA (米国食品医薬品局) では2025年までに年間10~20件の新製品を承認していく見通しです。

CAR-Tの分野では過去8年間に、合計76件の事業提携が観測されています。また、投資取引額は合計100億米ドルに達しています。特に2018年は他の年度より約28億米ドルもの増加となっています。

CAR-Tの分野では過去11年間で、産学間の事業協力が52件観察されました。また、2013年から2020年に78件の企業買収取引が観測されています。新規治療薬の認証と既存製品の販売増加を受けて、開発・製造拠点の拡張や新設も進んでいます。

当レポートでは、世界のキメラ抗原受容体 (CAR-T) 細胞療法の市場の開発・取引動向について分析し、治療法の概要や主な標的 (適応症・抗原)、実用化に向けた課題、主な資本取引の動き、現在の治験パイプラインの動向 - 治験中の主要製品のプロファイルと治験結果 -、上市済み製品の概略と売上高の見通し、全体的な市場規模の動向見通し (2021年~2030年)、KOLの見解、今後の成長機会と取るべき戦略、といった情報を取りまとめてお届けいたします。

目次

CAR-T療法:分析概要

CAR-T療法:成功のための重要な基準

CAR-T療法:イントロダクション

  • キメラ抗原受容体 (CAR-T) 細胞療法の概要
    • CARの発生
    • CAR-T細胞療法の設計
    • T細胞の遺伝子工学
    • 第2世代・第3世代のCARシグナリングの必要性
    • 共刺激ドメイン
  • CAR-T細胞療法の実用化への課題
    • 複雑な製造工程とサプライチェーン
    • CAR-T患者の「治療の旅」
    • CAR-Tの医療費償還の課題
  • CAR-Tによる課題の克服
    • 高度な遺伝子導入ツールの実装
    • 医療現場でのCAR-Tの管理
    • 固形腫瘍分野での急速な革新
  • CAR-T細胞療法:分析
    • CAR-T関連の事業提携取引
      • CAR-T細胞療法関連の事業提携取引の年度
      • CAR-T投資の分析
      • 事業提携の取引金額の動向
    • CAR-T関連の企業買収取引
      • CAR-T細胞療法の企業買収の動向
      • CAR-T細胞療法の企業買収の内容
    • CAR-T細胞の開発施設
  • 同種異系CAR-T療法:CAR-T空間における有望なアプローチ
  • CAR-Tのライセンシングの機会
  • パイプラインシナリオ
    • 開発中のパイプライン製品:概要
      • 各企業が開発中のパイプライン製品
      • CAR-T細胞の標的抗原

パイプライン製品のシナリオ

  • 標的:CD19関連医薬品
  • 標的:CD19関連医薬品以外
  • CAR-T細胞技術と関連企業
  • CAR-Tのセーフティスイッチと関連企業

市販薬のプロファイル

  • Tisagenlecleucel (Kymriah)
  • Axicabtagene ciloleucel (Yescarta)
  • Brexucabtagene autoleucel (Tecartus)
  • Lisocabtagene maraleucel (Breyanzi)
  • Idecabtagene vicleucel (Abecma)

市場規模の計測と市場機会の分析

  • CAR-T細胞治療市場:全体的な市場動向 (2021年~2030年)
    • CAR-T細胞治療市場:標的適応症別
    • CAR-T細胞治療市場:標的抗原別
    • CAR-T細胞治療市場:主要企業別

製品ごとの売上高の予測 (2030年)

  • KYMRIAH (Novartis)
  • YESCARTA (Gilead Sciences)
  • Tecartus / Brexucabtagene Autoleucel (Gilead Sciences)
  • BREYANZI / Lisocabtagene Maraleucel / JCAR017JCAR017 (Bristol Myers Squibb / Juno Therapeutics)
  • Idecabtagene Vicleucel / bb2121 (bluebird bio / Bristol Myers Squibb)
  • Ciltacabtagene Autoleucel / LCAR-B38M CAR-T (Nanjing Legend Biotech / Janssen)

臨床パイプライン製品のプロファイル:企業別

前臨床パイプライン製品のプロファイル:企業別

CAR-T療法:上市時の規制経路

  • EU:上市時の規制経路
  • 米国:上市時の規制経路

CAR-Tに関する専門家 (KOL) の見解

CAR-Tのコスト削減のための戦略

分析手法

目次
Product Code: MM202028

Chimeric antigen receptor (CAR) T-cell therapy has generated a great amount of interest and have encouraged investors to support development in the field of adoptive cellular immunotherapy. Over the past couple of years, there has been rapid progress in the field. Researchers are refining the safety and efficacy profiles of CAR T cells with new concepts and technologies. These will be therapies that will address current challenges through mechanisms of superior efficacy, safety and delivery.

