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CD19 Therapeutics Market, 2016 - 2030

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    March 2016

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Example Insights

  1. CD19 is an important antigen expressed during B cell development; 80% of all ALL cases, 88% of B cell lymphomas and 100% of B cell leukemias express this antigen.
  2. During the course of our research, we identified over 50 products in various phases of development. Of these, 70% are in the clinical phase of development (with one molecule in phase II/III trial and six molecules in phase II stage).
  3. CAR-T therapies (constituting 70% of the development pipeline) are the most common, followed by bsAbs (11%), ADCs (7%) and engineered antibodies (7%).
  4. The market is highly fragmented with the involvement of several start-ups and many eminent research organizations. Big pharmaceutical players engaged in this space include Amgen, ImmunoGen, MedImmune, Merck and Novartis. Emerging new players/start-ups that are actively investing in this market include Affimed, Bellicum Pharmaceuticals, Juno Therapeutics, Kite Pharma, MorphoSys, Xencor and Zymeworks. The premier research institutes involved in this space include the National Cancer Institute (NCI), MD Anderson Cancer Centre, the University of Pennsylvania, Fred Hutchinson Cancer Research Center (FHCRC) and Memorial Sloan Kettering Cancer Center (MSKCC).
  5. Hematological malignancies remain the prime focus of drug developers in this space. However, efforts are also being made to use these therapies in the treatment of other indications including certain autoimmune diseases and solid tumors.
  6. Over the coming decade, we expect at least eight anti-CD19 therapies to be made commercially available in addition to marketed drugs. During this period, we believe the market is likely to expand at an annualized growth rate of 41.0%; the overall opportunity could be much higher and depends on a number of factors such as favourable market environment, regulatory regimes and therapeutic performance of candidates in the late stages of development.

Overview

The human immune system is comprised of a number of different types of specialized molecules and cells that are involved in complex interactions and activities to facilitate an immune response. Immunotherapies exploit the body's innate potential to specifically target a particular molecular antigen and mount an efficient immune response against the cells bearing the diseased signature. Currently, four major types of immunotherapies (classified by product class) targeting the CD19 antigen are under development, namely engineered antibodies, bispecific antibodies (bsAbs), antibody drug conjugates (ADCs) and CAR-T cell therapies. CD19 antigen, an important biomarker has emerged as a promising therapeutic target for a number of disease indications, specifically hematological malignancies (leukemias and lymphomas). The antigen is expressed both on normal cells and malignant B cells as well as follicular dendritic cells. Upon initial discovery, the CD19 antigen was dubbed as the B4 antigen on human B cells.

The pioneer CD19 targeted drug to hit the US and the EU markets was BLINCYTO® (blinatumomab), a bsAb. Different technologies have catered to the development of CD19 targeted therapies. Several researchers and therapy developers are actively involved in developing therapeutics targeting the CD19 antigen for the treatment of B cell malignancies and various autoimmune disorders. With several advantages such as high therapeutic performance and favorable clinical outcomes, the promising pipeline of anti-CD19 drugs is expected to result in a multi-billion dollar market by 2030.

 

Scope of the Report

The CD19 Therapeutics Market, 2016-2030 report provides a comprehensive analysis of the current market landscape and the future outlook of the growing pipeline of anti-CD19 therapeutics. The recent approval of BLINCYTO®, a CD19 targeting bsAb, and emergence of CAR-T therapies has provided a significant boost to this market that has actively evolved in the past few years.

The pipeline comprises of products across four major classes of drugs, namely, engineered antibodies, bsAbs, ADCs and CAR-T therapies. The major focus of these novel molecules is hematological cancers, specifically B cell malignancies, with CAR-T therapies leading the table. Post initial research in CAR-T therapies, many non-industry players have entered into collaborations with industry stakeholders to fund the clinical and commercial development of these products. Some late stage products that have emerged out of such collaborations include KTE-C19, CTL019, JCAR015 and JCAR017.

One of the key objectives of the study is to review and quantify the opportunities laid by the innovative CD19 targeted programs of both small and big pharma firms. Amongst other elements, the report elaborates upon the following key areas:

  • The current state of the market with respect to key players, developmental stages of pipeline products (both clinical/preclinical) and target indications
  • Partnerships that have taken place in the recent past covering research and development collaborations, manufacturing agreements and license agreements specific to technology platforms, product co-development and co-commercialization
  • Competitive landscape and inherent threats to growth in the short and long term
  • Development and sales potential based on target consumer segments, likely adoption rate and expected pricing

The study provides an estimate of the short-mid term and long term market forecast for the period 2015 - 2030. The research, analysis and insights presented in this report include potential sales of various marketed and late stage (phase II and phase II/III) anti-CD19 products based on our understanding of the likely future development of individual therapeutics. The opinions and insights, presented in this study, were influenced by discussions that we conducted with experts in this area. These included senior representatives at Kite Pharma, MorphoSys and Theravectys.

Owing to niche nature of the market, we have provided three market forecast scenarios to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of industry evolution. All actual figures have been sourced and analyzed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.

Contents

Chapter 2  presents an executive summary of the report. It offers a high level view on where the CD19 therapeutics market is headed in the mid-long term. 

Chapter 3  provides a detailed introduction to the CD19 antigen. In this section, we have talked about the structure and role of the human CD19 antigen. Further, we have briefly discussed the conventional therapies being used for different oncological indications and the advent of cancer immunotherapy.

