Published: August 2023
CAR-T companies are making persistent efforts towards the development and approval of this innovative drug class for the treatment of oncological disorders. We analyzed close to 175 industry players that are engaged in the development of over 970 CAR-T Cell therapies, across different stages of development. In this article, discover Top 5 CAR-T companies and their capabilities in this industry.
Cancer is one of the leading cause of deaths, globally. As per World Health Organization (WHO), 10 million cancer related deaths were reported in 2020. Further, it is estimated that by the end of 2040, 27.5 million new cases will add to the global cancer burden, exerting tremendous physical, emotional and financial strain on affected individuals, their families, communities and national health systems. Although there are several treatment options available to control disease progression and keep malignant cells from spreading throughout the body, lasting remission is difficult to achieve. Amidst the current initiatives undertaken to develop more targeted anti-cancer therapies, CAR-T therapies have emerged as a promising option, owing to their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Given the consistent increase in number of cell therapies being developed and launched, this upcoming therapeutic segment is on its way to becoming one of the highest valued markets within the biopharmaceutical industry.
Presently, more than 170 CAR-T companies are engaged in the development of more than 970 early and late-stage CAR T cell therapy, worldwide. CAR T cell therapy market is dynamic, with six FDA approvals as of 2023 and several other regional approvals. Recently, in July 2023, Innovent Biologics and IASO Bio’s Fucaso® became the latest CAR T cell therapy to receive approval from China’s State Drug Administration (NMPA) for the treatment of relapsed / refractory multiple myeloma, while more candidates are anticipated to be commercially launched over the coming decade. All the currently approved CAR T cell therapy candidates are autologous in nature, which present several manufacturing and supply chain challenges. However, the industry is looking forward to allogeneic CAR T approvals, specifically since the EMA approval of the first allogeneic T Cell therapy, Ebvallo™ from Atara Biotherapeutics, in December 2022, for the treatment relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease. Further, the global CAR T cell therapy market size is poised to reach USD 25 billion by 2035, growing at a CAGR of 20% from 2022 to 2035.
Roots Analysis has conducted an exhaustive study on CAR T Cell Therapy Market featuring the current market landscape of CAR-T companies and future opportunity associated with CAR-T therapies, respectively, over the forecasted period 2023-2035.
In the table below, we have listed (in decreasing order of 2022 market share), the top 5 CAR-T companies.
Table: Top CAR-T Companies
| Company | YoE | Headquarters | Company Size (Employees) |
| Gilead Sciences | 1987 | California, US | 10,001+ |
| Bristol Myers Squibb | 1887 | New Jersey, US | 10,001+ |
| Novartis | 1996 | Basel, Switzerland | 10,001+ |
| Janssen | 1968 | Ontario, Canada | 5,001-10,000 |
| JW Therapeutics | 2016 | Shanghai, China | 51-200 |
Abbreviation: YoE: Year of Establishment
Source: Roots Analysis
This article highlights the five leading CAR-T companies to watch out for in this industry. These companies were chosen based on their market share (2022) in the global CAR T cell therapy market. It is essential to note that the selection of top CAR-T companies can differ substantially according to the defined criteria(s).
Interested in exploring all 170+ CAR-T companies, their pipeline and business strategy?
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Gilead Sciences is a global biopharmaceutical company focused on the development of novel therapeutics for various life-threatening indications. The company is also developing various CAR-T cell therapies for the treatment of several types of cancers. In August 2017, the company acquired Kite Pharma, the originator of second CAR T cell therapy Yescarta®. Kite Pharma operates as an independent business unit focusing on cell therapies. At the time of acquisition, Yescarta was in priority review at the FDA and expedited review in EU. Further, in February 2023, Kite Pharma completed acquisition of Tmunity Therapeutics, another CAR T cell therapy company, providing access to clinical programs and an armored CAR T technology platform.
Gilead Sciences with two approved CAR-T therapies, Yescarta® and Tecartus®, reported total revenues of USD 1,459 million in FY 2022 from the sales of its CAR-T therapies. For the company, nearly 66% of the cell therapy sales are generated in the US.
