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Global CAR-T Cell Therapy Market: Size, Forecasts, Trials & Trends, 2023

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    Report

  • 321 Pages
  • November 2023
  • Region: Global
  • BioInformant
  • ID: 5331298

Living Drugs: How CAR-T Cell Therapy Is Transforming Cancer Care

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. Once infused into the patient, these CARs enable the T-cells to recognize and attach to an antigen on the cancer cell, leading to its destruction.

Scientific progress within the field of cancer immunotherapy has led to seven CAR-T cell therapy approvals, including:

  1. Kymriah (tisagenlecleucel)
  2. Yescarta (axicabtagene ciloleucel)
  3. Tecartus (brexucabtagene autoleucel)
  4. Breyanzi (lisocabtagene maraleucel)
  5. Abecma (idecabtagene vicleucel)
  6. Relma-cel (Relmacabtagene)
  7. Carvykti (Ciltacabtagene autoleucel)

While Relma-cel has been approved by NMPA in China, all the other six therapies have been approved in the U.S. by the FDA.

These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm. This has driven CAR-T funding to staggering new heights. At first the trend was subtle, but the tide has swelled as CAR-T start-ups have been richly funded by investors eager to get into this expanding area of regenerative medicine. In total, there has been an astonishing $100 billion of market capitalization from CAR-T companies in recent years.

Financing rounds by CAR-T companies have approached $4 billion, while CAR-T industry partnerships have contributed an astounding $2 billion. M&A activity has been even more aggressive, with Celgene snagging Juno Therapeutics for $9 billion in 2018 and Bristol-Myers Squibb (BMS) acquiring Celgene for $74B by 2019. Gilead’s acquisition of Kite Pharma for $11.9 billion also made waves, as did other transactions, such as Astellas Pharma’s acquisition of Xyphos Biosciences and its CAR-T technology for $665 million. The billion-dollar CAR-T cell therapy market would not have been possible without the remarkable efficacy of the early CAR-T therapies in treating several types of blood cancers. Ranging from small start-ups to billion-dollar companies, CAR-T companies are proliferating in all healthcare markets worldwide.

This 321-page market report reveals:

  • Global CAR-T cell therapy market size, with segmentation by product, geography, and indication
  • Future market size forecasts by segment through 2030
  • Detailed coverage of the approved CAR-T products, including regulatory approvals, pricing, reimbursement, and degree of market penetration
  • Clinical trial activity by type, geography, phase, and sponsor
  • Comprehensive CAR-T patent analysis, including top inventors, patent holders, patent types, geographies, and most cited patents
  • CAR-T industry mergers and acquisitions, IPOs, and financing events
  • Strategic partnerships, alliances, and co-commercialization agreements within the CAR-T sector
  • Market trends, future directions, and emerging opportunities
  • Profiles of leading CAR-T competitors composing the global marketplace
  • and much more

Table of Contents

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary
1.3 Introduction

2. CAR-T CELL THERAPY: TECHNOLOGY DEVELOPMENT
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
2.2.1.5 Fifth Generation CARs
2.3 Antigens Present on Hematological Malignant Cells
2.4 Tools for Inserting Receptor Genes into T Cells
2.5 Transforming T Cells into CAR-T Cells
2.6 The Seven CAR-T Therapies Available in the Market: A Brief Overview
2.7 Toxicities Associated with CAR-T Treatment
2.8 Strategies for the Future of CAR-T Therapies
2.8.1 Switchable CARs (sCARs)
2.8.2 Suicide Genes to Destroy CAR-T Cells In Vivo
2.8.3 Transient Transfection
2.8.4 Affinity-Tuned CARs
2.8.5 Armored CARs
2.8.6 Shift from Liquid Cancers to Solid Tumors
2.8.7 Focus on Shortening Hospital Stay
2.8.8 Focus on Discovering New Antigens
2.8.9 Shifting from Autologous to Allogeneic CAR-T Therapies
2.8.10 CAR-T for the Masses
2.8.11 New In Vivo CAR-T Approach
2.8.12 Combination with mRNA Vaccine
2.8.13 Combination with Oncolytic Virus
2.9 Direct Competition between Autologous CAR-T Therapies

3. CAR-T CELL THERAPY: PRODUCT DEVELOPMENT
3.1 History of Development of CAR-T Cells
3.2 Top Ten Milestones Crossed by CAR-T Therapy
3.2.1 First Pediatric Patient to Receive CAR-T Therapy
3.2.2 CAR-T Granted Breakthrough Therapy Designation
3.2.3 The Beginning of CAR-T Development to Combat Solid Cancers
3.2.4 First CRISPR CAR-T Built
3.2.5 The First Two CAR-T Approvals
3.2.6 EMA’s Approval for Kymriah and Yescarta
3.2.7 Approval of Tecartus, Breyanzi and Abecma
3.2.8 NMPA Approval of Relma-cel (Carteyva)
3.2.9 Approval of Carvykti
3.3 Current Status of CAR-T Therapy Products
3.3.1 Kymriah (Tisagenlecleucel)
3.3.1.1 Kymriah’s Mechanism of Action
3.3.1.2 Clinical Trials on Kymriah
3.3.2 Yescarta (Axicabtagene ciloleucel)
3.3.2.1 Mechanism of Action
3.3.2.2 Yeskarta on Clinical Trials
3.3.3 Tecartus (Brexucabtagene autoleucel)
3.3.3.1 Tecartus Approvals
3.3.3.2 Mechanism of Action
3.3.3.3 Clinical Trials on Tecartus
3.3.4 Breyanzi (Lisocabtagene maraleucel)
3.3.5 Abecma (Idecabtagene vicleucel)
3.3.5.1 Regulatory Approvals for Abecma
3.3.5.2 Mechanism of Action
3.3.5.3 Clinical Trials on Abecma
3.3.6 Relma-Cel (Relmacabtagene autoleucel)
3.3.7 Carvykti (Ciltacabtagene autoleucel)
3.3.7.1 Regulatory Approvals for Carvykti
3.3.7.2 Mechanism of Action
3.3.7.3 Clinical Trials on Carvykti
3.4 Other Promising CAR-T Product Candidates
3.4.1 ALLO-501
3.4.2 CTX-110
3.4.3 UCART19
3.4.4 AUT01
3.4.5 JCARH125
3.4.6 PBCAR20A
3.4.7 UCART123
3.4.8 PRGN-3006
3.4.9 UCART22
3.4.10 UCARTCS1
3.5 Transformative Potential of CAR-T Therapy
3.6 Cancer Population Addressed by CAR-T Therapy
3.7 Advantages of CAR-T Cell Therapy
3.8 Disadvantages of CAR-T Therapy

