Within the cancer therapeutics space, which today is worth over $160 billion globally, immunotherapeutic drugs have gained worldwide acceptance. This is because they are targeted therapeutics that have high specificity for cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $75 billion in 2019 alone and are forecast to surpass $143 billion in 2025. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 450 pages.
- An overview of cancer immunotherapy that includes: monoclonal antibodies, ADC’s, cancer vaccines and non-specific cancer immunotherapies and CAR T therapies.
- Focus on current trends in cancer immunotherapies that include: anti-PD-1 and anti-PDL1 drugs, Dendritic cell vaccines, T-cell therapies and cancer vaccines.
- Insight into the challenges faced by drug developers, particularly about the success vs. failure ratios in developing cancer immunotherapy drugs.
- Descriptions of more than 23 cancer immunotherapeutics approved and used as targeted drugs
- Insight into the various immunotherapeutics available for specific cancer types.
- Description and data for the prevalence of cancer types that are addressed by cancer immunotherapeutics.
- Overall global cancer therapeutics market, leading market players and the best selling cancer drugs.
- Detailed account of the market for cancer immunotherapeutics by geography, indication, company and individual drugs.
- Profiles, marketed products and products in the pipeline of 79 companies that are located globally
- Summary table to identify the category of immunotherapy drug offered by the 79 companies.
- Specific chapter on the CAR-T industry detailing manufacturing, regulations and pricing
Key Questions Answered in this Report
- What is the global market for cancer immunotherapeutics by product class such as MAbs, vaccines and non-specific immunotherapies, through 2025?
- What is the global market for cancer immunotherapeutics by geography, through 2025?
- What is the global market for cancer immunotherapeutics by indication, through 2025?
- What is the global market for MAbs by type such as naked MAbs and ADCs, through 2025?
- What are the market values for Herceptin, Avastin, Erbitux, Yervoy, Mabthera, Adectris, and Keytruda?
- What is the global market for cancer vaccines?
- What is the global market for cytokines in cancer immunotherapy?
- The projected market values for Nivolumab, Tecentriq, DCVax-L, Imfinzi?
- What immunotherapies have been approved to date?
- What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
- What are naked MAbs and how many of them have been approved by the FDA?
- What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
- What are the common cytotoxic “wareheads” used in ADCs?
- What are the important clinical assets in ADCs?
- How many bispecific MAbs are in late-stage development?
- What are the common side effects of MAbs in cancer immunotherapy?
- What are cancer vaccines and how many of them have been licensed to be marketed?
Table of Contents
1. Executive Summary
1.1 Objectives of the Report
1.2 Key Questions Answered in this Report
1.3 Data Sources and Methodology
2. Cancer Immunotherapy: An Overview
2.1 Human Immune System
2.1.1 Components of Human Immune System
2.2 Types of Cancer Immunotherapy
2.3 Monoclonal Antibodies (Mabs) to Treat Cancer
2.3.1 Most Frequently Targeted Antigens by MAbs
2.4 Types of Monoclonal Antibodies (MAbs)
2.4.1 Naked MAbs
2.4.2 Conjugated Monoclonal Antibodies
184.108.40.206 Components of an Antibody Drug Conjugate (ADC)
220.127.116.11 Mechanism of Action of Antibody Drug Conjugate (ADC)
18.104.22.168 The Cytotoxic Wareheads used in ADCs
22.214.171.124 Successful Cytotoxin Wareheads
126.96.36.199 Developmental Timeline of ADCs
188.8.131.52 Target Antigens for ADCs in Preclinical and Clinical Development
184.108.40.206 Important Clinical Assets in ADCs
2.4.3 Bispecific Monoclonal Antibodies
220.127.116.11 Technology Platforms for the Production of Bispecific MAbs
2.4.4 Safety and Side Effects of MAbs in Cancer Immunotherapy
2.5 Cancer Vaccines
2.5.1 Cancer Vaccines in Development
2.6 Non-Specific Cancer Immunotherapies and Adjuvants
2.6.2 Interferon (IFN)
2.7 New Frontiers in Cancer Immunotherapy Research
2.7.1 Drugs for Targeting Immune Checkpoints
18.104.22.168 Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4)
22.214.171.124 Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1)
126.96.36.199 Major Checkpoint Inhibitors in Clinical Development
2.7.2 Chimeric Antigen Receptor (CAR) T Cell Therapy
2.7.3 Tumor-Infiltrating Lymphocytes (TILs) and Interleukin-2 (IL-2)
2.8 Cancer Immunotherapy: Timeline of Progress
3. Current Status of Cancer Immunotherapy: An Overview
3.1 Programmed Death (PD-1) Inhibitors
3.1.1 Important Events and Advantages for Nivolumab in Melanoma Indication
3.1.2 Important Events and Advantages for Nivolumab in Non-Small Cell Lung Cancer
3.1.3 Important Events and Advantages for Nivolumab in Renal Cell Cancer
3.1.4 Nivolumab Studies for Melanoma
3.1.5 Nivolumab Studies for Non-Small Cell Lung Cancer (NSCLC)
3.1.6 Nivolumab Studies for Renal Cell Cancer (RCC)
3.2 MK-3475 (Pembrolizumab)
3.2.1 Important Events and Advantages for MK-3475 in Melanoma
3.2.2 Important Events and Advantages for MK-3475 in NSCLC
3.2.3 Important Events for MK-3475 in RCC
3.3 RG7446 from Roche
3.3.1 Important Events for RG7446 in Melanoma
3.3.2 Important Events and Advantages for RG7446 in NSCLC
3.3.3 Important Event for RG7446 in RCC
3.3.4 RG7446 Studies in NSCLC
3.3.5 RG7446 Studies in RCC
3.3.6 RG7446 Study in RCC
3.4 Pidilizumab from CureTech
3.5 An Overview of Anti-PD-1 Clinical Development
3.5.1 Other Checkpoint Inhibitors in Development
3.6 Studies with Yervoy (Ipilimumab)
3.7 Studies with Tremelimumab
3.9 TIM3 Antibody
3.11 ImmuTune IMP701 and ImmuFact IMP321
3.12 Dendritic Cell Therapies
3.12.1 Provenge (Sipuleucel-T)
3.12.2 AGS-003 from Argos Therapeutics
3.12.3 DCP-001 from DCPrime
3.12.4 DC-Vax from Northwest Biotherapeutics
3.13 Chimeric Antigen Receptor T-Cells (CAR-T) Therapies
3.13.2 Chimeric Antigen Receptors (CAR) Program by Juno
3.13.3 Chimeric Antigen Receptor (CAR) T-Cell Program by Bluebird Bio
3.13.4 UCART19 from Cellectis
3.13.5 Chimeric Immune Receptor (CIR) T-Cells from Abramson Cancer Center
3.13.6 CD19 eACT CAR-T Therapy from Kite Pharma
3.13.7 Autologous CAR-T Program for Breast Cancer from Adaptimmune
3.14 Cancer Vaccines
3.14.2 MAGE-A3 Antigen-Specific Cancer Immunotherapeutic
3.14.4 IDO Inhibitors
3.14.5 Indoximod and NLG-919 (INCY)
3.14.6 INCB24360 (INCY)
3.14.7 deCellVax (BMSN)
