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Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, and Trends, 2024

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    Report

  • 329 Pages
  • June 2024
  • Region: Global
  • BioInformant
  • ID: 5331298

Between 2017 and Today, Nine CAR-T Products Reached Commercialization, and this Number is Estimated to Reach Double-Digits by 2032

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.

Between 2017 and today, nine CAR-T products reached commercialization, and this number is estimated to reach double-digits by 2032. Of these, six are U.S. FDA-approved CAR-T cell therapies, each of which has received approvals in other major healthcare markets as well. The six U.S.

FDA approved products include:

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

In addition, two CAR-T therapies have received approval from the Chinese National Medical Products Administration (NMPA), Relma-cel and Yuanruida, and one CAR-T cell therapy has received approval from the Indian Central Drugs Standard Control Organisation (CDSCO), NexCAR19.

These historic approvals demonstrate that the CAR-T market has arrived and is taking the biotech industry by storm. M&A activity has been particularly 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 early CAR-T therapies in treating several types of blood cancers. The next frontier for CAR-T cell therapies will be to apply them in the fight against solid tumors. All of the nine marketed CAR-T cell therapy products and nearly three-quarters (75%) of the ongoing clinical trials utilize an autologous treatment approach. Thus, the development of allogeneic CAR-T cell therapies will open critical market opportunities.

Another key issue is the “vein-to-vein” time or the time that elapses between apheresis and product delivery. Thus, CAR-T therapies are usually recommended for end-stage patients who have exhausted all other treatment options. Another challenge encountered by CAR-T therapies is the reimbursement issues across the U.S. and Europe.

For the continued progress of CAR-T cell therapies, the industry is trying to mitigate these challenges. Several CAR-T players have started to use efficient gene-transfer tools to impregnate T cells with CARs, and there are numerous examples of partnerships to develop CRISPR and electroporation technologies to modify T cells. Some companies also use “on-off” switches that can turn off CAR-T cells to prevent toxicity. Thus far, the goal of achieving success with solid tumors remains elusive with clinical trials producing a low response rate. Thus, ongoing efforts within the CAR-T sector are focused on discovering effective solid tumor-specific antigens.

The purpose of this report is to describe the current state of CAR-T cell therapies, as well as the future of the CAR-T industry landscape at large. Importantly, it describes details of the CAR-T cell therapy products approved to date, as well as late-stage CAR-T clinical trials that could lead to near-term market approvals. Ranging from small start-ups to billion-dollar companies, CAR-T companies are now proliferating in all healthcare markets worldwide.

Key questions answered in this report include:

  • How many automated manufacturing systems are available within the global market?
  • What are the most targeted antigens for liquid and solid cancers?
  • What are anticipated developments within the CAR-T sector? What commercial opportunities and patient outcomes will they unlock?
  • How many CAR-T-related patent publications and granted patents were issued from 2012 to the present?
  • Which two countries have the largest number of CAR-T patents?
  • Which 20 companies have filed the largest number of CAR-T patents?
  • Who are the top 20 CAR-T patent inventors?
  • How many clinical trials were registered between 2003 and the present?
  • Which biomarker antigens dominate in the CAR-T clinical trial landscape?
  • Which are the most common indications addressed by clinical trials in the U.S. and China?
  • Who are the U.S., Chinese, and European companies involved in CAR-T-related clinical trials?
  • How many deals have been signed within the CAR-T sector within the past year?
  • What are promising CAR-T candidates that could soon reach commercialization?
  • How are CAR-T therapies reimbursed within the U.S. and Europe?
  • What is the current market size for CAR-T cell therapies by Geography, Product, and Indication?
  • What are the future market forecasts for CAR-T cell therapies by Geography, Product, and Indication?
  • What are the barriers, risks, and opportunities for growth within the global CAR-T industry?
  • Who are the major companies that are developing CAR-T cell therapies, what are their core technologies, and what products do they have under development?

This 329-page market report reveals:

  • Global CAR-T Cell Therapy Market Size, with Segmentation by Product, Geography, and Indication, including Future Market Size Forecasts through 2032
  • 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