4. SCALABLE MANUFACTURING OF CAR-T CELLS
4.1 The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
4.2 The Evolution of CAR-T Cell Manufacturing Platforms
4.2.1 Open vs. Closed Systems
4.2.2 Manual Processing vs. Automation
4.2.3 Autologous vs. Allogeneic Manufacturing
4.4 Operating Expenses in Autologous CAR-T Manufacturing
4.5 Operating Expenses in Allogeneic CAR-T Manufacturing

5. CAR-T TARGET ANTIGENS
5.1 CAR-T Target Antigens on Hematalogical Malignancies
5.2 CAR-T Target Antigens on Solid Tumors
5.3 Common Antigens Targeted by CAR-T Cells in Clinical Trials
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 Patent Applicants
6.4 Top 20 Companies in CAR-T Patent Landscape
6.5 Top 20 Research Centers in CAR-T Patent Landscape
6.6 Top Ten CAR-T Inventors
6.7 Top Five CAR-T Patents with Most Family Members
6.8 Top Five CAR-T Patents with Most Inventors in Co-Authorship
6.9 Top Five Patents with Most Co-Applicants
6.10 Top 5 CAR-T Patents with Most Co-Applicants

7. CAR-T CLINICAL TRIAL LANDSCAPE
7.1 Most Addressed Indications in Clinical Trials
7.2 Current Focus of Ongoing Clinical Trials
7.3 Countries with Most Clinical Trials
7.4 Phase of Clinical Trial Studies
7.5 CAR-T Clinical Trials for Hematalogical Malignancies
7.6 Simultaneous Targets by One CAR-T
7.7 CAR-T Generations Used in Clinical Trials
7.8 CAR-T Clinical Trials Focusing on Solid Tumors
7.9 CAR-T Targeted Biomarkers in Clinical Trials
7.10 CAR-T Targeted Biomarkers in the U.S. Clinical Trials
7.11 CAR-T Targeted Biomarkers in Chinese Clinical Trials
7.12 CAR-T Targeted Indications in the U.S. Clinical Trials
7.13 Indications Addressed by CAR-T Clinical Trials in China
7.14 Hematological Malignancies v.s. Solid Cancers in CAR-T Clinical Trials
7.15 CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
7.16 CAR-T Clinical Trial Sponsor Companies & Institutions in China
7.17 CAR-T Clinical Trial Sponsor Companies & Institutions in other Countries
7.18 Improved CAR-T Constructs in Clinical Trials
7.18.1 CAR-T with PD1Fc
7.18.2 CAR-T with Truncated with EGFR (EGFRt)
7.18.3 CAR-T with IL7 and CCL19
7.18.4 CAR-T with PD1/CD28 Switch Receptor
7.18.5 CAR-T with PD1 shRNA Expressing Cassette
7.18.6 CAR-T with CTLA-4/PD-1 Antibody
7.18.7 CAR-T with PD-1 Antibodies
7.19 Distribution of CAR-T Trials by Type of SeFv Used
7.20 Distribution of CAR-T Clinical Trials by Type of Vectors Used

8. PUBLISHED CAR-T SCIENTIFIC PAPERS IN PUBMED.GOV & NIH FUNDING
8.1 PubMed.gov Published Papers on the Five Generation of CARs
8.2 PubMed.gov Papers Published on Autologous and Allogeneic CAR-Ts
8.3 Published CAR-T PubMed Papers on Solid & Liquid Cancers
8.4 NIH Funding for CAR-T Research in 2022

9. DEALS IN CAR-T THERAPY SPACE
9.1 Most Recent CAR-T Deals
9.1.1 Autolus Therapeutics/Bristol Myers Squibb
9.1.2 ArsenalBio/Genentech
9.1.3 Chugai Pharmaceutical/Noile Immune Biotech
9.1.4 Roche/Poseida Therapeutics
9.1.5 Oxford Biomedica/Undisclosed U.S. Company
9.1.6 Immatics/Bristol Myers Squibb
9.1.7 Galapagos/CellPoint/AboundBio
9.1.8 Coeptis/University of Pittsburgh
9.1.9 Pregene/CellPont
9.1.10 Intellia/Kyverna
9.2 Funding for CAR-T Therapy in H1 2022
9.2.1 Neukio Bio
9.2.2 Arsenal Biosciences
9.2.3 Eyestem
9.2.4 Legend Biotech
9.2.5 Immuneel Therapeutics
9.2.6 Tessa Therapeutics
9.2.7 Elicera Therapeutics
9.2.8 Inceptor Bio
9.2.9 AvenCell Therapeutics
9.2.10 Ucello Theraputics
9.2.11 Kyverna Therapeutics

