Global Cancer Immunotherapies Market to 2024 – Increased Uptake of Immune Checkpoint Inhibitors Driving Growth, Supported by a Large, Robust Pipeline

Cancer immunotherapy, which can predominantly be classed as a form of targeted therapy, drives an immune response against cancer cells. This may include stimulating a patient’s immune system in a general way or aiding the identification of specific antigens associated with the cancer.

The interest in cancer immunotherapy development has been driven by the growing understanding of the immune system as a hallmark of cancer pathophysiology, particularly immune evasion of developing cancer cells. Overall, 3,863 products are being actively developed in the cancer immunotherapy pipeline, approximately half of the overall oncology pipeline.

The report focuses on the key indications of breast cancer, leukemia, lymphoma, melanoma and non-small cell lung cancer, these indications are the largest in terms of size, with 448, 526, 456, 415 and 374 in active development, respectively. The pipeline is dominated mAbs, cell therapies, small molecules and cancer vaccines.

Scope

– Global revenue from the cancer immunotherapies market is forecast to increase from $33.7 billion in 2017 to $103.4 billion in 2024, at a compound annual growth rate of 17.4%. What is driving this growth?

– The leading companies in terms of market share are Celgene, Merck & Co., Bristol-Myers Squibb and Roche. Which of these are forecast to experience the largest growth?

– There are some key new approvals and late-stage products set to enter the market during the forecast period. Which impact will these drugs have on the market?

– The market has been dominated by immune checkpoint inhibitors and drugs that target tumor associated antigens. To what extent will these classes of drugs and others dominate the market over the forecast period?

– There are 3,863 cancer immunotherapy products in the pipeline. What molecular targets are most abundant in the pipeline and what role will pipeline product approvals play in market growth?

– Cancer immunotherapy clinical trials have an overall attrition rate of around 96%, what can companies do to maximize their chance of success?

Reasons to buy

- Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyze the cancer immunotherapy pipeline through a comprehensive review of the pipeline segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at current cancer immunotherapies to provide an insight into the risk associated of attempting to bring pipeline products to market.

- Predict growth in market size, with in-depth market forecasting from 2017 to 2024. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and certain patent expirations will influence market value.

- Identify commercial opportunities in the cancer immunotherapies deals landscape by analyzing trends in licensing and co-development deals

