Table of Contents for Commercial Insight: HIV - Simplicity and Survival
ABOUT DATAMONITOR HEALTHCARE
2
About the Infectious Disease pharmaceutical analysis team
2
CHAPTER 1 EXECUTIVE SUMMARY
3
Objective of the analysis
3
Datamonitor insight into the HIV market
3
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
14
Market definition for this report
14
Current market situation
14
Class overview
18
Nucleoside reverse transcriptase inhibitors
19
Non-nucleoside reverse transcriptase inhibitors
21
Protease inhibitors
23
Entry inhibitors
26
Strategic scoping and focus
27
The emerging markets
29
CHAPTER 3 COUNTRY MARKET ASSESSMENTS
31
Current and future opportunities and threats in the HIV market
31
Global opportunities and threats
31
Opportunities
31
Threats
41
US: opportunities and threats
48
Market overview
48
Opportunities
50
Threats
52
Japan: opportunities and threats
57
Market overview
57
Opportunities
59
Threats
65
France: opportunities and threats
68
Market overview
68
Opportunities
70
Threats
72
Germany: opportunities and threats
75
Market overview
75
Opportunities
77
Threats
78
Italy: opportunities and threats
81
Market overview
81
Opportunities
83
Threats
86
Spain: opportunities and threats
87
Market overview
87
Opportunities
88
Threats
91
UK: opportunities and threats
92
Market overview
92
Opportunities
94
Threats
97
Summary of environmental issues affecting the antiretroviral market size
101
CHAPTER 4 FORECAST ANALYSIS
102
Assumptions and events
102
Events not included
102
Global events
102
Increase in the number of patients receiving antiretroviral therapy
102
Pricing adjustments
103
Product-specific events
103
Launch of new combination drugs - tenofovir/emtricitabine (Truvada) and lamivudine/abacavir (Epzicom)
103
Antiretroviral patent expiries
105
Launch of new drugs with activity against resistant strains of HIV
114
Launch of new entry inhibitors and mABs
117
Limitations of data
120
Standard units
120
Japanese market data
120
Regional launch dates for new products
121
Forecasts
121
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
122
Introduction
122
Fixed-dose combinations - the future of NRTI therapy?
122
Fixed-dose combinations - an overview
122
Convenience and simplicity drive FDC uptake
124
FDC prescription practices
126
NRTI FDC clinical trials - the three go head-to-head
128
The need for data - is bioequivalence enough?
133
Generic incursion - are FDCs adequate protection?
133
The cost of FDCs - what price for convenience?
134
FDCs - the future of antiretroviral therapy?
137
NRTIs - will the backbone be fixed?
137
PI fixed dose combinations - generic ritonavir may open the way for new FDCs
138
Cross class fixed-dose combinations - could HAART be reduced to a single pill?
140
Once-daily dosing
142
Once-daily dosing - a double-edged sword for HIV therapy?
143
Few products now require more than twice daily dosing
147
Aptivus (tipranavir, TPV) - Boehringer pulls it through
150
Open label trial design leads to differences in analyses
151
Safety concerns and required follow-up
154
Lessons for HIV trials in "heavily treatment experienced patients"
156
Commercial outlook for BI's HIV portfolio
158
Guideline changes for nevirapine
158
Aptivus - a Fuzeon-like product?
160
Generics and patent expiries
163
Generic impact is likely to vary considerably
165
Older products are not expected to raise generic interest
166
Those hardest hit will be the most widely prescribed products - Epivir, Viread, Sustiva and Kaletra
167
168
APPENDIX A -MAJOR BRAND KEY FACTS
169
NRTI market data
169
PI market data
182
NNRTI market data
192
Others market data
197
APPENDIX B
199
Bibliography
199
Journal articles and conference abstracts
199
Press releases
207
General
207
EU
208
France
209
Italy
209
Japan
209
Spain
211
UK
211
US
212
Conferences
215
Websites
216
Organizations
219
Miscellaneous
220
MARKET FORECAST DATA
224
Forecasts for the HIV market in the US to 2014
224
Forecasts for the HIV market in Japan to 2014
228
Forecasts for the HIV market in France to 2014
232
Forecasts for the HIV market in Germany to 2014
236
Forecasts for the HIV market in Italy to 2014
240
Forecasts for the HIV market in Spain to 2014
244
Forecasts for the HIV market in the UK to 2014
248
M5EU forecasts for the HIV market to 2014
252
Global forecasts for the HIV market to 2014
256
Report methodology
261
About Datamonitor
261
About Datamonitor Healthcare
262
About the Infectious Disease analysis team
263
Disclaimer
264
List of Tables
Table 1: Overview of the NRTIs
20
Table 2: Overview of the NNRTIs
22
Table 3: Overview of the PIs
24
Table 4: HIV/AIDS prevalence, incidence and death rates by region, 2004
29
Table 5: HIV/AIDS prevalence and diagnosis rates in the seven major markets, 2004*
34
Table 6: Exposure category of HIV infections diagnosed in the US and UK, 1999 to 2003
35
Table 7: Patent expiries of antiretrovirals, 2005-15
41
Table 8: US antiretroviral market, 2000-04
48
Table 9: Pacific Rim antiretroviral market, 2000-04
57
Table 10: French antiretroviral market, 2000-04
69
Table 11: German antiretroviral market, 2000-04
75
Table 12: Italian antiretroviral market, 2000-04
82
Table 13: Spanish antiretroviral market, 2000-04
87
Table 14: UK antiretroviral market, 2000-04