Table of Contents

1. REPORT OVERVIEW
1.2 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 Development
2.2.1 The CAR-T cell Family
2.2.1.1 First Generation CARs
2.2.1.2 The Second Generation CARs
2.2.1.3 Third Generation CARs
2.2.1.4 Fourth Generation CARs
2.2.1.5 Fifth Generation CARs
2.2.1.6 CAR Constructs in the FDA Approved CAR-T Cell Products
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 Eight CAR-T Therapies Available in the Market: A Brief Overview
2.6.1 Kymriah (tisagenlecleucel)
2.6.1.1 Indication
2.6.1.2 Product Description & Machanism of Action
2.6.1.3 Manufacturing
2.6.1.4 Dosage Composition
2.6.1.5 Approval History
2.6.1.6 Market
2.6.1.7 Competition
2.6.2 Yescarta (axicabtagene ciloleucel)
2.6.2.1 Indication
2.6.2.2 Product Description & Mechanism of Action
2.6.2.3 Manufacturing Process of Yescarta
2.6.2.4 Dosage Composition
2.6.2.5 Approval History
2.6.2.7 Sales Revenues
2.6.2.8 Competitors
2.6.3 Tecartus (brexucabtagene autoleucel)
2.6.3.1 Indication
2.6.3.2 Product Description & Mechanism of Action
2.6.3.3 Tecartus Manufacturing Process
2.6.3.4 Dosage Composition
2.6.3.5 Approval History
2.6.3.6 Sales Revenues
2.6.3.7 Competitors
2.6.4 Carvykti (ciltacabtagene autoleucel)
2.6.4.1 Indication
2.6.4.2 Product Description & Mechanism of Action
2.6.4.3 Manufacturing Process of Carvykti
2.6.4.4 Dosage & Composition
2.6.4.5 Approval History
2.6.4.6 Sales Revenues
2.6.4.7 Competition
2.6.5 Abecma (idecabtagene vicleucel)
2.6.5.1 Indication
2.6.5.2 Product Description and Mechanism of Action
2.6.5.3 Manufacturing of Abecma
2.6.5.4 Dosage & Composition
2.6.5.5 Approval History
2.6.5.6 Sales Revenues
2.6.5.7 Competitors
2.6.6 Breyanzi (lisocabtagene maraleucel)
2.6.6.1 Indication
2.6.6.2 Product Description & Mechanism of Action
2.6.6.3 Manufacturing
2.6.6.4 Breyanzi Dosage & Composition
2.6.6.5 Approval History
2.6.6.6 Sales Revenues
2.6.7 Relma-cel (relmacabtagene autoleucel)
2.6.8 NexCAR19 (Actalycabtagene autoleucel)
2.6.9 Yuanruida (inaticabtagene autoleucel; CNCT19)
2.7 Toxicities Associated with CAR-T Treatment

3. STRATEGIES FOR FUTURE CAR-T THERAPIES
3.1 Switchable CARs (sCARs)
3.2 Suicide Genes to Destroy CAR-T Cells in vivo
3.3 Transient Transfection
3.4 Affinity-Tuned CARs
3.5 Armored CARs
3.6 Shifts from Liquid Cancers to Solid Tumors
3.7 Focus on Shortening Hospital Stay
3.8 Focus on Discovering New Antigens
3.9 Shifting from Autologous to Allogeneic CAR-T Therapies
3.10 CAR-T for the Masses
3.11 New in vivo CAR-T Approaches
3.12 Combination with mRNA Vaccine
3.13 Combination with Oncolytic Virus

4. MAJOR EVENTS DURING THE DEVELOPMENT OF CAR-T, 1989-2024
4.1 CAR-T Development Timeline
4.2 Top Ten Milestones Crossed by CAR-T Therapy
4.2.1 First Pediatric Patient to Receive CAR-T Therapy
4.2.2 CAR-T Granted Breakthrough Therapy Designation
4.2.3 The Beginning of CAR-T Development to Combat Solid Cancers
4.2.4 First CRISPR CAR-T Built
4.2.5 The First Two CAR-T Approvals by FDA
4.2.6 The First Two CAR-T Approvals by EMA
4.2.7 Approval of Tecartus, Breyanzi and Abecma
4.2.8 NMPA Approval of Relma-cel (Carteyva)
4.2.9 Approval of Carvykti
4.2.10 Approval of NexCAR19 (actalycabtagene autoleucel)
4.2.11 Approval of Yuanruida (inaticabtagene autoleucel)
4.3 Current Status of CAR-T Therapy Products
4.4 The Upcoming CAR-T Stars
4.4.1 ALLO-501
4.4.2 CTX-110
4.4.3 UCART19
4.4.4 AUT01
4.4.5 JCARH125
4.4.6 PBCAR20A
4.4.7 UCART123
4.4.8 PRGN-3006
4.4.9 UCART22
4.4.10 UCARTCS1
4.5 Cancer Population Addressed by CAR-T Therapy
4.6 Advantages of CAR-T Cell Therapy
4.7 Disadvantages of CAR-T Cell Therapy

5. SCALABLE MANUFACTURING OF CAR-T CELLS
5.1 The Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
5.2 The Evolution of CAR-T Cell Manufacturing Platforms
5.2.1 Open vs. Closed Systems
5.2.2 Manual Processing vs. Automation
5.2.3 Autologous vs. Allogeneic CAR-T Manufacturing
5.2.4 Operating Expenses in Allogeneic CAR-T Manufacturing
5.2.5 Operating Expenses in Allogeneic CAR-T Manufacturing

6. CAR-T TARGET ANTIGENS
6.1 CAR-T Target Antigens in Hematological Cancers
6.2 CAR-T Target Antigens on Solid Tumors
6.3 Common Antigens Targeted by CAR-T Cells in Clinical Trials
6.3.1 Cluster Differentiation 19 (CD19)
6.3.2 Mesothelin
6.3.3 Beta Cell Maturation Agent (BCMA)
6.3.4 GD2
6.3.5 Glypican-3 (GPC3)
6.3.6 Cluster Differentiation-22 (CD22)

7. CAR-T PATENT LANDSCAPE
7.1 Geographical Distribution of CAR-T Patents
7.2 Top Ten Applicants of CAR-T Patents
7.3 Top Ten Inventors of CAR-T Patents
7.4 Top Ten Owners of CAR-T Patents
7.5 Legal Status of CAR-T Patents

