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Global & Usa Cancer Immunotherapy Market Analysis To 2020: 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

Published: Jul 15, 2016 | Pages: 317 | Publisher: Kelly Scientific Publications | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

This report provides a comprehensive overview of the size of cancer immunotherapy market, the segmentation of the market, key players and the vast potential of therapies that are in clinical trials. Oncologic therapeutics cannot cure cancer and yet in 2014, the overall market for cancer therapeutics stood at about $84.3 billion.  Any drug that can provide a reasonable survival of more than five years for cancer patients can achieve a blockbuster status. Within cancer therapeutics, immunotherapeutic drugs have gained worldwide acceptance, because they are targeted drugs targeting only cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $41.0 billion in 2014 alone. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 317 pages.

• An overview of cancer immunotherapy that includes: monoclonal antibodies, cancer vaccines and non-specific cancer immunotherapies and CAR T therapies.
• Focus on current trends in cancer immunotherapies that include: anti-PD-1 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 mostly located in the U.S. and Europe.
• Summary table to identify the category of immunotherapy drug offered by the 79 companies.

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 2020?
• What is the global market for cancer immunotherapeutics by geography, through 2020?
• What is the global market for cancer immunotherapeutics by indication, through 2020?
• What is the global market for MAbs by type such as naked MAbs and ADCs, through 2020?
• 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, RG7446, DCVax-L, MEDI4736 etc.?
• What  immunotherapies were approved between 1986 and 2016?
• What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
• What are naked MAbs and how many of them have been approved by the  FDA?
• What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
• What are the common cytotoxic “wareheads” used in ADCs?
• What are the important clinical assets in ADCs?
• How many bispecific MAbs are in late-stage development?
• What are the common side effects of MAbs in cancer immunotherapy?
• What are cancer vaccines and how many of them have been licensed to be marketed?
• 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 2020 Number of melanoma drugs approved between 1998 and 2016?
• Number of lung cancer drugs approved between 1998 and 2016?
• Number of brain cancer drugs approved between 1998 and 2016?
• What is CAR T Therapy?
• What are the main challenges associated with CAR T therapy?
• When will the first CAR T therapeutics be approved?
• What are the current regulations for immunotherapies in USA, Europe & Japan?
• What are the main manufacturing steps in CAR T therapy?
• What challenges lie ahead for CAR T production?

The report is supported by over 180 tables & figures over 317 pages. This report is presented as follows:
The global market for cancer immunotherapy by 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
 
Executive Summary
 
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.
 
Therefore, it is no wonder that in 2013, most science journals hailed cancer immunotherapy as the breakthrough treatment of the year. Conceivably, what makes advancements in cancer immunotherapy research even more dramatic is the fact it has the potential to treat a wide range of tumor types. If the present trends continue, cancer immunotherapy drugs will have a market value of about $80 billion in 2020. A single drug, Bristol-Myers Squibb’s Yervoy, for example has earned revenues of about $960 million in 2013 and it is expected to have a market value of $1,775.2 million in 2020.
 
Recently, a new class of anti-cancer agents called checkpoint inhibitors has hit the market. In  the  first week of September 2014, Bristol-Myers Squibb and Ono Pharmaceutical launched their  PD-1 (programmed cell death-1) inhibitor Opdivo (nivolumab) in Japan for unresectable  melanoma.  Later, Merck got FDA clearance for PD-1 inhibitor Keytruda (pembrolizumab) for unresectable melanoma following the treatment with Yervoy (ipilimumab).
 
In the U.S., Opdivo was granted approval in 2015 for renal carcinoma, non-small-cell lung cancer (NSCLC) and previously treated advanced melanoma. In May 2016, Opdivo was granted FDA approval for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT).
 
Keytruda (pembrolizumab), another PD-1 inhibitor was granted FDA approval in October 2015 for advanced NSCLC, and was granted EMA approval for melanoma in July 2015. Both Keytruda and Opdivo have six figure price tags in the market. Keytruda will cost $12,500 a month and Merck says the median usage is 6.2 months, which works out to a $77,500 price tag, or $150,000 on annualized basis. In Japan, Opdivo costs about $143,000 a patient. Industry experts have predicted that Keytruda and Opdivo will generate sales revenues of $2.9 billion and $4.3 billion respectively in 2019.
 
Another area of anticancer therapy is cancer vaccines. There are two different types of cancer vaccines: prophylactic vaccines to prevent cancers from occurring, and therapeutic vaccines to treat pre-existing cancers. A few prophylactic vaccines for viral-associated cancers have had significant success, such as the human papillomavirus vaccine that helps prevent cervical cancer. On the other hand, therapeutic vaccines have proven much more elusive and a string of failures bred significant skepticism.  Ultimately, in 2010, perseverance  paid off and the first therapeutic vaccine sipuleucel-T for the treatment  of metastatic prostate cancer was approved by the FDA: In spite of its financial restructuring efforts, Dendreon earned $303.8 million in 2014 which was $20.1 million more than its 2013 sales revenue.
 
The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? Some patients do indeed 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 Juno Therapeutics, Kite Pharma, Novartis and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From 2017, 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.
 TABLE  OF CONTENTS

1.	Executive Summary									21
1.1	Objectives of Report									22
1.2	Key Questions Answered in this Report							22
1.3	Data Sources and Methodology								23

2.	Cancer Immunotherapy: An Overview						24
2.1	Human Immune System									24
2.1.1	Components of Human Immune System							25
2.2	Types of Cancer Immunotherapy							26
2.3	Monoclonal Antibodies (Mabs) to Treat Cancer						27
2.3.1	Most Frequently Targeted Antigens by MAbs						27
2.4	Types of Monoclonal Antibodies (MAbs)						29
2.4.1	Naked MAbs										29
2.4.2	Conjugated Monoclonal Antibodies							30
2.4.2.1	Components of an Antibody Drug Conjugate (ADC)					30
2.4.2.2	Mechanism of Action of Antibody Drug Conjugate (ADC)				31
2.4.2.3	The Cytotoxic Wareheads used in ADCs							31
2.4.2.4	Successful CytotoxinWareheads							32
2.4.2.5	Developmental Timeline of ADCs							33
2.4.2.6	Target Antigens for ADCs in Preclinical and Clinical Development	                          34
2.4.2.7	Important Clinical Assets in ADCs							34
2.4.3	Bispecific Monoclonal Antibodies							36
2.4.3.1	Technology Platforms for the Production of Bispecific MAbs				37
2.4.4	Safety and Side Effects of MAbs in Cancer Immunotherapy				37
2.5	Cancer Vaccines									38
2.5.1	Cancer Vaccines in Development							39
2.6	Non-Specific Cancer Immunotherapies and Adjuvants					42
2.6.1	Cytokines										42
2.6.2	Interferon (IFN)										42
2.7	New Frontiers in Cancer Immunotherapy Research					43
2.7.1	Drugs for Targeting Immune Checkpoints						43
2.7.1.1	Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4)				43
2.7.1.2	Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1)			43	
2.7.1.3	Major Checkpoint Inhibitors in Clinical Development					43
2.7.2	Chimeric Antigen Receptor (CAR) T Cell Therapy					44
2.7.3	Tumor-Infiltrating Lymphocytes (TILs) and Interleukin-2 (IL-2)				44
2.8	Cancer Immunotherapy: Timeline of Progress						44

