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CAR-T細胞治療の世界市場:市場規模、予測、試験および動向(2021年)

Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends, 2021

出版日: | 発行: BIOINFORMANT WORLDWIDE, LLC | ページ情報: 英文 232 Pages | 納期: 即納可能 即納可能とは

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CAR-T細胞治療の世界市場:市場規模、予測、試験および動向(2021年)
出版日: 2021年02月01日
発行: BIOINFORMANT WORLDWIDE, LLC
ページ情報: 英文 232 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 目次
概要

CAR-T細胞療法はバイオテクノロジー業界を席巻し、がん治療の新時代を切り開くのではないかとの期待が高まっています。しかし、成功例はCD19を標的としたものであり、これは現在では限られた範囲の血液がんの鍵を握る抗原と考えられています。現在、この血液学的分野は非常に競争の激しい分野であり、多数のCAR-T細胞療法の競合が標的としています。

科学者、投資家、開発者は、この分野での長期的な成功の鍵は、2つの大きな問題を解決することにかかっています。固形腫瘍を標的としたCAR-T細胞製品は、より大きな市場の可能性を提供すると見込まれています。

当レポートは、世界のCAR-T細胞療法について調査しており、市場規模や予測、適応症および地位別の承認されたCAR-T製品、タイプ・フェーズ・地域別の臨床試験活動、競合情勢、戦略、主要企業のプロファイルなどの情報を提供しています。

目次

第1章 レポートの概要

第2章 CAR-T細胞療法:概要の要約

  • CAR-T細胞
  • CAR-T細胞開発の進化
  • 血液がん細胞に存在する抗原
  • T細胞に受容体遺伝子を挿入するためのツール
  • T細胞のCAR-T細胞への変換
  • フィニッシュラインを越える3つのCAR-T療法
  • CAR-T療法に関連する毒性
  • CAR-T細胞療法の未来
  • CAR-T療法の利点
  • CAR-T療法の欠点

第3章 CAR-T細胞療法の歴史

  • CAR-T療法製品の現状
  • 将来のCAR-T製品候補
  • CAR-T療法の変革の可能性
  • 少ない患者人口と巨大な臨床試験の情勢

第4章 CAR-T細胞の製造

  • CAR-T製造における自動化
  • 自家CAR-T製造における経費
  • 同種異系CAR-T製造における経費

第5章 CAR-T標的抗原:概要の要点

  • 血液がんのCAR-T標的抗原
  • 固形腫瘍のCAR-T標的抗原
  • CAR-T細胞が標的とする一般的な抗原
    • 分化抗原クラスター19(CD19)
    • メソテリン
    • B細胞成熟剤(BCMA)
    • GD2
    • グリピカン3(GPC3)
    • 分化抗原クラスター22(CD22)

第6章 CAR-T特許の情勢

  • CAR-T特許出願の地理的起源
  • CAR-T特許管轄区域の主要10地域
  • CAR-T細胞特許出願人の所属

第7章 世界のCAR-T臨床試験:概要

  • 臨床試験におけるCAR-T標的バイオマーカー
    • 米国
    • 中国
    • その他の国
  • 米国の臨床試験におけるCAR-T標的の適応症
  • 中国でのCAR-T臨床試験で対処された適応症
  • 進行中のCAR-T臨床試験で対処された適応症の割合
  • CAR-T臨床試験のフェーズ
  • 米国のCAR-T臨床試験スポンサー企業および機関
  • 中国のCAR-T臨床試験スポンサー企業および機関
  • その他の国のCAR-T臨床試験スポンサー企業および機関
  • 改善されたCAR-Tコンストラクト別進行中の臨床試験
  • CAR-T臨床試験の地理的分布
  • CAR世代タイプ別のCAR-T臨床試験の分布
  • 使用したScFvタイプ別のCAR-T臨床試験の分布
  • 使用したベクタータイプ別のCAR-T臨床試験の分布

第8章 出版された科学論文とNIH助成金

  • 発表論文数
  • CAR-T調査のためのNIH資金

第9章 CAR-T療法空間での取引

  • 最新のCAR-T取引
    • Gilead Sciences/Tango Therapeutics
    • Kite/Teneobio
    • Fate/Janssen
    • Juno/Oxford Biomedica
    • Allogene/MaxCyte
    • Applied DNA Sciences, Inc.
    • Cellectis/Servier
    • Cell Therapies, Pvt. Ltd
    • Astellas/Adaptimmune
    • Astellas/Xyphos
    • Carisma Therapeutics, Inc./NYU Langone Health

第10章 市販のCAR-T製品

  • Kymriah (Tisagenlecleucel)
    • 作用機序
    • 投薬
    • 安全性と有効性
    • 費用
    • 現在の売上高
  • Yescarta(Axicabtagene ciloleucel)
  • Tecartus(Brexucabtagene autoleucel)
  • その他の有望なCAR-T製品候補
    • Liso-Cel(Lisocabtagene Maraleucel)
    • 0Idecabtagene Vicleucel(Ide-cel、bb2121)
    • ALLO-501
    • CTX110
    • UCART19
    • AUTO1
    • JCARH125
    • LCAR-B38M
    • PBCAR20A
    • UCART123
    • PRGN-3006
    • UCART22
    • UCARTCS1

第11章 CAR-T療法の償還

  • CAR-T療法に対する米国の病院償還
  • EU5諸国におけるCAR-T療法の結果ベースの償還
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国