8. CAR-T CLINICAL TRIAL LANDSCAPE
8.1 Most Addressed Indications in Clinical Trials
8.2 Current Focus of Ongoing Clinical Trials
8.3 Clinical Trial by Country
8.4 Phase of Studies
8.5 CAR-T Clinical Trials by Funding Type
8.6 Types of Hematological Malignancies Addressed in Clinical Trials
8.7 Simultaneous Targets by One CAR-T
8.8 CAR-T Generation Types used in Clinical Trials
8.9 CAR-T Clinical Trials Focusing on Solid Cancers
8.10 Distribution of CAR-T Trials by Type of SeFv Used
8.11 Distribution of CAR-T Trials by Type of Vectors Used
8.12 Geographical Distribution of CAR-T Studies in Solid Tumors
8.12.1 CAR-T Solid Tumor Clinical Trials by Phase of Study
8.12.2 Funding Types in CAR-T Solid Tumor Clinical Trials
8.12.3 Solid Tumor Types in Clinical Trials
8.13 CAR-T Targeted Biomarkers in Clinical Trials
8.13.1 CAR-T Targeted Indications in the U.S. Clinical Trials
8.13.2 Indications Addressed by CAR-T Clinical Trials in China
8.13.3 Liquid Cancers vs. Solid Cancers in CAR-T Clinical Trials
8.13.4 CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
8.13.5 CAR-T Clinical Trial Sponsor Companies and Institutions in China
8.13.6 CAR-T Trial Sponsor Companies and Institutions in Other Countries
8.14 Improved CAR-T Constructs in Clinical Trials
8.14.1 CAR-T with PD1Fc
8.14.2 CAR-T with Truncated EFGR
8.14.3 CAR-T with IL7 and CCL 19
8.14.4 CAR-T with PD1/CD28 Switch Receptor
8.14.5 CAR-T with PD1 shRNA Expressing Cassette
8.14.6 CAR-T with CTLA-4/PD-1 Antibody
8.14.7 CAR-T with PD-1 Antibodies

9. PUBLISHED CAR-T SCIENTIFIC PAPERS IN PUBMED.GOV
9.1 PubMed.gov Papers on Autologous and Allogeneic CAR-T Therapies
9.2 PubMed.gov Papers on CAR-T for Liquid vs. Solid Cancers, 2013-March 2024
9.3 PubMed Papers on the Five Generations of CARs
9.4 NIH Funding for CAR-T Research

10. CAR-T FUNDING LANDSCAPE
10.1 Venture Capital Funding in CAR-T Sector, 2014-March 2024
10.1.1 Venture Capital Funding for CAR-T Companies by Year, 2014-March 2024
10.2 IPO Funding in Invested in CAR-T Companies, 2014-March 2024
10.3 CAR-T Licensing Deals
10.4 CAR-T Collaboration Deals
10.5 CAR-T Merger and Acquisition (M&A) Deals, 2015-March 2024
10.6 Overview of CAR-T Funding

11. COST OF CAR-T TREATMENT AND REIMBURSEMENT
11.1 New Payment Models
11.1.1 List Price of approved CAR-Ts
11.1.2 Component Cost in addition to Treatment Acquisition Cost
11.1.3 Adverse Event Costs (AEs)
11.2 Reimbursement in the U.S. for CAR-T Therapy
11.2.1 Policy Changes for FY 2024
11.3 Cost of CAR-T Therapies in Europe
11.3.1 Cost Components and Resource Use
11.3.2 Average Total Component Costs for CAR-T Therapy in Former EU-5 and NL
11.3.3 Reimbursement for CAR-T Therapies in Europe
11.3.4 Innovative Reimbursement Schemes in Europe
11.4 Cost & Reimbursement for CAR-T Therapy in Asia
11.4.1 Cost & Reimbursement for CAR-T in Japan
11.4.2 Cost & Reimbursement for CAR-T Therapy in South Korea
11.4.3 Cost & Reimbursement for CAR-T Therapy in Malaysia
11.4.4 Cost & Reimbursement for CAR-T Therapy in Singapore
11.4.5 Cost & Reimbursement for CAR-T Therapy in China
11.4.6 Cost of CAR-T Therapy in India

12. BLOOD CANCERS ADDRESSED BY CAR-T
12.1 Acute Lymphoblastic Leukemia (ALL)
12.1.1 Available Therapies
12.2 Diffuse Large B-Cell Lymphoma (DLBCL)
12.2.1 Available Therapies
12.3 Mantle Cell Lymphoma (MCL)
12.3.1 Available Therapies
12.4 Multiple Myeloma (MM)
12.4.1 Available Therapies
12.5 Follicular Lymphoma
12.5.1 Available Therapies
12.6 The Staggering Cost of Blood Cancer Therapies

13. MARKET ANALYSIS
13.1 Uptake of CAR-T Cell Therapy, 2017-2023
13.1.1 Current Global Market for CAR-T Cell Therapy by Product
13.2 Estimated Global Market for CAR-T Cell Therapy Products, 2024-2032
13.2.1 Global Market for CAR-T Therapy by Geography
13.2.2 Global Market for CAR-T Therapy by Indication
13.3 Challenges & Opportunities for CAR-T Therapies in Blood Cancers
13.3.1 Barriers to Access
13.3.2 Targets other than CD19
13.3.3 Resistance for CAR-T Therapy
13.3.4 Manufacturing Time
13.3.5 Autologous vs. Allogeneic CAR-Ts

