CAR T Cell Therapy Market

CAR T Cell Therapy Market Overview

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. Cancer is one of the leading cause of deaths, globally. In fact, as per the 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 be added to the global cancer burden, exerting tremendous physical, emotional and financial strain on affected individuals, their families, communities as well as the national health systems. Even though a number of treatment options are available to control disease progression and keep malignant cells from spreading throughout the body, lasting remission is still difficult to achieve. Amidst the active initiatives undertaken to develop more targeted anti-cancer therapies, CAR T cell therapies have emerged as a promising option, given their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Further, CAR-T immunotherapies, a relatively recent addition to the gamut of anticancer interventions, have demonstrated significant promise. Overall, this highly specific and promising form of cell therapy, which harnesses the versatile effector machinery of the human immune system, has revolutionized cancer treatment, globally. Given the consistent increase in number of cell therapies being developed and launched, this upcoming CAR T-cell therapy market is on its way to becoming one of the highest valued markets within the biopharmaceutical industry. 

Key Market Insights

The CAR T Cell Therapy Market (4th Edition) by Key Drugs (Axicabtagene Ciloleucel, Tisagenlecleucel, Brexucabtagene Autoleucel, Ciltacabtagene Autoleucel, Lisocabtagene Maraleucel, Others), Target Indications (Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Hodgkin Lymphoma, Acute Myeloid Leukemia, Ovarian Cancer, Generalized Myasthenia Gravis And Renal Cell Carcinoma), Target Antigens (CD19, BCMA, CD19 / CD22, EGFR, NY-ESO-1 and Others), Key Players and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World) – Global Forecast 2022-2035 report features an extensive study of the current market size and the future potential of CAR-T therapies. The report highlights the efforts of both industry players and academic organizations in this rapidly evolving segment of the biopharmaceutical industry. Amongst other elements, the market report answers several key questions related to the market.

Pipeline Analysis: 600+ CAR T Cell Therapy Programs in Clinical Trials

At present, of the seven approved CAR T cell therapies, six have been approved for several hematological malignancies in the US; these are Tisagenlecleucel-T (KYMRIAH®), Axicabtagene ciloleucel (YESCARTA®), Brexucabtagene Autoleucel (TECARTUS™), Lisocabtagene maraleucel (Breyanzi®), Idecabtagene Vicleucel (Abecma™) and Ciltacabtagene Autoleucel (CARVYKTI™). With 679 therapy programs in the clinical phases of development, CAR-T cell therapies have already established a strong foothold in the overall pharmaceutical industry. In addition, there are 289 CAR-T cell therapy programs in the preclinical stages of development that are likely to emerge as potential therapy candidates in the long term. The currently approved CAR-T therapies target the CD19 receptor and BCMA. However, CAR-T companies are developing therapies against several other novel targets that have been analyzed in this report. The expected launch of several promising leads over the forecast period, will drive the market growth.

CAR T Companies Analysis: Collaborations, Funding, Patents and More 

170+ CAR T cell therapy companies are engaged in the development of over 970 early and late-stage CAR-T therapies, worldwide. More than 260 collaborations have been inked between several industry / academic stakeholders in order to advance the development of various pipeline candidates. To fund CAR-T cell therapy development, capital investments worth more than USD 24 billion have been made by various private and public sector investors, in the last few years. Additionally, over 6,500 patents related to CAR-T cell therapy have been recently filed / granted, demonstrating the continued innovation in this market. Driven by the ongoing pace of innovation in this field, sufficient financial support from investors and encouraging clinical trial results, the CAR T-cell therapy market size is likely to witness significant growth during the forecast period.

Target Indication Analysis: Acute Lymphoblastic Leukemia, B-Cell Lymphoma and Multiple Myeloma to Drive CAR T Cell Therapy Market Growth

According to the cancer data published by World Cancer Research Fund International, there were 474,519 new cases of leukemia, 176,404 new cases of multiple myeloma and 627,439 new cases of lymphoma worldwide in 2020. Many of the approved and clinical stage CAR T cell therapies target these hematological indications. Rising incidence and prevalence of cancer, as well as an increase in the relapse / remission rates will drive the adoption of CAR T cell therapies, driving the market growth. The developers of Idecabtagene Vicleucel (BMS) and Ciltacabtagene Autoleucel (Janssen and Legend Biotech) have published positive results from phase III trials for the treatment of multiple myeloma as earlier line of treatment compared to the currently approved status as fifth line therapies. Such developments will expand the potential market size for CAR-T therapies.