3.15 Miscellaneous Immunotherapies
3.15.1 Contego (Lion Biotechnologies)
3.15.2 TG4010 (Transgene)
3.16 Most Valuable R&D Projects in Cancer Immunotherapy
3.16.1 Nivolumab (Opdivo)
4. Challenges in Cancer Medicine Research: An Overview
4.1 Years of Failures and Emerging Successes in Melanoma Medicine Research
4.1.1 Future Outlook for Melanoma Drugs
4.2 A New Era for Lung Cancer Medicines
4.2.1 Progresses Made in Lung Cancer Medicine Research
4.2.2 Successes and Failures in Lung Cancer Medicine Development
4.2.3 Future Outlook for Lung Cancer Medicines
4.3 Ray of Hope for Brain Cancer Patients
4.3.1 Progress made for Brain Cancer Treatment in Recent Years
4.3.2 Successes and Failures in Brain Cancer Drug Development
5. Cancer Immunotherapeutic Products: An Overview
5.1 I-Labelled Tositumomab (Bexxar)
5.2 Y-Labelled Ibritumomab (Zevalin)
5.3 Alemtuzumab (Campath)
5.4 Adotrastuzumab Emtansine (Kadcyla)
5.5 Bacillus Calmette-Guerin (BCG)
5.6 Bevacizumab (Avastin)
5.7 Brentuximab Vedotin (Adcetris)
5.8 Cetuximab (Erbitux)
5.10 Denileukin Diftitox (Ontak)
5.12 Gemtuzumab (Mylotarg)
5.13 Hepatitis B Vaccine
5.14 Interferon Alfa (IFN-alfa)
5.15 Interleukin-2 (IL-2)
5.16 Ipilimumab (Yervoy)
5.17 Ofatumumab (Arzerra)
5.18 Panitumumab (Vectibix)
5.19 Pembrolizumab (Keytruda)
5.20 Rituximab (Mabthera)
5.21 Sargramostim (Leukine)
5.22 Sipuleucel-T (Provenge)
5.23 Trastuzumab (Herceptin)
6. Available Immunotherapies for Cancer by Disease Type: An Overview
6.1 Melanoma Skin Cancer and Immunotherapy
6.1.1 Ipilimumab (Yervoy) for Advanced Melanoma
6.1.2 PD-1 Inhibitors (Keytruda and Opdivo) for Advanced Melanoma
6.1.3 Cytokines for Advanced Melanoma
6.1.4 Interferon Alfa as Adjuvant Therapy for Melanoma
6.1.5 Bacille Calmette-Guerin (BCG) Vaccine for Melanoma
6.1.6 Imiquimod (zyclara) Cream for Melanoma
6.2 Breast Cancer and Immunotherapy
6.2.1 Promising Therapeutic Vaccine Product Candidates for Breast Cancer
6.2.2 Promising Checkpoint Inhibiting Product Candidates for Breast Cancer
6.2.3 Promising Adoptive T Cell Therapy Product Candidates for Breast Cancer
6.2.4 Promising Antibody Product Candidates for Breast Cancer
6.3 Immunotherapy for Prostate Cancer
6.3.1 Therapeutic Vaccines for Prostate Cancer
6.3.2 Checkpoint Inhibitors for Prostate Cancer
6.3.3 Adoptive Cell Therapy for Prostate Cancer
6.4 Immunotherapy for Lung Cancer
6.4.1 Monoclonal Antibodies for Lung Cancer
188.8.131.52 Promising MAb Product Candidates for Lung Cancer
184.108.40.206 Checkpoint Inhibitors for Lung Cancer
220.127.116.11 Therapeutic Vaccines for Lung Cancer
18.104.22.168 Promising Adoptive T Cell Transfer Product Candidates for Lung Cancer
6.5 Immunotherapy for Colorectal Cancer
6.5.1 Promising Monoclonal Antibody Product Candidates for Colorectal Cancer
6.5.2 Trials Using Checkpoint Inhibitors and Immune Modulators for Colorectal Cancer
6.5.3 Clinical Trials for Vaccines Indicated for Colorectal Cancer
6.5.4 Adoptive Cell Therapy for Colorectal Cancer
6.5.5 Oncolytic Virus Therapy for Colorectal Cancer
6.5.6 Adjuvant Immunotherapy for Colorectal Cancer
6.5.7 Cytokines for Colorectal Cancer
6.6 Immunotherapies in Development for Lymphoma
6.6.1 Therapeutic Vaccines in Development for Lymphoma
6.6.2 Checkpoint Inhibitors for Lymphoma
6.6.3 Adoptive T Cell Transfer for Lymphoma
6.6.4 Monoclonal Antibodies for Lymphoma
6.7 Immunotherapy for Kidney Cancer
6.7.1 Checkpoint Inhibitors for Kidney Cancer
6.7.2 Vaccines for Kidney Cancer
6.7.3 Adoptive Cell Therapy for Kidney Cancer
6.8 Dominance of MAbs and Vaccines in Cancer Clinical Research
6.9 Oncology Biologics Losing Patent Protection
7. Cancer Incidence and Mortality: An Overview
7.1 Global Economic Burden of Cancer
7.2 Global Burden of Cancer
7.3 Top Five Most Frequent Cancers, Globally
7.3.1 Global Prevalence of Colorectal, Breast and Lung Cancers
7.3.2 Percentage of Top Three Cancers Diagnosed Globally
22.214.171.124 Mortality due to Lung, Liver and Stomach Cancers
126.96.36.199 Percentage of Death due to Lung, Liver and Stomach Cancers
7.4 Cancer Deaths in Women
7.5 Prevalence and Mortality for Cancer Types Addressed by Immunotherapy
7.5.1 Breast Cancer
188.8.131.52 Worldwide Incidence of Breast Cancer and Mortality Rate by Geography
184.108.40.206 Female Breast Cancer Incidence in the U.S
220.127.116.11 Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S
18.104.22.168 Breast Cancer Incidence in Canada
22.214.171.124 Breast Cancer Incidence and Mortality in Latin America
126.96.36.199 Breast Cancer Incidence and Mortality in Europe
188.8.131.52 Breast Cancer Incidence in Asia/Pacific
184.108.40.206 Breast Cancer Incidence by Country
7.5.2 Gastric Cancer (Stomach Cancer)
220.127.116.11 Incidence of Gastric Cancer in Top 15 Countries
