Global Cancer Immunotherapies Market to 2022 - Immune Checkpoint Inhibitors and Therapeutic Cancer Vaccines to Characterize Increasingly Competitive Market

GBI Research
363 Pages - GBI10580
$4,995.00

Summary

Cancer is a group of diseases characterized by abnormal cell growth. It is a multi-step process, as a single mutation is almost certainly insufficient to cause a cell to become malignant. A number of cellular processes must be deregulated to allow cells to proliferate uncontrollably while evading apoptosis. Initially, key cell growth, proliferative and pro-apoptotic signaling pathways are deregulated in most cancers. These signaling pathways enable cell survival, continued proliferation, and the avoidance of programmed cell death.

It is now widely believed that many tumors express antigens that can be identified by the adaptive immune system, and that can therefore potentially be used to produce an anti-tumor immune response. The immune system is believed to have the greatest potential in terms of treating cancer, as there is evidence tumors are recognized by the immune system, and this tumor-specific immune response is due to the recognition of tumor antigens. However, in many cancers, disease progression is also accompanied by immune suppression, which hinders an effective anti-tumor response and tumor elimination.

Over the past few decades cancer immunotherapies have developed into important therapeutic options for some types of cancer. Some of these therapies generally enhance the activity of the body’s immune system, while others drive the immune system to target specific cancer cells.

The different types of cancer immunotherapies used to treat cancer include monoclonal antibodies (mAbs) directed at specific tumor-associated antigens (TAA); immune checkpoint inhibitors, which target key proteins involved in the immune response, such as programmed cell death-1 (PD-1); cancer vaccines, which can be used to stimulate an immune response in a patient; and non-specific immunotherapies, which are therapies that do not target cancer cells specifically, but stimulate the immune system in a more general way, such as interferon therapy.

Overall, there are 2,037 products in active development in the cancer immunotherapy pipeline. This makes it a notable portion of the entire oncology pipeline, and reflects the strong interest in this class of therapy in product development. This is due to growing clinical rationale behind developing such therapies, and the willingness of drug developers to invest in novel therapeutics, which will offer significant product differentiation from market competitors.

The leading indications in terms of cancer immunotherapy product development are breast cancer, melanoma, non-small-cell lung cancer (NSCLC) and ovarian cancer, which are the focus of this report. This is based on the high level of activity in terms of cancer immunotherapy product development in these specific oncology indications, with the aforementioned indications ranking highest in this regard.

Scope

The cancer immunotherapies market already consists of some commercially successful products.
 - Which classes of drug dominate the market?
 - What additional benefits have newly approved therapies brought to the market?
The cancer immunotherapies pipeline is vast, with a significant degree of diversity in terms of molecule types and targets.
 - Which molecular targets appear most frequently in the pipeline?
 - What are the commercial prospects for the most promising late-stage pipeline products?
The cancer immunotherapies market is forecast to rise from a value of $16.9 billion in 2015 to $75.8 billion in 2022, at a compound annual growth rate of 23.9%.
 - Which products are forecast to drive this substantial degree of growth?
 - Will generic competition have a significant impact on the market over the forecast period?
The company landscape is growing increasingly competitive.
 - What are the leading companies in terms of market share?
 - Which companies are forecast to experience the greatest growth in market share?
 - What are the drivers of growth for key companies in the market?
 - How dependent are the key companies on this disease cluster for revenue?
 - Which companies rely heavily on this disease cluster for revenue?

Reasons to buy

This report will allow you to -
- Understand the current clinical and commercial landscape through a comprehensive study of disease epidemiology, pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report, which includes breast cancer, melanoma, NSCLC and ovarian cancer.
- Assess the current treatment landscape, with product profiles covering prominent marketed therapies, including revenue forecasts.
- Analyze the cancer immunotherapies pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.
- Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.
- Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from cancer immunotherapy products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.
- Identify commercial opportunities in the cancer immunotherapies deals landscape by analyzing trends in licensing and co-development deals.

