Generic Cancer Market - New Legislation and a Wave of Patent Expiries to Transform the Market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Oncology pharmaceutical analysis team - page 2
- Richard Faint - Director of Oncology - page 2
- About the Oncology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of analysis - page 3
- Datamonitor insight into the generic cancer market - page 4
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 15
- Market definition for this report - page 15
- Cytotoxics - page 16
- L1A - Alkylating agents - page 16
- L1B - Antimetabolites - page 16
- L1C - Vinca alkaloids and other plant-derived products - page 16
- L1D - Antineoplastic antibiotics - page 17
- L1X2 - Platinum compounds - page 17
- L1X9 - All other antineoplastics - page 17
- Antihormonal therapies - page 17
- L2A3 - Luteinizing hormone-releasing hormone analogs - page 17
- L2B1 - Anti-estrogens - page 18
- L2B2 - Anti-androgens - page 18
- L2B3 - Aromatase inhibitors - page 18
- L2B9 - Other hormone antagonists - page 19
- Immunostimulating agents - page 19
- L3A9 - Immunostimulating agents excluding interferons - page 19
- L3B1 - Interferons alfa - page 19
- Targeted therapies - page 20
- L1X3 - Antineoplastic monoclonal antibodies - page 20
- L1X9 - All other antineoplastics - page 20
- Supportive care products - page 21
- B3C - Erythropoietin products - page 21
- L3A1 - Colony-stimulating factors - page 21
- Miscellaneous - page 21
- L1X9 - All other antineoplastics - page 21
- Cytotoxics - page 16
- Generics drugs - page 22
- Generic small molecule drugs - page 22
- Biogeneric agents - page 23
- Drugs profiled - page 24
- Generic opportunities within the drug classes - page 24
- Current market situation - page 26
- Key companies - page 27
- Market definition for this report - page 15
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 29
- Current and future opportunities and threats in the generic cancer market - page 29
- Global opportunities and threats - page 29
- Opportunities - page 29
- Threats - page 36
- US: opportunities and threats - page 40
- Opportunities - page 40
- Threats - page 44
- Japan: opportunities and threats - page 47
- Opportunities - page 47
- Threats - page 48
- EU5: opportunities and threats - page 50
- Opportunities - page 50
- Threats - page 52
- France: opportunities and threats - page 54
- Opportunities - page 54
- Threats - page 55
- Germany: opportunities and threats - page 56
- Opportunities - page 56
- Threats - page 57
- Italy: opportunities and threats - page 57
- Opportunities - page 57
- Threats - page 59
- Spain: opportunities and threats - page 60
- Opportunities - page 60
- Threats - page 60
- UK: opportunities and threats - page 61
- Opportunities - page 61
- Threats - page 62
- Global opportunities and threats - page 29
- Summary of environmental issues affecting the antihormonal therapies market size - page 64
- Current and future opportunities and threats in the generic cancer market - page 29
- CHAPTER 4 FORECAST ANALYSIS - page 66
- Country-specific assumptions and effects - page 66
- Effect of Medicare Modernization Act in the US - page 66
- Biennial price cuts in Japan - page 66
- Generic erosion assumptions - page 66
- Product assumptions and effects - page 67
- Cytotoxics - page 67
- Long history and reliance on cytotoxics represent a billion-dollar generics market - page 67
- Further growth will be driven by patent expiries on several key products - page 68
- Schering-Plough's Temodar/Temodal (temozolomide) - page 68
- Eli Lilly's Gemzar (gemcitabine) - page 69
- Eli Lilly's Alimta (pemetrexed) - page 70
- Bristol-Myers Squibb's Taxol (paclitaxel) - page 71
- Sanofi-Aventis's Taxotere (docetaxel) - page 73
- Pfizer/Yakult/Daiichi's Camptosar (irinotecan) - page 75
- Bristol-Myers Squibb's Paraplatin (carboplatin) - page 76
- Sanofi-Aventis's Eloxatin (oxaliplatin) - page 77
- Antihormonal therapies - page 80
- Opportunities will arise in the form of reformulations and patent expiries on newer products - page 80
- Takeda/TAP/Abbott/Wyeth's Lupron (leuprolide) - page 81
- AstraZeneca's Nolvadex (tamoxifen) - page 83
- AstraZeneca's Arimidex (anastrozole) - page 84
- Novartis's Femara (letrozole) - page 86
- Pfizer's Aromasin (exemestane) - page 87
- Immunostimulating agents - page 88
- Due to use across a range of disease types, opportunities for generic cancer therapy manufacturers may be limited - page 88
- Chiron's Proleukin (aldesleukin) - page 89
- Targeted therapies - page 91
- Due to youth of market and lack of biogeneric legislation, opportunities for generic targeted therapies will not arise for years - page 91
- Novartis's Gleevec (imatinib) - page 92