7.5.3 Colorectal Cancer
18.104.22.168 Global Incidence of Colorectal Cancer
22.214.171.124 Worldwide Variations in the Incidence of Colorectal Cancer
126.96.36.199 Risk Factors for Colorectal Cancer
188.8.131.52 Colorectal Cancer Screening in the U.S
184.108.40.206 Colorectal Cancer Incidence Rates in the U.S. by State
220.127.116.11 Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States
7.5.4 Lung Cancer
18.104.22.168 Non-Small Cell Lung Cancer (NSCLC)
22.214.171.124 Global NSCLC Incidence
126.96.36.199 Lung Cancer in the Americas by Gender
188.8.131.52 Tobacco Use and Lung Cancer
184.108.40.206 Current Therapeutic Options for Lung Cancer
220.127.116.11 Global Incidence of Glioblastoma
7.5.6 Kidney Cancer
18.104.22.168 Global Incidence of Kidney Cancer
7.5.7 Blood Cancer
22.214.171.124 Blood Cancer in the U.S
7.5.8 Cervical Cancer
126.96.36.199 Global Incidence of Cervical Cancer
7.5.9 Prostate Cancer
188.8.131.52 Global Incidence of Prostate Cancer
184.108.40.206 Prostate Cancer Incidence and Mortality by Geography
220.127.116.11 Prostrate Cancer in the U. S
18.104.22.168 Skin Cancer in the U. S
8. Market Analysis
8.1 Global Oncology Market
8.2 Top Ten Companies in Oncology Drug Sales
8.3 Top Five Oncology Drugs
8.4 Global Oncology Therapeutics Market by Cancer Type
9. Market for Cancer Immunotherapy
9.1 Key Drivers
9.2 Global Market for Cancer Immunotherapeutics
9.3 Global Market for Cancer Immunotherapy by Product Class
9.4 Global Market for Immunotherapy Drugs by Cancer Type
9.5 Global Market for Monoclonal Antibodies for Cancer by Type
9.5.1 Best Selling MAbs
22.214.171.124 Market Forecast for Herceptin
126.96.36.199 Market Value and Forecast for Avastin
188.8.131.52 Global Market for Erbitux
184.108.40.206 Global Market for Yervoy
220.127.116.11 Global Market for Mabthera
9.5.2 Global Market for Antibody Drug Conjugates (ADCs)
18.104.22.168 Global Market for Adcetris
22.214.171.124 Global Market for Keytruda
9.6 Global Market for Cancer Vaccines
9.6.1 Global Market for Cancer Vaccines by Type
9.7 Global Market for Non-Specific Cancer Immunotherapeutics
9.8 Market Values for Selected Forthcoming Cancer Immunotherapeutics
9.8.1 Market Value for Nivolumab (Opdivo)
9.8.2 Market Value for RG7446
9.8.3 Market Value for DCVax-L
9.8.4 Market Value for MEDI4736
9.8.5 High Cost of MAbs
10. Company Profiles
10.1 Ablynx NV
10.2 Activartis Biotech GmbH
10.2.1 GBM Vax Study
10.3 Advaxis Inc
10.3.1 Advaxis’ Technology
10.3.2 Advaxis’ Product Pipeline
10.4 Aduro BioTech Inc
10.4.1 Aduro’s Technology
10.5 Agenus Inc
10.5.1 QS-21 Stimulon
10.6 AlphaVax Inc
10.6.1 Alpha Vax’s Technology
10.7 A. Menarini Industrie Farmaceutiche Riunite Srl
10.8 Amgen Inc
10.8.1 Vectibix (panitumumab)
10.8.2 Blinatumomab (Blincyto)
10.9 Antigen Express Inc
10.9.1 Li-Key Hybrid Vaccines (AE37)
10.10 Argos Therapeutics Inc
10.11 Bavarian Nordic A/S
10.11.3 MVA-BN PRP
10.11.4 MVA-BN HER2
10.11.4.1 MVA-BN Brachyury
10.12 Bellicum Pharmaceuticals Inc
10.13 Biogen Idec Inc
10.13.1 Rituxan (Rituximab)
10.13.2 Gazyva (Obinutuzumab)
10.14 Biovest International Inc
10.15 Bristol-Myers Squibb Company
10.15.1 Erbitux (cetuximab)
10.15.2 OPDIVO (nivolumab)
10.15.3 Yervoy (ipilimumab)
10.17 Cellerant Therapeutics Inc
10.18 Celldex Therapeutics
10.18.2 Glembatumumab vedotin (CDX-011)
10.18.3 Varlilumab (CDX-1127)
10.19 CEL-SCI Corp.
10.20 CureTech Ltd.
10.20.1 Pidilizumab (CT-011)
10.21 Delta-Vir GmbH
10.22 Dendreon Corp.
10.22.1 Provenge (Sipuleucel-T)
10.23 DenDrit Biotech USA
10.24 DNAtrix Inc
10.25 Eli Lilly and Co.
10.25.1 Erbitux (Cetuximab)
10.26 EMD Serono Inc
10.27 Etubics Corp.
10.28 Galena Biopharma Inc
10.29 Genentech Inc
10.29.1 Avastin (bevacizumab) for Metastatic Colorectal Cancer
10.29.1.1 Avastin and Interferon Alfa for Metastatic Kidney Cancer
10.29.1.2 Avastin for Metastatic NLCLC
10.29.2 Gazyva (obinutuzumab) for Chronic Lymphocytic Leukemia
10.29.3 Herceptin (trastuzumab) for Breast Cancer
10.29.3.1 Herceptin and Chemotherapy for Gastric Cancer
10.29.4 Kadcyla (ado-trastuzumab emtansine)
10.29.5 Perjeta (pertuzumab)
10.29.6 Rituxan (rituximab)
10.29.7 Genentech’s Cancer Immunotherapy Pipeline Products
10.30 Genmab AS
10.31.1 Arzerra (Ofatumumab)
10.32 Gliknik Inc
10.33 GlobeImmune Inc
10.34 Heat Biologics Inc
10.35 Immatics Biotechnologies GmbH
10.36 ImmunoCellular Therapeutics Ltd.
10.37 Immunocore Ltd.
10.37.1 Product Pipeline
10.38 ImmunoFrontier Inc
10.39 ImmunoGen Inc
10.40 Immunomedics Inc
10.41 Immunotope Inc
10.41.1 IMT-1012 Immunotherapeutic Vaccine
10.42 Immunovaccine Inc
10.43 Inovio Pharmaceuticals Inc
10.44 Janssen Biotech Inc
10.45 Juno Therapeutics Inc
10.46 Kite Pharma Inc
10.46.1 Kite Pharma’s Technology
10.46.1.1 eACT (engineered Autologous Cell Therapy)