3.	Current Status of Cancer Immunotherapy: An Overview				48
3.1	Programmed Death (PD-1) Inhibitors							48
3.1.1	Important Events and Advantages for Nivolumab in Melanoma Indication		49
3.1.2	Important Events and Advantages for Nivolumab in Non-Small Cell Lung Cancer	50
3.1.3	Important Events and Advantages for Nivolumab in Renal Cell Cancer			50
3.1.4	Nivolumab Studies for Melanoma							50
3.1.5	Nivolumab Studies for Non-Small Cell Lung Cancer (NSCLC)				51
3.1.6	Nivolumab Studies for Renal Cell Cancer (RCC)						51
3.2	MK-3475 (Pembrolizumab)								51
3.2.1	Important Events and Advantages for MK-3475 in Melanoma				51
3.2.2	Important Events and Advantages for MK-3475 in NSCLC				52
3.2.3	Important Events for MK-3475 in RCC							52
3.3	RG7446 from Roche									52
3.3.1	Important Events for RG7446 in Melanoma						53
3.3.2	Important Events and Advantages for RG7446 in NSCLC				53
3.3.3	Important Event for RG7446 in RCC							54
3.3.4	RG7446 Studies in NSCLC								54
3.3.5	RG7446 Studies in RCC								54
3.3.6	RG7446 Study in RCC									55
3.4	Pidilizumab from CureTech								56
3.5	An Overview of Anti-PD-1 Clinical Development					56
3.5.1	Other Checkpoint Inhibitors in Development						58
3.6	Studies with Yervoy (Ipilimumab)							58
3.7	Studies with Tremelimumab								60
3.8	KAHR-102										60
3.9	TIM3 Antibody										60
3.10	BMS-989016										60
3.11	ImmuTune IMP701 and ImmuFact IMP321						61
3.12	Dendritic Cell Therapies								61
3.12.1	Provenge (Sipuleucel-T)								62
3.12.2	AGS-003 from Argos Therapeutics							62
3.12.3	DCP-001 from DCPrime								63
3.12.4	DC-Vax from Northwest Biotherapeutics						63
3.13	Chimeric Antigen Receptor T-Cells (CAR-T) Therapies					63
3.13.1	CLT109										63
3.13.2	Chimeric Antigen Receptors (CAR) Program by Juno					64
3.13.3	Chimeric Antigen Receptor (CAR) T-Cell Program by Bluebird Bio			64
3.13.4	UCART19 from Cellectis								64
3.13.5	Chimeric Immune Receptor (CIR) T-Cells from Abramson Cancer Center		65
3.13.6	CD19 eACT CAR-T Therapy from Kite Pharma						65
3.13.7	Autologous CAR-T Program for Breast Cancer from Adaptimmune			65
3.14	Cancer Vaccines									65
3.14.1	HyperAcute										65
3.14.2	MAGE-A3 Antigen-Specific Cancer Immunotherapeutic					67
3.14.3	ADXS-HPV										67
3.14.4	IDO Inhibitors										68
3.14.5	Indoximod and NLG-919 (INCY)							68
3.14.6	INCB24360 (INCY)									68
3.14.7	deCellVax (BMSN)									68
3.15	Miscellaneous Immunotherapies								69
3.15.1	Contego (Lion Biotechnologies)								69
3.15.2	TG4010 (Transgene)									69
3.16	Most Valuable R&D Projects in Cancer Immunotherapy					69
3.16.1	Nivolumab (Opdivo)									70
3.16.2	MK-3475										70
3.16.3	RG7446										70
3.16.4	Palbociclib										71
3.16.5	DCVax-L										71
3.16.6	MEDI4736										71

4.	Challenges in Cancer Medicine Research: An Overview				64
4.1	Years of Failures and Emerging Successes in Melanoma Medicine Research		64
4.1.1	Future Outlook for Melanoma Drugs							73
4.2	A New Era for Lung Cancer Medicines							74
4.2.1	Progresses Made in Lung Cancer Medicine Research					74
4.2.2	Successes and Failures in Lung Cancer Medicine Development				75
4.2.3	Future Outlook for Lung Cancer Medicines						75
4.3	Ray of Hope for Brain Cancer Patients							76
4.3.1	Progress made for Brain Cancer Treatment in Recent Years				76
4.3.2	Successes and Failures in Brain Cancer Drug Development				76

5.	Cancer Immunotherapeutic Products: An Overview					78
5.1	I-Labelled Tositumomab (Bexxar)							78
5.2	Y-Labelled Ibritumomab (Zevalin)							78
5.3	Alemtuzumab (Campath)								79
5.4	AdotrastuzumabEmtansine (Kadcyla)							79
5.5	Bacillus Calmette-Guerin (BCG)							80
5.6	Bevacizumab (Avastin)									80
5.7	BrentuximabVedotin (Adcetris)								80
5.8	Cetuximab (Erbitux)									81
5.9	Cervarix										81
5.10	DenileukinDiftitox (Ontak)								82
5.11	Gardasil										82
5.12	Gemtuzumab (Mylotarg)								82
5.13	Hepatitis B Vaccine									82
5.14	Interferon Alfa (IFN-alfa)								82
5.15	Interleukin-2 (IL-2)									83
5.16	Ipilimumab (Yervoy)									83
5.17	Ofatumumab (Arzerra)									83
5.18	Panitumumab (Vectibix)								83
5.19	Pembrolizumab (Keytruda)								83
5.20	Rituximab (Mabthera)									84
5.21	Sargramostim (Leukine)									84
5.22	Sipuleucel-T (Provenge)								84
5.23	Trastuzumab (Herceptin)								84