Regional Analysis: North America Holds the Largest Share of the Current CAR T Cell Therapy Market

On the basis of region, North America held 54% market share in terms of revenues generated through sales of approved CAR T cell therapies. This is likely to change during the forecast period, as Europe is projected to hold more than 37% share of the global market size. Although the process of approval of CAR-T therapies is accelerated through various grants, the high prices of treatment options continue to be one of the key challenges associated with CAR T cell therapy adoption. In the UK, Yescarta and Kymriah have been to date provided through National Health Services’s (NHS) Cancer Drugs Fund. However, this situation is likely to change as National Institute for Health and Care Excellence (NICE) is working on gathering evidence on cost-effectiveness of Yescarta. If approved, Axicabtagene Ciloleucel will become the first CAR T cell therapy to be provided to the patients through NHS. The European market will continue to grow at a healthy CAGR during the forecast period of this market report.

Market Forces Analysis: Therapy Price and Manufacturing Challenges Likely to Slow Down the CAR T Therapy Market Growth

Manufacturing biologics and cell therapies is considerably complex, as compared to small molecule drugs. The high manufacturing cost also contributes to high price of the therapy, essentially leading to limited adoption in case of unavailability of reimbursement. In 2021, BMS faced manufacturing bottleneck for its CAR-T idecabtagene vicleucel (ABECMA®), driven by shortage of viral vectors in addition to other reasons. In 2022, Janseen and Legend Biotech rolled out their CAR-T ciltacabtagene autoleucel (CARVYKTI ®) in a phased manner in the US instead of a nationwide launch owing to manufacturing limitations.

These challenges may be temporary as the market matures and is supported by the cell therapy contract manufacturers.

Recent Developments in CAR T Therapy Market

Several recent developments have taken place in the field of CAR T cell therapy. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In August 2023, the US FDA granted orphan drug designation (ODD) to NXC-201 (Nexcella), a next generation chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients suffering from multiple myeloma. 
• In August 2023, Invectys announced that FDA granted a Fast Track Designation to the chimeric antigen receptor (CAR) T-cell therapy, IVS-3001, which is used for the treatment of patients suffering from renal cell carcinoma.  
• In August 2023, GenScript Biotech entered into a strategic agreement with T-MAXIMUM Biotech with an aim to develop CAR T cell therapy by using GenScript's CRISPR nucleic acid reagents

Scope of the Report

Report Attribute	Details
Forecast Period	2022 – 2035
Market Size 2035	$25 billion
CAGR	20%
Base Year	2021
Target Indications	Non-Hodgkin's Lymphoma, Multiple Myeloma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Hodgkin's Lymphoma, Acute Myeloid Leukemia, Ovarian Cancer, Generalized Myasthenia Gravis, Renal Cell Carcinoma
Target Antigens	CD19, BCMA, CD19/CD22, Others
Key Players	Bristol Myers Squibb, Gilead Sciences, Novartis, Autolus, Janssen, JW Therapeutics, Beijing Immunochina Medical Science & Technology, Bioray Laboratories
Key Geographies	North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America, Rest of the World

The market research report features an extensive study of the current market size and the future potential of CAR-T therapies. The report highlights the efforts of both industry players and academic organizations in this rapidly evolving segment of the biopharmaceutical industry. Amongst other elements, the report features the following:

