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Reportlinker Adds Forecast Insight: HIV - Increasing Dominance of Fixed Dose Combinations Raises Bar for Single Agents

Tuesday, August 10, 2010 AIDS/HIV News J E 4
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NEW YORK, Aug. 10 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

http://www.reportlinker.com/p0234178/Forecast-Insight-HIV-–-Increasing-dominance-of-fixed-dose-combinations-raises-bar-for-single-agents.html

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.

ABOUT DATAMONITOR HEALTHCARE 2

About the Infectious Diseases pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Related reports 5

Upcoming related reports 6

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8

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 24

Major patent expiries and launch of pipeline FDCs are expected to have a significant impact on HIV sales development 26

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 41

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 55

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 60

New cross-class FDCs and Shionogi & Co, Ltd./ViiV Healthcare's integrase inhibitor are most promising pipeline drugs 62

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 101

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 106

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 115

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 118

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

List of Tables

Table 1: Key events impacting the antiretroviral market in human immunodeficiency virus (HIV), 2010-19 27

Table 2: Impact of US healthcare reform on HIV market 37

Table 3: Leading branded drug sales for human immunodeficiency virus (HIV) in the seven major markets($m), 2009-2019 57

Table 4: Key products in late-stage R&D pipeline for human immunodeficiency virus (HIV),2010 63

Table 5: Key products in late-stage R&D pipeline for human immunodeficiency virus (HIV),2010 89

Table 6: Datamonitor's estimated launch dates for human immunodeficiency virus (HIV)in the seven major markets, 2010-19 115

Table 7: Patent expiry dates for the approved antiretrovirals in human immunodeficiency virus (HIV) in the seven major markets, 2010-2019 116

List of Figures

Figure 1: Total antiretroviral sales for human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2005-2019 10

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 12

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 13

Figure 4: Antiretroviral sales for human immunodeficiency virus (HIV) by drug class in the seven major markets ($ billion), 2005-2019 14

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 15

Figure 6: Sales of the integrase inhibitor class for human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019 16

Figure 7: Sales of the protease inhibitor (PI) class for human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019 17

Figure 8: Sales of the nucleoside reverse transcriptase inhibitor (NRTI) class in human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019 19

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 21

Figure 10: Sales of the entry inhibitor (EI) class for human immunodeficiency virus (HIV) across the seven major markets ($m), 2009-2019 23

Figure 11: Antiretroviral sales for human immunodeficiency virus (HIV) in the seven major markets by region($ billion), 2009-2019 25

Figure 12: Human immunodeficiency virus (HIV) drug market share in the seven major markets by region (%), 2009-2019 26

Figure 13: Number of people living with human immunodeficiency virus (HIV) in the seven major markets by region, 2009-2019 29

Figure 14: Antiretroviral sales in human immunodeficiency virus (HIV) in the US ($ billion), 2005-2019 32

Figure 15: Antiretroviral sales for human immunodeficiency virus (HIV) in the US by drug class ($ billion), 2009-2019 33

Figure 16: Antiretroviral sales in human immunodeficiency virus (HIV) across the five EU markets ($ billion), 2005-2019 42

Figure 17: Antiretroviral sales for human immunodeficiency virus (HIV) by country in the five major EU markets($ billion), 2009-2019 43

Figure 18: Antiretroviral sales for human immunodeficiency virus (HIV) by class in the five major EU markets ($ billion), 2009-2019 44

Figure 19: Antiretroviral sales in human immunodeficiency virus (HIV) in Japan ($m), 2009-2019 45

Figure 20: Antiretroviral sales for human immunodeficiency virus (HIV) by drug class in Japan ($m), 2009-2019 46

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 47

Figure 22: Global antiretroviral sales in human immunodeficiency virus (HIV) by region, 2009 51

Figure 23: Antiretroviral sales for human immunodeficiency virus (HIV) by region ($ billion), 2005-09 52

Figure 24: Annual global sales of antiretrovirals in human immunodeficiency virus (HIV) by region ($ billion), 2009-2019 53

Figure 25: Market share (%) of the 10 top-selling drugs for human immunodeficiency virus (HIV) across the seven major markets, 2009 56

Figure 26: Sales development of the 10 2009 top-selling antiretrovirals in human immunodeficiency virus (HIV) in the seven major markets($m), 2009-2019 60

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 61

Figure 28: Datamonitor's forecast for Truvada sales in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 68

Figure 29: Sales of Atripla, Truvada/rilpivirine and the Quad pill in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 71

Figure 30: Datamonitor's forecast for Atripla in human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2009-2019 73

Figure 31: Comparison of sales of the three leading protease inhibitors (PI) across the seven major markets and major impacting events ($m), 2009-2019 76

Figure 32: Datamonitor's sales forecast for Reyataz in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 78

Figure 33: Datamonitor's 2009 and updated sales forecast for Prezista in human immunodeficiency virus (HIV) across the seven major markets($m), 2009-2019 81

Figure 34: Datamonitor's sales forecast for Prezista in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 83

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 85

Figure 36: Datamonitor's sales forecast for Isentress in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 87

Figure 37: Datamonitor's sales forecast for Truvada/rilpivirine in human immunodeficiency virus (HIV) in the seven major markets ($ billion), 2009-2019 95

Figure 38: Datamonitor's sales forecast for rilpivirine in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 97

Figure 39: Datamonitor's sales forecast for the Quad pill in human immunodeficiency virus (HIV) across the seven major markets ($ billion), 2009-2019 99

Figure 40: Datamonitor's sales forecast for cobicistat versus Norvir (ritonavir) in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 103

Figure 41: Datamonitor's sales forecast for elvitegravir in human immunodeficiency virus (HIV) in the seven major markets ($m), 2009-2019 105

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 107

To order this report:

Therapy Industry: Forecast Insight: HIV – Increasing dominance of fixed dose combinations raises bar for single agents

Therapy Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg

Reportlinker

Email: nbo@reportlinker.com

US: (805)-652-2626

Intl: +1 805-652-2626

SOURCE Reportlinker

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