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Global Cancer Vaccines Market to 2022-Robust Growth Driven by Increasing Prevalence, New Therapeutic Vaccine Approvals and Strong Uptake of Treatments Targeting CD19

Global Cancer Vaccines Market to 2022-Robust Growth Driven by Increasing Prevalence, New Therapeutic Vaccine Approvals and Strong Uptake of Treatments Targeting CD19


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Executive Summary

Global Cancer Vaccines Market to 2022-Robust Growth Driven by Increasing Prevalence, New Therapeutic Vaccine Approvals and Strong Uptake of Treatments Targeting CD19

Summary

Cancer vaccines are being developed as a method of preventing certain types of cancer, and as therapeutic treatments to treat existing cancers across a range of indications in oncology, either as stand-alone therapies or in combination with traditional cancer therapeutics such as chemotherapy and surgery. The high mortality rate associated with cancer and its resistance to conventional treatments such as radiation and chemotherapy has led to the investigation of a variety of anti-cancer immunotherapies, which have a lower toxicity associated with their use than traditional chemotherapies. Therapeutic vaccine administration will increase the overall survival of poor-performance-status patients, and enable more rounds of treatment to be given-factors that will contribute to growing global revenues for this class of therapy. However, cancer vaccines are not perceived as having strong commercial potential, as immune checkpoint inhibitors are expected to dominate the treatment landscape for leukemia and lymphoma during the forecast period.

A number of common etiologic factors have been strongly characterized as raising the risk of developing cancer, including age, chronic inflammation, gender, obesity, tobacco usage and heritable cancer syndromes. The risk of cancer increases greatly in patients over the age of 65. Populations in developed countries are projected to become increasingly aged and show rising obesity incidence, which will drive cancer prevalence and revenue growth for its treatments.

Prophylactic vaccines are currently used to immunize against viruses, which have been shown to increase the risk of cancer, with viral factors being the underlying cause of approximately 15% of cancers worldwide. Prophylactic vaccines such as Gardasil are currently the most commercially successful and well-established class of cancer vaccines. However, there has been a shift towards the clinical testing of therapeutic vaccines-which constitute the majority of the pipeline-such as Imlygic, which was recently approved for melanoma.

Scope

Global revenues for the cancer vaccines market are forecast to grow at a compound annual growth rate (CAGR) of 16.93%, from $2.5 billion in 2015 to $7.5 billion in 2022. Which drugs will achieve blockbuster status and how will the key player companies perform during the forecast period?

The cancer vaccine pipeline is large and fairly diverse, and contains 1,286 products. How does the composition of the pipeline compare with that of the existing market? What are the most popular molecule types and molecular targets in the pipeline?

What mechanisms of action and molecule types are most common for pipeline vaccines being trialed in the various key indications?

How will the market shares and CAGRs of the top 20 pharma companies compare within cancer vaccines?

What proportion of the key players' revenues will be attributable to cancer vaccines?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis

Visualize the composition of the cancer vaccines market across each indication, in terms of dominant molecule types and targets, highlighting the key commercial assets and players

Analyze the cancer vaccine pipeline and stratify by stage of development, molecule type and molecular target, with a granular breakdown across key indications

Understand the growth in patient epidemiology and market revenues for the cancer vaccine market globally and across the key players and product types

Stratify the market in terms of the split between therapeutic and prophylactic vaccines, and assess the role of these product types in the treatment of the various cancers