6.	Available Immunotherapies for Cancer by Disease Type: An Overview		86
6.1	Melanoma Skin Cancer and Immunotherapy						87
6.1.1	Ipilimumab (Yervoy) for Advanced Melanoma						87
6.1.2	PD-1 Inhibitors (Keytruda and Opdivo) for Advanced Melanoma				87
6.1.3	Cytokines for Advanced Melanoma							87
6.1.4	Interferon Alfa as Adjuvant Therapy for Melanoma					87
6.1.5	BacilleCalmette-Guerin (BCG) Vaccine for Melanoma					88
6.1.6	Imiquimod (zyclara) Cream for Melanoma						88
6.2	Breast Cancer and Immunotherapy							88
6.2.1	Promising Therapeutic Vaccine Product Candidates for Breast Cancer			88
6.2.2	Promising Checkpoint Inhibiting Product Candidates for Breast Cancer			89
6.2.3	Promising Adoptive T Cell Therapy Product Candidates for Breast Cancer		89
6.2.4	Promising Antibody Product Candidates for Breast Cancer				89
6.3	Immunotherapy for Prostate Cancer							89
6.3.1	Therapeutic Vaccines for Prostate Cancer						90
6.3.2	Checkpoint Inhibitors for Prostate Cancer						91
6.3.3	Adoptive Cell Therapy for Prostate Cancer						92
6.4	Immunotherapy for Lung Cancer							92
6.4.1	Monoclonal Antibodies for Lung Cancer							92
6.4.1.1	Promising MAb Product Candidates for Lung Cancer					92
6.4.1.2	Checkpoint Inhibitors for Lung Cancer							93
6.4.1.3	Therapeutic Vaccines for Lung Cancer							95
6.4.1.4	Promising Adoptive T Cell Transfer Product Candidates for Lung Cancer			95
6.5	Immunotherapy for Colorectal Cancer							96
6.5.1	Promising Monoclonal Antibody Product Candidates for Colorectal Cancer		96
6.5.2	Trials Using Checkpoint Inhibitors and Immune Modulators for Colorectal Cancer	97
6.5.3	Clinical Trials for Vaccines Indicated for Colorectal Cancer				97
6.5.4	Adoptive Cell Therapy for Colorectal Cancer						98
6.5.5	Oncolytic Virus Therapy for Colorectal Cancer						98
6.5.6	Adjuvant Immunotherapy for Colorectal Cancer						98
6.5.7	Cytokines for Colorectal Cancer								98
6.6	Immunotherapies in Development for Lymphoma					99
6.6.1	Therapeutic Vaccines in Development for Lymphoma					99
6.6.2	Checkpoint Inhibitors for Lymphoma							99
6.6.3	Adoptive T Cell Transfer for Lymphoma						99
6.6.4	Monoclonal Antibodies for Lymphoma							100
6.7	Immunotherapy for Kidney Cancer							100
6.7.1	Checkpoint Inhibitors for Kidney Cancer						100
6.7.2	Vaccines for Kidney Cancer								100
6.7.3	Adoptive Cell Therapy for Kidney Cancer						101
6.8	Dominance of MAbs and Vaccines in Cancer Clinical Research				101
6.9	Oncology Biologics Losing Patent Protection						101

7.	Cancer Incidence and Mortality: An Overview					103
7.1	Global Economic Burden of Cancer							103
7.2	Global Burden of Cancer								104
7.3	Top Five Most Frequent Cancers, Globally						104
7.3.1	Global Prevalence of Colorectal, Breast and Lung Cancers				105
7.3.2	Percentage of Top Three Cancers Diagnosed Globally					105
7.3.2.1	Mortality due to Lung, Liver and Stomach Cancers					106
7.3.2.2	Percentage of Death due to Lung, Liver and Stomach Cancers				107
7.4	Cancer Deaths in Women								107
7.5	Prevalence and Mortality for Cancer Types Addressed by Immunotherapy		108
7.5.1	Breast Cancer										108
7.5.1.1	Worldwide Incidence of Breast Cancer and Mortality Rate by Geography			109
7.5.1.2	Female Breast Cancer Incidence in the U.S						109
7.5.1.3	Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S	110
7.5.1.4	Breast Cancer Incidence in Canada							111
7.5.1.5	Breast Cancer Incidence and Mortality in Latin America					111
7.5.1.6	Breast Cancer Incidence and Mortality in Europe					112
7.5.1.7	Breast Cancer Incidence in Asia/Pacific							113
7.5.1.8	Breast Cancer Incidence by Country							114
7.5.2	Gastric Cancer (Stomach Cancer)							118
7.5.2.1	Incidence of Gastric Cancer in Top 15 Countries						118
7.5.3	Colorectal Cancer									119
7.5.3.1	Global Incidence of Colorectal Cancer							119
7.5.3.2	Worldwide Variations in the Incidence of Colorectal Cancer				120
7.5.3.3	Risk Factors for Colorectal Cancer							121
7.5.3.4	Colorectal Cancer Screening in the U.S							122
7.5.3.5	Colorectal Cancer Incidence Rates in the U.S. by State					122
7.5.3.6	Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States			123
7.5.4	Lung Cancer										124
7.5.4.1	Non-Small Cell Lung Cancer (NSCLC)							125
7.5.4.2	Global NSCLC Incidence								126
7.5.4.3	Lung Cancer in Americas by Gender							126
7.5.4.4	Tobacco Use and Lung Cancer								127
7.5.4.5	Current Therapeutic Options for Lung Cancer						128
7.5.5	Glioblastoma										130
7.5.5.1	Global Incidence of Glioblastoma							130
7.5.6	Kidney Cancer										131
7.5.6.1	Global Incidence of Kidney Cancer							132
7.5.7	Blood Cancer										133
7.5.7.1	Leukemia										133
7.5.7.2	Blood Cancer in the U.S									134
7.5.8	Cervical Cancer										136
7.5.8.1	Global Incidence of Cervical Cancer							136
7.5.9	Prostate Cancer										137
7.5.9.1	Global Incidence of Prostate Cancer							137
7.5.9.2	Prostate Cancer Incidence and Mortality by Geography					138
7.5.9.3	Prostrate Cancer in the U. S								139
7.5.10	Melanoma										140
7.5.10.1 Skin Cancer in the U. S									141

8.	Market Analysis									142
8.1	Global Oncology Market								142
8.2	Top Ten Companies in Oncology Drug Sales						143
8.3	Top Five Oncology Drugs								144
8.4	Global Oncology Therapeutics Market by Cancer Type					145

