CD19 Therapeutics Market, 2016 - 2030

  • ID: 3672810
  • Report
  • Region: Global
  • 302 Pages
  • Roots Analysis
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The Promising Pipeline of Anti-CD19 Drugs Is Expected to Result in a Multi-Billion Dollar Market by 2030

FEATURED COMPANIES

  • AbDSerotec
  • Bellicum Pharmaceuticals
  • FivePrime Therapeutics
  • Jichi Medical University
  • Novartis
  • Servier
  • MORE
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.

Chapter Outlines

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.
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FEATURED COMPANIES

  • AbDSerotec
  • Bellicum Pharmaceuticals
  • FivePrime Therapeutics
  • Jichi Medical University
  • Novartis
  • Servier
  • MORE
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

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)

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)
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FEATURED COMPANIES

  • AbDSerotec
  • Bellicum Pharmaceuticals
  • FivePrime Therapeutics
  • Jichi Medical University
  • Novartis
  • Servier
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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.

Example Highlights

- 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.
- 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).
- CAR-T therapies (constituting 70% of the development pipeline) are the most common, followed by bsAbs (11%), ADCs (7%) and engineered antibodies (7%).
- 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).
- 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.
- 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.

Research Methodology

Most of the data presented in this report has been gathered via secondary research. For all our projects, we also 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 ten 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 sources of information.

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- AbDSerotec
- Amphivena
- ADC Therapeutics
- Advaxis
- AFA Försäkring AB
- Affimed
- Agensys
- AgonOx
- AIMM Therapeutics
- Alexion
- Amgen
- arGEN-X
- Astellas Pharma
- AstraZeneca
- Autolus
- Bayer Healthcare
- Baylor College of Medicine
- Beijing Doing Biomedical Co
- Bellicum Pharmaceuticals
- Bio-Rad
- Biotest
- BioWa
- Bluebird Bio
- BoehringerIngelheim
- Cancer Research UK
- Cantargia
- Celgene
- Cellectis
- Cellular Biomedicine Group
- Cephalon
- Center for Cell and Gene Therapy
- Chinese PLA General Hospital
- City of Hope Medical Center
- CSL Limited
- Daiichi Sankyo
- Dana-Farber Cancer Institute
- Dendreon Corporation
- Dr Reddy’s Laboratories
- European Medical Agency
- First Hospital of Jilin University
- FivePrime Therapeutics
- Formula Pharmaceuticals
- Fred Hutchinson Cancer Research Center
- Fuda Cancer Hospital
- Galapagos
- Genentech
- Gilead Sciences
- GSK
- Hospital to Academy of Military Medical Sciences
- HumabsBioMed
- Human Genome Sciences
- Immatics
- ImmunoCellular Therapeutics
- ImmunoCore
- ImmunoGen
- Immunomedics
- Incyte Corporation
- Intrexon Corporation
- Janssen
- Jichi Medical University
- Juno Therapeutics
- Kalibios
- Karolinska University Hospital
- Kite Pharma
- Kyowa Hakko Kirin
- Lonza
- M.D Anderson Cancer Center
- Max Delbrück Center for Molecular Medicine in the Helmholtz Association
- Medarex (acquired by BMS)
- MedImmune
- Memorial Sloan Kettering Cancer Center
- Merck
- Merck KGaA
- Merck Serono
- Mereo
- Mirati Therapeutics
- MorphoSys
- National Cancer Institute
- National Institute of Allergy and Infectious Diseases
- National Institute of Health
- NKT Therapeutics
- Novartis
- NovImmune
- Novo Nordisk
- Ohio State University
- OncoMed
- OncoTherapy Science
- Otsuka Pharmaceuticals
- Oxford BioMedica
- Oxis Biotech
- Oxford BioTherapeutics
- Peking University
- Pfizer
- Roche
- Sanofi Aventis
- Seattle Children Hospital
- Seattle Genetics
- Servier
- Shanghai GeneChem Co., Ltd.
- Shanghai Tongji Hospital
- Shenzhen Second People's Hospital
- Sidney Kimmel Comprehensive Research Center
- Spirogen
- Southwest Hospital
- Swedish Cancer Society
- Takara Bio
- Takeda
- Teva Pharmaceuticals
- Texas Children's Hospital
- The Methodist Hospital System
- Theravectys
- UCB
- University College, London
- University of California
- University of Florida
- University of Pennsylvania
- Uppsala University
- Uppsala University Hospital
- US Food and Drug Administration
- Ventana
- Xencor
- Xinqiao Hospital of Chongqing
- Ziopharm
- Zymeworks
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