Colorectal Cancer - Shaping the future dynamics of colorectal cancer management
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Oncology pharmaceutical analysis team - page 2
- Nish Saini - Director of Oncology - page 2
- About the Oncology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the colorectal cancer market - page 4
- High incidence of colorectal cancer and unmet needs in diagnosis and treatment present a significant opportunity for pharmaceutical and biotechnology companies - page 4
- The emergence of third-generation cytotoxics has shifted the colorectal cancer treatment paradigms in recent years, significantly improving patient prognosis and resulting in high uptake of these drugs. However, Pfizer's Camptosar/Campto (irinotecan) and Sanofi-Aventis's Eloxatin (oxaliplatin) will face generic competition, especially in the EU, in the coming years, and sales are expected to decline during the forecast period - page 4
- Genentech/Roche's Avastin (bevacizumab) will continue to show strong sales growth, particularly in Europe where it has yet to become widely used. However, the launch of Amgen's Vectibix (panitumumab) will signficantly affect sales of BMS/Merck KGaA/ImClone's Erbitux (cetuximab) due to clinical and cost advantages of the former - page 5
- There are few drugs currently in Phase III development for colorectal cancer despite the high unmet needs in the disease. Datamonitor believes that Amgen's Vectibix (panitumumab), approved in September 2006 is likely to overtake Erbitux as the leading monoclonal antibody EGFR inhibitor for colorectal cancer and is predicted to achieve blockbuster status by 2015 - page 6
- Key metrics - page 8
- Incidence - page 8
- Sales forecasts to 2015 - page 8
- Datamonitor pipeline assessment summary - page 10
- CHAPTER 2 PATIENT POTENTIAL - page 21
- Overview - page 21
- Definition of colorectal cancer - page 21
- Epidemiology - page 22
- Incidence - page 22
- Comparison of incidence with other major tumor types - page 24
- Prevalence - page 26
- Incidence - page 22
- Unmet need in colorectal cancer - page 27
- Lack of identifiable risk factors - page 27
- Lack of effective diagnostic tests as screening tools - page 28
- Poor prognosis - page 29
- Disease recurrence - page 31
- Overview - page 21
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 32
- Current and future opportunities and threats in the cancer market - page 32
- Global opportunities and threats - page 32
- Opportunities - page 32
- Threats - page 36
- US: opportunities and threats - page 41
- Opportunities - page 41
- Threats - page 42
- Japan: opportunities and threats - page 43
- Opportunities - page 43
- Threats - page 44
- EU5: opportunities and threats - page 46
- Opportunities - page 46
- Threats - page 49
- France: opportunities and threats - page 51
- Opportunities - page 51
- Threats - page 51
- Germany: opportunities and threats - page 53
- Opportunities - page 53
- Threats - page 53
- Italy: opportunities and threats - page 55
- Opportunities - page 55
- Threats - page 56
- Spain: opportunities and threats - page 58
- Opportunities - page 58
- Threats - page 58
- UK: opportunities and threats - page 59
- Opportunities - page 59
- Threats - page 60
- Global opportunities and threats - page 32
- Summary of environmental issues affecting the cancer market size - page 62
- Current and future opportunities and threats in the cancer market - page 32
- CHAPTER 4 R&D APPROACH - page 63
- Classification of pipeline and marketed products for colorectal cancer - page 63
- Cytotoxics - page 63
- L1A - Alkylating agents - page 63
- L1B - Antimetabolites - page 64
- L1C - Vinca alkaloids and other plant-derived products - page 64
- L1D - Antineoplastic antibiotics - page 64
- L1X2 - Platinum compounds - page 65
- Targeted therapies - page 65
- L1X3 - Antineoplastic monoclonal antibodies - page 65
- L1X9 - All other antineoplastics - page 65
- Cytotoxics - page 63
- Classification of pipeline and marketed products for colorectal cancer - page 63
- CHAPTER 5 MARKETED DRUG ANALYSIS & FORECASTS - page 67
- Marketed drugs - page 67
- Roche/Chugai's Xeloda (capecitabine) - page 68
