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

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 the cancer patients can achieve a blockbuster status. Within the cancer therapeutics, the immunotherapeutic drugs have gained worldwide acceptance, because they are targeted drugs targeting only the 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 11 chapters supported by 114 tables and 41 figures over 256 pages.

• An overview of cancer immunotherapy that includes: monoclonal antibodies, cancer vaccines and non-specific cancer immunotherapies.
• 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 about 23 cancer immunotherapeutics approved and used as targeted drugs (some of these products have already been withdrawn from the market).
• 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 bestselling cancer drugs.
• Detailed account of the market for cancer immunotherapeutics by geography, indication, company and individual drugs.
• Profiles, marketed products and products in pipeline of 76 companies that are mostly located in the U.S. and Europe.
• Summary table to identify the category of immunotherapy drug offered by the 76 companies.

The report is supported by 155 tables & figures over 246 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 78 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.

Key Questions Answered in this Report

• What are the three types of cancer immunotherapies?
• What are the immunotherapies approved between 1986 and 2014?
• What are the monoclonal antibodies (MAbs) approved by FDA to treat different types of cancers?
• What are naked MAbs and how many of them have been approved by FDA?
• What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
• What are the common cytotoxic “warheads” used in ADCs?
• What are the important clinical assets in ADCs?
• How many bispecific MAbs are in late-stage development?
• What are the common side effects of MAbs in cancer immunotherapy?
• What are cancer vaccines and how many of them have been licensed to be marketed?
• How many cytokines have been approved for being used in cancer immunotherapy?
• What are the major checkpoint inhibitors in clinical development?
• What is the current status of anti-PD-1 drugs, dendritic cell therapies, T-cell therapies and cancer vaccines?
• What are the most valuable R&D projects in cancer immunotherapy and what would be their approximate sales revenues in 2020?
• Number of melanoma drugs approved between 1998 and 2014?
• Number of lung cancer drugs approved between 1998 and 2014?
• Number of brain cancer drugs approved between 1998 and 2014?
• What is the global market for cancer immunotherapeutics by geography, through 2020?
• 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 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.?

Table of Contents

1.0 Executive Summary 13
1.1 Objectives of Report 14
1.1 Key Questions Answered in this Report 14
1.2 Data Sources and Methodology 15

2.0 Cancer Immunotherapy: An Overview 16
2.1 Human Immune System 16
2.1.1 Components of Human Immune System 17
2.2 Types of Cancer Immunotherapy 18
2.3 Monoclonal Antibodies (Mabs) to Treat Cancer 19
2.3.1 Most Frequently Targeted Antigens by MAbs 19
2.4 Types of Monoclonal Antibodies (MAbs) 21
2.4.1 Naked MAbs 21
2.4.2 Conjugated Monoclonal Antibodies 22
2.4.2.1 Components of an Antibody Drug Conjugate (ADC) 22
2.4.2.2 Mechanism of Action of Antibody Drug Conjugate (ADC) 23
2.4.2.3 The Cytotoxic Warheads used in ADCs 23
2.4.2.4 Successful Cytotoxin Warheads 24
2.4.2.5 Developmental Timeline of ADCs 25
2.4.2.6 Target Antigens for ADCs in Preclinical and Clinical Development 26
2.4.2.7 Important Clinical Assets in ADCs 26
2.4.3 Bispecific Monoclonal Antibodies 28
2.4.3.1 Technology Platforms for the Production of Bispecific MAbs 29
2.4.4 Safety and Side Effects of MAbs in Cancer Immunotherapy 29
2.5 Cancer Vaccines 30
2.5.1 Cancer Vaccines in Development 31
2.6 Non-Specific Cancer Immunotherapies and Adjuvants 34
2.6.1 Cytokines 34
2.6.1 Interferon (IFN) 34
2.7 New Frontiers in Cancer Immunotherapy Research 35
2.7.1 Drugs for Targeting Immune Checkpoints 35
2.7.1.1 Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4) 35
2.7.1.2 Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1) 35
2.7.1.3 Major Checkpoint Inhibitors in Clinical Development 35
2.7.2 Chimeric Antigen Receptor (CAR) T Cell Therapy 36
2.7.3 Tumor-Infiltrating Lymphocytes (TILs) and Interleukin-2 (IL-2) 36
2.8 Cancer Immunotherapy: Timeline of Progress 36