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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 11
2.1 Therapy Area Introduction 11
2.2 Epidemiology 12
2.2.1 Breast Cancer 12
2.2.2 Melanoma 13
2.2.3 Non-Small-Cell Lung Cancer 14
2.2.4 Ovarian Cancer 15
2.3 Pathophysiology and Etiology 16
2.3.1 Breast Cancer 18
2.3.2 Melanoma 19
2.3.3 Non-Small-Cell Lung Cancer 21
2.3.4 Ovarian Cancer 25
2.4 Symptoms 26
2.4.1 Breast Cancer 26
2.4.2 Melanoma 27
2.4.3 NSCLC 29
2.4.4 Ovarian Cancer 29
2.5 Diagnosis and Disease Staging 29
2.5.1 Breast Cancer 30
2.5.2 Melanoma 33
2.5.3 Non-Small-Cell Lung Cancer 35
2.5.4 Ovarian Cancer 36
2.6 Prognosis 36
2.6.1 Breast Cancer 36
2.6.2 Melanoma 37
2.6.3 Non-Small-Cell Lung Cancer 38
2.6.4 Ovarian Cancer 39
2.7 Treatment 39
3 Key Marketed Products 42
3.1 Overview 42
3.2 Rituxan/MabThera - Roche 43
3.3 Revlimid (lenalidomide) - Celgene 44
3.4 Yervoy (ipilimumab) - Bristol-Myers Squibb 46
3.5 Opdivo (nivolumab) - Bristol-Myers Squibb 48
3.6 Keytruda (pembrolizumab) - Merck & Co. 50
3.7 Pomalyst (pomalidomid) - Celgene 52
3.8 Gardasil/Gardasil 9 (human papillomavirus [types 6, 11, 16, 18] (quadrivalent) vaccine-prophylactic vaccine) - Merck & Co. 53
3.9 Provenge (sipuleucel-T) - Valeant Pharmaceuticals 55
3.10 Conclusion 57
4 Pipeline Landscape Assessment 58
4.1 Overview 58
4.2 Pipeline Development Landscape 58
4.3 Molecular Targets in the Pipeline 61
4.4 Clinical Trials 64
4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 64
4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 68
4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 72
4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 75
4.4.5 Conclusion 78
4.5 Assessment of Key Pipeline Products 79
4.5.1 Durvalumab - AstraZeneca 79
4.5.2 Durvalumab + Tremelimumab - AstraZeneca 80
4.5.3 Tisagenlecleucel-T (CTL-019) - Novartis 81
4.5.4 KTE-C19 - Kite Pharma 82
4.5.5 Avelumab - Merck KGaA/Pfizer 84
4.5.6 Epacadostat - Incyte Corporation 85
4.5.7 Conclusion 86
5 Multi-scenario Market Forecast to 2022 88
5.1 Overall Market Size 88
5.2 Generic Penetration 90
5.3 Revenue Forecast by Molecular Target 90
5.3.1 Immune-Checkpoint Proteins 91
5.3.2 Tumor Associated Antigens 91
5.3.3 Cancer Vaccines 92
5.3.4 Signal Transduction 93
5.4 Revenue and Market Share Analysis by Company 94
5.4.1 Celgene - Revlimid to Maintain Celgene’s Position as Market Leader 98
5.4.2 Bristol-Myers Squibb - Opdivo to Drive Revenue from Cancer Immunotherapies 100
5.4.3 Roche - Revenue Generated from Cancer Immunotherapies Forecast to Grow due to Tecentriq and Gazyva 101
5.4.4 Merck & Co. - Keytruda Key to Cancer Immunotherapy Market Growth 103
5.4.5 AstraZeneca - New Approvals to Mark Entry of AstraZeneca in Cancer Immunotherapy Market 104
5.4.6 Novartis - Cancer Immunotherapies Constitute Small Proportion of Vast Overall Revenue 105
5.4.7 Amgen - Innovative Imlygic to Help Generate above $1 Billion from Cancer Immunotherapy Market 106
5.4.8 Pfizer - Overall Cancer Immunotherapy Revenue to Surpass $1 Billion by 2022 due to PD-L1-Inhibitor Avelumab 107
5.4.9 Kite Pharma - KTE-C19 CAR to Drive Revenue Growth in Forecast Period 108
6 Company Analysis and Positioning 109
6.1 Company Landscape 110
6.2 Marketed and Pipeline Portfolio Analysis 111
7 Strategic Consolidations 114
7.1 Licensing Deals 114
7.1.1 Deal by Region, Year and Value 114
7.1.2 Deals by Stage of Development and Value 116
7.1.3 Deals by Molecule Type, Molecular Target and Value 117
7.1.4 Table for Licensing Deals Valued above $500m 119
7.2 Co-development Deals 121
7.2.1 Deals by Region, Year and Value 121
7.2.2 Deals by Stage of Development and Value 122
7.2.3 Deals by Molecule Type, Mechanism of Action and Value 123
7.2.4 Table for Co-development Deals Valued above $100m 125
8 Appendix 126
8.1 Bibliography 126
8.2 All Pipeline Drugs by Phase of Development 136
8.2.1 Discovery 136
8.2.2 Preclinical 160
8.2.3 IND/CTA-filed 242
8.2.4 Phase I 245
8.2.5 Phase II 284
8.2.6 Phase III 346
8.2.7 Pre-registration 355
8.2.8 Unknown 357
8.3 Abbreviations 358
8.4 Disease List 360
8.5 Methodology 360
8.5.1 Coverage 361
8.5.2 Secondary Research 361
8.5.3 Market Size and Revenue Forecasts 361
8.5.4 Pipeline Analysis 362
8.5.5 Competitive Landscape 362
8.6 Contact Us 362
8.7 Disclaimer 363

