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Global Cancer Immunotherapy Market Analysis & Forecast to 2023

  • ID: 4860922
  • Report
  • January 2020
  • Region: Global
  • 450 Pages
  • Kelly Scientific Publications
1 of 6

FEATURED COMPANIES

  • Ablation Technology
  • Bavarian Nordic A/S
  • DNAtrix Inc
  • Heat Biologics Inc
  • Merck
  • Polynoma LLC
  • MORE

Global Cancer Immunotherapy Market Analysis & Forecast to 2023: Antibody-Drug Conjugates (ADCs), Bispecific Monoclonal Antibodies, Cancer Vaccines, Cytokines, Interferons, Chimeric Antigen Receptor (CAR) T-Cell Therapy, PD-1/PD-L1 inhibitors, Dendritic Cells, Checkpoint Inhibitors, Adopted Cell Therapy (ACT) & IDO Inhibitors

Within the cancer therapeutics space, which today is worth over $100 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 $115 billion in 2023. 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
  • A summary table to identify the category of immunotherapy drugs offered by the 79 companies.
  • A 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 2023?
  • What is the global market for cancer immunotherapeutics by geography, through 2023?
  • What is the global market for cancer immunotherapeutics by indication, through 2023?
  • What is the global market for MAbs by types such as naked MAbs and ADCs, through 2023?
  • 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 is 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?
  • How many cytokines have been approved for being used in cancer immunotherapy?
  • What are the major checkpoint inhibitors in clinical development?
  • What is the current status of anti-PD-1 drugs, dentritic cell therapies, T-cell therapies, and cancer vaccines?
  • What are the most valuable R&D projects in cancer immunotherapy and what would be their approximate sales revenues in 2023?
  • Number of melanoma drugs approved to date?
  • Number of lung cancer drugs approved to date?
  • Number of brain cancer drugs approved to date?
  • What is CAR T Therapy?
  • What are the main challenges associated with CAR T therapy?
  • What is the status of CAR T therapeutic approval?
  • What are the current regulations for immunotherapies in the USA, Europe & Japan?
  • What are the main manufacturing steps in CAR T therapy?
  • What challenges lie ahead for CAR T production

 

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Ablation Technology
  • Bavarian Nordic A/S
  • DNAtrix Inc
  • Heat Biologics Inc
  • Merck
  • Polynoma LLC
  • MORE

1.0 Executive Summary         
1.1 Objectives of Report         
1.2 Key Questions Answered in this Report       
1.3 Data Sources and Methodology        

2.0 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       
2.4.2.1 Components of an Antibody-Drug Conjugate (ADC)     
2.4.2.2 Mechanism of Action of Antibody Drug Conjugate (ADC)     
2.4.2.3 The Cytotoxic Wareheads used in ADCs       
2.4.2.4 Successful Cytotoxin Wareheads        
2.4.2.5 Developmental Timeline of ADCs       
2.4.2.6 Target Antigens for ADCs in Preclinical and Clinical Development                                
2.4.2.7 Important Clinical Assets in ADCs       
2.4.3 Bispecific Monoclonal Antibodies        
2.4.3.1 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     
2.6.1 Cytokines          
2.6.2 Interferon (IFN)          
2.7 New Frontiers in Cancer Immunotherapy Research     
2.7.1 Drugs for Targeting Immune Checkpoints      
2.7.1.1 Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4)     
2.7.1.2 Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1)   
2.7.1.3 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     