10. REIMBURSEMENT FOR CAR-T THERAPIES
10.1 Potential Barriers to CAR-T Treatments
10.1.1 Patient Barriers
10.1.2 Limited Number of Treatment Centers
10.1.3 Travel, Lodging & Meal Expenses
10.1.4 Utilization Management Policies
10.1.5 Out-of-Pocket Costs
10.1.6 Geography
10.1.7 Logistics of Follow-Up
10.1.8 Reimbursement Uncertainty
10.2 Manufacturer Challenges
10.2.1 Lingering Manufacturing Issues
10.2.2 Difficulties with Scaling Up
10.3 CAR-T Reimbursement Updated for FY 2023 IPPS Final Rule
10.3.1 Payment Changes for CAR-T Cases
10.3.2 High-Cost Outlier Payments
10.4 Use of 2021 Data to Establish Payment
10.4.1 Adjustment for Clinical Trial Cases
10.4.2 Product NTAP Decisions
10.5 Reimbursement for CAR-T Therapy in Europe
10.5.1 Cost Components of Pre- and Post-CAR-T Cell Therapy
10.5.2 Average Total Costs Pre- and Post CAR-T Cell Administration in E.U.
10.6 Outcomes-Based Reimbursement for CAR-T Therapies in Europe
10.6.1 France
10.6.2 Germany
10.6.3 Italy
10.6.4 Spain
10.6.5 Reimbursement for CAR-T Therapies in U.K.
10.7 CAR-T Cell Treated Patients Registered in EBMT Registry

11. BLOOD CANCERS: INCDENCE AND AVAILABLE TREATMENTS
11.1 Lymphoma
11.1.1 Hodgkin Lymphoma (HL)
11.1.2 Non-Hodgkin Lymphoma (NHL)
11.1.3 Diffuse Large B Cell Lymphoma (DLBCL)
11.1.4 Follicular Lymphoma (FL)
11.2 Leukemia
11.2.1 Types of Leukemia
11.2.1.1 Acute Myeloid Leukemia (AML)
11.2.1.2 Acute Lymphoblastic Leukemia (ALL)
11.2.1.3 Chronic Myeloid Leukemia (CML)
11.2.1.4 Chronic Lymphocytic Leukemia (CLL)
11.2.1.5 Multiple Myeloma (MM)
11.3 Treatment Options for Blood Cancers
11.3.1 Chemotherapy
11.3.2 Radiation Therapy
11.3.3 Targeted Therapy
11.3.4 Stem Cell Transplantation
11.3.5 Immunotherapy
11.3.5.1 Monoclonal Antibodies (mAbs)
11.3.6 Adoptive Cell Transfer Therapy/T Cell Transfer Therapy
11.4 The Staggering Cost of Cancer Therapies

12. MARKET ANALYSIS
12.1 Global Market for CAR-T Cell Therapy by Product
12.2 Global Market for CAR-T Therapy by Geography
12.3 Global Market for CAR-T Therapy by Indication

13. BARRIERS & STRATEGIES FOR SUCCESS IN CAR-T 2.0 MARKET PLACE
13.1 Barriers to CAR-T 2.0 Commercial Success
13.2 Capacity Constraints
13.3 Competition among Manufacturers
13.4 Competition from other Treatments
13.5 Market Development Strategies for CAR-T 2.0
13.5.1 Effective Physician Education
13.5.2 Logistical Excellence
13.5.3 Evidence Generation

