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Aug 9, 2010

Forecast Insight: HIV – Increasing dominance of fixed dose combinations raises bar for single agents now available at ReportsandReports

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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.


  • 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.


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 the Infectious Diseases pharmaceutical analysis team 2


Related reports 5

Upcoming related reports 6


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


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


Journal papers 109

Websites 111

Datamonitor reports 114


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


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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