Herpes and Respiratory Antivirals
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the herpes and respiratory antivirals market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 11
- Market definition for this report - page 11
- Pathogens and disease indications - page 13
- Herpesviruses - page 13
- Herpes simplex virus (HSV) - page 14
- Varicella zoster virus (VZV) - page 18
- Cytomegalovirus (CMV) - page 20
- Respiratory viruses - page 23
- Influenza (flu) - page 23
- Respiratory syncytial virus (RSV) - page 25
- Unmet needs in the herpes and respiratory antiviral market - page 28
- Herpesviruses - page 13
- Current market situation - page 29
- Higher pricing fuels double-digit growth - page 31
- Herpes products dominate - page 35
- Brands account for the majority of sales - page 37
- Herpes drug Valtrex propels GSK to market leader - page 38
- Activity in the herpes and respiratory antiviral pipeline is low - page 40
- Indication expansion favored over new drug development - page 41
- Novartis and Medivir take the lead in the herpes and RSV antiviral pipelines - page 42
- Influenza and RSV are the main vaccine pipeline drivers - page 43
- Future market outlook - page 44
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 46
- Current and future opportunities and threats in the herpes and respiratory antiviral market - page 46
- Global opportunities and threats - page 46
- Opportunities - page 46
- Threats - page 53
- US: opportunities and threats - page 58
- Herpes and respiratory antiviral market overview - page 58
- Opportunities - page 61
- Threats - page 64
- Japan: opportunities and threats - page 64
- Herpes and respiratory antiviral market overview - page 64
- Opportunities - page 67
- Threats - page 68
- France: opportunities and threats - page 70
- Herpes and respiratory antiviral market overview - page 70
- Opportunities - page 73
- Threats - page 75
- Germany: opportunities and threats - page 77
- Herpes and respiratory antiviral market overview - page 77
- Opportunities - page 80
- Threats - page 82
- Italy: opportunities and threats - page 85
- Herpes and respiratory antiviral market overview - page 85
- Opportunities - page 88
- Threats - page 89
- Spain: opportunities and threats - page 91
- Herpes and respiratory antiviral market overview - page 91
- Opportunities - page 94
- Threats - page 96
- UK: opportunities and threats - page 98
- Herpes and respiratory antiviral market overview - page 98
- Opportunities - page 100
- Threats - page 101
- Global opportunities and threats - page 46
- Summary of environmental issues affecting the herpes and respiratory antiviral market size - page 105
- Current and future opportunities and threats in the herpes and respiratory antiviral market - page 46
- CHAPTER 4 FORECAST ANALYSIS - page 106
- Assumptions and events - page 106
- Events excluded from the forecast - page 106
- Product-specific events - page 107
- Valtrex (valacyclovir) - page 109
- Zovirax (acyclovir) - page 110
- Valcyte (valganciclovir) - page 110
- Tamiflu (oseltamivir) - page 111
- Relenza (zanamivir) - page 113
- Patent expiries - page 114
- General assumptions for the assessment of generic incursion following patent expiry - page 115
- Overview of patent expiries expected to occur in the forecast period - page 116
- Cytovene - effective switching to Valcyte discourages generic manufacturers from market entry - page 116
- Valtrex is expected to suffer the same fate as predecessor Zovirax - page 117
- Famvir - attractive target in the US - page 119
- Vistide - limited use and toxicity likely to deter generic competition - page 119
- Relenza - poor historic and anticipated future performance in the influenza prescription market is unlikely to attract generic incursion - page 120
- Valcyte - page 120
- New drug launches - page 120
- Valomaciclovir - efficacy in treating PHN provides competitive edge - page 121
- A60444 - first-in-class RSV antiviral with blockbuster potential - page 123
- CS8958 (R118958) - too similar to Relenza to be successful? - page 126
- Limitations of data - page 126
- Standard units - page 126
- Japanese market data - page 127
- Regional launch dates for new products - page 127
- Forecasts - page 127
- Assumptions and events - page 106
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 128
- Introduction - page 128
- Portfolio management of the top herpes and respiratory antiviral players - page 128
- Modest market with few significant players and little new product development - page 128
- GSK is both ID and herpes market leader - page 132
- Roche - strong present and future position in CMV and influenza - page 142
- Novartis - pioneer of the RSV antiviral market? - page 153
- Achieving and maintaining market leadership - page 162