9.	Market for Cancer Immunotherapy							147
9.1	Key Drivers										147
9.2	Global Market for Cancer Immunotherapeutics						147
9.3	Global Market for Cancer Immunotherapy by Product Class				149
9.4	Global Market for Immunotherapy Drugs by Cancer Type				150
9.5	Global Market for Monoclonal Antibodies for Cancer by Type				151
9.5.1	Best Selling MAbs									152
9.5.1.1	Market Forecast for Herceptin								152
9.5.1.2	Market Value and Forecast for Avastin							153
9.5.1.3	Global Market for Erbitux								154
9.5.1.4	Global Market for Yervoy								155
9.5.1.5	Global Market for Mabthera								156
9.5.2	Global Market for Antibody Drug Conjugates (ADCs)					157
9.5.2.1	Global Market for Adcetris								157
9.5.2.2	Global Market for Keytruda								158
9.6	Global Market for Cancer Vaccines							159
9.6.1	Global Market for Cancer Vaccines by Type						160
9.7	Global Market for Non-Specific Cancer Immunotherapeutics				162
9.8	Market Values for Selected Forthcoming Cancer Immunotherapeutics			163
9.8.1	Market Value for Nivolumab (Opdivo)							163
9.8.2	Market Value for RG7446								163
9.8.3	Market Value for DCVax-L								163
9.8.4	Market Value for MEDI4736								164
9.8.5	High Cost of MAbs									164

10.	Company Profiles									165
10.1	Ablynx NV										165
10.2	Activartis Biotech GmbH								166
10.2.1	GBM Vax Study									166
10.3	AdvaxisInc										166
10.3.1	Advaxis’ Technology									167
10.3.2	Advaxis’ Product Pipeline								167
10.3.2.1	 ADXS-HPV										162
10.3.2.2	 ADXS-PSA										167
10.3.2.3	 ADXS-cHER2										167
10.4	AduroBioTechInc									168
10.4.1	Aduro’s Technology									168
10.4.1.1		CRS-207									169
10.4.1.2		AUD-623									169
10.4.1.3		ADU-741									169
10.4.1.4		ADU-S100									169
10.5	Agenus Inc										170
10.5.1	QS-21 Stimulon										170
10.6	AlphaVaxInc										171
10.6.1	Alpha Vax’s Technology								171
10.7	A. MenariniIndustrieFarmaceuticheRiuniteSrl						171
10.7.1	MEN1112										172
10.8	Amgen Inc										172
10.8.1	Vectibix (panitumumab)								172
10.8.2	Blinatumomab (Blincyto)								173
10.8.3	Rilotumumab										173
10.9	Antigen Express Inc									173
10.9.1	Li-Key Hybrid Vaccines (AE37)							173
10.10	Argos Therapeutics Inc									174
10.10.1	AGS-003										174
10.11	Bavarian Nordic A/S									175
10.11.1	Prostvac										175
10.11.2	CV-301											175	
10.11.3	MVA-BN PRP										176
10.11.4	MVA-BN HER2									176
10.11.4.1 MVA-BN Brachyury									176
10.12	Bellicum Pharmaceuticals Inc								176
10.12.1	BPX-501										176
10.12.2	BPX-201										177
10.12.3	BPX-401										177
10.12.4	BPX-601										177
10.12.5	BPX-701										177
10.13	Biogen Idec Inc										178
10.13.1	Rituxan (Rituximab)									178
10.13.2	Gazyva (Obinutuzumab)								178
10.14	Biovest International Inc								179
10.14.1	BiovaxID										179
10.15	Bristol-Myers Squibb Company								179
10.15.1	Erbitux (cetuximab)									180
10.15.2	OPDIVO (nivolumab)									180
10.15.3	Yervoy (ipilimumab)									180
10.16	Cellectis										180
10.17	Cellerant Therapeutics Inc								181
10.17.1	CLT-008										182
10.17.2	CLT-009										182
10.18	Celldex Therapeutics									182
10.18.1	Rindopepimut										182
10.18.2	Glembatumumabvedotin (CDX-011)							183
10.18.3	Varlilumab (CDX-1127)								183
10.18.4	CDX-1401										183
10.18.5	CDX-301										183
10.19	CEL-SCI Corp.										183
10.19.1	Multikine										184
10.20	CureTech Ltd.										184
10.20.1	Pidilizumab (CT-011)									184
10.21	Delta-Vir GmbH									185
10.21.1	Treatment										185
10.22	Dendreon Corp.										185
10.22.1	Provenge (Sipuleucel-T)								185
10.23	DenDrit Biotech USA									186
10.23.1	MelCancerVac										186
10.24	DNAtrixInc										186
10.24.1	DNX-2401										186
10.25	Eli Lilly and Co.									187
10.25.1	Erbitux (Cetuximab)									187
10.26	EMD SeronoInc									187
10.27	Etubics Corp.										188
 10.28	Galena Biopharma Inc									189
10.29	Genentech Inc										189
10.29.1	Avastin (bevacizumab) for Metastatic Colorectal Cancer					190
10.29.1.1	Avastin and Interferon Alfa for Metastatic Kidney Cancer			190
10.29.1.2	Avastin for Metastatic NLCLC							190
10.29.2	Gazyva (obinutuzumab) for Chronic Lymphocytic Leukemia				190
10.29.3	Herceptin (trastuzumab) for Breast Cancer						190
10.29.3.1	Herceptin and Chemotherapy for Gastric Cancer					190
10.29.4	Kadcyla (ado-trastuzumabemtansine)							191
10.29.5	Perjeta (pertuzumab)									191
10.29.6	Rituxan (rituximab)									191
10.29.7	Genentech’s Cancer Immunotherapy Pipeline Products					192
10.30	Genmab AS										193
10.30.1	Ofatumumab										193
10.31	GlaxoSmithKline									194
10.31.1	Arzerra (Ofatumumab)									194
10.31.2	Cervarix										194
10.32	GliknikInc										194
10.33	GlobeImmuneInc									195
10.34	Heat Biologics Inc									196
10.35	Immatics Biotechnologies GmbH							196
10.36	ImmunoCellular Therapeutics Ltd.							197
10.37	Immunocore Ltd.									198
10.37.1	Product Pipeline									198
10.38	ImmunoFrontierInc									198
10.39	ImmunoGenInc									199
10.39.1	IMGN853										199
10.39.2	IMGN529										199
10.39.3	IMGN289										199
10.39.4	IMGN779										199
10.40	ImmunomedicsInc									200
10.41	ImmunotopeInc									200
10.41.1	IMT-1012 Immunotherapeutic Vaccine							201
10.42	ImmunovaccineInc									201
10.43	Inovio Pharmaceuticals Inc								202
10.44	Janssen Biotech Inc									202
10.44.1	Doxil											202
10.44.2	Procrit											203
10.44.3	Zytiga											203
10.44.4	Imbruvicia										203
10.45	Juno Therapeutics Inc									203
10.46	Kite Pharma Inc									204
10.46.1	Kite Pharma’s Technology								204
10.46.1.1	eACT (engineered Autologous Cell Therapy)					204
10.46.1.2	DC-Ad GM-CAIX								204
10.47	MabVax Therapeutics Holdings Inc							205
10.48	MedImmune LLC									206
10.49	Merck & Co., Inc									207
10.49.1	Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine		207
10.49.2	Keytruda (Pembrolizumab)								207
10.50	Merrimack Pharmaceuticals Inc								208
10.51	MorphotekInc										208
10.51.1	Farletuzumab (MORAb-003)								209
10.51.2	Amatuximab (MORAb-009)								209
10.51.3	Ontuxizumab (MORAb-004)								209
10.51.4	MORAb-066										209
10.52	NewLink Genetics Corp.								209
10.53	Northwest BiotherapeuticsInc								210
10.54	NovaRx Corp.										211
10.55	OncoPepInc										211
10.55.1	PVX-410										211
10.56	OncothyreonInc									212
10.57	OSE Pharma SA									212
10.58	Oxford BioTherapeutics Ltd.								213
10.58.1	Technologies										213
10.58.1.1 OGAP – Cancer Targeting								213
10.58.1.2 Antibody Development								213
10.58.1.3 Antibody “arming”									214
10.58.2	 Lead Programs										214
10.58.2.1  OX001/MEN1112									214
10.58.2.2  OX002										214
10.58.2.3  OX003										214
10.58.2.4  OX004										214
10.59	Pique Therapeutics									215
10.60	Polynoma LLC										215
10.60.1	MAVIS Trial										215
10.61	Prima BioMed Ltd.									216
10.62	Progenics Pharmaceuticals Inc								216
10.62.1	PSMA Targeted Imaging Compound (1404)						217
10.62.2	PSMA ADC Therapeutic								217
10.62.3	Small Molecule Therapeutic (1095)							217
10.62.4	Azedra											217
10.63	Regen Biopharma Inc									218
10.63.1	HemaXellerate										218
10.63.2	dCellVax										218
10.63.3	Diffron C										218
10.64	Roche Holdings Inc									219
10.64.1	Avastin (Bevacizumab)									219
10.64.2	Gazyva/Gazyvaro (Obinutuzumab; GA101)						219
10.64.3	Herceptin (Trastuzumab)								219
10.64.4	Kadcyla (Trastuzumabumemtansinum)							219
10.64.5	Mabthera (Rituximab)									219
10.64.6	Perjeta (Pertuzumab)									220
10.65	Seattle Genetics Inc									221
10.65.1	Adcetris (Brentuximabvedotin)								222
10.65.2	Seattle Genetics’ Collaborarator Pipeline						222
10.66	Sorrento Therapeutics Inc								223
10.66.1	Sorrento’s Antibody Technologies							224
10.66.1.1  G-MAB										224
10.66.1.2  Antibody Drug Conjugates (ADCs)							224
10.67	Spectrum Pharmaceuticals Inc								224
10.67.1	Zevalin											224
10.68	Synthon Pharmaceuticals Inc								225
10.69	TapImmuneInc										225
10.70	ThioLogics Ltd.										226
10.71	Transgene SA										227
10.72	TVAX Biomedical Inc									228
10.72.1	TVI-Brain-1										228
10.72.2	TVI-Kidney-1										228
10.73	VaccinogenInc										228
10.74	Viventia Biotechnologies Inc								229
10.75	Wilex AG										229
10.76	Ziopharm Oncology Inc									230