Chapter 4  includes information on over 50 molecules that are either approved or in different stages of development (both clinical and preclinical/discovery). The detailed analysis of this development pipeline includes information on types of molecules, most commonly targeted indications, the phase of development and the developers. In addition, we have also highlighted specific details on the different types of partnerships that have been inked over the last few years; this showcases the growing interest in this field.

Chapter 5  focuses on CAR-T based therapies and highlights prevailing trends pertaining to the ongoing research in this field. It features discussions on targets under investigation, current challenges, toxicity issues and other relevant parameters. To credit the work of the eminent researchers in this space, we have mapped the regional locations of prominent key opinion leaders (KOLs). Similar to earlier chapters, this chapter provides detailed technology and drug profiles for CD19 targeting late stage CAR-T molecules. 

Chapter 6  provides detailed information on engineered antibodies, namely Fc and glycoengineered antibodies. It also covers detailed drug profiles for late stage molecules that specifically target the CD19 antigen. Each drug profile includes information such as the clinical stage of development of the molecule, dosage regimen, key clinical trial results and information about the developer. The chapter also includes profiles of technologies being used for the development of these candidate therapies. These profiles provide a brief technology background, pipeline molecules based on the particular technology platform, specific advantages and recent collaborations. 

Chapter 7  provides detailed information on bsAbs. Similar to the previous chapter, it provides both drug and technology profiles for CD19 targeting bsAb therapeutics in late stages of clinical development. 

Chapter 8  provides detailed information on ADCs. Similar to the previous chapters, it provides both drug and technology profiles for CD19 targeting ADC therapeutics in late stages of clinical development.

Chapter 9  highlights promising therapeutic areas for which CD19 therapeutics are being developed. The chapter also highlights the epidemiological facts and currently available treatment options for each of the discussed indications.

Chapter 10  elaborates on the monetary opportunity presented by anti-CD19 therapeutics. It provides a comprehensive market forecast analysis for molecules in advanced stages of development (approved, phase II/III, phase II and phase I/II) taking into consideration the target patient population, competition, likely adoption rate and price points.

Chapter 11  is an overall summary of the report. In this chapter, we have provided a list of key takeaways and expressed our independent opinion based on the research and analysis described in earlier chapters.

Chapter 12  is a collection of transcripts of interviews conducted during the course of the study.

Chapter 13  is an appendix, containing tabulated data for all figures in the report. It also features a list of companies and organizations involved in this space.

Table of Contents

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. The CD19 Antigen
3.2.1. Overview
3.2.2. Structure of the Human CD19 Antigen
3.2.3. Role of the CD19 Antigen
3.2.3.1. Development and Maturation of B cells
3.2.3.2. Role in B cell Signaling
3.2.4. CD19: A Promising Antigen
3.3. Treating Cancer: A Growing Concern
3.3.1. Evolution of Cancer Treatment
3.3.2. Conventional Cancer Treatment Methods
3.3.2.1. Surgery
3.3.2.2. Radiation Therapy
3.3.2.3. Chemotherapy
3.3.3. Immunotherapy
3.3.3.1. Classification of Cancer Immunotherapies
3.3.3.1.1. By Mechanism of Action
3.3.3.1.2. By Type of Target
3.3.3.1.3. By Approach
3.3.3.1.4. By Product Class
3.3.3.1.4.1. Monoclonal Antibodies
3.3.3.1.4.2. Bispecific Antibodies
3.3.3.1.4.3. Antibody Drug Conjugates
3.3.3.1.4.4. Chimeric Antigen Receptor-T Cells
3.4. Antibody Based Therapeutics
3.4.1. Approved Antibody Therapies: Distribution by Year of Approval
3.5. CD19 Based Therapeutics: New Frontiers
 
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. CD19 Therapeutics: A Promising Pipeline
4.3. Pipeline Analysis
4.3.1. CD19 Therapeutics: Distribution by Phase of Development
4.3.2. CD19 Therapeutics: Distribution by Indication
4.3.3. CD19 Therapeutics: Distribution by Type of Molecule
4.3.4. CD19 Therapeutics: Distribution by Type of Developer
4.3.5. Active Players in the CD19 Therapeutics Industry
4.4. CD19 Therapeutics: Collaborations
 
5. CHIMERIC ANTIGEN RECEPTOR-T CELL THERAPIES
5.1. Chapter Overview
5.2. Introduction
5.3. History of Development
5.4. Current Research Landscape
5.5. Anatomical Layout of Chimeric Antigen Receptor
5.6. Generations of Chimeric Antigen Receptors
5.7. Development of Car-T Cells
5.8. Toxicity Issues
5.8.1. Cytokine Release Syndrome (CRS)
5.8.2. On-Target Off-Tumor Toxicity
5.8.3. Encephalopathy and B Cell Aplasia
5.9. Management of Toxicity Issues
5.9.1. Target Selection
5.9.2. Cell Persistence
5.9.3. Receptor Expression
5.10. Challenges Associated With CAR-T Therapy
5.10.1. Competitive Risks
5.10.2. Clinical Risks
5.10.3. Regulatory Challenges
5.10.4. Commercial Risks
 