14. CAR-T COMPNIES: AN OVERVIEW
14.1 2seventy bio
14.1.1 Abecma (idecabtagene vicleucel)
14.2 Abintus Bio, Inc.
14.3 AffyImmune Therapeutics, Inc.
14.3.1 Affinity-Tuned CARs
14.3.1.1 ICAM-1: AffyImmune’s Target Antigen
14.3.1.2 Targeted Indication
14.4 Aleta BioTherapeutics
14.4.1 Aleta’s CAR-T Engager Pipeline
14.5 Allogene Therapeutics
14.5.1 AlloCAR-T
14.5.1.1 Manufacturing of AlloCAR-T
14.6 Anixa Biosciences, Inc.
14.7 Arbele, Ltd.
14.7.1 Advanced Cell Therapy
14.8 Arcellx
14.8.1 D-Domain Technology
14.8.2 ddCAR Platform
14.8.3 ARC-SparX Platform
14.9 Atara Biotherapeutics
14.9.1 Technology
14.9.2 Allogeneic CAR-T Programs
14.10 Aurora BioPharma
14.10.1 HER2 Platform
14.11 Autolus Therapeutics plc
14.11.1 Technology
14.11.2 CAR-T Cell Production
14.11.3 Manufacturing
14.11.4 Therapies in Development
14.11.4.1 obe-cel
14.12 AvenCell Europe GmbH
14.12.1 Universal Switchable CAR
14.12.2 Allogeneic Platform
14.12.3 Clinical & Preclinical Pipeline Overview
14.13 Beam Therapeutics, Inc.
14.13.1 BEAM-201
14.14 Bellicum Pharmaceuticals
14.14.1 GoCAR Technology
14.14.2 CaspaCIDe Safety Switch
14.15 BioNTech
14.15.1 BioNtech’s Engineered Cell Therapies
14.15.2 BN211
14.15.3 BN212
14.16 Biosceptre
14.16.1 Biosceptre’s Unique Target nf2X7
14.16.2 BRiDGECAR Program
14.17 Bluebird bio
14.17.1 Blebird bio’s CAR-T Collaborations
14.17.2 Collaboration with BMS
14.17.3 Collaboration with TC BioPharm
14.17.4 Collaboration with Inhibrx
14.17.5 Collaboration with PsiOxus
14.18 Bristol Myers Squibb/Celgene Corporation
14.18.1 Products
14.18.1.1 Abecma (idecabtagene vicleucel)
14.18.1.2 Breyanzi (lisocabtagene maraleucel)
14.19 Cabaletta Bio
14.19.1 CABA Platform
14.19.2 Cabaletta’s Pipeline
14.20 Carina Biotech
14.21 CARsgen Therapeutics
14.21.1 CycloCAR-T
14.21.2 THANK-uCAR
14.21.3 LADAR
14.22 Cartesian Therapeutics
14.22.1 mRNA CAR-T Cell Program (RNA Armory)
14.22.2 Pipeline
14.23 CARTherics Pty Ltd.
14.23.1 Autologous CAR-T Cells
14.24 CASI Pharmaceuticals
14.24.1 Yuanruida (inaticabtagene autoleucel; CNCT19)
14.25 Cellectis
14.25.1 TAL nucleases, or TALEN
14.25.2 Gene Editing
14.25.3 PulseAgile Technology
14.25.4 Main Product Candidates
14.26 Celularity, Inc.
14.26.1 P CAR-T
14.27 Celyad Oncology
14.27.1 NKG2D-Based CAR-T Cells
14.27.2 Multispecific CAR
14.27.3 Short Hairpin RNA-based Platform
14.27.4 CAR-T Therapy Development Services
14.27.5 Biomarker Identification and Selection
14.27.6 scFv Generation
14.27.7 CAR-T Gene Packaging and Delivery
14.27.8 Virus Testing Servive
14.27.9 CAR Cell in vitro Assay Service
14.27.10 CAR-T Preclinical in vivo Assay
14.27.11 IND Development for CAR-T Cell Therapy
14.27.12 GMP Production for CAR-T Products
14.27.13 CAR-T Clinical Trial Services
14.28 CRISPR Therapeutics
14.28.1 CRISPR Therapeutics’ Immuno-Oncology Programs
14.28.2 CRISPR/Cas9-enabled Allogeneic CAR-T Design
14.29 Curocell, Inc.
14.29.1 OVIS Technology
14.30 DiaCarta
14.30.1 Personalized CAR-T Immunotherapy Platform
14.31 Elicera Therapeutics AB
14.31.1 iTANK CAR-T Technology
14.31.2 Elicera’s Product Pipeline
14.32 EXUMA Biotech
14.32.1 TMR CAR-T Technology
14.32.2 CCT3 CAR-T
14.32.3 rPOC SC CAR-TaNKs
14.32.4 GCAR “in vivo Cell Therapy”
14.33 Fate Therapeutics
14.33.1 FT819
14.33.2 FT825
14.34 Galapagos NV
14.35 Gilead Sciences, Inc.
14.35.1 CAR-T Products
14.35.1.1 Tecartus (brexucabtagene autoleucel)
14.34.1.2 Yescarta (axicabtagene ciloleucel)
14.36 Gracell Biotechnologies
14.36.1 FasTCAR
14.36.2 TruUCAR
14.36.3 SMART CAR-T
14.36.4 Gracell’s Product Pipeline
14.37 IASO Biotherapeutics
14.37.1 Technology Platforms
14.37.2 Fully Human Antibody Discovery Platform
14.37.3 High-Throughput Screening Platform for CAR-T Candidates
14.37.4 Universal CAR-T Technology Platform
14.37.5 CAR-T Manufacturing Technology Platform
