Commercial Insight: HIV - Reshaping Treatment Paradigms
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases 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
- Contributing experts - page 5
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 8
- Market definition for this report - page 8
- Current market situation - page 8
- Overview of antiretroviral classes - page 13
- Nucleoside reverse transcriptase inhibitors - page 13
- Cross-class fixed dose combination - Atripla - page 15
- Non-nucleoside reverse transcriptase inhibitors - page 16
- Protease inhibitors - page 17
- Entry Inhibitors - page 20
- Overview of antiretroviral classes - page 13
- Strategic scoping and focus - page 21
- Emerging markets - page 23
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 27
- Summary of environmental issues affecting HIV market size - page 27
- Six major market opportunities and threats - page 27
- Epidemiology: Increase in the HIV population - page 27
- Increase in diagnosis rates - page 27
- Increase in life expectancy - page 28
- Increase in risk behavior - page 29
- Increased immigration from areas of high HIV prevalence - page 29
- Continuing rise in development of resistance - page 32
- Acceleration and harmonization of approval procedures - page 33
- Threats - page 34
- Generic incursion - page 34
- Pricing pressure imposed by governments - page 37
- Parallel trade - page 37
- Preventative measures - page 39
- Vaccine/microbicide development - page 39
- US: opportunities and threats - page 40
- HIV market overview - page 40
- Opportunities - page 41
- Increased government funding for treatment of HIV - page 41
- Direct to Consumer Advertising - page 44
- Branded products achieve high prices as a result of the free pricing system - page 45
- Threats - page 45
- Introduction of Medicare Part D has resulted in difficulties in accessing treatment for HIV - page 45
- Waiting lists and other cost-containment measures implemented by several ADAPs due to underfunding - page 48
- Opposition to the rising prices of antiretrovirals - page 49
- Genericization - page 51
- Parallel trade currently illegal in the US - page 53
- France: opportunities and threats - page 53
- HIV market overview - page 53
- Opportunities - page 54
- Critical attitude towards MRP slows down generic approvals - page 54
- Creation of HAS facilitates P&R approval - page 55
- High volume of prescription - page 55
- Reimbursement system favors use of innovative drugs - page 56
- Threats - page 57
- Cost-containment policies aim at reducing expenditure on prescription drugs - page 57
- Genericization set to increase and be further supported - page 58
- Germany: opportunities and threats - page 59
- HIV market overview - page 59
- Opportunities - page 60
- Legalization of mail order - page 60
- Free pricing system in Germany facilitates novel drug development - page 61
- Threats - page 62
- Jumbo reference pricing - page 62
- Genericization - page 63
- Italy: opportunities and threats - page 64
- HIV market overview - page 64
- Opportunities - page 66
- Lack of confidence in generics may limit their uptake - page 66
- Reimbursement based on negotiations - page 67
- Threats - page 67
- Unpredictability of regulations hampers reliable strategic planning - page 67
- Reference pricing may result in downward price trends - page 68
- Changes in reimbursement rules for lipid-lowering drugs pose a significant threat to the protease inhibitor market - page 69
- Spain: opportunities and threats - page 69
- HIV market overview - page 69
- Opportunities - page 70
- Supportive legislation and reimbursement schemes for innovative drugs - page 70
- Decentralized system provides localized opportunities - page 71
- Threats - page 72
- Cost containment measures proposed by Spanish authorities - page 72
- The use of generics is being promoted by the Spanish government - page 73