11.   Cancer Immunotherapy Market Participants by Product Segment			231

12.	CAR T Therapy									233
12.1	Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy 		233
12.1.1	Clinical Status of CD19 CAR-T Cells To Date 						234
12.1.2	Clinical and Regulatory Challenges for Development of CAR T Cells 			234 
12.1.3	Key Regulatory Challenges Associated with CAR-T Development 			235
12.1.4	Summary of Select CAR-T Products by Juno, Novartis and Kite  				235
12.1.5	Clinical Benefit Versus Toxicity in CD19-Directed ALL Clinical Trials 			236
12.1.6	How to Manage Toxicity of CAR-T Therapy 						236

13.	Regulations Pertaining to Immunotherapy Regulation in the USA 			238	
13.1	Center for Biologics Evaluation and Research (CBER) 					238
13.1.1	Compliance and Surveillance 								238
13.1.2	Extra Resources on Immunotherapeutics from the FDA 					239
13.1.3	Cellular, Tissue and Gene Therapies Advisory Committee 				240
13.1.4	Consumer Affairs Branch (CBER) Contact in FDA 					242
13.1.5	FDA Regulations Pertaining to Immunotherapies 					242
13.1.6	Case Study Ovarian Cancer Immunotherapy Regulations 				243
13.1.6.1		Efficacy 									243
13.1.6.2		Adverse Effects 								246
13.1.7	Trial Design Considerations for Immunotherapy						246
13.1.8	Development of Immune-Related Response Criteria (irRC) & Clinical Endpoints Specific to Immunotherapies 										246

14.	Regulations for Immunotherapy in Japan 						249
14.1	PMDA and Immunotherapy								251
12.1.1	Increasing the Efficiency in Immunotherapy Regulatory Review 				253
12.1.2	Forerunner Review Assignment System 							254
12.1.3	Revised Guidelines for Clinical Evaluation of Anti‐Malignant Tumor Agents 		255
12.1.4	Key Contacts Within the PMDA for Immunotherapeutics				256

15.	European Regulation and Immunotherapeutics					263
15.1	Introduction 										263
15.2	Challenges for Immunotherapy in EMEA 						263
15.2.1	EMA Status on Potency Testing 							264
15.2.1.1		In Vivo Potency Testing 							264
15.2.1.2		In Vitro Potency Testing 							264
15.2.1.3		Viable Cell Count 								265
15.2.1.4		Autologous Cell Based Products 						265
15.2.1.5		Reference Preparation 								265
15.2.1.6		Adjuvant Containing Immunotherapy Products					265
15.2.2	EMA Status on Identifying hyper, Hypo or non-Responders 				266
15.3	Challenges Relating to Biomarkers in Immunotherapy 					266
15.4	Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy 		267
15.5	Estimating Optimal Cut-Off Parameters 							268
15.6	EU-Approved Immunotherapies in Melanoma 						268
15.7	Key Contacts Within EMA for Immunotherapeutics					271

