T-Cell Immunotherapy Market (2nd Edition), 2017-2030

NEW YORK, Feb. 6, 2017 /PRNewswire/ --

INTRODUCTION
The concept of immunotherapies dates back to the 18th century; however, since inception, the field has evolved tremendously and is currently cited as one of the most rapidly growing segments of the pharmaceutical industry. Harnessing immune system components for developing therapeutic solutions has demonstrated significant clinical benefit for various diseases areas, specifically against a number of oncological indications. Immunotherapeutics have gradually gained a strong foothold in the pharmaceutical industry. Post the early success of immune checkpoint inhibitors, T-cell immunotherapy has emerged as another innovative and potent arm of this market.

Adoptive immunotherapy is an emerging concept that involves the passive transfer of immune cells, which may or may not be modified / genetically altered to express a desired set of traits and / or features. Characterized by key features such as target specificity, adaptability and the capability to retain immunologic memory, T-cells have been effectively used as therapeutic tools to mediate an artificial immune response. More specifically, T-cell immunotherapies are classified into three major segments, namely chimeric antigen receptor (CAR) T-cell, T-cell receptor (TCR) and tumor infiltrating lymphocyte (TIL) based therapies. Academicians across the globe have significantly contributed to this field by convening the initial research on potential product candidates; this has served as the intellectual framework for establishment of several start-ups and evolution of the product portfolios of established players in the industry.

The overall market is expected to witness a significant growth in opportunities for a variety of stakeholders in the coming decade. It is important to highlight that various technology providers, aiming to develop and / or support the development of T-cell immunotherapy products with improved efficacy and safety, have designed and introduced advanced platforms for engineering of T-cells. Innovation in this domain, backed by lucrative rounds of venture capital (VC) funding, has led to the discovery of several novel molecular targets and strengthened the research pipelines of companies focused in this space. The capability to target diverse therapeutic areas is amongst the most prominent growth drivers of this market.

SCOPE OF THE REPORT
The "T-Cell Immunotherapy Market, 2017-2030 (2nd edition)" report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies. Immuno-oncology has been gradually nurtured by researchers over the last several years and is now considered as the fourth major pillar of cancer therapy, after surgery, chemotherapy and radiotherapy. As indicated earlier, the T-cell therapy market has evolved significantly over the last few years, offering promising opportunities for a variety of stakeholders. The domain is characterized by a robust and opportunistic pipeline of product candidates focused on targeting hematological cancers and solid tumors. However, with no marketed products, this emerging field is still in its infancy. The report provides a comprehensive overview of the market, focusing particularly on CAR-T therapies, TCR therapies and TIL therapies.

The role of academic players / research institutes has been critical in this domain. Post the establishment of initial proof-of-concept, several industry players have entered into collaboration with non-industry participants to fund the clinical and commercial development of potential product candidates. Some late stage products that have emerged out of such collaborations include CTL-019 (Novartis / University of Pennsylvania), KTE-C19 and HPV-16 E6 TCR (Kite Pharma / National Cancer Institute), and LN-144 (Lion Biotechnologies / National Cancer Institute). As mentioned before, encouraging clinical results have significantly accelerated the progress of these therapies.

Several technology providers, especially those with capabilities in genome editing, and viral and non-viral gene transfer, are also actively involved in this emerging market. Many of these players have entered into partnerships with therapy developers in order to assist in designing novel features to enhance the efficacy and potency of existing T-cell therapies. A prominent example of such a technology is safety switches; these are innovative molecular tools designed to manage known side effects, such as cytokine release syndrome and B-cell aplasia, by allowing control over the expression of certain genes in the engineered cell population.

