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Forecast Insight: HIV - Increasing dominance of fixed dose combinations raises bar for single agents

Description:
Introduction

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.
 
Contents:
CHAPTER 1 EXECUTIVE SUMMARY
Related reports
Upcoming related reports
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
Market definition for this report
Countries and regions included in this report
Seven major market assessment
Current and future market overview
Total HIV antiretroviral sales set to decline over forecast period
Drug class analysis
Country analysis
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
US/five major EU markets: European countries not expected to follow US example to recommend higher CD4 threshold for initiation of therapy
US: market growth to slow by 2013
US healthcare reform
EU countries are increasingly looking to cut healthcare spending
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
Comparison with previous forecast
Higher impact of patent expiries on branded drugs compared to previous forecast
Pipeline updates include separate Truvada/rilpivirine forecast as well as discontinuation of apricitabine and new restrictions for vicriviroc
Rest of the world snapshot
CHAPTER 3 BRAND DYNAMICS
Overview of competitive landscape
Atripla overtook Truvada as top selling antiretroviral drug in 2009
Nine out of the 10 2009 top-selling drugs are set to experience major sales losses
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
Truvada set to maintain high sales due to Sustiva patent expiry
Atripla (tenofovir disoproxil/emtricitabine/efavirenz, Gilead Sciences/Bristol Myers Squibb)
Sustiva remains Atripla's key disadvantage enabling Truvada/rilpivirine to become the preferred cross-class FDC
Sustiva patent expiry will lead to a shift from Atripla back to the use of single components
Reyataz (atazanavir, Bristol-Myers Squibb)
Reyataz to be replaced by Prezista as leading protease inhibitor
Cobicistat has potential to rescue popularity of Reyataz and the protease inhibitor (PI) class
Predicted higher loss of share to Prezista and the cross-class FDCs compared to the 2009 forecast
Prezista (darunavir, Tibotec Pharmaceuticals/Johnson & Johnson)
Prezista sales to exceed those of Reyataz and Kaletra
No available information on development of cross-class FDCs featuring a PI
Isentress (raltegravir, Merck-Schering-Plough)
Merck's decision to slash Isentress's price will boost sales
Pipeline drugs
Overview of the HIV pipeline in 2010
The HIV pipeline is shrinking and moving towards regimens with better tolerability
Truvada/rilpivirine, the Quad pill and S/GSK1349572 are the only pipeline drugs expected to become top-selling HIV drugs
Truvada/rilpivirine (Tibotec Pharmaceuticals/Johnson & Johnson/Gilead Sciences)
Rilpivirine's improved safety profile over Sustiva will enable Truvada/rilpivirine to beat Atripla in the race for best-selling cross-class FDC
Truvada/rilpivirine will outstrip the Quad pill's sales due to earlier launch and questions about cobicistat's superiority to ritonavir
Rilpivirine is not expected to have a significant impact as a standalone agent
Quad pill (tenofovir disoproxil/emtricitabine/elvitegravir/cobicistat; Gilead Sciences)
The Quad pill's launch after Truvada/rilpivirine puts it at a big disadvantage
Unresolved questions remain about tolerability and kidney function impairment of the Quad pill's component cobicistat
Cobicistat could emerge as possible successor to Norvir (ritonavir) as antiretroviral boosting agent
Elvitegravir will have little impact as a standalone integrase inhibitor
S/GSK1349572 (ViiV Healthcare)
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
Early study results suggest S/GSK1349572 is a strong competitor to Isentress
Rest of the pipeline
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS
New product launches
Patent expiries
Data definitions, limitations and assumptions
Standard units
Derivation of sales forecasts and pricing trends
Forecast methodology
APPENDIX B
Contributing experts
Conferences attended
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Infectious Diseases analysis team
Disclaimer
List of Tables
Table 1: Key events impacting the antiretroviral market in human immunodeficiency virus (HIV), 2010-19
Table 2: Impact of US healthcare reform on HIV market
Table 3: Leading branded drug sales for human immunodeficiency virus (HIV) in the seven major markets($m), 2009-2019
Table 4: Key products in late-stage R&D pipeline for human immunodeficiency virus (HIV),2010
Table 5: Key products in late-stage R&D pipeline for human immunodeficiency virus (HIV),2010
Table 6: Datamonitor's estimated launch dates for human immunodeficiency virus (HIV)in the seven major markets, 2010-19
Table 7: Patent expiry dates for the approved antiretrovirals in human immunodeficiency virus (HIV) in the seven major markets, 2010-2019
List of Figures
Figure 1: Total antiretroviral sales for human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2005-2019
Figure 2: Antiretroviral sales for human immunodeficiency virus (HIV) in the seven major markets by type of product (marketed versus pipeline versus generics) ($ billion), 2009-2019
