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Global Cancer Immunotherapy Market Analysis & Forecast to 2023

  • Published Date: 01 Jan 2020
  • Number of Pages: 450
  • Category: Healthcare and Medical
  • Country: Global

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 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 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 type 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 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 “warheads” 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, dendritic 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

Executive Summary

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 the 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 capital and small clinical studies. From now on, Kelly Scientific 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 the 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.

Publisher Name : Kelly Scientific Publications

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
  



List Of Tables

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 Roches 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 the 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 the Americas
 Table 7.16: Incidence and Mortality Rates for Melanoma in the 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 Pipeline
 Table 10.9: Bellicum’s Pipeline Product Candidates
 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’ Collaborator 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 



List Of Figures

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 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 



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