1.1 List of Tables
Table 1: Cancer Immunotherapies Market, Global, Epidemiology of Key Oncology Indications, 2016 12
Table 2: Cancer Immunotherapies Market, Global, Regional Lymph Node and Metastasis Staging, 2016 30
Table 3: Cancer Immunotherapies Market, Global, Eastern Co-operative Oncology Group Criteria, 2016 30
Table 4: Cancer Immunotherapies Market, Global, Breast Cancer Histopathological and Molecular Classification, 2016 31
Table 5: Cancer Immunotherapies Market, US, Breast Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 37
Table 6: Cancer Immunotherapies Market, US, Ovarian Cancer Stage and Survival Rates (%), 2016 38
Table 7: Cancer Immunotherapies Market, US, Lung Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 38
Table 8: Cancer Immunotherapies Market, US, Ovarian Cancer Stage at Diagnosis and Five-year Relative Survival (%), 2016 39
Table 9: Cancer Immunotherapies Market, Global, Approved Indications for Rituxan, 2016 43
Table 10: Cancer Immunotherapies Market, Global, Approved Indications for Revlimid, 2016 45
Table 11: Cancer Immunotherapies Market, Global, Approved Indications for Yervoy, 2016 46
Table 12: Cancer Immunotherapies Market, Global, Approved Indications for Opdivo, 2016 49
Table 13: Cancer Immunotherapies Market, Global, Approved Indications for Keytruda, 2016 51
Table 14: Cancer Immunotherapies Market, Global, Approved Indications for Pomalyst, 2016 52
Table 15: Cancer Immunotherapies Market, Global, Approved Indications for Gardasil, 2016 54
Table 16: Cancer Immunotherapies Market, Global, Approved Indications for Provenge, 2016 55
Table 17: Cancer Immunotherapies Market, Global, Forecast Revenue by Company, 2016 95
Table 18: Cancer Immunotherapies Market, Global, Licensing Deals Valued above $500m, 2006-2016 119
Table 19: Cancer Immunotherapies Market, Global, Co-development Deals Valued above $100m, 2006-2016 125
Table 20: Cancer Immunotherapies Market, Global, Pipeline Products, Discovery, 2016 136
Table 21: Cancer Immunotherapies Market, Global, Pipeline Products, Preclinical, 2016 160
Table 22: Cancer Immunotherapies Market, Global, Pipeline Products, IND/CTA filed, 2016 242
Table 23: Cancer Immunotherapies Market, Global, Pipeline Products, Phase I, 2016 245
Table 24: Cancer Immunotherapies Market, Global, Pipeline Products, Phase II, 2016 284
Table 25: Cancer Immunotherapies Market, Global, Pipeline Products, Phase III, 2016 346
Table 26: Cancer Immunotherapies Market, Global, Pipeline Products, Pre-Registration, 2016 355
Table 27: Cancer Immunotherapies Market, Global, Pipeline Products, Unknown, 2016 357