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 12

2.1 Therapy Area Introduction 12

2.2 Overview of Key Indications and Symptoms 12

2.2.1 Breast Cancer 13

2.2.2 Leukemia 15

2.2.3 Lymphoma 15

2.2.4 Melanoma 16

2.2.5 Non-Small Cell Lung Cancer 17

2.3 Diagnosis 18

2.3.1 Breast Cancer 18

2.3.2 Leukemia 18

2.3.3 Lymphoma 19

2.3.4 Melanoma 20

2.3.5 Non-Small Cell Lung Cancer 22

2.4 Etiology and Pathophysiology 23

2.4.1 Breast Cancer 26

2.4.2 Leukemia 27

2.4.3 Lymphoma 29

2.4.4 Melanoma 32

2.4.5 Non-Small Cell Lung Cancer 33

2.5 Epidemiology 37

2.5.1 Breast Cancer 38

2.5.2 Leukemia 38

2.5.3 Lymphoma 39

2.5.4 Melanoma 40

2.5.5 Non-Small Cell Lung Cancer 41

2.6 Prognosis 42

2.6.1 Breast Cancer 42

2.6.2 Leukemia 43

2.6.3 Lymphoma 44

2.6.4 Melanoma 44

2.6.5 Non-Small Cell Lung Cancer 45

2.7 Treatment 46

3 Key Marketed Products 49

3.1 Overview 49

3.2 Revlimid (lenalidomide) - Celgene 50

3.3 Opdivo (nivolumab) - Ono Pharma/Bristol-Myers Squibb 53

3.4 Keytruda (pembrolizumab) - Merck & Co. 55

3.5 Tecentriq (atezolizumab) - Roche 57

3.6 Darzalex (daratumumab) - Johnson & Johnson 59

3.7 Imfinzi (durvalumab) - AstraZeneca/Celgene 60

3.8 Gardasil/Gardasil 9 (human papillomavirus vaccine) - Merck & Co. 62

3.9 Pomalyst/Imnovid (pomalidomide) - Celgene 65

3.10 Yescarta (axicabtagene ciloleucel) - Gilead Sciences 66

3.11 Gazyva (obinutuzumab) - Roche 68

3.12 Yervoy (ipilimumab) - Bristol-Myers Squibb 69

3.13 Rituxan (rituximab) - Roche/Biogen 71

3.14 Kymriah (tisagenlecleucel) - Novartis 73

4 Pipeline Landscape Assessment 76

4.1 Overview 76

4.2 Pipeline Development Landscape 76

4.3 Molecular Targets in the Pipeline 79

4.4 Clinical Trials Landscape 82

4.4.1 Clinical Trial Failure Rates 83

4.4.2 Clinical Trial Duration 87

4.4.3 Clinical Trial Size 91

4.4.4 Cumulative Clinical Trial Size 94

4.5 Late-Stage Drugs of the Developmental Pipeline 99

4.5.1 Lisocabtagene maraleucel - Juno Therapeutics/Celgene 99

4.5.2 Durvalumab plus Tremelimumab - AstraZeneca 100

4.5.3 Tremelimumab - AstraZeneca 101

4.5.4 Cemiplimab - Regeneron/Sanofi 103

4.5.5 Epacadostat - Incyte Corp 104

4.5.6 Axalimogene filolisbac - Advaxis 106

5 Multi-scenario Market Forecast to 2024 108

5.1 Overall Market Size 108

5.2 Generic Penetration 112

5.3 Revenue Forecast by Molecular Target 113

5.3.1 Immune Checkpoint Proteins 114

5.3.2 Tumor Associated Antigens 114

5.3.3 Cytokine Signaling 117

5.3.4 HPV 118

6 Company Analysis and Positioning 119

6.1 Revenue and Market Share Analysis by Company 120

6.1.1 Celgene - Revlimid to Maintain Celgene’s Position as Market Leader 124

6.1.2 Merck & Co. - Keytruda Key to Cancer Immunotherapy Market Growth 126

6.1.3 Bristol-Myers Squibb - Opdivo to Drive Revenue from Cancer Immunotherapies 127

6.1.4 Roche - Strong Revenue from Tecentriq and Gazyva Set to Offset Loss from Rituxan 127

6.1.5 AstraZeneca - Revenue from Imfinzi set to Drive Growth amid Growing Immunotherapy Presence 128

6.1.6 Johnson & Johnson - Darzalex Key to Strong Growth 130

6.1.7 Novartis - Diverse Cancer Immunotherapies Portfolio Contributes Small Portion to Overall Revenue 131

6.1.8 AbbVie - Recent New Approvals to Result in AbbVie Becoming a Leading Player in 2024 132

6.1.9 Gilead Sciences - Growth Driven by CAR-T Therapy Yescarta 133

6.1.10 Amgen - Rituximab Biosimilar to Drive Growth for Amgen in a Portfolio with No Novel Blockbusters 134

6.2 Market and Pipeline Company Landscape 134

7 Strategic Consolidations 138

7.1 Licensing Deals 138

7.1.1 Deals by Region, Deal Value and Year 138

7.1.2 Deals by Indication and Deal Value 140

7.1.3 Deals by Stage of Development and Deal Value 141

7.1.4 Deals by Molecule Type, Molecular Target and Deal Value 142

7.1.5 Table for Licensing Deals with Disclosed Deal Value 143

7.2 Co-development Deals 154

7.2.1 Deals by Region, Deal Value and Year 154

7.2.2 Deals by Indication and Deal Value 156

7.2.3 Deals by Stage of Development and Deal Value 157

7.2.4 Deals by Molecule Type, Molecular Target and Deal Value 158

7.2.5 Table for Co-development Deals with Disclosed Deal Value 159

8 Appendix 164

8.1 References 164

8.2 Figures of All Clinical Stage Pipeline Products 177

8.3 Abbreviations 203

8.4 Disease List 205

8.5 Methodology 206

8.5.1 Coverage 206

8.5.2 Secondary Research 207

8.5.3 Market Size and Revenue Forecasts 207

8.5.4 Pipeline Analysis 207

8.5.5 Competitive Landscape 208

8.6 Contact Us 209

8.7 Disclaimer 209

List of Tables

1.1 List of Tables

Table 1: Cancer Immunotherapies Drugs Market, Global, Breast Cancer Histopathological and Molecular Classification, 2018 13

Table 2: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology of Key Indications, 2016 37

Table 3: Cancer Immunotherapies Drugs Market, US, Breast Cancer Stage at Diagnosis and Five-Year Relative Survival Rate (%), 2016 42

Table 4: Cancer Immunotherapies Drugs Market, US, Leukemia Subtype and Five-Year Survival Rates (%), 2016 43

Table 5: Cancer Immunotherapies Drugs Market, US, Lymphoma Subtype and Survival Rates (%), 2016 44

Table 6: Cancer Immunotherapies Drugs Market, US, Cutaneous Melanoma Stage and Survival Rates (%), 2016 44

Table 7: Cancer Immunotherapies Drugs Market, US, NSCLC Stage at Diagnosis and Five-Year Relative Survival (%), 2017 46

Table 8: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Revlimid, 2018 50

Table 9: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Opdivo, 2018 53

Table 10: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Keytruda, 2018 55

Table 11: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Tecentriq, 2018 58

Table 12: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Darzalex, 2018 59

Table 13: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications Imfinzi, 2018 61

Table 14: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Gardasil, 2018 63

Table 15: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Pomalyst, 2018 65

Table 16: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Yescarta, 2018 67

Table 17: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Gazyva, 2018 68

Table 18: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Yervoy, 2018 70

Table 19: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Rituxan, 2018 71

Table 20: Cancer Immunotherapies Drugs Market, Global, Approved Cancer Immunotherapies Indications for Kymriah, 2018 73