10.46.1.2 DC-Ad GM-CAIX
10.47 MabVax Therapeutics Holdings Inc
10.48 MedImmune LLC
10.49 Merck & Co., Inc
10.49.1 Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine
10.49.2 Keytruda (Pembrolizumab)
10.50 Merrimack Pharmaceuticals Inc
10.51 Morphotek Inc
10.51.1 Farletuzumab (MORAb-003)
10.51.2 Amatuximab (MORAb-009)
10.51.3 Ontuxizumab (MORAb-004)
10.52 NewLink Genetics Corp.
10.53 Northwest Biotherapeutics Inc
10.54 NovaRx Corp.
10.55 OncoPep Inc
10.56 Oncothyreon Inc
10.57 OSE Pharma SA
10.58 Oxford BioTherapeutics Ltd.
10.58.1.1 OGAP – Cancer Targeting
10.58.1.2 Antibody Development
10.58.1.3 Antibody “arming”
10.58.2 Lead Programs
10.59 Pique Therapeutics
10.60 Polynoma LLC
10.60.1 MAVIS Trial
10.61 Prima BioMed Ltd.
10.62 Progenics Pharmaceuticals Inc
10.62.1 PSMA Targeted Imaging Compound (1404)
10.62.2 PSMA ADC Therapeutic
10.62.3 Small Molecule Therapeutic (1095)
10.63 Regen Biopharma Inc
10.63.3 Diffron C
10.64 Roche Holdings Inc
10.64.1 Avastin (Bevacizumab)
10.64.2 Gazyva/Gazyvaro (Obinutuzumab; GA101)
10.64.3 Herceptin (Trastuzumab)
10.64.4 Kadcyla (Trastuzumabum emtansinum)
10.64.5 Mabthera (Rituximab)
10.64.6 Perjeta (Pertuzumab)
10.65 Seattle Genetics Inc
10.65.1 Adcetris (Brentuximab vedotin)
10.65.2 Seattle Genetics’ Collaborarator Pipeline
10.66 Sorrento Therapeutics Inc
10.66.1 Sorrento’s Antibody Technologies
10.66.1.2 Antibody Drug Conjugates (ADCs)
10.67 Spectrum Pharmaceuticals Inc
10.68 Synthon Pharmaceuticals Inc
10.69 TapImmune Inc
10.70 ThioLogics Ltd.
10.71 Transgene SA
10.72 TVAX Biomedical Inc
10.73 Vaccinogen Inc
10.74 Viventia Biotechnologies Inc
10.75 Wilex AG
10.76 Ziopharm Oncology Inc
11. Cancer Immunotherapy Market Participants by Product Segment
12. CAR T Therapy
12.1 Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy
12.1.1 Clinical Status of CD19 CAR-T Cells To Date
12.1.2 Clinical and Regulatory Challenges for Development of CAR T Cells
12.1.3 Key Regulatory Challenges Associated with CAR-T Development
12.1.4 Summary of Select CAR-T Products by Juno, Novartis and Kite
12.1.5 Clinical Benefit Versus Toxicity in CD19-Directed ALL Clinical Trials
12.1.6 How to Manage Toxicity of CAR-T Therapy
13. Regulations Pertaining to Immunotherapy Regulation in the USA
13.1 Center for Biologics Evaluation and Research (CBER)
13.1.1 Compliance and Surveillance
13.1.2 Extra Resources on Immunotherapeutics from the FDA
13.1.3 Cellular, Tissue and Gene Therapies Advisory Committee
13.1.4 Consumer Affairs Branch (CBER) Contact in FDA
13.1.5 FDA Regulations Pertaining to Immunotherapies
13.1.6 Case Study Ovarian Cancer Immunotherapy Regulations
126.96.36.199 Adverse Effects
13.1.7 Trial Design Considerations for Immunotherapy
13.1.8 Development of Immune-Related Response Criteria (irRC) & Clinical Endpoints Specific to Immunotherapies
14. Regulations for Immunotherapy in Japan
14.1 PMDA and Immunotherapy
12.1.1 Increasing the Efficiency in Immunotherapy Regulatory Review
12.1.2 Forerunner Review Assignment System
12.1.3 Revised Guidelines for Clinical Evaluation of Anti‐Malignant Tumor Agents
12.1.4 Key Contacts Within the PMDA for Immunotherapeutics
15. European Regulation and Immunotherapeutics
15.2 Challenges for Immunotherapy in EMEA
15.2.1 EMA Status on Potency Testing
188.8.131.52 In Vivo Potency Testing
184.108.40.206 In Vitro Potency Testing
220.127.116.11 Viable Cell Count
18.104.22.168 Autologous Cell Based Products
22.214.171.124 Reference Preparation
126.96.36.199 Adjuvant Containing Immunotherapy Products
15.2.2 EMA Status on Identifying hyper, Hypo or non-Responders
15.3 Challenges Relating to Biomarkers in Immunotherapy
15.4 Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy
15.5 Estimating Optimal Cut-Off Parameters
15.6 EU-Approved Immunotherapies in Melanoma
15.7 Key Contacts Within EMA for Immunotherapeutics
16. Manufacturing of Immunotherapies
16.2 Generation of CAR-Modified T Cells
16.2.1 What Co-Stimulation and Activity Domain is Optimal to Use?
16.2.2 Optimizing Cell Culture Media
16.2.3 Manufacturing Lentiviral Vectors
16.2.4 Detection of Integrated CAR-Expressing Vectors
16.2.5 Donor Lymphocyte Infusion Procedure
16.2.6 Ex Vivo Costimulation & Expansion of Donor T Cells
16.2.7 Infusion to the Patient
16.3 Manufacturing Devices and Instruments Required for Immunotherapy Production
16.3.2 Cell Counters and Analyzer
16.3.3 Cell Seeding, Growth and Propagation
16.4 Good Manufacturing Procedure (GMP) for Immunotherapy
16.5 Case Study Production of Lentivirus Induced Dendritic Cells under GMP Conditions