Chimeric Antigen Receptor (CAR-T) Cell Therapy has the potential to be a driver of growth through the introduction of new technologies and mechanisms that solve current clinical and commercial challenges, which ultimately can expand FDA approved cell

therapies. With cell and gene therapies emerging as innovative treatment options for many cancers and other rare diseases, there are currently thousands of cell and gene therapies in the development and commercialization pipeline. As a result, the FDA is preparing for the wave of experimental therapies, and by 2025, the FDA may approve 10 to 20 new cell and gene therapy products a year.

"In the big picture, I think that this technology is a game changer. For the first time, we are seeing a powerful immune technology dramatically impact myeloma, even in [patients with] relapsed or refractory disease. This could lead at some point to a cure or give us clues to lead us in that direction."

CAR-T Therapy Key Summary

  • Currently, there are five approved CAR-T cell therapies, namely KYMRIAH® (Novartis), YESCARTA® (Gilead Sciences), TECARTUS ™ (Gilead Sciences) and BREYANZI® (Bristol Myers Squibb / Juno Therapeutics) and ABECMA (Bristol Myers Squibb) .
  • Haematological Malignancy market in 2019 was ~ based on the Diffuse Large B-Cell Lymphoma Acute Lymphocytic Leukemia (<25 y.o.) was 0.7 billion and with the new indications in liquid tumors are currently under clinical development and could expand the market to an estimated $6.2 bn by 2030.
  • CD19 holds 100% market share in haematological malignancies in 2020. As BCMA-based CAR-T therapies enter the market beginning from 2021, the market share is expected to split to 72% (CD19)/ 28% (BCMA) by 2030
  • Currently, in 2021, Gilead holds the major market share of around 60% with its two products Yescarta and Tecartus. In 2030, BMS with its therapies, namely Breyanzi and Abecma, is expected to surpass Gilead's sales and become the leader in the CAR-T therapy space.
  • Solid Tumors to Drive Market Expansion for Cellular Therapies
  • Around 76 Companies Collaborations in CAR-T Space have been observed in the past 8 years. CAR-T companies are on the rise, supported by growing investment flowing into CAR-T research, landmark approvals of CAR-T cell therapies by the U.S. FDA (Kymriah, Yescarta, Breyanzi, Tecartus and Abecma), and major collaborations within the CAR-T space.
  • There has been a total of $ 10 billion investment deals that have been seen in the CAR-T space for the past 8 years. The year 2018 saw the highest investment compared to other years of approximately USD 2.8 billion.
  • ~52 University & Companies Collaborations in CAR-T Space have been observed in the past 11 year
  • ~78 Acquisition Deals were observed in CAR-T Space have been observed from 2013 to 2020
  • Manufacturing Facilities for the Development of CAR-T cells have increased with approval of new CAR-T therapies as well as the expansion of the sites for the existing ones. For instance
    • Commercial manufacturing for Kymriah takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) has also approved a further increase in manufacturing capacity in Dec, 2020. In 2020, Novartis made significant progress in expanding our global manufacturing capacity with a 70% increase compared to 2019 year.
    • Gilead purchased a new building in Santa Monica, California that were formerly owned by the Japanese pharma Astellas
    • BMS plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facilities, initially in Bothell, Washington and then also expanding to later manufacture it in Summit, New Jersey to support clinical and commercial capacity and accommodate patient geographic spread.
  • Allogeneic approaches could provide a workaround for lengthy manufacturing times. The pre-dominant leaders in allogeneic CAR-T space are Cellectis, Servier, Allogene, Autolus and Precision Therapeutics which have entered into the clinical stages. Allogene, Servier, and Cellectistechnology uses a healthy donor's T-cells and engineers them to target the CD19 antigen and delivers those cells to the patient.
  • There are ~444 products in the Pre-clinical stage of development, representing 64% of the total share of the developing CAR-T landscape
  • The clinical staged CAR-Ts are dominated by biotech companies headquartered in China with the Chinese companies holding the top ten positions. They represent ~40% of all the pipeline CAR-Ts in clinical stages.
  • There are ~166 Companies presently developing CAR-T with CD19 & BCMA, together forming 43.8% share in the field of CAR T-cells therapy.
  • There are ~28 key next generation technologies based CAR-T therapies in the Clinical Stage of development in addition to the conventional CAR T-cell technologies
  • Bellicum Pharmaceuticals is a leading company with two interesting Safety Switch technologies - An emergency "kill" switch and Default state to off switch.
  • To be continued...