第12章 血液がん:概要

  • リンパ腫
    • ホジキンリンパ腫(HL)
    • 非ホジキンリンパ腫(NHL)
  • 白血病
    • 白血病の種類
  • 多発性骨髄腫(MM)
  • 血液がんの治療法の選択肢
    • 化学療法
    • 放射線療法
    • 標的療法
    • 幹細胞移植
    • 免疫療法
  • がん治療の莫大なコスト

第13章 市場分析

  • 製品別
  • 地域別
  • 適応症別
  • CAR-T市場の最前線にいる企業
  • CAR-T 2.0マーケットプレイスで成功するための障壁と戦略
    • CAR-T 2.0の商業的成功への障壁
    • CAR-T 2.0の市場開発戦略

第14章 企業プロファイル

  • Aleta BioTherapeutics
  • Allogene Therapeutics
  • Anixa Biosciences、Inc。
  • Attars Biotherapeutics
  • Autolus Therapeutics、plc
  • Bellicum Pharmaceuticals、Inc。
  • BioNTech
  • bluebird bio
  • Carina Biotech
  • CARsgen Therapeutics
  • Cartesian Therapeutics, Inc.
  • CARTherics
  • Celgene Corporation
  • Cellectis
  • Celularity, Inc.
  • Celyad Oncology
  • Creative Biolabs
  • CRISPR Therapeutics
  • Cytovia Therapeutics
  • DiaCarta, Inc.
  • Empirica Therapeutics
  • Eureka Therapeutics, Inc.
  • EXUMA Biotech Corp.
  • Fate Therapeutics、Inc。
  • Formula Pharmaceuticals, Inc.
  • Gilead Sciences, Inc.
  • Gracell Biotechnologies
  • iCell Gene Therapeutics
  • Janssen Biotech, Inc.
  • Juno Therapeutics
  • JW Therapeutics, Co., Ltd.
  • Kite Pharma, Inc.
  • MaxCyte, Inc.
  • Minerva Biotechnologies Corporation
  • Mustang Bio, Inc.
  • Nanjing Legend Biotechnology Co., Ltd.
  • Noile-Immune Biotech
  • Novartis International, AG
  • Oxford Biomedica plc
  • PeproMene Bio, Inc.
  • Poseida Therapeutics, Inc.
  • Precigen, Inc.
  • Precision Biosciences
  • Prescient Therapeutics
  • ProMab Biotechnologies, Inc.
  • Protheragen
  • Sorrento Therapeutics, Inc.
  • TC Biopharm
  • T-CURX
  • Tessa Therapeutics, Pvt. Ltd.
  • Tmunity Therapeutics、Inc。
  • Wugen
  • Xyphos Biosciences, Inc.
  • Ziopharm Oncology, Inc.

図の索引

表の索引

目次

EXECUTIVE SUMMARY

CAR-T cell therapy is a remarkably promising treatment for cancer patients. It is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as "living drugs."

T-cells form the backbone of CAR-T cell therapy. T-cells are the workhorses of our immune system and play a key role in directing the immune response and killing cells infected by pathogens. In CAR-T cell therapy, blood is drawn from the patient and the T-cells are separated out. In the laboratory, a disarmed virus is then used to genetically engineer the T-cells to produce chimeric antigen receptors (CARs) on their surface. These receptors are synthetic and do not exist naturally. Once infused into the patient, these CARs enable the T-cells to recognize and get attached to an antigen (specific protein) on the tumor cell leading to the destruction of the tumor.

Since the approval of the first CAR-T cell therapeutic in 2017, widespread research, an exponential increase in clinical trial activity, proliferative M&A activity, and lucrative IPOs have created a robust CAR-T cell market. This billion dollar market would not have been possible without the remarkable efficacy of Kymriah, Yescarta and Tecartus in treating several types of blood cancers.

CAR-T Cell Therapy Market

In 2012, there were only 12 clinical trials investing CAR-T cell therapy products. Today, that number has risen to 514. Between 2017 and 2020, three CAR-T products reached the market, and this number is projected to reach double digits by 2024. The earliest approvals, Kymriah and Yescarta, have been commercially available since 2017 and 2018, respectively, and have been infused into nearly a half million patients worldwide. In July 2020, the U.S. FDA approved a third CAR-T cell therapy, Kite Pharma's brexucabtagene autoleucel (sold as Tecartus).

All the three of the approved CAR-T products and nearly 75% of the ongoing clinical trials take an autologous treatment approach. Autologous (self-derived) CAR-T cells are expensive to produce because they are manufactured on a patient-by-patient basis. At times, autologous production can be hampered by a shortage of CAR-T cells or viral vectors. The cost of autologous CAR-T therapy is further escalated by the need for a complex cold chain during transportation. Another key issue is the "vein-to-vein" time or the time that elapses between apheresis and product delivery.

Thus, CAR-T therapies are most often recommended for the end-stage patients who have exhausted all the other treatment options. These challenges drive up the price, making CAR-T therapy unaffordable for a large percentage of patients.

To support the adoption of CAR-T cell therapies, the industry is taking measures to mitigate these challenges. Several CAR-T players have started using efficient gene-transfer tools to impregnate the T cells with CARs. There are numerous examples of partnerships to develop CRISPR and electroporation technologies to modify the T cells. Some companies are also using "on-off" switches that can turn off CAR-T cells to prevent toxicity.