1.2 List of Figures
Figure 1: Cancer Immunotherapies Market, Global, Epidemiology Patterns for Breast Cancer, 2015-2023 13
Figure 2: Cancer Immunotherapies Market, Global, Epidemiology Patterns for Melanoma, 2015-2023 14
Figure 3: Cancer Immunotherapies Market, Global, Epidemiology Patterns for NSCLC, 2015-2023 15
Figure 4: Cancer Immunotherapies Market, Global, Epidemiology Patterns for Ovarian Cancer, 2015-2023 16
Figure 5: Cancer Immunotherapies Market, Global, NSCLC Molecular Characteristic Frequency (%) 21
Figure 6: Cancer Immunotherapies Market, Global, Key Marketed Products and Approved Indications, 2016 42
Figure 7: Cancer Immunotherapies Market, Global, Annual Revenue for Rituxan ($bn), 2006-2022 44
Figure 8: Cancer Immunotherapies Market, Global, Annual Revenue for Revlimid ($bn), 2006-2022 46
Figure 9: Cancer Immunotherapies Market, Global, Annual Revenue for Yervoy ($bn), 2011-2022 48
Figure 10: Cancer Immunotherapies Market, Global, Annual Revenue for Opdivo ($bn), 2014-2022 50
Figure 11: Cancer Immunotherapies Market, Global, Annual Revenue for Keytruda ($bn), 2014-2022 52
Figure 12: Cancer Immunotherapies Market, Global, Annual Revenue for Pomalyst ($bn), 2013-2022 53
Figure 13: Cancer Immunotherapies Market, Global, Annual Revenue for Gardasil ($bn), 2006-2022 55
Figure 14: Cancer Immunotherapies Market, Global, Annual Revenue for Provenge ($m), 2010-2022 56
Figure 15: Cancer Immunotherapies Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016 58
Figure 16: Cancer Immunotherapies Market, Global, Pipeline for Cancer Immunotherapies by Stage of Development, Molecule Type and Program Type, 2016 59
Figure 17: Cancer Immunotherapies Market, Global, Pipeline for Key Cancers by Stage of Development, 2016 60
Figure 18: Cancer Immunotherapies Market, Global, Pipeline for Key Cancers by Molecule Type, 2016 61
Figure 19: Cancer Immunotherapies Market, Global, Pipeline for Cancer Immunotherapies by Molecular Target, 2016 63
Figure 20: Cancer Immunotherapies Market, Global, Pipeline for Key Cancers by Molecular Target, 2016 64
Figure 21: Cancer Immunotherapies Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2016 65
Figure 22: Cancer Immunotherapies Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2016 66
Figure 23: Cancer Immunotherapies Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2016 67
Figure 24: Cancer Immunotherapies Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2016 68
Figure 25: Cancer Immunotherapies Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2016 69
Figure 26: Cancer Immunotherapies Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2016 70
Figure 27: Cancer Immunotherapies Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 71
Figure 28: Cancer Immunotherapies Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 72
Figure 29: Cancer Immunotherapies Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2016 73
Figure 30: Cancer Immunotherapies Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2016 73
Figure 31: Cancer Immunotherapies Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2016 74
Figure 32: Cancer Immunotherapies Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2016 75
Figure 33: Cancer Immunotherapies Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2016 76
Figure 34: Cancer Immunotherapies Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2016 76
Figure 35: Cancer Immunotherapies Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2016 77
Figure 36: Cancer Immunotherapies Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2016 78
Figure 37: Cancer Immunotherapies Market, Global, Revenue for Durvalumab ($bn), 2017-2022 80
Figure 38: Cancer Immunotherapies Market, Global, Revenue for Durvalumab and Tremelimumab ($bn), 2018-2022 81
