CAR-T Therapies Market, 2030 - Robust Development Pipeline

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CAR-T Therapies Market, 2030 - Robust Development Pipeline Following Recent Approval of Kymriah (Novartis) and Yescarta (Gilead Sciences)

Dublin, Aug. 30, 2018 (GLOBE NEWSWIRE) -- The "CAR-T Therapies Market, 2018-2030" report has been added to ResearchAndMarkets.com's offering.

The "CAR-T Therapies 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.

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. 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. 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.

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).

Key Topics Covered:

1. PREFACE 1.1. Scope of the Report 1.2. Research Methodology 1.3. Chapter Outlines 2. EXECUTIVE SUMMARY 3. INTRODUCTION 3.1. Chapter Overview 3.2. Pillars of Cancer Therapy 3.3. Immunotherapy, an Emerging Therapeutic Option 3.4. Fundamentals of Cancer Immunotherapy 3.5. Classification of Cancer Immunotherapies 3.5.1. By Mechanism of Action 3.5.1.1. Active Immunotherapy 3.5.1.2. Passive Immunotherapy 3.5.2. By Type of Target 3.5.3. By Approach 3.5.3.1. Activation and Suppression Immunotherapy 3.5.4. By Product Class 3.5.4.1. Monoclonal Antibodies 3.5.4.2. Bispecific Antibodies 3.5.4.3. Cytokines 3.5.4.4. Oncolytic Virus Therapy 3.5.4.5. Therapeutic Cancer Vaccines 3.5.4.6. Cell Based Therapies 3.6. Evolution of T-Cell Immunotherapies 3.7. Key Considerations for T-Cell Immunotherapies 3.8. Strategies Employed for Redirection of T-Cells 3.9. Manufacturing of Engineered T-Cells 3.10. T-Cell Transduction / Transfection Methods 3.10.1. Retroviral Vectors 3.10.2. Lentiviral Vectors 3.10.3. Non-viral Transfection Methods 3.10.3.1. Sleeping Beauty Transposon 3.11. T-Cell Immunotherapy: Targeted Therapeutic Areas 3.12. T-Cell Immunotherapies: Key Challenges 4. CHIMERIC ANTIGEN RECEPTOR-T CELL THERAPY 4.1. Chapter Overview 4.2. History of Development 4.3. Anatomical Layout of Chimeric Antigen Receptor 4.4. Development Of CAR-T Therapies 4.5. Universal CAR-Ts 4.6. Preferred Routes of Administration 4.7. Toxicity Issues 4.7.1. Cytokine Release Syndrome (CRS) 4.7.2. On-Target, Off-Tumor Toxicity 4.7.3. Encephalopathy and B-Cell Aplasia 4.7.4. Neurological Toxicity 4.7.5. Anaphylaxis 4.7.6. Insertional Oncogenesis 4.7.7. Graft versus Host Disease (GVHD) 4.8. Management of Toxicity Issues 4.8.1. Pharmacological Immunosuppression 4.8.2. Target Selection 4.8.3. Safety Switches 4.8.4. Elimination Genes 4.8.5. Receptor Expression 4.9. CD19: An Attractive Target 4.10. Other Targets 4.11. Challenges Associated with CAR-T Therapy 4.11.1. Competitive Risks 4.11.2. Clinical Risks 4.11.3. Regulatory Risks 4.11.4. Commercial Risks 5. EMERGING TRENDS ON SOCIAL MEDIA 5.1. Chapter Overview 5.2. Trends on Twitter 5.2.1. Social Media Analysis: Yearly Trends on Twitter 5.2.2. Social Media Analysis: Popular Keywords on Twitter 5.3. Social Media Analysis: Most Popular Drugs on Twitter 6. MARKET LANDSCAPE 6.1. Chapter Overview 6.2. CAR-T Therapies: Pipeline Overview 6.2.1. Distribution by Type of Developer 6.2.2. Distribution by Phase of Development 6.2.3. Target Oncological Indications 6.2.3.1. Popular Target Indications 6.2.4. Popular Target Antigens 6.2.5. Distribution by