• A detailed assessment of the current market landscape of CAR-T therapies with respect to type of developer (industry and non-industry), phase of development (approved, phase III, phase II / III, phase II, phase I / II, phase I, clinical (phase unknown), preclinical), therapeutic area (oncological disorders, non-oncological disorders and undisclosed), key target indication (acute lymphoblastic leukemia, B-cell lymphoma, multiple myeloma, non-Hodgkin lymphoma, acute myeloid leukemia, hepatocellular carcinoma, diffuse large B-cell lymphoma, pancreatic cancer, gastric cancer, lung cancer, mantle cell lymphoma, ovarian cancer, breast cancer and follicular lymphoma), key target antigen (CD19, BCMA, CD19 / CD22, GPC3, NY-ESO-1 and others), source of T-cells (autologous and allogeneic), route of administration (intravenous, intratumoral, intraperitoneal, intrapleural, intracranial and others), dose frequency (single dose, multiple doses and split doses), patient segment (children, adults and seniors) and type of therapy (monotherapy and combination therapy). Additionally, it highlights the most active industry and non-industry players (in terms of number of pipeline candidates) engaged in the development of CAR T cell therapy. Further, chapter also includes developer landscape analysis based on some relevant parameters, including year of establishment, company size (small, mid-sized and large) and location of headquarters (North America, Europe and Asia Pacific).
• An analysis of key insights derived from the study featuring a competitive analysis, highlighting the popular target antigens related to hematological malignancies and solid tumors. Additionally, it includes CAR construct analysis of clinical-stage CAR-T therapies based on the generation of CAR (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of virus used (lentivirus and retrovirus), type of gene transfer method used (transduction and transfection) and type of co-stimulatory domain used.
• A detailed analysis of completed, ongoing and planned clinical studies related to CAR T cell therapies, based on several relevant parameters, such as trial registration year, enrolled patient population, trial recruitment status, trial phase, target patient segment, type of sponsor / collaborator, most active players and regional distribution of trials.
• An insightful analysis highlighting the key opinion leaders (KOLs) in this domain featuring an analysis of the various principal investigators of clinical trials related to CAR-T therapies, considering them to be KOLs, who are actively involved in R&D of CAR T cell therapies. In addition, the chapter presents an analysis, comparing the relative expertise of KOLs based on a proprietary scoring criterion and that of a third party.
• Elaborate profiles of marketed and mid- to late-stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results.
• An analysis of various type of partnership that have been inked between several stakeholders in the domain of CAR-T cell therapies, covering various type of partnership such as, R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures and others.
• An analysis of the investments that have been made into CAR-T companies that have proprietary CAR-T therapies / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing.
• An in-depth analysis of patents related to CAR T cell therapies, filed / granted till 2022, based on several relevant parameters, such as type of patent (granted patents, patent applications and others), publication year, geographical distribution, Cooperative Patent Classification (CPC) symbols, emerging focus areas, type of applicant, leading players (on the basis of number of patents) and patent benchmarking. In addition, it features a patent valuation analysis which evaluates the qualitative and quantitative aspects of the patents. 
• A case study on manufacturing cell therapy products, highlighting the key challenges, and a detailed list of contract service providers and in-house manufacturers involved in this space.
• An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a CAR T therapy that is likely to be marketed in the coming years.
• A review of the key promotional strategies being adopted by the developers of the approved CAR T cell therapies, namely Kymriah®, Yescarta®, Tecartus™, Breyanzi®, Abecma™, Carvykti™ and TCR-based therapies (Kimmtrak®).
• Elaborate profiles of the several leading players in the domain of CAR T cell therapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T therapies, technology portfolio (if available), recent developments related to T-cell immunotherapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

One of the key objectives of the report was to estimate the CAR T therapy market size and identify potential growth opportunities for CAR-T cell therapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have developed informed estimates of the likely evolution of the market over the period 2022-2035. The report also includes likely sales forecasts of CAR T cell therapies that are already marketed or in the late stages of development. Additionally, it features market size projections for the overall CAR T-cell therapy market, wherein opportunity has been segmented across [A] key drugs (Axicabtagene Ciloleucel, Tisagenlecleucel, Brexucabtagene Autoleucel, Ciltacabtagene Autoleucel, Lisocabtagene Maraleucel, Others), [B] target indications (non-hodgkin lymphoma, multiple myeloma, acute lymphoblastic leukemia, chronic lymphocytic leukemia, hodgkin lymphoma, acute myeloid leukemia, ovarian cancer, generalized myasthenia gravis and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19 / CD22 and others), Key Players and [D] key geographies (North America (US and Canada), Europe (UK, Germany, France, Italy, Spain and rest of EU), Asia Pacific (China, Japan, Australia), Latin America, Latin America, Middle East and North Africa and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent different tracks of the industry’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

• Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics)
• Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies)
• Miguel Forte (Chief Operating Officer, TxCell)
• Adrian Bot (Vice President, Scientific Affairs, Kite Pharma)
• Vincent Brichard (Vice President, Immuno-Oncology, Celyad)
• Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
• Aino Kalervo (Former Competitive Intelligence Manager, Strategy & Business Development, Theravectys)
• Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital)
• Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is CAR T cell therapy?

Answer: CAR-T therapy is defined as a genetically enhanced T-cell therapy or adoptive T-cell therapy that harnesses the innate potential of immune cells, specifically T-cells, to potentially combat a myriad of diseases.

Question 2: How many CAR-T therapies are on the market?

Answer: There are currently seven approved CAR-T therapies, of which six have received FDA approval.

Question 3: What is the market size for CAR T cell therapy?

Answer: The global CAR T cell therapy market size is poised to reach USD 25 billion by 2035. These represent the potential revenues generated by the currently marketed CAR-T therapies and the drugs that are likely to receive approval during the forecast period.

Question 4: What is the global CAR T cell therapy market growth?

Answer: Global CAR T cell therapy market is expected to grow at a CAGR of 23% from 2022 to 2035.

Question 5: Who are the largest CAR T cell therapy companies?

Answer: Currently, close to 55% of the CAR T cell therapy market share is captured by Novartis and Gilead Sciences as both the companies have one and two approved CAR-T cell therapies, respectively, in the market.

Question 6: How many clinical trials are running for CAR-T therapies?

Answer: As of March 2022, there were more than 600 active trials for CAR T-cell therapies. Of these active trials, more than 50% trials are being conducted in Asia-Pacific.

Question 7: What kind of partnership models are commonly adopted by players in CAR-T industry?

Answer: 50% agreements signed in the domain of CAR T-cell therapy were related to licensing and R&D agreements. In addition, more than 30 agreements were inked for the product development and commercialization of CAR-T therapies.

Question 8: How much funding has been raised in the CAR T-cell therapy market?

Answer: In the year 2021, CAR T-cell therapy developers raised USD 4 billion. In terms of type of funding, a number of players developing CAR T cell therapy have managed to secure significant capital amounts through secondary offerings.

Question 9: How is the intellectual property landscape for global CAR T-cell therapy likely to evolve in the foreseen future?

Answer: A number of patents have been filed by several companies / organizations in order to protect novel intellectual property generated within this field, with majority of the patents (35%) filed / granted in Asia-Pacific. The trend is likely to continue due to extensive involvement of academic institutes based in China in the CAR T cell therapy product and technology development.

Question 10: Who are the key CAR T cell therapy CMOs?

Answer: Some of the key T-cell therapy CMOs include (in alphabetical order) BioNTech, CELLforCure, Cell and Gene Therapy Catapult, Cellular Biomedicine Group, Cellular Therapeutics, Lonza, MaSTherCell, Oxford BioMedica and WuXi AppTec.

Question 11: What are the key promotional strategies used by CAR T cell therapy companies having marketed products?

Answer: Promotional messages for all the therapies are primarily focused on the treatment process, dosing and route of administration. Detailed analysis for promotional strategies for the marketed CAR-T therapies is available in the report.

Question 12: What is the outlook for CAR T therapy?

Answer: CAR T therapies are promising class of immunotherapy, that have provided late line of treatment option for some of the leading hematological cancers. The pipeline is wide, with currently approved CAR-Ts also being tested for second-line of treatment. These approvals will lead the market growth in the near future, with long-term CAR T cell therapy market growth driven by new approvals and improved access of these therapies across the world.