14.37.6 IASO’s Diverse Product Pipeline
14.38 ImmPACT Bio
14.38.1 CD19/20 Bispecific CAR
14.38.2 TGF-ß
14.39 Immuneel Therapeutics, Pvt., Ltd.
14.39.1 Immuneel’s R&D Roadmap
14.40 ImmunoACT
14.40.1 NexCAR19 (Actalycabtagene autoleucel)
14.41 Interius BioTherapeutics
14.41.1 Core Technology
14.42 Juventas Cell Therapy
14.42.1 Yuanruida (inaticabtagene autoleucel)
14.43 JW Therapeutics
14.43.1 Carteyva (relmacabtagene autoleucel; relma-cel)
14.44 Kite Pharma (Gilead)
14.44.1 Kite’s Marketed CAR-T Products
14.44.1.1 Yescarta (axicabtagene ciloleucel)
14.44.1.2 Tecartus (brexucabtagene autoleucel)
14.44.2 Kite’s Pipeline Cancer Therapies
14.45 Kyverna Therapeutics
14.45.1 Kyverna’s CAR-T Therapy for Autoimmune Diseases
14.46 Legend Biotech
14.46.1 Technology Platforms
14.46.1.1 CAR-T
14.46.1.2 CAR-?d T
14.46.1.3 CAR-NK
14.46.1.4 Non-Gene-Editing Universal CAR-T
14.46.2 Product Pipeline
14.47 Leucid Bio
14.47.1 Leucid’s Lateral CAR-Platform
14.47.2 LEU011 - NKG2D CAR-T Cell Therapy
14.47.3 T2, ?d T-Cells for Off-The-Shelf Therapy
14.47.4 T4 Immunotherapy
14.47.5 Novel Manufacturing Platform
14.48 Luminary Therapeutics, Inc.
14.48.1 Allogeneic Gamma 2.0+ Platform
14.48.2 Non-Viral Gene Modification Process
14.48.3 Split Co-Stim Dual CAR
14.48.4 Ligand-Based CAR to Target Three Antigens
14.48.5 Product Pipeline
14.49 Lyell Immunopharma, Inc.
14.49.1 Technology
14.49.1.1 Gen-R Technology
14.49.1.2 Epi-R Technology
14.49.2 Lyell’s Product Pipeline
14.50 March Biosciences
14.50.1 MB-105
14.50.2 March Biosciences’ Pipeline
14.51 MaxCyte, Inc.
14.51.1 Technology: Flow Electroporation
14.51.2 MaxCyte’s Electroporation Systems
14.51.2.1 ATx
14.51.2.2 GTx
14.51.2.3 STx
14.51.2.4 VLx
14.52 Minerva Biotechnologies Corporation
14.52.1 CAR-T (huMNC2-CAR44)
14.53 Mustang Bio
14.53.1 Mustang’s CAR-T Focus
14.54 Noile-Immune Biotech
14.54.1 PRIME CAR-T
14.55 Novartis AG
14.55.1 The Pioneer in CAR-T
14.55.2 Kymriah (tisagenlecleucel)
14.55.3 T-Charge Platform
14.55.3.1 Phase I YTB323 Clinical Study
14.55.3.2 Phase I PHE 885 Clinical Study
14.56 Oncternal Therapeutics
14.56.1 ONCT-808
14.57 Oxford Biomedica plc
14.57.1 LentiVector Platform
14.57.2 inAAVate Platform
14.57.3 CDMO Services
14.58 PeproMene Bio, Inc.
14.58.1 BAFFR CAR-T Cells
14.59 Poseida Therapeutics, Inc.
14.59.1 Poseida’s Genetic Engineering Platforms
14.59.2 PiggyBac Platform for Insertion
14.59.3 Cas-CLOVER Platform for Editing
14.59.4 Poseida’s CAR-T Product Candidates
14.60 Precigen, Inc.
14.60.1 UltraCAR-T
14.60.2 Sleeping Beauty System
14.60.3 UltraPorator System
14.60.4 Product Pipeline
14.61 Prescient Therapeutics
14.61.1 OmniCAR
14.61.2 CellPryme
14.62 ProMab Biotechnologies, Inc.
14.62.1 ProMab’s CAR-T Cells
14.62.2 ProMab’s Services
14.62.3 ProMab’s Preclinical and Clinical Study Services
14.63 SOTIO Biotech BV
14.63.1 BOXR Technology
14.63.2 BOXR1030
14.64 Syngene International, Ltd.
14.64.1 CAR-T Services
14.65 Synthekine
14.65.1 STK-009 + SYNCAR-001
14.66 TC BioPharm
14.66.1 Gamma Delta T Cells
14.66.2 Cell Banks
14.66.3 Co-Stim CAR-T
14.66.4 Product Pipeline
14.66.4.1 OmnImmune
14.66.5 CAR-T Programs
14.67 T-CURX
14.67.1 Technologies
14.68 Umoja Biopharma
14.68.1 Umoja’s Technology Platforms
14.68.1.1 VivoVec in vivo Gene Delivery
14.68.1.2 RACR-Induced Cytotoxic Lymphocytes (iCIL)
14.68.1.3 RACR/CAR: in vivo Cell Programming
14.68.1.4 TumorTag: Universal CAR Tumor Targeting
14.69 ViTToria Biotherapeutics
14.69.1 Senza5
14.69.2 VIPER-101
14.70 Vor Biopharma
14.70.1 Vor Biopharma’s Approach
14.71 Wugen
14.72 WuXi Advanced Therapies
14.72.1 WuXi’s Closed Process CAR-T manufacturing
14.73 Xenetic Biosciences
14.73.1 DNase-based Oncology Platform
14.74 Xyphos Biosciences, Inc.
14.74.1 ACCEL & UDC Technology
14.74.2 convertibleCAR
14.74.3 Universal Donor Cells