16.6 Quality Control
16.7 Regulatory Affairs
16.8 Key Challenges in Manufacturing
16.8.1 Electroporation of T-cells
16.8.2 Allogenic CAR T cells
16.8.3 Relapse Rates are Critical
16.8.4 Antigen Negative Relapse
16.8.5 Incorporating Suicide Genes
16.8.16 Automation in Cell Therapy Manufacturing
16.8.17 Autologous Cell Therapy Manufacture Scale Up
17. Supply Chain & Logistics
17.2 Case Study: Juno Therapeutics
18. Pricing & Cost Analysis
18.2 CAR T Therapy Market Evaluation
19. Current Deals Within the CAR T Market
20. CAR T Therapy Company Case Studies
20.1 Juno Therapeutics
20.2 Kite Pharma
Immuno-Oncology Highlights and Approvals over the last number of years
Future Directions of Immuno-Oncology
INDEX OF FIGURES
Figure 2.1: Components of an Antibody Drug Conjugate (ADC)
Figure 2.2: Mechanism of Action of Antibody Drug Conjugates
Figure 2.3: Ranking of Commonly Used Cytotoxin Warheads
Figure 4.1: Number of Successful and Unsuccessful Melanoma Drugs
Figure 4.2: Successes and Failures in Lung Cancer Medicine Development
Figure 4.3: Successes and Failures in Brain Cancer Drug Development
Figure 5.1: Ibritumomab Linked to Yttrium Radfionucleotide
Figure 5.2: Kadcyla (Trastuzumab + DMI)
Figure 6.1: Dominance of MAbs and Vaccines in Cancer Clinical Research
Figure 7.1: Global Economic Burden of Cancer
Figure 7.2: Number of Colorectal, Breast and Lung Cancer Cases Diagnosed Globally
Figure 7.3 Percentage of Top Three Cancers Diagnosed Globally
Figure 7.4: Number of Deaths due to Lung, Liver and Stomach Cancers Globally
Figure 7.5: Percentage of Deaths due to Lung, Liver and Stomach Cancers
Figure 7.6: Global Cancer Deaths in Women by Type of Cancer
Figure 7.7: Worldwide Incidence of Female Breast Cancer and Mortality Rate by Geography
Figure 7.8: Five Year Relative US Breast Cancer Survival Rates by Stage at Diagnosis & Age
Figure 7.9: Breast Cancer Incidence and Mortality in Latin America
Figure 7.10: Breast Cancer Incidence and Mortality in Europe
Figure 7.11: Breast Cancer Incidence Rates in Asia/Pacific Region
Figure 7.12: Top 15 Countries in Gastric Cancer Incidence
Figure 7.13: Top 15 Countries in Colorectal Cancer Incidence
Figure 7.14: Adults Aged 50-75 Years (%) That are Up-to-Date with Colorectal Screening Tests by State in the U.S
Figure 7.15 Colorectal Cancer Incidence Rates (per 100,000) by State in the U.S
Figure 7.16: Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States
Figure 7.17: Top 15 Countries with Lung Cancer
Figure 7.18: Global NSCLC Incidence
Figure 7.19: Number of Smokers in China, India, Russia, the U.K. and U.S
Figure 7.20: Global Incidence of Glioblastoma
Figure 7.21: Global Incidence of Kidney Cancer
Figure 7.22: Top 15 Countries in Leukemia Mortality
Figure 7.23: Five Year Survival Rates in the U.S. for Blood Cancer Patients
Figure 7.24 Top 15 Countries in Cervical Cancer
Figure 7.25: Top 15 Countries with Prostate Cancer
Figure 7.26: Skin Cancer Death Rates for Top 15 Countries
Figure 8.1: Global Market for Oncology Drugs to 2025
Figure 8.2: Global Oncology Drug Sales by Top Companies, Through 2025
Figure 8.3: Top Oncology Drugs, Through 2025
Figure 8.4: Global Oncology Therapeutics Market by Cancer Type
Figure 9.1: Global Cancer Immunotherapy Market, Through 2025
Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2025
Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025
Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025
Figure 9.5: Global and U.S. Market for Herceptin, Through 2025
Figure 9.6: Global and U.S. Market for Avastin, Through 2025
Figure 9.7: Global Market for Erbitux, Through 2025
Figure 9.8: Global Market for Yervoy, Through 2025
Figure 9.9: Global Market for Mabthera, Through 2025
Figure 9.10: Global Market for Adcetris, Through 2025
Figure 9.11: Global Market for Keytruda, Through 2025
Figure 9.12: Global Market for Cancer Vaccines, Through 2025
Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2025
Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2025
Figure 13.1: Clinical Regulatory Pathway – Conventional Route
Figure 13.2: Clinical Regulatory Pathway – Option for Rapid Translation
Figure 14.1: PMDA Total Review Period of Standard Drugs
Figure 14.2: PMDA Total Review Period of Priority Drugs
Figure 14.3: Number of Approved Recombinant Protein Products by PMDA
Figure 14.4: Forerunner Review Assignment System Timeframe
Figure 14.5: Adaptive Licensing and Accelerated Approval in Japan‐US‐EU
Figure 15.1: CheckMate 066 Clinical Trial
Figure 15.2: CheckMate 037 Clinical Trial
Figure 16.1: Method of Generating CAR-Modified T Cells
