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SUMMARY
Overview
Introduction
Until a decade ago, 5FU/leucovorin formed the mainstay of colorectal cancer
treatment but Camptosar and Eloxatin quickly established themselves as
components of gold-standard therapy. The advent of Avastin and Erbitux
heralded a new era in the disease management, and the emergence of other
molecular targeted agents should further push survival to an unprecedented
level in the coming years.
Scope
- Overview of colorectal cancer including epidemiology forecasts and unmet
needs in the disease
- Clinical and commercial evaluation of key marketed and late-phase pipeline
drugs for colorectal cancer
- Sales forecasts for existing and Phase III developmental drugs for
colorectal cancer to 2015 in the seven major markets
- Key events and factors influencing the sales forecasts for colorectal
cancer drugs to 2015 at country level
Highlights
Despite remaining the mainstay of colorectal cancer treatment, sales of
cytotoxics are expected to be overtaken by those of molecular targeted
therapies by 2008, caused by the genericization of Camptosar/Campto and
Eloxatin, and the growth of Avastin and Vectibix.
In spite of strong growth to date, sales of Eloxatin are expected to slow down
significantly in the coming years as generic oxaliplatin begins to enter the
EU markets. However, continuing growth in the US market means that overall
sales of the drug will not decline in the seven major markets until 2013 when
the US patent expires.
There are few drugs currently in Phase III development for colorectal cancer
despite the high unmet needs in the disease. Amgen's Vectibix, approved in
September 2006 remains the most promising and is likely to overtake Erbitux as
the leading monoclonal antibody EGFR inhibitor for colorectal cancer.
Reasons to Purchase
- Understand patient segmentation relevant to marketed and pipeline
colorectal cancer drugs
- Assess current and future competitive dynamics of colorectal cancer to
determine the future size and scope of the market
- Identify licensing and lifecycle management opportunities in the
colorectal cancer market based on company portfolio and market needs
TABLE OF CONTENTS
- ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- Nish Saini - Director of Oncology
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the colorectal cancer market
- High incidence of colorectal cancer and unmet needs in diagnosis and
treatment present a significant opportunity for pharmaceutical and
biotechnology companies
- 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
- 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
- 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
- Key metrics
- Incidence
- Sales forecasts to 2015
- Datamonitor pipeline assessment summary
- CHAPTER 2 PATIENT POTENTIAL
- Overview
- Definition of colorectal cancer
- Epidemiology
- Incidence
- Comparison of incidence with other major tumor types
- Prevalence
- Unmet need in colorectal cancer
- Lack of identifiable risk factors
- Lack of effective diagnostic tests as screening tools
- Poor prognosis
- Disease recurrence
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Current and future opportunities and threats in the cancer market
- Global opportunities and threats
- US: opportunities and threats
- Japan: opportunities and threats
- EU5: opportunities and threats
- France: opportunities and threats
- Germany: opportunities and threats
- Italy: opportunities and threats
- Spain: opportunities and threats
- UK: opportunities and threats
- Summary of environmental issues affecting the cancer market size
- CHAPTER 4 R&D APPROACH
- Classification of pipeline and marketed products for colorectal cancer
- Cytotoxics
- L1A - Alkylating agents
- L1B - Antimetabolites
- L1C - Vinca alkaloids and other plant-derived products
- L1D - Antineoplastic antibiotics
- L1X2 - Platinum compounds
- Targeted therapies
- L1X3 - Antineoplastic monoclonal antibodies
- L1X9 - All other antineoplastics
- CHAPTER 5 MARKETED DRUG ANALYSIS & FORECASTS
- Marketed drugs
- Roche/Chugai's Xeloda (capecitabine)
- Leading agent in the third-line market
- Growth from the adjuvant market
- Avastin as a suitable partner?
- Pfizer/Yakult/Daiichi's Camptosar/Campto/Topotecin (irinotecan)
- Irinotecan's stigma of toxicity
- Camptosar losing grounds to competitors
- EU physicians use irinotecan due to Avastin's labeling
- Irinotecan limited to second-line use
- Patent expiry
- Sanofi-Aventis's Eloxatin (oxaliplatin)
- Gold standard for colorectal cancer
- Neuropathy remains the main barrier
- Generic oxaliplatin entering the EU markets
- US patent remains protected until 2013
- Elplat surpassing Campto in Japan
- Genentech/Roche/Chugai's Avastin (bevacizumab)
- Avastin is the gold standard in the US
- Limitations in Europe
- Market expansion potential
- Is toxicity a major limiting factor?
