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 12
2.4 Etiology and Pathophysiology 13
2.4.1 Etiology 13
2.4.2 Pathophysiology 14
2.4.3 Biomarkers/Targets of Interest 14
2.5 Diagnosis 16
2.5.1 Digital Rectal Examination 16
2.5.2 Fecal Occult Blood Test 16
2.5.3 Flexible Sigmoidoscopy 16
2.5.4 Colonoscopy 16
2.5.5 Virtual Colonoscopy 17
2.5.6 Double Contrast Barium Enema 17
2.6 Disease Stages 18
2.7 Prognosis 19
2.8 Treatment Guidelines and Options 20
2.8.1 Surgery and Radiation Therapy 20
2.8.2 Chemotherapy 21
2.8.3 Targeted Therapies 22
2.8.4 Resistance to Pharmacological Therapies 23
2.8.5 Treatment Algorithm 24
3 Marketed Products 27
3.1 Overview 27
3.2 Chemotherapies 27
3.2.1 Lonsurf (Trifluridine plus Tipiracil) – Taiho Pharma 28
3.2.2 TS-1 (Tegafur plus Gimeracil plus Oteracil) – Taiho Pharma 29
3.2.3 UFT (tegafur plus uracil) – Merck KGaA 30
3.3 Epidermal Growth Factor Receptor Targeted Therapies 31
3.3.1 Erbitux (cetuximab) – Eli Lilly/Merck KGaA 31
3.3.2 Vectibix (panitumumab) – Amgen/Takeda 33
3.4 Anti-angiogenesis Therapies 35
3.4.1 Avastin (bevacizumab) – Roche 36
3.4.2 Cyramza (ramucirumab) – Eli Lilly 38
3.4.3 Zaltrap (Ziv-Aflibercept) – Sanofi/Regeneron 39
3.5 Kinase Inhibitors 40
3.5.1 Stivarga (regorafenib) – Bayer/Onyx 40
3.6 Comparative Efficacy and Safety of Marketed Products 41
4 Pipeline Analysis 44
4.1 Overview 44
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 44
4.3 Pipeline by Molecular Target 47
4.4 Promising Pipeline Candidates 49
4.4.1 Keytruda (pembrolizumab) – Merck & Co. 49
4.4.2 Opdivo (nivolumab) – Bristol-Myers Squib 51
4.4.3 Napabucasin (BBI-608) – Sumitomo Dainippon Pharma 53
4.4.4 Encorafenib plus binimetinib (LGX-818/MEK-162) – Array BioPharma 55
4.4.5 Fruquintinib (HMPL-013) – Hutchison MediPharma 57
4.4.6 Famitinib (SHR-1020) – Jiangsu Hengrui Medicine 58
4.4.7 Anlotinib (AL-3818) – Jiangsu Chia-Tai Tianqing 59
4.4.8 Donafenib (CM-4307) – Suzhou Zelgen Biopharmaceuticals 60
4.5 Comparative Efficacy and Safety of Pipeline Products 61
4.6 Product Competitiveness Framework 63
5 Clinical Trial Analysis 64
5.1 Failure Rate 64
5.1.1 Overall Failure Rate 64
5.1.2 Failure Rate by Phase and Molecule Type 66
5.1.3 Failure Rate by Phase and Molecular Target 67
5.2 Clinical Trial Size 68
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 68
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 69
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 69
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 71
5.3 Clinical Trial Duration 71
5.3.1 Trial Duration by Molecule Type and Stage of Development 72
5.3.2 Trial Duration by Molecular Target and Stage of Development 73
5.4 Summary of Clinical Trial Metrics 74
6 Multi-scenario Forecast 75
6.1 Overview 75
6.2 Asia-Pacific Market 75
6.3 India 77
6.3.1 Treatment Usage Patterns 77
6.3.2 Annual Cost of Therapy 77
6.3.3 Market Size 79
6.4 China 80
6.4.1 Treatment Usage Patterns 80
6.4.2 Annual Cost of Therapy 81
6.4.3 Market Size 82
6.5 Australia 83
6.5.1 Treatment Usage Patterns 83
6.5.2 Annual Cost of Therapy 84
6.5.3 Market Size 84
6.6 South Korea 86
6.6.1 Treatment Usage Patterns 86
6.6.2 Annual Cost of Therapy 87
6.6.3 Market Size 88
6.7 Japan 89
6.7.1 Treatment Usage Patterns 89
6.7.2 Annual Cost of Therapy 89
6.7.3 Market Size 90
7 Drivers and Barriers 92
7.1 Drivers 92
7.1.1 Increasing Elderly Population and Incidence of CRC 92
7.1.2 Increasing Screening Programs and Approval of New Screening Tests for CRC to Drive Early Diagnosis Rate 92
7.1.3 Increase in Mutation Testing to Drive Market Growth 92
7.1.4 Availability of Novel First-, Second- and Third-Line Therapy Options in Pipeline 92
7.1.5 Diversified Healthcare Reform to Boost Market Growth 93
7.1.6 Diversified Health Insurance System to Help Nurture Growth 93
7.2 Barriers 94
7.2.1 Patent Expiration of Branded Therapies to Affect CRC Market Growth 94
7.2.2 High Prices of Therapeutics to Slow Down Market Growth 94
7.2.3 Limited Incorporation of Immunotherapies in the CRC Treatment Algorithm 94
7.2.4 Lack of Development of Neoadjuvant and Adjuvant Pipeline Products 94
7.2.5 Lack of Reimbursement and Penetration of Generic Drugs to Hinder Market Growth in China and India 95
7.2.6 Drug Pricing Reforms 95
8 Deals and Strategic Consolidations 96
8.1 Licensing Deals 96
8.1.1 Deals by Region and Value 96
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 97
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 98
8.1.4 Key Licensing Deals 100
8.2 Co-development Deals 103
8.2.1 Deals by Region and Value 103
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 104
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 105
8.2.4 Key Co-development Deals 107
9 Appendix 110
9.1 All Pipeline Drugs by Stage of Development 110
9.1.1 Discovery 110
9.1.2 Preclinical 111
9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 119
9.1.4 Phase I 120
9.1.5 Phase II 125
9.1.6 Phase III 130
9.1.7 Pre-registration 131
9.2 Summary of Multi-scenario Market Forecasts to 2024 131
9.2.1 Asia-Pacific 131
9.2.2 India 131
9.2.3 China 132
9.2.4 Australia 132
9.2.5 South Korea 133
9.2.6 Japan 133
9.3 Bibliography 134
9.4 Abbreviations 145
9.5 Research Methodology 148
9.5.1 Secondary Research 149
9.5.2 Marketed Product Profiles 149
9.5.3 Late-Stage Pipeline Candidates 149
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 149
9.5.5 Product Competitiveness Framework 149
9.5.6 Pipeline Analysis 150
9.5.7 Forecasting Model 150
9.5.8 Deals Data Analysis 151
9.6 Contact Us 152
9.7 Disclaimer 152