- Leading agent in the third-line market - page 68
- Growth from the adjuvant market - page 69
- Avastin as a suitable partner? - page 70
- Pfizer/Yakult/Daiichi's Camptosar/Campto/Topotecin (irinotecan) - page 73
- Irinotecan's stigma of toxicity - page 73
- Camptosar losing grounds to competitors - page 74
- EU physicians use irinotecan due to Avastin's labeling - page 77
- Irinotecan limited to second-line use - page 77
- Patent expiry - page 77
- Sanofi-Aventis's Eloxatin (oxaliplatin) - page 78
- Gold standard for colorectal cancer - page 79
- Neuropathy remains the main barrier - page 80
- Generic oxaliplatin entering the EU markets - page 81
- US patent remains protected until 2013 - page 82
- Elplat surpassing Campto in Japan - page 82
- Genentech/Roche/Chugai's Avastin (bevacizumab) - page 82
- Avastin is the gold standard in the US - page 83
- Limitations in Europe - page 83
- Market expansion potential - page 84
- Is toxicity a major limiting factor? - page 87
- Cost implications of Avastin plus Erbitux - page 88
- Bristol-Myers Squibb/Merck KGaA/ImClone's Erbitux (cetuximab) - page 89
- Standard therapy in third line - page 89
- Futility of EGFR tests - page 90
- Line extensions in colorectal cancer - page 91
- Cost hampering the uptake - page 93
- Competition from Vectibix - page 93
- Forecasting assumptions and events - page 95
- Sales forecasts to 2015 - page 97
- Roche/Chugai's Xeloda (capecitabine) - page 68
- Marketed drugs - page 67
- CHAPTER 6 PIPELINE ANALYSIS - page 99
- Pipeline overview - page 99
- Pre-registration/Phase III pipeline drugs - page 101
- Phase II pipeline drugs - page 101
- Phase I/II pipeline drugs - page 103
- Pipeline drugs by class - page 104
- Key companies - page 106
- Key companies involved in current products for colorectal cancer - page 106
- Sanofi-Aventis's over-reliance on colorectal cancer - page 107
- Low reliance on colorectal cancer for Roche - page 107
- Genentech's sales are almost exclusively from the cancer franchise - page 107
- Key companies involved in current products for colorectal cancer - page 106
- Pipeline overview - page 99
- CHAPTER 7 LATE-STAGE PIPELINE DRUG ANALYSIS & FORECASTS - page 110
- Pipeline - page 110
- Amgen's Vectibix (panitumumab) - page 110
- Clinical trial data - page 111
- Factors driving sales of Vectibix - page 116
- ADVENTRX Pharmaceuticals' CoFactor (ANX-510) - page 116
- Phase II trials - page 117
- Ongoing trials - page 117
- Merck Eprova and ADVENTRX - page 118
- The rise of Xeloda will make CoFactor redundant - page 118
- Need to corner the adjuvant market - page 119
- Pro-Pharmaceuticals' Davanat - page 119
- Ongoing trials - page 120
- Dearth of data - page 121
- Novartis/Schering AG's vatalanib (PTK-787) - page 121
- Anticipated regulatory filing for vatalanib in colorectal cancer is becoming increasingly unlikely following disappointing CONFIRM-1 and CONFIRM-2 interim results - page 121
- Vatalanib unlikely to compete with Avastin - page 122
- Two possible strategies to salvage vatalanib - page 122
- Go or no-go? - page 123
- Forecasting assumptions - page 124
- Sales forecasts to 2015 - page 124
- Datamonitor drug assessment summary - page 126
- Amgen's Vectibix (panitumumab) - page 110
- Pipeline - page 110
- CHAPTER 8 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES - page 128
- Case study 1 - page 128
- Lifecycle management of Eloxatin - page 128
- Eloxatin events - page 128
- FOLFOX as standard therapy - page 129
- Consolidation of Eloxatin with aqueous formulation - page 132
- Minimizing neuropathy - page 133
- Genericization of oxaliplatin in the EU - page 134
- Lifecycle management of Eloxatin - page 128
- Case study 2 - page 134
- Cost-scenario-based forecasts for Vectibix - page 134
- Higher cost will lead to lower uptake - page 134
- Sales forecasts for Vectibix in different cost scenarios - page 135
- Cost-scenario-based forecasts for Vectibix - page 134
- Case study 1 - page 128
- CHAPTER 9 APPENDIX A - page 139
- Market forecasts - page 139
- US forecasts - page 139
- Japan forecasts - page 139
- France forecasts - page 140