16.	Manufacturing of Immunotherapies 							272
16.1	Introduction 										272
16.2	Generation of CAR-Modified T Cells 							272
16.2.1	What Co-Stimulation and Activity Domain is Optimal to Use? 				275
16.2.2	Optimizing Cell Culture Media 								276
16.2.3	Manufacturing Lentiviral Vectors 							276
16.2.4	Detection of Integrated CAR-Expressing Vectors 					277
16.2.5	Donor Lymphocyte Infusion Procedure 							277
16.2.6	Ex Vivo Costimulation& Expansion of Donor T Cells 					277
16.2.7	Infusion to the Patient 									277
16.3	Manufacturing Devices and Instruments Required for Immunotherapy Production		278
16.3.1	Leukapheresis										278
16.3.2	Cell Counters and Analyzer 								279
16.3.3	Cell Seeding, Growth and Propagation 							281
16.4	Good Manufacturing Procedure (GMP) for Immunotherapy 				281
16.5	Case Study Production of Lentivirus Induced Dendritic Cells under GMP Conditions 	282
16.6	Quality Control 									283
16.7	Regulatory Affairs 									284
16.8	Key Challenges in Manufacturing 							285
16.8.1	Electroporation of T-cells 								285
16.8.2	Allogenic CAR T cells 									286
16.8.3	Relapse Rates are Critical 								288
16.8.4	Antigen Negative Relapse 								289
16.8.5	Incorporating Suicide Genes 								289
16.8.16	Automation in Cell Therapy Manufacturing 						290
16.8.17	Autologous Cell Therapy Manufacture Scale Up 					292

17.	Supply Chain & Logistics 								293
17.1	Introduction 										293
17.2	Case Study: Juno Therapeutics 								293

18.	Pricing & Cost Analysis 								296
18.1	Introduction 										296
18.2	CAR T Therapy Market Evaluation 							298

19.	Current Deals Within the CAR T Market 						301

20.	CAR T Therapy Company Case Studies						303
20.1	Juno Therapeutics									303
20.2	Kite Pharma										311
20.3	Cellectis										315
LIST OF TABLES