Report Coverage

The CAR-T report is a 1000 pager Report which provides an in-depth analysis of key market trends and governing factors along with market attractiveness by segments. The report also provides the qualitative impact of various market factors on various CAR-T market segments and geographies. The comprehensive information provided in this report will help companies identify better opportunities. The report covers the more than 300 companies with over 700 CAR-T therapies, which are active in this field targeting more than 95 different antigens and ~ 28 next-generation CAR-T technologies.

The Report provides in-depth analysis of CAR-T cell profiles covering preclinical and clinical studies, details of partnerships and business deal values, targeted technologies and antigens, investments, and funding and acquisition trends. The Report provides CAR-T licensing opportunities, acquisition trends, Product analysis by phases, antigen type & indications. Furthermore, the report covers KOL's views on CAR-T therapy. The report also estimates the size of the existing market and identifies potential growth opportunities for CAR-T cell therapies in the next decade in the 2021-2030 period. Strategists can gain detailed insight and devise appropriate strategies to target a specific market.

Report Highlights:

  • Chimeric Antigen Receptor (CAR-T) Cell Therapy market potential based on Indications
  • Business Transactions & Strategies: Key collaborations and deal values
  • Chimeric Antigen Receptor (CAR-T) Cell Therapy Pipeline Development: Product Profiles, Clinical Trials & Results
  • Chimeric Antigen Receptor (CAR-T) Cell Therapy Acquisition Targets
  • Chimeric Antigen Receptor (CAR-T) Cell Therapy Competitive Intelligence
  • Recent & Upcoming event

Table of Contents

CAR-T Therapy Report Overview

Key Criteria for Success in CAR-T Therapies

The CAR-Therapy Introduction

  • Chimeric Antigen Receptor (CAR) T-cells Therapy Overview
    • CARS Generations
    • CAR-T Cell Therapy Design
    • Genetic Engineering of T-Cells
    • Necessity of 2nd Generation and 3rd generation CAR Signalling
    • Co-stimulatory domains
  • Challenges to the commercialization of CAR T-cell therapies
    • Complex manufacturing and supply chain
    • CAR T patient treatment journey
    • Reimbursement challenges for CAR T
  • Overcoming Challenges with CAR-T
    • Introduction of Advanced gene-transfer tools
    • Healthcare Settings to administer CAR-T
    • Rapid Innovation into Solid tumours
  • CAR-T Cell Therapy-Analysis
    • CAR-T Collaboration Deals
      • CAR-T Cells Therapy Collaborations and Deal Year
      • CAR-T Investment Analysis
      • Collaborations & Deal Value Trends
    • CAR-T Acquisitions Deals
      • CAR-T Cells Therapy Acquisitions Trends
      • CAR-T Cells Therapy Acquisitions Offerings
    • Manufacturing Facilities for the Development of CAR-T cells
  • Allogeneic CAR-T therapy: a promising approach in CAR-T space
  • CAR-T Licensing Opportunities
  • Pipeline Scenario
    • Pipeline Products under Development - An Overview
      • Pipeline Products under Development by Company
      • CAR-T cells Targeted Antigens

Pipeline Scenario

  • Target: CD19 Related Drug Products
  • Targets: Other than CD19, Related drug products
  • CAR T-cell Technologies & Companies Involved
  • CAR-T Safety Switches & Company Involved

Marketed Drug Profiles

  • Tisagenlecleucel (Kymriah)
  • Axicabtagene ciloleucel (Yescarta)
  • Brexucabtagene autoleucel (Tecartus)
  • Lisocabtagene maraleucel (Breyanzi)
  • Idecabtagene vicleucel (Abecma)

Market Sizing and Opportunity Analysis

  • Overall CAR-T Cell Therapy Market, 2021-2030
    • CAR-T Cell Therapies Market: Distribution by Target Indication
    • CAR-T Cell Therapies Market: Distribution by Target Antigen
    • CAR-T Cell Therapies Market: Distribution by Key Players

Product Wise Sales Forecast -2030

  • KYMRIAH (Novartis)
  • YESCARTA (Gilead Sciences)
  • Tecartus / Brexucabtagene Autoleucel (Gilead Sciences)
  • BREYANZI / Lisocabtagene Maraleucel / JCAR017JCAR017 (Bristol Myers Squibb / Juno Therapeutics)
  • Idecabtagene Vicleucel / bb2121 (bluebird bio / Bristol Myers Squibb)
  • Ciltacabtagene Autoleucel / LCAR-B38M CAR-T (Nanjing Legend Biotech / Janssen)

Clinical Pipeline Product Profiles by Companies

Pre-Clinical Pipeline Product Profiles by Companies

CAR-T Therapy Regulatory Route To Market

  • EU Regulatory Route To Market
  • US Regulatory Route To Market

KOLs View on CAR-T

Strategies to reduce Cost of CAR-T

Report Methodology