14. CAR-T COMPANIES: AN OVERVIEW
14.1 Abintus Bio, Inc.
14.2 Adicet Bio
14.2.1 Gamma Delta T Cells
14.2.2 Proprietary Cell Platform Process
14.2.3 Pipeline
14.3 AffyImmune Therapeutics, Inc.
14.3.1 Affinity-Tuned CARs
14.3.2 Real-Time CAR-T Cell Monitoring
14.4 Alaunos Therapeutics, Inc.
14.5 Aleta BioTherapeutics
14.5.1 Aleta’s CAR-T Engager Pipeline
14.6 Allogene Therapeutics
14.6.1 AlloCAR-T
14.7 Anixa Biosciences, Inc.
14.8 Appia Bio
14.9 Arbele Ltd.
14.9.1 AI-CAR-T/NK Cell Platform
14.10 Arcellx
14.10.1 D-Domain Technology
14.10.2 ddCAR
14.10.3 ARC-SparX
14.11 Artiva Biotherapeutics
14.11.1 Artiva’s AlloNK Platform
14.11.2 Artiva’s CAR-NK Platform
14.12 Atara Biotherapeutics
14.12.1 Technology
14.12.2 Atara’s Robust Pipeline
14.13 Aurora BioPharma
14.14 Autolus Therapeutics plc
14.14.1 Technology
14.14.2 CAR-T Cell Production
14.14.3 Manufacturing
14.14.4 Autolus’ Therapies in Development
14.14.5 obe-cel
14.15 AvenCell Europe GmbH
14.15.1 AvenCell’s Proprietary Platforms
14.15.2 UniCAR
14.15.3 RevCAR
14.15.4 TCE
14.15.5 AvenCell’s Clinical and Preclinical Pipeline
14.16 Aavocyte, Inc.
14.16.1 AAVOT Technology
14.16.2 Indications for AAVOT Therapy
14.17 Beam Therapeutics, Inc.
14.17.1 Base Editing Technology
14.18 Bellicum Pharmaceuticals
14.18.1 GoCAR Technology
14.18.2 CaspaCIDe Safety Switch
14.19 BioNTech
14.19.1 BioNTech’s Engineered Cell Therapies
14.9.2 BNT211
14.19.3 BNT212
14.20 Biosceptre
14.20.1 nfP2X7
14.20.2 Biosceptre’s Product Pipeline
14.21 bluebird bio
14.21.1 CAR-T Collaborations
14.21.2 Collaboration with Celgene
14.21.3 Collaboration with Bristol Myers Squibb
14.21.4 Collaboration with TC BioPharm
14.21.5 Collaboration with Inhibrx
14.21.6 Collaboration with PsiOxus
14.22 Bristol Myers Squibb/Celgene Corp.
14.22.1 Products
14.22.1.1 ABECMA (idecabtagene vicleucel)
14.22.1.2 Breyanzi (lisocabtagene maraleucel)
14.23 Cabaletta Bio
14.23.1 CAAR Technology
14.24 Carina Biotech
14.25 CARsgen Therapeutics
14.26 Cartesian Therapeutics
TABLE 14.19: Cartesian’s Growing Product Pipeline
14.27 CARTherics Pty Ltd.
14.27.1 Technology
14.28 Cellectis
14.28.1 Product Candidates
TABLE 14.20: Cellectis’ Products in Development
14.29 CellPoint BV
14.30 Celularity, Inc.
14.30.1 P CAR-T
14.31 Celyad Oncology
14.31.1 Technologies
14.31.2 All-In-One Vector Approach
14.31.3 Pipeline
14.32 Century Therapeutics, Inc.
14.32.1 Century’s Approach
14.32.2 Gene Editing Technology
14.32.3 Proprietary Allo-Evasion Technology
14.32.4 CAR and Protein Engineering
14.32.5 Common Engineered iPSC Progenitors
14.32.6 Streamlined Manufacturing
14.32.7 Century’s Pipeline Overview
14.33 Clade Therapeutics
14.34 Coeptis Therapeutics, Inc.
14.34.1 SNAP CAR-T
14.35 Creative Biolabs
14.35.1 CAR-T Therapy Development
14.35.2 Biomarker Identification and Selection
14.35.3 scFv Generation
14.35.4 CAR-T Gene Packaging & Delivery
14.35.5 Replication-Competent Virus Testing Service
14.35.6 CAR Cell In Vitro Assay Service
14.35.7 CAR-T Preclinical In Vivo Assay
14.35.8 IND Development for CAR-T Cell Therapy
14.35.9 GMP Production for CAR-T Products
14.35.10 CAR-T Clinical Trials
14.36 CRISPR Therapeutics
14.36.1 CRISPR/Cas9 Immuno-Oncology Cell Therapy
14.36.2 CRISPR/Cas9 Allogeneic CAR-T Design
14.37 Curocell, Inc.
17.37.1 OVIS Technology
17.38 CytoSeek
14.38.1 Technology
14.38.2 Pipeline
14.39 Cytovia Therapeutics
14.39.1 Technology
14.40 DiaCarta
14.40.1 Personalized CAR-T Immunotherapy Platform
14.41 Elicera Therapeutics AB
14.41.1 iTANK CAR-T Technology
14.41.2 Elicera’s Product Pipeline
14.42 Eureka Therapeutics, Inc.
14.42.1 Technology
14.42.1.1 E-ALPHA Phage Display Platform
14.42.1.2 ARTEMIS Cell Receptor Platform
14.42.2 Eureka’s Product Pipeline
14.43 EXUMA Biotech Corp.
14.43.1 TMR CAR-T Technology
14.44 Fate Therapeutics, Inc.
14.45 Gilead Sciences, Inc.
14.45.1 CAR-T Products
14.45.1.1 TECARTUS (Brexucabtagene autoleucel)
14.45.1.2 Yescarta (Axicabtagene ciloleucel)
14.45.2 CAR-T Programs
14.46 Gracell Biotechnologies
14.46.1 FasTCAR
14.46.2 TruUCAR
14.46.3 SMART CART
14.46.4 Gracell’s Clinical Pipeline
14.47 IASO Biotherapeutics
14.47.1 Technology Platforms
14.47.1.1 Fully Human Antibody Discovery Platform (IMARS)
14.47.1.2 High-Throughput Screening Platform for CAR-T Candidates
14.47.1.3 Universal CAR-T Technology Platform
14.47.1.4 Manufacturing Technology Platform
14.47.2 IASO’s Diverse Product Pipeline
14.48 iCell Gene Therapeutics
14.48.1 CARvac Platform
14.48.2 T-Cell Targeted CARs
14.48.3 Non-Gene Edited Universal CARs
14.48.4 C-TPS1
14.48.5 Compound CARs
14.48.5 Pipeline
14.49 ImmPACT Bio
14.49.1 Technologies