3.0 Current Status of Cancer Immunotherapy: An Overview 40
3.1 Programmed Death (PD-1) Inhibitors 40
3.1.1 Important Events and Advantages for Nivolumab in Melanoma Indication 41
3.1.2 Important Events and Advantages for Nivolumab in Non-Small Cell Lung Cancer 42
3.1.3 Important Events and Advantages for Nivolumab in Renal Cell Cancer 42
3.1.4 Nivolumab Studies for Melanoma 42
3.1.5 Nivolumab Studies for Non-Small Cell Lung Cancer (NSCLC) 43
3.1.6 Nivolumab Studies for Renal Cell Cancer (RCC) 43
3.2 MK-3475 (Pembrolizumab) 43
3.2.1 Important Events and Advantages for MK-3475 in Melanoma 43
3.2.2 Important Events and Advantages for MK-3475 in NSCLC 44
3.2.3 Important Events for MK-3475 in RCC 44
3.3 RG7446 from Roche 45
3.3.1 Important Events for RG7446 in Melanoma 45
3.3.2 Important Events and Advantages for RG7446 in NSCLC 45
3.3.3 Important Event for RG7446 in RCC 46
3.3.4 RG7446 Studies in NSCLC 46
3.3.5 RG7446 Studies in RCC 46
3.3.6 RG7446 Study in RCC 47
3.4 Pidilizumab from CureTech 48
3.5 An Overview of Anti-PD-1 Clinical Development 48
3.5.1 Other Checkpoint Inhibitors in Development 50
3.6 Studies with Yervoy (Ipilimumab) 50
3.7 Studies with Tremelimumab 52
3.8 KAHR-102 52
3.9 TIM3 Antibody 52
3.10 BMS-989016 52
3.11 ImmuTune IMP701 and ImmuFact IMP321 53
3.12 Dendritic Cell Therapies 53
3.12.1 Provenge (Sipuleucel-T) 54
3.12.2 AGS-003 from Argos Therapeutics 54
3.12.3 DCP-001 from DCPrime 55
3.12.4 DC-Vax from Northwest Biotherapeutics 55
3.13 Chimeric Antigen Receptor T-Cells (CAR-T) Therapies 55
3.13.1 CLT109 55
3.13.2 Chimeric Antigen Receptors (CAR) Program by Juno 56
3.13.3 Chimeric Antigen Receptor (CAR) T-Cell Program by Bluebird Bio 56
3.13.4 UCART19 from Cellectis 56
3.13.5 Chimeric Immune Receptor (CIR) T-Cells from Abramson Cancer Center 57
3.13.6 CD19 eACT CAR-T Therapy from Kite Pharma 57
3.13.7 Autologous CAR-T Program for Breast Cancer from Adaptimmune 57
3.14 Cancer Vaccines 57
3.14.1 HyperAcute 59
3.14.2 MAGE-A3 Antigen-Specific Cancer Immunotherapeutic 59
3.14.3 ADXS-HPV 59
3.14.4 IDO Inhibitors 60
3.14.5 Indoximod and NLG-919 (INCY) 60
3.14.6 INCB24360 (INCY) 60
3.14.7 deCellVax (BMSN) 60
3.15 Miscellaneous Immunotherapies 61
3.15.1 Contego (Lion Biotechnologies) 61
3.15.2 TG4010 (Transgene) 61
3.16 Most Valuable R&D Projects in Cancer Immunotherapy 61
3.16.1 Nivolumab (Opdivo) 62
3.16.2 MK-3475 62
3.16.3 RG7446 62
3.16.4 Palbociclib 63
3.16.5 DCVax-L 63
3.16.6 MEDI4736 63