Unfortunately, the goal of achieving CAR-T success against solid tumors remains elusive thus far, with clinical trials demonstrating a severely limited response.

Trends in CAR-T Cell Therapy

CAR-T cell therapy has taken the biotech industry by storm, creating hope that it could usher in a new era of cancer treatment. However, the success stories have come from targeting CD19, which is now considered an antigen that holds the key to a limited range of blood cancers. Presently, this hematological arena is a highly competitive and is being targeted by numerous CAR-T cell therapy competitors.

Scientists, investors and developers invariably agree that the key to longer-term success in this sector depends on solving two major problems: identifying antigens other than CD19 that can be targeted with CAR-T therapy with strong efficacy and going beyond liquid cancers into solid tumor indications. CAR-T cell products targeted against solid tumors will undoubtedly offer a larger market potential.

However, it is not an easy task to identify the antigens found on the cells of solid tumors. There are reasons why CD19 is the most common target. It is seen solely on B cells, whose destruction via CAR-T therapy offers a straightforward route for treating B-cell leukemias and lymphomas. At the same time, loss of the body's B cells is not particularly problematic, because their antibody-producing function can be reinstated by injecting intravenous immunoglobulin (IVIG) to patients.

Driving Forces Impacting the CAR-T Cell Therapy Market

2017 was the first year that the U.S. FDA approved a CAR-T cell therapy, approving Kymriah in August 2017 and Yescarta in October 2017. Novartis produced Kymriah, a CAR-T therapy used to treat leukemia, while Gilead/Kite Pharma produced Yescarta, a CAR-T therapy to designed for patients with lymphoma. Approvals for these products spread like wildfire, with the EU, Canada, Australia, Japan, and other nations following suit.

In July 2020, the U.S. FDA approved the third CAR-T cell therapy, approving Kite Pharma's brexucabtagene autoleucel, sold as Tecartus. It is the first CAR-T therapeutic to treat relapsed or refractory mantle cell lymphoma (MCL). The approval of these early CAR-T cell therapies has opened the gates for many other types of cell and gene therapies to claim respect, from regulators, as well as the scientific and medical community at large.

Today, the CAR-T cell therapy industry is witnessing:

  • Landmark approvals of CAR-T cell therapies by regulatory bodies worldwide
  • Lucrative acquisitions within the CAR-T industry
  • Large IPOs within the industry
  • An increasingly competitive IP environment
  • Unprecedented investment flowing into CAR-T cell research

CAR-T cell therapy has proven a promising new treatment approach. As its manufacture, administration, and safety profile improve, we will usher in a new era of CAR-T cell therapeutics.

This global strategic report reveals:

  • Market size determinations with segmentation and forecasts through 2027
  • Approved CAR-T products by indication and region
  • Clinical trial activity by type, region, phase, and sponsor
  • CAR-T industry M&A transactions and IPOs
  • Strategic partnerships and commercialization agreements
  • Industry trends and future directions
  • Competitors composing the global marketplace

This 232-page global strategic report will position you to:

  • Capitalize on emerging trends
  • Improve internal decision-making
  • Reduce company risk
  • Approach outside partners and investors
  • Outcompete your competition
  • Implement an informed and advantageous business strategy in 2021

With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.

TABLE OF CONTENTS

1. REPORT OVERVIEW

  • 1.1. Statement of the Report
  • 1.2. EXECUTIVE SUMMARY
  • 1.3. INTRODUCTION

2. CHIMERIC ANTIGEN RECEPTOR-T (CAR-T) CELL THERAPY: A BRIEF OVERVIEW

  • 2.1. CAR-T Cell
  • 2.2. Evolution of CAR-T Cell Development
    • 2.2.1. The CAR-T Cell Family
      • 2.2.1.1. First Generation CARs
      • 2.2.1.2. Second Generation CARs
      • 2.2.1.3. Third Generation CARs
      • 2.2.1.4. Fourth Generation CARs
  • 2.3. Antigens Present on Hematological Cancer Cells
  • 2.4. Tools for Inserting Receptor Genes into T Cells
  • 2.5. Transforming T Cells into CAR-T Cells
  • 2.6. The Three CAR-T Therapies Crossing the Finishing Line
  • 2.7. Toxicities Associated with CAR-T Treatment
  • 2.8. The Future of CAR-T Cell Therapy
    • 2.8.1. Transition from Liquid Cancers to Solid Tumors
    • 2.8.2. Reduction in the Length of Hospital Stay
    • 2.8.3. Discovery of New Target Antigens
    • 2.8.4. Shifting from Autologous to Allogeneic CAR-T Therapy
    • 2.8.5. CAR-T for the Masses
  • 2.9. Advantages of CAR-T Therapy
  • 2.10. Disadvantages of CAR-T Therapy

3. HISTORY OF CAR-T CELL THERAPY

  • 3.1. Current Status of CAR-T Therapy Products
  • 3.2. Prospective CAR-T Product Candidates
  • 3.3. Transformative Potential of CAR-T Therapy
  • 3.4. Small Patient Population & Huge Clinical Trial Landscape

4. MANUFACTURE OF CAR-T CELLS

  • 4.1. Automation in CAR-T Manufacturing
  • 4.2. Operating Expenses in Autologous CAR-T Manufacturing
  • 4.3. Operating Expenses in Allogeneic CAR-T Manufacturing

