Commercial Insight: HIV
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 HIV market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 14
- Market definition for this report - page 14
- Current market situation - page 14
- Class overview - page 18
- Nucleoside reverse transcriptase inhibitors - page 19
- Non-nucleoside reverse transcriptase inhibitors - page 21
- Protease inhibitors - page 23
- Entry inhibitors - page 26
- Class overview - page 18
- Strategic scoping and focus - page 27
- The emerging markets - page 29
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 31
- Current and future opportunities and threats in the HIV market - page 31
- Global opportunities and threats - page 31
- Opportunities - page 31
- Threats - page 41
- US: opportunities and threats - page 48
- Market overview - page 48
- Opportunities - page 50
- Threats - page 52
- Japan: opportunities and threats - page 57
- Market overview - page 57
- Opportunities - page 59
- Threats - page 65
- France: opportunities and threats - page 68
- Market overview - page 68
- Opportunities - page 70
- Threats - page 72
- Germany: opportunities and threats - page 75
- Market overview - page 75
- Opportunities - page 77
- Threats - page 78
- Italy: opportunities and threats - page 81
- Market overview - page 81
- Opportunities - page 83
- Threats - page 86
- Spain: opportunities and threats - page 87
- Market overview - page 87
- Opportunities - page 88
- Threats - page 91
- UK: opportunities and threats - page 92
- Market overview - page 92
- Opportunities - page 94
- Threats - page 97
- Global opportunities and threats - page 31
- Summary of environmental issues affecting the antiretroviral market size - page 101
- Current and future opportunities and threats in the HIV market - page 31
- CHAPTER 4 FORECAST ANALYSIS - page 102
- Assumptions and events - page 102
- Events not included - page 102
- Global events - page 102
- Increase in the number of patients receiving antiretroviral therapy - page 102
- Pricing adjustments - page 103
- Product-specific events - page 103
- Launch of new combination drugs - tenofovir/emtricitabine (Truvada) and lamivudine/abacavir (Epzicom) - page 103
- Antiretroviral patent expiries - page 105
- Launch of new drugs with activity against resistant strains of HIV - page 114
- Launch of new entry inhibitors and mABs - page 117
- Limitations of data - page 120
- Standard units - page 120
- Japanese market data - page 120
- Regional launch dates for new products - page 121
- Forecasts - page 121
- Assumptions and events - page 102
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 122
- Introduction - page 122
- Fixed-dose combinations - the future of NRTI therapy? - page 122
- Fixed-dose combinations - an overview - page 122
- Convenience and simplicity drive FDC uptake - page 124
- FDC prescription practices - page 126
- NRTI FDC clinical trials - the three go head-to-head - page 128
- The need for data - is bioequivalence enough? - page 133
- Generic incursion - are FDCs adequate protection? - page 133
- The cost of FDCs - what price for convenience? - page 134
- FDCs - the future of antiretroviral therapy? - page 137
- NRTIs - will the backbone be fixed? - page 137
- PI fixed dose combinations - generic ritonavir may open the way for new FDCs - page 138
- Cross class fixed-dose combinations - could HAART be reduced to a single pill? - page 140
- Once-daily dosing - page 142
- Once-daily dosing - a double-edged sword for HIV therapy? - page 143
- Few products now require more than twice daily dosing - page 147
- Aptivus (tipranavir, TPV) - Boehringer pulls it through - page 150
- Open label trial design leads to differences in analyses - page 151
- Safety concerns and required follow-up - page 154
- Lessons for HIV trials in "heavily treatment experienced patients" - page 156
- Commercial outlook for BI's HIV portfolio - page 158
- Guideline changes for nevirapine - page 158
- Aptivus - a Fuzeon-like product? - page 160
- Generics and patent expiries - page 163
- Generic impact is likely to vary considerably - page 165
- Older products are not expected to raise generic interest - page 166
- Those hardest hit will be the most widely prescribed products - Epivir, Viread, Sustiva and Kaletra - page 167
- Generic impact is likely to vary considerably - page 165
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 169
- NRTI market data - page 169
- PI market data - page 182
- NNRTI market data - page 192
- Others market data - page 195
- APPENDIX B - page 196
- Bibliography - page 196
- Journal articles and conference abstracts - page 196
- Press releases - page 202
- General - page 202
- EU - page 203
- France - page 204
- Italy - page 204
- Japan - page 204
- Spain - page 205
- UK - page 206
- US - page 207
- Conferences - page 209
- Websites - page 210
- Organizations - page 212
- Miscellaneous - page 213
- Report methodology - page 215
- About Datamonitor - page 215
- About Datamonitor Healthcare - page 216
- About the Infectious Disease analysis team - page 217
- Disclaimer - page 218
- Bibliography - page 196
- List of Tables
- Table 1: Overview of the NRTIs - page 20
- Table 2: Overview of the NNRTIs - page 22
- Table 3: Overview of the PIs - page 24
- Table 4: HIV/AIDS prevalence, incidence and death rates by region, 2004 - page 29
- Table 5: HIV/AIDS prevalence and diagnosis rates in the seven major markets, 2004* - page 34
- Table 6: Exposure category of HIV infections diagnosed in the US and UK, 1999 to 2003 - page 35
- Table 7: Patent expiries of antiretrovirals, 2005-15 - page 41