5.11. CAR-T Molecules Targeting CD19
5.11.1. CTL019, Novartis
5.11.1.1. Introduction
5.11.1.2. History of Development
5.11.1.3. Clinical Development
5.11.1.4. Dosage Regimen
5.11.1.5. Key Clinical Trial Results
5.11.1.5.1. Acute Lymphoblastic Leukemia
5.11.1.5.2. Non Hodgkin Lymphoma
5.11.1.5.3. Chronic Lymphocytic Leukemia
5.11.1.5.4. Multiple Myeloma
5.11.1.6. Developer Overview: Novartis
5.11.1.6.1. Financial Information
5.11.1.6.2. Product Portfolio
5.11.1.6.3. Patent Litigation
5.11.1.6.4. Manufacturing Capabilities
5.11.1.7. Collaborations
 
5.11.2. JCAR015, Juno Therapeutics
5.11.2.1. Drug Overview
5.11.2.2. CAR-T Design
5.11.2.3. Clinical Development
5.11.2.4. Dosage Regimen
5.11.2.5. Key Clinical Trial Results
5.11.2.5.1. Acute Lymphoblastic Leukemia
5.11.2.5.2. Non-Hodgkin Lymphoma
5.11.2.6. Developer Overview: Juno Therapeutics
5.11.2.6.1. Financial Information
5.11.2.6.2. Product Portfolio
5.11.2.6.3. Patent Litigation
5.11.2.6.4. Manufacturing Capabilities
5.11.2.7. Collaborations
 
5.11.3. KTE-C19, Kite Pharma
5.11.3.1. Introduction
5.11.3.2. Clinical Development
5.11.3.3. Dosage Regimen
5.11.3.4. Key Clinical Trial Results
5.11.3.4.1. Non-Hodgkin Lymphoma
5.11.3.4.2. Acute Lymphoblastic Leukemia
5.11.3.5. Next Generation eACT CAR Candidates
5.11.3.6. Developer Overview: Kite Pharma
5.11.3.6.1. Financial Information
5.11.3.6.2. Product Portfolio
5.11.3.6.3. Manufacturing Capabilities
5.11.3.7. Collaborations
 
6. ENGINEERED ANTIBODIES
6.1. Chapter Overview
6.2. Monoclonal Antibody
6.2.1. How Monoclonal Antibody Therapy Works?
6.2.2. Parts of a Monoclonal Antibody
6.2.3. Fc Region and Effector Functions
6.2.4. Types of Fc Receptors
6.2.5. Engineering the Fc Region
6.2.5.1. Glycoengineering
6.2.5.2. Protein Engineering
6.2.5.3. Isotype Chimerism
6.3. Advantages of Engineered Antibodies
 
6.4. Engineered Antibodies Targeting CD19
6.4.1. MEDI-551, MedImmune
6.4.1.1. Drug Overview
6.4.1.2. Clinical Development
6.4.1.3. Dosage Regimen
6.4.1.4. Key Clinical Trial Results
6.4.1.4.1. Chronic Lymphocytic Leukemia
6.4.1.4.2. B Cell Malignancies
6.4.1.4.3. Multiple Sclerosis
6.4.1.4.4. Scleroderma
6.4.1.5. Developer Overview: MedImmune
6.4.1.5.1. Product Portfolio
6.4.1.5.2. Manufacturing Capabilities
6.4.1.6. Collaborations
 
6.4.2. MOR208, MorphoSys
6.4.2.1. Drug Overview
6.4.2.2. History of Development
6.4.2.3. Clinical Development
6.4.2.4. Dosage Regimen
6.4.2.5. Key Clinical Trial Results
6.4.2.5.1. Non-Hodgkin Lymphoma
6.4.2.5.2. Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia
6.4.2.6. Developer Overview: MorphoSys
6.4.2.6.1. Financial Information
6.4.2.6.2. Product Portfolio
6.4.2.7. Collaborations
 
6.5. Technologies Used For Developing Cd19 Based Engineered Antibodies
6.5.1. POTELLIGENT®, BioWa (A Subsidiary of Kyowa Hakko Kirin)
6.5.1.1. The Technology
6.5.1.2. Discovery of POTELLIGENT®
6.5.1.3. Advantages of POTELLIGENT® Technology
6.5.1.4. POTELLIGENT® CHOK1SV: A 2-in-1 Technology
6.5.1.5. Drugs Based on POTELLIGENT®
6.5.1.6. Technology Licensees
6.5.1.6.1. Cantargia
6.5.1.6.2. arGEN-X
6.5.1.6.3. MedImmune
6.5.1.6.4. Pfizer
6.5.1.6.5. FivePrime Therapeutics
6.5.1.6.6. ImmunoCellular Therapeutics
6.5.1.6.7. Oxford BioTherapeutics
6.5.1.6.8. Kalobios
6.5.1.6.9. Agensys
6.5.1.6.10. Daiichi Sankyo
6.5.1.6.11. GSK
6.5.1.6.12. NKT Therapeutics
6.5.1.6.13. Otsuka Pharmaceuticals
6.5.1.6.14. Merck KGaA
6.5.1.6.15. Sanofi Aventis
6.5.1.6.16. CSL Limited
6.5.1.6.17. Novartis
6.5.1.6.18. Genentech
6.5.1.6.19. Takeda
6.5.1.6.20. UCB
6.5.1.6.21. OncoTherapy Science
6.5.1.6.22. Medarex (Acquired by BMS)
6.5.1.7. Product Alliances
6.5.1.7.1. Amgen
6.5.1.7.2. Teva Pharmaceuticals
6.5.1.7.3. MedImmune
 
