Cancer Immunotherapy & CAR-T Market Analysis & Forecast Report to 2025

Cancer Immunotherapy & CAR-T Market Analysis & Forecast Report to 2025

4,50013,500

Immunotherapy Market Report Includes:

  • An overview of cancer immunotherapy that includes: monoclonal antibodies, ADC’s, anti-PD-1 & anti-PDL1 drugs, Dendritic cell vaccines, T-cell therapies & CAR T therapies
  • Overall global cancer immunotherapy market, leading market players and the best selling cancer drugs, competitor analysis & revenue breakdown
  • Detailed account of the market for cancer immunotherapeutics by geography, disease indication & company
  • Profiles, marketed products & products in the pipeline of 79 companies that are located globally
  • Specific chapter on the CAR-T immunotherapy market detailing manufacturing, regulations & pricing
  • 20 chapters supported by over 180 tables and figures in 450 pages

Contact deirdre@kellysci.com for more information and sample pages

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Description

GLOBAL CANCER IMMUNOTHERAPY & CAR-T MARKET ANALYSIS  & FORECAST TO 2025

Within the cancer therapy market, which today is worth over $160 billion globally, immunotherapeutic drugs have gained worldwide acceptance. This is because they are targeted therapeutics that have high specificity for cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $75 billion in 2019 alone and are forecast to surpass $143 billion in 2025. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 450 pages (published November 2020).

Strong Immunotherapy Market Growth Through Key Drug Approvals

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 market approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $143 billion by 2025. Overall strong market 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. 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 market, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. 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 is CAR-T Immunotherapy? How Will it 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. Breyanzi (lisocabtagene maraleucel) from Juno/Bristol Myers Squibb achieved FDA approval on February 5, 2021 for the treatment of adults with relapsed/refractory large B-cell lymphomas. Breyanzi is now the third CAR-T therapy approved after Yescarta and Kymriah.

The CAR-T market 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 2019, 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 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.

Key Questions Answered in this Immunotherapy Market Report

  • What is the global market for cancer immunotherapeutics by product class such as MAbs, vaccines and non-specific immunotherapies, through 2025?
  • What is the global market for cancer immunotherapeutics by geography, through 2025?
  • What is the global market for cancer immunotherapeutics by indication, through 2025?
  • What is the global market for MAbs by type such as naked MAbs and ADCs, through 2025?
  • What are the market values for Herceptin, Avastin, Erbitux, Yervoy, Mabthera, Adectris, and Keytruda?
  • What is the global market for cancer vaccines?
  • What is the global market for cytokines in cancer immunotherapy?
  • The projected market values for Nivolumab, Tecentriq, DCVax-L, Imfinzi?
  • What immunotherapies have been approved to date?
  • What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
  • What are naked MAbs and how many of them have been approved by the FDA?
  • What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
  • What are the common cytotoxic “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, 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 2025?
  • 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 USA, Europe & Japan?
  • What are the main manufacturing steps and challenges in CAR T therapy?

The immunotherapy market report is supported by over 180 tables & figures over 450 pages. This report is presented in the following sub-categories are presented:

  • By Segment (Monoclonal Antibodies, Cancer Vaccines, Non-Specific Therapies, Checkpoint Inhibitors)
  • By Product Segment (Antibody Drug Conjugates (ADCs), Bispecific Monoclonal Antibodies, Cytokines, Interferons, Chimeric Antigen Receptor (CAR) T-Cell Therapy, PD-1/PD-L1 inhibitors, Dendritic Cells, Adopted Cell Therapy (ACT) & IDO Inhibitors)
  • By Company (e.g Amgen, Merck, Eli Lilly, GlaxoSmithKline, Janssen, Genentech, Roche, Bristol Myers Squibb)

A comprehensive account of company product portfolios are provided for 79 Cancer Immunotherapy pharma and biotech companies including:

  • Amgen Inc.
  • Biogen Idec Inc.x
  • Bristol-Myers Squibb Co.
  • Cellectis
  • Cellerant Therapeutics Inc.
  • Celldex Therapeutics
  • Eli Lilly and Co.
  • EMD Serono Inc.
  • Genentech Inc.
  • Genmab AS
  • GlaxoSmithKline
  • ImmunoGen Inc.
  • Immunomedics Inc.
  • Janssen Biotech Inc.
  • Juno Therapeutics Inc.
  • Merck & Co., Inc.
  • Oxford BioTherapeutics Ltd.
  • Progenics Pharmaceuticals Inc.
  • Roche Holdings Inc.
  • Seattle Genetics Inc.
  • Sorrento Therapeutics Inc.
  • Kite Pharma
  • Novartis