4.0 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 65
4.2 A New Era for Lung Cancer Medicines 66
4.2.1 Progresses Made in Lung Cancer Medicine Research 66
4.2.2 Successes and Failures in Lung Cancer Medicine Development 67
4.2.3 Future Outlook for Lung Cancer Medicines 67
4.3 Ray of Hope for Brain Cancer Patients 68
4.3.1 Progress made for Brain Cancer Treatment in Recent Years 68
4.3.2 Successes and Failures in Brain Cancer Drug Development 68

5.0 Cancer Immunotherapeutic Products: An Overview 70
5.1 I-Labelled Tositumomab (Bexxar) 70
5.2 Y-Labelled Ibritumomab (Zevalin) 70
5.3 Alemtuzumab (Campath) 71
5.4 AdotrastuzumabEmtansine (Kadcyla) 71
5.5 Bacillus Calmette-Guerin (BCG) 72
5.6 Bevacizumab (Avastin) 72
5.7 BrentuximabVedotin (Adcetris) 72
5.8 Cetuximab (Erbitux) 73
5.9 Cervarix 73
5.10 DenileukinDiftitox (Ontak) 74
5.11 Gardasil 74
5.12 Gemtuzumab (Mylotarg) 74
5.13 Hepatitis B Vaccine 74
5.14 Interferon Alfa (IFN-alfa) 74
5.15 Interleukin-2 (IL-2) 75
5.16 Ipilimumab (Yervoy) 75
5.17 Ofatumumab (Arzerra) 75
5.18 Panitumumab (Vectibix) 75
5.19 Pembrolizumab (Keytruda) 75
5.20 Rituximab (Mabthera) 76
5.21 Sargramostim (Leukine) 76
5.22 Sipuleucel-T (Provenge) 76
5.23 Trastuzumab (Herceptin) 76

6.0 Available Immunotherapies for Cancer by Disease Type: An Overview 78
6.1 Melanoma Skin Cancer and Immunotherapy 79
6.1.1 Ipilimumab (Yervoy) for Advanced Melanoma 79
6.1.2 PD-1 Inhibitors (Keytruda and Opdivo) for Advanced Melanoma 79
6.1.3 Cytokines for Advanced Melanoma 79
6.1.4 Interferon Alfa as Adjuvant Therapy for Melanoma 79
6.1.5 BacilleCalmette-Guerin (BCG) Vaccine for Melanoma 80
6.1.6 Imiquimod (zyclara) Cream for Melanoma 80
6.2 Breast Cancer and Immunotherapy 80
6.2.1 Promising Therapeutic Vaccine Product Candidates for Breast Cancer 80
6.2.2 Promising Checkpoint Inhibiting Product Candidates for Breast Cancer 81
6.2.3 Promising Adoptive T Cell Therapy Product Candidates for Breast Cancer 81
6.2.4 Promising Antibody Product Candidates for Breast Cancer 81
6.3 Immunotherapy for Prostate Cancer 81
6.3.1 Therapeutic Vaccines for Prostate Cancer 82
6.3.2 Checkpoint Inhibitors for Prostate Cancer 83
6.3.3 Adoptive Cell Therapy for Prostate Cancer 84
6.4 Immunotherapy for Lung Cancer 84
6.4.1 Monoclonal Antibodies for Lung Cancer 84
6.4.1.1 Promising MAb Product Candidates for Lung Cancer 84
6.4.1.2 Checkpoint Inhibitors for Lung Cancer 85
6.4.1.3 Therapeutic Vaccines for Lung Cancer 87
6.4.1.4 Promising Adoptive T Cell Transfer Product Candidates for Lung Cancer 87
6.5 Immunotherapy for Colorectal Cancer 88
6.5.1 Promising Monoclonal Antibody Product Candidates for Colorectal Cancer 88
6.5.2 Trials Using Checkpoint Inhibitors and Immune Modulators for Colorectal Cancer 88
6.5.3 Clinical Trials for Vaccines Indicated for Colorectal Cancer 89
6.5.4 Adoptive Cell Therapy for Colorectal Cancer 90
6.5.5 Oncolytic Virus Therapy for Colorectal Cancer 90
6.5.6 Adjuvant Immunotherapy for Colorectal Cancer 90
6.5.7 Cytokines for Colorectal Cancer 90
6.6 Immunotherapies in Development for Lymphoma 91
6.6.1 Therapeutic Vaccines in Development for Lymphoma 91
6.6.2 Checkpoint Inhibitors for Lymphoma 91
6.6.3 Adoptive T Cell Transfer for Lymphoma 91
6.6.4 Monoclonal Antibodies for Lymphoma 92
6.7 Immunotherapy for Kidney Cancer 92
6.7.1 Checkpoint Inhibitors for Kidney Cancer 92
6.7.2 Vaccines for Kidney Cancer 92
6.7.3 Adoptive Cell Therapy for Kidney Cancer 93
6.8 Dominance of MAbs and Vaccines in Cancer Clinical Research 93
6.9 Oncology Biologics Losing Patent Protection 93

