LONDON, August 22, 2018 /PRNewswire/ -- INTRODUCTION
Amidst the current initiatives to develop more targeted anti-cancer therapies, chimeric antigen receptor T-cell (CAR-T) therapy has emerged as a potent and viable therapeutic intervention to eradicate tumor cells, with minimal side effects. It is based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. There are certain key characteristics that render CAR-T cells suitable for use as effective therapeutic tools; these include target specificity, adaptability and the capability to retain immunologic memory.
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Close to 70 academic and research institutes across the globe have made significant contributions to this field, mostly by convening the initial research on potential product candidates. These efforts have built the intellectual framework for the establishment of several start-ups. The ongoing innovation has also led to the discovery of several novel molecular targets, strengthening the research pipelines of various companies engaged in this domain. Given the recent approval of two CAR-T therapies, namely Kymriah® (Novartis) and Yescarta® (Gilead Sciences), and a robust development pipeline, the CAR-T therapy market also offers considerable promise to a number of industry stakeholders.
SCOPE OF THE REPORT
The "CAR-T Therapy Market, 2018-2030" report features an extensive study of the current market landscape and the future potential of CAR-T therapies. One of the key objectives of the study was to review and quantify the future opportunities associated with the ongoing development programs of both small and big pharmaceutical firms. Amongst other elements, the report features the following:
• An analysis depicting prevalent and emerging trends related to CAR-T therapies as observed on the social media platform, Twitter. In addition to the yearly chatter trends, the analysis highlights the most frequently talked about product candidates as well.
• A detailed assessment of the current market landscape of CAR-T therapies with respect to type of developer (industry and non-industry), phase of development, target therapeutic indications, key target antigens, source of T-cells (autologous and allogenic), and route of administration (intravenous infusion and regional route).
• 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, history of development, current development status, key clinical trial results, details on administered dose, price and manufacturing process of the therapy (wherever available).
• An analysis of the CAR constructs of clinical stage therapies based on generation of CAR-T product (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector (lentivirus, retrovirus, mRNA electroporation, sleeping beauty and other vectors) and type of co-stimulatory domain used.
• An analysis of the CAR-T clinical trials registered across the world in the period between 2009 and 2018, highlighting the year wise trend and the geographical distribution.
• A detailed analysis highlighting the 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 CAR-T therapies.
• 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 CAR-T therapies, along with profiles of key technology providers.
• 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, featuring different models / approaches that a pharmaceutical company may choose to adopt to decide the price of its proprietary products that are 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 CAR-T therapies, Kymriah® and Yescarta®.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. The report includes information on (potential) sales-based revenues of CAR-T therapies that are currently marketed or are in late stages of development. Additionally, it presents detailed segmentation of the overall opportunity on the basis of geography (North America, Europe and Asia Pacific) and target indications (acute lymphoblastic leukemia, chronic lymphocytic leukemia, multiple myeloma, hepatocellular carcinoma and non-Hodgkin's lymphoma). 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 individuals:
• Adrian Bot (Vice President, Scientific Affairs, Kite Pharma)
• Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys)
• Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
• Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado)
• Miguel Forte (Chief Operating Officer, TxCell)
• Vincent Brichard (Vice President, Immuno-Oncology, Celyad)
• Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital).
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.
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 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 over the coming 12 years, the report also provides our independent 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 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 therapy market in the short to mid-term and long term.
Chapter 3 provides a general overview of CAR-T therapies. 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 conception and historical evolution of cancer immunotherapy, general manufacturing procedures used for the production of T-cell immunotherapies, factors supporting the growing popularity of T-cell based therapies and the challenges associated with such therapeutic options.
Chapter 4 focuses on CAR-T therapies and highlights the prevailing trends pertaining to the ongoing research in this field. It features details on the historical development of CAR-T products, such as the structure of CAR-T constructs (including information on all four generations of CAR-Ts), a discussion on the process of CAR-T development, molecular targets that are currently under investigation (for the development of such therapeutic products) and the current challenges (such as toxicity issues) that are associated with this therapy segment.
Chapter 5 provides insights on the popularity of CAR-T therapies on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2012-2017, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter showcases the most frequently mentioned keywords and drug candidates, as observed on social media.