- UK: opportunities and threats - page 73
- HIV market overview - page 73
- Opportunities - page 74
- A less stringent pricing and reimbursement system makes the UK attractive - page 74
- The UK has one of highest new infection rates in Europe - page 75
- Threats - page 76
- Improper management of HIV drugs budgets may lead to tighter restrictions on prescription of antiretrovirals - page 76
- Prevention programmes - page 77
- NICE: the pre-guidance and post-guidance effect - page 77
- CHAPTER 4 FORECAST ANALYSIS - page 80
- Key events - page 80
- Events not included - page 80
- Six major market events - page 80
- Increase in the population of HIV-infected patients - page 80
- New product launches - page 80
- Product-specific events - page 82
- New product launches in the NRTI class to have relatively small impact - page 82
- Atripla to take market share away from NRTI FDCs - page 83
- Tibotec's compounds will be valuable additions to the NNRTI class - page 84
- Kaletra and Reyataz challenged by Prezista - page 86
- Novel classes to enter the EIs & others - page 87
- Antiretroviral patent expiries - page 89
- Retrovir patent expiry - page 90
- Hivid patent expiry - page 91
- Zerit patent expiry - page 91
- Videx patent expiry - page 91
- Ziagen patent expiry - page 92
- Epivir patent expiry - page 92
- Emtriva patent expiry - page 93
- Invirase patent expiry - page 93
- Crixivan patent expiry - page 93
- Viramune patent expiry - page 94
- Combivir patent expiry - page 94
- Sustiva patent expiry - page 94
- Agenerase patent expiry - page 95
- Norvir patent expiry - page 95
- Fuzeon patent expiry - page 95
- Viracept patent expiry - page 96
- Kaletra patent expiry - page 96
- Data definitions, limitations and assumptions - page 96
- Derivation of sales forecasts and pricing trends - page 97
- Forecasts - page 97
- Forecast methodology - page 97
- Key events - page 80
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 98
- Introduction - page 98
- Case studies - page 98
- Pfizer's maraviroc, close to approval, despite hurdles along the way - page 98
- CCR5 inhibitors, a novel class of antiretrovirals - page 99
- Collaboration with Monogram to make tropism assay globally available with Maraviroc - page 102
- Setbacks suffered by GSK and Schering-Plough damage class reputation - page 103
- Clinical trials demonstrate good safety and efficacy profiles - page 104
- Maraviroc's place in therapy - page 108
- Needle-free Fuzeon (enfuvirtide, T-20) - page 110
- Slow uptake of Fuzeon due to high cost and mode of administration - page 111
- Roche and Trimeris aim to develop needle-free format of Fuzeon - page 112
- Impact of a needle-free version - page 115
- Commercial outlook for Roche HIV portfolio - page 116
- Pfizer's maraviroc, close to approval, despite hurdles along the way - page 98
- BIBLIOGRAPHY - page 119
- Journal papers and news articles - page 119
- Press releases - page 128
- Websites - page 130
- Datamonitor reports - page 131
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 133
- Summary HIV market data - page 133
- NRTI market data - page 134
- NNRTI market data - page 147
- PI market data - page 149
- EI and others market data - page 159
- APPENDIX B - MARKET FORECAST DATA - page 160
- Six major market - page 160
- M5EU - page 163
- US - page 166
- France - page 169
- Germany - page 172
- Italy - page 175
- Spain - page 178
- UK - page 181
- APPENDIX C - page 184
- Contributing experts - page 184
- Report methodology - page 184
- About Datamonitor - page 184
- About Datamonitor Healthcare - page 185
- About the Infectious Diseases and Respiratory analysis team - page 186
- Disclaimer - page 187
- List of Tables
- Table 1: Overview of the NRTIs, 2007 - page 15
- Table 2: Overview of the NNRTIs, 2007 - page 16
- Table 3: Overview of currently marketed PIs, 2007 - page 19