- Cost implications of Avastin plus Erbitux
- Bristol-Myers Squibb/Merck KGaA/ImClone's Erbitux (cetuximab)
- Standard therapy in third line
- Futility of EGFR tests
- Line extensions in colorectal cancer
- Cost hampering the uptake
- Competition from Vectibix
- Forecasting assumptions and events
- Sales forecasts to 2015
- CHAPTER 6 PIPELINE ANALYSIS
- Pipeline overview
- Pre-registration/Phase III pipeline drugs
- Phase II pipeline drugs
- Phase I/II pipeline drugs
- Pipeline drugs by class
- Key companies
- Key companies involved in current products for colorectal cancer
- Sanofi-Aventis's over-reliance on colorectal cancer
- Low reliance on colorectal cancer for Roche
- Genentech's sales are almost exclusively from the cancer franchise
- CHAPTER 7 LATE-STAGE PIPELINE DRUG ANALYSIS & FORECASTS
- Pipeline
- Amgen's Vectibix (panitumumab)
- ADVENTRX Pharmaceuticals' CoFactor (ANX-510)
- Phase II trials
- Ongoing trials
- Merck Eprova and ADVENTRX
- The rise of Xeloda will make CoFactor redundant
- Need to corner the adjuvant market
- Pro-Pharmaceuticals' Davanat
- Ongoing trials
- Dearth of data
- Novartis/Schering AG's vatalanib (PTK-787)
- Anticipated regulatory filing for vatalanib in colorectal cancer is
becoming increasingly unlikely following disappointing CONFIRM-1 and
CONFIRM-2 interim results
- Vatalanib unlikely to compete with Avastin
- Two possible strategies to salvage vatalanib
- Go or no-go?
- Forecasting assumptions
- Sales forecasts to 2015
- Datamonitor drug assessment summary
- CHAPTER 8 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES
- Case study 1
- Lifecycle management of Eloxatin
- Eloxatin events
- FOLFOX as standard therapy
- Consolidation of Eloxatin with aqueous formulation
- Minimizing neuropathy
- Genericization of oxaliplatin in the EU
- Case study 2
- Cost-scenario-based forecasts for Vectibix
- Higher cost will lead to lower uptake
- Sales forecasts for Vectibix in different cost scenarios
- CHAPTER 9 APPENDIX A
- Market forecasts
- US forecasts
- Japan forecasts
- France forecasts
- Germany forecasts
- Italy forecasts
- Spain forecasts
- UK forecasts
- Five EU market forecasts
- Seven major market forecasts
- Market data
- CHAPTER 10 APPENDIX B
- Contributing experts
- Reference
- Report methodology
- Epidemiology forecasts
- Product forecast methodology
- Estimating peak sales
- Treatable population size
- Market penetration rate
- Drug costs
- Treatment duration
- Eventing
- Plotting the sales curve
- Datamonitor drug assessment summary
- LIST OF TABLES
- LIST OF FIGURES
- About Datamonitor
- About Datamonitor Healthcare
- About the Oncology analysis team
- Disclaimer
- List of Tables
- Table 1: Incidence forecasts of colorectal cancer in the seven major
pharmaceutical markets, 2002-2016
- Table 2: Sales forecasts for marketed and pipeline drugs in the seven
major markets between 2006 and 2015
- Table 3: Summary of commercial and research/clinical attractiveness of
late-phase drugs for colorectal cancer, 2006
- Table 4: Crude incidence rates of colorectal cancer by gender (per
100,000 population) in the seven major pharmaceutical markets, 2002
- Table 5: Incidence of colorectal cancer in the seven major
pharmaceutical markets, 2002-2016
- Table 6: Comparative incidence of major tumor types, 2002
- Table 7: One-, three- and five-year prevalence of colorectal cancer in
the seven major markets
- Table 8: Incidence of colorectal cancer by risk category
- Table 9: Summary of characteristics of screening tests
- Table 10: Definition of the cancer market, based on the Anatomical
Therapeutic Chemical Classification System, 2006
- Table 11: Marketed drugs for colorectal cancer
- Table 12: Global sales growth of Xeloda between 2002 and 2005
- Table 13: Quarter-by-quarter sales and sales growth of Avastin in the
US
- Table 14: Ongoing Phase III trials for Erbitux
- Table 15: Cost of major drug regimens for colorectal cancer
- Table 16: Unevented forecasting assumptions for marketed drugs for
colorectal cancer in the seven major markets
- Table 17: Events used in sales forecast estimation of marketed drugs
for colorectal cancer in the seven major markets
- Table 18: Evented sales forecasts for marketed drugs in the seven
major markets between 2006 and 2015
- Table 19: Number of marketed and pipeline colorectal cancer drugs
- Table 20: Phase III pipeline drugs for colorectal cancer
- Table 21: Phase II pipeline drugs for colorectal cancer
- Table 22: Phase I and Phase I/II pipeline drugs for colorectal cancer
- Table 23: Number of pipeline drugs for colorectal cancer by class and
phase