Index of Figures
Figure 2.1: The Basic Structure of a T cell
Figure 2.2: Binding of a T cell on to 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: CAR Constructs in the FDA Approved CAR-T Cell Products
Figure 2.11: Antigens Present on Normal and Cancer Cells
Figure 2.12: Preparation and Administration of CAR-T cell Therapy
Figure 2.13: Kymriah in Infusion Bag
Figure 2.14: Yescarta in Infusion Bag
Figure 2.15: Tecartus in Infusion Bag
Figure 2.16: Carvykti in Infusion Bag
Figure 2.17: Abecma in the Infusion Bag
Figure 2.18: Breyanzi in Package
Figure 2.19: Relma-cel Infusion Bag
Figure 3.1: Switchable CARs [sCARs; Universal CARs]
Figure 3.2: Action of Suicide Genes
Figure 3.3: Graphical Abstract for Transient Transfection
Figure 3.4: A Model of Armored CAR
Figure 4.1: The Five Generations of CARs
Figure 5.1: Manufacturing Process of Clinical-Scale Autologous CAR-T Therapies
Figure 5.2: G-Rex Bioreactors
Figure 5.3: CliniMACS Prodigy
Figure 5.4: Scaling Up of Allogeneic CAR-T Cells
Figure 5.5: Operating Expenses in Autologous CAR-T Manufacturing
Figure 5.6: Operating Expenses in Allogeneic CAR-T Manufacturing
Figure 6.1: CAR-T Target Antigens Evaluated in Clinical Trials
Figure 7.1: Number of CAR-T Patents Filed from 2000 to March 2024
Figure 8.1: CAR-T Clinical Trials by Phase of Study, March 2024
Figure 8.2: Types of Hematological Malignancies Addressed in Clinical Trials
Figure 8.3: Studies for Simultaneous Targets by One CAR-T
Figure 8.4: CAR-T Generation Types used in Clinical Trials
Figure 8.5: Distribution of CAR-T Trials by Type of SeFv Used
Figure 8.6: Distribution of CAR-T Trials by Type of Vectors Used
Figure 8.7: Solid Tumor Types in Clinical Trials, March 2024
Figure 8.8: Liquid Cancers vs. Solid Cancers in CAR-T Clinical Trials
Figure 9.1: Number of Published CAR-T Papers on PubMed.gov, 2000-March 2024
Figure 9.2: PubMed. Papers on Autologous vs. Allogeneic CAR-T Therapies, 2000-2024
Figure 9.3: PubMed Papers on CAR-T for Liquid vs. Solid Cancers, 2013-March 2024
Figure 9.4: PubMed Papers on the Five Generations of CARs
Figure 10.1: Venture Capital Funding for CAR-T Companies by Year, 2014-March 2024
Figure 10.2: IPO Invested in CAR-T Companies, 2014-March 2024
Figure 13.1: Uptake of CAR-T Doses, 2017-2023
Figure 13.2: Revenue Generation by CAR-T Therapy by Product, 2017-2023
Figure 13.3: Estimated Modest Growth of CAR-T Market by Product, 2023-2032
Figure 13.4: Global Market for CAR-T Products by Geography, 2023-2032
Figure 13.5: Global Market for CAR-T Therapies by Indication, 2024-2032
Figure 14.1: Atara’s Approach to Allogeneic Cell Therapy
Figure 14.2: Illustration of CycloCAR-T
Figure 14.3: Illustration of THANK-uCAR-T
Figure 14.5: Schematic of Allogeneic P CAR-T with TCR KO
Figure 14.6: NKG2D-based CAR
Figure 14.7: Celyad’s Multispecific CAR
Figure 14.8: CRISPR/Cas9-enabled Allogeneic CAR-T Design
Figure 14.9: FT819
Figure 14.10: FT825
Figure 14.11: FasTCAR vs. Conventional CAR-T Manufacturing Time
Figure 14.12: Action of TruUCAR
Figure 14.13: SMART CAR-T
Figure 14.14: CD19/CD20 CAR-T Technology
Figure 14.15: TGF-ß Bispecific CAR Technology
Figure 14.16: Lateral CAR
Figure 14.17: T4 T-Cell
Figure 14.18: Split Co-Stim Dual CAR
Figure 14.19: Ligand-Based CAR to Target Three Antigens
Figure 14.20: Natural Killing of CAR-T Cells
Figure 14.21: ATx
Figure 14.22: GTx
Figure 14.23: STx
Figure 14.24: VLx
Figure 14.25: Features of PRIME CAR-T Cell Therapy
Figure 14.26: BAFFR CAR-T Cells
Figure 14.27: Poseida’s PiggyBac Platform for Insertion
Figure 14.28: Poseida’s Cas-CLOVER Platform for Editing
Figure 14.29: UltraCAR-T Cell
Figure 14.30: Precigen’s Ultraporator System
Figure 14.31: Prescient’s OmniCAR
Figure 14.32: VIPER-101, the Lead Program of ViTToria
Figure 14.33: WuXi’s Closed Process CAR-T Platform
Figure 14.34: Convertible CAR Parts
Figure 14.35: Xyphos’ Universal Donor Cells