- Millennium Pharmaceuticals/Ortho Biotech's Velcade (bortezomib) - page 94
- Biogen IDEC/Genentech/Roche's Rituxan (rituximab) - page 95
- Genentech/Roche's Avastin (bevacizumab) - page 96
- Supportive care products - page 99
- Genericization of blockbuster status supportive care products could be two years away - page 99
- Amgen's Epogen (epoetin alfa) - page 100
- Roche's Recormon (epoetin beta) - page 101
- Amgen's Neupogen (filgrastim) - page 101
- Cytotoxics - page 67
- Forecasts - page 102
- Country-specific assumptions and effects - page 66
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 103
- Introduction - page 103
- Case study 1 - page 103
- Taxotere's rise to superiority in the face of Taxol's losses - page 103
- Taxol had first-to-market status and blockbuster sales... - page 103
- ...while Taxotere lagged behind - page 104
- How did Taxotere become the superior product? - page 106
- Taxol has fallen out of favor in the Bristol-Myers Squibb pipeline - page 107
- A change in physician opinion following positive clinical trial data - page 107
- Taxotere's clinical superiority in metastatic breast cancer - page 107
- Taxol is being replaced by more efficacious therapies in all indications - page 108
- Taxotere's applicability for use keeps growing with time - page 109
- Lessons to learn from Sanofi-Aventis's strategy - page 109
- Taxotere's rise to superiority in the face of Taxol's losses - page 103
- Case study 2 - page 110
- Nolvadex's patent challenge resulted in benefits for both companies involved - page 110
- AstraZeneca's dominant position - page 110
- Barr Pharmaceuticals's history of patent challenges - page 111
- Nolvadex: gold-standard treatment for breast cancer - page 112
- Nolvadex's patent expiries in other countries represents the lucrative opportunity that arose for generics manufacturers - page 112
- Patent litigation resulted in the formation of a settlement between the two companies - page 113
- Further litigation left redundant by conclusion of the settlement agreement - page 114
- Issues for AstraZeneca - page 114
- Issues for Barr - page 115
- Future focus - page 116
- Nolvadex's patent challenge resulted in benefits for both companies involved - page 110
- Case study 3 - page 117
- Genericization of the supportive care class - page 117
- Enormous commercial potential but not without significant hurdles - page 117
- The erythropoetin market - page 118
- The colony-stimulating factors market - page 122
- Future potential - page 126
- Genericization of the supportive care class - page 117
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 128
- Cytotoxics market data - page 128
- Antihormonal therapies market data - page 132
- Immunostimulating agents market data - page 135
- Targeted therapies market data - page 136
- Supportive care products market data - page 138
- Sales data and forecasts - page 140
- PowerPoint Executive Presentation - page 140
- APPENDIX B - SALES FORECASTS - page 141
- US forecasts - page 141
- Japan forecasts - page 143
- France forecasts - page 144
- Germany forecasts - page 147
- Italy forecasts - page 150
- Spain forecasts - page 152
- UK forecasts - page 155
- EU5 forecasts - page 158
- Global forecasts - page 161
- APPENDIX C - page 164
- Bibliography - page 164
- List of tables - page 170
- List of figures - page 174
- Report methodology - page 175
- Forecast methodology - page 175
- Standard units - page 175
- Japanese market data - page 175
- Derivation of sales forecasts and pricing trends - page 175
- Generic erosion and pricing assumptions - page 176
- About Datamonitor - page 177
- About Datamonitor Healthcare - page 177
- About the Oncology analysis team - page 178
- Disclaimer - page 179
- List of Tables
- Table 1: Definition of the cancer market - page 15
- Table 2: Key anticancer therapies to be profiled - page 25
- Table 3: Generic cancer drug sales in the seven major markets, 2003-04 - page 26
- Table 4: Generic cancer drug sales in the seven major markets by drug class, 2003-04 - page 26
- Table 5: Key generic cancer therapy manufacturers, 2005 - page 28
- Table 6: Generic cancer sales as a proportion of all cancer therapy sales, 2004-14 - page 33
- Table 7: Order of generic vinorelbine launch and accompanying sales - page 34
- Table 8: Sales in year of patent expiry for key cytotoxic products - page 68
- Table 9: Phase III clinical trial results comparing Abraxane with standard paclitaxel - page 72
- Table 10: Market share of Taxotere - page 74
- Table 11: Market share of Eloxatin - page 78
- Table 12: Sales in year of patent expiry for key antihormonal therapies - page 81
- Table 13: 2004 sales for Lupron and its generic versions - page 82