Chapter 6 provides information on around 366 CAR-T cell therapies that are currently in different stages of development (clinical and preclinical / discovery). It features a comprehensive analysis of pipeline molecules with respect to the type of developer(s), phase of development, target therapeutic areas and disease indications, key target antigens, source of T-cells (autologous and allogenic) and route of administration (intravenous infusion and regional route). Further, the chapter identifies the most active players (in terms of number of pipeline candidates) and features a logo landscape representation, highlighting product developers in North America, Europe and the Asia Pacific region. In addition, it includes an analysis of the CAR constructs that are presently being used in clinical stage CAR-T therapies on the basis of generation of CAR product, type of binding domain, type of vector and type of co-stimulatory domain.
Chapter 7 presents a collection of key insights derived from the study. It includes a bubble analysis, highlighting the most popular targets of CAR-T therapies being developed against hematological cancers and solid tumors. Further, the chapter includes an analysis of global CAR-T trials that were registered in the time period between 2009 to 2018, featuring the year wise trend and distribution of CAR-T trials across different geographies. In addition, it includes a comprehensive analysis of close to 290 clinical trials (completed / ongoing) to evaluate CAR-T therapies with respect to the phase of development, patient segment (children, adults and senior citizens), and type of therapy (monotherapy and combination therapy). To offer due credit to the work of eminent researchers in this domain, we have also mapped the presence of key opinion leaders (who are involved in this field of research) across the globe.
Chapter 8 includes detailed profiles of approved / late stage CAR-T therapies. Each profile features a general overview of the therapy and provides information on its history of development, clinical trial timeline, clinical trial results, manufacturing process, estimated cost of treatment and treatment regimen details.
Chapter 9 highlights the most common therapeutic indications targeted by CAR-T therapies, and features brief discussions on the CAR-T therapies being developed against them. The section also highlights key epidemiological facts and the currently available treatment options for each indication.
Chapter 10 provides a list of technology platforms that are either available in the market or under development, for designing and / or manufacturing CAR-T therapies. It features brief profiles of some of the key technologies; each profile contains details on the various pipeline molecules that have been / are being developed using the technology, its advantages and the associated partnerships.
Chapter 11 provides insights on the cell therapy manufacturing process, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining such manufacturing sites. It includes a list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house capabilities. For all the players mentioned in this chapter, we have included details on location of manufacturing facilities, products manufactured, scale of operation and compliance to cGMP standards.
Chapter 12 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 considerations for T-cell immunotherapies and a case study on the National Institute for Health and Care Excellence (NICE) appraisal of CAR-T therapies.
Chapter 13 features an elaborate discussion on the commercial opportunity associated with CAR-T therapies. It provides a comprehensive market forecast analysis for therapies that are either already approved or are in the mid-phases of clinical development (phase I/II, phase II and phase III), 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 segmentation of the opportunity on the basis of geography (North America, Europe and Asia Pacific) and target indications (acute lymphoblastic leukemia, chronic lymphocytic leukemia, multiple myeloma, hepatocellular carcinoma and non-Hodgkin's lymphoma).
Chapter 14 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 15 includes brief company profiles of the leading players in the CAR-T therapy market. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T therapies, affiliated technology portfolio (if available), recent developments related to CAR-T therapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.
Chapter 16 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 17 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 Adrian Bot (Vice President, Scientific Affairs, Kite Pharma), Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Enkhtsetseg Purev (Assistant Professor Of Medicine, University Of Colorado), Miguel Forte (Chief Operating Officer, TxCell), Vincent Brichard (Vice President, Immuno-Oncology, Celyad) and Xian-Bao Zhan (Professor Of Medicine and Director, Department Of Oncology, Changhai Hospital).
Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 19 is an appendix, which contains the list of companies and organizations mentioned in the report.
1. Over 365 CAR-T therapies are presently being developed across various preclinical / clinical stages. Amongst these, two products, namely Kymriah® (Novartis) and Yescarta® (Gilead Sciences), were approved in 2017 for the treatment of acute lymphoblastic leukemia and large B-cell lymphoma, respectively.
2. More than 60% of the pipeline therapies are under clinical evaluation. Of the total number of clinical candidates, close to 100 CAR-T therapies are in the mid to late-stages of development (phase I/II and above) and are anticipated to enter the market in the next 5-10 years. Examples include bb2121 (bluebird bio / Celgene), MB-CART19.1 (Miltenyi Biotec / Shanghai Children's Medical Center), EPCAM CAR-T and CD19 CAR-T (Sinobioway Cell Therapy) and mixed CAR-T (Shanghai Unicar-Therapy Bio-medicine Technology / The First Affiliated Hospital of Soochow University).