6.5.2. XmAb® Antibody Technology, Xencor
6.5.2.1. The Technology
6.5.2.2. Drugs Based on XmAb® Antibody Technology
6.5.2.3. Technology Licensees
6.5.2.3.1. Amgen
6.5.2.3.2. Novo Nordisk
6.5.2.3.3. Merck (MSD outside the US and Canada)
6.5.2.3.4. CSL Limited
6.5.2.3.5. Janssen (Formerly Centocor Research & Development)
6.5.2.3.6. Merck & Co
6.5.2.3.7. Pfizer
6.5.2.3.8. Human Genome Sciences (HGS)
6.5.2.3.9. Boehringer Ingelheim
6.5.2.4. Product Alliances
6.5.2.4.1. Amgen
6.5.2.4.2. MorphoSys
 
7. BISPECIFIC ANTIBODIES
7.1. Chapter Overview
7.2. Bispecific Antibody
7.3. The Bispecific Advantage
7.4. Bispecific Antibody Formats
7.5. Evolution of Bispecific Antibodies
7.5.1. First Generation Bispecific Antibodies
7.5.1.1. Triomabs: Made Using Hybridomas/Quadromas
7.5.1.2. Shortcomings of First Generation Bispecific Antibodies
7.5.2. Second Generation Bispecific Antibodies
7.5.2.1. Tandem Single-chain Variable Fragment (ScFv)
7.5.2.2. Diabodies
7.5.2.3. Two-in-one Antibody
7.5.2.4. Dual Variable Domain Antibodies (DVD-Ig)
7.5.2.5. Shortcoming of Recombinant Bispecific Antibodies
7.6. Types of Bispecific Antibodies by Mode of Action
7.6.1. T Cell Engagement
7.6.2. Pre-Targeting Systems
7.6.3. Ligand Neutralization and Cross Linking of Receptors System
 
7.7. Bispecific Antibodies Targeting CD19
7.7.1. Blincyto® (Blinatumomab/Mt 103/Medi 538/Amg 103), Amgen/Astellas Pharma
7.7.1.1. Drug Overview
7.7.1.2. History of Development
7.7.1.3. Mechanism of Action
7.7.1.4. Clinical Development
7.7.1.5. Dosing Regimen
7.7.1.6. Key Clinical Trial Results
7.7.1.6.1. Philadelphia Chromosome-Negative B Cell Precursor ALL
7.7.1.6.2. Philadelphia Chromosome-Positive B Cell Precursor ALL
7.7.1.6.3. Minimal Residual Disease of Acute Lymphoblastic Leukemia
7.7.1.6.4. Relapsed/Refractory Acute Lymphoblastic Leukemia
7.7.1.6.5. Diffuse Large B Cell Lymphoma
7.7.1.6.6. Non-Hodgkin Lymphoma
7.7.1.7. Developer Overview: Amgen
7.7.1.7.1. Financial Performance
7.7.1.7.2. Product Portfolio
7.7.1.8. Collaborations
 
7.8. Technologies Used For Developing CD19 Based Bispecific Antibodies
7.8.1. Bispecific T Cell Engager (BiTE®), Amgen
7.8.1.1. The Technology
7.8.1.2. Advantages of BiTE® Technology
7.8.1.3. Drugs Based on BiTE® Technology
7.8.1.4. Technology Licensees
7.8.1.4.1. MD Anderson Cancer Center (University of Texas)
7.8.1.4.2. Boehringer Ingelheim
7.8.1.4.3. Bayer Healthcare (previously Bayer Schering Pharma)
7.8.1.4.4. Sanofi Aventis
7.8.1.5. Product Alliances
7.8.1.5.1. MedImmune
 
7.8.2. Dual-Affinity Re-Targeting (DART®), MacroGenics
7.8.2.1. The Technology
7.8.2.2. Advantages of DART® Technology
7.8.2.3. Drugs Based on DART® Technology
7.8.2.4. Technology Licensees
7.8.2.4.1. Boehringer Ingelheim
7.8.2.4.2. Pfizer
7.8.2.5. Product Alliances
7.8.2.5.1. NIAID
7.8.2.5.2. Janssen
7.8.2.5.3. Takeda
7.8.2.5.4. Gilead Sciences
7.8.2.5.5. Servier
 
7.8.3. TandAb, Affimed
7.8.3.1. The Technology
7.8.3.2. Advantages of TandAb Technology
7.8.3.3. Drugs Based on TandAb Technology
7.8.3.4. Technology Licensees
 
8. ANTIBODY DRUG CONJUGATES (ADCs)
8.1. Chapter Overview
8.2. History of Development
8.3. Essential Components of ADCs
8.3.1. Antibody
8.3.2. Cytotoxin
8.3.3. Linker
8.4. Mechanism of Action
 
8.5. Antibody Drug Conjugates Targeting CD19
8.5.1. Coltuximab Ravtansine (formerly SAR3419), ImmunoGen
8.5.1.1. Drug Overview
8.5.1.2. History of Development
8.5.1.3. Mechanism of Action
8.5.1.4. Clinical Development
8.5.1.5. Dosage Regimen
8.5.1.6. Key Clinical Trial Results
8.5.1.6.1. Diffuse Large B Cell Lymphoma
8.5.1.6.2. Non-Hodgkin Lymphoma
8.5.1.7. Developer Overview: ImmunoGen
8.5.1.7.1. Financial Performance
8.5.1.7.2. Product Portfolio
8.5.1.7.3. Technology Portfolio
8.5.1.8. Collaborations
 