7.0 Cancer Incidence and Mortality: An Overview 95
7.1 Global Economic Burden of Cancer 95
7.2 Global Burden of Cancer 96
7.3 Top Five Most Frequent Cancers, Globally 96
7.3.1 Global Prevalence of Colorectal, Breast and Lung Cancers 97
7.3.2 Percentage of Top Three Cancers Diagnosed Globally 97
7.3.2.1 Mortality due to Lung, Liver and Stomach Cancers 98
7.3.2.2 Percentage of Death due to Lung, Liver and Stomach Cancers 99
7.4 Cancer Deaths in Women 99
7.5 Prevalence and Mortality for Cancer Types Addressed by Immunotherapy 100
7.5.1 Breast Cancer 100
7.5.1.1 Worldwide Incidence of Breast Cancer and Mortality Rate by Geography 101
7.5.1.2 Female Breast Cancer Incidence in the U.S. 101
7.5.1.3 Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S. 102
7.5.1.4 Breast Cancer Incidence in Canada 103
7.5.1.5 Breast Cancer Incidence and Mortality in Latin America 103
7.5.1.6 Breast Cancer Incidence and Mortality in Europe 104
7.5.1.7 Breast Cancer Incidence in Asia/Pacific 105
7.5.1.8 Breast Cancer Incidence by Country 106
7.5.2 Gastric Cancer (Stomach Cancer) 110
7.5.2.1 Incidence of Gastric Cancer in Top 15 Countries 110
7.5.3 Colorectal Cancer 111
7.5.3.1 Global Incidence of Colorectal Cancer 111
7.5.3.2 Worldwide Variations in the Incidence of Colorectal Cancer 112
7.5.3.3 Risk Factors for Colorectal Cancer 113
7.5.3.4 Colorectal Cancer Screening in the U.S. 114
7.5.3.5 Colorectal Cancer Incidence Rates in the U.S. by State 114
7.5.3.6 Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States 115
7.5.4 Lung Cancer 116
7.5.4.1 Non-Small Cell Lung Cancer (NSCLC) 117
7.5.4.2 Global NSCLC Incidence 118
7.5.4.3 Lung Cancer in Americas by Gender 118
7.5.4.4 Tobacco Use and Lung Cancer 119
7.5.4.5 Current Therapeutic Options for Lung Cancer 120
7.5.5 Glioblastoma 122
7.5.5.1 Global Incidence of Glioblastoma 122
7.5.6 Kidney Cancer 123
7.5.6.1 Global Incidence of Kidney Cancer 124
7.5.7 Blood Cancer 125
7.5.7.1 Leukemia 125
7.5.7.2 Blood Cancer in the U.S. 126
7.5.8 Cervical Cancer 128
7.5.8.1 Global Incidence of Cervical Cancer 128
7.5.9 Prostate Cancer 129
7.5.9.1 Global Incidence of Prostate Cancer 129
7.5.9.2 Prostate Cancer Incidence and Mortality by Geography 130
7.5.9.3 Prostrate Cancer in the U.S. 131
7.5.10 Melanoma 132
7.5.10.1 Skin Cancer in the U.S. 133

8.0 Market Analysis 134
8.1 Global Oncology Market 134
8.2 Top Ten Companies in Oncology Drug Sales 135
8.3 Top Five Oncology Drugs 136
8.4 Global Oncology Therapeutics Market by Cancer Type 137