- Valtrex - leading in herpes simplex and herpes zoster - page 162
- Cytovene and Valcyte - gold standards in the CMV transplant market - page 173
- Portfolio management of the top herpes and respiratory antiviral players - page 128
- Introduction - page 128
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 183
- Definition of the Pacific Rim - page 183
- Market forecast data - page 184
- Global herpes and respiratory antiviral market forecasts, 2005-2014 - page 184
- M5EU herpes and respiratory antiviral market forecasts, 2005-2014 - page 185
- US herpes and respiratory antiviral market forecasts, 2005-2014 - page 186
- Pacific Rim herpes and respiratory antiviral market forecasts, 2005-2014 - page 187
- France herpes and respiratory antiviral market forecasts, 2005-2014 - page 188
- Germany herpes and respiratory antiviral market forecasts, 2005-2014 - page 189
- Italy herpes and respiratory antiviral market forecasts, 2005-2014 - page 190
- Spain herpes and respiratory antiviral market forecasts, 2005-2014 - page 191
- UK herpes and respiratory antiviral market forecasts, 2005-2014 - page 192
- Global herpes and respiratory antiviral market data - page 193
- HSV and VZV antivirals market data - page 194
- CMV antivirals market data - page 199
- Influenza antivirals market data - page 203
- RSV antivirals market data - page 207
- APPENDIX B - page 208
- Bibliography - page 208
- Journals - page 208
- Clinical guidelines - page 209
- Datamonitor reports - page 209
- Clinical trial data - page 210
- Miscellaneous - page 210
- Press releases - page 212
- Websites - page 216
- Report methodology - page 217
- Disclaimer - page 218
- Bibliography - page 208
- List of Tables
- Table 1: Herpes and respiratory antivirals analyzed and forecasted within this report - page 12
- Table 2: Infectious agents and indications covered in this report - page 13
- Table 3: The human herpesviruses (HHV) fall into three sub-families - page 13
- Table 4: Prevalence of HSV-2 in the seven major markets - page 17
- Table 5: Marketed HSV antivirals - page 18
- Table 6: Marketed VZV antivirals - page 20
- Table 7: Marketed CMV antivirals - page 22
- Table 8: Populations targeted for influenza vaccination, 2003, US - page 24
- Table 9: Marketed influenza antivirals - page 25
- Table 10: Marketed RSV antiviral - page 27
- Table 11: Price per standard unit for seven herpes and respiratory antivirals, seven major markets, 2000-04 - page 32
- Table 12: Valtrex is the first herpes and respiratory antiviral among the top four to lose patent protection in the seven major markets - page 37
- Table 13: Key players in the herpes and respiratory antiviral market, 2004 - page 40
- Table 14: There is currently a limited number of antivirals in clinical development - page 43
- Table 15: Activity in the antiviral vaccines pipeline is high - page 55
- Table 16: Herpes and respiratory antiviral sales in the US by disease indication, 2000-04 - page 59
- Table 17: Herpes and respiratory antiviral sales in the Pacific Rim by disease indication, 2000-04 - page 65
- Table 18: Herpes and respiratory antiviral sales in France by disease indication, 2000-04 - page 71
- Table 19: Key French herpes and respiratory antiviral product patent expiry dates - page 76
- Table 20: Herpes and respiratory antiviral sales in Germany by disease indication, 2000-04 - page 77
- Table 21: Value in the German herpes and respiratory antiviral market has been driven by price increase - page 78
- Table 22: Seroprevalence of HSV-1 and HSV-2 in the old (1984 and 1998) and new (1998) German federal states - page 83
- Table 23: Herpes and respiratory antiviral sales in Italy by disease indication, 2000-04 - page 85
- Table 24: Herpes and respiratory antiviral sales in Spain by disease indication, 2000-04 - page 92
- Table 25: Herpes and respiratory antiviral sales in UK by disease indication, 2000-04 - page 98
- Table 26: List of key events, September 2004-October 2005 - page 108
- Table 27: Patent expiries expected to occur in the forecast period - page 116
- Table 28: Zovirax sales in the US following patent expiry in April 1997 - page 118
- Table 29: Overview of the three herpes and respiratory pipeline drugs expected to be launched in the forecast period - page 121
- Table 30: Market potential for A-60444 in the seven major markets - page 125
- Table 31: New drug launches in the herpes and respiratory antiviral market have been limited to two products in the period 2000-04 - page 130
- Table 32: Earliest and US patent expiries of currently marketed herpes and respiratory antiviral drugs, seven major markets - page 131
- Table 33: Overview of total ethical revenues, and ID and herpes and respiratory antiviral sales for the top three antiviral players, seven major markets, 2004 - page 133