3.0 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 Keytruda (Pembrolizumab, MK-3475)        
3.2.1 Important Events and Advantages for Keytruda in Melanoma    
3.2.2 Important Events and Advantages for Keytruda in NSCLC     
3.2.3 Important Events for Keytruda in RCC       
3.3 Tecentriq from Roche         
3.3.1 Important Events for Tecentriq in Melanoma      
3.3.2 Important Events and Advantages for Tecentriq in NSCLC     
3.3.3 Important Event for Tecentriq in RCC       
3.3.4 Tecentriq Studies in NSCLC        
3.3.5 Tecentriq Studies in RCC         
3.3.6 Tecentriq 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        
3.8 KAHR-102          
3.9 TIM3 Antibody          
3.10 BMS-989016          
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     
3.13.1 CLT109           
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          
3.14.1 HyperAcute          
3.14.2 MAGE-A3 Antigen-Specific Cancer Immunotherapeutic     
3.14.3 ADXS-HPV          
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)         
3.16.2 Keytruda          
3.16.3 Tecentriq          
3.16.4 Palbociclib          
3.16.5 DCVax-L          
3.16.6 Imfinzi          

4.0 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    

5.0 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)         
5.9 Cervarix           
5.10 Denileukin Diftitox (Ontak)        
5.11 Gardasil           
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)        

6.0 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       
6.4.1.1 Promising MAb Product Candidates for Lung Cancer     
6.4.1.2 Checkpoint Inhibitors for Lung Cancer       
6.4.1.3 Therapeutic Vaccines for Lung Cancer       
6.4.1.4 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      

7.0 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     
7.3.2.1 Mortality due to Lung, Liver and Stomach Cancers     
7.3.2.2 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          
7.5.1.1 Worldwide Incidence of Breast Cancer and Mortality Rate by Geography   
7.5.1.2 Female Breast Cancer Incidence in the U.S      
7.5.1.3 Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S  
7.5.1.4 Breast Cancer Incidence in Canada       
7.5.1.5 Breast Cancer Incidence and Mortality in Latin America     
7.5.1.6 Breast Cancer Incidence and Mortality in Europe      
7.5.1.7 Breast Cancer Incidence in Asia/Pacific       
7.5.1.8 Breast Cancer Incidence by Country       
7.5.2 Gastric Cancer (Stomach Cancer)       
7.5.2.1 Incidence of Gastric Cancer in Top 15 Countries      
7.5.3 Colorectal Cancer         
7.5.3.1 Global Incidence of Colorectal Cancer       
7.5.3.2 Worldwide Variations in the Incidence of Colorectal Cancer    
7.5.3.3 Risk Factors for Colorectal Cancer       
7.5.3.4 Colorectal Cancer Screening in the U.S       
7.5.3.5 Colorectal Cancer Incidence Rates in the U.S. by State     
7.5.3.6 Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States   
7.5.4 Lung Cancer          
7.5.4.1 Non-Small Cell Lung Cancer (NSCLC)       
7.5.4.2 Global NSCLC Incidence         
7.5.4.3 Lung Cancer in Americas by Gender      
7.5.4.4 Tobacco Use and Lung Cancer        
7.5.4.5 Current Therapeutic Options for Lung Cancer      
7.5.5 Glioblastoma          
7.5.5.1 Global Incidence of Glioblastoma       
7.5.6 Kidney Cancer          
7.5.6.1 Global Incidence of Kidney Cancer       
7.5.7 Blood Cancer          
7.5.7.1 Leukemia         
7.5.7.2 Blood Cancer in the U.S         
7.5.8 Cervical Cancer          
7.5.8.1 Global Incidence of Cervical Cancer       
7.5.9 Prostate Cancer          
7.5.9.1 Global Incidence of Prostate Cancer       
7.5.9.2 Prostate Cancer Incidence and Mortality by Geography     
7.5.9.3 Prostrate Cancer in the U. S        
7.5.10 Melanoma          
7.5.10.1 Skin Cancer in the U. S         

8.0 Global Oncology Market Analysis and Forecast to 2023    
8.1 Global Oncology Market Geographical Analysis and Forecast to 2023   
8.2 Top Companies in Oncology Drug Sales
8.2.1 Roche
8.2.2 Novartis
8.2.3 Pfizer
8.2.4 Bristol-Myers Squibb
8.2.5 Merck
8.2.6 Celgene
8.2.7 AstraZeneca
8.2.8 Eli Lilly
8.2.9 Takeda   
8.3 FDA approved oncology drugs to 2019
8.4 Top Oncology Drug Market Forecast to 2023      
8.5 Global Oncology Therapeutics Market by Cancer Type     