5. CAR-T TARGET ANTIGENS: A BRIEF OVERVIEW

  • 5.1. CAR-T Target Antigens on Hematological Cancers
  • 5.2. CAR-T Target Antigens on Solid Tumors
  • 5.3. Common Antigens Targeted by CAR-T Cells
    • 5.3.1. Cluster of Differentiation 19 (CD19)
    • 5.3.2. Mesothelin
    • 5.3.3. B-Cell Maturation Agent (BCMA)
    • 5.3.4. GD2
    • 5.3.5. Glypican-3 (GPC3)
    • 5.3.6. Cluster Differentiation-22 (CD22)

6. CAR-T PATENT LANDSCAPE

  • 6.1. Geographical Origin of CAR-T Patent Applications
  • 6.2. Top Ten CAR-T Patent Jurisdictions
  • 6.3. Affiliations of CAR-T Cell Patent Applicants
    • 6.3.1. Top 20 Companies in CAR-T Patent Landscape
    • 6.3.2. TOP 20 Research Centers in CAR-T Patent Landscape
    • 6.3.3. Top 20 CAR-T Cell Inventors
    • 6.3.4. Top Five CAR-T Patents with Most Family Members
    • 6.3.5. Top Five CAR-T Patents with Most Inventors in Co-Authorship
    • 6.3.6. Top Five Patents with Most Co-Applicants
    • 6.3.7. Top Five CAR-T Patents with Most Citations Received

7. GLOBAL CAR-T CLINICAL TRIALS: AN OVERVIEW

  • 7.1. CAR-T Targeted Biomarkers in Clinical Trials
    • 7.1.1. CAR-T Targeted Biomarkers in U.S. Clinical Trials
    • 7.1.2. CAR-T Targeted Biomarkers in Chinese Clinical Trials
    • 7.1.3. CAR-T Targeted Biomarkers in other Countries
  • 7.2. CAR-T Targeted Indications in the U.S. Clinical Trials
  • 7.3. Indications Addressed by CAR-T Clinical Trials in China
  • 7.4. Percent Share of Indications Addressed by the Ongoing CAR-T Clinical Trials
  • 7.5. Phase of CAR-T Clinical Trials
  • 7.6. CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
  • 7.7. CAR-T Clinical Trial Sponsor Companies and Institutions in China
  • 7.8. CAR-T Clinical Trial Sponsor Companies and Institutions in other Countries
  • 7.9. Ongoing Clinical Trials with Improved CAR-T Constructs
    • 7.9.1. CAR-T with PD1Fc
    • 7.9.2. CAR-T with Truncated EGFR (EGFRt)
    • 7.9.3. CAR-T with IL7 and CCL19
    • 7.9.4. CAR-T with PD1/CD28 Switch-Receptor
    • 7.9.5. CAR-T with PD1 shRNA-expressing cassette
    • 7.9.6. CAR-T with CTLA-4/PD-1 Antibody
    • 7.9.7. CAR-T with PD-1 Antibodies
  • 7.10. Geographic Distribution of CAR-T Clinical Trials
  • 7.11. Distribution of CAR-T Clinical Trials by Type of CAR Generations
  • 7.12. Distribution of CAR-T Clinical Trials by Type of ScFv Used
  • 7.13. Distribution of CAR-T Clinical Trials by Type of Vectors Used

8. PUBLISHED SCIENTIFIC PAPERS & NIH GRANTS

  • 8.1. Number of Published Papers
  • 8.2. NIH Funding for CAR-T Research

9. DEALS IN CAR-T THERAPY SPACE

  • 9.1. Most Recent CAR-T Deals
    • 9.1.1. Gilead Sciences/Tango Therapeutics
    • 9.1.2. Kite/Teneobio
    • 9.1.3. Fate/Janssen
    • 9.1.4. Juno/Oxford Biomedica
    • 9.1.5. Allogene/MaxCyte
    • 9.1.6. Applied DNA Sciences, Inc.
    • 9.1.7. Cellectis/Servier
    • 9.1.8. Cell Therapies, Pvt. Ltd
    • 9.1.9. Astellas/Adaptimmune
    • 9.1.10. Astellas/Xyphos
    • 9.1.11. Carisma Therapeutics, Inc./NYU Langone Health

10. MARKETED CAR-T PRODUCTS

  • 10.1. Kymriah (Tisagenlecleucel)
    • 10.1.1. Mechanism of Action
    • 10.1.2. Dosing
    • 10.1.3. Safety and Efficacy of Kymriah
    • 10.1.4. Kymriah's Cost
    • 10.1.5. Current Sales of Kymriah
  • 10.2. Yescarta (Axicabtagene ciloleucel)
    • 10.2.1. Mechanism of Action
    • 10.2.3. Dosing
    • 10.2.4. Safety and Efficacy of Yescarta
    • 10.2.5. Manufacturing Network
    • 10.2.6. Current sales of Yescarta
    • 10.2.7. Sales of Kymriah and Yescarta: A Comparison
  • 10.3. Tecartus (Brexucabtagene autoleucel)
    • 10.3.1. Mechanism of Action
    • 10.3.2. Dosing
    • 10.3.3. Safety and Efficacy of Tecartus
    • 10.3.4. Efficacy, Safety and Composition of Approved CAR-T Products
  • 10.4. Other Promising CAR-T Product Candidates
    • 10.4.1. Liso-Cel (Lisocabtagene Maraleucel)
    • 10.4.2. 0Idecabtagene Vicleucel (Ide-cel, bb2121)
    • 10.4.3. ALLO-501
    • 10.4.4. CTX110
    • 10.4.5. UCART19
    • 10.4.6. AUTO1
    • 10.4.7. JCARH125
    • 10.4.8. LCAR-B38M
    • 10.4.9. PBCAR20A
    • 10.4.10. UCART123
    • 10.4.11. PRGN-3006
    • 10.4.12. UCART22
    • 10.4.13. UCARTCS1