- Table 34: GSK's herpes and respiratory antiviral portfolio is focused on HSV/VZV products - page 134
- Table 35: GSK's pipeline vaccines in Phase III or NDA filed - page 140
- Table 36: Roche's herpes and respiratory antiviral portfolio - page 144
- Table 37: Famvir: key events - page 156
- Table 38: Price comparison between Zovirax, Valtrex and Famvir for the treatment of herpes zoster and genital herpes - page 159
- Table 39: Zovirax: key events - page 163
- Table 40: Price per standard unit ratios, seven major markets, 2000-04 - page 167
- Table 41: Valtrex: key events - page 169
- Table 42: Formulations, dosing and cost of therapy, Zovirax versus Valtrex - page 170
- Table 43: Valtrex (valacyclovir) product patent expiry dates, seven major markets - page 172
- Table 44: Cytovene: key events - page 174
- Table 45: Valcyte: key events - page 175
- Table 46: Valcyte and Cytovene are the least toxic CMV products on the market - page 179
- Table 47: Average therapy prices for marketed CMV drugs in the treatment of CMV retinitis in AIDS patients with normal renal function - page 181
- Table 48: Definition of the Pacific Rim in terms of countries and distribution channels - page 183
- Table 49: Global herpes and respiratory antiviral market forecasts, 2005-2014 - page 184
- Table 50: MEU5 herpes and respiratory antiviral market forecasts, 2005-2014 - page 185
- Table 51: US herpes and respiratory antiviral market forecasts, 2005-2014 - page 186
- Table 52: Pacific Rim herpes and respiratory antiviral market forecasts, 2005-2014 - page 187
- Table 53: France herpes and respiratory antiviral market forecasts, 2005-2014 - page 188
- Table 54: Germany herpes and respiratory antiviral market forecasts, 2005-2014 - page 189
- Table 55: Italy herpes and respiratory antiviral market forecasts, 2005-2014 - page 190
- Table 56: Spain herpes and respiratory antiviral market forecasts, 2005-2014 - page 191
- Table 57: UK herpes and respiratory antiviral market forecasts, 2005-2014 - page 192
- Table 58: Historical sales used for the forecasts, seven major markets, 2001-04 - page 193
- Table 59: Valtrex: key facts - page 194
- Table 60: Famvir: key facts - page 195
- Table 61: Zovirax: key facts - page 196
- Table 62: Zostex: key facts - page 197
- Table 63: Arasena-A: key facts - page 198
- Table 64: Valcyte: key facts - page 199
- Table 65: Cytovene: key facts - page 200
- Table 66: Vistide: key facts - page 201
- Table 67: Foscavir: key facts - page 202
- Table 68: Tamiflu: key facts - page 203
- Table 69: Relenza: key facts - page 204
- Table 70: Flumadine: key facts - page 205
- Table 71: Amantadine (molecule): key facts - page 206
- Table 72: Virazole: key facts - page 207
- List of Figures
- Figure 1: Unmet needs in the herpes and respiratory antiviral market - page 29
- Figure 2: Market share of the leading anti-infective drug classes, ATC 'J' code, seven major markets, 2004 - page 30
- Figure 3: Historic timeline of herpes and respiratory antivirals - page 31
- Figure 4: Double digit-growth in the herpes and respiratory antiviral market has been driven by price increases - page 32
- Figure 5: Herpes and respiratory antiviral sales by geographic region, seven major markets, 2000-04 - page 33
- Figure 6: Compound annual sales growth rates (CAGR) by geographical region, seven major markets, 2000-04 - page 34
- Figure 7: Herpes and respiratory antiviral sales and market share by indication, seven major markets, 2000-04 - page 35
- Figure 8: Leading brands and market share by viral infection, seven major markets, 2004 - page 36
- Figure 9: In the herpes and respiratory antiviral market, brands dominate by sales, while generics lead in terms of volume use - page 37
- Figure 10: Market share of the top three herpes and respiratory antiviral players, key brands and total sales, seven major markets, 2004 - page 38
- Figure 11: In 2004, the six leading herpes and respiratory antiviral products accounted for 86% of the seven major markets - page 39
- Figure 12: Growth up to 2014 will be fuelled mainly by CMV and respiratory antivirals - page 45
- Figure 13: In 2004, generic sales market share across the seven major markets was low - page 47
- Figure 14: Common herpesvirus infections and disease manifestations in immunocompromised patient sub-groups - page 49
- Figure 15: Valtrex sales between 2000 and 2004 in the seven major markets have been growing at a CAGR of 33.1% - page 52
- Figure 16: Total number of AIDS cases, seven major markets, 1993-2003 - page 56
- Figure 17: Generic acyclovir has captured significant market share across the seven major markets (2004 sales) - page 58
- Figure 18: Leading herpes and respiratory antiviral brands by value, US, 2000 and 2004 - page 60
- Figure 19: Brand versus generic sales, US, 2000-04 - page 61