Table 2.1: Types of Immune Cells and their Functions						25
Table 2.2: FDA-Approved Cancer Immunotherapies, 1986-2014					26
Table 2.3: FDA-Approved Monoclonal Antibodies (MAbs) to Treat Cancer			27
Table 2.4: Most Frequently Targeted Antigens by MAbs						28
Table 2.5: FDA-Approved Monoclonal Antibodies							29
Table 2.6: Cytotoxic Wareheads Used in ADCs								32
Table 2.7: Targeted Indications for ADCs								33
Table 2.8: Antibody Drug Conjugates: Developmental Tmeline						33
Table 2.9: Target Antigens for ADCs in Preclinical and Clinical Development				34
Table 2.10: Current ADCs Launched, Withdrawn and in Phase I/II/III Trials by Sponsor, Indication, Antigen, Cytotoxin and Linker 											35
Table 2.11: MAb Products and Candidates that Recruit T Cells						36
Table 2.12: Bispecific MAbs in Clinical Trials Targeting Cancer by Indication and Company		36
Table 2.13: Bispecific Antibody Technology Platforms							37
Table 2.14: Side Effects of Some of the Approved Cancer Immunotherapy MAbs				38
Table 2.15: FDA-Approved Cancer Vaccines								39
Table 2.16: Cancer Vaccines in Development								39
Table 2.17: FDA-Approved Cytokines for Cancer Immunotherapy					42
Table 2.18: Cancer Indications Approved for IFN-alfa							42
Table 2.19: FDA-Approved Immune Checkpoint Modulators						43
Table 2.20: Immune Checkpoint Inhibitors in Clinical Development					44
Table 2.21: Cancer Immunotherapy: Timeline of Progress						45
Table 3.1: PD-1 Therapies Targeting either the PD-L1/L2 or PD-1 Receptor				48
Table 3.2: Overview of Clinical Trial Landscape for Top Five Anti-PD-1 and Anti-PD-L1 Drugs		49
Table 3.3: Nivolumab Efficacy from Expansion Coharts of Study 003					50
Table 3.4: Phase I Data of MK-3475 in Melanoma							52
Table 3.5: Phase I Data of RG7446 in NSCLC Patients							54
Table 3.6: RG7446 Phase I Data from RCC Patients							55
Table 3.7: Phase I Melanoma Data for RG7446								55
Table 3.8: Phase II Data for Pidilizumab in Diffuse Large B Cell Lymphoma (DLBCL)			56
Table 3.9: Phase II Melanoma Data for Pidilizumab							56
Table 3.10: An Overview of Anti-PD-1 Development by Company, Drug Candidate, Indication and Clinical Phase 													57
Table 3.11: Clinical Development of CTLA-4, TIM3, and LAG3 Checkpoint Inhibitors by Company, Drug Candidate, Indication and Clinical Trial Stage 								58
Table 3.12: Pivotal Phase III Results for Yervoy in Second-Line Patients with Metastatic Melanoma	59
Table 3.13: Updated Data from Phase III Clinical Study 024 for Yervoy					59
 Table 3.14: Data from the Failed Phase III Study of Tremelimumab for Melanoma			60
Table 3.15: An Overview of Clinical Development of Dendritic Cell Therapies by Company, Drug Candidate, Indication and Clinical Phase 										61
Table 3.16: Pivotal Phase III Rwesults for Yervoy in Second-Line Patients with Metastatic Melanoma..	63
Table 3.17: Phase I/Iia Results from Kite Pharma’s CAR-T Therapy 					65
Table 3.18: Cancer Vaccines in Development by Company, Drug Candidate, Indication & Clinical Phase  66
Table 3.19: Advaxis Phase II Results for Cervical Cancer Patients in India				68
Table 3.20: Phase II Data for Contego
Table 3.21: Valuable R&D Projects in Cancer Immunotherapy						70
Table 6.1: Cancer Types Addressed by Immunotherapies by Drug, Trade Name and Company		86
Table 6.2: Oncology Drugs Losing Patent Protection by 2020 by Product, U.S. Expiry Date and E.U. Expiry Date 												102
Table 7.1: Global Cancer Statistics – Key Facts							104
Table 7.2: Top Five Most Frequent Cancers, Globally						104
Table 7.3: Estimated Breast Cancer Cases and Deaths in the U.S. by Age, 2013			110
Table 7.4: Estimated Canadian Breast Cancer Statistics for 2014					111
Table 7.5: Age-Standardized Breast Cancer Incidence Rate per 100,000 Women by Country	114
Table 7.6: Global Colorectal Cancer Incidence and Mortality Rates by Gender per 100,000 people	121
Table 7.7: Risk Factors for Colorectal Cancer							121
Table 7.8: Lung Cancer Incidence and Mortality Rate in Americas by Gender			127
Table 7.9: Current Therapeutic Options for Lung Cancer						129
Table 7.10: Estimated Number of New Leukemia Cases in the U.S., 2014				134
Table 7.11: Estimated Deaths in the U.S. from Leukemia, 2014					135
Table 7.12: Estimated Deaths from HL and NHL in the U.S., 2014				135
Table 7.13: Estimated Incidence and Deaths for Myeloma in the U.S., 2014			135
Table 7.14 Global Prostate Cancer Incidence and Mortality Rates by Geography			138
Table 7.15: Incidence and Mortality Rates of Prostate Cancer in Americas			139
Table 7.16: Incidence and Mortality Rates for Melanoma in Americas				141
Table 8.1: Global Market for Oncology Drugs by Geography/Country, Through 2020		142
Table 8.2: Top Ten Companies in Oncology Sales, Through 2020				143
Table 8.3: Top Five Oncology Drugs, Through 2020						145	
Table 9.1: Global Cancer Immunotherapy Market, Through 2020					148
Table 9.2: Global Market for Immunotherapy by Product Class, Through 2020			149
Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2020		150
Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2020		151
Table 9.5: Global and U.S. Market for Herceptin, Through 2020					153
Table 9.6: Global and U.S. Market for Avastin, Through 2020					154
Table 9.7: Global Market for Cancer Vaccines, Through 2020					160
Table 9.8: Global Market for Cancer Vaccines by Type, Through 2020				161
Table 9.9: Projected Market for the Forthcoming Nivolumab, RG7446, DCVax-L and MEDI4736	164
Table 9.10: Annual Cost of MAbs in the U.S. by Product, Indication and Biomarker		164
Table 10.1: Ablynx’s Product Pipeline								165
Table 10.2: Aduro’s Product Pipeline								168
Table 10.3: Agenus’ Product Pipeline								170
Table 10.4: AlphaVax Cancer Immunology Product Pipeline					171
Table 10.5: Amgen’s Product Pipeline								172
Table 10.6: Antigen Express’ Cancer Therapeutic Pipeline					173
Table 10.7: Argos’ Cancer Product Pipeline							174
Table 10.8: Bavarian Nordic’s Product Pipenine							175
Table 10.9: Bellicum’s Pipeline Product Candidatea						177
Table 10.10: Biogen’s Oncology Pipeline							178
Table 10.11: Bristol-Myers Squibb’s Pipeline Products in Cancer Immunotherapy		179
Table 10.12: Cellectis’ Products in Development							181
Table 10.13: Cellerant’s Product Pipeline							181
Table 10.14: Celldex’s Therapeutic Pipeline							182
Table 10.15: CEL-SCI’s Immunotherapy Products in Development				184
Table 10.16: EMD Serono’s Product Pipeline							188
Table 10.17: Etubic’s Product Pipeline								188
Table 10.18: Galena’s Product Pipeline								189
Table 10.19: Genentech’s Cancer Immunotherapy Pipeline Products				192
Table 10.20: Genmab’s Products in Development						193
Table 10.21: Gliknik’s Product Pipeline								195
Table 10.22: GlobeImmune’s Product Pipeline							195
Table 10.23: Heat Biologic’s Product Pipeline							196
Table 10.24: Immatics Biotechnology’s Product Pipeline						197
Table 10.25: ImmunoCellular’s Product Pipeline							197
Table 10.26: Immunomedics’ Late-Stage Antibody-Based Therapies				200
Table 10.27: Immunovaccine’s Product Pipeline							201
Table 10.28: Inovio Pharmaceuticals Product Pipeline						202
Table 10.29: Juno Therapeutics’ Current Pipeline						204
Table 10.30: Kite Pharma’s Product Pipeline							205
Table 10.31: MabVax’s Product Pipeline							205
Table 10.32: MedImmune’s Products in Development						206
Table 10.33: Merck’s Pipeline of Cancer Immunotherapy Products				207
Table 10.34: Merrimack’s Product Pipeline							208
Table 10.35: NewLink Genetics’ Product Pipeline						210
Table 10.36: Northwest’s Product Pipeline							210
Table 10.37: NovaRx Clinical Development Pipeline						211
Table 10.38: Oncothyreon’s Immunotherapy Product Pipeline					212
Table 10.39: OSE Pharma’s Product Pipeline							213
Table 10.40: Pique Therapeutics’ Product Pipeline						215
Table 10.41: Prima BioMed’s Pipeline								216
Table 10.42: Progenics Pharmaceutical’s Pipeline						217
Table 10.43: Roche Holding’s Cancer Immunotherapy Product Pipeline				220
Table 10.44: Seattle Genetics’ Pipeline Products							222
Table 10.45: Seattle Genetics’ Collaborarator Pipeline						223
Table 10.46: Synthon Biopharmaceuticals’ Pipeline						225
Table 10.47: TapImmune’s Product Pipeline							226
Table 10.48: ThioLogic’s Product Pipeline							226
Table 10.49: Transgene’s Product Pipeline							227
Table 10.50: Vaccinogen’s Product Pipeline							228
Table 10.51: Viventia’s Product Pipeline								229
Table 10.52: Wilex’s Product Pipeline								230
Table 10.53: Ziopharm’s Products in Development						230
Table 11.1: Cancer Immunotherapy Market Participants by Product Segment			231
Table 12.1: Selected CD19-directed Product Candidates in Clinical Trials by Costimulatory & Binding Domains, Starting Cell Population, Vector and Ablation Technology 				236
Table 12.2: Select CD19-Directed ALL Clinical Trials						237
Table 12.3: Select Anti-CD22 CAR-T Clinical Projects 						237
Table 13.1: CBER Compliance and Surveillance Activities 					239
Table 13.2: Contacts for the Cellular, Tissue and Gene Therapies Advisory Committee, FDA 	240
Table 14.1: Key Contacts Within PMDA, Japan 							256
Table 15.1: Contact Details for EMA Immunotherapy Experts 					271
Table 16.1: General Technical and Personnel Requirements of a GMP, QC, QA, FDA Regulated Cell Therapy Manufacturing Facility 										274
Table 16.2: Technician/Scientific Requirements for CAR T Manufacturing 			275
Table 16.3: Selection of Apheresis Instruments Currently on the Market 				278
Table 16.4: Selection of Cell Counters and Analyzer Instruments Currently on the Market 	279
Table 16.5: Main Objectives of GMP Manufacturing Immunotherapeutics			282
Table 16.6: Main Objectives of Quality Control While Manufacturing Immunotherapeutics	284
Table 16.7: Main Objectives of Regulatory Affairs During Manufacturing Immunotherapeutics	284
Table 16.8: CAR-T Studies Using mRNA Transfection Electroporation 				286
Table 16.9: Challenges for Autologous Cell Therapy Manufacture 				287
Table 16.10: Current Company/Institutions with Suicide Gene CAR T Projects 			290
Table 16.11: Advantages of Using Automated Cell Therapy Manufacturing 			291
Table 16.12: Main Drivers to Implement Automated Cell Therapy Manufacturing 		291
Table 16.13: Main Benefits of Automated Cell Therapy Manufacturing 				292
Table 16.14: Advantages & Disadvantages of Autologous Cell Therapy Manufacture Scale Up 	292
Table 17.1: Juno Therapeutics Manufacturing Facility Objectives 				295
Table 18.1: Current Juno Therapeutics Trials and CAR T Products 				300
Table 19.1: Current CAR T Business Deals							302
Table20.1: Juno Therapeutics Target Biomarker Portfolio					303
Table 20.2 Juno Therapeutics CAR Technology							304
Table 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology				306	
Table 20.4 Juno Therapeutics Clinical Pipeline by Target, Product and Trial			307
Table 20.5: Select CD19-Directed ALL Clinical Trials						308
Table 20.6: Select Anti-CD22 CAR-T Clinical Projects						308
Table 20.7 Juno Therapeutics Manufacturing Facility Objectives					310
Table 20.8 Current Kite Pharma CAR T Clinical Studies and Trials				313
Table 20.9 Current Kite Pharma TCR Clinical Studies and Trials					314