Figure 16.2: Clinical Activity, Cost Structure Patient Flow Chart of CAR-T Therapy
Figure 16.3: Allogenic Versus Autologous Cell Manufacturing
Figure 17.1: Streptamer® - Based Magnetic Bead Cell Isolation
Figure 18.1: Annual Cost of Patented Cancer Therapeutics from 2000 to Today
Figure 18.2: Cost of Nivolumab, Pembrolizumab & Ipilimumab per mg
Figure 20.1 Juno Therapeutics CAR T Therapeutic Molecular Design
Figure 20.2 Juno Therapeutics CAR T Therapeutic Mechanism of Action
Figure 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology Mechanism of Action
Figure 20.4: Streptamer® -Based Magnetic Bead Cell Isolation
Figure 20.5 Kite Pharma CAR Technology
Figure 20.6 Kite Pharma TCR Technology
INDEX OF TABLES
Table 2.1: Types of Immune Cells and their Functions
Table 2.2: FDA-Approved Cancer Immunotherapies
Table 2.3: FDA-Approved Monoclonal Antibodies (MAbs) to Treat Cancer
Table 2.4: Most Frequently Targeted Antigens by MAbs
Table 2.5: FDA-Approved Monoclonal Antibodies
Table 2.6: Cytotoxic Warheads Used in ADCs
Table 2.7: Targeted Indications for ADCs
Table 2.8: Antibody Drug Conjugates: Developmental Timeline
Table 2.9: Target Antigens for ADCs in Preclinical and Clinical Development
Table 2.10: Current ADCs Launched, Withdrawn and in Phase I/II/III Trials by Sponsor, Indication, Antigen, Cytotoxin and Linker
Table 2.11: MAb Products and Candidates that Recruit T Cells
Table 2.12: Bispecific MAbs in Clinical Trials Targeting Cancer by Indication and Company
Table 2.13: Bispecific Antibody Technology Platforms
Table 2.14: Side Effects of Some of the Approved Cancer Immunotherapy MAbs
Table 2.15: FDA-Approved Cancer Vaccines
Table 2.16: Cancer Vaccines in Development
Table 2.17: FDA-Approved Cytokines for Cancer Immunotherapy
Table 2.18: Cancer Indications Approved for IFN-alfa
Table 2.19: FDA-Approved Immune Checkpoint Modulators
Table 2.20: Immune Checkpoint Inhibitors in Clinical Development
Table 2.21: Cancer Immunotherapy: Timeline of Progress
Table 3.1: PD-1 Therapies Targeting either the PD-L1/L2 or PD-1 Receptor
Table 3.2: Overview of Clinical Trial Landscape for Top Five Anti-PD-1 and Anti-PD-L1 Drugs
Table 3.3: Nivolumab Efficacy from Expansion Cohorts of Study 003
Table 3.4: Key Clinical Trial Data of Pembrolizumab in Melanoma
Table 3.5: IMpower132 Phase III Data of Tecentriq, (atezolizumab RG7446) in NSCLC Patients
Table 3.6: Phase III IMmotion151 study results of Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) in Renal Cell Carcinoma
Table 3.7: Phase I Melanoma Data for Tecentriq
Table 3.8: Phase II Data for Pidilizumab in Diffuse Large B Cell Lymphoma (DLBCL)
Table 3.9: Phase II Melanoma Data for Pidilizumab
Table 3.10: An Overview of Anti-PD-1 Development by Company, Drug Candidate, Indication and Clinical Phase
Table 3.11: Clinical Development of CTLA-4, TIM3, and LAG3 Checkpoint Inhibitors by Company, Drug Candidate, Indication and Clinical Trial Stage
Table 3.12: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma
Table 3.13: Updated Data from Phase III Clinical Study 024 for Yervoy
Table 3.14: Data from the Failed Phase III Study of Tremelimumab for Melanoma
Table 3.15: An Overview of Clinical Development of Dendritic Cell Therapies by Company, Drug Candidate, Indication and Clinical Phase
Table 3.16: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma
Table 3.17: Phase I/Iia Results from Kite Pharma’s CAR-T Therapy
Table 3.18: Cancer Vaccines in Development by Company, Drug Candidate, Indication & Clinical Phase
Table 3.19: Advaxis Phase II Results for Cervical Cancer Patients in India
Table 3.20: Phase II Data for Contego
Table 3.21: Valuable R&D Projects in Cancer Immunotherapy
Table 6.1: Cancer Types Addressed by Immunotherapies by Drug, Trade Name and Company
Table 6.2: Oncology Drugs Losing Patent Protection by 2020 by Product, U.S. Expiry Date and E.U. Expiry Date
Table 7.1: Global Cancer Statistics – Key Facts
Table 7.2: Top Five Most Frequent Cancers, Globally
Table 7.3: Estimated Breast Cancer Cases and Deaths in the U.S. by Age
Table 7.4: Estimated Canadian Breast Cancer Statistics
Table 7.5: Age-Standardized Breast Cancer Incidence Rate per 100,000 Women by Country
Table 7.6: Global Colorectal Cancer Incidence and Mortality Rates by Gender per 100,000 people
Table 7.7: Risk Factors for Colorectal Cancer
Table 7.8: Lung Cancer Incidence and Mortality Rate in Americas by Gender
Table 7.9: Current Therapeutic Options for Lung Cancer
Table 7.10: Estimated Number of New Leukemia Cases in the U.S.
