Between 2017 and Today, Nine CAR-T Products Have Reached Commercialization and this Number is Expected to Reach Double-Digits Soon
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 global strategic 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
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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