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市場調查報告書

全球 CAR-T 細胞療法市場:市場規模、預測、臨床試驗、趨勢(2021 年)

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

出版商 BIOINFORMANT WORLDWIDE, LLC 商品編碼 1007219
出版日期 內容資訊 英文 235 Pages
訂單完成後即時交付
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全球 CAR-T 細胞療法市場:市場規模、預測、臨床試驗、趨勢(2021 年) Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends, 2021
出版日期: 2021年06月01日內容資訊: 英文 235 Pages
簡介

2020年,CAR-T細胞治療產品的臨床試驗只有12個,但今天這個數字已經增長到500多個。 2017 年至 2021 年間推出了四款 CAR-T 產品,預計該數字將在五年內達到兩位數。最早獲批的 Kimriah 和 Yescarta 分別於 2017 年和 2018 年上市,並已用於全球約 500,000 名患者。 2020年7月,美國FDA批准了第三個CAR-T細胞療法——Kite Pharma的blexucabtagene autoleucel(商品名:Tecartus)。

CAR-T細胞療法有望在生物科技行業掀起轟動,開啟癌症治療新時代。然而,成功的案例已經針對抗原CD19,並被認為是治療一些有限的血癌的關鍵抗原。如今,血液腫瘤學領域的競爭日益激烈,許多公司都瞄準了 CAR 細胞療法。

本報告探討了全球CAR-T細胞療法市場,概述了CAR-T細胞療法、歷史、專利狀況、各地區臨床試驗趨勢、CAR-T細胞療法行業交易趨勢、場外交易產品和候選藥物。詳細信息、報銷制度、血癌詳細信息、按產品/適應症/地區劃分的市場規模趨勢和預測、成功策略和障礙、主要公司簡介等。

目錄

第 1 章報告概述

第 2 章 CAR-T 細胞療法:概述

  • CAR-T 細胞
  • CAR-T細胞研發進展
  • 血癌細胞中存在的抗原
  • 將受體基因插入 T 細胞的工具
  • T 細胞轉化為 CAR-T 細胞
  • 4 種 CAR-T 療法跨越終點線
  • 與 CAR-T 治療相關的毒性
  • CAR-T 細胞療法的未來
  • CAR-T 細胞療法的好處
  • CAR-T細胞療法的缺點

第 3 章 CAR-T 細胞療法的歷史

  • CAR-T療法產品現狀
  • 未來 CAR-T 候選產品
  • CAR-T 療法的潛在轉變
  • 患者人群小,臨床試驗大的情況

第 4 章CAR-T細胞的製造

  • CAR-T 製造中的自動化
  • 內部製造 CAR-T 的費用
  • 製造同源 CAR-T 的成本

第 5 章CAR-T靶抗原:概述

  • CAR-T 血癌靶抗原
  • CAR-T 實體瘤靶向抗原
  • CAR-T 細胞靶向的常見抗原
    • 分化簇 19 (CD19)
    • Mesoterin
    • B 細胞成熟劑 (BCMA)
    • GD2
    • Glypican-3 (GPC3)
    • 聚類分化-22 (CD22)

第 6 章CAR-T專利情況

  • 各地區CAR-T專利申請情況
  • CAR-T 前 10 名專利管轄區
  • CAR-T細胞專利申請人隸屬關係

第 7 章全球 CAR-T 臨床試驗:概述

  • CAR-T 臨床試驗中的靶標生物標誌物
    • 美國
    • 中國
    • 其他領域
  • CAR-T 在美國臨床試驗中的適應症
  • CAR-T 在中國臨床試驗中的適應症
  • 正在進行的 CAR-T 臨床試驗中的適應症百分比
  • 測試階段
  • 美國CAR-T臨床試驗贊助公司/機構
  • 中國CAR-T臨床試驗贊助企業/機構
  • 其他國家的CAR-T臨床試驗贊助公司/機構
  • CAR-T 臨床試驗:按地區
  • CAR-T 臨床試驗:按代
  • CAR-T 臨床試驗:按使用的 ScFv 類型
  • CAR-T 臨床試驗:按使用的載體類型

第 8 章科學論文和 NIH 資助

  • 發表論文數
  • NIH 資助 CAR-T 研究

CAR-T治療領域的第九章交易

  • 最新CAR-T交易
    • 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 章商用CAR-T產品