Source of T-Cells 6.2.6. Distribution by Route of Administration 6.2.7. Key Industry Players 6.2.8. Key Non-Industry Players 6.3. CAR-T Therapies: Analysis of CAR Constructs 6.3.1. Analysis by Generation of CAR-T Therapies 6.3.2. Analysis by Type of scFv Antibody 6.3.3. Analysis by Type of Vector 6.3.4. Analysis by Type of Co-Stimulatory Domain(s) 7. KEY INSIGHTS 7.1. Chapter Overview 7.2. CAR-T Therapies: Analysis by Popularity of Target Antigens 7.2.1. Hematological Cancers: Popular Targets 7.2.1.1. CD19 CAR-T Therapies: Competitive Landscape 7.2.1.2. CD19 CAR-T Therapies: Clinical Trial Results of Prominent Product Candidates 7.2.1.3. BCMA CAR-T Therapies: Competitive Landscape 7.2.1.4. BCMA CAR-T Therapies: Clinical Trial Results of Prominent Product Candidates 7.2.2. Solid Tumors: Popular Targets 7.2.2.1. Meso CAR-T Therapies: Competitive Landscape 7.2.2.2. GD2 CAR-T Therapies: Competitive Landscape 7.3. CAR-T Therapies: Clinical Trial Trends, 2009-2018 7.3.1. Analysis by Trial Registration Year 7.3.2. Geographical Analysis by Number of Registered Trials 7.4. CAR-T Therapies: Clinical Trial Overview 7.4.1. Clinical Trial Analysis: Distribution by Phase of Development 7.4.2. Clinical Trial Analysis: Distribution by Patient Segment 7.4.3. Clinical Trial Analysis: Distribution by Type of Therapy 7.5. CAR-T Therapies: Key Opinion Leaders 7.5.1. Most Prominent Key Opinion Leaders 8. MARKETED AND LATE-STAGE CAR-T THERAPY PROFILES 8.1. Chapter Overview 8.2. Kymriah / Tisagenlecleucel / CTL019 (Novartis) 8.2.1. Therapy Overview 8.2.2. History of Development 8.2.3. Current Development Status 8.2.4. Key Clinical Trial Results 8.2.5. Dosage Regimen, Price and Manufacturing 8.3. Yescarta / Axicabtagene Ciloleucel / KTE-C19 (Kite Pharma) 8.3.1. Therapy Overview 8.3.2. Current Development Status 8.3.3. Key Clinical Trial Results 8.3.4. Dosage Regimen, Price and Manufacturing 8.3.5. Next Generation eACT CAR Candidates 8.4. JCAR (Juno Therapeutics) 8.4.1. Therapy Overview 8.4.2. CAR-T Design 8.4.3. Development Status 8.4.4. Key Clinical Results 8.4.4.1. JCAR014 8.4.4.2. JCAR017 8.4.4.3. JCAR018 8.4.5. Dosage Regimen and Manufacturing 8.5. CAR-T Series (Cellular Biomedicine Group) 8.5.1. Therapy Overview 8.5.2. History of Development 8.5.3. Current Development Status 8.5.4. Key Clinical Trial Results 8.5.4.1. CBM-EGFR.1 8.5.4.2. CBM-C19.1 8.5.4.1. CBM-C20.1 8.5.4.2. CBM-C30.1 8.5.5. Dosage Regimen and Manufacturing 8.5.6. Patent Portfolio 8.6. CD19 CAR (Takara Bio) 8.6.1. Therapy Overview 8.6.2. Current Developmental Status 8.6.3. Key Clinical Trial Results 8.6.4. Dosage Regimen and Manufacturing 8.7. Dual Targeting CAR-T Cell therapies (Autolus) 8.7.1. Therapy Overview 8.7.2. Current Development Status 8.7.3. Key Clinical Trial Results 8.7.4. Dosage Regimen and Manufacturing 8.8. CAR-T Therapies (Sinobioway Cell Therapy) 8.8.1. Therapy Overview 8.8.2. Current Development Status 9. KEY THERAPEUTIC AREAS CAR-T THERAPIES 9.1. Chapter Overview 9.2. Hematological Malignancies 9.2.1. Leukemia and Lymphoma 9.2.1.1. Leukemia: Introduction and Epidemiology 9.2.1.1.1. Acute Myeloid Leukemia (AML) 9.2.1.1.2. Chronic Myeloid Leukemia (CML) 9.2.1.1.3. Acute Lymphocytic Leukemia (ALL) 9.2.1.1.4. Chronic Lymphocytic Leukemia (CLL) 9.2.1.2. Lymphoma: Introduction and