- Germany forecasts - page 140
- Italy forecasts - page 141
- Spain forecasts - page 141
- UK forecasts - page 142
- Five EU market forecasts - page 142
- Seven major market forecasts - page 143
- Market data - page 143
- Market forecasts - page 139
- CHAPTER 10 APPENDIX B - page 146
- Contributing experts - page 146
- Reference - page 146
- Report methodology - page 150
- Epidemiology forecasts - page 150
- Product forecast methodology - page 150
- Estimating peak sales - page 150
- Treatable population size - page 150
- Market penetration rate - page 151
- Drug costs - page 152
- Treatment duration - page 152
- Eventing - page 152
- Plotting the sales curve - page 153
- Estimating peak sales - page 150
- Datamonitor drug assessment summary - page 156
- LIST OF TABLES - page 159
- LIST OF FIGURES - page 163
- About Datamonitor - page 165
- About Datamonitor Healthcare - page 165
- About the Oncology analysis team - page 166
- Disclaimer - page 167
- List of Tables
- Table 1: Incidence forecasts of colorectal cancer in the seven major pharmaceutical markets, 2002-2016 - page 8
- Table 2: Sales forecasts for marketed and pipeline drugs in the seven major markets between 2006 and 2015 - page 9
- Table 3: Summary of commercial and research/clinical attractiveness of late-phase drugs for colorectal cancer, 2006 - page 10
- Table 4: Crude incidence rates of colorectal cancer by gender (per 100,000 population) in the seven major pharmaceutical markets, 2002 - page 22
- Table 5: Incidence of colorectal cancer in the seven major pharmaceutical markets, 2002-2016 - page 23
- Table 6: Comparative incidence of major tumor types, 2002 - page 24
- Table 7: One-, three- and five-year prevalence of colorectal cancer in the seven major markets - page 26
- Table 8: Incidence of colorectal cancer by risk category - page 28
- Table 9: Summary of characteristics of screening tests - page 29
- Table 10: Definition of the cancer market, based on the Anatomical Therapeutic Chemical Classification System, 2006 - page 63
- Table 11: Marketed drugs for colorectal cancer - page 68
- Table 12: Global sales growth of Xeloda between 2002 and 2005 - page 69
- Table 13: Quarter-by-quarter sales and sales growth of Avastin in the US - page 84
- Table 14: Ongoing Phase III trials for Erbitux - page 92
- Table 15: Cost of major drug regimens for colorectal cancer - page 93
- Table 16: Unevented forecasting assumptions for marketed drugs for colorectal cancer in the seven major markets - page 95
- Table 17: Events used in sales forecast estimation of marketed drugs for colorectal cancer in the seven major markets - page 96
- Table 18: Evented sales forecasts for marketed drugs in the seven major markets between 2006 and 2015 - page 97
- Table 19: Number of marketed and pipeline colorectal cancer drugs - page 99
- Table 20: Phase III pipeline drugs for colorectal cancer - page 101
- Table 21: Phase II pipeline drugs for colorectal cancer - page 102
- Table 22: Phase I and Phase I/II pipeline drugs for colorectal cancer - page 103
- Table 23: Number of pipeline drugs for colorectal cancer by class and phase - page 104
- Table 24: Reliance of key companies on the oncology franchise and colorectal cancer, 2005 - page 106
- Table 25: Phase III pipeline drugs for colorectal cancer - page 110
- Table 26: Ongoing clinical trials of Vectibix for colorectal cancer - page 111
- Table 27: Ongoing clinical trials involving CoFactor in metastatic colorectal cancer, 2006 - page 117
- Table 28: Ongoing clinical trials involving Davanat in metastatic colorectal cancer, 2006 - page 120
- Table 29: Unevented forecasting assumptions for pipeline drugs for colorectal cancer in the seven major markets - page 124
- Table 30: Sales forecasts for pipeline drugs in the seven major markets between 2006 and 2015 - page 124
- Table 31: Summary of commercial and research/clinical attractiveness of late-phase drugs for colorectal cancer, 2006 - page 126
- Table 32: Sales of Eloxatin and Camptosar/Campto by quarter - page 131
- Table 33: Forecasting assumptions for Vectibix for colorectal cancer in the seven major markets - page 135
