Global CAR-T Cell Therapy Market (4th Edition), 2022-2035

Global CAR-T Cell Therapy Market (4th Edition), 2022-2035

The cancer is the 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 CAR-T cell treatment, 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 therapeutic segment is on its way to becoming one of the highest valued markets within the biopharmaceutical industry.

At present, more than 5 CAR-T therapies have been approved for several hematological malignancies, including KYMRIAH® (Novartis), YESCARTA® (Gilead Sciences), TECARTUS™ (Gilead Sciences), Breyanzi® (Bristol Myers Squibb), Abecma™ (Bristol Myers Squibb) and CARVYKTI™ (Janssen Biotech / Legend Biotech). In fact, more than 170 companies are engaged in the development of over 970 early and late-stage CAR-T cell therapies, worldwide. Moreover, several promising leads are anticipated to be commercially launched over the coming decade, following which the market is projected to grow at a substantial pace. Over 6,500 patents related to CAR-T cell therapies have been recently filed / granted, demonstrating the continued innovation in this domain. In addition, more than 260 collaborations have been inked between several industry / academic stakeholders in order to advance the development of various pipeline candidates. To fund product development initiatives, capital investments worth more than USD 24 billion have been made by various private and public sector investors, in the last few years. 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 is likely to witness significant growth in the foreseen future.

The “CAR-T Cell Therapy Market (4th Edition) by 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 landscape and the future potential of CAR-T cell 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-cell immunotherapies 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 therapies. 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 cell 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 companies that have proprietary CAR-T cell-based products / 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 cell based immunotherapy 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 cell 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 existing 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] 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), [B] target antigens (CD19, BCMA, CD19 / CD22 and others), Key Players and [C] 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 report are in USD, unless otherwise specified.

MARKET SEGMENTATIONS

Global CAR-T cell Therapies: Market Segmentations

Market Segments Details

Forecast Period 2022 – 2035

Target Indications Non-Hodgkin Lymphoma

Multiple Myeloma

Acute Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Hodgkin 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 Geographical Regions North America

Europe

Asia-Pacific

MENA

Latin America

Rest of the World

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in this domain (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

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

KEY QUESTIONS ANSWERED

What are the prevalent R&D trends related to CAR-T cell therapies?

Which different types of clinical conditions can be treated using CAR-T cell therapies?

Who are the leading industry and non-industry players in this market?

In which geographies, extensive research on CAR-T cell therapy is being conducted?

What kind of partnership models are commonly adopted by industry stakeholders?

Who are the key investors in the CAR-T cell immunotherapy domain?

Who are the key opinion leaders / experts from renowned academic and research institutes which can help drive product development efforts in this domain?

How is the intellectual property landscape for global CAR-T cell therapies likely to evolve in the foreseen future?

Who are the key service providers (CMOs / CDMOs) with capabilities to develop and manufacture CAR-T cell therapies?

What are the key factors that are likely to influence the evolution of the CAR-T cell immunotherapies market?

How is the current and future market opportunity likely to be distributed across key market segments?

What are the key promotional strategies used by companies having marketed products?

CHAPTER OUTLINES

Chapter 2 provides an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the CAR-T cell therapy market in the short to mid-term and long term.

Chapter 3 provides a general overview of CAR-T cell immunotherapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes a discussion on the advent and historical evolution of cancer immunotherapy, general manufacturing procedure of T-cell immunotherapies, factors supporting the growing popularity of CAR-T cell-based therapies and the challenges associated with such therapies.

Chapter 4 includes detailed assessment of the current market landscape of more than 970 CAR-T cell therapies that are currently approved or are in different stages of the development. It features a comprehensive analysis of pipeline molecules with respect to the 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, CD19/22, EGFR, 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 development of CAR-T cell therapies. 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).

Chapter 5 presents a collection of key insights derived from the study. It includes a bubble analysis, highlighting the most 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.

Chapter 6 presents 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.

Chapter 7 presents an 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 cell 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.

Chapter 8 provides detailed profiles of marketed and mid to late stage CAR-T therapies (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.

Chapter 9 features an analysis of the various collaborations and partnerships that have been inked amongst players in this market, in the past few years. Further, the partnership activity in this domain has been analyzed on the basis of the type of partnership model (R&D collaborations, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements and others), companies involved, type of therapy, prominent product candidates involved and regional distribution of the collaborations.

Chapter 10 provides details on the various investments and grants that have been awarded to several stakeholders focused on the development of CAR-T cell therapies. It includes a detailed analysis of the funding instances that have taken place in the period between 2000 to 2020, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 11 provides 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, 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.

Chapter 12 provides insights on cell therapy manufacturing, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining cell therapy manufacturing sites. Additionally, it includes a detailed list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house manufacturing capabilities. For the players mentioned in the chapter, we have included details on location of various manufacturing facilities, the products being manufactured, scale of operation and compliance to cGMP standards.

Chapter 13 highlights our views on the various factors that must be taken into consideration while deciding the prices of cell-based therapies. It features discussions on different models / approaches that a pharmaceutical company may choose to follow to decide the price at which their CAR-T cell-based immunotherapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for CAR-T cell immunotherapies and a case study on the National Institute for Health and Care Excellence (NICE) appraisal of CAR-T therapy.

Chapter 14 features an elaborate discussion on the future commercial opportunity offered by CAR-T cell therapies. It provides a comprehensive market forecast analysis for CAR-T cell products that are approved or are in phase I/II, phase II and phase III of development, taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price of different therapies. The chapter also presents a detailed market segmentation on the basis of [A] 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), [B] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, and others) and [C] 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).

Chapter 15 highlights the key promotional strategies that are being implemented by the developers of the approved CAR-T Cell therapies (Kymriah®, Yescarta®, Tecartus™, Breyanzi®, Abecma™, Carvykti™) and TCR-based therapies (Kimmtrak®). The promotional aspects covered in the chapter include details that are provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings and informative downloadable content.

Chapter 16 includes brief company profiles of the leading players in the domain of CAR-T cell immunotherapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T cell therapies, technology portfolio (if available), recent developments related to CAR-T cell immunotherapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

Chapter 17 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 18 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with 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) and Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.