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 identify and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as “living drugs.”
The backbone of CAR-T therapy is T-cells, which are essential to the immune system's ability to direct immune responses and eliminate cells infected by pathogens. For CAR-T therapy, blood is drawn from the patient, and T-cells are isolated. These cells are then genetically engineered in the laboratory using a modified virus, which enables the T-cells to produce chimeric antigen receptors (CARs) on their surface. Once reintroduced into the patient's body, these CARs allow the T-cells to recognize and bind to specific antigens on cancer cells, leading to their destruction.
From 2017 to today, 11 CAR-T products have reached commercialization. Of these, seven are U.S. FDA-approved CAR-T cell therapies, each of which have received approvals in other major healthcare markets as well.
The seven U.S. FDA approved products include:
- Kymriah - Developed by Novartis in collaboration with the University of Pennsylvania. Marketed by Novartis.
- Yescarta - Developed by Kite Pharma, a subsidiary of Gilead Sciences. Marketed by Gilead Sciences.
- Tecartus - Developed by Kite Pharma, a subsidiary of Gilead Sciences. Marketed by Gilead Sciences.
- Breyanzi - Developed by Juno Therapeutics (a Celgene company), which was acquired by Bristol-Myers Squibb (BMS). Marketed by BMS.
- Abecma - Developed by bluebird bio in partnership with Bristol-Myers Squibb (BMS). Marketed by BMS in collaboration with bluebird bio.
- Carvykti - Developed by Legend Biotech in partnership with Janssen Biotech, a subsidiary of Johnson & Johnson. Marketed by Janssen Biotech and Legend Biotech.
- Aucatzyl - Developed and marketed by Autolus Therapeutics.
Additionally, two CAR-T therapies have been approved by the Chinese National Medical Products Administration (NMPA): Relma-cel and Yuanruida. Two CAR-T therapies have also been approved by the Indian Central Drugs Standard Control Organisation (CDSCO): NexCAR19 and Qartemi.
These approvals highlight the rapid growth of the CAR-T market, which is having a significant impact on the biotech industry. Mergers and acquisitions have been particularly active, with Celgene acquiring Juno Therapeutics for $9 billion in 2018, and Bristol-Myers Squibb (BMS) purchasing Celgene for $74 billion by 2019. Gilead's $11.9 billion acquisition of Kite Pharma also made headlines.
The billion-dollar CAR-T cell therapy market owes much of its success to the early therapies' impressive effectiveness in treating blood cancers. However, the next major challenge for CAR-T therapies will be expanding their use to treat solid tumors. Currently, all nine marketed CAR-T products, along with nearly 75% of ongoing clinical trials, utilize an autologous approach (using the patient’s own cells). Developing allogeneic CAR-T therapies-using donor cells-will open up critical market opportunities.
Another hurdle for CAR-T therapies is the "vein-to-vein" time-the time between apheresis (the process of collecting the T-cells) and the delivery of the final product. This process can be lengthy, so CAR-T therapies are typically recommended for end-stage patients who have exhausted other treatment options. Additionally, reimbursement remains a significant challenge in the U.S. and Europe.
The industry is working to overcome these challenges. Several CAR-T companies are using advanced gene-transfer techniques to introduce CARs into T-cells more efficiently. Partnerships are also emerging to develop CRISPR and electroporation technologies to enhance T-cell modification. Additionally, some companies are incorporating "on-off" switches in CAR-T cells to prevent toxicity. Despite progress, achieving success with solid tumors has proven difficult, with clinical trials so far showing low response rates. The focus now is on identifying effective antigens specific to solid tumors.
This report provides detailed analysis of the current state of CAR-T cell therapies and the broader CAR-T industry landscape. It highlights approved CAR-T therapies and late-stage clinical trials that could reach commercialization soon. CAR-T companies, ranging from small startups to billion-dollar giants, are now proliferating in all major healthcare markets worldwide.
Key questions answered in this report include:
- What are the most targeted antigens for liquid and solid tumors?
- What developments are anticipated in the CAR-T sector, and what commercial opportunities and patient outcomes will they create?
- How many CAR-T-related patent publications and granted patents have been issued since 2012?
- Which countries hold the largest number of CAR-T patents?
- Which companies have filed the most CAR-T patents?
- Who are the leading inventors in CAR-T patent filings?
- How many CAR-T clinical trials have been registered over the past 20 years?
- Which biomarker antigens are most prominent in the CAR-T clinical trial landscape?
- What are the most common indications being addressed by CAR-T clinical trials in the U.S. and China?
- Which companies are leading CAR-T clinical trials?
- How many deals have been made within the CAR-T sector in recent years?
- Which promising CAR-T candidates are likely to reach commercialization soon?
- How are CAR-T therapies reimbursed in the U.S. and Europe?
- How many automated manufacturing systems are currently available in the global market?
- 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 barriers, risks, and opportunities exist for growth in the global CAR-T industry?
- Who are the major companies developing CAR-T cell therapies, what are their core technologies, and what products do they have in development?
This global strategic report reveals:
- Global CAR-T Cell Therapy Market Size, segmented by Product, Geography, and Indication, with future market size forecasts through 2032
- In-depth coverage of approved CAR-T products, including regulatory approvals, pricing, reimbursement, and market penetration
- Analysis of clinical trial activity by type, geography, phase, and sponsor
- Comprehensive CAR-T patent analysis, including top inventors, patent holders, patent types, geographies, and the most cited patents
- Overview of CAR-T industry mergers and acquisitions, IPOs, and financing events
- Examination of 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 in the global marketplace
Table of Contents
Companies Mentioned
- 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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