For more information and sample pages, please email deirdre@kellysci.com

Table of Contents

Global Cancer Immunotherapy Market Analysis & Forecast to 2025

 

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 2025                                                     

8.1         Global Oncology Market Geographical Analysis and Forecast to 2025

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

8.4         Top Oncology Drug Market Forecast to 2025

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 Warheads

Figure 4.1: Number of Successful and Unsuccessful Melanoma  Drugs

Figure 4.2: Successes and Failures in Lung Cancer Medicine Development

Figure 4.3: Successes and Failures in Brain Cancer Drug Development

Figure 5.1: Ibritumomab Linked to Yttrium Radfionucleotide

Figure 5.2: Kadcyla (Trastuzumab + DMI)

Figure 6.1: Dominance of MAbs and Vaccines in Cancer Clinical Research

Figure 7.1: Global Economic Burden of Cancer

Figure 7.2: Number of Colorectal, Breast and Lung Cancer Cases Diagnosed Globally

Figure 7.3 Percentage of Top Three Cancers Diagnosed Globally

Figure 7.4: Number of Deaths due to Lung, Liver and Stomach Cancers Globally

Figure 7.5: Percentage of Deaths due to Lung, Liver and Stomach Cancers

Figure 7.6: Global Cancer Deaths in Women by Type of Cancer

Figure 7.7: Worldwide Incidence of Female Breast Cancer and Mortality Rate by Geography

Figure 7.8: Five Year Relative US Breast Cancer Survival Rates by Stage at Diagnosis & Age

Figure 7.9: Breast Cancer Incidence and Mortality in Latin America

Figure 7.10: Breast Cancer Incidence and Mortality in Europe

Figure 7.11: Breast Cancer Incidence Rates in Asia/Pacific Region

Figure 7.12: Top 15 Countries in Gastric Cancer Incidence

Figure 7.13: Top 15 Countries in Colorectal Cancer Incidence

Figure 7.14: Adults Aged 50-75 Years (%) That are Up-to-Date with Colorectal Screening Tests by State in the U.S

Figure 7.15 Colorectal Cancer Incidence Rates (per 100,000) by State in the U.S

Figure 7.16: Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States

Figure 7.17: Top 15 Countries with Lung Cancer

Figure 7.18: Global NSCLC Incidence

Figure 7.19: Number of Smokers in China, India, Russia, the U.K. and U.S

Figure 7.20: Global Incidence of Glioblastoma

Figure 7.21: Global Incidence of Kidney Cancer

Figure 7.22: Top 15 Countries in Leukemia Mortality

Figure 7.23: Five Year Survival Rates in the U.S. for Blood Cancer Patients

Figure 7.24 Top 15 Countries in Cervical Cancer

Figure 7.25: Top 15 Countries with Prostate Cancer

Figure 7.26: Skin Cancer Death Rates for Top 15 Countries

Figure 8.1: Global Market for Oncology Drugs to 2025

Figure 8.2: Global Oncology Drug Sales by Top Companies, Through 2025

Figure 8.3: Top Oncology Drugs, Through 2025

Figure 8.4: Global Oncology Therapeutics Market by Cancer Type

Figure 9.1: Global Cancer Immunotherapy Market, Through 2025

Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2025

Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025

Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025

Figure 9.5: Global and U.S. Market for Herceptin, Through 2025

Figure 9.6: Global and U.S. Market for Avastin, Through 2025

Figure 9.7: Global Market for Erbitux, Through 2025

Figure 9.8: Global Market for Yervoy, Through 2025

Figure 9.9: Global Market for Mabthera, Through 2025

Figure 9.10: Global Market for Adcetris, Through 2025

Figure 9.11: Global Market for Keytruda, Through 2025

Figure 9.12: Global Market for Cancer Vaccines, Through 2025

Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2025

Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2025

Figure 13.1: Clinical Regulatory Pathway – Conventional Route

Figure 13.2: Clinical Regulatory Pathway – Option for Rapid Translation

Figure 14.1: PMDA Total Review Period of Standard Drugs

Figure 14.2: PMDA Total Review Period of Priority Drugs

Figure 14.3: Number of Approved Recombinant Protein Products by PMDA

Figure 14.4: Forerunner Review Assignment System Timeframe

Figure 14.5: Adaptive Licensing and Accelerated Approval in Japan‐US‐EU

Figure 15.1: CheckMate 066 Clinical Trial

Figure 15.2: CheckMate 037 Clinical Trial

Figure 16.1: Method of Generating CAR-Modified T Cells

Figure 16.2: Clinical Activity, Cost Structure Patient Flow Chart of CAR-T Therapy