9.0 Market for Cancer Immunotherapy       
9.1 Key Drivers          
9.2 Global Market for Cancer Immunotherapeutics by Geography    
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         
9.5.1.1 Market Forecast for Herceptin        
9.5.1.2 Market Value and Forecast for Avastin       
9.5.1.3 Global Market and forecast for Erbitux       
9.5.1.4 Global Market and Forecast for Yervoy       
9.5.1.5 Global Market and Forecast for Mabthera
9.5.1.6 Global Market and Forecast For Opdivo (Nivolumab)
9.5.2 Global Market and Forecast for Antibody Drug Conjugates (ADCs)    
9.5.2.1 Global Market and Forecast for Adcetris       
9.5.2.2 Global Market and Forecast for Keytruda       
9.6 Global Market and Forecast for Cancer Vaccines      
9.6.1 Global Market for Cancer Vaccines by Type      
9.7 Global Market for Non-Specific Cancer Immunotherapeutics    
9.7.1 High Cost of MAbs         

10.0 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        
10.3.2.1  ADXS-HPV         
10.3.2.2  ADXS-PSA         
10.3.2.3  ADXS-cHER2         
10.4 Aduro BioTech Inc         
10.4.1 Aduro’s Technology         
10.4.1.1  CRS-207        
10.4.1.2  AUD-623        
10.4.1.3  ADU-741        
10.4.1.4  ADU-S100        
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      
10.7.1 MEN1112          
10.8 Amgen Inc          
10.8.1 Vectibix (panitumumab)         
10.8.2 Blinatumomab (Blincyto)        
10.8.3 Rilotumumab          
10.9 Antigen Express Inc         
10.9.1 Li-Key Hybrid Vaccines (AE37)        
10.10 Argos Therapeutics Inc         
10.10.1 AGS-003          
10.11 Bavarian Nordic A/S         
10.11.1 Prostvac          
10.11.2 CV-301           
10.11.3 MVA-BN PRP          
10.11.4 MVA-BN HER2          
10.11.4.1 MVA-BN Brachyury         
10.12 Bellicum Pharmaceuticals Inc        
10.12.1 BPX-501          
10.12.2 BPX-201          
10.12.3 BPX-401          
10.12.4 BPX-601          
10.12.5 BPX-701          
10.13 Biogen Idec Inc          
10.13.1 Rituxan (Rituximab)         
10.13.2 Gazyva (Obinutuzumab)        
10.14 Biovest International Inc        
10.14.1 BiovaxID          
10.15 Bristol-Myers Squibb Company        
10.15.1 Erbitux (cetuximab)         
10.15.2 OPDIVO (nivolumab)         
10.15.3 Yervoy (ipilimumab)         
10.16 Cellectis           
10.17 Cellerant Therapeutics Inc        
10.17.1 CLT-008          
10.17.2 CLT-009          
10.18 Celldex Therapeutics         
10.18.1 Rindopepimut          
10.18.2 Glembatumumab vedotin (CDX-011)       
10.18.3 Varlilumab (CDX-1127)        
10.18.4 CDX-1401          
10.18.5 CDX-301          
10.19 CEL-SCI Corp.          
10.19.1 Multikine          
10.20 CureTech Ltd.          
10.20.1 Pidilizumab (CT-011)         
10.21 Delta-Vir GmbH          
10.21.1 Treatment          
10.22 Dendreon Corp.          
10.22.1 Provenge (Sipuleucel-T)        
10.23 DenDrit Biotech USA         
10.23.1 MelCancerVac          
10.24 DNAtrix Inc          
10.24.1 DNX-2401          
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          
10.30.1 Ofatumumab          
10.31 GlaxoSmithKline          
10.31.1 Arzerra (Ofatumumab)        
10.31.2 Cervarix          
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          
10.39.1 IMGN853          
10.39.2 IMGN529          
10.39.3 IMGN289          
10.39.4 IMGN779          
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         
10.44.1 Doxil           
10.44.2 Procrit           
10.44.3 Zytiga           
10.44.4 Imbruvicia          
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)        
10.51.4 MORAb-066          
10.52 NewLink Genetics Corp.         
10.53 Northwest Biotherapeutics Inc        
10.54 NovaRx Corp.          
10.55 OncoPep Inc          
10.55.1 PVX-410          
10.56 Oncothyreon Inc         
10.57 OSE Pharma SA          
10.58 Oxford BioTherapeutics Ltd.        
10.58.1 Technologies          
10.58.1.1 OGAP – Cancer Targeting        
10.58.1.2 Antibody Development        
10.58.1.3 Antibody “arming”         
10.58.2  Lead Programs         
10.58.2.1  OX001/MEN1112         
10.58.2.2  OX002          
10.58.2.3  OX003          
10.58.2.4  OX004          
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)       
10.62.4 Azedra           
10.63 Regen Biopharma Inc         
10.63.1 HemaXellerate          
10.63.2 dCellVax          
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       
10.66.1.1  G-MAB          
10.66.1.2  Antibody Drug Conjugates (ADCs)       
10.67 Spectrum Pharmaceuticals Inc        
10.67.1 Zevalin           
10.68 Synthon Pharmaceuticals Inc        
10.69 TapImmune Inc          
10.70 ThioLogics Ltd.          
10.71 Transgene SA          
10.72 TVAX Biomedical Inc         
10.72.1 TVI-Brain-1          
10.72.2 TVI-Kidney-1          
10.73 Vaccinogen Inc          
10.74 Viventia Biotechnologies Inc        
10.75 Wilex AG          
10.76 Ziopharm Oncology Inc         