14.49.1.1 Dual-Targeted CAR-T Cell Therapy
14.49.1.2 ICAR Dual Targeting Technology
14.49.1.3 TGF-B CARS Targeting TME
14.50 Immuneel Therapeutics, Pvt. Ltd.
14.51 Inceptor Bio
14.51.1 Inceptor’s Technology Platforms
14.52 Interius BioTherapeutics
14.52.1 Core Technology
14.53 Janssen Biotech, Inc.
14.53.1 JNJ-4528
14.54 JW Therapeutics
14.54.1 Relma-cel (JWCAR029)
14.55 Kite Pharma (Gilead)
14.55.1 Kite’s Technology
14.55.2 Kite’s Marketed Therapies
14.55.2.1 Yescarta (Axicabtagene ciloleucel)
14.55.2.2 Tecartus (Brexucabtagene autoleucel)
14.55.3 Kite’s Pipeline Cancer Therapies
14.56 Kuur Therapeutics
14.56.1 Kuur’s Product Candidates
14.57 Kyverna Therapeutics
14.57.1 CAR-T Cells
14.57.1.1 SynNotch CAR-T Cells
14.57.1.2 SynReg T Cells
14.58 Legend Biotech
14.58.1 LCAR-B38M/JNJ-4528
14.59 Leucid Bio
14.59.1 Leucid’s Science
14.59.2 Leucid’s Product Pipeline
14.60 Luminary Therapeutics, Inc.
14.60.1 BAFF CAR-T
14.60.2 Universal Receptor
14.60.3 Luminary Therapeutics’ Pipeline
14.61 Lyell Immunopharma, Inc.
14.61.1 Technologies
14.61.1.1 Gen-R Technology
14.61.1.2 Epi-R Technology
14.62 MaxCyte, Inc.
14.62.1 ExPERT Technology Platform
14.62.1.1 ATx
14.62.1.2 GTx
14.62.1.3 STx
14.62.1.4 VLx
14.63 Minerva Biotechnologies Corporation
14.63.1 Autologous huMNC2-CAR44
14.64 Mnemo Therapeutics
14.64.1 Mnemo’s Approach
14.64.1.1 Mnemo’s 1XX CAR
14.65 Mustang Bio
14.66 Neukio Biotherapeutics
14.66.1 iPSC-CAR-NK Technology
14.67 NKarta, Inc.
14.67.1 Technology
14.67.2 NKarta’s Pipeline
14.68 Noile-Immune Biotech
14.68.1 PRIME Technology
14.69 Novartis AG
14.69.1 The Pioneers of CAR-T Cell & Gene Therapy
14.69.2 Approval of Kymriah (tisagenlecleucel)
14.70 Oncternal Therapeutics
14.70.1 Oncternal’s Product Pipeline
14.71 Orna Therapeutics
14.71.1 oRNA Circular RNA
14.71.2 oRNA’s Pipeline Products
14.72 Oxford Biomedica plc
14.72.1 LentiVector Platform
14.72.2 LentiStable Platform
14.72.3 Adeno-Associated Virus (AAV) Platform
14.72.4 TRiP System
14.73 PeproMene Bio, Inc.
14.73.1 BAFFR CAR-T Cells
14.73.2 Bispecific T Cell Engager (BiTE)
14.73.3 CAR NK Cells
14.74 Poseida Therapeutics, Inc.
14.74.1 Platforms
14.74.1.1 piggyBac
14.74.1.2 Cas-CLOVER
14.74.1.3 Gene Delivery
14.74.1.4 TSCM Cells
14.74.2 Pipeline Products
14.74.2.1 P-BCMA-ALL01
14.74.2.2 P-MUC1C-ALL01
14.74.2.3 P-PSMA-ALL01
14.74.2.4 Dual CAR Allogeneic Programs
14.74.2.5 P-PSMA-101
14.75 Precigen, Inc.
14.75.1 Therapeutic Platforms
14.75.1.1 UltraCAR-T
14.75.1.2 AdenoVerse Immunotherapy
14.75.1.3 ActoBiotics
14.75.1.4 Multifunctional Therapeutics
14.75.2 Technology Platforms
14.75.2.1 UltraVector
14.75.2.2 Sleeping Beauty System
14.75.2.3 AdenoVerse
14.75.2.4 UltraPorator
14.75.2.5 RheoSwitch
14.75.3 Precigen’s Pipeline
14.76 Precision Biosciences
14.76.1 ARCUS Genome Editing
14.76.2 Precision’s CAR-T Immunotherapy Pipeline
14.77 Prescient Therapeutics
14.77.1 Technology
14.77.1.1 OmniCAR
14.77.1.2 CellPryme-M
14.77.1.3 PTX-100
14.77.1.4 PTX-200
14.78 ProMab Biotechnologies, Inc.
14.78.1 Products
14.78.2 Services
14.78.2.1 Cell Line Engineering Services
14.78.2.2 Custom CAR-T Cell Development
14.78.2.3 Custom CAR-NK Cell Development
14.78.2.4 Custom CAR-Macrophage Cell Development
14.78.2.5 Custom Gamma Delta T Cell Development
14.78.3 Lentivirus Production
14.78.4 mRNA-Lipid Nanoparticle Gene Delivery
14.78.5 Cancer Stem Cell Line Services
14.79 Quell Therapeutics, Ltd.
14.79.1 Quell’s Platform
14.80 Sorrento Therapeutics, Inc.
14.80.1 DAR-T (Dimeric Antigen Receptor T Cell)
14.81 SOTIO Biotech, A.S.
14.81.1 SOTIO’s Pipeline
14.82 Syngene International, Ltd.
14.82.1 CAR-T Services
14.83 Synthekine
14.83.1 STK-009 + SYNCAR-001
14.84 TC BioPharm
14.84.1 Gamma Delta T Cells
14.84.2 Cell Banks
14.84.3 Co-Stim CAR-T
14.84.4 TC BioPharm’s Product Pipeline
14.84.5 Omnlmmune
14.84.6 CAR-T Programs
14.85 T-CURX
14.85.1 CARAMBA Project
14.85.2 imSAVAR Project
14.86 Tessa Therapeutics, Ltd.
14.87 Tmunity Therapeutics
14.87.1 Technology
14.87.2 Pipeline
14.88 Umoja Biopharma
14.88.1 Umoja’s Core Technology Platforms
14.88.1.1 VivoVec in vivo Gene Delivery
14.88.1.2 RACR/CAR in vivo Cell Programming
14.88.1.3 TumorTag (Universal CAR Tumor Targeting)
14.89 Vor Biopharma
14.89.1 Vor Biopharma’s Ap[proach
14.89.2 Vor’s Platform
14.89.3 Vor’s Pipeline
14.90 Wugen
14.91 WuXi Advanced Therapies
14.91.1 Closed-Process CAR-T Platform
14.92 Xenetic Biosciences
14.92.1 The DNase Platform Technology
14.92.2 XCART Personalized CAR-T Platform Technology
14.92.3 PolyXen PSA Technology Platform
14.93 Xyphos Biosciences, Inc.
14.93.1 ACCEL & UDC Technology
14.93.2 convertibleCAR
14.93.3 Univeral Donor Cells