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

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 10

2.1 Therapy Area Introduction 10

2.2 Symptoms 11

2.3 Etiology and Pathophysiology 12

2.3.1 Etiology 12

2.3.2 Cancer Pathophysiology 14

2.3.3 Virus Pathophysiology 15

2.4 Epidemiology Patterns-Prevalence, Patient Segmentation, and Diagnostic and Treatment Usage Rates 16

2.4.1 Cervical Cancer 17

2.4.2 Liver Cancer 17

2.4.3 Melanoma 18

2.4.4 Prostate Cancer 19

2.5 Co-morbidities and Complications 20

2.6 Treatment 21

2.6.1 Surgery and Radiation Therapy 21

2.6.2 Chemotherapy 23

2.6.3 Hormonal Therapies 25

2.6.4 Targeted Therapies 26

2.6.5 Types of Cancer Vaccines 27

3 Key Marketed Products 31

3.1 Overview 31

3.2 Gardasil/Gardasil 9 31

3.3 Provenge 33

3.4 Cervarix 35

3.5 Imlygic 36

3.6 DCVax-L 38

3.7 Recombivax HB 39

3.8 Conclusion 40

4 Pipeline Landscape Assessment 41

4.1 Overview 41

4.2 Pipeline Development Landscape 41

4.2.1 Therapeutic Vaccine Molecule Type and Development Stage 41

4.2.2 Prophylactic Vaccine Molecule Type and Development Stage 42

4.2.3 Key Oncology Indications by Molecule Type and Development Stage 43

4.3 Pipeline by Molecular Targets and Indication 45

4.3.1 Therapeutic Vaccine Molecular Targets 45

4.4 Clinical Trials 48

4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 48

4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 52

4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 56

4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 59

4.4.5 Conclusion 63

4.5 Assessment of Key Pipeline Products 64

4.5.1 Tisagenlecleucel-T (CTL-019)-Novartis 64

4.5.2 KTE-C19-Kite Pharma 65

4.5.3 JCAR017-Juno Therapeutics 66

4.5.4 JCAR015-Juno Therapeutics 67

4.5.5 bb-2121-Bluebird Bio 68

4.5.6 Prostvac-Bavarian Nordic 69

4.5.7 Cellular Immunotherapy to Target HPV-16 E6 Protein for Cancer-Kite Pharma 70

4.5.8 Conclusion 72

5 Multi-scenario Market Forecast to 2022 73

5.1 Overall Market Size 73

5.2 Prophylactic and Therapeutic Vaccine Market Split 75

5.3 Revenue Forecast by Molecular Target 78

5.3.1 HPV L1 Major Capsid Protein 78

5.3.2 Hepatitis B Surface Antigen 79

5.3.3 Cluster of Differentiation 19 79

5.3.4 Granulocyte Macrophage Colony Stimulating Factor 80

5.3.5 Tumor Necrosis Factor Receptor Superfamily Member 17 81

5.3.6 Prostatic Acid Phosphatase 81

6 Company Analysis and Positioning 83

6.1 Revenue and Market Share Analysis by Company 84

6.1.1 Merck & Co-How Will Cancer Vaccine Revenues Be Affected by Recombivax HB's Patent Expiry? 87

6.1.2 GSK-How Will Its Prophylactic Vaccines Fair Against Merck & Co's Competitors? 89

6.1.3 Novartis-How Will This Top 20 Company Perform in The Cancer Vaccines Market? 90

6.1.4 Kite Pharma-Could it Develop a Blockbuster? 91

6.1.5 Amgen-How Will Recent Approval Imlygic Perform? 92

6.1.6 Juno Therapeutics-Great Potential for its CD19 Targeting Therapies 92

6.1.7 Valeant Pharma-Uncertain Times and Financial Difficulties 93

6.1.8 Bluebird Bio-How Will This Small Company Perform in the Cancer Vaccines Market? 94

6.1.9 Bavarian Nordic-How Will Prostvac Perform? 94

6.2 Company Landscape 95

6.3 Marketed and Pipeline Portfolio Analysis 96

7 Strategic Consolidations 99

7.1 Licensing Deals 99

7.1.1 Deals by Region and Value 99

7.1.2 Deals by Indication, Stage of Development and Value 100

7.1.3 Deals by Molecule Type, Molecular Target and Value 102

7.1.4 Table for Licensing Deals with Disclosed Values 104

7.2 Co-development Deals 107

7.2.1 Deals by Region and Value 107

7.2.2 Deals by Indication, Stage of Development and Value 109

7.2.3 Deals by Molecule Type, Molecular Target and Value 110

7.2.4 Table for Co-development Deals With a Disclosed Value 112

8 Appendix 113

8.1 References 113

8.2 Table of All Pipeline Products 126

8.3 Abbreviations 180

8.4 Methodology 181

8.4.1 Coverage 181

8.4.2 Secondary Research 182

8.4.3 Market Size and Revenue Forecasts 182

8.4.4 Pipeline Analysis 182

8.4.5 Competitive Landscape 183

8.5 Contact Us 183

8.6 Disclaimer 183

1.2 List of Figures

Figure 1: Cancer Vaccines Market, Major Markets, Treatment Usage Patterns for Cervical Cancer, Patients ('000), 2015-2022 17

Figure 2: Cancer Vaccines Market, Major Markets, Treatment Usage Patterns for Liver Cancer, Patients ('000), 2015-2022 18

Figure 3: Cancer Vaccines Market, Major Markets, Treatment Usage Patterns for Melanoma, Patients ('000), 2015-2022 19

Figure 4: Cancer Vaccines Market, Major Markets, Treatment Usage Patterns for Prostate Cancer, Patients ('000), 2015-2022 20

Figure 5: Cancer Vaccines Market, Global, Key Marketed Products and Approved Indications, 2016 31

Figure 6: Cancer Vaccines Market, Global, Annual Revenues for Gardasil ($bn), 2006-2022 33

Figure 7: Cancer Vaccines Market, Global, Annual Revenues for Provenge ($m), 2010-2022 34