  • Kimria (Tisagenlecleucelle)
    • 作用機制
    • 劑量
    • 安全性和有效性
    • 成本
    • 當前銷售額
  • Yescarta (Axicabtagene ciloleucel)
  • Tecartus (Brexucabtagene autoleucel)
  • Breyanzi (Lisocabtagene maraleucel)
  • 其他有前景的 CAR-T 候選產品
    • 0Idecabtagene Vicleucel (Ide-cel, bb2121)
    • ALLO-501
    • CTX110
    • UCART19
    • AUTO1
    • JCARH125
    • LCAR-B38M
    • PBCAR20A
    • UCART123
    • PRGN-3006
    • UCART22
    • UCARTCS1

第 11 章CAR-T治療報銷系統

  • 美國CAR-T治療報銷制度
  • 基於 5 個歐盟國家 CAR-T 治療結果的報銷制度
    • 法國
    • 德國
    • 意大利
    • 西班牙
    • 英國

第 12 章血癌:概述

  • 淋巴瘤
    • 霍奇金淋巴瘤 (HL)
    • 非霍奇金淋巴瘤 (NHL)
  • 白血病
  • 多發性骨髓瘤 (MM)
  • 血癌治療方案
    • 化療
    • 放射治療
    • 靶向治療
    • 幹細胞移植
    • 免疫療法
  • 癌症治療費用

第 13 章市場分析

  • 全球 CAR-T 細胞治療市場:按產品分類
  • 全球 CAR-T 細胞療法市場:按地區
  • 全球 CAR-T 細胞療法市場:按適應症
  • 活躍在市場前沿的公司
  • 在 CAR-T 2.0 市場取得成功的策略和障礙
    • 商業成功的障礙
    • 市場發展戰略

第 14 章公司簡介

  • Aleta BioTherapeutics
  • Aleta BioTherapeutics
  • Allogene Therapeutics
  • Anixa Biosciences, Inc.
  • Atara 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.

附錄

  • 附錄 1:美國提供 CAR-T 療法的醫療中心
目錄

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, Tecartus, and Breyanzi 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 over 500. Between 2017 and 2021, four CAR-T products reached the market, and this number is projected to reach double digits within five years. 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). In February 2021, Breyanzi became the fourth CAR-T approval and the first product with RMAT designation to be licensed by the FDA.

All 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).

By February 2021, the U.S. FDA granted approval of Breyanzi (lisocabtagene maraleucel) to Juno Therapeutics, a Bristol-Myers Squibb company. Breyanzi is approved for the treatment of adults with relapsed or refractory large-B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 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 2028
  • 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 235-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

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 Four 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. A BRIEF 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. DEAL-MAKING WITHIN THE CAR-T THERAPY SECTOR

  • 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
  • 10.4. Breyanzi (Lisocabtagene maraleucel)
    • 10.4.1. Mechanism of Action
    • 10.4.2. Dosing
    • 10.4.3. Safety and Efficacy of Breyanzi
    • 10.4.4. Efficacy, Safety and Composition of Approved CAR-T Products
  • 10.5. Other Promising CAR-T Product Candidates
    • 10.5.1. 0Idecabtagene Vicleucel (Ide-cel, bb2121)
    • 10.5.2. ALLO-501
    • 10.5.3. CTX110
    • 10.5.4. UCART19
    • 10.5.5. AUTO1
    • 10.5.6. JCARH125
    • 10.5.7. LCAR-B38M
    • 10.5.8. PBCAR20A
    • 10.5.9. UCART123
    • 10.5.10. PRGN-3006
    • 10.5.11. UCART22
    • 10.5.12. 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. Atara 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
  • 4.35. 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

APPENDIX

  • Appendix 1: Medical Centers offering CAR-T Therapies in the U.S.

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
  • FIGURE 6.2: Granted CAR-T-Related Patents
  • 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 CAR-T Clinical Trials per Year, U.S. vs. China
  • 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
  • FIGURE 10.2: Sales Revenues for Yescarta
  • FIGURE 10.3: Sales Data for Kymriah and Yescarta
  • FIGURE 12.1: Global Incidence of Blood Cancers
  • 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, 2020-2028
  • FIGURE 13.2: Global Market for CAR-T Therapy by Geography, 2020-2028
  • FIGURE 13.3: Global Market for CAR-T Therapy by Indication, 2020-2028
  • FIGURE 14.1: Illustration of a Dual CAR

INDEX OF TABLES

  • TABLE 2.1: Potential 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 Cell Research
  • TABLE 8.1: (CONTINUED)
  • TABLE 9.1: Deal-Making in CAR-T Cell Therapy Sector
  • 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
  • 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, 2020-2028
  • TABLE 13.2: Global Market for CAR-T Therapy by Geography, 2020-2028
  • TABLE 13.3: Global Market for CAR-T Therapy by Indication, 2020-2028
  • 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