11. REIMBURSEMENT FOR CAR-T THERAPIES

  • 11.1. Hospital Reimbursement in the U.S. for CAR-T Therapy
  • 11.2. Outcomes-Based Reimbursement for CAR-T Therapies in EU5 Countries
    • 11.2.1. France
    • 11.2.2. Germany
    • 11.2.3. Italy
    • 11.2.4. Spain
    • 11.2.5. U.K.

12. BLOOD CANCERS: AN OVERVIEW

  • 12.1. Lymphoma
    • 12.1.1. Hodgkin Lymphoma (HL)
    • 12.1.2. Non-Hodgkin Lymphoma (NHL)
      • 12.1.2.1. Diffuse Large B Cell Lymphoma (DLBCL)
      • 12.1.2.2. Follicular Lymphoma (FL)
  • 12.2. Leukemia
    • 12.2.1. Types of Leukemia
      • 12.2.1.1. Acute Myeloid Leukemia (AML)
      • 12.2.1.2. Acute Lymphoblastic Leukemia (ALL)
      • 12.2.1.3. Chronic Myeloid Leukemia (CML)
      • 12.2.1.4. Chronic Lymphocytic Leukemia (CLL)
  • 12.3. Multiple Myeloma (MM)
  • 12.4. Treatment Options for Blood Cancers
    • 12.4.1. Chemotherapy
    • 12.4.2. Radiation Therapy
    • 12.4.3. Targeted Therapy
    • 12.4.4. Stem Cell Transplantation
    • 12.4.5. Immunotherapy
      • 12.4.5.1. Monoclonal Antibodies (mAbs)
      • 12.4.5.2. Immune Check-point Inhibitors
      • 12.4.5.3. Adoptive Cell Transfer Therapy/T-Cell Transfer Therapy
  • 12.5. The Staggering Cost of Cancer Therapy

13. MARKET ANALYSIS

  • 13.1. Global Market for CAR-T Cell Therapy by Product
  • 13.2. Global CAR-T Market by Geography
  • 13.3. Global Market for CAR-T Therapy by Indication
  • 13.4. Companies at the Forefront of CAR-T Market
  • 13.5. Barriers and Strategies for Success in CAR-T 2.0 Market Place
    • 13.5.1. Barriers to CAR-T 2.0 Commercial Success
      • 13.5.1.1. Capacity constraints
      • 13.5.1.2. Competition among Manufacturers
      • 13.5.1.3. Competition from other Treatments
    • 13.5.2. Market Development Strategies for CAR-T 2.0
      • 13.5.2.1. Effective Physician Education
      • 13.5.2.2. Logistical Excellence
      • 13.5.2.3. Evidence Generation