8.5.2. Denintuzumab Mafodotin (SGN-CD19A), Seattle Genetics
8.5.2.1. Drug Overview
8.5.2.2. Mechanism of Action
8.5.2.3. Clinical Development
8.5.2.4. Dosage Regimen
8.5.2.5. Key Clinical Trial Results
8.5.2.5.1. Non-Hodgkin Lymphoma
8.5.2.5.2. Acute Lymphocytic Leukemia
8.5.2.6. Developer Overview: Seattle Genetics
8.5.2.6.1. Financial Performance
8.5.2.6.2. Product Portfolio
8.5.2.6.3. Technology Platform
 

9. KEY THERAPEUTIC AREAS
9.1. Context and Background
9.2. Leukemia
9.2.1. Introduction and Epidemiology
9.2.1.1. Acute Myeloid Leukemia
9.2.1.2. Chronic Myeloid Leukemia
9.2.1.3. Acute Lymphocytic Leukemia
9.2.1.4. Chronic Lymphocytic Leukemia
9.3. Lymphoma
9.3.1. Introduction and Epidemiology
9.4. Current Treatment Landscape for Leukemia and Lymphoma
9.4.1. Targeted Therapies
9.4.2. CD19 Therapies and Research Landscape for Treatment of Leukemia/Lymphoma
9.4.2.1. CD19 Based Engineered Antibodies
9.4.2.2. CD19 Based Bispecific Antibodies
9.4.2.3. CD19 Based Antibody Drug Conjugates
9.4.2.4. CD19 Based Chimeric Antigen Receptor T Cells
9.5. Autoimmune Disorders: A Potential Area for Anti-CD19 Drugs
 
10. MARKET FORECAST
10.1. Chapter Overview
10.2. Scope and Limitations
10.3. Forecast Methodology
10.4. Overall CD19 Therapeutics Market
 
10.5. BLINCYTO® (Amgen)
10.5.1. Target Patient Population
10.5.2. Sales Forecast
 
10.6. CTL019 (Novartis)
10.6.1. Target Patient Population
10.6.2. Sales Forecast
 
10.7. KTE-C19 (Kite Pharma)
10.7.1. Target Patient Population
10.7.2. Sales Forecast
 
10.8. JCAR015 (Juno Therapeutics)
10.8.1. Target Patient Population
10.8.2. Sales Forecast
 
10.9. Coltuximab Ravtansine (Immunogen)
10.9.1. Target Patient Population
10.9.2. Sales Forecast
 
10.10. MEDI-551 (MedImmune)
10.10.1. Target Patient Population
10.10.2. Sales Forecast
 
10.11. MOR208 (Morphosys)
10.11.1. Target Patient Population
10.11.2. Sales Forecast
 
10.12. XMAB®5871 (Xencor)
10.12.1. Target Patient Population
10.12.2. Sales Forecast
 
10.13 SGN-CD19A (Seattle Genetics)
10.13.1. Target Patient Population
10.13.2. Sales Forecast
 
11. CONCLUSION
11.1. CD19: Potential Antigen for Targeted Therapy
11.2. Hematological Malignancies: The Main Focus Area
11.3. Immunotherapy: The Fourth Major Pillar of Cancer Therapy
11.4. CAR-T Therapies: The Current Flag-Bearer
11.5. Market Landscape: An Amalgamation of Industry and Non-Industry Participants
11.6. Advanced Stage Molecules Expected to Result in a Multi-Billion Dollar Market
 
12. INTERVIEW TRANSCRIPTS
12.1. Chapter Overview
12.2. Adrian Bot, Vice President, Translational Sciences, Kite Pharma
12.3. Dr. Andrea Gnirke-Maier, Senior Business Analyst, Business Development, Morphosys
12.4. Aino Kalervo, Competitive Intelligence Manager - Strategy & Business Development, Theravectys
 
