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市場調查報告書

嵌合抗原受體 (CAR-T) 細胞療法:市場機會、管道產品、競爭信息(2020 年)

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

出版商 Mellalta Meets LLP 商品編碼 1015904
出版日期 內容資訊 英文 1,083 Pages
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嵌合抗原受體 (CAR-T) 細胞療法:市場機會、管道產品、競爭信息(2020 年) Chimeric Antigen Receptor (CAR-T) Cell Therapy - Market Opportunity, Pipeline & Competitive Intelligence 2020
出版日期: 2021年06月22日內容資訊: 英文 1,083 Pages
簡介

近年來,嵌合抗原受體(CAR-T)細胞療法的研發取得進展,安全性和有效性不斷提高,投資者的興趣也在增加。數以千計的細胞和基因治療管道產品目前正在臨床試驗和推出,預計到 2025 年 FDA(美國食品和藥物管理局)每年將批准 10 到 20 個新產品。

在CAR-T領域,8年來共觀察到76個商業聯盟。此外,投資交易總額已達100億美元。特別是2018年比其他年份增加約28億美元。

在CAR-T領域,11年來觀察到52個產學業合作案例。此外,從 2013 年到 2020 年,觀察到了 78 筆收購交易。隨著新治療劑的認證和現有產品銷量的增加,開發和製造基地正在擴大,新機構正在進行中。

在本報告中,我們分析了全球嵌合抗原受體(CAR-T)細胞治療市場的發展和交易趨勢,旨在概述治療方法、主要目標(適應症/抗原)和實際應用。挑戰、主要資金交易動向、當前臨床試驗管線趨勢-主要在研產品的概況和臨床試驗結果-、上市產品概述和銷售前景、整體市場規模趨勢展望(2021年至2030年),我們將為您提供有關 KOL 觀點、未來增長機會和要採取的策略的信息。

目錄

CAR-T療法:分析總結

CAR-T 療法:成功的重要標準

CAR-T 療法:介紹

  • 嵌合抗原受體 (CAR-T) 細胞療法概述
    • CAR 出現
    • CAR-T 細胞療法設計
    • T細胞基因工程
    • 第二代和第三代 CAR 信號的必要性
    • 共刺激域
  • CAR-T 細胞療法實際應用的挑戰
    • 複雜的製造流程和供應鏈
    • CAR-T 患者的 "治療之旅"
    • CAR-T 醫療費用報銷的挑戰
  • 用 CAR-T 克服挑戰
    • 實施先進的基因轉移工具
    • 醫療領域的CAR-T管理
    • 實體瘤領域快速創新
  • CAR-T 細胞療法:分析
    • CAR-T相關業務聯盟交易
      • CAR-T細胞治療相關業務聯盟交易年份
      • CAR-T投資分析
      • 商業聯盟交易金額趨勢
    • CAR-T 相關企業收購交易
      • CAR-T細胞治療公司收購趨勢
      • CAR-T細胞療法收購詳情
    • CAR-T 細胞開發設施
  • 同種異體 CAR-T 療法:CAR-T 領域的一種有前景的方法
  • CAR-T 許可機會
  • 流水線場景
    • 正在開發的流水線產品:概覽
      • 各公司正在開發的流水線產品
      • CAR-T細胞的靶抗原

流水線產品場景

  • 目標:CD19 相關藥物
  • 目標:CD19 相關藥物以外的藥物
  • CAR-T細胞技術及相關公司
  • CAR-T安全開關及相關企業

非處方藥概況

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

衡量市場規模和分析市場機會

  • CAR-T 細胞療法市場:整體市場趨勢(2021-2030)
    • CAR-T 細胞療法市場:按目標適應症
    • CAR-T 細胞療法市場:按目標抗原
    • CAR-T 細胞治療市場:主要公司

產品銷售預測 (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)

臨床管道產品簡介:按公司

臨床前管道產品簡介:按公司

CAR-T 療法:啟動時的監管路徑

  • 歐盟:推出時的監管路線
  • 美國:啟動時的監管路線

CAR-T 專家 (KOL) 查看

CAR-T 成本降低策略

分析方法

目錄
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