Table 7.11: Estimated Deaths in the U.S. from Leukemia
Table 7.12: Estimated Deaths from HL and NHL in the U.S.
Table 7.13: Estimated Incidence and Deaths for Myeloma in the U.S.
Table 7.14 Global Prostate Cancer Incidence and Mortality Rates by Geography
Table 7.15: Incidence and Mortality Rates of Prostate Cancer in Americas
Table 7.16: Incidence and Mortality Rates for Melanoma in Americas
Table 8.1: Global Market for Oncology Drugs Through 2025
Table 8.2: Top Ten Companies in Oncology Sales, Through 2025
Table 8.3: Top Five Oncology Drugs, Through 2025
Table 9.1: Global Cancer Immunotherapy Market, Through 2025
Table 9.2: Global Market for Immunotherapy by Product Class, Through 2025
Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025
Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025
Table 9.5: Global and U.S. Market for Herceptin, Through 2025
Table 9.6: Global and U.S. Market for Avastin, Through 2025
Table 9.7: Global Market for Cancer Vaccines, Through 2025
Table 9.8: Global Market for Cancer Vaccines by Type, Through 2025
Table 9.9: Projected Market for the Forthcoming DCVax-L and Imfinzi
Table 9.10: Annual Cost of MAbs in the U.S. by Product, Indication and Biomarker
Table 10.1: Ablynx’s Product Pipeline
Table 10.2: Aduro’s Product Pipeline
Table 10.3: Agenus’ Product Pipeline
Table 10.4: AlphaVax Cancer Immunology Product Pipeline
Table 10.5: Amgen’s Product Pipeline
Table 10.6: Antigen Express’ Cancer Therapeutic Pipeline
Table 10.7: Argos’ Cancer Product Pipeline
Table 10.8: Bavarian Nordic’s Product Pipenine
Table 10.9: Bellicum’s Pipeline Product Candidatea
Table 10.10: Biogen’s Oncology Pipeline
Table 10.11: Bristol-Myers Squibb’s Pipeline Products in Cancer Immunotherapy
Table 10.12: Cellectis’ Products in Development
Table 10.13: Cellerant’s Product Pipeline
Table 10.14: Celldex’s Therapeutic Pipeline
Table 10.15: CEL-SCI’s Immunotherapy Products in Development
Table 10.16: EMD Serono’s Product Pipeline
Table 10.17: Etubic’s Product Pipeline
Table 10.18: Galena’s Product Pipeline
Table 10.19: Genentech’s Cancer Immunotherapy Pipeline Products
Table 10.20: Genmab’s Products in Development
Table 10.21: Gliknik’s Product Pipeline
Table 10.22: GlobeImmune’s Product Pipeline
Table 10.23: Heat Biologic’s Product Pipeline
Table 10.24: Immatics Biotechnology’s Product Pipeline
Table 10.25: ImmunoCellular’s Product Pipeline
Table 10.26: Immunomedics’ Late-Stage Antibody-Based Therapies
Table 10.27: Immunovaccine’s Product Pipeline
Table 10.28: Inovio Pharmaceuticals Product Pipeline
Table 10.29: Juno Therapeutics’ Current Pipeline
Table 10.30: Kite Pharma’s Product Pipeline
Table 10.31: MabVax’s Product Pipeline
Table 10.32: MedImmune’s Products in Development
Table 10.33: Merck’s Pipeline of Cancer Immunotherapy Products
Table 10.34: Merrimack’s Product Pipeline
Table 10.35: NewLink Genetics’ Product Pipeline
Table 10.36: Northwest’s Product Pipeline
Table 10.37: NovaRx Clinical Development Pipeline
Table 10.38: Oncothyreon’s Immunotherapy Product Pipeline
Table 10.39: OSE Pharma’s Product Pipeline
Table 10.40: Pique Therapeutics’ Product Pipeline
Table 10.41: Prima BioMed’s Pipeline
Table 10.42: Progenics Pharmaceutical’s Pipeline
Table 10.43: Roche Holding’s Cancer Immunotherapy Product Pipeline
Table 10.44: Seattle Genetics’ Pipeline Products
Table 10.45: Seattle Genetics’ Collaborarator Pipeline
Table 10.46: Synthon Biopharmaceuticals’ Pipeline
Table 10.47: TapImmune’s Product Pipeline
Table 10.48: ThioLogic’s Product Pipeline
Table 10.49: Transgene’s Product Pipeline
Table 10.50: Vaccinogen’s Product Pipeline
Table 10.51: Viventia’s Product Pipeline
Table 10.52: Wilex’s Product Pipeline
Table 10.53: Ziopharm’s Products in Development
Table 11.1: Cancer Immunotherapy Market Participants by Product Segment
Table 12.1: Selected CD19-directed Product Candidates in Clinical Trials by Costimulatory & Binding Domains, Starting Cell Population, Vector and Ablation Technology
Table 12.2: Select CD19-Directed ALL Clinical Trials
Table 12.3: Select Anti-CD22 CAR-T Clinical Projects
Table 13.1: CBER Compliance and Surveillance Activities
Table 13.2: Contacts for the Cellular, Tissue and Gene Therapies Advisory Committee, FDA
Table 14.1: Key Contacts Within PMDA, Japan