Figure 16.3: Allogenic Versus Autologous Cell Manufacturing

Figure 17.1: Streptamer® -Based Magnetic Bead Cell Isolation

Figure 18.1: Annual Cost of Patented Cancer Therapeutics from 2000 to Today

Figure 18.2: Cost of Nivolumab, Pembrolizumab & Ipilimumab per mg

Figure 20.1 Juno Therapeutics CAR T Therapeutic Molecular Design

Figure 20.2 Juno Therapeutics CAR T Therapeutic Mechanism of Action

Figure 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology Mechanism of Action

Figure 20.4: Streptamer® -Based Magnetic Bead Cell Isolation

Figure 20.5 Kite Pharma CAR Technology

Figure 20.6 Kite Pharma TCR Technology

 

 

INDEX OF TABLES

 

Table 2.1: Types of Immune Cells and their Functions

Table 2.2: FDA-Approved Cancer Immunotherapies

Table 2.3: FDA-Approved Monoclonal Antibodies (MAbs) to Treat Cancer

Table 2.4: Most Frequently Targeted Antigens by MAbs

Table 2.5: FDA-Approved Monoclonal Antibodies

Table 2.6: Cytotoxic Warheads Used in ADCs

Table 2.7: Targeted Indications for ADCs

Table 2.8: Antibody Drug Conjugates: Developmental Timeline

Table 2.9: Target Antigens for ADCs in Preclinical and Clinical Development

Table 2.10: Current ADCs Launched, Withdrawn and in Phase I/II/III Trials by Sponsor, Indication, Antigen, Cytotoxin and Linker

Table 2.11: MAb Products and Candidates that Recruit T Cells

Table 2.12: Bispecific MAbs in Clinical Trials Targeting Cancer by Indication and Company

Table 2.13: Bispecific Antibody Technology Platforms

Table 2.14: Side Effects of Some of the Approved Cancer Immunotherapy MAbs

Table 2.15: FDA-Approved Cancer Vaccines

Table 2.16: Cancer Vaccines in Development

Table 2.17: FDA-Approved Cytokines for Cancer Immunotherapy

Table 2.18: Cancer Indications Approved for IFN-alfa

Table 2.19: FDA-Approved Immune Checkpoint Modulators

Table 2.20: Immune Checkpoint Inhibitors in Clinical Development

Table 2.21: Cancer Immunotherapy: Timeline of Progress

Table 3.1: PD-1 Therapies Targeting either the PD-L1/L2 or PD-1 Receptor

Table 3.2: Overview of Clinical Trial Landscape for Top Five Anti-PD-1 and Anti-PD-L1 Drugs

Table 3.3: Nivolumab Efficacy from Expansion Cohorts of Study 003

Table 3.4: Key Clinical Trial Data of Pembrolizumab in Melanoma

Table 3.5: IMpower132 Phase III Data of Tecentriq, (atezolizumab RG7446) in NSCLC  Patients

Table 3.6: Phase III IMmotion151 study results of Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) in Renal Cell Carcinoma

Table 3.7: Phase I Melanoma Data for Tecentriq

Table 3.8: Phase II Data for Pidilizumab in Diffuse Large B Cell Lymphoma (DLBCL)

Table 3.9: Phase II Melanoma Data for Pidilizumab

Table 3.10: An Overview of Anti-PD-1 Development by Company, Drug Candidate, Indication and Clinical Phase

Table 3.11: Clinical Development of CTLA-4, TIM3, and LAG3 Checkpoint Inhibitors by Company, Drug Candidate, Indication and Clinical Trial Stage

Table 3.12: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma

Table 3.13: Updated Data from Phase III Clinical Study 024 for Yervoy

Table 3.14: Data from the Failed Phase III Study of Tremelimumab for Melanoma

Table 3.15: An Overview of Clinical Development of Dendritic Cell Therapies by Company, Drug Candidate, Indication and Clinical Phase