14. COMPANY PROFILES

  • 14.1. Aleta BioTherapeutics
    • 14.1.1. Atela's Pipeline
  • 14.2. Allogene Therapeutics
    • 14.2.1. AlloCAR-T Therapy
  • 14.3. Anixa Biosciences, Inc.
  • 14.4. Attars Biotherapeutics
    • 14.4.1. Technology
    • 14.4.2. Next-Generation CAR-T
  • 14.5. Autolus Therapeutics, plc
  • 14.6. Bellicum Pharmaceuticals, Inc.
    • 14.6.1. GoCAR Technology
    • 14.6.2. Bellicum's Pipeline
  • 14.7. BioNTech
    • 14.7.1. Collaborators
    • 14.7.2. Services
    • 14.7.3. Engineered Cell Therapies
    • 14.7.4. CAR-T Programs
      • 14.7.4.1. BNT211
      • 14.7.4.2. BNT212
  • 14.8. bluebird bio
    • 14.8.1. CAR-T Collaborations
      • 14.8.1.1. Collaboration with Celgene
      • 14.8.1.2. Collaboration with Inhibrx
      • 14.8.1.3. Collaboration with TC BioPharm
  • 14.9. Carina Biotech
    • 14.9.1. New CAR-T Cells
    • 14.9.2. CAR-T Access Technologies
      • 14.9.2.1. Chemokine Receptor Mediation
      • 14.9.2.2. Gel Formulation to Deliver CAR-T Cells
  • 14.10. CARsgen Therapeutics
  • 14.11. Cartesian Therapeutics, Inc.
    • 14.11.1. Cartesian's Approach
  • 14.12. CARTherics
    • 14.12.1. Technology
  • 14.13. Celgene Corporation
    • 14.13.1. Lisocabtagene maraleucel (liso-cel)
  • 14.14. Cellectis
    • 14.14.1. Universal Chimeric Antigen Receptor T-Cells (UCARTs)
      • 14.14.1.1. UCART 123
      • 14.14.1.2. UCART22
      • 14.14.1.3. UCARTCS1
      • 14.14.1.4. UCART19
      • 14.14.1.5. ALLO-501
      • 14.14.1.6. ALLO-715
  • 14.15. Celularity, Inc.
    • 14.15.1. P CAR-T
  • 14.16. Celyad Oncology
    • 14.16.1. TIM Technology
    • 14.16.2. shRNA Technology
  • 14.17. Creative Biolabs
    • 14.17.1. CAR Construction and Production Platform
  • 14.18. CRISPR Therapeutics
    • 14.18.1. CRISPR/Cas9 Immuno-Oncology Cell Therapy
  • 14.19. Cytovia Therapeutics
  • 14.20. DiaCarta, Inc.
    • 14.20.1. Personalized CAR-T Immunotherapy Platform
  • 14.21. Empirica Therapeutics
    • 14.21.1. Technology
  • 14.22. Eureka Therapeutics, Inc.
  • 14.23. EXUMA Biotech Corp.
    • 14.23.1. Logic Gate CAR-T Technology
    • 14.23.2. Same-Day CAR-T Therapy
  • 14.24. Fate Therapeutics, Inc.
  • 14.25. Formula Pharmaceuticals, Inc.
    • 14.25.1. Technology
  • 14.26. Gilead Sciences, Inc.
    • 14.26.1. TECARTUS (Brexucabtagene autoleucel)
    • 14.26.2. Yescarta (Axicabtagene ciloleucel)
    • 14.26.3. Cell Therapy
  • 14.27. Gracell Biotechnologies
    • 14.27.1. Dual CAR
    • 14.27.2. FasTCAR
    • 14.27.3. TrUCAR
  • 14.28. iCell Gene Therapeutics
    • 14.28.1. iCell Platforms
      • 14.28.1.1. CARvac
      • 14.28.1.2. Non Gene Edited Universal CARs
      • 14.28.1.3. C-TPS1
      • 14.28.1.4. T-Cell Targeted CARs
      • 14.28.1.5. Compound CARs
  • 14.29. Janssen Biotech, Inc.
    • 14.29.1. JNJ-4528
  • 14.30. Juno Therapeutics
  • 14.31. JW Therapeutics, Co., Ltd.
    • 14.31.1. Relmacabtagene autoleucel (Relma-cel)
  • 14.32. Kite Pharma, Inc.
    • 14.32.1. Kite's Technologies (CAR-T & TCR)
    • 14.32.2. Kite's Therapies
      • 14.32.2.1. Yescarta (Axicabtagene ciloleucel)
      • 14.32.2.2. Tecartus (Brexucabtagene autoleucel)
  • 14.33. MaxCyte, Inc.
    • 14.33.1. CARMA Cell Therapies
    • 14.33.2. Flow Electroporation Technology
  • 14.34. Minerva Biotechnologies Corporation
    • 14.34.1. HuMNC2-CAR44
  • 14.35. Mustang Bio, Inc.
  • 14.36. Nanjing Legend Biotechnology Co., Ltd.
    • 14.36.1. LCAR-B38M/JNJ-4528
  • 14.37. Noile-Immune Biotech
  • 14.38. Novartis International, AG
    • 14.38.1. Kymriah (Tisagenlecleucel)
  • 14.39. Oxford Biomedica plc
  • 14.40. PeproMene Bio, Inc.
    • 14.40.1. BAFF-R CAR-T Cells
  • 14.41. Poseida Therapeutics, Inc.
    • 14.41.1. PiggyBac DNA Modification System
    • 14.41.2. Autologous & Allogeneic Programs
      • 14.41.2.1. P-BCMA-101
      • 14.41.2.2. P-PSMA-101
      • 14.41.2.3. P-BCMA-ALLO1
      • 14.41.2.4. P-MUC1C-ALLO1
      • 14.41.2.5. P-PSMA-ALLO1
  • 14.42. Precigen, Inc.
  • 14.43. Precision Biosciences
  • 14.44. Prescient Therapeutics
    • 14.44.1. OmniCAR Technology
  • 14.45. ProMab Biotechnologies, Inc.
    • 14.45.1. Custom CAR-T Cell Development
  • 14.46. Protheragen
    • 14.46.1. PR-18-01
  • 14.47. Sorrento Therapeutics, Inc.
  • 14.48. TC Biopharm
    • 14.48.1. Co-Stim CAR-T
  • 14.49. T-CURX
    • 14.49.1. CARAMBA
  • 14.50. Tessa Therapeutics, Pvt. Ltd.
    • 14.50.1. CD30 CAR-T Cells
    • 14.50.2. Allogeneic CD30-CAR EBVSTs
  • 14.51. Tmunity Therapeutics, Inc.
  • 14.52. Wugen
  • 14.53. Xyphos Biosciences, Inc.
    • 14.53.1. Xyphos' Strategy
  • 14.54. Ziopharm Oncology, Inc.
    • 14.54.1. Non-Viral CAR-T Therapy