9.0 Market for Cancer Immunotherapy 139
9.1 Key Drivers 139
9.2 Global Market for Cancer Immunotherapeutics 139
9.3 Global Market for Cancer Immunotherapy by Product Class 141
9.4 Global Market for Immunotherapy Drugs by Cancer Type 142
9.5 Global Market for Monoclonal Antibodies for Cancer by Type 143
9.5.1 Best Selling MAbs 144
9.5.1.1 Market Forecast for Herceptin 144
9.5.1.2 Market Value and Forecast for Avastin 145
9.5.1.3 Global Market for Erbitux 146
9.5.1.4 Global Market for Yervoy 147
9.5.1.5 Global Market for Mabthera 148
9.5.2 Global Market for Antibody Drug Conjugates (ADCs) 149
9.5.2.1 MGlobal Market for Adcetris 149
9.5.2.1 Global Market for Keytruda 150
9.6 Global Market for Cancer Vaccines 151
9.6.1 Global Market for Cancer Vaccines by Type 152
9.7 Global Market for Non-Specific Cancer Immunotherapeutics 154
9.8 Market Values for Selected Forthcoming Cancer Immunotherapeutics 155
9.8.1 Market Value for Nivolumab (Opdivo) 155
9.8.2 Market Value for RG7446 155
9.8.3 Market Value for DCVax-L 155
9.8.4 Market Value for MEDI4736 156
9.8.5 High Cost of MAbs 156