Table 3.16: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma

Table 3.17: Phase I/Iia Results from Kite Pharma’s CAR-T Therapy

Table 3.18: Cancer Vaccines in Development by Company, Drug Candidate, Indication & Clinical Phase

Table 3.19: Advaxis Phase II Results for Cervical Cancer Patients in India

Table 3.20: Phase II Data for Contego

Table 3.21: Valuable R&D Projects in Cancer Immunotherapy

Table 6.1: Cancer Types Addressed by Immunotherapies by Drug, Trade Name and Company

Table 6.2: Oncology Drugs Losing Patent Protection by 2020 by Product, U.S. Expiry Date and E.U. Expiry Date

Table 7.1: Global Cancer Statistics – Key Facts

Table 7.2: Top Five Most Frequent Cancers, Globally

Table 7.3: Estimated Breast Cancer Cases and Deaths in the U.S. by Age

Table 7.4: Estimated Canadian Breast Cancer Statistics

Table 7.5: Age-Standardized Breast Cancer Incidence Rate per 100,000 Women by Country

Table 7.6: Global Colorectal Cancer Incidence and Mortality Rates by Gender per 100,000 people

Table 7.7: Risk Factors for Colorectal Cancer

Table 7.8: Lung Cancer Incidence and Mortality Rate in Americas by Gender

Table 7.9: Current Therapeutic Options for Lung Cancer

Table 7.10: Estimated Number of New Leukemia Cases in the U.S.

Table 7.11: Estimated Deaths in the U.S. from Leukemia

Table 7.12: Estimated Deaths from HL and NHL in the U.S.

Table 7.13: Estimated Incidence and Deaths for Myeloma in the U.S.