LIST OF FIGURES
FIGURE 2.1: The Basic Structure of a T cell
FIGURE 2.2: Binding of a T cell 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: The First Generation CARs
FIGURE 2.6: Second Generation CARs
FIGURE 2.7: Third Generation CARs
FIGURE 2.8: Fourth Generation CARs
FIGURE 2.9: Fifth Generation CARs
FIGURE 2.10: Antigens Present on Normal & Cancer Cells
FIGURE 2.11: The Process of CAR-T Manufacturing
FIGURE 2.12: Preparation & Administration of CAR-T Therapy
FIGURE 3.1: The Five Generations of CARs
FIGURE 3.2: A Package of Kymriah
FIGURE 3.3: Yescarta in a Blood Bag
FIGURE 3.4: Tecartus in a Blood Bag
FIGURE 3.5: Abecma in a Blood Bag
FIGURE 3.6: Relma-cel in a Blood Bag
FIGURE 3.7: Carvykti in a Blood Bag
FIGURE 4.1: The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
FIGURE 4.2: G-Rex Bioreactors
FIGURE 4.3: CliniMACS Prodigy
FIGURE 4.4: Scaling Up of Allogeneic CAR-T Cells
FIGURE 4.5: Operating Expenses in Autologous CAR-T Manufacturing
FIGURE 4.6: Operating Expenses in Allogeneic CAR-T Manufacturing
FIGURE 5.1: CAR-T Global Distribution in Clinical Trials
FIGURE 6.1: CAR-T Patent Publications
FIGURE 6.2: Granted CAR-T 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 Patent Applicants
FIGURE 7.1: Percent Share of CAR-T Clinical Trials by Phase
FIGURE 7.2: Percent Share of Hematological Malignancy Types in CAR-T Clinical Trials
FIGURE 7.3: Simultaneous Targets by One CAR-T
FIGURE 7.4: CAR-T Generations Used in Clinical Trials
FIGURE 7.5: % Share of Ten Major Solid Tumor Indications in CAR-T Clinical Trials
FIGURE 7.6: Hematological Malignancies v.s. Solid Cancers in CAR-T Clinical Trials
FIGURE 7.7: Distribution of CAR-T Clinical Trials by ScFv Used
FIGURE 7.8: Distribution of CAR-T Clinical Trials by Type of Vectors Used 115
FIGURE 8.1: Number of Published CAR-T Papers in PubMed.gov
FIGURE 8.2: Published PubMed Papers on the Five Generations of CAR-Ts
FIGURE 8.3: Published PubMed Papers, Autologous v.s Allogeneic CAR-Ts
FIGURE 8.4: Published CAR-T PubMed Papers on Solid & Liquid Cancers
FIGURE 10.1: CAR-T Cell Treated Patients Registered in EBMT Registry
FIGURE 11.1: Global Incidence of Blood Cancers & Death in 2020
FIGURE 11.2: Percent Distribution of New Leukemia Cases in the U.S. by Type
FIGURE 12.1: Estimated Global Market for CAR-T Therapy by Product, 2022-2030
FIGURE 12.2: Global Market for CAR-T by Geography, 2021-2030
FIGURE 12.3: Global Market for CAR-T Therapies by Indication, 2021-2030
FIGURE 14.1: Proprietary Cell Platform Process
FIGURE 14.2: Atara’s Differentiated Approach to Allogeneic Cell Therapy
FIGURE 14.3: Schematic of P CAR-T with TCR-KO
FIGURE 14.4: All-In-One Vector Approach
FIGURE 14.5: Century’s Approach in Developing Drug Product
FIGURE 14.6: Century’s Precision Gene Editing Technology
FIGURE 14.7: Century’s Allo-Evasion Technology
FIGURE 14.8: Century’s CAR Engineering
FIGURE 14.9: Century’s Common Engineered iPSC Progenitors
FIGURE 14.10: Difference between Donor-Derived and iPSC-Derived Cell Expansion
FIGURE 14.11: OVIS Technology
FIGURE 14.12: FasTCAR vs. Conventional CAR-T Manufacturing Process
FIGURE 14.13: Schematic of CD19/CD20 CAR-T Technology
FIGURE 14.14: Schematic of SynNotch CAR-T Cells Recognizing Target Cells
FIGURE 14.15: Schematic of Reprogrammed SynReg T Cells Targeting Disease Tissues
FIGURE 14.16: Schematic of BAFF CAR-T’s Action
FIGURE 14.17: ATx
FIGURE 14.18: GTx
FIGURE 14.19: STx
FIGURE 14.20: MaxCyte VLx
FIGURE 14.21: NKarta’s Engineered CAR-NK Cell
FIGURE 14.22: Mechanism of Action of BAFFR CAR-T Cells
FIGURE 14.23: Mechanism of Action of BAFF-R BiTE
FIGURE 14.24: PeproMene’s CAR NK Cells
FIGURE 14.25: UltraCAR-T Cell
FIGURE 14.26: WuXi’s Closed-Process CAR-T Platform
FIGURE 14.27: Convertible CAR Parts
FIGURE 14.28: Universal Donor Cells