Figure 8: Cancer Vaccines Market, Global, Annual Revenues for Cervarix ($m), 2007-2022 36

Figure 9: Cancer Vaccines Market, Global, Annual Revenues for Imlygic ($m), 2015-2022 37

Figure 10: Cancer Vaccines Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016 41

Figure 11: Cancer Vaccines Market, Global, Pipeline for Therapeutic Cancer Vaccines by Stage of Development and Molecule Type, 2016 42

Figure 12: Cancer Vaccines Market, Global, Pipeline for Prophylactic Cancer Vaccines by Stage of Development and Molecule Type, 2016 43

Figure 13: Cancer Vaccines Market, Global, Pipeline for Key Oncology Indications by Stage of Development, 2016 44

Figure 14: Cancer Vaccines Market, Global, Pipeline for Key Oncology Indications by Molecule Type, 2016 45

Figure 15: Cancer Vaccines Market, Global, Pipeline for Therapeutic Vaccines by Indication and Molecular Target, 2016 46

Figure 16: Cancer Vaccines Market, Global, Pipeline for Prophylactic Vaccines by Indication and Molecular Target, 2016 47

Figure 17: Cancer Vaccines Market, Global, Pipeline for Key Oncology Indications by Molecular Target, 2016 48

Figure 18: Cancer Vaccines Market, Global, Clinical Trial Failure Rates by Stage of Development and Overall Clinical Trial Attrition Rate (%), 2006-2016 49

Figure 19: Cancer Vaccines Market, Global, Clinical Trial Failure Rates by Stage of Development and Indication (%), 2006-2016 50

Figure 20: Cancer Vaccines Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecule Type (%), 2006-2016 51

Figure 21: Cancer Vaccines Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecular Target (%), 2006-2016 52

Figure 22: Cancer Vaccines Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2016 53

Figure 23: Cancer Vaccines Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2016 54

Figure 24: Cancer Vaccines Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 55

Figure 25: Cancer Vaccines Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 56

Figure 26: Cancer Vaccines Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2016 57

Figure 27: Cancer Vaccines Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2016 57

Figure 28: Cancer Vaccines Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2016 58

Figure 29: Cancer Vaccines Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2016 59

Figure 30: Cancer Vaccines Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2016 60

Figure 31: Cancer Vaccines Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2016 61

Figure 32: Cancer Vaccines Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2016 62

Figure 33: Cancer Vaccines Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2016 63

Figure 34: Cancer Vaccines Market , Global, Revenue Forecast for Tisagenlecleucel-T ($bn), 2017-2022 65

Figure 35: Cancer Vaccines Market, Global, Revenue Forecast for KTE-C19 ($bn), 2017-2022 66

Figure 36: Cancer Vaccines Market, Global, Revenue Forecast for JCAR-017 ($bn), 2017-2022 67

Figure 37: Cancer Vaccines Market, Global, Revenue Forecast for JCAR-015 ($m), 2018-2022 68

Figure 38: Cancer Vaccines Market, Global, Revenue Forecast for bb-2121 ($m), 2019-2022 69

Figure 39: Cancer Vaccines Market, Global, Revenue Forecast for Prostvac ($m), 2016-2022 70

Figure 40: Cancer Vaccines Market, Global, Revenue Forecast for Cellular Immunotherapy to Target HPV-16 E6 Protein for Cancer ($m), 2018-2022 71

Figure 41: Cancer Vaccines Market, Global, Market Size ($bn), 2015-2022 74

Figure 42: Cancer Vaccines Market, Global, Market Size ($bn) 75

Figure 43: Cancer Vaccines Market, Global, Annual Revenue Forecast for Prophylactic and Therapeutic Products ($bn), 2015-2022 76

Figure 44: Cancer Vaccines Market, Global, Annual Revenue Forecast for HPV L1 Major Capsid Protein ($bn), 2015-2022 78

Figure 45: Cancer Vaccines Market, Global, Annual Revenue Forecast for Hepatitis B Surface Antigen ($m), 2015-2022 79

Figure 46: Cancer Vaccines Market, Global, Annual Revenue Forecast for Cluster of Differentiation 19 ($bn), 2017-2022 80

Figure 47: Cancer Vaccines Market, Global, Annual Revenue Forecast for Granulocyte Macrophage Colony Stimulating Factor ($m), 2016-2022 80

Figure 48: Cancer Vaccines Market, Global, Annual Revenue Forecast for Tumor Necrosis Factor Receptor Superfamily Member 17 ($m), 2019-2022 81

Figure 49: Cancer Vaccines Market, Global, Annual Revenue Forecast for Prostatic Acid Phosphatase ($m), 2015-2022 82

