T-Cell Immunotherapies Market (4th Edition), 2019-2030

NEW YORK, July 25, 2019 /PRNewswire/ --

INTRODUCTION
The cancer therapeutics market is considered to be one of the most active segments within the pharmaceutical industry. In the past five years, the USFDA has approved more than 100 drugs for the treatment of different types of cancer. However, there is still a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. It is also worth highlighting that, in the coming years, the number of cancer patients is anticipated to increase substantially along with the growing global population. According to the International Agency for Research on Cancer (IARC), close to 17 million new cases of cancer were diagnosed in 2018, worldwide. By 2040, it is estimated that the aforementioned number is likely to grow to 27.5 million. In fact, the global cancer burden is anticipated to increase by 70% in the next 20 years.



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Among the current initiatives focused on developing targeted anti-cancer therapies, T-cell therapies (specifically CAR-T, TCR and TIL therapies) have emerged as a promising option owing to their capability to eradicate tumor cells from the body with minimal treatment-related side effects. These adoptive T-cell therapies (ACT) are based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. With the recent approval of KYMRIAH® (Novartis) and YESCARTA® (Gilead Sciences) for the treatment of CD19-positive relapsed / refractory leukemias and lymphomas, such ACTs have become a part of mainstream healthcare solutions.

Encouraging clinical trial results and therapeutic response rates achieved across various hematological cancers and solid tumors have further inspired research groups to focus their efforts on the development of these novel therapies. So far, more than 150 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential therapy candidates. In fact, multiple collaborations have been inked in the past decade between various therapy developers and academic / research institutes to advance the development of various pipeline candidates. The ongoing research activity in this field has also led to the discovery of several novel molecular targets. Further research and characterization of the aforementioned targets have significantly strengthened the research pipelines of companies engaged in this market. Driven by the availability of innovative technology platforms, lucrative funding and encouraging clinical trial results, the T-cell immunotherapies market is poised for success in the long-run as multiple product candidates are expected to be approved over the coming decade.

SCOPE OF THE REPORT
The "T-Cell Immunotherapy Market, 2019-2030 (4th edition)" report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies (focusing particularly on CAR-T therapies, TCR therapies and TIL therapies). The report highlights the efforts of both industry players and academic organizations. Amongst other elements, the report features the following:
An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers.
A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of therapy, type of developer (industry / non-industry), phase of development, target therapeutic indication(s), key target antigen(s), source of T-cells (autologous / allogenic), and route of administration. In addition, we have provided an overview of the competitive landscape, key challenges and anticipated future trends associated with CAR-T, TCR and TIL-based therapies.
Comprehensive 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 the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector and type of co-stimulatory domain used.
A detailed analysis highlighting several key opinion leaders (KOLs) in this domain. It features a 2X2 analysis to assess the relative experience of certain KOLs, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of T-cell therapies.
An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China.
An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity offered by oncological and non-oncological disease indications.
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. Further, it includes a relative competitiveness analysis of different T-cell immunotherapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.
An analysis of the partnerships that have been established in the recent past, covering 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.
A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs. It presents a detailed analysis of the approved / pipeline products in this domain, including information on the 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 list of contract service providers and in-house manufacturers that are 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 that have been adopted by the developers of the marketed T-cell therapies, namely KYMRIAH® and YESCARTA®.

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 parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report includes potential sales forecasts of T-cell immunotherapies that are currently marketed or are in late stages of development. Additionally, it provides forecasts 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) and [D] key geographies (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individualss:
Tim Oldham (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 (Director, Process Development, Iovance Biotherapeutics)
Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
Aino Kalervo (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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry 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. Where 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
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

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 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 provides insights on the popularity of T-cell immunotherapies on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2012-2019, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter highlights the most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers.

Chapter 5 provides information on around 650 T-cell immunotherapies that are currently approved or are in different stages of development (clinical and preclinical / discovery). It features a comprehensive analysis of pipeline molecules with respect to the type of therapy (CAR-T, TCR and TIL), type of developer(s), phase of development, target therapeutic area(s) and indication(s), key target antigen(s), source of T-cells (autologous / allogenic) and route of administration. Further, the chapter features the most active players (in terms of number of pipeline candidates) and a logo landscape, highlighting product developers in North America, Europe and the Asia Pacific region.

Chapter 6 presents a collection of key insights derived from the study. It includes a bubble analysis, highlighting the most popular targets of CAR-T and TCR therapies in hematological cancer and solid tumor space. To offer due credit to the work of eminent researchers in this domain, we have mapped the presence of key opinion leaders (who are involved in this field of research) across the globe. In addition, we have presented an analysis of the CAR constructs being used in the clinical CAR-T therapies on the basis of generation of CAR-T therapy, type of binding domain, type of vector and type of co-stimulatory domain.

Chapter 7 presents an analysis of the CAR-T clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend and the distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies market in China.

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 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 10 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 11 identifies the most commonly targeted therapeutic indications, including hematological cancers and solid tumors and features brief discussions on the T-cell therapies being developed against them. The section also highlights key epidemiological facts and the currently available treatment options for each indication.

Chapter 12 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. Further, it includes a competitiveness analysis of different T-cell immunotherapy-based gene editing platforms, based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.

Chapter 13 features an elaborate discussion and 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 14 provides details on the various investments and grants that have been awarded to players 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 2019, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 15 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 the 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 16 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. It includes a 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 17 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 18 features an elaborate discussion on the future commercial opportunity offered by T-cell therapies. It provides a comprehensive market forecast analysis for molecules 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) and [D] key geographies (North America, Europe and Asia Pacific).

Chapter 19 highlights the key promotional strategies that are being implemented by the developers of the marketed products, KYMRIAH® and YESCARTA®. 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 20 includes brief company profiles of the leading players in the T-cell immunotherapy market. 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 21 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 22 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 (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 (Director, Process Development, Iovance Biotherapeutics), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Aino Kalervo (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 23 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 24 is an appendix, which contains the list of companies and organizations mentioned in the report.

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