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Global T-Cell Therapy Market - Distribution by Type of Therapy, Target Indications, Target Antigens, Key Players and Key Geographies : Industry Trends and Global Forecasts, 2022-2035

Global T-Cell Therapy Market - Distribution by Type of Therapy, Target Indications, Target Antigens, Key Players and Key Geographies : Industry Trends and Global Forecasts, 2022-2035

  • August 2022
  • 1180 pages
  • ID: 6316297
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Cancer is known to be one of the leading causes of deaths worldwide. In fact, as per the WHO, close to 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 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. In this context, immunotherapies, a relatively recent addition to the gamut of anticancer interventions, have demonstrated significant promise. Amidst the current initiatives undertaken to develop more targeted anti-cancer therapies, T-cell therapies (specifically CAR-T, TCR and TIL therapies) have emerged as a promising option, owing to their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Overall, this highly specific and promising form of 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. A number of chimeric antigen receptor T-cell (CAR-T) therapies have so far been evaluated and 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). It is worth mentioning that, recently, KIMMTRAK® (Immunocore) became the first T-cell receptor (TCR) therapy to receive approval from the USFDA.

Presently, more than 250 companies are engaged in the development of more than 1,200 early and late-stage T-cell therapies, worldwide. 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 6,800 patents related to CAR-T, TCR and TIL therapeutics have been recently filed / granted, demonstrating the continued innovation in this domain. In addition, close to 440 collaborations have been inked between industry / academic stakeholders to advance the development of various pipeline candidates. Moreover, to fund product development initiatives in this domain, capital investments worth USD 30 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 T-cell immunotherapy market is anticipated to witness substantial growth in the mid to long-term.

SCOPE OF THE REPORT
The “Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (6th Edition) - Distribution by Type of Therapy (CAR-T, TCR and TIL), Target Indications (Acute Lymphoblastic Leukemia, Non-Hodgkin’s Lymphoma, Melanoma, Bladder Cancer, Lung Cancer, Head and Neck Cancer, Multiple Myeloma, Sarcoma, Chronic Lymphocytic Leukemia, Ovarian Cancer, Esophageal Cancer, Colorectal Cancer, Nasopharyngeal Carcinoma, Hepatocellular Carcinoma, Acute Myeloid Leukemia and Renal Cell Carcinoma), Target Antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-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 T-cell immunotherapies. The report highlights the efforts of several stakeholders engaged 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 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, CD22, CD20, Meso, CD7, HER2, GPC3, GD2, CD123, MUC, EGFR and CD38), 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-Ts, TCRs and TIL, 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-Ts, TCRs and TILs, considering them to be KOLs, who are actively involved in R&D of 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.
A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers, and a relative competitiveness analysis of different gene editing platforms (used for the development of T-cell therapies), based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.
An analysis of various type of partnership that have been inked between several stakeholders in the domain of 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 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-Ts, TCRs and TILs, 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.
A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs, including a detailed analysis of approved / pipeline products, featuring information on current phase of development, target therapeutic area(s), type of T-cells used and source of T-cells.
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 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 T-cell immunotherapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T, TCR and TIL 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 T-cell immunotherapies over the coming decade. Based on several relevant 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 T-cell immunotherapies that have been already commercialized or are in the late stages of development. Additionally, it features market size projections for the overall T-cell immunotherapies market, wherein both the current and upcoming opportunity is segmented across [A] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others), [D] key players and [E] key geographies (North America, Europe, Asia Pacific, 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.

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 T-cell immunotherapies (specifically CAR-Ts, TCRs and TILs)?
What kind of clinical conditions can be treated using T-cell immunotherapies?
Who are the leading industry and non-industry players in this market?
In which geographies extensive research on T-cell immunotherapy is being conducted?
What kind of partnership models are commonly adopted by industry stakeholders?
Who are the key investors in T-cell immunotherapy domain?
Who are the key opinion leaders / experts from renowned academic and research institutes who can help drive product development efforts in this domain?
How is the intellectual property landscape for global T-cell therapies likely to evolve in the foreseen future?
Who are the key service providers (CMOs / CDMOs) with capabilities to develop and manufacture T-cell therapies?
What are the key factors that are likely to influence the evolution of the 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 is an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the T-cell immunotherapy market in the short to mid-term and long term.