Gilead Sciences is engaged in the development of following CAR T cell therapies:
| Drug Candidate | Phase of Development | Target Indication |
| Yescarta® (CD19 CAR-T) | Approved | Diffuse Large B-Cell Lymphoma, Primary mediastinal large B cell lymphoma and transformed follicular lymphoma |
| Yescarta® (CD19 CAR-T) | Phase II | Non-Hodgkin lymphoma, mantle cell lymphoma |
| Yescarta® (CD19 CAR-T) | Phase III | Acute lymphoblastic leukemia, B-cell lymphoma |
| Yescarta® (CD19 CAR-T) | Phase I / II | CNS Lymphoma |
| Tecartus® (Brexucabtagene Autoleucel) | Phase 1 | Mantle cell Lymphoma |
| Tecartus® (Brexucabtagene Autoleucel) | Approved | Acute lymphoblastic leukemia |
| KITE-585 (BCMA CAR-T) | Phase II | Multiple myeloma |
| HuCAR- 19 | Phase I | Hodgkin lymphoma, non-Hodgkin lymphoma, B-cell leukemia |
| KITE-222 | Phase I | Acute Myeloid Leukemia |
| KITE-037 | Pre-clinical | Cancer (Specific Type Unknown) |
| KITE-363 | Pre-clinical | Cancer (Specific Type Unknown) |
| Unnamed (Allogeneic CAR-T Cells) | Pre-clinical | Undisclosed |
| Unnamed Pre-clinical | Pre-clinical | Undisclosed |
Recent Developments:
January 2023 was another highlight for the company when UK’s National Institute for Health and Care Excellence (NICE) moved Yescarta from availability under Cancer Drugs Fund to reimbursement under the National Health Service (NHS). In June 2023, the company changed its market authorization from Daichi Sankyo to its subsidiary Gilead Sciences K.K. to manage sales and promotional activities of Yescarta® in Japan. In the same month, company also announced positive findings of real-world analysis of Tecartus® in patients with relapsed or refractory mantle cell lymphoma.
Key Strengths:
Gilead Sciences has experience and expertise in development and commercialization of CAR T cell therapy. The company has successfully established its sales and marketing network for oncology cell therapy. With Yescarta’s blockbuster status, the company has emerged as the commercial leader in the CAR T cell therapy market. It witnessed significant adoption of Yescarta, specifically in the US. Further, the access to Yescarta on the NHS is likely to drive a positive sales growth for the drug in EU in FY 2023.
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Bristol Myers Squibb (BMS) is a global biopharmaceutical company focused on discovery, development and commercialization of innovative therapies for the treatment of various types of cancer, through gene editing. In the T-cell immunotherapy space, the company is presently engaged in the development of a series of CAR-T therapies targeting various hematological cancers and solid tumors, in collaboration with several industry players. In November 2019, the Bristol Myers Squibb acquired Celgene, which now operates as a subsidiary of the former company. It is worth highlighting that earlier, in March 2018, Celgene acquired Juno Therapeutics. With this acquisition, Celgene gained full global rights to Juno’s CAR-T therapy pipeline and novel technology.
BMS, which has two approved CAR-T therapies, Abecma® and Breyanzi®, has reported total revenues of USD 570 million in FY 2022 from their sales. BMS is hopeful to remain one of the leaders in the CAR T cell therapy market, with both Abecma and Breyanzi being investigated for additional indications and awaiting approval in more geographies.
Bristol Myers Squibb is engaged in the development of the following CAR T cell therapies:
| Drug Candidate | Phase of Development | Target Indication |
| Abecma® (Idecabtagene Vicleucel / bb2121) | Approved | Multiple Myeloma |
| BREYANZI® (Lisocabtagene maraleucel, JCAR017) | Approved | Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma, Primary Mediastinal B-Cell Lymphoma, Follicular Lymphoma |
| BREYANZI® (Lisocabtagene maraleucel, JCAR017) | Phase I / II | Acute Lymphoblastic Leukemia, Small Lymphocytic Lymphoma |
| JCAR014 | Phase I / II | Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma |
| bb21217 | Phase I | Multiple Myeloma |
| JCAR018 | Phase I | Acute Lymphoblastic Leukemia, Follicular Lymphoma, Large Cell Lymphoma |
| JCAR023 | Phase I | Neuroblastoma |
| JCAR020 / armored CAR | Phase I | Ovarian Cancer |
| MCARH109 (GPRC5D-CAR-T) | Phase I | Multiple Myeloma |
| 1st CAR-T / TCR-T | Phase I | Undisclosed |
| CC-97540 / BMS-986353 (Nex-T CAR-T) | Phase I | Systemic Lupus Erythematosus |
Recent Developments:
In May 2023, the company received European Commission approval for CAR-T Therapy, Breyanzi for Relapsed or Refractory Large B-cell Lymphoma after one prior therapy. In June 2023, BMS’s third commercial scale CAR T manufacturing facility in Devens (US) received FDA approval. In the previous month, the company acquired a viral vector manufacturing site in Illinois, US from Novartis in order to produce viral vectors for its commercialized CAR-T therapies, Abecma and Breyanzi.
