Market Overview

CAR-T Therapies Market, 2030 - Over 350 Product Candidates Being Developed for Various Oncological Indications

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CAR-T Therapies Market, 2030 - Over 350 Product Candidates Being Developed for Various Oncological Indications

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DUBLIN, Aug. 30, 2018 /PRNewswire/ --

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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

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