- Figure 20: Online DTC advertising for Valtrex (valacyclovir) - page 62
- Figure 21: Online DTC advertising for Tamiflu (oseltamivir) - page 62
- Figure 22: Herpes and respiratory antiviral sales by indication, Pacific Rim, 2000-04 - page 66
- Figure 23: Leading herpes and respiratory antiviral brands by value, Pacific Rim, 2000 and 2004 - page 66
- Figure 24: Valtrex (valacyclovir) sales and volume use, Pacific Rim, 2000-04 - page 67
- Figure 25: Brand versus generic sales, Pacific Rim, 2000-04 - page 69
- Figure 26: Generic ganciclovir versus Denosine/Cymevene volume use, Pacific Rim, 2000-04 - page 69
- Figure 27: Leading herpes and respiratory antiviral brands by value, France, 2000 and 2004 - page 72
- Figure 28: Brand versus generic sales, France, 2000-04 - page 73
- Figure 29: Leading herpes and respiratory antiviral brands by value, Germany, 2000 and 2004 - page 79
- Figure 30: Brand versus generic sales, Germany, 2000-04 - page 80
- Figure 31: Generic versus branded acyclovir sales in Germany, 2000-04 - page 84
- Figure 32: Herpes and respiratory antiviral sales and volume use, Italy, 2000-04 - page 86
- Figure 33: Leading herpes and respiratory antiviral brands by value, Italy, 2000 and 2004 - page 87
- Figure 34: Brand versus generic sales, Italy, 2000-04 - page 89
- Figure 35: Zovirax versus generic acyclovir sales in Italy, 2000-04 - page 90
- Figure 36: Leading herpes and respiratory antiviral brands by value, Spain, 2000 and 2004 - page 93
- Figure 37: Brand versus generic sales, Spain, 2000-04 - page 94
- Figure 38: Sales and volume use of anti-herpes agents (HSV and VZV only) in Spain, 2000-04 - page 95
- Figure 39: Branded versus generic acyclovir sales in Spain, 2000-04 - page 97
- Figure 40: Leading herpes and respiratory antiviral brands by value, UK, 2000 and 2004 - page 99
- Figure 41: Branded versus generic sales in the UK, 2000-04 - page 103
- Figure 42: Branded versus generic acyclovir sales in the UK, 2004 - page 104
- Figure 43: Summary of environmental issues affecting the herpes and respiratory antiviral market - page 105
- Figure 44: Forecasted effect of patent expiry on Valtrex sales in the US - page 118
- Figure 45: Forecasted effect of patent expiry on Famvir sales in the US - page 119
- Figure 46: The key unmet need in shingles is chronic pain (PHN) - page 122
- Figure 47: Estimation of the RSV antiviral market potential in the US - page 125
- Figure 48: Herpes and respiratory antiviral sales market share of the top three players, 2000 and 2004 - page 129
- Figure 49: GSK's ID portfolio consists mainly of antivirals - page 133
- Figure 50: GSK's herpes and respiratory antiviral portfolio - page 135
- Figure 51: GSK SWOT analysis - page 141
- Figure 52: Outlook for GSK's herpes and respiratory antiviral portfolio - page 142
- Figure 53: Roche's ID portfolio is split equally between antibacterials and antivirals - page 143
- Figure 54: Roche's herpes and respiratory antiviral portfolio - page 144
- Figure 55: Cytovene and Valcyte US sales, 2000-04 - page 147
- Figure 56: Comparison of Tamiflu and Relenza sales, seven major markets, 2000-04 - page 150
- Figure 57: A clinical comparison of Tamiflu versus Relenza - page 151
- Figure 58: Roche SWOT analysis - page 152
- Figure 59: Outlook for Roche's herpes and respiratory antiviral portfolio - page 153
- Figure 60: Novartis's ID portfolio is dominated by antifungals - page 154
- Figure 61: Famvir's market share in the HSV/VZV antiviral market has remained below 20%, seven major markets, 2000-04 - page 155
- Figure 62: Total promotional expenditure for Famvir has been significantly lower than for Valtrex, US drugstores, 2000-04 - page 158
- Figure 63: In 2004, 83.1% of Famvir prescriptions in seven major markets* were due to infections caused by herpes zoster - page 159
- Figure 64: Novartis SWOT analysis - page 161
- Figure 65: Outlook for Novartis's herpes and respiratory antiviral portfolio - page 162
- Figure 66: Volume use of Valtrex, Zovirax and generic acyclovir, seven major markets, 2000-04 - page 166
- Figure 67: Valtrex, Zovirax and generic acyclovir sales, seven major markets, 2000-04 - page 167
- Figure 68: Valtrex, Zovirax and generic acyclovir sales, US, 2000-04 - page 168
- Figure 69: Valtrex: key success factors - page 172
- Figure 70: Valcyte, Cytovene and generic ganciclovir sales, seven major markets, 2000-04 - page 176
- Figure 71: Valcyte, Cytovene and generic ganciclovir volume use, seven major markets, 2000-04 - page 177
- Figure 72: CMV products sales market share, seven major markets, 2000-04 - page 178
- Figure 73: Total quarterly promotional expenditure for Cytovene and Valcyte in US drugstores, 2000-04 - page 180
- Figure 74: Comparative analysis of marketed CMV products - page 182
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