Table 21: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Key Products ($bn), 2017-2024 110

Table 22: Cancer Immunotherapies Drugs Market, Global, Forecast Revenue by Company, 2017-2024 120

Table 23: Cancer Immunotherapies Drugs Market, Global, Licensing Deals, 2006-2018 143

Table 24: Cancer Immunotherapies Drugs Market, Global, Co-development Deals, 2006-2018 159

List of Figures

1.2 List of Figures

Figure 1: Cancer Immunotherapies Drugs Market, Global, Frequency of Molecular Aberrations in Non-Small Cell Lung Cancer (%), 2018 34

Figure 2: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology Patterns for Breast Cancer, 2016-2023 38

Figure 3: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology Patterns for Leukemia, 2016-2023 39

Figure 4: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology Patterns for Lymphoma, 2016-2023 40

Figure 5: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology Patterns for Cutaneous Melanoma, 2016-2023 41

Figure 6: Cancer Immunotherapies Drugs Market, 7MM, Epidemiology Patterns for NSCLC, 2016-2023 42

Figure 7: Cancer Immunotherapies Drugs Market, Global, Key Marketed Products and Approved Indications, 2018 50

Figure 8: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Revlimid ($bn), 2006-2024 52

Figure 9: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Opdivo ($bn), 2014-2024 55

Figure 10: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Keytruda ($bn), 2014-2024 57

Figure 11: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Tecentriq ($bn), 2016-2024 59

Figure 12: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Darzalex ($bn), 2015-2024 60

Figure 13: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Imfinzi ($bn), 2017-2024 62

Figure 14: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Gardasil ($bn), 2006-2024 64

Figure 15: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Pomalyst ($bn), 2013-2024 66

Figure 16: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Yescarta ($bn), 2018-2024 68

Figure 17: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Gazyva ($bn), 2013-2024 69

Figure 18: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Yervoy ($bn), 2011-2024 71

Figure 19: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Rituxan ($bn), 2006-2024 73

Figure 20: Cancer Immunotherapies Drugs Market, Global, Annual Revenue for Kymriah ($bn), 2017-2024 75

Figure 21: Cancer Immunotherapies Drugs Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018 76

Figure 22: Cancer Immunotherapies Drugs Market, Global, Cancer Immunotherapies Pipeline by Stage of Development, Molecule Type and Program Type, 2018 77

Figure 23: Cancer Immunotherapies Drugs Market, Global, Pipeline for Key Indications by Stage of Development, 2018 78

Figure 24: Cancer Immunotherapies Drugs Market, Global, Pipeline for Key Indications by Molecule Type, 2018 79

Figure 25: Cancer Immunotherapies Drugs Market, Global, Cancer Immunotherapies Pipeline by Molecular Target, 2018 81

Figure 26: Cancer Immunotherapies Drugs Market, Global, Pipeline for Key Indications by Molecular Target, 2018 82

Figure 27: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rate by Stage of Development (%), 2006-2018 83

Figure 28: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2018 84

Figure 29: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2018 85

Figure 30: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2018 86

Figure 31: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2018 87

Figure 32: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2018 88

Figure 33: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2018 89

Figure 34: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2018 90

Figure 35: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2018 91

Figure 36: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2018 92

Figure 37: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2018 93

Figure 38: Cancer Immunotherapies Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2018 94

Figure 39: Cancer Immunotherapies Drugs Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2018 95

Figure 40: Cancer Immunotherapies Drugs Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2018 96

Figure 41: Cancer Immunotherapies Drugs Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2018 97

Figure 42: Cancer Immunotherapies Drugs Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2018 98

Figure 43: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Lisocabtagene maraleucel ($m), 2018-2024 100

Figure 44: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Durvalumab plus Tremelimumab ($m), 2018-2024 101

Figure 45: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Tremelimumab ($m), 2018-2024 103

Figure 46: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Cemiplimab ($m), 2019-2024 104

Figure 47: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Epacadostat ($bn), 2020-2024 105

Figure 48: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Axalimogene filolisbac ($m), 2020-2024 107

Figure 49: Cancer Immunotherapies Drugs Market, Global, Market Size ($bn), 2017-2024 108

Figure 50: Cancer Immunotherapies Drugs Market, Global, Key Products Market Share, 2017-2024 112

Figure 51: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Premium and Generic Products ($bn), 2017-2024 113

Figure 52: Cancer Immunotherapies Market, Global, Annual Revenue Forecast for Immune Checkpoint Proteins ($bn), 2017-2024 114

Figure 53: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Tumor Associated Antigens ($bn), 2017-2024 116

Figure 54: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for Cytokine Signaling ($bn), 2017-2024 117

Figure 55: Cancer Immunotherapies Drugs Market, Global, Annual Revenue Forecast for HPV Vaccines ($bn), 2017-2024 118

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