Figure 3: Antiretroviral market share (%) for human immunodeficiency virus (HIV) in the seven major markets by type of product (marketed versus pipeline versus generics), 2009-2019
Figure 4: Antiretroviral sales for human immunodeficiency virus (HIV) by drug class in the seven major markets ($ billion), 2005-2019
Figure 5: Sales of the cross-class fixed dose combination (FDC) class for human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019
Figure 6: Sales of the integrase inhibitor class for human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019
Figure 7: Sales of the protease inhibitor (PI) class for human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019
Figure 8: Sales of the nucleoside reverse transcriptase inhibitor (NRTI) class in human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019
Figure 9: Sales of the non nucleoside reverse transcriptase inhibitor (NNRTI) class for human immunodeficiency virus (HIV) across the seven major markets ($m), 2009-2019
Figure 10: Sales of the entry inhibitor (EI) class for human immunodeficiency virus (HIV) across the seven major markets ($m), 2009-2019
Figure 11: Antiretroviral sales for human immunodeficiency virus (HIV) in the seven major markets by region($ billion), 2009-2019
Figure 12: Human immunodeficiency virus (HIV) drug market share in the seven major markets by region (%), 2009-2019
Figure 13: Number of people living with human immunodeficiency virus (HIV) in the seven major markets by region, 2009-2019
Figure 14: Antiretroviral sales in human immunodeficiency virus (HIV) in the US ($ billion), 2005-2019
Figure 15: Antiretroviral sales for human immunodeficiency virus (HIV) in the US by drug class ($ billion), 2009-2019
Figure 16: Antiretroviral sales in human immunodeficiency virus (HIV) across the five EU markets ($ billion), 2005-2019
Figure 17: Antiretroviral sales for human immunodeficiency virus (HIV) by country in the five major EU markets($ billion), 2009-2019
Figure 18: Antiretroviral sales for human immunodeficiency virus (HIV) by class in the five major EU markets ($ billion), 2009-2019
Figure 19: Antiretroviral sales in human immunodeficiency virus (HIV) in Japan ($m), 2009-2019
Figure 20: Antiretroviral sales for human immunodeficiency virus (HIV) by drug class in Japan ($m), 2009-2019
Figure 21: Comparison of Datamonitor's 2009 and updated 2010 antiretroviral forecasts in human immunodeficiency virus (HIV) for the seven major markets ($ billion), 2009-2019
Figure 22: Global antiretroviral sales in human immunodeficiency virus (HIV) by region, 2009
Figure 23: Antiretroviral sales for human immunodeficiency virus (HIV) by region ($ billion), 2005-09
Figure 24: Annual global sales of antiretrovirals in human immunodeficiency virus (HIV) by region ($ billion), 2009-2019
Figure 25: Market share (%) of the 10 top-selling drugs for human immunodeficiency virus (HIV) across the seven major markets, 2009
Figure 26: Sales development of the 10 2009 top-selling antiretrovirals in human immunodeficiency virus (HIV) in the seven major markets($m), 2009-2019
Figure 27: Market share (%) of antiretrovirals in human immunodeficiency virus (HIV) that are expected to achieve sales of $400m across the seven major markets, 2019
Figure 28: Datamonitor's forecast for Truvada sales in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 29: Sales of Atripla, Truvada/rilpivirine and the Quad pill in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 30: Datamonitor's forecast for Atripla in human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2009-2019
Figure 31: Comparison of sales of the three leading protease inhibitors (PI) across the seven major markets and major impacting events ($m), 2009-2019
Figure 32: Datamonitor's sales forecast for Reyataz in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 33: Datamonitor's 2009 and updated sales forecast for Prezista in human immunodeficiency virus (HIV) across the seven major markets($m), 2009-2019
Figure 34: Datamonitor's sales forecast for Prezista in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 35: Datamonitor's 2009 and updated sales forecast ($m) for Isentress in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 36: Datamonitor's sales forecast for Isentress in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 37: Datamonitor's sales forecast for Truvada/rilpivirine in human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2009-2019
Figure 38: Datamonitor's sales forecast for rilpivirine in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 39: Datamonitor's sales forecast for the Quad pill in human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019
Figure 40: Datamonitor's sales forecast for cobicistat versus Norvir (ritonavir) in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 41: Datamonitor's sales forecast for elvitegravir in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019
Figure 42: Datamonitor's sales forecast for S/GSK1349572 compared to Isentress in human immunodeficiency virus (HIV) across the seven major markets($m), 2009-2019
 
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