Index of Tables
Table 2.1: Potential CAR-T Targeted Antigens Present on Hematological Malignant Cells
Table 2.2: Key Differences between the Available Vectors
Table 2.3: The Eight CAR-T Cell Therapies Available in the Market
Table 2.4: Toxicities Associated with CAR-T Treatment
Table 3.1: Strategies for Future CAR-T Therapies
Table 3.2: A Sample of CAR-T Studies on Solid Tumors
Table 3.3: New Target Antigens and New Target Cancers
Table 3.4: A sample of Allogeneic CAR-T Studies
Table 4.1: History of Development of CAR-T Cell Therapy
Table 4.2: Approved CAR-T Products, their Developers and Indications
Table 4.3: Upcoming CAR-T Stars
Table 4.4: Cancer Population Addresses by CAR-T Therapy
Table 6.1: CAR-T Target Antigens in Hematological Cancers
Table 6.2: Targeted Antigens involved in the Approved CAR-Ts
Table 7.1: Geographical Distribution of CAR-T Patents, March 2024
Table 7.2: Top Ten Applicants for CAR-T Patents, March 2024
Table 7.3: Top Ten Inventors of CAR-T Patents, March 2024
Table 7.4: Top Ten Owners of CAR-T Patents, March 2024
Table 7.5: Legal Status of CAR-T Patent Applications, March 2024
Table 8.1: CAR-T Clinical Trials by Country, March 2024
Table 8.2: Number of CAR-T Clinical Trials by Funding Type, March 2024
Table 8.3: Clinical Trials Focusing on Solid Tumors by Country, March 2024
Table 8.4: CAR-T Solid Tumor Clinical Trials by Phase of Study, March 2024
Table 8.5: Funding Types in CAR-T Solid Tumor Clinical Trials, March 2024
Table 8.6: Percent Biomarker Distribution in CAR-T Clinical Trials
Table 8.7: CAR-T Targeted Indications in the U.S. Clinical Trials
Table 8.8: Indications Addressed by CAR-T Clinical Trials in China
Table 8.9: CAR-T Clinical Trial Sponsor Companies and Institutions in the U.S.
Table 8.10: CAR-T Clinical Trial Sponsor Companies and Institutions in China
Table 8.11: CAR-T Clinical Trial Sponsor Companies and Institutions in Other Countries
Table 8.12: Clinical Trials of 4th, 5th gen. and Gene Edited CAR-Ts
Table 9.1: NIH Funding for CAR-T Research, 2024
Table 10.1: CAR-T Venture Capital Funding, 2014-March 2024
Table 10.2: IPO Invested in CAR-T Companies, 2014-March 2024
Table 10.3: CAR-T Licensing Deals, 2015-March 2024
Table 10.4: CAR-T Collaboration Deals Signed between 2013 and March 2024
Table 10.5: CAR-T Merger and Acquisition (M&A) Deals, 2015-March 2024
Table 10.6: Overview of CAR-T Funding, 2014-March 2024
Table 11.1: List Prices of CAR-T Cells
Table 11.2: Pre-, Peri-, and Post Infusion Unit Costs
Table 11.3: Adverse Events Rates and Unit Costs of Management
Table 11.4: Reimbursement for CAR-T Cases, FY 2023 vs. FY 2024
Table 11.5: Cost of CAR-T cell Products in the EU Countries
Table 11.6: Cost Components and Resource Use of Pre- and Post- CAR-T Cell Therapy
Table 11.7: Average Total Costs Pre- and Post- CAR-T Treatment in Former EU 5 and NL
Table 11.8: CAR-T Reimbursement Schemes in Europe
Table 12.1: FDA-Approved Therapies for R/R ALL Pediatric and Young Adult Patients
Table 12.2: FDA Approved Therapies for DLBCL
Table 12.3: FDA Approved Therapies for MCL
Table 12.4: FDA Approved Drugs for Multiple Myeloma
Table 12.5: FDA-Approved Drugs for Follicular Lymphoma
Table 12.6: Cost of Treating Blood Cancers
Table 13.1: Uptake of CAR-T Doses, 2017-2023
Table 13.2: Revenue Generation by CAR-T Therapy by Product, 2017-2023
Table 13.3: Estimated Modest Growth of CAR-T Cell Market by Product, 2023-2032
Table 13.4: Global Market for CAR-T Products by Geography, 2023-2032
Table 13.5: Global Market for CAR-T Therapies by Indication, 2024-2032
Table 14.1: AffyImmune’s Affinity-Tuned Pipeline Products
Table 14.2: Aleta’s CAR-T Engager Pipeline
Table 14.3: Allogene’s AlloCAR-T Pipeline
Table 14.4: Anixa’s CAR-T Pipeline
Table 14.5: Arbele’s Advanced Cell Therapy Product Candidates
Table 14.6: ArcellX’s Current Product Pipeline
Table 14.7: Atara’s Product Pipeline
Table 14.8: Autolus’ Therapies in Development
Table 14.9: Clinical & Preclinical Pipeline Overview
Table 14.10: Bellicum’s Pipeline
Table 14.11: BRiDGECAR Program
Table 14.12: Cabaletta’s Autoimmune Therapy Candidates in Development
Table 14.13: Carina’s Clinical Programs
Table 14.14: CARsgen’s Product Pipeline
Table 14.15: Cartesian’s Product Pipeline
Table 14.16: Cellectis’ Allogeneic CAR-T Cell Product Pipeline
Table 14.17: CRISPR Therapeutics’ CAR-T Programs
Table 14.18: Elicera’s Product Pipeline
Table 14.19: EXUMA’s Pipeline Assets
Table 14.20: Galapagos’ Oncology CAR-T Pipeline
Table 14.21: Gracell’s Rich Product Pipeline
Table 14.22: IASO’s Diverse Product Pipeline
Table 14.23: ImmPACT Bio’s Product Pipeline
Table 14.24: Immuneels Product Pipeline
Table 14.25: JW Therapeutics’ Product Pipeline
Table 14.26: Kite’s Pipeline Cancer Therapies
Table 14.27: Product Pipeline to address Autoimmune Diseases
Table 14.28: Legend Biotech’s Product Pipeline
Table 14.29: Leucid’s Product Pipeline
Table 14.30: Luminary’s Product Pipeline
Table 14.31: Lyell’s Product Pipeline
Table 14.32: March Biosciences’ Product Pipeline
Table 14.33: A Comparison Guide for MaxCyte’s Elecroporation Systems
Table 14.34: Minerva’s CAR-T Pipeline Products for Solid Tumors
Table 14.35: Mustang’s CAR-T Product Candidates
Table 14.36: Noile-Immune’s PRIME-Based Product Pipeline
Table 14.37: Oxford Biomedica’s CDMO Services
Table 14.38: PeproMene’s Product Pipeline
Table 14.39: Poseida’s CAR-T Product Pipeline
Table 14.40: Precigen’s UltraCAR-T Pipeline
Table 14.41: Prescient’s CAR-T Product Pipeline
Table 14.42: ProMabs CAR-T Cells
Table 14.43: ProMab’s Discovery Services Plans & Prices
Table 14.44: Synthekine’s Pipeline with SYNCAR-001 + STK-009
Table 14.45: T-CURX’ Product Candidates in Clinical Trials
Table 14.46: Umoja’s Product Pipeline
Table 14.47: Vor Biopharma’s Current Product Pipeline
Table 14.48: Wugen’s Product Pipeline
Table 14.49: Xenetic’s CAR-T Product Pipeline