- Table 8: US antiretroviral market, 2000-04 - page 48
- Table 9: Pacific Rim antiretroviral market, 2000-04 - page 57
- Table 10: French antiretroviral market, 2000-04 - page 69
- Table 11: German antiretroviral market, 2000-04 - page 75
- Table 12: Italian antiretroviral market, 2000-04 - page 82
- Table 13: Spanish antiretroviral market, 2000-04 - page 87
- Table 14: UK antiretroviral market, 2000-04 - page 93
- Table 15: An overview of selected pipeline products included in the HIV market forecasts - page 115
- Table 16: Comparison of Combivir, Epzicom & Truvada - page 129
- Table 17: Key products in late-stage R&D pipeline for NRTIs - page 137
- Table 18: Boosted PI regimes - page 139
- Table 19: Key antiretroviral combinations, not currently available in the seven major markets, 2005 - page 141
- Table 20: Once-daily ARVs currently available (in US) - page 144
- Table 21: Patient populations for the tipranavir RESIST trials - page 153
- Table 22: Tipranavir post-marketing studies, as requested by the FDA - page 156
- Table 23: Patent expiries of antiretrovirals, 2005-15 - page 163
- Table 24: Combivir: key facts - page 169
- Table 25: Viread: key facts - page 170
- Table 26: Trizivir: key facts - page 171
- Table 27: Epivir: key facts - page 172
- Table 28: Zerit: key facts - page 173
- Table 29: Ziagen: key facts - page 174
- Table 30: Videx EC: key facts - page 175
- Table 31: Videx: key facts - page 176
- Table 32: Retrovir: key facts - page 177
- Table 33: Truvada: key facts - page 178
- Table 34: Emtriva: key facts - page 179
- Table 35: Epzicom: key facts - page 180
- Table 36: Hivid: key facts - page 181
- Table 37: Kaletra: key facts - page 182
- Table 38: Reyataz: key facts - page 183
- Table 39: Viracept: key facts - page 184
- Table 40: Norvir: key facts - page 185
- Table 41: Crixivan: key facts - page 186
- Table 42: Lexiva: key facts - page 187
- Table 43: Invirase: key facts - page 188
- Table 44: Fortovase: key facts - page 189
- Table 45: Agenerase: key facts - page 190
- Table 46: Sustiva: key facts - page 192
- Table 47: Viramune: key facts - page 193
- Table 48: Rescriptor: key facts - page 194
- Table 49: Fuzeon: key facts - page 195
- List of Figures
- Figure 1: Pharmaceutical market, 2004 - page 15
- Figure 2: Infectious disease markets, seven major markets, 2000-04 - page 16
- Figure 3: Timeline of the development of the HIV market - page 17
- Figure 4: Relative contribution of the leading products to total HIV sales, seven markets, 2000-04 - page 18
- Figure 5: Combivir and Viread sales in the first four years following launch - page 21
- Figure 6: Kaletra quarterly sales in the seven major markets, 2000-04 - page 25
- Figure 7: Reyataz and Kaletra initial post-launch uptake - page 26
- Figure 8: HIV market share by company, seven major markets, 2000-04 - page 28
- Figure 9: Annual HIV incidence, US, Germany and UK, 1995-2003 - page 32
- Figure 10: Total AIDS cases per year, seven major markets, 1991-2004 - page 36
- Figure 11: Persons living with HIV/AIDS in 30 areas* in the US by age group, 2000 & 2003 - page 37
- Figure 12: US HIV market shares, top brands by value ($m) and by volume (SU millions), 2004 - page 49
- Figure 13: Pacific Rim HIV market shares, top 10 brands by value, 2004 - page 59
- Figure 14: France HIV market shares, top six brands by value, 2004 - page 70
- Figure 15: The number of new cases of AIDS in women according to their nationality - page 72
- Figure 16: German HIV market shares, top five brands by value, 2004 - page 76
- Figure 17: Italian HIV market shares, top 10 brands by value, 2004 - page 83
- Figure 18: Spanish HIV market shares, top brands by value ($m) and by volume (SU million), 2004 - page 88
- Figure 19: Most important sexual health concerns in Spain - page 88
- Figure 20: UK HIV market shares, top 10 brands by value, 2004 - page 94
- Figure 21: Probable route of infection and ethnic group of diagnosed HIV patients in the UK, 2003 - page 95
- Figure 22: An overview of the key opportunities and threats in the HIV market, 2005 - page 101
- Figure 23: Truvada and Epzicom forecast sales, 2005 - 2015 - page 104
- Figure 24: Expected antiretroviral patent expiries, 2005-15 - page 105
- Figure 25: The NRTI pill burden has been significantly reduced following the introduction of the FDCs - page 124
- Figure 26: Sales of the components of the FDCs have either stalled or fallen since the launches of Epzicom and Truvada - page 127
- Figure 27: Combivir and Trizivir are likely to lose share as uptake of Truvada and Epzicom increases - page 128
- Figure 28: Combivir is still the highest selling NRTI FDC in terms of value and volume in the seven major markets, 2004 - page 131
- Figure 29: Price comparison of FDCs and their components in US - page 135
- Figure 30: Price comparison of FDCs and their components in UK - page 136
- Figure 31: PI sales by product, seven major markets, 2000-04 - page 145
- Figure 32: Total pill burden associated with each antiretroviral drug - page 148
- Figure 33: Crixivan and Agenerase sales in the seven major markets, 2000-04 - page 149
- Figure 34: Overview of the tipranavir clinical development program - page 152
- Figure 35: Country-specific sales of Aptivus, 2005 - 2015 - page 162
- Figure 36: Videx/Videx EC sales following generic didanosine approval - page 165
- Figure 37: Sales of older antiretrovirals have fallen since 2000 - page 166
- Figure 38: Viread, Sustiva, Epivir and Kaletra forecast sales, seven major markets, 2005-15 - page 168
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