Global CAR-T Cell Therapy Market Forecasts, Trials and Trends Report 2024: Since 2017 to Now, Nine CAR-T Products Reached Commercialization, and this Number is Estimated to Reach Double-Digits by 2032 - ResearchAndMarkets.com

The "Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, and Trends, 2024" report has been added to ResearchAndMarkets.com's offering.

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:

• Kymriah (tisagenlecleucel)
• Yescarta (axicabtagene ciloleucel)
• Tecartus (brexucabtagene autoleucel)
• Breyanzi (lisocabtagene maraleucel)
• Abecma (idecabtagene vicleucel)
• 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 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

Key Topics Covered:

1. REPORT OVERVIEW

2. CAR-T CELL THERAPY: TECHNOLOGY DEVELOPMENT

2.1 CAR-T cell

2.2 Evolution of CAR-T Development

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

2.7 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

4.3 Current Status of CAR-T Therapy Products

4.4 The Upcoming CAR-T Stars

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

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

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

8.13 CAR-T Targeted Biomarkers in Clinical Trials

8.14 Improved CAR-T Constructs in Clinical Trials

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

10.2 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

11.2 Reimbursement in the U.S. for CAR-T Therapy

11.3 Cost of CAR-T Therapies in Europe

11.4 Cost & Reimbursement for CAR-T Therapy in Asia

12. BLOOD CANCERS ADDRESSED BY CAR-T

12.1 Acute Lymphoblastic Leukemia (ALL)

12.2 Diffuse Large B-Cell Lymphoma (DLBCL)

12.3 Mantle Cell Lymphoma (MCL)

12.4 Multiple Myeloma (MM)

12.5 Follicular Lymphoma

12.6 The Staggering Cost of Blood Cancer Therapies

13. MARKET ANALYSIS

13.1 Uptake of CAR-T Cell Therapy, 2017-2023

13.2 Estimated Global Market for CAR-T Cell Therapy Products, 2024-2032

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 COMPANIES

• 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.
• TC BioPharm
• T-CURX
• Umoja Biopharma
• ViTToria Biotherapeutics
• Wugen
• Xenetic Biosciences
• Xyphos Biosciences, Inc.

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