3. More than 85% of the products in the development pipeline are being developed to treat various types of cancers, which include both hematological malignancies and solid tumors, including (in decreasing order of number of pipeline products) acute lymphoblastic leukemia (57), non-Hodgkin's lymphoma (50), multiple myeloma (29), chronic lymphocytic leukemia (28), pancreatic cancer (21), glioblastoma (20), hepatocellular carcinoma (18), breast cancer (16), acute myeloid leukemia (16) and lung cancer (15). Several therapy candidates are also being developed for other therapeutic areas, such as autoimmune disorders and infectious diseases.
4. Amongst the various CAR-T therapies, we observed that 36% are designed to target the CD19 receptor. Other molecular targets that are being investigated for therapy development include CD22, BCMA, Meso, CD20, GD2, CD30, HER1, HER2, EGFRvIII, MUC1, CD33, CD123, PSMA, GPC3, PD-L1, CEA, CD38, EPCAM and PSCA.
5. Over 100 companies, consisting of start-ups, small pharma and big pharma firms, are involved in the development of CAR-T therapies. The key players involved in development of CAR-T therapies (based on the number of candidate therapies in their respective pipelines) include Shanghai GeneChem, Juno Therapeutics, Marino Biotechnology, Cellular Biomedicine Group, Novartis, CARsgen Therapeutics, The Beijing Pregene Science and Technology, Shanghai Unicar-Therapy Bio-Medicine Technology and Celgene.
6. Academic institutions continue to drive the innovation in this domain; many universities and research institutes have played a critical role in the discovery, design and development of novel CAR-T therapies. Currently, around 55% of the pipeline therapies are being developed by academic players, either alone or in collaboration with industry players. The most active non-industry players (based upon the number of therapies under clinical development) include the Baylor College of Medicine (17), National Cancer Institute (13), Shenzhen Geno-immune Medical Institute (13), University of Pennsylvania (13), Southwest Hospital (11), Chinese PLA General Hospital (9), Memorial Sloan Kettering Cancer Center (7), Xinqiao Hospital of Chongqing (6), Peking University (6), Fuda Cancer Hospital (6), City of Hope Medical Center (5) and Sun Yat-sen University (5).
7. Several prominent scientists have made significant contributions in advancing clinical development efforts and, therefore, have emerged as key opinion leaders in this field. We observed that, so far, over 175 investigators, across various regions, have been involved in conducting numerous clinical trials focused on novel CAR-T therapies; examples of some of the most active principle investigators in this domain are (on the basis of number of the clinical trials, and the highest phase of development of the studies with which they were / are affiliated) Dr. Noelle Frey (Abramson Cancer Center of the University of Pennsylvania), Dr. Cheng Qian (Southwest Hospital of Third Military Medical University), Dr. Lung-Ji Chang (Shenzhen Geno-Immune Medical Institute), Dr. Yangyi Bao (The First People's Hospital of Hefei), Dr. Lin Yang (Soochow University), Dr. Xiang Sun (The First People's Hospital of Hefei), Dr. Lizhi Niu (Fuda Cancer Hospital) and Dr. Jiangtao Wang (Ningbo Cancer Hospital).
8. Numerous contract manufacturing organizations (CMOs) with advanced capabilities have also emerged, offering services for manufacturing personalized T-cell based therapies. Examples of such CMOs include (in alphabetical order) Amsterdam Biotherapeutics Unit (AmBTU), apceth Biopharma, Atlantic Bio GMP, Brammer Bio, Cell and Gene Therapy Catapult, Cell Therapies, Cellular Therapeutics, EUFETS, MEDINET, MolMed, PCT, KBI Biopharma and WuXi AppTec.
9. The CAR-T therapy market is projected to grow at an annualized rate of over 51% during the time period 2018-2030. The market, in the long term, is likely to be driven by three indications, namely non-Hodgkin's lymphoma (74%), acute lymphoblastic leukemia (9%) and multiple myeloma (8%). Moreover, in the long term, several product candidates, such as Kymriah®, Yescarta® and JCAR017 are expected to achieve blockbuster status.
10. In terms of geographical distribution, North America is currently considered to be the major hub for development and manufacturing of T-cell therapies; it is likely to continue to dominate the market over the next decade as well. However, there is a general perception that, owing to the fact that more than 60% of the CAR-T trials are currently being conducted in China, this market is likely to grow at a relatively faster rate as compared to those in the developed regions.
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