INDEX OF FIGURES

  • FIGURE 2.1: The Basic Structure of a T Cell
  • FIGURE 2.2: The Binding of T Cells onto an Infected Cell
  • FIGURE 2.3: Components of a CAR-T Cell
  • FIGURE 2.4: The Three Domains of a CAR
  • FIGURE 2.5: First Generation CARs
  • FIGURE 2.6: Second Generation CARs
  • FIGURE 2.7: Third Generation CARs
  • FIGURE 2.8: Fourth Generation CARs
  • FIGURE 2.9: Flow Chart Showing the Process of Manufacture of CAR-T Cells
  • FIGURE 2.10: Diagrammatic Illustration of Autologous CAR-T
  • FIGURE 2.11: Diagrammatic Illustration of Allogeneic CAR-T
  • FIGURE 4.1: Leukopheresis and T Cell Isolation
  • FIGURE 4.2: T Cell Culture and Transduction
  • FIGURE 4.3: The Workflow in an Automated Manufacturing Unit
  • FIGURE 4.4: Operating Expenses in Autologous CAR-T Manufacturing
  • FIGURE 4.5: Operating Expenses in Allogeneic CAR-T Manufacturing
  • FIGURE 5.1: The CAR-T Target Distribution in Global Clinical Trials
  • FIGURE 6.1: CAR-T-Related Patent Publications, 2012-2019
  • FIGURE 6.2: Granted CAR-T-Related Patents, 2012-2019
  • FIGURE 6.3: Geographical Origin of CAR-T Patent Applications
  • FIGURE 6.4: Top Ten CAR-T Patent Jurisdictions
  • FIGURE 6.5: Affiliations of CAR-T Cell Patent Applicants
  • FIGURE 7.1: Number of Clinical Trials per Year, U.S. vs. China, 2003-2019
  • FIGURE 7.2: CAR-T Targeted Biomarkers in other Countries
  • FIGURE 7.3: Percent Share of Indications Addressed by the Ongoing CAR-T Clinical Trials
  • FIGURE 7.4: CAR-T Clinical Trials Phase Summary, U.S. vs. China
  • FIGURE 7.5: Geographic Distribution of CAR-T Clinical Trials
  • FIGURE 7.6: Distribution of CAR-T Clinical Trials by Type of CAR Generations
  • FIGURE 7.7: Distribution of CAR-T Clinical Trials by Type of ScFv Used
  • FIGURE 7.8: Distribution of CAR-T Clinical Trials by Type of Vectors Used
  • FIGURE 8.1: Number of CAR-T-Related Published Papers in PubMed.gov
  • FIGURE 10.1: Sales Revenues for Kymriah, 2018-2020
  • FIGURE 10.2: Sales Revenues for Yescarta, 2018-2020
  • FIGURE 10.3: Sales Data for Kymriah and Yescarta, Q1 of 2018 to Q2 of 2020
  • FIGURE 12.1: Global Incidence of Blood Cancers in 2018
  • FIGURE 12.2: Rate of Incidence and Death for Hodgkin Lymphoma in the U.S.
  • FIGURE 12.3: Rate of New NHL Cases in the U.S.
  • FIGURE 12.4: Rate of New DLBCL Cases in the U.S.
  • FIGURE 12.5: Rate of New FL Cases in the U.S.
  • FIGURE 12.6: Rate of New Leukemia Cases in the U.S.
  • FIGURE 12.7: Distribution of New Leukemia Cases in the U.S. by Type
  • FIGURE 12.8: Rate of New AML Cases in the U.S.
  • FIGURE 12.9: Rate of New ALL Cases in the U.S.
  • FIGURE 12.10: Rate of New CML Cases in the U.S.
  • FIGURE 12.11: Rate of New CLL Cases in the U.S.
  • FIGURE 12.12: Rate of New MM Cases in the U.S.
  • FIGURE 13.1: Estimated Global Market for CAR-T Therapy by Products, 2019-2027
  • FIGURE 13.2: Global Market for CAR-T Therapy by Geography, 2019-2027
  • FIGURE 13.3: Global Market for CAR-T Therapy by Indication, 2019-2027
  • FIGURE 14.1: Illustration of a Dual CAR