Epidemiology 9.2.1.3. Current Treatment Landscape 9.2.1.3.1. Targeted Therapies 9.2.1.4. CAR-T Therapy and Research Landscape 9.2.2. Multiple Myeloma 9.2.2.1. Introduction and Epidemiology 9.2.2.2. Current Treatment Landscape 9.2.2.3. CAR-T Therapy and Research Landscape 9.3. Solid Tumors 9.3.1. Metastatic Melanoma 9.3.2. Lung Cancer 9.3.3. Bladder Cancer 9.3.4. Kidney Cancer 9.3.5. Ovarian Cancer 9.3.6. Breast Cancer 10. EMERGING TECHNOLOGIES 10.1. Chapter Overview 10.2. Genome Editing Technologies 10.2.1. Technology Overview 10.2.2. Applications 10.2.3. Emerging Technology Platforms Used in CAR-T Therapies 10.2.3.1. CRISPR/Cas9 System 10.2.3.1.1. Key Components and Function 10.2.3.1.2. Mechanism of Action 10.2.3.1.3. Targeting Efficiency and Challenges 10.2.3.1.4. Next-GEN CRISPR Technology 10.2.3.1.5. Technology Providers 10.2.3.2. TALENs 10.2.3.2.1. Key Components and Function 10.2.3.2.2. Mechanism of Action 10.2.3.2.3. Advantages and Challenges 10.2.3.2.4. Technology Providers 10.2.3.3. megaTAL 10.2.3.3.1. Technology Providers 10.2.3.4. Zinc Finger Nuclease 10.2.3.4.1. Technology Providers 10.3. Designing T-Cell Therapies with Improved Characteristics 10.3.1. Technologies for Targeting Multiple Cancers 10.3.1.1. NKR-T Platform (Celyad) 10.3.2. Technologies for Improved Safety 10.3.2.1. Armored CAR and EGFRt technology (Juno Therapeutics) 10.3.2.2. RheoSwitch Therapeutic System (Intrexon) 10.3.2.3. Inducible Caspase 9 Safety Switch (Bellicum Pharmaceuticals) 10.3.2.3.1. CaspaCIDe Technology 10.3.2.3.2. CIDeCAR Technology 10.3.2.3.3. GoCAR-T Technology 10.3.2.4. On-Off Switch, Multiple Companies 10.3.2.4.1. Inhibitory CAR (iCAR) (Juno Therapeutics) 10.3.2.4.2. On-Off Switch (Theravectys) 10.3.2.5. Other Technologies to Improve CAR-T Safety 10.3.3. Allogeneic Technologies 10.3.3.1. CIK CAR-T Cells (Formula Pharmaceuticals) 10.3.3.2. Allogeneic Platform (Celyad) 10.3.3.3. Allogeneic Platform (Cellectis) 11. CASE STUDY: CELL THERAPY MANUFACTURING 11.1. Chapter Overview 11.2. Introduction 11.3. Key Challenges 11.4. Current Trends 11.4.1. Companies with In-House Capabilities 11.4.2. Contract Manufacturers 11.5. Key Considerations for a Manufacturing Site 11.6. Regulatory Landscape 12. T-CELL IMMUNOTHERAPY: COST PRICE ANALYSIS 12.1. Chapter Overview 12.2. Factors Contributing to the Price of Cell / Gene Therapies 12.3. Pricing Models for T-Cell Immunotherapies 12.3.1. On the Basis of Associated Costs 12.3.2. On the Basis of Competition 12.3.3. On the Basis of Patient Segment 12.3.4. On the Basis of Expert Opinions 12.4. Reimbursement Considerations for T-Cell Immunotherapies 12.4.1. Case Study: The National Institute for Health and Care Excellence (NICE) Appraisal of CAR-T Therapy 13. MARKET SIZING AND OPPORTUNITY ANALYSIS 13.1. Chapter Overview 13.2. Scope and Limitations 13.3. Forecast Methodology 13.4. Overall CAR-T Therapy Market 13.4.1. CAR-T Therapy Market: Distribution by Geography 13.4.2. CAR-T Therapy Market: Distribution by Target Indications 13.5. CAR-T Therapy Market: Product-Wise Sales Forecasts 13.5.1. Kymriah (Novartis) 13.5.2. Yescarta (Gilead Sciences) 13.5.3. bb2121 (Celgene / bluebird bio) 13.5.4. MB-CART19.1 (Miltenyi Biotec / Shanghai Children's Medical Center) 13.5.5. CD19 CAR-T (Sinobioway Cell Therapy / The First Affiliated Hospital