One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing programs of both small and big pharmaceutical firms in this domain. It is worth mentioning that there is a lot of hope pinned on multiple start-ups, which have received significant backing by several strategic investors and venture capital firms. Amongst other elements, the report elaborates on the following areas:
- The current state of the market with respect to key players, developmental stages of pipeline products (both clinical / preclinical) and target therapeutic indications. In addition, we have also provided an overview of the competitive landscape, key challenges and anticipated future trends within the three major types of T-cell based therapies.
- Detailed profiles of candidate therapies that are in the mid to late stages of development (phase I/II or above).
- The partnerships that have been established in the recent past, covering research and development collaborations, manufacturing agreements, license agreements specific to technology platforms, product development / commercialization agreements, clinical trial collaborations and joint venture agreements.
- Details of innovative technological platforms, such as safety switches, which have contributed significantly in overcoming existing gaps in the therapeutic regimen.
- An analysis of the various investments, grants and other types of funding provided to companies focused in this area.
- An overview of the various therapeutic areas being addressed by therapy developers, including an assessment of the opportunity offered by both oncological and non-oncological disease indications.
- A discussion on the emerging trends on social media and on the popularity of T-cell immunotherapy products on Twitter over the last few years.
- Details on novel T-cell immunotherapies that are being investigated, along with their respective mechanisms of action.
- A detailed case study on the manufacturing of cell therapy products, highlighting key challenges and a list of contract service providers and in-house manufacturers that are involved in this space.
- A discussion on the development and sales potential based on target consumer segments, likely adoption rates and expected pricing based upon different models / approaches.

With most products still in the early stages of clinical development, we have provided informed estimates of the potential future sales of different CAR-T, TCR and TIL therapies. The research, analysis and insights presented in this report are backed by a deep understanding of the key drivers behind the predicted growth. We have provided three market forecast scenarios to add robustness to our model. More specifically, the conservative, base and optimistic forecast scenarios represent three different tracks of the industry's evolution, taking into account the ambiguities associated with the development and approval of pharmaceutical products. All actual figures have been sourced from publicly available information. All figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
Most of 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, 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. Where possible, the available data has been checked for accuracy from multiple sources of information. The various secondary sources of information that we use include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' viewsWhile the focus has been on forecasting the market over the coming ten years, the report also provides our view on various technological and 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 presents an executive summary of the report. It offers a high level view on where the T-cell immunotherapy market is headed in the mid-long term.

Chapter 3 provides a general introduction to T-cell immunotherapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of oncological indications, the advent of cancer immunotherapy and the factors supporting the growing popularity of T-cell based therapies.

Chapter 4 provides a comprehensive overview of the current landscape of the T-cell immunotherapy market. It features information on various types of therapies that are currently in different stages of development (clinical and preclinical / discovery). It includes a detailed analysis of the T-cell immunotherapy pipeline, specifically, providing information on the most commonly targeted disease indications, current phases of development of individual therapies, specific molecular targets, type of developer(s) and the key companies involved in the development of different types of T-cell therapies, namely CAR-T, TCR and TIL.

Chapter 5 focuses on CAR-T cell based therapies and highlights the prevailing trends pertaining to the ongoing research in this field. It discusses the molecular targets that are currently under investigation, the current challenges in this domain, such as toxicity issues, and other relevant parameters. To offer due credit to the work of eminent researchers in this domain, we have mapped the locations of key opinion leaders across the globe. This section also includes detailed profiles of the late stage therapies that are under development. Each profile features a general overview of the therapy and provides information on additional aspects, such as the history of development, clinical trial timeline, clinical trial results, manufacturing information, estimated cost of treatment and details on the treatment regimen itself.

Chapter 6 focuses on TCR cell based therapies and highlights the prevailing trends pertaining to the ongoing research in this field. It discusses the molecular targets that are currently under investigation, the current challenges in this domain, such as toxicity issues, and other relevant parameters. To offer due credit to the work of eminent researchers in this domain, we have mapped the locations of key opinion leaders across the globe. This section also includes detailed profiles of the late stage therapies that are under development. Each profile features a general overview of the therapy and provides information on additional aspects, such as the history of development, clinical trial timeline, clinical trial results, manufacturing information, estimated cost of treatment and details on the treatment regimen itself.

Chapter 7 elaborates on the TIL based therapies and highlights the prevailing trends pertaining to the ongoing research in this field. To offer due credit to the work of eminent researchers in this domain, we have mapped the locations of key opinion leaders across the globe. This section also includes detailed profiles of the late stage therapies that are under development. Each profile features a general overview of the therapy and provides information on additional aspects, such as the history of development, clinical trial timeline, clinical trial results, manufacturing information, estimated cost of treatment and details on the treatment regimen itself.