Figure 50: Cancer Vaccines Market, Global, Companies by Type, Cluster by Growth and Market Share, 2015-2022 83

Figure 51: Cancer Vaccines Market, Global, Company Analysis Matrix, 2016 84

Figure 52: Cancer Vaccine Market, Global, Forecast Market Share by Company (%), 2015-2022 85

Figure 53: Cancer Vaccines Market, Global, Companies by Compound Annual Growth Rate (%), 2015-2022 86

Figure 54: Cancer Vaccines Market, Global, Revenues by Product Type, 2015-2022 87

Figure 55: Cancer Vaccines Market, Global, Merck & Co Annual Revenue Forecast ($bn), 2015-2022 88

Figure 56: Cancer Vaccines Market, Global, GSK Annual Revenue Forecast ($m), 2015-2022 89

Figure 57: Cancer Vaccines Market, Global, Novartis Annual Revenue Forecast ($bn), 2017-2022 90

Figure 58: Cancer Vaccines Market, Global, Kite Pharma Annual Revenue Forecast ($bn), 2017-2022 91

Figure 59: Cancer Vaccines Market, Amgen Annual Revenue Forecast ($m), 2016-2022 92

Figure 60: Cancer Vaccines Market, Juno Therapeutics Annual Revenue Forecast ($bn), 2017-2022 93

Figure 61: Cancer Vaccines Market, Global, Valeant Annual Revenue Forecast ($m), 2015-2022 93

Figure 62: Cancer Vaccines Market, Global, Bluebird Bio Annual Revenue Forecast ($m), 2019-2022 94

Figure 63: Cancer Vaccines Market, Global, Bavarian Nordic Annual Revenue Forecast ($m), 2016-2022 95

Figure 64: Cancer Vaccines Market, Global, Companies by Type, 2015-2022 96

Figure 65: Cancer Vaccines Market, Global, Pipeline, High-Activity and Late-Stage Developers by Level of Cancer Vaccine Specialization, 2015-2022 97

Figure 66: Cancer Vaccines Market, Global, Proportion of Total Company Revenue Attributed to Cancer Vaccines, 2015-2022 98

Figure 67: Cancer Vaccines Market, Global, Licensing Deals by Region and Value, 2006-2016 100

Figure 68: Cancer Vaccines Market, Global, Licensing Deals by Indication and Value, 2006-2016 101

Figure 69: Cancer Vaccines Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 102

Figure 70: Cancer Vaccines Market, Global, Licensing Deals by Molecule Type and Molecular Target, 2006-2016 103

Figure 71: Cancer Vaccines Market, Global, Co-development Deals by Region and Value, 2006-2016 108

Figure 72: Cancer Vaccines Market, Global, Co-development Deals by Indication and Value, 2006-2016 109

Figure 73: Cancer Vaccines Market, Global, Co-development Deals by Stage of Development and Value, 2006-2016 110

Figure 74: Cancer Vaccines Market, Global, Co-development Deals by Molecule Type and Mechanism of Action, 2006-2016 111

1.1 List of Tables

Table 1: Cancer Vaccines Market, Global, Symptoms of Key Indication Cancers, 2016 12

Table 2: Cancer Vaccines Market, Global, Infectious Agents and Associated Cancers, 2016 14

Table 3: Cancer Vaccines Market, Global, Epidemiology of Key Oncology Indications, 2016 16

Table 4: Cancer Vaccines Market, Complications Associated with Cervical, Liver, Melanoma and Prostate Cancers, 2016 21

Table 5: Cancer Vaccines Market, Optimal Chemotherapy Usage Rates 25

Table 6: Cancer Vaccines Market, Global, Approved Indications for Gardasil, 2016 32

Table 7: Cancer Vaccines Market, Global, Approved Indications for Provenge, 2016 34

Table 8: Cancer Vaccines Market, Global, Approved Indications for Cervarix, 2016 35

Table 9: Cancer Vaccines Market, Global, Approved Indications for Imlygic, 2016 37

Table 10: Cancer Vaccines Market, Global, Approved Indications for DCVax-L, 2016 38

Table 11: Cancer Vaccines Market, Global, Approved Indications for Recombivax HB, 2016 39

Table 12: Cancer Vaccines Market, Global, Usage of Prophylactic and Therapeutic Vaccines Across Key Indications, 2016 77

Table 13: Cancer Vaccines Market, Global, Forecast Revenue by Company, 2015-2022 85

Table 14: Cancer Vaccines Market, Global, Disclosed Licensing Deals, 2006-2016 104

Table 15: Cancer Vaccines Market, Global, Disclosed Co-development Deals, 2006-2016 112

Table 16: Cancer Vaccines, Global, All Pipeline Products, 2016 126

Table 17: Abbreviations 180

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