- Table 14: Sales in year of patent expiry for Proleukin - page 89
- Table 15: Sales in year of patent expiry for key targeted therapies - page 92
- Table 16: Sales in 2007 for key supportive care products - page 99
- Table 17: FDA approvals for Taxol - page 104
- Table 18: FDA approvals for Taxotere - page 105
- Table 19: Historical global sales of Taxol and Taxotere - page 105
- Table 20: Results from a Phase III head-to-head trial comparing Taxol and Taxotere in metastatic breast cancer - page 108
- Table 21: AstraZeneca's marketed oncology portfolio, 2005 - page 111
- Table 22: Commercial potential in the supportive care class - page 117
- Table 23: Biogeneric erythropoietin products in development, 2005 - page 121
- Table 24: Biogeneric epoetin market forecasts ($m), 2007-14 - page 122
- Table 25: Biogeneric erythropoietin products in development, 2005 - page 125
- Table 26: Biogeneric colony-stimulating factors market forecasts ($m), 2007-14 - page 126
- Table 27: Temodar: key facts - page 128
- Table 28: Gemzar: key facts - page 129
- Table 29: Alimta: key facts - page 129
- Table 30: Taxotere: key facts - page 130
- Table 31: Campto: key facts - page 130
- Table 32: Taxol: key facts - page 131
- Table 33: Eloxatin: key facts - page 131
- Table 34: Paraplatin: key facts - page 132
- Table 35: Lupron: key facts - page 132
- Table 36: Nolvadex: key facts - page 133
- Table 37: Arimidex: key facts - page 133
- Table 38: Femara: key facts - page 134
- Table 39: Aromasin: key facts - page 134
- Table 40: Proleukin: key facts - page 135
- Table 41: Gleevec: key facts - page 136
- Table 42: Velcade: key facts - page 136
- Table 43: Rituxan: key facts - page 137
- Table 44: Avastin: key facts - page 137
- Table 45: Epogen: key facts - page 138
- Table 46: Recormon: key facts - page 139
- Table 47: Neupogen: key facts - page 140
- Table 48: Forecasts for generic cancer therapies in the US to 2014 (1 of 2) - page 141
- Table 49: Forecasts for generic cancer therapies in the US to 2014 (2 of 2) - page 142
- Table 50: Forecasts for generic cancer therapies in Japan to 2014 - page 143
- Table 51: Forecasts for generic cancer therapies in France to 2014 (1 of 3) - page 144
- Table 52: Forecasts for generic cancer therapies in France to 2014 (2 of 3) - page 145
- Table 53: Forecasts for generic cancer therapies in France to 2014 (3 of 3) - page 146
- Table 54: Forecasts for generic cancer therapies in Germany to 2014 (1 of 3) - page 147
- Table 55: Forecasts for generic cancer therapies in Germany to 2014 (2 of 3) - page 148
- Table 56: Forecasts for generic cancer therapies in Germany to 2014 (3 of 3) - page 149
- Table 57: Forecasts for generic cancer therapies in Italy to 2014 (1 of 2) - page 150
- Table 58: Forecasts for generic cancer therapies in Italy to 2014 (2 of 2) - page 151
- Table 59: Forecasts for generic cancer therapies in Spain to 2014 (1 of 3) - page 152
- Table 60: Forecasts for generic cancer therapies in Spain to 2014 (2 of 3) - page 153
- Table 61: Forecasts for generic cancer therapies in Spain to 2014 (3 of 3) - page 154
- Table 62: Forecasts for generic cancer therapies in the UK to 2014 (1 of 3) - page 155
- Table 63: Forecasts for generic cancer therapies in the UK to 2014 (2 of 3) - page 156
- Table 64: Forecasts for generic cancer therapies in the UK to 2014 (3 of 3) - page 157
- Table 65: Forecasts for generic cancer therapies in the EU5 to 2014 (1 of 3) - page 158
- Table 66: Forecasts for generic cancer therapies in the EU5 to 2014 (2 of 3) - page 159
- Table 67: Forecasts for generic cancer therapies in the EU5 to 2014 (3 of 3) - page 160
- Table 68: Global forecasts for generic cancer therapies to 2014 (1 of 3) - page 161
- Table 69: Global forecasts for generic cancer therapies to 2014 (2 of 3) - page 162
- Table 70: Global forecasts for generic cancer therapies to 2014 (3 of 3) - page 163
- List of Figures
- Figure 1: Seven market population aged 60 and over, 1950-2050 - page 29
- Figure 2: Increasing incidence of breast and prostate cancer with increasing age - page 30
- Figure 3: Seven major market oncology sales, 2004-14 - page 31
- Figure 4: Number of US oncology product approvals by year, 1970-2005 - page 32
- Figure 5: Forecast sales of oncology products at risk from generic erosion, 2005-14 - page 33
- Figure 6: Sales of generic cancer products in the seven markets, 2004 - page 41
- Figure 7: Global opportunities and threats affecting the generic cancer therapies market - page 64
- Figure 8: Summary of regional opportunities and threats affecting the generic cancer therapies market - page 65
- Figure 9: Historical global sales of Taxol and Taxotere - page 106
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