Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 13
2.4 Etiology and Pathophysiology 13
2.4.1 Etiology 13
2.4.2 Pathophysiology 16
2.4.3 Biomarkers/Targets of Interest 20
2.5 Diagnosis 21
2.6 Disease Stages 22
2.7 Prognosis 29
2.8 Treatment Guidelines and Options 31
2.8.1 Surgery and Radiation Therapy 33
2.8.2 Chemotherapy 34
2.8.3 Targeted Therapies 35
3 Marketed Products 37
3.1 Overview 37
3.2 Chemotherapies 38
3.2.1 TS-1 (tegafur plus gimeracil plus oteracil) – Taiho Pharma 38
3.2.2 Cisplatin 40
3.2.3 Docetaxel 41
3.2.4 Fluorouracil (5-FU) 42
3.2.5 Methotrexate 42
3.3 Epidermal Growth Factor Receptor Targeted Therapies 43
3.3.1 Erbitux (cetuximab) – Eli Lilly/Merck KGaA 43
3.3.2 BIOMAb EGFR (nimotuzumab) – Biocon/Biotech Pharmaceutical Co. 45
3.4 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 47
3.4.1 Opdivo (nivolumab) – Bristol-Myers Squibb 47
3.4.2 Keytruda (pembrolizumab) – Merck & Co. 50
3.5 Comparative Efficacy and Safety of Marketed Products 53
4 Pipeline Analysis 56
4.1 Overview 56
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 57
4.3 Pipeline by Molecular Target 60
4.4 Promising Pipeline Candidates 62
4.4.1 Imfinzi (durvalumab) – MedImmune 62
4.4.2 Gilotrif/Giotrif/Xovoltib (afatinib) – Boehringer Ingelheim 66
4.4.3 Bavencio (avelumab) – Merck KgaA/Pfizer 68
4.5 Comparative Efficacy and Safety of Pipeline Products 70
4.6 Product Competitiveness Framework 71
5 Clinical Trial Analysis 73
5.1 Failure Rate 73
5.1.1 Overall Failure Rate 73
5.1.2 Failure Rate by Phase and Molecule Type 75
5.1.3 Failure Rate by Phase and Molecular Target 76
5.2 Clinical Trial Size 77
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 77
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 78
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 79
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 80
5.3 Clinical Trial Duration 81
5.3.1 Trial Duration by Molecule Type and Stage of Development 81
5.3.2 Trial Duration by Molecular Target and Stage of Development 82
5.4 Summary of Clinical Trial Metrics 83
6 Multi-scenario Forecast 84
6.1 Overview 84
6.2 Asia-Pacific Market 85
6.3 India 87
6.3.1 Treatment Usage Patterns 87
6.3.2 Annual Cost of Therapy 88
6.3.3 Market Size 89
6.4 China 90
6.4.1 Treatment Usage Patterns 90
6.4.2 Annual Cost of Therapy 91
6.4.3 Market Size 92
6.5 Australia 94
6.5.1 Treatment Usage Patterns 94
6.5.2 Annual Cost of Therapy 95
6.5.3 Market Size 95
6.6 South Korea 97
6.6.1 Treatment Usage Patterns 97
6.6.2 Annual Cost of Therapy 98
6.6.3 Market Size 99
6.7 Japan 100
6.7.1 Treatment Usage Patterns 100
6.7.2 Annual Cost of Therapy 101
6.7.3 Market Size 102
7 Drivers and Barriers 104
7.1 Drivers 104
7.1.1 Increasing Incidence of HNC 104
7.1.2 Adoption of Immuno-oncology Therapies in the HNC Treatment Algorithm 104
7.1.3 Launch of Premium Priced Pipeline Products 104
7.1.4 Increasing Usage of High Premium Priced Combination Therapies 105
7.1.5 Diversified Healthcare Reform and Insurance System to Boost Market Growth 105
7.2 Barriers 106
7.2.1 Usage of Surgical Therapies at Early Stage Reduces Drug Treatment Rate 106
7.2.2 Patent Expiration of Branded Therapies to Affect HNC Market Growth 106
7.2.3 Lack of Development of Pipeline Products for Locally Advanced HNC 106
7.2.4 High Prices of Therapeutics, Lack of Reimbursement and Penetration of Generics to Slow Down Market Growth in China and India 106
7.2.5 Drug Pricing Reforms 107
8 Deals and Strategic Consolidations 108
8.1 Licensing Deals 108
8.1.1 Deals by Region and Value 108
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 110
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 111
8.1.4 Key Licensing Deals 113
8.2 Co-development Deals 115
8.2.1 Deals by Region and Value 115
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 116
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 117
8.2.4 Key Co-development Deals 119
9 Appendix 121
9.1 All Pipeline Drugs by Stage of Development 121
9.1.1 Discovery 121
9.1.2 Preclinical 122
9.1.3 IND/CTA-filed 125
9.1.4 Phase I 126
9.1.5 Phase II 130
9.1.6 Phase III 133
9.2 Market Forecasts to 2023 134
9.2.1 Asia-Pacific 134
9.2.2 India 134
9.2.3 China 134
9.2.4 Australia 135
9.2.5 South Korea 135
9.2.6 Japan 136
9.3 Bibliography 136
9.4 Abbreviations 148
9.5 Research Methodology 150
9.5.1 Secondary Research 151
9.5.2 Marketed Product Profiles 151
9.5.3 Late-Stage Pipeline Candidates 152
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 152
9.5.5 Product Competitiveness Framework 152
9.5.6 Pipeline Analysis 152
9.5.7 Forecasting Model 153
9.5.8 Deals Data Analysis 154
9.6 Contact Us 154
9.7 Disclaimer 155