Table 15.1: Contact Details for EMA Immunotherapy Experts
Table 16.1: General Technical and Personnel Requirements of a GMP, QC, QA, FDA Regulated Cell Therapy Manufacturing Facility
Table 16.2: Technician/Scientific Requirements for CAR T Manufacturing
Table 16.3: Selection of Apheresis Instruments Currently on the Market
Table 16.4: Selection of Cell Counters and Analyzer Instruments Currently on the Market
Table 16.5: Main Objectives of GMP Manufacturing Immunotherapeutics
Table 16.6: Main Objectives of Quality Control While Manufacturing Immunotherapeutics
Table 16.7: Main Objectives of Regulatory Affairs During Manufacturing Immunotherapeutics
Table 16.8: CAR-T Studies Using mRNA Transfection Electroporation
Table 16.9: Challenges for Autologous Cell Therapy Manufacture
Table 16.10: Current Company/Institutions with Suicide Gene CAR T Projects
Table 16.11: Advantages of Using Automated Cell Therapy Manufacturing
Table 16.12: Main Drivers to Implement Automated Cell Therapy Manufacturing
Table 16.13: Main Benefits of Automated Cell Therapy Manufacturing
Table 16.14: Advantages & Disadvantages of Autologous Cell Therapy Manufacture Scale Up
Table 17.1: Juno Therapeutics Manufacturing Facility Objectives
Table 18.1: Current Juno Therapeutics Trials and CAR T Products
Table 19.1: Current CAR T Business Deals
Table 20.1: Juno Therapeutics Target Biomarker Portfolio
Table 20.2 Juno Therapeutics CAR Technology
Table 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology
Table 20.4 Juno Therapeutics Clinical Pipeline by Target, Product and Trial
Table 20.5: Select CD19-Directed ALL Clinical Trials
Table 20.6: Select Anti-CD22 CAR-T Clinical Projects
Table 20.7 Juno Therapeutics Manufacturing Facility Objectives
Table 20.8 Current Kite Pharma CAR T Clinical Studies and Trials
Table 20.9 Current Kite Pharma TCR Clinical Studies and Trials
A selection of companies mentioned in this report includes:
- Ablynx NV
- Activartis Biotech GmbH
- Advaxis Inc.
- Aduro BioTech Inc.
- Agenus Inc.
- AlphaVax Inc.
- A. Menarini
- Amgen Inc.
- Antigen Express Inc.
- Argos Therapeutics Inc.
- Bavarian Nordic A/S
- Bellicum Pharmaceuticals Inc.
- Biogen Idec Inc.x
- Biovest International Inc.
- Bristol-Myers Squibb Co.
- Cellerant Therapeutics Inc.
- Celldex Therapeutics
- CEL-SCI Corp.
- CureTech Ltd
- Delta-Vir GmbH
- Dendreon Corp.
- DenDrit Biotech USA
- DNAtrix Inc.
- Eli Lilly and Co.
- EMD Serono Inc.
- Etubics Corp.
- Galena Biopharma Inc.
- Genentech Inc.
- Genmab AS
- Gliknik Inc.
- GlobeImmune Inc.
- Heat Biologics Inc.
- Immatics Biotechnologies GmbH
- ImmunoCellular Therapeutics Ltd.
- Immunocore Ltd
- ImmunoFrontier Inc.
- ImmunoGen Inc.
- Immunomedics Inc.
- Immunotope Inc.
- Immunovaccine Inc.
- Inovio Pharmaceuticals Inc.
- Janssen Biotech Inc.
- Juno Therapeutics Inc.
- Kite Pharma Inc.
- MabVax Therapeutics Holdings Inc.
- MedImmune LLC
- Merck & Co., Inc.
- Merrimack Pharmaceuticals Inc.
- Morphotek Inc.
- NewLink Genetics Corp.
- Northwest Biotherapeutics Inc.
- NovaRx Corp.
- OncoPep Inc.
- Oncothyreon Inc.
- OSE Pharma SA
- Oxford BioTherapeutics Ltd.
- Pique Therapeutics
- Polynoma LLC
- Prima BioMed Ltd.
- Progenics Pharmaceuticals Inc.
- Regen Biopharma Inc.
- Roche Holdings Inc.
- Seattle Genetics Inc.
- Sorrento Therapeutics Inc.
- Spectrum Pharmaceuticals Inc.
- Synthon Pharmaceuticals Inc.
- TapImmune Inc.
- ThioLogics Ltd.
- Transgene SA
- TVAX Biomedical Inc.
- Vaccinogen Inc.
- Viventia Biotechnologies Inc.
- Wilex AG
Based on Locations in Europe and Asia, the analyst team are all PhD-level experts and industry-experienced professionals. They pool resources, contacts, business acumen, and technical experience to provide cutting edge insights for all of the reports. The senior analysts have at least ten years’ experience in major strategic corporations such as BCC research and TriMarkPublications. The methodologies are clearly defined from the outset. Initially, a number of clear objectives are set, e.g., to identify the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments:
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Key Strengths, Weaknesses and Threats InfluencingLeading Player Position within the Market
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