Companies Mentioned

  • 2seventy bio
  • Abintus Bio, Inc.
  • AffyImmune Therapeutics, Inc.
  • Aleta BioTherapeutics
  • Allogene Therapeutics
  • Anixa Biosciences, Inc.
  • Arbele, Ltd.
  • Arcellx
  • Atara Biotherapeutics
  • Aurora BioPharma
  • Autolus Therapeutics plc
  • AvenCell Europe GmbH
  • Beam Therapeutics, Inc.
  • Bellicum Pharmaceuticals
  • BioNTech
  • Biosceptre
  • Bluebird bio
  • Bristol Myers Squibb/Celgene Corporation
  • Cabaletta Bio
  • Carina Biotech
  • CARsgen Therapeutics
  • Cartesian Therapeutics
  • CARTherics Pty Ltd.
  • CASI Pharmaceuticals
  • Cellectis
  • Celularity, Inc.
  • Celyad Oncology
  • CRISPR Therapeutics
  • Curocell, Inc.
  • DiaCarta
  • Elicera Therapeutics AB
  • EXUMA Biotech
  • Fate Therapeutics
  • Galapagos NV
  • Gilead Sciences, Inc.
  • Gracell Biotechnologies
  • IASO Biotherapeutics
  • ImmPACT Bio
  • Immuneel Therapeutics, Pvt., Ltd.
  • ImmunoACT
  • Interius BioTherapeutics
  • Juventas Cell Therapy
  • JW Therapeutics
  • Kite Pharma (Gilead)
  • Kyverna Therapeutics
  • Legend Biotech
  • Leucid Bio
  • Luminary Therapeutics, Inc.
  • Lyell Immunopharma, Inc.
  • March Biosciences
  • MaxCyte, Inc.
  • Minerva Biotechnologies Corporation
  • Mustang Bio
  • Noile-Immune Biotech
  • Novartis AG
  • Oncternal Therapeutics
  • Oxford Biomedica plc
  • PeproMene Bio, Inc.
  • Poseida Therapeutics, Inc.
  • Precigen, Inc.
  • Prescient Therapeutics
  • ProMab Biotechnologies, Inc.
  • SOTIO Biotech BV
  • Syngene International, Ltd.
  • Synthekine
  • T-CURX
  • TC BioPharm
  • Umoja Biopharma
  • ViTToria Biotherapeutics
  • Vor Biopharma
  • Wugen
  • WuXi Advanced Therapies
  • Xenetic Biosciences
  • Xyphos Biosciences, 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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