- Table 4: Overview of sales and market share of antiretrovirals by company, 2006 - page 22
- Table 5: Methods for HIV prevention in clinical development, 2007 - page 39
- Table 6: Overview of vaccines in development, 2007 - page 40
- Table 7: Total funding for Ryan White Care Act, 2006 - page 43
- Table 8: Summary HIV Market Data - page 133
- Table 9: Key facts: Combivir - page 134
- Table 10: Key facts: Viread - page 135
- Table 11: Key facts: Trizivir - page 136
- Table 12: Key facts: Epivir - page 137
- Table 13: Key facts: Zerit - page 138
- Table 14: Key facts: Abacavir - page 139
- Table 15: Key facts: Videx - page 140
- Table 16: Key facts: Retrovir - page 141
- Table 17: Truvada - page 142
- Table 18: Key facts: Emtriva - page 143
- Table 19: Key facts: Epzicom - page 144
- Table 20: Key facts: Hivid - page 145
- Table 21: Key facts: Atripla - page 146
- Table 22: Key facts: Sustiva - page 147
- Table 23: Key facts: Viramune - page 148
- Table 24: Key facts: Kaletra - page 149
- Table 25: Key facts: Reyataz - page 150
- Table 26: Key facts: Viracept - page 151
- Table 27: Key facts: Norvir - page 152
- Table 28: Key facts: Crixivan - page 153
- Table 29: Key facts: Lexiva - page 154
- Table 30: Key facts: Invirase - page 155
- Table 31: Key facts: Agenerase - page 156
- Table 32: Key facts: Prezista - page 157
- Table 33: Key facts: Aptivus - page 158
- Table 34: Key facts: Fuzeon - page 159
- Table 35: Six major markets - page 160
- Table 36: M5EU - page 163
- Table 37: US - page 166
- Table 38: France - page 169
- Table 39: Germany - page 172
- Table 40: Italy - page 175
- Table 41: Spain - page 178
- Table 42: UK - page 181
- List of Figures
- Figure 1: Pharmaceutical sales across the seven major markets, 2002-06 - page 10
- Figure 2: Overview of sales of HIV treatments by class, 2002-06 - page 11
- Figure 3: Overview of 10 best-selling antiretrovirals and market share, 2007 - page 12
- Figure 4: Timeline of the development of the HIV market, 1985-2015 - page 13
- Figure 5: HIV market share by company, 2003-06 - page 23
- Figure 6: Regional HIV and AIDS overview, 2005 - page 24
- Figure 7: UK HIV diagnoses by the two main routes of transmission, 2005 - page 30
- Figure 8: HIV infections in the UK by the region they were acquired from - page 31
- Figure 9: US sales by class, 2003-06 - page 41
- Figure 10: Total funding for the Ryan White Care act, 1991-2006 - page 43
- Figure 11: France sales by class, 2002-06 - page 54
- Figure 12: Germany sales by class, 2003-06 - page 60
- Figure 13: Italy sales by class, 2003-06 - page 65
- Figure 14: Spanish sales by class 2003-06 - page 70
- Figure 15: UK sales by class, 2003-06 - page 74
- Figure 16: New HIV cases across Europe, 2006 - page 76
- Figure 17: Summary of opportunities and threats - page 79
- Figure 18: Sales forecasts for antiretrovirals across six major markets 2006-2016 - page 82
- Figure 19: Sales forecasts for Atripla, Truvada and Sustiva 2006-2016 - page 84
- Figure 20: Sales forecasts for the NNRTI class 2006-2016 - page 85
- Figure 21: Sales forecasts Reyataz, Kaletra and Prezista 2006-2016 - page 87
- Figure 22: Sales forecasts Fuzeon, raltegravir and maraviroc - page 89
- Figure 23: Sales forecasts of marketed drugs 2006-2016 with key patent expiries - page 90
- Figure 24: HIV mechanism of entry into host cell - page 100
- Figure 25: Percentage of CCR5 tropic patients - page 101
- Figure 26: MOTIVATE trial design - page 105
- Figure 27: Mean change in CD4+ count in patients failing treatment - page 106
- Figure 28: Sales forecast for maraviroc 2006-2016 - page 110
- Figure 29: Overview of sales of Fuzeon in the US and Canada, 2003-06 - page 112
- Figure 30: SWOT analysis for Fuzeon - page 114
- Figure 31: Sales forecasts for Fuzeon 2006-2016 - page 118
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