Key Strengths:
Bristol Myers Squibb has a portfolio of technologies supporting the development of its CAR-T therapies, including CAR technology, Armored CAR Technology and EGFRt technology. In addition to these technologies, the rich pipeline of company’s approved and clinical stage CAR-T therapies is a result of the research efforts, targeted acquisitions and timely manufacturing investments from BMS. The company has focused on being self-reliant for CAR T cell therapy manufacturing and its latest acquisition of viral vector manufacturing capability will ensure a reliable supply of this key starting material in order to meet the growing demand for the company’s approved CAR T cell therapy products. The company is also working on a Nex-T CAR-T manufacturing platform, which aims to reduce the manufacturing time to 1 week.
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Novartis is a multinational pharmaceutical company that was formed as a result of a merger between two Swiss companies, Ciba-Geigy and Sandoz. The company’s operations are segmented into two business divisions, namely Innovative Medicines Division and Sandoz (generics). The Innovative Medicines Division further has two separate business units and company’s CAR-T therapies are a part of the Oncology business unit. All of company’s clinical stage assets are allogeneic cell therapies and the research team at Novartis is putting their efforts on optimizing the autologous CAR-T manufacturing process to 1 week from the current 3-4 weeks.
Novartis’ Kymriah became the first CAR T cell therapy to receive approval in August 2017. In FY 2022, the company reported revenues of USD 536 million from its sales. Although, majority of the company’s CAR T pipeline is focused on oncology, the company is also evaluating a CAR T cell therapy candidate for treatment of autoimmune disorder, systemic lupus erythematosus.
Novartis is engaged in the development of following CAR T cell therapies:
| Drug Candidate | Phase of Development | Target Indication |
| Kymriah® (CD19 CAR-T) | Approved | Acute Lymphoblastic Leukemia, Diffuse large B cell lymphoma |
| Kymriah® (CD19 CAR-T) | Phase III | Non-Hodgkin lymphoma |
| Kymriah® (CD19 CAR-T) | Phase II | Chronic lymphocytic leukemia, Follicular lymphoma, Mantle Cell Lymphoma |
| Kymriah® (CD19 CAR-T) | Phase I / II | CNS lymphoma |
| huCART19 / CTL19 | Phase II | Acute lymphocytic leukemia |
| YTB323 | Phase I | Acute lymphocytic leukemia, chronic lymphocytic leukemia / small lymphocytic lymphoma, Diffuse large B cell lymphoma |
| YTB323 | Phase I | Systemic lupus erythematosus |
| PHE885 | Phase I | Multiple Myeloma |
| 2nd CAR-T | Phase I | Cancer (Specific Type Unknown) |
| BCMA CART+huCART19 | Phase I | Multiple myeloma |
| 6th CAR-T | Pre-clinical | Cancer (Specific Type Unknown) |
| Allogeneic CAR-T | Pre-clinical | Unknown indication |
| 3rd CAR-T | Pre-clinical | Cancer (Specific Type Unknown) |
| 4th CAR-T | Pre-clinical | Cancer (Specific Type Unknown) |
| 5th CAR-T | Pre-clinical | Cancer (Specific Type Unknown) |
Recent Developments:
In February 2023, Novartis initiated a phase I / II clinical trial evaluating YTB323, a CD19 targeted CAR T for treatment of severe refractory systemic lupus erythematosus. At the ASCO 2023 meeting in June, the company published positive results from a phase I clinical trial of PHE885, a BCMA targeted CAR-T manufactured using T-Charge platform. According to the published results the platform allows manufacturing of the CAR-T in less than 2 days, with a median of 16 days from apheresis to lymphodepletion.
In April 2023, Novartis extended its support to Janssen and Legend Biotech for manufacturing clinical supplies of Carvykti over a three-year period.
Key Strengths:
Novartis aims to solve the biggest bottleneck for the cell therapy market with its T-charge platform. Although the manufacturing time has been reduced to 2 days, the vein-to-vein time still stands at more than 2 weeks. The company is placed well to have a market advantage with its T-charge platform. Furthermore, its focus on development of CAR-T therapies for immunological diseases is also likely to reap benefits in the mid to long-term.
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Janssen, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company which is involved in the research and development in the field of CAR-T (Chimeric Antigen Receptor T-cell) therapies. The company entered the CAR T-cell therapy market with a worldwide license to co-develop and commercialize Carvykti® from China based Legend Biotech in 2017. Carvykti® became the latest CAR T cell therapy to receive FDA approval in February 2022 as fifth line treatment for relapsed / refractory multiple myeloma, competing with BMS’ Abecma® in this space. The EU gave a conditional marketing authorization to the drug in May 2022. In March 2023, the company shelved its plans for the launch of Carvykti® in the UK, citing supply constraints. This manufacturing bottleneck can hamper the sales growth of the drug, which is awaiting approval as second-line treatment for relapsed / refractory multiple myeloma.