Table 7.14 Global Prostate Cancer Incidence and Mortality Rates by Geography

Table 7.15: Incidence and Mortality Rates of Prostate Cancer in Americas

Table 7.16: Incidence and Mortality Rates for Melanoma in Americas

Table 8.1: Global Market for Oncology Drugs Through 2025

Table 8.2: Top Ten Companies in Oncology Sales, Through 2025

Table 8.3: Top Five Oncology Drugs, Through 2025

Table 9.1: Global Cancer Immunotherapy Market, Through 2025

Table 9.2: Global Market for Immunotherapy by Product Class, Through 2025

Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2025

Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2025

Table 9.5: Global and U.S. Market for Herceptin, Through 2025

Table 9.6: Global and U.S. Market for Avastin, Through 2025

Table 9.7: Global Market for Cancer Vaccines, Through 2025

Table 9.8: Global Market for Cancer Vaccines by Type, Through 2025

Table 9.9: Projected Market for the Forthcoming DCVax-L and Imfinzi

Table 9.10: Annual Cost of MAbs in the U.S. by Product, Indication and Biomarker

Table 10.1: Ablynx’s Product Pipeline

Table 10.2: Aduro’s Product Pipeline

Table 10.3: Agenus’ Product Pipeline

Table 10.4: AlphaVax Cancer Immunology Product Pipeline

Table 10.5: Amgen’s Product Pipeline

Table 10.6: Antigen Express’ Cancer Therapeutic Pipeline

Table 10.7: Argos’ Cancer Product Pipeline

Table 10.8: Bavarian Nordic’s Product Pipenine

Table 10.9: Bellicum’s Pipeline Product Candidatea

Table 10.10: Biogen’s Oncology Pipeline

Table 10.11: Bristol-Myers Squibb’s Pipeline Products in Cancer Immunotherapy

Table 10.12: Cellectis’ Products in Development

Table 10.13: Cellerant’s Product Pipeline

Table 10.14: Celldex’s Therapeutic Pipeline

Table 10.15: CEL-SCI’s Immunotherapy Products in Development

Table 10.16: EMD Serono’s Product Pipeline

Table 10.17: Etubic’s Product Pipeline

Table 10.18: Galena’s Product Pipeline

Table 10.19: Genentech’s Cancer Immunotherapy Pipeline Products

Table 10.20: Genmab’s Products in Development

Table 10.21: Gliknik’s Product Pipeline

Table 10.22: GlobeImmune’s Product Pipeline

Table 10.23: Heat Biologic’s Product Pipeline

Table 10.24: Immatics Biotechnology’s Product Pipeline

Table 10.25: ImmunoCellular’s Product Pipeline

Table 10.26: Immunomedics’ Late-Stage Antibody-Based Therapies

Table 10.27: Immunovaccine’s Product Pipeline

Table 10.28: Inovio Pharmaceuticals Product Pipeline

Table 10.29: Juno Therapeutics’ Current Pipeline

Table 10.30: Kite Pharma’s Product Pipeline

Table 10.31: MabVax’s Product Pipeline

Table 10.32: MedImmune’s Products in Development

Table 10.33: Merck’s Pipeline of Cancer Immunotherapy Products

Table 10.34: Merrimack’s Product Pipeline

Table 10.35: NewLink Genetics’ Product Pipeline

Table 10.36: Northwest’s Product Pipeline

Table 10.37: NovaRx Clinical Development Pipeline

Table 10.38: Oncothyreon’s Immunotherapy Product Pipeline

Table 10.39: OSE Pharma’s Product Pipeline

Table 10.40: Pique Therapeutics’ Product Pipeline

Table 10.41: Prima BioMed’s Pipeline

Table 10.42: Progenics Pharmaceutical’s Pipeline

Table 10.43: Roche Holding’s Cancer Immunotherapy Product Pipeline

Table 10.44: Seattle Genetics’ Pipeline Products

Table 10.45: Seattle Genetics’ Collaborarator Pipeline

Table 10.46: Synthon Biopharmaceuticals’ Pipeline

Table 10.47: TapImmune’s Product Pipeline

Table 10.48: ThioLogic’s Product Pipeline

Table 10.49: Transgene’s Product Pipeline

Table 10.50: Vaccinogen’s Product Pipeline

Table 10.51: Viventia’s Product Pipeline

Table 10.52: Wilex’s Product Pipeline

Table 10.53: Ziopharm’s Products in Development

Table 11.1: Cancer Immunotherapy Market Participants by Product Segment

Table 12.1: Selected CD19-directed Product Candidates in Clinical Trials by Costimulatory & Binding Domains, Starting Cell Population, Vector and Ablation Technology

Table 12.2: Select CD19-Directed ALL Clinical Trials

Table 12.3: Select Anti-CD22 CAR-T Clinical Projects

Table 13.1: CBER Compliance and Surveillance Activities

Table 13.2: Contacts for the Cellular, Tissue and Gene Therapies Advisory Committee, FDA

Table 14.1: Key Contacts Within PMDA, Japan

Table 15.1: Contact Details for EMA Immunotherapy Experts

Table 16.1: General Technical and Personnel Requirements of a GMP, QC, QA, FDA Regulated Cell Therapy Manufacturing Facility

Table 16.2: Technician/Scientific Requirements for CAR T Manufacturing

Table 16.3: Selection of Apheresis Instruments Currently on the Market

Table 16.4: Selection of Cell Counters and Analyzer Instruments Currently on the Market

Table 16.5: Main Objectives of GMP Manufacturing Immunotherapeutics

Table 16.6: Main Objectives of Quality Control While Manufacturing Immunotherapeutics

Table 16.7: Main Objectives of Regulatory Affairs During Manufacturing Immunotherapeutics

Table 16.8: CAR-T Studies Using mRNA Transfection Electroporation

Table 16.9: Challenges for Autologous Cell Therapy Manufacture

Table 16.10: Current Company/Institutions with Suicide Gene CAR T Projects

Table 16.11: Advantages of Using Automated Cell Therapy Manufacturing

Table 16.12: Main Drivers to Implement Automated Cell Therapy Manufacturing

Table 16.13: Main Benefits of Automated Cell Therapy Manufacturing

Table 16.14: Advantages & Disadvantages of Autologous Cell Therapy Manufacture Scale Up

Table 17.1: Juno Therapeutics Manufacturing Facility Objectives

Table 18.1: Current Juno Therapeutics Trials and CAR T Products

Table 19.1: Current CAR T Business Deals

Table 20.1: Juno Therapeutics Target Biomarker Portfolio

Table 20.2 Juno Therapeutics CAR Technology

Table 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology

Table 20.4 Juno Therapeutics Clinical Pipeline by Target, Product and Trial

Table 20.5: Select CD19-Directed ALL Clinical Trials

Table 20.6: Select Anti-CD22 CAR-T Clinical Projects

Table 20.7 Juno Therapeutics Manufacturing Facility Objectives

Table 20.8 Current Kite Pharma CAR T Clinical Studies and Trials

Table 20.9 Current Kite Pharma TCR Clinical Studies and Trials