LIST OF FIGURES
Figure 2.1: Components of an Antibody Drug Conjugate (ADC)					30
Figure 2.2: Mechanism of Action of Antibody Drug Conjugates					31
Figure 2.3: Ranking of Commonly Used CytotoxinWareheads					32
Figure 4.1: Number of Successful and Unsuccessful Melanoma  Drugs, 1998-2014		73
Figure 4.2: Successes and Failures in Lung Cancer Medicine Development, 1998-2014		75
Figure 4.3: Successes and Failures in Brain Cancer Drug Development, 1998-2014		77
Figure 5.1: Ibritumomab Linked to Yttrium Radfionucleotide					78
Figure 5.2: Kadcyla (Trastuzumab + DMI)							79
Figure 6.1: Dominance of MAbs and Vaccines in Cancer Clinical Research			101
Figure 7.1: Global Economic Burden of Cancer							103
Figure 7.2: Number of Colorectal, Breast and Lung Cancer Cases Diagnosed Globally, 2012	105
Figure 7.3 Percentage of Top Three Cancers Diagnosed Globally, 2012				106
Figure 7.4: Number of Deaths due to Lung, Liver and Stomach Cancers Globally, 2012		106
Figure 7.5: Percentage of Deaths due to Lung, Liver and Stomach Cancers, 2012			107
Figure 7.6: Global Cancer Deaths in Women by Type of Cancer					108
Figure 7.7: Worldwide Incidence of Female Breast Cancer and Mortality Rate by Geography	109
Figure 7.8: Five Year Relative US Breast Cancer Survival Rates by Stage at Diagnosis & Age	110
Figure 7.9: Breast Cancer Incidence and Mortality in Latin America				112
Figure 7.10: Breast Cancer Incidence and Mortality in Europe					113
Figure 7.11: Breast Cancer Incidence Rates in Asia/Pacific Region				114
Figure 7.12: Top 15 Countries in Gastric Cancer Incidence					119
Figure 7.13: Top 15 Countries in Colorectal Cancer Incidence					120
Figure 7.14: Adults Aged 50-75 Years (%) That are Up-to-Date with Colorectal Screening Tests by State in the U.S 	 114											122
Figure 7.15 Colorectal Cancer Incidence Rates (per 100,000) by State in the U.S			123
Figure 7.16: Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States		124
Figure 7.17: Top 15 Countries with Lung Cancer							125
Figure 7.18: Global NSCLC Incidence								126
Figure 7.19: Number of Smokers in China, India, Russia, the U.K. and U.S			127
Figure 7.20: Global Incidence of Glioblastoma							130
Figure 7.21: Global Incidence of Kidney Cancer							132
Figure 7.22: Top 15 Countries in Leukemia Mortality						133
Figure 7.23: Five Year Survival Rates in the U.S. for Blood Cancer Patients			134
Figure 7.24 Top 15 Countries in Cervical Cancer							136
Figure 7.25: Top 15 Countries with Prostate Cancer						137
Figure 7.26: Skin Cancer Death Rates for Top 15 Countries					140
Figure 8.1: Global Market for Oncology Drugs by Geography/Country, Through 2020		142
Figure 8.2: Global Oncology Drug Sales by Top Five Companies, Through 2020			144
Figure 8.3: Top Five Oncology Drugs, Through 2020						145
Figure 8.4: Global Oncology Therapeutics Market by Cancer Type, 2014				146
Figure 9.1: Global Cancer Immunotherapy Market, Through 2020				148
Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2020			149
Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2020		151

Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2020		152
Figure 9.5: Global and U.S. Market for Herceptin, Through 2020					153
Figure 9.6: Global and U.S. Market for Avastin, Through 2020					154
Table 9.7: Global Market for Erbitux, Through 2020						155
Figure 9.8: Global Market for Yervoy, Through 2020						156
Figure 9.9: Global Market for Mabthera, Through 2020						157
Figure 9.10: Global Market for Adcetris, Through 2020						158
Figure 9.11: Global Market for Keytruda, Through 2020						159
Figure 9.12: Global Market for Cancer Vaccines, Through 2020					160
Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2020				161
Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2020			162
Figure 13.1: Clinical Regulatory Pathway – Conventional Route 					245
Figure 13.2: Clinical Regulatory Pathway – Option for Rapid Translation 			245
Figure 14.1: PMDA Total Review Period of Standard Drugs 					250
Figure 14.2: PMDA Total Review Period of Priority Drugs 					250
Figure 14.3: Number of Approved Recombinant Protein Products by PMDA 1985-2013 		251
Figure 14.4: Forerunner Review Assignment System Timeframe 					254
Figure 14.5: Adaptive Licensing and Accelerated Approval in Japan‐US‐EU 			255
Figure 15.1: CheckMate 066 Clinical Trial 							269
Figure 15.2: CheckMate 037 Clinical Trial 							270
Figure 16.1: Method of Generating CAR-Modified T Cells 					273
Figure 16.2: Clinical Activity, Cost Structure Patient Flow Chart of CAR-T Therapy 		274
Figure 16.3: Allogenic Versus Autologous Cell Manufacturing 					287
Figure 17.1: Streptamer® -Based Magnetic Bead Cell Isolation 					294
Figure 18.1: Annual Cost of Patented Cancer Therapeutics from 2000 to Today 			296
Figure 18.2: Cost of Nivolumab, Pembrolizumab& Ipilimumab per mg  				297
Figure 20.1 Juno Therapeutics CAR T Therapeutic Molecular Design				305
Figure 20.2 Juno Therapeutics CAR T Therapeutic Mechanism of Action				305
Figure 20.3 Juno Therapeutics T Cell Receptor (TCR) Technology Mechanism of Action		306
Figure 20.4: Streptamer® -Based Magnetic Bead Cell Isolation					310
Figure 20.5 Kite Pharma CAR Technology							313
Figure 20.6 Kite Pharma TCR Technology	 



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