LIST OF TABLES
TABLE 2.1: Potential CAR-T Targeted Antigens Present on Hematological Malignancies
TABLE 2.2: Key Differences between the available Vectors
TABLE 2.3: The Seven CAR-T Therapies Available in the Market: A Brief Overview
TABLE 2.4: Toxicities Associated with CAR-T Treatment
TABLE 2.5: Strategies for the Future of CAR-T Therapies
TABLE 2.6: A Short List of ongoing CAR-T Studies on Solid Tumors
TABLE 2.7: New Target Antigens and New Target Cancers
TABLE 2.8: A Non-Comprehensive List of Allogeneic CAR-T Companies
TABLE 3.1: History of Development of CAR-T Cell Therapy
TABLE 3.2: Approved CAR-T Products, their Developers and Indications
TABLE 3.3: Other Promising CAR-T Product Candidates
TABLE 3.4: Increased CAR-T Activity
TABLE 3.5: Very Small Patient Population Addressed by CAR-T Therapy
TABLE 5.1: CAR-T Target Antigens on Hematalogical 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 Twenty CAR-T Inventors
TABLE 6.4: Top Five CAR-T Patents with Most Family Members
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 5 CAR-T Patents with Most Co-Applicants
TABLE 7.1: Number of CAR-T Clinical Trials by Country
TABLE 7.2: Percent Target Distribution of CAR-T Clinical Trials
TABLE 7.3: CAR-T Targeted Biomarkers in the U.S. Clinical Trials
TABLE 7.4: CAR-T Targeted Biomarkers in Chinese Clinical Trials
TABLE 7.5: CAR-T Targeted Indications in the U.S. Clinical Trials
TABLE 7.6: CAR-T Targeted Indications in the U.S. Clinical Trials
TABLE 7.7: CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
TABLE 7.8: CAR-T ClinicAl Trial Sponsor Companies & Institutions in China
TABLE 7.9: CAR-T Clinical Trial Sponsor Companies & Institutions in other Countries
TABLE 7.10: Clinical Trials of Fourth, Fifth and Gene Edited CAR-Ts
TABLE 8.1: A Short List of NIH Funding for CAR-T Research in 2022
TABLE 10.1: Hospital Reimbursement, Proposed & Final Rule FY 2022 and FY 2023
TABLE 10.2: List Prices of Kymriah and Yescarta in Europe
TABLE 10.3: Cost Components of Pre- and Post-CAR-T Cell Therapy, in E.U.
TABLE 10.4: Average Total Costs Pre- and Post CAR-T Cell Administration in E.U.
TABLE 10.5: Reimbursement for CAR-T Thrapies in France
TABLE 10.6: Reimbursement for CAR-T Therapies in Germany
TABLE 10.7: Reimbursement for CAR-T Therapies in Italy
TABLE 10.8: Reimbursement for CAR-T Therapies in Spain
TABLE 10.9: Reimbursement for CAR-T Therapies in U.K.
TABLE 11.1: Cost of Treating Blood Cancers
TABLE 12.1: Estimated Global Market for CAR-T Therapy by Product, 2021-2030
TABLE 12.2: Global Market for CAR-T by Geography, 2021-2030
TABLE 12.3: Global Market for CAR-T Therapies by Indication, 2021-2030
TABLE 14.1: Adicet’s Broad Pipeline in Cancer
TABLE 14.2: AffyImmune’s Affinity-Tuned Pipeline Products
TABLE 14.3: Alaunos’ Advanced Platform Targeting Solid Tumors
TABLE 14.4: Aleta’s CAR-T Engager Pipeline in High Unmet Need Indications
TABLE 14.5: Allogene’s AlloCAR-T Pipeline
TABLE 14.6: Anixa’s Product Pipeline
TABLE 14.7: Arbele’s Product Pipeline
TABLE 14.8: Arcellx’s Current Product Pipeline
TABLE 14.9: Artiva’s NK Cell Therapy Pipeline for Cancer
TABLE 14.10: Atara’s Robust Product Pipeline
TABLE 14.11: Autolus’ Therapies in Development
TABLE 14.12: AvenCell’s Clinical and Preclinical Pipeline
TABLE 14.13: Beam’s Product Pipeline
TABLE 14.14: Bellicum’s Pipeline of Investigational Immunotherapies
TABLE 14.15: Biosceptre’s Product Pipeline
TABLE 14.16: Cabaletta’s Autoimmune Therapy Candidates in Development
TABLE 14.17: Carina Biotech’s Clinical Programs
TABLE 14.18: CARsgen’s Product Pipeline
TABLE 14.21: Celyad’s Diversified Pipeline
TABLE 14.22: Century’s Pipeline Overview
TABLE 14.23: CRISPR Therapeutics’ Immuno-Oncology Programs
TABLE 14.24: CytoSeek’s Pipeline Product Candidates
TABLE 14.25: Cytovia’s Product Pipeline
TABLE 14.26: Elicera’s Product Portfolio
TABLE 14.27: Eureka’s Product Pipeline
TABLE 14.28: EXUMA’s Pipeline Assets
TABLE 14.29: Fate’s Product Pipeline
TABLE 14.30: Gilead’s Ongoing CAR-T Programs
TABLE 14.31: Gracell’s Clinical Pipeline
TABLE 14.32: IASO’s Diverse Product Pipeline
TABLE 14.33: iCell Gene’s Product Pipeline
TABLE 14.34: ImmPACT Bio’s Product Pipeline
TABLE 14.35: Inceptor’s Diversified Cell Therapy Programs
TABLE 14.36: JW Therapeutics’ Product Pipeline
TABLE 14.37: Kite’s Pipeline Cancer Therapies
TABLE 14.38: Legend’s Autologous Product Pipeline for Hematological Cancers
TABLE 14.39: Legend’s Allogeneic Product Pipeline for Hematological & Solid Cancers
TABLE 14.40: Leucid’s Product Pipeline
TABLE 14.41: Luminary’s Product Pipeline
TABLE 14.42: Lyell’s Diverse Pipeline Targeting Solid Tumor Cancers
TABLE 14.43: Minerva’s Pipeline Products for Solid Tumors
TABLE 14.44: Mustang Bio’s Five In Licensed CAR-T Programs
TABLE 14.45: NKarta’s Product Pipeline
TABLE 14.46: Noile-Immune’s PRIME-based Pipeline Products
TABLE 14.47: Oncternal’s Product Pipeline
TABLE 14.48: oRNA’s Pipeline Products
TABLE 14.49: Oxford Biomedica’s CDMO Services Pipeline
TABLE 14.50: PeproMene’s Product Pipeline
TABLE 14.51: Poseida’s Allogeneic & Autologous Product Candidates
TABLE 14.52: Precigen’s Pipeline
TABLE 14.53: Precision’s CAR-T Immunotherapy Pipeline
TABLE 14.54: Quell’s Pipeline
TABLE 14.55: SOTIO’s Pipeline
TABLE 14.56: Tessa’s Product Pipeline
TABLE 14.57: Tmunity’s Product Pipeline
TABLE 14.58: Umoja’s Product Pipeline
TABLE 14.59: Vor Biopharma’s Product Pipeline against Blood Cancers
TABLE 14.60: Wugen’s Product Pipeline
TABLE 14.61: Xenetic’s Product Pipeline
TABLE 14.62: Xyphos’ Product Pipeline

