HIV - Change of guard
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases & Respiratory 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 13
- Market definition for this report - page 13
- Current market situation - page 13
- Overview of antiretroviral classes - page 17
- Nucleoside reverse transcriptase inhibitors - page 17
- Non nucleoside reverse transcriptase inhibitors - page 22
- Protease inhibitors - page 23
- Entry Inhibitors - page 28
- Overview of antiretroviral classes - page 17
- Strategic scoping and focus - page 29
- Emerging markets - page 31
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 35
- Global opportunities and threats - page 35
- Opportunities - page 35
- Epidemiology: HIV population growth driven by increased diagnosis rates, new infections and rising life expectancy - page 35
- Acceleration and harmonization of approval procedures - page 39
- Threats - page 40
- Regulatory pathways for generics get streamlined across the globe - page 42
- Governments impose pricing pressure on drug manufacturers in response to cost containment needs - page 44
- Parallel trade - illegal in the US, encouraged in Europe - page 45
- New preventative measures - page 47
- Opportunities - page 35
- US: opportunities and threats - page 48
- HIV market overview - page 48
- Opportunities - page 50
- Direct-to-consumer advertising - page 50
- Branded products achieve high prices as a result of the free pricing system - page 51
- Threats - page 51
- Initiatives by public and private health providers aim to encourage cost containment - page 51
- Further genericization is encouraged by legislation and public programs - page 53
- Although still illegal, parallel trade is likely to be legalized in the medium term - page 54
- France: opportunities and threats - page 55
- HIV market overview - page 55
- Opportunities - page 56
- Critical attitude towards MRP slows down generic penetration - page 56
- High prescription volume boosts drug revenues - page 57
- The creation of HAS facilitates P&R approval - page 57
- Reimbursement system favors use of innovative drugs - page 58
- Threats - page 59
- Cost containment policies aim at reducing the expenditure for prescription drugs - page 59
- Genericization has increased recently and is further supported - page 60
- Germany: opportunities and threats - page 61
- HIV market overview - page 61
- Opportunities - page 63
- Legalization of mail order provides new distribution channels - page 63
- Free pricing system and culture of innovation encourages novel drug development - page 64
- Fewer cost containment restrictions make the hospital sector a valuable opportunity - page 64
- Threats - page 65
- Jumbo Reference Pricing is threatening drug revenue growth - page 65
- Increasing genericization is strongly supported by the government - page 65
- Italy: opportunities and threats - page 67
- HIV market overview - page 67
- Opportunities - page 69
- Low levels of generic penetration as a result of lack of confidence - page 69
- Reimbursement levels are determined by negotiations rather than regulations - page 70
- Threats - page 70
- Unpredictability of regulations hampers reliable strategic planning - page 70
- Reference pricing might result in downward price spirals and support genericization - page 72
- Spain: opportunities and threats - page 72
- HIV market overview - page 72
- Opportunities - page 74
- Legislation and reimbursement schemes support innovation - page 74
- Decentralization of the healthcare system provides localized opportunities - page 75
- Threats - page 75
- Cost containment measurements restrict manufacturer's profit margins - page 75
- Government encourages generic use - page 76
- UK: opportunities and threats - page 77
- HIV market overview - page 77
- Opportunities - page 79
- Decreasing incentives for pharmacists to prescribe generics as a result of new DoH initiative - page 79
- Threats - page 79
- Price reduction for branded products after PPRS change in 2004 - page 79
- Complex structures for P&R negotiations elongate time to market - page 80
- High generic penetration is a large challenge for brand manufacturers - page 82
- Summary of environmental issues affecting the antiretroviral country markets - page 83
- Global opportunities and threats - page 35
- CHAPTER 4 FORECAST ANALYSIS - page 84
- Assumptions and events - page 84
- Events not included - page 84
- Global events - page 84
- Increase in the number of patients receiving antiretroviral therapy - page 84
- Product-specific events - page 85
- Launch of Atripla - page 85
- Truvada and Epzicom - page 87
- Aptivus and Prezista - page 88
- Major Clinical Trials - page 90
- Three class strategies versus two class strategies evaluated in the FIRST trial - page 90
- Antiretroviral patent expiries - page 92
- Retrovir patent expiry - page 93
- Hivid patent expiry - page 93
- Zerit patent expiry - page 94
- Videx patent expiry - page 94
- Ziagen patent expiry - page 95
- Epivir patent expiry - page 95
- Emtriva patent expiry - page 95
- Invirase patent expiry - page 96
- Crixivan patent expiry - page 96
- Viramune patent expiry - page 96
- Combivir patent expiry - page 97
- Sustiva patent expiry - page 97
- Agenerase patent expiry - page 98
- Norvir patent expiry - page 98
- Fuzeon patent expiry - page 98
- Viracept patent expiry - page 99
- Kaletra patent expiry - page 99
- New product launches - page 100
- Launch of NNRTIs with novel resistance profiles - page 100
- Launch of new classes of drugs, CCR5 inhibitors, integrase inhibitors, etc. - page 101