APPENDIX 1: TABULATED DATA
 
APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

List of Figures

Figure 3.1 Structure of Human CD19 Antigen
Figure 3.2 Advantages of CD19 Antigen
Figure 3.3 Timeline of Cancer Treatments
Figure 3.4 Cancer Treatment: Type of Surgeries
Figure 3.5 Cancer Treatment: Type of Radiation Therapies
Figure 3.6 Cancer Treatment: Type of Chemotherapies
Figure 3.7 Cancer Immunotherapy: Active v/s Passive
Figure 3.8 Cancer Immunotherapy: Specific vs. Non-Specific
Figure 3.9 Approved Antibody Therapies: Distribution by Year of Approval
Figure 4.1 CD19 Therapeutics Pipeline: Distribution by Phase of Development (Clinical/Preclinical)
Figure 4.2 CD19 Therapeutics Pipeline: Distribution by Phase of Development (Marketed/Phase III/Phase II/Phase I/Preclinical)
Figure 4.3 CD19 Therapeutics Pipeline: Distribution by Indication
Figure 4.4 CD19 Therapeutics Pipeline: Distribution by Type of NHL
Figure 4.5 CD19 Therapeutics Pipeline: Distribution by Type of Molecule
Figure 4.6 CD19 Therapeutics Pipeline: Distribution by Type of Developer
Figure 4.7 CD19 Therapeutics Pipeline: Active Industry Players
Figure 5.1 Historical Timeline: Development of CAR-T Cells
Figure 5.2 CAR-T: Mapping Prominent Researchers
Figure 5.3 Development of CAR-T Cells
Figure 5.4 Challenges in CAR-T Therapy
Figure 5.5 CTL019: Clinical Trial Design (Industry)
Figure 5.6 CTL019: Clinical Trial Design (Non-Industry)
Figure 5.7 Novartis: Revenue, 2010- 2015 (USD Billion)
Figure 5.8 Novartis: Sales by Operating Segments, 2015 (USD Billion)
Figure 5.10 Juno Therapeutics: VC Funding Instances (USD Million)
Figure 5.11 KTE-C19: Clinical Trial Design (Non-Industry)
Figure 5.12 KTE-C19: Clinical Trial Design (Industry)
Figure 5.13 Kite Pharma: VC Funding Instances (USD Million)
Figure 5.14 Manufacturing of CD19 CAR-T Cells: Process Comparison
Figure 6.1 Structure of Antibody
Figure 6.2 MEDI-551: Clinical Trial Design
Figure 6.3 MOR208: Clinical Trial Design
Figure 6.4 MorphoSys: Revenue, 2011- Q3, 2015 (EUR Million)
Figure 7.1 Blinatumomab: Clinical Trial Design (Industry)
Figure 7.2 Blinatumomab: Clinical Trial Design (Non-Industry)
Figure 7.3 Amgen: Revenues, 2010 – 2015 (USD Billion)
Figure 8.1 Historical Development of ADCs
Figure 8.2 Components of ADCs
Figure 8.3 Mechanism of Action of ADCs
Figure 8.4 Coltuximab Ravtansine: Clinical Trial Design
Figure 8.5 ImmunoGen: Revenues, 2011 – H1 2016 (USD Million)
Figure 8.6 Denintuzumab Mafodotin: Clinical Trial Design
Figure 8.7 Seattle Genetics: Revenues, 2010- 9M, 2015 (USD Million)
Figure 9.1 Most Common Types of Leukemia
Figure 9.2 Leukemia: Global Epidemiological Distribution
Figure 9.3 Lymphoma: Global Epidemiological Distribution
Figure 10.1 Overall CD19 Based Therapeutics Market (USD Billion), 2016-2030
Figure 10.2 Evolution of CD19 Based Therapeutics Market: 2020, 2025 and 2030 (Base Scenario, USD Billion)
Figure 10.3 BLINCYTO®: Current Status by Highest Phase of Development
Figure 10.4 BLINCYTO®: Sales Forecast, 2016-2030: Base Scenario (USD Million)
Figure 10.5 CTL019: Current Status by Highest Phase of Development
Figure 10.6 CTL019 Sales Forecast, 2017-2030: Base Scenario (USD Million)
Figure 10.7 KTE-C19: Current Status by Highest Phase of Development
Figure 10.8 KTE-C19 Sales Forecast, 2018-2030: Base Scenario (USD Million)
Figure 10.9 JCAR015: Current Status by Highest Phase of Development
Figure 10.10 JCAR015 Sales Forecast, 2018-2030: Base Scenario (USD Million)
Figure 10.11 Coltuximab Ravtansine: Sales Forecast, 2019-2030: Base Scenario (USD Million)
Figure 10.12 MEDI-551: Current Status by Highest Phase of Development
Figure 10.13 MEDI-551: Sales Forecast, 2020-2030: Base Scenario (USD Million)
Figure 10.14 MOR208: Current Status by Highest Phase of Development
Figure 10.15 MOR208: Sales Forecast, 2020-2030: Base Scenario (USD Million)
Figure 10.16 XmAb®5871: Current Status by Highest Phase of Development
Figure 10.17 XmAb®5871: Sales Forecast, 2021-2030: Base Scenario (USD Million)
Figure 10.18 SGN-CD19A: Current Status by Highest Phase of Development
Figure 10.19 SGN-CD19A: Sales Forecast, 2024-2030: Base Scenario (USD Million)
Figure 11.1 CD19 Therapeutics: Distribution by Hematological Malignancies
Figure 11.2 CD19 Therapeutics: Market Opportunity Among Different Class of Therapeutics
Figure 11.3 CD19 Therapeutics: Market Landscape
Figure 11.4 CD19 Therapeutics Market Forecast: Conservative, Base and Optimistic Scenarios, 2016-2030 (USD Billion)