INDEX OF TABLES

  • TABLE 2.1: CAR-Targeted Antigens Present on Hematological Malignancies
  • TABLE 2.2: The Three CAR-T Therapies Crossing the Finishing Line: An Overview
  • TABLE 2.2: (CONTINUED)
  • TABLE 2.3: Toxicities Associated with CAR-T Treatment
  • TABLE 2.4: Strategies to Improve the Safety and Efficacy of CAR-T Therapy
  • TABLE 2.5: New Target Antigens and New Target Cancers
  • TABLE: 2.6: A Partial List of Allogeneic CAR-T Companies
  • TABLE 3.1: History of Development of CAR-T Cells
  • TABLE 3.2: Approved CAR-T Products and Indications
  • TABLE 3.3: The Next-Wave of CAR-T Approvals
  • TABLE 3.4: Increased CAR-T Activity
  • TABLE 3.5: Very Small Patient Population Addressed by CAR-T Clinical Trials
  • TABLE 5.1: CAR-T Cell Target Antigens for Hematological Malignancies
  • TABLE 5.2: CAR-T Target Antigens on Solid Tumors
  • TABLE 6.1: Top 20 Companies in CAR-T Patent Landscape
  • TABLE 6.2: TOP 20 Research Centers in CAR-T Patent Landscape
  • TABLE 6.3: Top 20 CAR-T Inventors
  • TABLE 6.4: Top Five CAR-T Patents with Maximum Patent Families
  • TABLE 6.5: Top Five CAR-T Patents with Most Inventors in Co-Authorship
  • TABLE 6.6: Top Five Patents with Most Co-Applicants
  • TABLE 6.7: Top Five Patents with Most Co-Applicants
  • TABLE 7.1: Percent Target Distribution of World's CAR-T Clinical Trials
  • TABLE 7.2: Targeted Biomarkers in the U.S. CAR-T Clinical Trials
  • TABLE 7.3: Targeted Biomarkers in Chinese CAR-T Clinical Trials
  • TABLE 7.4: Indications Addressed by CAR-T Clinical Trials in the U.S.
  • TABLE 7.5: Indications Addressed by CAR-T Clinical Trials in China
  • TABLE 7.6: CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
  • TABLE 7.6: (CONTINUED)
  • TABLE 7.7: CAR-T Clinical Trial Sponsor Companies and Institutions in China
  • TABLE 7.7: (CONTINUED)
  • TABLE 7.7: (CONTINUED)
  • TABLE 7.8: CAR-T Clinical Trial Sponsor Companies and Institutions in Other Countries
  • TABLE 7.9: Clinical Trials of Fourth Generation/Next-Generation and Gene-Edited CAR-T
  • TABLE 7.9: (CONTINUED)
  • TABLE 7.9: (CONTINUED)
  • TABLE 7.9: (CONTINUED)
  • TABLE 7.9: (CONTINUED)
  • TABLE 8.1: A Partial List of NIH Funding for CAR-T Research in 2020
  • TABLE 8.1: (CONTINUED)
  • TABLE 9.1: Deals in CAR-T Therapy Space, 2012-2019
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 9.1: (CONTINUED)
  • TABLE 10.1: Sales Data for Kymriah and Yescarta, 2018 Full Year to 2020 Mid-Year
  • TABLE 10.2: Efficacy, Safety and Composition of Approved CAR-T Products
  • TABLE 10.3: Other Promising CAR-T Product Candidates
  • TABLE 11.1: 2020 CAR-T Payment Disparities per Case in the U.S.
  • TABLE 11.2: Reimbursement of CAR-T Cell Therapies in France
  • TABLE 11.3: Reimbursement of CAR-T Cell Therapies in Germany
  • TABLE 11.4: Reimbursement of CAR-T Cell Therapies in Italy
  • TABLE 11.5: Reimbursement of CAR-T Cell Therapies in Spain
  • TABLE 11.6: Reimbursement of CAR-T Cell Therapies in U.K.
  • TABLE 12.1: Cost of Treating Blood Cancers
  • TABLE 13.1: Estimated Global Market for CAR-T Therapy by Products, 2019-2027
  • TABLE 13.2: Global Market for CAR-T Therapy by Geography, 2019-2027
  • TABLE 13.3: Global Market for CAR-T Therapy by Indication, 2019-2027
  • TABLE 13.4: Top Five CAR-T Companies by Marketed Products and Product Candidates
  • TABLE 14.1: Atela's Pipeline of Product Candidates
  • TABLE 14.2: Allogene's Product Pipeline
  • TABLE 14.3: Anixa's Product Pipeline
  • TABLE 14.4: Autolus' Pipeline of Clinical and Next Generation Programs
  • TABLE 14.5: Bellicum Pharmaceutical's Product Candidates
  • TABLE 14.6: CARsgen's Product Pipeline
  • TABLE 14.7: Cartesian's Product Pipeline
  • TABLE 14.8: Celyad's Product Pipeline
  • TABLE 14.9: Creative Biolab's CAR Construction and Production Platform
  • TABLE 14.9: (CONTINUED)
  • TABLE 14.10: CRISPR Therapeutics' Immuno-Oncology Programs
  • TABLE 14.11: Cartesian's Product Pipeline
  • TABLE 14.12: Eureka's CAR Products in Development for Juno Therapeutics
  • TABLE 14.13: iPSC-Derived Product Candidates from Fate Therapeutics
  • TABLE 14.14: Formula's Product Candidates
  • TABLE 14.15: Gilead's Cell Therapy Programs in Oncology
  • TABLE 14.16: iCell's Product Candidates
  • TABLE 14.17: Juno's CAR-T Product Candidates
  • TABLE 14.18: Kite's Pipeline of Product Candidates
  • TABLE 14.19: Mustang Bio's Product Candidates
  • TABLE 14.20: Nanjing's Autologous Product Pipeline for Hematologic Malignancies
  • TABLE 14.21: Nanjing's Allogeneic Product Pipeline for Hematologic and Solid Cancers
  • TABLE 14.22: Noil's Product Candidates for Solid Cancers
  • TABLE 14.23: Oxford Biomedica's IP Enabled and Royalty Bearing Product Candidates
  • TABLE 14.24: Poseida's Product Pipeline
  • TABLE 14.25: Precigen's CAR-T Programs
  • TABLE 14.26: Precision Bioscience's Off-the-Shelf Immunotherapy Pipeline
  • TABLE 14.27: Sorrento's Immunotherapy Pipeline
  • TABLE 14.28: TC Biopharm's Product Candidates
  • TABLE 14.29: Tmunity's CAR-T Programs for Liquid and Solid Tumors
  • TABLE 14.30: Wugen's Pipeline of Product Candidates
  • TABLE 14.31: Xyphos' Product Pipeline
  • TABLE 14.32: Ziopharm's CAR-T Product Candidates
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