11.0 Cancer Immunotherapy Market Participants by Product Segment   

12.0 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       

13.0 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      
13.1.6.1  Efficacy         
13.1.6.2  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           

14.0 Regulations for Immunotherapy in Japan       
14.1 PMDA and Immunotherapy        
14.1.1 Increasing the Efficiency in Immunotherapy Regulatory Review     
14.1.2 Forerunner Review Assignment System        
14.1.3 Revised Guidelines for Clinical Evaluation of Anti‐Malignant Tumor Agents   
14.1.4 Key Contacts Within the PMDA for Immunotherapeutics      

15.0 European Regulation and Immunotherapeutics      
15.1 Introduction           
15.2 Challenges for Immunotherapy in EMEA        
15.2.1 EMA Status on Potency Testing         
15.2.1.1  In Vivo Potency Testing        
15.2.1.2  In Vitro Potency Testing       
15.2.1.3  Viable Cell Count        
15.2.1.4  Autologous Cell Based Products       
15.2.1.5  Reference Preparation        
15.2.1.6  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      

16.0 Manufacturing of Immunotherapies       
16.1 Introduction           
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  
16.3.1 Leukapheresis           
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      

17.0 Supply Chain & Logistics         
17.1 Introduction           
17.2 Case Study: Juno Therapeutics         

18.0 Pricing & Cost Analysis         
18.1 Introduction           
18.2 CAR T Therapy Market Evaluation        

19.0 Current Deals Within the CAR T Market       

20.0 CAR T Therapy Company Case Studies      
20.1 Juno Therapeutics         
20.2 Kite Pharma          
20.3 Cellectis           

Appendix
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 Wareheads     
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 by Geography/Country, Through 2023  
Figure 8.2: Global Oncology Drug Sales by Top Five Companies, Through 2023   
Figure 8.3: Top Five Oncology Drugs, Through 2023      
Figure 8.4: Global Oncology Therapeutics Market by Cancer Type     
Figure 9.1: Global Cancer Immunotherapy Market, Through 2023     
Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2023   
Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2023   
Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2023  
Figure 9.5: Global and U.S. Market for Herceptin, Through 2023     
Figure 9.6: Global and U.S. Market for Avastin, Through 2023     
Figure 9.7: Global Market for Erbitux, Through 2023      
Figure 9.8: Global Market for Yervoy, Through 2023     
Figure 9.9: Global Market for Mabthera, Through 2023      
Figure 9.10: Global Market for Adcetris, Through 2023      
Figure 9.11: Global Market for Keytruda, Through 2023      
Figure 9.12: Global Market for Cancer Vaccines, Through 2023     
Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2023    
Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2023    
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 Wareheads Used in ADCs       
Table 2.7: Targeted Indications for ADCs        
Table 2.8: Antibody Drug Conjugates: Developmental Tmeline     
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 by Geography/Country, Through 2023  
Table 8.2: Top Ten Companies in Oncology Sales, Through 2023     
Table 8.3: Top Five Oncology Drugs, Through 2023       
Table 9.1: Global Cancer Immunotherapy Market, Through 2023     
Table 9.2: Global Market for Immunotherapy by Product Class, Through 2023   
Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2023  
Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2023  
Table 9.5: Global and U.S. Market for Herceptin, Through 2023     
Table 9.6: Global and U.S. Market for Avastin, Through 2023     