- Data definitions, limitations and assumptions - page 104
- Standard Units - page 104
- Derivation of Sales Forecasts and Pricing Trends - page 104
- Forecasts - page 104
- Forecast methodology - page 104
- Assumptions and events - page 84
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 105
- Introduction - page 105
- Case studies - page 105
- Tibotec - the emergence of a new kind of HIV competitor - page 106
- The path to market - page 106
- R&D approach focused on HIV - page 108
- Market conditioning and competitive positioning - page 110
- Positive market opinion - page 113
- Conclusions - page 114
- Kaletra versus Reyataz - lifecycle management battles for PI dominance - page 115
- PI market evolution, 2003-05 - page 115
- Efficacy versus safety versus convenience - page 118
- Kaletra versus Reyataz - page 119
- Conclusions - page 124
- Tibotec - the emergence of a new kind of HIV competitor - page 106
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 126
- Summary HIV market data - page 126
- Nucleoside reverse transcriptase inhibitors (NRTI) market data - page 127
- Protease Inhibitor market data - page 138
- Non-nucleoside reverse transcriptase inhibitor (NNRTI) market data - page 147
- Entry Inhibitors (EIs) and others market data - page 149
- BIBLIOGRAPHY - page 150
- General - page 150
- Websites - page 151
- Reports - page 151
- Datamonitor Reports - page 151
- Report methodology - page 152
- ABOUT DATAMONITOR - page 153
- About Datamonitor Healthcare - page 153
- About the Infectious Disease analysis team - page 154
- Key therapy team members - page 154
- Disclaimer - page 156
- List of Tables
- Table 1: Overview of the NRTI drug class, 2006 - page 19
- Table 2: Overview of marketed NNRTIs, 2002-05 - page 22
- Table 3: Overview of marketed PIs, 2002-05 - page 25
- Table 4: Regional HIV and AIDS overview, 2005 - page 32
- Table 5: Patent expiry dates of antiretroviral drugs in the US and EU5 - page 41
- Table 6: Methods for HIV prevention in clinical development - page 47
- Table 7: HIV vaccines in clinical development, 2006 - page 48
- Table 8: Prezista versus Aptivus trial data - page 112
- Table 9: Pill burden for leading PIs, 2006 - page 119
- Table 10: Kaletra versus Reyataz trial data - page 120
- Table 11: Summary: HIV market data in the six major markets, 2005 - page 126
- Table 12: Combivir: key facts - page 127
- Table 13: Viread: key facts - page 128
- Table 14: Trizivir: key facts - page 129
- Table 15: Epivir: key facts - page 130
- Table 16: Zerit: key facts - page 131
- Table 17: Ziagen: key facts - page 132
- Table 18: Videx: key facts - page 133
- Table 19: Retrovir: key facts - page 134
- Table 20: Truvada: key facts - page 135
- Table 21: Emtriva: key facts - page 136
- Table 22: Hivid: key facts - page 137
- Table 23: Kaletra: key facts - page 138
- Table 24: Reyataz: key facts - page 139
- Table 25: Viracept: key facts - page 140
- Table 26: Norvir: key facts - page 141
- Table 27: Crixivan: key facts - page 142
- Table 28: Lexiva: key facts - page 143
- Table 29: Invirase: key facts - page 144
- Table 30: Fortovase: key facts - page 145
- Table 31: Agenerase: key facts - page 146
- Table 32: Sustiva: key facts - page 147
- Table 33: Viramune: key facts - page 148
- Table 34: Fuzeon: key facts - page 149
- List of Figures
- Figure 1: Pharmaceutical market, 2001-2005 - page 15
- Figure 2: Infectious disease markets, 2001-05 - page 16
- Figure 3: Timeline of the development of the HIV market, 1985-2015 - page 17
- Figure 4: Quarterly sales of currently marketed NRTIs ($m), Q12002-Q42005 - page 21
- Figure 5: Quarterly sales of key PIs 2002-2006 - page 27
- Figure 6: HIV host cell entry mechanism - page 28
- Figure 7: HIV market share by company, six major markets, 2002-05 - page 31
- Figure 8: Source of new HIV infections in Western Europe, 1993-2005 - page 37
- Figure 9: Transmission categories of adults and adolescents with HIV/AIDS diagnosed in the US during 2004 - page 38
- Figure 10: Effect of advances in ART on HIV survival - page 39
- Figure 11: US sales by class - page 49
- Figure 12: US sales - top 10 products 2005 - page 50
- Figure 13: France Sales by class - page 55
- Figure 14: France sales - Top 10 products 2005 - page 56
- Figure 15: Germany Sales by class - page 62
- Figure 16: Germany sales - Top 10 products 2005 - page 63
- Figure 17: Italy Sales by class - page 68
- Figure 18: Italy sales - Top 10 products 2005 - page 69
- Figure 19: Spain, Sales by class 2002-2005 - page 73
- Figure 20: Spain sales - Top 10 products 2005 - page 74
- Figure 21: UK sales by class - page 78
- Figure 22: UK sales - Top 10 products 2005 - page 78
- Figure 23: A range of bodies having an impact on drug prescription in the UK - page 81
- Figure 24: Overview of Opportunities and Threats - page 83
- Figure 25: Sales forecasts for antiretrovirals across six major markets, 2005-2015 - page 85
- Figure 26: Forecast sales for Atripla ($m), 2005-2015 - page 86
- Figure 27: Forecast sales for Aptivus and Prezista, 2002-2015 - page 90
- Figure 28: Design of the FIRST trial - page 91
- Figure 29: Tibotec historical timeline - page 107
- Figure 30: Tibotec portfolio product positioning - page 113
- Figure 31: Evolution of US PI market by sales and standard unit doses, 2003-2005 - page 116
- Figure 32: US promotional data for Kaletra and Reyataz, 2003-2005 - page 122
Other users found this report page using the following search terms: hiv ccr5 integrase invirase sales reyataz patent expiry
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.