10.0 Company Profiles 157
10.1 Ablynx NV 157
10.2 Activartis Biotech GmbH 158
10.2.1 GBM Vax Study 158
10.3 Advaxis Inc. 158
10.3.1 Advaxis’ Technology 159
10.3.2 Advaxis’ Product Pipeline 159
10.3.2.1 ADXS-HPV 159
10.3.2.2 ADXS-PSA 159
10.3.2.3 ADXS-cHER2 159
10.4 AduroBioTech Inc. 160
10.4.1 Aduro’s Technology 160
10.4.1.1 CRS-207 161
10.4.1.2 AUD-623 161
10.4.1.3 ADU-741 161
10.4.1.4 ADU-S100 161
10.5 Agenus Inc. 162
10.5.1 QS-21 Stimulon 162
10.6 AlphaVax Inc. 163
10.6.1 Alpha Vax’s Technology 163
10.7 A. MenariniIndustrieFarmaceuticheRiuniteSrl 163
10.7.1 MEN1112 164
10.8 Amgen Inc. 164
10.8.1 Vectibix (panitumumab) 164
10.8.2 Blinatumomab (Blincyto) 164
10.8.3 Rilotumumab 165
10.9 Antigen Express Inc. 165
10.9.1 Li-Key Hybrid Vaccines (AE37) 165
10.10 Argos Therapeutics Inc. 166
10.10.1 AGS-003 166
10.11 Bavarian Nordic A/S 167
10.11.1 Prostvac 167
10.11.2 CV-301 167
10.11.3 MVA-BN PRP 168
10.11.4 MVA-BN HER2 168
10.11.4 MVA-BN Brachyury 168
10.12 Bellicum Pharmaceuticals Inc. 168
10.12.1 BPX-501 168
10.12.2 BPX-201 169
10.12.3 BPX-401 169
10.12.4 BPX-601 169
10.12.5 BPX-701 169
10.13 Biogen Idec Inc. 170
10.13.1 Rituxan (Rituximab) 170
10.13.2 Gazyva (Obinutuzumab) 170
10.14 Biovest International Inc. 171
10.14.1 BiovaxID 171
10.15 Bristol-Myers Squibb Company 171
10.15.1 Erbitux (cetuximab) 172
10.15.2 OPDIVO (nivolumab) 172
10.15.3 Yervoy (ipilimumab) 172
10.16 Cellectis 172
10.17 Cellerant Therapeutics Inc. 173
10.17.1 CLT-008 174
10.17.2 CLT-009 174
10.18 Celldex Therapeutics 174
10.18.1 Rindopepimut 174
10.18.2 Glembatumumabvedotin (CDX-011) 175
10.18.3 Varlilumab (CDX-1127) 175
10.18.4 CDX-1401 175
10.18.5 CDX-301 175
10.19 CEL-SCI Corp. 175
10.19.1 Multikine 176
10.20 CureTech Ltd. 176
10.20.1 Pidilizumab (CT-011) 176
10.21 Delta-Vir GmbH 177
10.21.1 Treatment 177
10.22 Dendreon Corp. 177
10.22.1 Provenge (Sipuleucel-T) 177
10.23 DenDrit Biotech USA 178
10.23.1 MelCancerVac 178
10.24 DNAtrix Inc. 178
10.24.1 DNX-2401 178
10.25 Eli Lilly and Co. 179
10.25.1 Erbitux (Cetuximab) 179
10.26 EMD Serono Inc. 179
10.27 Etubics Corp. 180
10.28 Galena Biopharma Inc. 181
10.29 Genentech Inc. 181
10.29.1 Avastin (bevacizumab) for Metastatic Colorectal Cancer 182
10.29.1.1 Avastin and Interferon Alfa for Metastatic Kidney Cancer 182
10.29.1.2 Avastin for Metastatic NLCLC 182
10.29.2 Gazyva (obinutuzumab) for Chronic Lymphocytic Leukemia 182
10.29.3 Herceptin (trastuzumab) for Breast Cancer 182
10.29.3.1 Herceptin and Chemotherapy for Gastric Cancer 183
10.29.4 Kadcyla (ado-trastuzumab emtansine) 183
10.29.5 Perjeta (pertuzumab) 183
10.29.6 Rituxan (rituximab) 183
10.29.7 Genentech’s Cancer Immunotherapy Pipeline Products 184
10.30 Genmab AS 185
10.30.1 Ofatumumab 185
10.31 GlaxoSmithKline 186
10.31.1 Arzerra (Ofatumumab) 186
10.31.2 Cervarix 186
10.32 Gliknik Inc. 186
10.33 GlobeImmune Inc. 187
10.34 Heat Biologics Inc. 188