Table 9.7: Global Market for Cancer Vaccines, Through 2023     
Table 9.8: Global Market for Cancer Vaccines by Type, Through 2023    
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

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  • Ablation Technology
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Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies, and cancer vaccines are all driving the market. The rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early detection techniques, higher patient awareness, and a growing aging population. Furthermore, the FDA’s pro-science attitude will accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $115 billion by 2023. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.

Prior to the launching of Yervoy, the five-year survival rate for patients with early-stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%. Yervoy has been reported to have a survival rate of 25% when tested alone. When tested as part of a combination therapy treatment with Bristol’s nivolumab, the two-year survival rates rose to 88% for patients with late-stage cancer. An increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated. Other key therapeutic players in this market include Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), Ibrance (palbociclib) the newly approved Bavencio (avelumab) and Imfinzi (durvalumab) and of course the first CAR-T therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel).

Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy space and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given a fast-track approval on December 22, 2014. The majority of immune-oncology agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1/PDL1 mechanisms.  A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting. Of course, Novartis gained the first CAR-T FDA approval for Kymriah (tisagenlecleucel, CTL019), in August 2017, for children and young adults with B-cell ALL. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval. This is a major boost for the global and US immunotherapy, and gene therapy markets.

What Are CAR-T Therapies? How Will They Impact the Market?

CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date, publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered T cells have numerous advantages including:

  • Intracellular domain can be modified to increase efficacy and durability of CAR-T
  • CAR-T are still subject to the same regulatory and tolerogenic constraints of natural T cells, including checkpoints, Treg, MDSC
  • CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration
  • Can be modified to express suicide genes that limit CAR-T population if toxicity occurs

To date, the main challenges associated with CAR T therapy include manufacturing, regulations, pricing, and toxicity in patients. Currently, there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China, and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome. In July 2017, an FDA advisory panel determined that the benefits of CAR T outperform the risks.  Kymriah (tisagenlecleucel) by Novartis is indicated to treat children and young adults with acute leukemia and performed well in the ELIANA trial. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval and became the first CAR-T cell therapy on the US market. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval.

The CAR-T industry is addressing unmet needs in specific relapsed cancers, and trials have indicated that some patients show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Novartis, Juno Therapeutics, Kite Pharma and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From now on, the analyst forecasts that CAR T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.