93
Table 15: An overview of selected pipeline products included in the HIV market forecasts
115
Table 16: Comparison of Combivir, Epzicom & Truvada
129
Table 17: Key products in late-stage R&D pipeline for NRTIs
137
Table 18: Boosted PI regimes
139
Table 19: Key antiretroviral combinations, not currently available in the seven major markets, 2005
141
Table 20: Once-daily ARVs currently available (in US)
144
Table 21: Patient populations for the tipranavir RESIST trials
153
Table 22: Tipranavir post-marketing studies, as requested by the FDA
156
Table 23: Patent expiries of antiretrovirals, 2005-15
163
Table 24: Combivir: key facts
169
Table 25: Viread: key facts
170
Table 26: Trizivir: key facts
171
Table 27: Epivir: key facts
172
Table 28: Zerit: key facts
173
Table 29: Ziagen: key facts
174
Table 30: Videx EC: key facts
175
Table 31: Videx: key facts
176
Table 32: Retrovir: key facts
177
Table 33: Truvada: key facts
178
Table 34: Emtriva: key facts
179
Table 35: Epzicom: key facts
180
Table 36: Hivid: key facts
181
Table 37: Kaletra: key facts
182
Table 38: Reyataz: key facts
183
Table 39: Viracept: key facts
184
Table 40: Norvir: key facts
185
Table 41: Crixivan: key facts
186
Table 42: Lexiva: key facts
187
Table 43: Invirase: key facts
188
Table 44: Fortovase: key facts
189
Table 45: Agenerase: key facts
190
Table 46: Sustiva: key facts
192
Table 47: Viramune: key facts
193
Table 48: Rescriptor: key facts
195
Table 49: Fuzeon: key facts
197
Table 50: Forecasts for the HIV market in the US to 2014
224
Table 51: Forecasts for the HIV market in Japan to 2014
228
Table 52: Forecasts for the HIV market in France to 2014
232
Table 53: Forecasts for the HIV market in Germany to 2014
236
Table 54: Forecasts for the HIV market in Italy to 2014
240
Table 55: Forecasts for the HIV market in Spain to 2014
244
Table 56: Forecasts for the HIV market in the UK to 2014
248
Table 57: M5EU forecasts for the HIV market to 2014
252
Table 58: Global forecasts for the HIV market to 2014
256
List of Figures
Figure 1: Pharmaceutical market, 2004
15
Figure 2: Infectious disease markets, seven major markets, 2000-04
16
Figure 3: Timeline of the development of the HIV market
17
Figure 4: Relative contribution of the leading products to total HIV sales, seven markets, 2000-04
18
Figure 5: Combivir and Viread sales in the first four years following launch
21
Figure 6: Kaletra quarterly sales in the seven major markets, 2000-04
25
Figure 7: Reyataz and Kaletra initial post-launch uptake
26
Figure 8: HIV market share by company, seven major markets, 2000-04
28
Figure 9: Annual HIV incidence, US, Germany and UK, 1995-2003
32
Figure 10: Total AIDS cases per year, seven major markets, 1991-2004
36
Figure 11: Persons living with HIV/AIDS in 30 areas* in the US by age group, 2000 & 2003
37
Figure 12: US HIV market shares, top brands by value ($m) and by volume (SU millions), 2004
49
Figure 13: Pacific Rim HIV market shares, top 10 brands by value, 2004
59
Figure 14: France HIV market shares, top six brands by value, 2004
70
Figure 15: The number of new cases of AIDS in women according to their nationality
72
Figure 16: German HIV market shares, top five brands by value, 2004
76
Figure 17: Italian HIV market shares, top 10 brands by value, 2004
83
Figure 18: Spanish HIV market shares, top brands by value ($m) and by volume (SU million), 2004
88
Figure 19: Most important sexual health concerns in Spain
88
Figure 20: UK HIV market shares, top 10 brands by value, 2004
94
Figure 21: Probable route of infection and ethnic group of diagnosed HIV patients in the UK, 2003
95
Figure 22: An overview of the key opportunities and threats in the HIV market, 2005
101
Figure 23: Truvada and Epzicom forecast sales, 2005 - 2015
104
Figure 24: Expected antiretroviral patent expiries, 2005-15
105
Figure 25: The NRTI pill burden has been significantly reduced following the introduction of the FDCs
124
Figure 26: Sales of the components of the FDCs have either stalled or fallen since the launches of Epzicom and Truvada
127
Figure 27: Combivir and Trizivir are likely to lose share as uptake of Truvada and Epzicom increases
128
Figure 28: Combivir is still the highest selling NRTI FDC in terms of value and volume in the seven major markets, 2004
131
Figure 29: Price comparison of FDCs and their components in US
135
Figure 30: Price comparison of FDCs and their components in UK
136
Figure 31: PI sales by product, seven major markets, 2000-04
145
Figure 32: Total pill burden associated with each antiretroviral drug
148
Figure 33: Crixivan and Agenerase sales in the seven major markets, 2000-04
149
Figure 34: Overview of the tipranavir clinical development program
152
Figure 35: Country-specific sales of Aptivus, 2005 - 2015
162
Figure 36: Videx/Videx EC sales following generic didanosine approval
165
Figure 37: Sales of older antiretrovirals have fallen since 2000
166
Figure 38: Viread, Sustiva, Epivir and Kaletra forecast sales, seven major markets, 2005-15
168
CMS, P&A House, Alma Road, Chesham, Bucks. HP5 3HB, UK
Tel: +44 (0)1494 771734
Fax: +44 (0)1494 778994
e-mail: jenniferc@cmsinfo.com
copyright © 2005 all rights reserved
For more information about us, visit CMSinfo.