Samples

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Companies Mentioned

  • Abbvie
  • Adaptimmune
  • Aleta BioTherapeutics
  • Allogene
  • Allogene Therapeutics
  • Anixa Biosciences, Inc.
  • Applied DNA Sciences, Inc.
  • Arcellx, Inc.
  • Astellas Pharma
  • Atara Biotherapeutics
  • Autolus Therapeutics, plc
  • Bellicum Pharmaceuticals, Inc.
  • BioNTech
  • bluebird bio
  • Bristol-Myers Squibb (BMS)
  • Cabaletta Bio
  • Caribou Biosciences
  • Carina Biotech
  • Carisma Therapeutics, Inc.
  • CARsgen Therapeutics
  • Cartesian Therapeutics, Inc.
  • CARTherics
  • Celgene Corporation
  • Cell Therapies, Pvt. Ltd
  • Cellectis
  • Celularity, Inc.
  • Celyad Oncology
  • Creative Biolabs
  • CRISPR Therapeutics
  • CytoSeek
  • Cytovia Therapeutics
  • DiaCarta, Inc.
  • Dr. Reddy’s Laboratories
  • Empirica Therapeutics
  • Eureka Therapeutics, Inc.
  • EXUMA Biotech Corp.
  • Fate Therapeutics, Inc.
  • Formula Pharmaceuticals, Inc.
  • GEMoaB
  • Gilead Sciences, Inc.
  • Gracell Biotechnologies
  • iCell Gene Therapeutics
  • Janssen Biotech, Inc.
  • Juno Therapeutics
  • JW Therapeutics, Co., Ltd.
  • Kite Pharma, Inc.
  • Kyverna Therapeutics
  • Lyell Immunopharma, Inc.
  • MaxCyte, Inc.
  • Minerva Biotechnologies Corporation
  • Mnemo Therapeutics
  • Mustang Bio, Inc.
  • Nanjing Legend Biotechnology Co., Ltd.
  • Noile-Immune Biotech
  • Novartis International, AG
  • NYU Langone Health
  • Oxford Biomedica plc
  • PeproMene Bio, Inc.
  • Poseida Therapeutics, Inc.
  • Precigen, Inc.
  • Precision Biosciences
  • Prescient Therapeutics
  • ProMab Biotechnologies, Inc.
  • Protheragen
  • Servier
  • Shenzhen Pregene Biopharma
  • Sorrento Therapeutics, Inc.
  • Synthekine
  • T-CURX
  • Tango Therapeutics
  • TC Biopharm
  • Teneobio
  • Tessa Therapeutics, Pvt. Ltd.
  • Tmunity Therapeutics, Inc.
  • Wugen
  • Xyphos Biosciences, Inc.
  • Ziopharm Oncology, Inc.

Methodology

The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.

Input Sources

  • Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
  • Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
  • Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
  • Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
  • Product Launch Announcements (Trade Journals, Google News)
  • Industry Events (Google News, Google Alerts, Press Releases)
  • Company News (SEC Filings, Investor Publications, Historical Performance)
  • Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
  • Interviews with Stem Cell Industry Leaders

Research & Analysis Methodologies

The publisher employs the following techniques for deriving its market research:

  • Historical Databases: As the first and only market research firm to specialize in the stem cell industry, the publisher has 13+ years of historical data on each segment of the stem cell the industry. This provides an extremely rare and robust database for establishing market size determinations, as well as making future market predictions.
  • Prolific Interviews with Industry Leaders: As the global leader in stem cell industry data, the publisher has interviewed hundreds of leaders from across the stem cell industry, including the CEO of FUJIFILM CDI, FUJIFILM Irvine Scientific, Pluristem Therapies, Celularity, and many others.
  • Industry Relationships: The research team and its President/Founder, Cade Hildreth, Chair and present at a wide range of stem cell industry events, including Phacilitate's Advanced Therapies Week, World Stem Cell Summit (WSCS), Perinatal Stem Cell Society Congress, AABB's International Cord Blood Symposium (ICBS), and other events hosted within the U.S. and worldwide.
  • Global Integrated Feedback: Because the publisher maintains the world's largest stem cell industry news site that is read by nearly a million unique readers per year and the company has large social media audiences (25.7K+ followers on Linked, 21.2K+ followers on Twitter, and 4.3K+ followers on Facebook), the publisher is able to publish content relevant to the industry and receive immediate feedback/input from a global community of readers. In short, the publisher's data is crowd-sourced from market participants worldwide, including those in diverse geographic regions.
  • Preliminary Research: In addition to the interviews described above, the publisher conducts market surveys, executes social media polls, and aggregates market data from stem cell industry announcements, press releases, and corporate filings/presentations.
  • Secondary Research: The publisher summarizes, collects and synthesizes existing market research that is relevant to the market area of interest.
  • Future Projections: Using the resources described above, the publisher is uniquely positioned to make future projections about market size, market growth by segment, market trends, technology evolution, funding activities (financing rounds, M&A, and IPOs), and importantly, market leadership (market share by company).
 

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