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  • Aduro BioTech Inc         
  • Agenus Inc          
  • AlphaVax Inc          
  • Amgen Inc          
  • Antigen Express Inc         
  • Ablation Technology     
  • Ablynx NV          
  • Activartis Biotech GmbH                   
  • Advaxis Inc          
  • Argos Therapeutics Inc         
  • AstraZeneca
  • Bavarian Nordic A/S         
  • Bellicum Pharmaceuticals Inc        
  • Biogen Idec Inc          
  • Bristol-Myers Squibb
  • Bristol-Myers Squibb Company        
  • CEL-SCI Corp.          
  • Celgene
  • Celldex Therapeutics         
  • Cellectis           
  • CureTech Ltd.          
  • DNAtrix Inc          
  • Delta-Vir GmbH          
  • DenDrit Biotech USA         
  • Dendreon Corp.          
  • EMD Serono Inc          
  • Eli Lilly
  • Eli Lilly and Co.          
  • Etubics Corp.          
  • Galena Biopharma Inc         
  • Genentech Inc          
  • Genmab AS          
  • GlaxoSmithKline          
  • Gliknik Inc          
  • GlobeImmune Inc         
  • Heat Biologics Inc         
  • Immatics Biotechnologies GmbH        
  • ImmunoCellular Therapeutics Ltd.       
  • ImmunoFrontier Inc         
  • ImmunoGen Inc          
  • Immunocore Ltd.                 
  • 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
  • Merck & Co., Inc         
  • Merrimack Pharmaceuticals Inc        
  • Morphotek Inc          
  • NewLink Genetics Corp.         
  • Northwest Biotherapeutics Inc        
  • NovaRx Corp.          
  • Novartis
  • OSE Pharma SA          
  • OncoPep Inc          
  • Oncothyreon Inc         
  • Oxford BioTherapeutics Ltd.        
  • Pfizer
  • Pique Therapeutics         
  • Polynoma LLC                  
  • Prima BioMed Ltd.         
  • Progenics Pharmaceuticals Inc        
  • Regen Biopharma Inc         
  • Roche
  • Roche Holdings Inc         
  • Seattle Genetics Inc         
  • Sorrento Therapeutics Inc        
  • Spectrum Pharmaceuticals Inc        
  • Synthon Pharmaceuticals Inc        
  • TVAX Biomedical Inc         
  • Takeda   
  • TapImmune Inc          
  • ThioLogics Ltd.          
  • Transgene SA          
  • Vaccinogen Inc          
  • Viventia Biotechnologies Inc        
  • Wilex AG          
  • Ziopharm Oncology Inc         
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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:

  • By Company
  • By Geography (US, UK, EU, Asia)
  • By Segment
  • By Sub-market

Key Strengths, Weaknesses and Threats InfluencingLeading Player Position within the Market

  • Technologies Driving the Market
  • Top Fastest Growing Market Segments and Emerging Opportunities
  • Top Pharmaceutical Companies within the IPM by Market Share and Revenue
  • Comprehensive Product Portfolios, R&D Activity, and Pipeline Therapeutics
  • M&A Activity and Future Strategies of Top Personalized Medicine Pharmacos

Following this, the analyst determines key financial data & business strategy information to give clients the most accurate information required to identify areas of profitable growth and what technical advantages are required in a competitive landscape such as company financials, sales & revenue figures.

Market analysis is initiated using primary research tools such as speaking directly with end-users, identifying their needs, and any un-met needs in the market place. This exploratory research identifies any specific requirements in the market and is tailored specifically to niche markets such as gene therapy, regenerative medicine, personalized medicine, targeted therapeutics and companion diagnostics, drug delivery systems, cosmetic surgery and services, cancer biomarkers and immunotherapy. At KellyScientific, we have a wide range of contacts within these niche areas that provide us with cutting edge insights into a marketplace that is beyond the reach of many. We also travel to international conferences quarterly to source new data and trends from global experts.
 
Secondary research performed by Kelly Scientific is meticulously scrutinized and analysed prior to integration into a final report. We only use validated and confirmed sources of information from company-specific corporate websites, government websites and documents, annual reports, press releases, international peer-reviewed scientific and medical journals, and research reports. Together both primary and secondary research and also unique insights from the chief analysts and editor alike provide the client with a report that exceeds its competitors. 

 

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