- Table 24: Reliance of key companies on the oncology franchise and
colorectal cancer, 2005
- Table 25: Phase III pipeline drugs for colorectal cancer
- Table 26: Ongoing clinical trials of Vectibix for colorectal cancer
- Table 27: Ongoing clinical trials involving CoFactor in metastatic
colorectal cancer, 2006
- Table 28: Ongoing clinical trials involving Davanat in metastatic
colorectal cancer, 2006
- Table 29: Unevented forecasting assumptions for pipeline drugs for
colorectal cancer in the seven major markets
- Table 30: Sales forecasts for pipeline drugs in the seven major
markets between 2006 and 2015
- Table 31: Summary of commercial and research/clinical attractiveness
of late-phase drugs for colorectal cancer, 2006
- Table 32: Sales of Eloxatin and Camptosar/Campto by quarter
- Table 33: Forecasting assumptions for Vectibix for colorectal cancer
in the seven major markets
- Table 34: Scenario-based sales forecasts for Vectibix in the seven
major markets between 2006 and 2015
- Table 35: US forecasts for marketed and pipeline drugs in colorectal
cancer to 2015
- Table 36: Japan forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 37: France forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 38: Germany forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 39: Italy forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 40: Spain forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 41: UK forecasts for marketed and pipeline drugs in colorectal
cancer to 2015
- Table 42: Five EU market forecasts for marketed and pipeline drugs in
colorectal cancer to 2015
- Table 43: Seven major market forecasts for marketed and pipeline drugs
in colorectal cancer to 2015
- Table 44: Xeloda: key facts
- Table 45: Camptosar: key facts
- Table 46: Eloxatin: key facts
- Table 47: Avastin: key facts
- Table 48: Erbitux: key facts
- Table 49: Specific events used in Commercial/Pipeline Insight:
Colorectal Cancer for sales forecast estimation of marketed drugs
- Table 50: Sales of marketed drugs for colorectal cancer in 2005
- Table 51: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Sales forecasts for marketed and pipeline drugs in the seven
major markets between 2006 and 2015
- Figure 2: Drug assessment summary for pipeline colorectal cancer
drugs, 2006
- Figure 3: Incidence of colorectal cancer in the seven major
pharmaceutical markets in 2006 and 2016
- Figure 4: Comparative incidence of major tumor types, 2002
- Figure 5: One-, three- and five-year cumulative prevalence of
colorectal cancer in the seven major markets
- Figure 6: Five-year survival rates for the four major tumors between
1975 and 1988 in the US
- Figure 7: Seven market population aged 60 and over, 2000-50
- Figure 8: Increasing incidence of colorectal cancer with age
- Figure 9: Summary of global opportunities and threats affecting the
cancer market, 2006
- Figure 10: Improving survival with newer drug regimens in colorectal
cancer
- Figure 11: Global sales growth of Xeloda between 2002 and 2005
- Figure 12: Percentage of first-line patients treated with oxaliplatin-
and irinotecan-based regimens in the seven major markets
- Figure 13: Global sales of Eloxatin and Campto/Camptosar by quarter
- Figure 14: Proportion of Eloxatin sales in 2005 by market
- Figure 15: Quarter-by-quarter sales and sales growth of Avastin in the
US
- Figure 16: Sales of Avastin by quarter in the US and Europe/RoW
- Figure 17: Sales forecasts for marketed drugs in the seven major
markets between 2006 and 2015
- Figure 18: Number of marketed and pipeline colorectal cancer drugs
- Figure 19: Number of pipeline drugs for colorectal cancer by class and
phase
- Figure 20: Reliance of key companies on the oncology franchise in 2005
- Figure 21: Reliance of key companies on the oncology franchise in 2005
- Figure 22: Sales forecasts for pipeline drugs in the seven major
markets between 2006 and 2015
- Figure 23: Drug assessment summary for pipeline colorectal cancer
drugs, 2006
- Figure 24: Event timeline for Eloxatin
- Figure 25: Percentage of first-line patients treated with Eloxatin-
and Camptosar-based regimens in the seven major markets
- Figure 26: Sales of Eloxatin and Camptosar/Campto by quarter
- Figure 27: Sales of aqueous and lyophilized formulations of Eloxatin
in the US in 2005
- Figure 28: Scenario-based sales forecasts for Vectibix in the seven
major markets between 2006 and 2015
- Figure 29: Example of Datamonitor drug assessment scorecard
- Figure 30: Example of Datamonitor drug assessment graph
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