List of Tables

Table 3.1  List of Approved Antibody Therapies
Table 4.1  CD19 Therapeutics: Pipeline Molecules
Table 4.2  CD19 Therapeutics: Collaborations
Table 5.1 Key Characteristics of CAR-T Cells
Table 5.2 Comparison between 1st and 2nd Generation CARs
Table 5.3 CD19 CAR-T Cells: Preclinical Results
Table 5.4 Grading Criteria for CRS
Table 5.5 Safety Switches under Development for CAR-T Therapy
Table 5.6 CD19 Targeted CAR-T: Pipeline Molecules and Current Status of Development
Table 5.7 CTL019: Clinical Development
Table 5.8 CTL019: Clinical Trial Endpoints (Adult Studies (Leukemia))
Table 5.9 CTL019: Clinical Trial Endpoints (Pediatric Studies)
Table 5.10 CTL019: Clinical Trial Endpoints (Adult Studies (Lymphoma & Multiple Myeloma))
Table 5.11 Novartis: T Cell Immunotherapy Pipeline
Table 5.12 JCAR015: Clinical Development
Table 5.13 JCAR015: Clinical Trial Endpoint
Table 5.14 JCAR015: Dosage Regimen
Table 5.15 Juno Therapeutics: T Cell Immunotherapy Pipeline
Table 5.16 KTE-C19: Clinical Development
Table 5.17 KTE-C19: Clinical Trial Endpoint (Lymphoma)
Table 5.18 KTE-C19: Clinical Trial Endpoint (Leukemia)
Table 5.19 Kite Pharma: CAR-T Pipeline
Table 6.1 Features of Engineered Fc Regions
Table 6.2 CD19 Targeted Engineered Antibodies: Pipeline Molecules and Current Status of Development
Table 6.3 MEDI-551: Clinical Trials
Table 6.4 MEDI-551: Clinical Trial Endpoints (Oncological Indications)
Table 6.5 MEDI-551: Clinical Trial Endpoints (Non-Oncological Indications)
Table 6.6 MEDI-551: Dosage Regimen
Table 6.7 MedImmune: Antibody Based Pipeline
Table 6.8 MOR208: Clinical Development
Table 6.9 MOR208: Clinical Trial Endpoints
Table 6.10 MOR208: Dosage Regimen
Table 6.11 MorphoSys: Antibody Based Pipeline
Table 6.12 Drugs Based on POTELLIGENT® Technology
Table 6.13 Drugs Based on XmAb® Antibody Technology
Table 7.1 CD19 Targeted Bispecific Antibodies: Pipeline Molecules and Current Status of Development
Table 7.2 Blinatumomab: Orphan Drug Designations
Table 7.3 Blinatumomab: Clinical Development
Table 7.4 Blinatumomab: Clinical Trial Endpoints (Relapsed/ Refractory ALL)
Table 7.5 Blinatumomab: Clinical Trial Endpoints (Minimal Residual Disease of B-ALL)
Table 7.6 Blinatumomab: Clinical Trial Endpoints (Relapsed/ Refractory B-ALL)
Table 7.7 Blinatumomab: Clinical Trial Endpoints (Relapsed/ Refractory DLBCL, NHL and Untreated ALL)
Table 7.8 Amgen: Bispecific Antibody Pipeline
Table 7.9 Drugs Based on BiTE® Technology
Table 7.10 Drugs Based on DART® Technology
Table 7.11 Drugs Based on TandAb Technology
Table 8.1 Commonly Used Cytotoxins for ADC Therapeutics
Table 8.2 OEL Bands, SafeBridge Consultants
Table 8.3 CD19 Targeted ADC: Pipeline Molecules and Current Status of Development
Table 8.4 Coltuximab Ravtansine: Clinical Development
Table 8.5 Coltuximab Ravtansine: Clinical Trial Endpoints
Table 8.6 Coltuximab Ravtansine: Dosage Regimen
Table 8.7 ImmunoGen: ADC Pipeline
Table 8.8 Denintuzumab Mafodotin: Clinical Development
Table 8.9 Denintuzumab Mafodotin: Clinical Trial Endpoints
Table 8.10 Denintuzumab Mafodotin: Dosage Regimen
Table 8.11 Seattle Genetics: ADC Pipeline
Table 9.1 Comparison of Hodgkin’s and Non-Hodgkin Lymphoma
Table 9.2 Leukemia: Marketed Targeted Therapeutics
Table 9.3 Lymphoma: Marketed Targeted Therapeutics
Table 9.4 Targets under Investigational Trials for Engineered Antibodies: Hematological Cancer
Table 9.5 Targets under Investigational Trials for Bispecific Antibodies: Hematological Cancer
Table 9.6 Targets under Investigational Trials for ADC: Hematological Cancer
Table 9.7 Targets under Investigational Trials for CAR-T: Hematological Cancer
Table 10.1 Anti-CD19 Therapeutics: Market Potential of Candidates
Table 10.2 BLINCYTO®: Target Patient Population
Table 10.3 CTL019: Target Patient Population
Table 10.4 KTE-C19: Target Patient Population
Table 10.5 JCAR015: Target Patient Population
Table 10.6 Coltuximab Ravtansine: Target Patient Population
Table 10.7 MEDI-551: Target Patient Population
Table 10.8 MOR208: Target Patient Population
Table 10.9 XmAb®5871: Target Patient Population
Table 10.10 SGN-CD19A: Target Patient Population
Table 13.1 Approved Antibody Therapeutics: Distribution by Year of Approval
Table 13.2 CD19 Therapeutics Pipeline: Distribution by Phase of Development (Clinical/ Preclinical)
Table 13.3 CD19 Therapeutics Pipeline: Distribution by Phase of Development (Phase III, Phase II, Phase I, Preclinical)
Table 13.4 CD19 Therapeutics Pipeline: Distribution by Indication
Table 13.5 CD19 Therapeutics Pipeline: Distribution Type of NHL 
Table 13.6 CD19 Therapeutics Pipeline: Distribution by Type of Molecule
Table 13.7 CD19 Therapeutics Pipeline: Distribution by Type of Developer
Table 13.8 CD19 Therapeutics Pipeline: Active Players in the Industry
Table 13.9 Novartis: Revenue, 2010- 2015 (USD Billion)
Table 13.10 Novartis: Sales by Operating Segments, 2015 (USD Billion)
Table 13.11 Juno Therapeutics: VC Funding Instances (USD Million)
Table 13.12 Kite Pharma: VC Funding Instances (USD Million)
Table 13.13 MorphoSys: Revenue, 2011- Q3, 2015 (EUR Million)
Table 13.14 Amgen: Revenues, 2010 – 2015 (USD Billion)
Table 13.15 ImmunoGen: Revenues, 2011 – H1 2016 (USD Million)
Table 13.16 Seattle Genetics: Revenues, 2010-Q3, 2015 (USD Million)
Table 13.17 Overall CD19 Based Therapeutics Market, 2016-2030:  Conservative Scenario, Base Scenario & Optimistic Scenario (USD Billion)
Table 13.18 Evolution of CD19 Based Therapeutics Market: 2020, 2025 and 2030(Base Scenario, USD Billion)
Table 13.19 BLINCYTO®: Sales Forecast, 2016-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.20 CTL019 Sales Forecast, 2017-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.21 KTE-C19 Sales Forecast, 2018-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.22 JCAR015 Sales Forecast, 2018-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.23 Coltuximab Ravtansine: Sales Forecast, 2019-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.24 MEDI-551: Sales Forecast, 2020-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.25 MOR208: Sales Forecast, 2020-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.26 XmAb5871: Sales Forecast, 2021-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.27 SGN-CD19A: Sales Forecast, 2024-2030: Conservative Scenario, Base Scenario & Optimistic Scenario (USD Million)
Table 13.28 CD19 Therapeutics: Distribution by Hematological Malignancies
Table 13.29 CD19 Therapeutics Market Forecast: Conservative, Base and Optimistic Scenarios, 2016, 2023 and 2030 (USD Billion)