Chapter 3 provides a general overview of 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 T-cell based therapies and the challenges associated with such therapies. Moreover, it features detailed sections on the three major types of T-cell immunotherapies, namely CAR-T, TCR and TIL-based therapies, which are the main focus of the study.

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, CD22, CD20, Meso, CD7, HER2, GPC3, GD2, CD123, MUC, EGFR and CD38), 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 includes detailed assessment of the current market landscape of more than 190 TCR-based therapies that are currently approved or are in different stages of 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 II, phase I / II, phase I, clinical (phase unknown), preclinical), therapeutic area (oncological disorders, non-oncological disorders and undisclosed), key target indication (lung cancer, melanoma, hepatocellular carcinoma, cervical cancer, ovarian cancer, sarcoma, breast cancer, gastric cancer, multiple myeloma, pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome and nasopharyngeal carcinoma), key target antigen (NY-ESO-1, MAGE, HBV, PRAME, KRAS, EBV, HPV, Neoantigen, LAGE-1a, Meso and HLA), source of T-cells (autologous and allogeneic), route of administration (intravenous and intratumoral), 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 TCR-based 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 6 includes detailed assessment of current market landscape of more than 75 TIL-based therapies that are currently in different stages of development. Additionally, it features a comprehensive analysis of pipeline molecules with respect to the type of developer (industry and non-industry), phase of development (phase III, phase II, phase I / II, phase I, clinical (phase unknown), preclinical), therapeutic areas (oncological disorders, non-oncological disorders), key target indications (melanoma, ovarian cancer, cervical cancer, lung cancer, pancreatic cancer, sarcoma, breast cancer and squamous cell carcinoma ), source of T-cells (autologous and allogeneic), route of administration (intravenous and hepatic arterial infusion), dose frequency (single dose and multiple doses), patient segment (children, adults, and seniors), and type of therapy (monotherapy and combination therapy). Further, it highlights the most active industry and non-industry players (in terms of number of pipeline candidates) engaged in the development of TIL-based therapies. The chapter also features an analyses on the developers landscape based on some relevant parameters, including year of establishment, company size (in terms of number of employees), and location of headquarters ( North America, Europe and Asia-Pacific).

Chapter 7 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 8 presents a detailed analysis of completed, ongoing and planned clinical studies related to CAR-Ts, TCRs and TILs, 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 9 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-Ts, TCRs and TILs, considering them to be KOLs, who are actively involved in R&D of 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 10 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 11 provides detailed profiles of the mid to late stage TCR therapies. 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 12 provides detailed profiles of the mid to late stage TIL therapies. 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 13 provides a list of technology platforms that are either available in the market or under designed for the development of T-cell immunotherapies. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers, and a relative competitiveness analysis of different gene editing platforms (used for the development of T-cell therapies), based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.

Chapter 14 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 15 provides details on the various investments and grants that have been awarded to several stakeholders focused on the development of T-cell immunotherapies. 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 16 provides an in-depth analysis of patents related to CAR-Ts, TCRs and TILs, 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 17 features details of other novel T-cell based therapies, apart from CAR-Ts, TCRs and TILs, which are currently being investigated. It presents a detailed analysis of the approved / clinical products in this domain, including information on current phase of development, target therapeutic areas, type of cells, and source of T-cells. Additionally, we have provided a brief overview of the upcoming therapies, along with details on their mechanisms of action.

Chapter 18 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 19 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 T-cell based immunotherapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for T-cell immunotherapies and a case study on the National Institute for Health and Care Excellence (NICE) appraisal of CAR-T therapy.

Chapter 20 features an elaborate discussion on the future commercial opportunity offered by T-cell therapies. It provides a comprehensive market forecast analysis for 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] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others), [D] key players and [E] 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 21 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 22 includes brief company profiles of the leading players in the domain of T-cell immunotherapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T, TCR and TIL 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.

Chapter 23 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 24 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 Tim Oldham (Former Chief Executive Officer, Cell Therapies), Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics, Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Miguel Forte (Chief Operating Officer, TxCell), Adrian Bot (Vice President, Scientific Affairs, Kite Pharma), Vincent Brichard (Vice President, Immuno-Oncology, Celyad), Peter Ho (Former Director, Process Development, Iovance Biotherapeutics), 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 25 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 26 is an appendix, which contains the list of companies and organizations mentioned in the report.

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