Figure 39: Cancer Immunotherapies Market, Global, Revenue for Tisagenlecleucel-T ($bn), 2017-2022 82
Figure 40: Cancer Immunotherapies Market, Global, Revenue for KTE-C19 ($m), 2017-2022 84
Figure 41: Cancer Immunotherapies Market, Global, Revenue for Avelumab ($m), 2017-2022 85
Figure 42: Cancer Immunotherapies Market, Global, Revenue for Epacadostat ($m), 2018-2022 86
Figure 43: Cancer Immunotherapies Market, Global, Market Size ($bn), 2015-2022 89
Figure 44: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Key Products ($m), 2015-2022 89
Figure 45: Cancer Immunotherapies Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2015-2022 90
Figure 46: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Immune-Checkpoint Proteins ($bn), 2015-2022 91
Figure 47: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Tumor Associated Antigens ($bn), 2015-2022 92
Figure 48: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Cancer Vaccines ($bn), 2015-2022 93
Figure 49: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Signal Transduction ($bn), 2015-2022 93
Figure 50: Cancer Immunotherapies Market, Global, Company Analysis Matrix, 2015-2022 94
Figure 51: Cancer Immunotherapies Market, Global, Forecast Market Share by Company (%), 2015-2022 96
Figure 52: Cancer Immunotherapies Market, Global, Companies by Compound Annual Growth Rate (%), Base Year-2022 97
Figure 53: Cancer Immunotherapies Market, Global, Revenue by Product Type, 2015-2022 98
Figure 54: Cancer Immunotherapies Market, Global, Celgene Annual Revenue Forecast ($bn), 2015-2022 99
Figure 55: Cancer Immunotherapies Market, Global, Bristol-Myers Squibb Annual Revenue ($bn), 2015-2022 101
Figure 56: Cancer Immunotherapies Market, Global, Roche Annual Revenue ($bn), 2015-2022 102
Figure 57: Cancer Immunotherapies Market, Global, Merck & Co. Annual Revenue ($bn), 2015-2022 103
Figure 58: Cancer Immunotherapies Market, Global, AstraZeneca Annual Revenue ($bn), 2017-2022 104
Figure 59: Cancer Immunotherapies Market, Global, Novartis Annual Revenue ($bn), 2015-2022 105
Figure 60: Cancer Immunotherapies Market, Global, Amgen Annual Revenue ($bn), 2015-2022 106
Figure 61: Cancer Immunotherapies Market, Global, Pfizer Annual Revenue ($bn), 2016-2022 107
Figure 62: Cancer Immunotherapies Market, Global, Kite Pharma Annual Revenue ($m), 2017-2022 108
Figure 63: Cancer Immunotherapies Market, Global, Cluster by Growth and Market Share, 2015-2022 109
Figure 64: Cancer Immunotherapies Market, Global, Companies by Type, 2016 111
Figure 65: Cancer Immunotherapies Market, Global, High-Activity and Late-Stage Developers by Level of Specialization, 2016 112
Figure 66: Cancer Immunotherapies Market, Global, Proportion of Total Company Revenue Attributed to Cancer Immunotherapies, 2015-2022 113
Figure 67: Cancer Immunotherapies Market, Global, Licensing Deals by Region, Year and Value, 2006-2016 115
Figure 68: Cancer Immunotherapies Market, Global, Licensing Deals by Indication and Value, 2006-2016 116
Figure 69: Cancer Immunotherapies Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 117
Figure 70: Cancer Immunotherapies Market, Global, Licensing Deals by Molecule Type and Target, 2006-2016 118
Figure 71: Cancer Immunotherapies Market, Global, Co-development Deals by Region, Year and Value, 2006-2016 121
Figure 72: Cancer Immunotherapies Market, Global, Co-development Deals by Indication, 2006-2016 122
Figure 73: Cancer Immunotherapies Market, Global, Co-development Deals by Stage of Development and Value, 2006-2016 123
Figure 74: Cancer Immunotherapies Market, Global, Co-development Deals by Molecule Type and Target, 2006-2016 12

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