10.35 Immatics Biotechnologies GmbH 188
10.36 ImmunoCellular Therapeutics Ltd. 189
10.37 Immunocore Ltd. 190
10.37.1 Product Pipeline 190
10.38 ImmunoFrontier Inc. 190
10.39 ImmunoGen Inc. 191
10.39.1 IMGN853 191
10.39.2 IMGN529 191
10.39.3 IMGN289 191
10.39.4 IMGN779 191
10.40 Immunomedics Inc. 192
10.41 Immunotope Inc. 192
10.41.1 IMT-1012 Immunotherapeutic Vaccine 193
10.42 Immunovaccine Inc. 193
10.43 Inovio Pharmaceuticals Inc. 194
10.44 Janssen Biotech Inc. 194
10.44.1 Doxil 194
10.44.2 Procrit 195
10.44.3 Zytiga 195
10.44.4 Imbruvicia 195
10.45 Juno Therapeutics Inc. 195
10.46 Kite Pharma Inc. 196
10.46.1 Kite Pharma’s Technology 196
10.46.1.1 eACT (engineered Autologous Cell Therapy) 196
10.46.1.2 DC-Ad GM-CAIX 196
10.47 MabVax Therapeutics Holdings Inc. 197
10.48 MedImmune LLC 198
10.49 Merck & Co., Inc. 199
10.49.1 Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine 199
10.49.2 Keytruda (Pembrolizumab) 199
10.50 Merrimack Pharmaceuticals Inc. 200
10.51 Morphotek Inc. 200
10.51.1 Farletuzumab (MORAb-003) 201
10.51.2 Amatuximab (MORAb-009) 201
10.51.3 Ontuxizumab (MORAb-004) 201
10.51.4 MORAb-066 201
10.52 NewLink Genetics Corp. 201
10.53 Northwest Biotherapeutics Inc. 202
10.54 NovaRx Corp. 203
10.55 OncoPep Inc. 203
10.55.1 PVX-410 203
10.56 Oncothyreon Inc. 204
10.57 OSE Pharma SA 204
10.58 Oxford BioTherapeutics Ltd. 205
10.58.1 Technologies 205
10.58.1.1 OGAP – Cancer Targeting 205
10.58.1.2 Antibody Development 205
10.58.1.3 Antibody “arming” 206
10.58.2 Lead Programs 206
10.58.2.1 OX001/MEN1112 206
10.58.2.2 OX002 206
10.58.2.3 OX003 206
10.58.2.4 OX004 206
10.59 Pique Therapeutics 207
10.60 Polynoma LLC 207
10.60.1 MAVIS Trial 207
10.61 Prima BioMed Ltd. 208
10.62 Progenics Pharmaceuticals Inc. 208
10.62.1 PSMA Targeted Imaging Compound (1404) 209
10.62.2 PSMA ADC Therapeutic 209
10.62.3 Small Molecule Therapeutic (1095) 209
10.62.4 Azedra 209
10.63 Regen Biopharma Inc. 210
10.63.1 HemaXellerate 210
10.63.2 dCellVax 210
10.63.3 Diffron C 210
10.64 Roche Holdings Inc. 211
10.64.1 Avastin (Bevacizumab) 211
10.64.2 Gazyva/Gazyvaro (Obinutuzumab; GA101) 211
10.64.3 Herceptin (Trastuzumab) 211
10.64.4 Kadcyla (Trastuzumabumemtansinum) 211
10.64.5 Mabthera (Rituximab) 211
10.64.6 Perjeta (Pertuzumab) 212
10.65 Seattle Genetics Inc. 213
10.65.1 Adcetris (Brentuximabvedotin) 214
10.65.2 Seattle Genetics’ Collaborarator Pipeline 214
10.66 Sorrento Therapeutics Inc. 215
10.66.1 Sorrento’s Antibody Technologies 216
10.66.1.1 G-MAB 216
10.66.1.2 Antibody Drug Conjugates (ADCs) 216
10.67 Spectrum Pharmaceuticals Inc. 216
10.67.1 Zevalin 216
10.68 Synthon Pharmaceuticals Inc. 217
10.69 TapImmune Inc. 217
10.70 ThioLogics Ltd. 218
10.71 Transgene SA 219
10.72 TVAX Biomedical Inc. 219
10.72.1 TVI-Brain-1 220
10.72.2 TVI-Kidney-1 220
10.73 Vaccinogen Inc. 220
10.74 Viventia Biotechnologies Inc. 221
10.75 Wilex AG 221
10.76 Ziopharm Oncology Inc. 222

