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In 2009, HIV antiretroviral sales across the seven major markets totalled $11.8 billion, growing at a CAGR of 10.8% between 2005 and 2009. While new cross-class fixed dose combinations will ensure market growth until 2015, Datamonitor expects major patent expiries and rising pressure to reduce healthcare costs to trigger a decline in HIV sales in the second half of the forecast period until 2019.
Scope
- Analysis of the current and future market dynamics for HIV antiretrovirals across the US, 5EU and Japan, supported by insights of key opinion leaders.
- Detailed sales forecasts for the major antiretroviral classes, molecules and brands in each of the seven major markets.
- Thorough assessment of key marketed antiretroviral brands and late stage pipeline products.
- Snapshot of HIV drug sales in the Rest of World by region.
Highlights
In 2009 Atripla replaced Truvada as top-selling antiretroviral in the seven major markets, illustrating the increasing popularity of one-pill-once-a-day treatment regimens. This trend is set to intensify following the launch of Tibotec/J&J/Gilead’s Truvada/rilpivirine and Gilead’s Quad pill from 2012 onwards.
Despite predicting continuously rising sales for Prezista until 2013, Datamonitor expects protease inhibitors overall to see the highest sales loss on a class level over the forecast period due to an empty pipeline and the dominance of cross-class fixed dose combinations.
Datamonitor anticipates the increasing pressure to reduce healthcare costs to lead to more cost-control measurements across the seven major markets, resulting in enhanced possibilities for generics to penetrate the HIV drug market. This, in combination with key patent expiries, will result in a decline of HIV antiretroviral sales from 2016 onwards.
Reasons to Purchase
- Understand the changing market dynamics of HIV drugs, success factors for leading brands and the commercial potential of late stage pipeline products.
- Assess the impact of events such as patent expiries and new product launches on individual brands and the overall HIV antiretroviral market.
- Obtain full country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2010 to 2019.
Table Of contents
ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious Diseases pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY
Related reports 5
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
Market definition for this report 8
Countries and regions included in this report 8
Seven major market assessment 9
Current and future market overview 9
Total HIV antiretroviral sales set to decline over forecast period 9
Drug class analysis 13
Country analysis 24
Among the seven major markets the US will remain the largest antiretroviral market in 2019
Major patent expiries and launch of pipeline FDCs are expected to have a significant impact on HIV sales development
Patient population set to rise across seven major markets 28
US/five major EU markets: European countries not expected to follow US example to recommend higher CD4 threshold for initiation of therapy 30
US: market growth to slow by 2013 31
US healthcare reform 34
EU countries are increasingly looking to cut healthcare spending 39
Five major EU markets: later introduction of pipeline drugs will stall sales decline until after 2015
Japan: HIV market to remain small despite rising overall antiretroviral sales figures 44
Comparison with previous forecast 46
Higher impact of patent expiries on branded drugs compared to previous forecast 47
Pipeline updates include separate Truvada/rilpivirine forecast as well as discontinuation of apricitabine and new restrictions for vicriviroc 49
Rest of the world snapshot 50
CHAPTER 3 BRAND DYNAMICS
Overview of competitive landscape 55
Atripla overtook Truvada as top selling antiretroviral drug in 2009 55
Nine out of the 10 2009 top-selling drugs are set to experience major sales losses 58
Dominance of cross-class FDCs will limit chances of single agents reaching blockbuster status
New cross-class FDCs and Shionogi & Co, Ltd./ViiV Healthcare’s integrase inhibitor are most promising pipeline drugs
Marketed drugs 64
Truvada set to maintain high sales due to Sustiva patent expiry 64
Atripla (tenofovir disoproxil/emtricitabine/efavirenz, Gilead Sciences/Bristol Myers Squibb) 68
Sustiva remains Atripla’s key disadvantage enabling Truvada/rilpivirine to become the preferred cross-class FDC 70
Sustiva patent expiry will lead to a shift from Atripla back to the use of single components 72
Reyataz (atazanavir, Bristol-Myers Squibb) 74
Reyataz to be replaced by Prezista as leading protease inhibitor 74
Cobicistat has potential to rescue popularity of Reyataz and the protease inhibitor (PI) class 77
Predicted higher loss of share to Prezista and the cross-class FDCs compared to the 2009 forecast 78
Prezista (darunavir, Tibotec Pharmaceuticals/Johnson & Johnson) 79
Prezista sales to exceed those of Reyataz and Kaletra 79
No available information on development of cross-class FDCs featuring a PI 82
Isentress (raltegravir, Merck-Schering-Plough) 83
Merck’s decision to slash Isentress’s price will boost sales 84
Pipeline drugs 88
Overview of the HIV pipeline in 2010 88
The HIV pipeline is shrinking and moving towards regimens with better tolerability 88
Truvada/rilpivirine, the Quad pill and S/GSK1349572 are the only pipeline drugs expected to become top-selling HIV drugs 91
Truvada/rilpivirine (Tibotec Pharmaceuticals/Johnson & Johnson/Gilead Sciences) 94
Rilpivirine’s improved safety profile over Sustiva will enable Truvada/rilpivirine to beat Atripla in the race for best-selling cross-class FDC 95
Truvada/rilpivirine will outstrip the Quad pill’s sales due to earlier launch and questions about cobicistat’s superiority to ritonavir 96
Rilpivirine is not expected to have a significant impact as a standalone agent 97
Quad pill (tenofovir disoproxil/emtricitabine/elvitegravir/cobicistat; Gilead Sciences) 98
The Quad pill’s launch after Truvada/rilpivirine puts it at a big disadvantage 99
Unresolved questions remain about tolerability and kidney function impairment of the Quad pill’s component cobicistat 100
Cobicistat could emerge as possible successor to Norvir (ritonavir) as antiretroviral boosting agent
Elvitegravir will have little impact as a standalone integrase inhibitor 103
S/GSK1349572 (ViiV Healthcare) 105
Phase IIa study results show substantial viral load reduction with S/GSK1349572 monotherapy
In vitro studies show activity of S/GSK1349572 against raltegravir- and elvitegravir-resistant HIV strains 106
Early study results suggest S/GSK1349572 is a strong competitor to Isentress 106
Rest of the pipeline 108
BIBLIOGRAPHY 109
Journal papers 109
Websites 111
Datamonitor reports 114
APPENDIX A – MARKET ASSUMPTIONS
New product launches 115
Patent expiries 116
Data definitions, limitations and assumptions 117
Standard units 117
Derivation of sales forecasts and pricing trends 117
Forecast methodology 117
APPENDIX B
Contributing experts 118
Conferences attended 118
Report methodology 118
About Datamonitor 118
About Datamonitor Healthcare 119
About the Infectious Diseases analysis team 120
Disclaimer 122
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