In FY 2022, Janssen recorded revenues of USD 118 million from sales of Carvykti®.
Janssen is engaged in the development of following CAR T cell therapies:
| Drug Candidate | Phase of Development | Target Indication |
| CARVYKTI® | Approved | Multiple Myeloma |
| JNJ-75229414 | Phase I | Prostate Cancer |
| C-CAR039 | Phase I | Relapsed/refractory non-Hodgkin's lymphoma |
| C-CAR066 | Phase I | Relapsed/refractory non-Hodgkin's lymphoma |
Recent Developments:
In July 2023, the company signed a deal with Cellular Biomedicine Group for the development of next-generation chimeric antigen receptor (CAR) T-cell therapies to treat B-cell malignancies. This deal provided Janssen with exclusive rights to develop and commercialize CBMG’s CAR-T assets, C-CAR039 and C-CAR066 outside China. Additionally, from its existing portfolio of CAR-T, the company filed an application with the FDA for approval of Carvykti as second-line treatment for multiple myeloma.
In order to overcome the manufacturing challenges, the company collaborated with Novartis in April 2023. Under the three-year contract manufacturing agreement, Novartis will provide Janssen with clinical supplies of Carvykti. Janssen is also investing in its European production site for cell therapies along with Legend Biotech to meet its future demand for CAR-T therapy.
Key Strengths:
J&J and Legend recently filed Carvykti as a second-line treatment option with the FDA, based on CARTITUDE-4 clinical trial results. An approval will significantly increase the market potential for the drug. Janssen is also evaluating the CAR T cell therapy as a front-line therapy for newly diagnosed multiple myeloma patients in a phase III clinical trial. If filed for approval, it will change the way the industry is looking at CAR-T therapies, which are currently only considered for second-line and above treatment.
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JW Therapeutics, is a joint venture between Bristol Myers Squibb and WuXi AppTec. It was established in 2016 with focus on development of cell therapies for the local Chinese market. In September 2021, the company received NMPA approval for its CAR T cell therapy, relma-cel, for use in the treatment of adult patients with relapsed or refractory large B-cell lymphoma. It was the second approved CAR T cell therapy to receive approval in China.
Relma-cel, old under the brand name Cartevya®, generated revenues of USD 12.58 million in FY 2022.
JW Therapeutics is engaged in the development of following CAR T cell therapies:
| Drug Candidate | Phase of Development | Target Indication |
| Carteyva® | Approved | Relapsed or refractory large B-cell lymphoma, Follicular Lymphoma |
| Carteyva® | Phase II / III | Mantle Cell Lymphoma |
| Carteyva® | Phase II | Large B-cell lymphoma |
| Carteyva® | Phase I | Acute lymphocytic leukemia, Systemic lupus erythematosus |
| Carteyva® | Pre-clinical | Chronic lymphocytic leukemia |
| JWCAR129 | Pre-clinical | Relapsed or refractory multiple myeloma |
Recent Developments:
In April 2023, JW Therapeutics received NMPA clearance for initiating a phase I clinical trial of Relma-cel in patients with moderately or severely refractory systemic lupus erythematosus. Furthermore, in line with its plans to expand the use of relma-cel in hematological malignancies, the company announced the initiation of an investigator-initiated trial in China evaluating Cartevya as a first line treatment for high-risk large B-cell lymphoma.
Key Strengths:
The company has put together a strong business strategy to capture the Chinese cell therapy market. This includes expansion of relma-cel in additional hematological cancers, entering the non-oncological market with CAR-Ts, and focus on growing the solid tumor portfolio through partnerships. The company, with technology access from Juno Therapeutics and manufacturing know how from WuXi AppTec, is a frontrunner in the Chinese CAR T cell therapy market.
The above presentation features five CAR-T companies selected from a pool of over 170 CAR T cell therapy companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Ajay is a Senior Business Analyst, working with Roots Analysis since 2020. He has made significant contributions to the success of Roots Analysis since joining the organization in July 2020. With a strong academic background and a master's degree in pharmacology from a renowned university, he brought invaluable knowledge and expertise to the firm's diverse projects. Through his work on projects like mRNA contract manufacturing, ADC therapeutics and T-cell therapeutics, which involved extensive research, Ajay has gathered experience and expertise in the growing segments of the biologics market. He understands the complexities and challenges of the biologics market and the business strategies of the drug developers.
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