Chapter 8 features an elaborate discussion on the future opportunity presented by T-cell therapies. It provides a comprehensive market forecast analysis for molecules that are in the advanced stages of development (phase I/II, phase II and phase II/III), taking into consideration the target patient population, existing competition, likely adoption rates and the likely price of T-cell therapies.

Chapter 9 provides an analysis of the various T-cell therapies that are being developed for the treatment of commonly targeted indications, including hematological cancers and solid tumors. It is worth mentioning that the aforementioned types of oncological indications have been the prime focus of companies developing T-cell immunotherapies. The section also highlights key epidemiological facts and the currently available treatment solutions for each indication.

Chapter 10 focuses on emerging technological platforms that mediate / assist the growth of the T-cell market. It includes detailed discussions on various novel and innovative technologies, along with brief information about key technology providers.

Chapter 11 provides an overview of the emerging trends related to T-cell immunotherapy on social media. It includes data representing the popularity of T-cell products on Twitter over the last five years.

Chapter 12 presents a detailed analysis on the partnerships and agreements established between various players concerning T-cell immunotherapies in the past few years. The section also highlights the financial details of the agreements (wherever available). The partnership activity in this domain has been analyzed on the basis of the year of establishment of the company, the type of partnership model employed, the companies involved, therapy type and prominent product candidates involved.

Chapter 13 provides details on the various investments and grants awarded to players focused on the development of T-cell immunotherapies. The analysis highlights the growing interest of the VC community and other strategic investors in this domain.

Chapter 14 offers details of other novel T-cell based technologies, apart from CAR-Ts, TCRs and TILs, which are currently being investigated. We have provided a brief overview of these upcoming therapies, along with details of their mechanisms of action and the process followed for dose administration.

Chapter 15 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 these players, we have included details, such as the scale of operation, compliance to cGMP standards, location of various manufacturing facilities and the products being manufactured.

Chapter 16 highlights our view point on the various factors that must be considered while pricing the cell based therapies. It features discussions on different models / approaches that a pharmaceutical company can follow to decide the price at which their T-cell based immunotherapy product is likely to be marketed.

Chapter 17 includes detailed company profiles of the leading players in the T-cell immunotherapy market. Each company profile includes information such as financial performance, geographical presence, T-cell immunotherapy pipeline, collaborations and recent developments. Additionally, we have also provided details of the strategic / venture capital investments made in these companies.

Chapter 18 is a collection of transcripts of interviews conducted during the course of this study. In this chapter, we have presented the details of our conversations with Vincent Brichard (Vice President, Immuno-Oncology, Celyad), Peter Ho (Director, Process Development, Lion Biotechnologies), Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys), Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) and Miguel Forte (Chief Operating Officer, TxCell).

Chapter 19 summarizes the entire report. Here, we have provided a list of key takeaways and our independent opinion on the current state and future opportunity in this field.

Chapter 20 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 21 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