- Table 34: Scenario-based sales forecasts for Vectibix in the seven major markets between 2006 and 2015 - page 137
- Table 35: US forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 139
- Table 36: Japan forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 139
- Table 37: France forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 140
- Table 38: Germany forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 140
- Table 39: Italy forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 141
- Table 40: Spain forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 141
- Table 41: UK forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 142
- Table 42: Five EU market forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 142
- Table 43: Seven major market forecasts for marketed and pipeline drugs in colorectal cancer to 2015 - page 143
- Table 44: Xeloda: key facts - page 143
- Table 45: Camptosar: key facts - page 144
- Table 46: Eloxatin: key facts - page 144
- Table 47: Avastin: key facts - page 145
- Table 48: Erbitux: key facts - page 145
- Table 49: Specific events used in Commercial/Pipeline Insight: Colorectal Cancer for sales forecast estimation of marketed drugs - page 153
- Table 50: Sales of marketed drugs for colorectal cancer in 2005 - page 155
- Table 51: Datamonitor drug assessment parameters - page 156
- List of Figures
- Figure 1: Sales forecasts for marketed and pipeline drugs in the seven major markets between 2006 and 2015 - page 9
- Figure 2: Drug assessment summary for pipeline colorectal cancer drugs, 2006 - page 11
- Figure 3: Incidence of colorectal cancer in the seven major pharmaceutical markets in 2006 and 2016 - page 23
- Figure 4: Comparative incidence of major tumor types, 2002 - page 25
- Figure 5: One-, three- and five-year cumulative prevalence of colorectal cancer in the seven major markets - page 27
- Figure 6: Five-year survival rates for the four major tumors between 1975 and 1988 in the US - page 30
- Figure 7: Seven market population aged 60 and over, 2000-50 - page 32
- Figure 8: Increasing incidence of colorectal cancer with age - page 33
- Figure 9: Summary of global opportunities and threats affecting the cancer market, 2006 - page 62
- Figure 10: Improving survival with newer drug regimens in colorectal cancer - page 67
- Figure 11: Global sales growth of Xeloda between 2002 and 2005 - page 70
- Figure 12: Percentage of first-line patients treated with oxaliplatin- and irinotecan-based regimens in the seven major markets - page 75
- Figure 13: Global sales of Eloxatin and Campto/Camptosar by quarter - page 76
- Figure 14: Proportion of Eloxatin sales in 2005 by market - page 79
- Figure 15: Quarter-by-quarter sales and sales growth of Avastin in the US - page 85
- Figure 16: Sales of Avastin by quarter in the US and Europe/RoW - page 86
- Figure 17: Sales forecasts for marketed drugs in the seven major markets between 2006 and 2015 - page 97
- Figure 18: Number of marketed and pipeline colorectal cancer drugs - page 100
- Figure 19: Number of pipeline drugs for colorectal cancer by class and phase - page 105
- Figure 20: Reliance of key companies on the oncology franchise in 2005 - page 108
- Figure 21: Reliance of key companies on the oncology franchise in 2005 - page 109
- Figure 22: Sales forecasts for pipeline drugs in the seven major markets between 2006 and 2015 - page 125
- Figure 23: Drug assessment summary for pipeline colorectal cancer drugs, 2006 - page 127
- Figure 24: Event timeline for Eloxatin - page 128
- Figure 25: Percentage of first-line patients treated with Eloxatin- and Camptosar-based regimens in the seven major markets - page 130
- Figure 26: Sales of Eloxatin and Camptosar/Campto by quarter - page 132
- Figure 27: Sales of aqueous and lyophilized formulations of Eloxatin in the US in 2005 - page 133
- Figure 28: Scenario-based sales forecasts for Vectibix in the seven major markets between 2006 and 2015 - page 137
- Figure 29: Example of Datamonitor drug assessment scorecard - page 157
- Figure 30: Example of Datamonitor drug assessment graph - page 158
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