of Anhui Medical University) 13.5.6. GPC3 CAR-T (Shanghai GeneChem) 13.5.7. TBI-1501 (Takara Bio / Jichi Medical University) 13.5.8. JCAR017 (Juno Therapeutics / Celgene) 13.5.9. IM19 CAR-T (Beijing Immunochina Medical Science & Technology) 13.5.10. PCAR-019 (PersonGen BioTherapeutics) 13.5.11. AUTO2 (Autolus) 13.5.12. AUTO3 (Autolus) 13.5.13. BCMA CAR-T (The Beijing Pregene Science and Technology / Henan Cancer Hospital) 13.5.14. CD19 CAR-T (The Pregene (ShenZhen) Biotechnology / Henan Cancer Hospital) 13.5.15. CD19 CAR-T (Shanghai Unicar-Therapy Bio-medicine Technology / The First Affiliated Hospital of Soochow University) 13.5.16. LCAR-B38M CAR-T (Nanjing Legend Biotech) 13.5.17. CD19 CAR-T (Shanghai Bioray Laboratory) 14. PROMOTIONAL ANALYSIS 14.1. Chapter Overview 14.2. Channels Used for Promotional Campaigns 14.3. Summary of Product Website Analysis 14.4. Summary of Patient Support Services and Informative Downloads 14.5. Kymriah: Promotional Analysis 14.6. Yescarta: Promotional Analysis 15. COMPANY PROFILES 15.1. Chapter Overview 15.2. Autolus 15.3. bluebird bio 15.4. CARsgen Therapeutics 15.5. Celgene 15.6. Cell Medica 15.7. Cellectis 15.8. Cellular Biomedicine Group 15.9. Innovative Cellular Therapeutics 15.10. Kite Pharma (A Gilead Sciences Company) 15.11. Novartis 15.12. Sinobioway Cell Therapy 15.13. Takara Bio 15.14. ZIOPHARM Oncology 16. CONCLUSION 16.1. CAR-T Therapies Market is Characterized by a Robust Pipeline of Over 350 Product Candidates Being Developed for Various Oncological Indications 16.2. The Primary Focus of CAR-Based Therapeutic Interventions is on Hematological Malignancies and Solid Tumors 16.3. Both Established Players and Start-Ups are Actively Involved in Developing CAR-T Therapies; Academic Institutes Continue to Make Significant Contributions to the Innovation in this Domain 16.4. Several Innovative Technology Platforms have been Developed, and are Expected to Enable the Development of Better Therapies, With Favorable Safety and Efficacy Profiles 16.5. Owing to High R&D Investments, CAR-T Therapies Bear Premium Price Tags; Developers are Striving to Offer Reimbursement Plans and Implement Various Promotional Strategies to Achieve Commercial Success 16.6. Post the Approval of Multiple Late-Phase Product Candidates, the Market is Anticipated to Grow at a Rapid Pace in the Foreseen Future 17. EXECUTIVE INSIGHTS 17.1. Chapter Overview 17.2. Enkhtsetseg Purev, Assistant Professor of Medicine, University of Colorado (Q1 2018) 17.3. Xian-Bao Zhan, Professor of Medicine and Director, Department of Oncology, Changhai Hospital (Q4 2017) 17.4. Brian Dattilo, Manager of Business Development, Waisman Biomanufacturing (Q1 2017) 17.5. Miguel Forte, Chief Operating Officer, TxCell (Q3 2016) 17.6. Adrian Bot, Vice President, Scientific Affairs, Kite Pharma (Q1, 2016) 17.7. Aino Kalervo, Competitive Intelligence Manager, Strategy & Business Development, Theravectys (Q3, 2015) 17.8. Vincent Brichard, Vice President, Immuno-Oncology, Celyad (Q3 2015) 18. APPENDIX 1: TABULATED DATA 19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/research/c...apies?w=12

CONTACT: ResearchAndMarkets.com Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 Related Topics: Oncology Drugs

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