Listed Companies

The following companies have been mentioned in this report.

  1. AbDSerotec
  2. Amphivena
  3. ADC Therapeutics
  4. Advaxis
  5. AFA Försäkring AB
  6. Affimed
  7. Agensys
  8. AgonOx
  9. AIMM Therapeutics
  10. Alexion
  11. Amgen
  12. arGEN-X
  13. Astellas Pharma
  14. AstraZeneca
  15. Autolus
  16. Bayer Healthcare
  17. Baylor College of Medicine
  18. Beijing Doing Biomedical Co
  19. Bellicum Pharmaceuticals
  20. Bio-Rad
  21. Biotest
  22. BioWa
  23. Bluebird Bio
  24. BoehringerIngelheim
  25. Cancer Research UK
  26. Cantargia
  27. Celgene
  28. Cellectis
  29. Cellular Biomedicine Group
  30. Cephalon
  31. Center for Cell and Gene Therapy
  32. Chinese PLA General Hospital
  33. City of Hope Medical Center
  34. CSL Limited
  35. Daiichi Sankyo
  36. Dana-Farber Cancer Institute
  37. Dendreon Corporation
  38. Dr Reddy’s Laboratories
  39. European Medical Agency
  40. First Hospital of Jilin University
  41. FivePrime Therapeutics
  42. Formula Pharmaceuticals
  43. Fred Hutchinson Cancer Research Center
  44. Fuda Cancer Hospital
  45. Galapagos
  46. Genentech
  47. Gilead Sciences
  48. GSK
  49. Hospital to Academy of Military Medical Sciences
  50. HumabsBioMed
  51. Human Genome Sciences
  52. Immatics
  53. ImmunoCellular Therapeutics
  54. ImmunoCore
  55. ImmunoGen
  56. Immunomedics
  57. Incyte Corporation
  58. Intrexon Corporation
  59. Janssen
  60. Jichi Medical University
  61. Juno Therapeutics
  62. Kalibios
  63. Karolinska University Hospital
  64. Kite Pharma
  65. Kyowa Hakko Kirin
  66. Lonza
  67. M.D Anderson Cancer Center
  68. Max Delbrück Center for Molecular Medicine in the Helmholtz Association
  69. Medarex (acquired by BMS)
  70. MedImmune
  71. Memorial Sloan Kettering Cancer Center
  72. Merck
  73. Merck KGaA
  74. Merck Serono
  75. Mereo
  76. Mirati Therapeutics
  77. MorphoSys
  78. National Cancer Institute
  79. National Institute of Allergy and Infectious Diseases
  80. National Institute of Health
  81. NKT Therapeutics
  82. Novartis
  83. NovImmune
  84. Novo Nordisk
  85. Ohio State University
  86. OncoMed
  87. OncoTherapy Science
  88. Otsuka Pharmaceuticals
  89. Oxford BioMedica
  90. Oxis Biotech
  91. Oxford BioTherapeutics
  92. Peking University
  93. Pfizer
  94. Roche
  95. Sanofi Aventis
  96. Seattle Children Hospital
  97. Seattle Genetics
  98. Servier
  99. Shanghai GeneChem Co., Ltd.
  100. Shanghai Tongji Hospital
  101. Shenzhen Second People's Hospital
  102. Sidney Kimmel Comprehensive Research Center
  103. Spirogen
  104. Southwest Hospital
  105. Swedish Cancer Society
  106. Takara Bio
  107. Takeda
  108. Teva Pharmaceuticals
  109. Texas Children's Hospital
  110. The Methodist Hospital System
  111. Theravectys
  112. UCB
  113. University College, London
  114. University of California
  115. University of Florida
  116. University of Pennsylvania
  117. Uppsala University
  118. Uppsala University Hospital
  119. US Food and Drug Administration
  120. Ventana
  121. Xencor
  122. Xinqiao Hospital of Chongqing
  123. Ziopharm
  124. Zymeworks

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