EXAMPLE HIGHLIGHTS
1. During the course of our research, we identified around 280 T-cell therapies being evaluated across various phases of development. Among these, CAR-T cell products are the most common (67%), followed by TCR (23%) and TIL (10%) based therapies.
2. Overall, 29% of the pipeline therapies are being evaluated in phase II / phase III clinical trials; on the other hand, 38% of the therapies are in the preclinical / discovery stage of development. Examples of promising late-stage therapies include CTL-019 (Novartis), JCAR015 (Juno Therapeutics), KTE-C19 and HPV-16 E6 TCR (Kite Pharma), NY-ESO-1 TCR (Adaptimmune / GSK), LN-144 (Lion Biotechnologies), ALT801 (Altor BioScience) and IMCgp100 (Immunocore).
3. Academic institutions are the leading innovators in this domain. Many universities and research institutes have made significant contributions by investing time and building expertise in the design and development of novel CAR-Ts, TCRs and TILs. We observed that non-industry players are involved in the development of around 50% of all the therapies currently in the pipeline. The most active non-industry players (based upon the number of therapies under development) include the National Cancer Institute, MD Anderson Cancer Center, Baylor College of Medicine, University of Pennsylvania, Chinese PLA General Hospital, Southwest Hospital, Fred Hutchinson Cancer Research Center, Fuda Cancer Hospital, Memorial Sloan Kettering Cancer Center, Uppsala University and City of Hope Medical Center.
4. The market is highly fragmented and characterized by the presence of several start-ups, small pharma and big pharma firms. The key players involved in development of T-cell therapies (based upon the number of candidate therapies in their respective product pipelines) include Juno Therapeutics, Shanghai Genechem, Kite Pharma, Cellular Biomedicine Group, Lion Biotechnologies, Takara Bio, Celgene, Adaptimmune and ZIOPHARM Oncology. AURORA BioPharma, Beijing Doing Biomedical, Bellicum Pharmaceuticals, CARsgen Therapeutics, iCarTAB BioMed, Intrexon, Mustang Bio, Novartis, Sinobioway Cell Therapy, Unum Therapeutics and Shionogi are other players that have more than one clinical stage therapies.
5. In addition to some of the companies outlined above, there are several other start-ups that are focused in this domain; these include (in alphabetical order) Altor BioScience, Autolus, Adicet Bio, Catapult Therapy TCR, Chimeric Therapeutics, Formula Pharmaceuticals, Gadeta, Immatics US, JW Biotechnology, Lion TCR, Leucid Bio, Mustang Therapeutics, Poseida Therapeutics, TILT Biotherapeutics, TNK Therapeutics, Tmunity Therapeutics and Vor Biopharma.
6. Stakeholders have forged synergistic partnerships in order to exploit the commercial potential of their respective assets. Overall, we identified more than 135 partnerships that have been inked in the T-cell immunotherapy field over the period 2005-2016. Most common forms of partnerships were related to research (20%), followed by technology licensing (15%), product discovery, development and commercialization (12%), manufacturing (11%), clinical trials (7%) and acquisitions (7%).
7. Amidst several challenges, including the complexities associated with manufacturing cell-based products, and competition from existing drug / therapy classes (such as monoclonal antibodies, bi-specific antibodies and immune checkpoint inhibitors), therapy developers are engaged in extensive research in order to effectively deal with these issues. Several contract manufacturing organizations with advanced capabilities have emerged to provide manufacturing services for the personalized T-cell based therapies. Examples of the CMOs providing manufacturing services for T-cell therapies include apceth Biopharma, Atlantic Bio GMP, Cell and Gene Therapy Catapult, Cell Therapies, CELLforCURE, Cellular Therapeutics, MolMed and PCT (a Caladrius company).
8. A number of technological advancements have taken place in order to support the development of these therapies; engineered CAR-Ts with switch technologies are amongst the latest additions to next-generation T-cell immunotherapies. Funding from VC firms and strategic investors has been a key enabler to the market's growth. Notably, close to USD 5 billion has been invested in this domain over the past few years. Several big ticket investments have recently taken place. For instance, Juno Therapeutics raised USD 896.8 million in June 2015, Immunocore raised USD 320 million in July 2015, Kite Pharma raised USD 288 million in December 2015 and Cellectis raised USD 228 million in March 2015.
9. A variety of novel types of immunotherapies, other than CAR-T, TCR and TIL, are expected to emerge in the mid-long term. Companies such as TxCell, Caladrius Biosciences, TRACT Therapeutics, Green Cross Cell and Tmunity Therapeutics, are developing T-regulatory cell based therapies. Other players, namely Opexa Therapeutics, TVAX and Immunovative Therapies, are developing T-cell based vaccines for treating autoimmune disorders and various forms of cancer. Further, Atara Biotherapeutics, Cell Medica and Tessa Therapeutics are working on the development of virus-driven T-cell therapies. A number of companies have developed unique technology platforms based on T-cells. Examples include Targazyme (Fucosylated T-cells), Triumvira (TAC-T cells), Chengdu MedGenCell (PD-1 Knockout Engineered T-cells) and GammaCell Bio-Technologies (?? T-cells).
10. Overall, we believe the T-cell therapy market is likely to be worth USD 25 billion by 2030, expanding at an annualized growth rate of over 101% during this time period. Specifically, by 2030, the markets for CAR-T and TCR therapies market are likely to be worth over USD 11 billion each. Product candidates, such as KTE-C19, CTL019, NY-ESO-1 TCR, ALT 801 and JCAR017, are expected to emerge as potential blockbusters in the long term.

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