11.0 Cancer Immunotherapy Market Participants by Product Segment 223

List of Tables

Table 2.1: Types of Immune Cells and their Functions
Table 2.2: FDA-Approved Cancer Immunotherapies, 1986-2014
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 Tmeline
Table 2.9: Target Antigens for ADCs in Preclinical and Clinical Development
Table 2.10: Current ADCs Launched, Withdrawn and in Phase I/II/III Trials by Sponsor, Indication, Antigen, Cytotoxin and Linker
Table 2.11: MAb Products and Candidates that Recruit T Cells
Table 2.12: Bispecific MAbs in Clinical Trials Targeting Cancer by Indication and Company
Table 2.13: Bispecific Antibody Technology Platforms
Table 2.14: Side Effects of Some of the Approved Cancer Immunotherapy MAbs
Table 2.15: FDA-Approved Cancer Vaccines
Table 2.16: Cancer Vaccines in Development
Table 2.17: FDA-Approved Cytokines for Cancer Immunotherapy
Table 2.18: Cancer Indications Approved for IFN-alfa
Table 2.19: FDA-Approved Immune Checkpoint Modulators
Table 2.20: Immune Checkpoint Inhibitors in Clinical Development
Table 2.21: Cancer Immunotherapy: Timeline of Progress
Table 3.1: PD-1 Therapies Targeting either the PD-L1/L2 or PD-1 Receptor
Table 3.2: Overview of Clinical Trial Landscape for Top Five Anti-PD-1 and Anti-PD-L1 Drug
Table 3.3: Nivolumab Efficacy from Expansion Coharts of Study 003
Table 3.4: Phase I Data of MK-3475 in Melanoma
Table 3.5: Phase I Data of RG7446 in NSCLC Patients
Table 3.6: RG7446 Phase I Data from RCC Patients
Table 3.7: Phase I Melanoma Data for RG7446
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 Rwesults 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 and 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, 2013
Table 7.4: Estimated Canadian Breast Cancer Statistics for 2014
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., 2014
Table 7.11: Estimated Deaths in the U.S. from Leukemia, 2014
Table 7.12: Estimated Deaths from HL and NHL in the U.S., 2014
Table 7.13: Estimated Incidence and Deaths for Myeloma in the U.S., 2014
Table 7.14 Global Prostate Cancer Incidence and Mortality Rates by Geography
Table 7.15: Incidence and Mortality Rates of Prostate Cancer in Americas
Table 7.16: Incidence and Mortality Rates for Melanoma in Americas
Table 8.1: Global Market for Oncology Drugs by Geography/Country, Through 2020
Table 8.2: Top Ten Companies in Oncology Sales, Through 2020
Table 8.3: Top Five Oncology Drugs, Through 2020
Table 9.1: Global Cancer Immunotherapy Market, Through 2020
Table 9.2: Global Market for Immunotherapy by Product Class, Through 2020
Table 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2020
Table 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2020
Table 9.5: Global and U.S. Market for Herceptin, Through 2020
Table 9.6: Global and U.S. Market for Avastin, Through 2020
Table 9.7: Global Market for Cancer Vaccines, Through 2020
Table 9.8: Global Market for Cancer Vaccines by Type, Through 2020
Table 9.9: Projected Market for the Forthcoming Nivolumab, RG7446, DCVax-L and MEDI4736
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

List 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, 1998-2014
Figure 4.2: Successes and Failures in Lung Cancer Medicine Development, 1998-2014
Figure 4.3: Successes and Failures in Brain Cancer Drug Development, 1998-2014
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, 2012
Figure 7.3 Percentage of Top Three Cancers Diagnosed Globally, 2012
Figure 7.4: Number of Deaths due to Lung, Liver and Stomach Cancers Globally, 2012
Figure 7.5: Percentage of Deaths due to Lung, Liver and Stomach Cancers, 2012
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 Breast Cancer Survival Rates by Stage at Diagnosis and Age in theU.S.
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. ans U.S.
Figure 7.20: Global Incidence of Glioblastoma
Figure 7.21: Global Incidence of Kidney Cancer
Figure 7.22: Top 15 Countries in Leukemia Mortality
Figure 7.23: Five Year Survival Rates in the U.S. for Blood Cancer Patients
Figure 7.24 Top 15 Countries in Cervical Cancer
Figure 7.25: Top 15 Countries with Prostate Cancer
Figure 7.26: Skin Cancer Death Rates for Top 15 Countries
Figure 8.1: Global Market for Oncology Drugs by Geography/Country, Through 2020
Figure 8.2: Global Oncology Drug Sales by Top Five Companies, Through 2020
Figure 8.3: Top Five Oncology Drugs, Through 2020
Figure 8.4: Global Oncology Therapeutics Market by Cancer Type, 2014
Figure 9.1: Global Cancer Immunotherapy Market, Through 2020
Figure 9.2: Global Market for Immunotherapy by Product Class, Through 2020
Figure 9.3: Global Market for Immunotherapy Drugs by Cancer Type, Through 2020
Figure 9.4: Global Market for Monoclonal Antibodies for Cancer by Type, Through 2020
Figure 9.5: Global and U.S. Market for Herceptin, Through 2020
Figure 9.6: Global and U.S. Market for Avastin, Through 2020
Table 9.7: Global Market for Erbitux, Through 2020
Figure 9.8: Global Market for Yervoy, Through 2020
Figure 9.9: Global Market for Mabthera, Through 2020
Figure 9.10: Global Market for Adcetris, Through 2020
Figure 9.11: Global Market for Keytruda, Through 2020
Figure 9.12: Global Market for Cancer Vaccines, Through 2020
Figure 9.13: Global Market for Cancer Vaccines by Type, Through 2020
Figure 9.14: Global Market for Cytokine Drugs for Cancer, Through 2020