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Published by: Datamonitor
Published: Jun. 17, 2009 - 56 Pages
Table of Contents ABOUT DATAMONITOR HEALTHCAREAbout the Infectious Diseases pharmaceutical analysis team CHAPTER 1 EXECUTIVE SUMMARY Strategic scoping and focus Datamonitor insight into the disease market 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 The US will remain the largest HIV market Early initiation of therapy to contribute to market growth Dynamics of first-line therapy to change but cross-class fixed dose combinations will dominate NRTI sales to decline over the next decade but Truvada will continue to grow Comparison with previous forecast Both forecasts display an overall growth in the HIV market driven by new product launches Truvada maintains a steady growth in updated forecasts Additional pipeline drugs Rest of the world snapshot Rest of the world sales accounted for 13% of global total antiretroviral sales Outside the seven major markets the Canadian market remains the largest Branded drugs are less popular in Rest of the World due to the availability of PEPFAR combinations CHAPTER 3 BRAND DYNAMICS Overview of competitive landscape The top 10 brands accounted for 80% of total antiretroviral sales in 2008 Atripla will surpass Truvada in 2009 Reyataz displaces Kaletra as leading protease inhibitor Despite being the fifth best selling antiretroviral, Epzicom sales lag behind Truvada Marketed drugs Atripla (tenofovir disoproxil/emtricitabine/efavirenz; Gilead Sciences/Bristol Myers Squibb) Atripla's dominance threatened by drugs offering better tolerability Sustiva patent expiry to shift market share back to Truvada Updated forecasts reflect the impact of the Quad Pill and Sustiva patent expiry on Atripla sales Reyataz (atazanavir; Bristol Myers Squibb) Reyataz is the new protease inhibitor class leader Reyataz being studied as part of a nucleoside sparing strategy No significant changes in new Reyataz forecasts Prezista (darunavir; Tibotec/Johnson & Johnson) ARTEMIS results win first-line approval for Prezista Isentress (raltegravir; Merck & Co) 48-week STARTMRK data confirm efficacy in treatment-naïve patients Isentress is being investigated in nucleoside sparing regimens SWITCHMRK fails to demonstrate the benefit of switching to Isentress in fully suppressed patients Updated Isentress forecasts reflect the impact of the Quad Pill Pipeline drugs Quad pill (tenofovir disoproxil/emtricitabine/ elvitegravir/GS 9350; Gilead Sciences) Elvitegravir alone is unlikely to make a significant impact on the HIV market Phase II study investigates Quad Pill in naïve patients against Atripla Atripla and Truvada to lose significant share to Quad Pill Rilpivirine (TMC278; Tibotec/Johnson & Johnson) Phase III studies investigate rilpivirine in naïve patients Rilpivirine has potential to replace Sustiva but Atripla's convenience will be tough to compete with Updated rilpivirine forecasts are similar to the previous forecasts BIBLIOGRAPHY Websites Others Datamonitor reports APPENDIX A - MARKET ASSUMPTIONS Data definitions, limitations and assumptions Standard units Japanese market data 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: Comparison of leading branded drug sales ($m) for human immunodeficiency virus (HIV) in the seven major markets and the Rest of the World (ROW), 2008 Table 2: Leading branded drug sales ($m) for human immunodeficiency virus (HIV) in the seven major markets, 2008-2018 Table 3: Key products in late-stage R&D pipeline for the treatment of human immunodeficiency virus (HIV), 2009 Table 4: Datamonitor's estimated launch dates for human immunodeficiency virus (HIV) products in the seven major markets, 2008-2017 List of Figures Figure 1: Antiretroviral sales ($m) in human immunodeficiency virus (HIV) by type of product (marketed versus pipeline) in the seven major markets, 2004-2018 Figure 2: Branded antiretroviral sales ($m) by drug class in the seven major markets, 2004-2018 Figure 3: Human immunodeficiency virus (HIV) market share by region, 2008-2018 Figure 4: Estimated number of people living with human immunodeficiency virus (HIV) in the US, 5EU and Japan, 1997-2007 Figure 5: Comparison of Datamonitor's 2008 and updated sales ($m) antiretroviral forecasts in human immunodeficiency virus (HIV) for the seven major markets, 2007-2018 Figure 6: Rest of the World versus seven major market sales ($m) split for antiretrovirals in the human immunodeficiency virus (HIV) market, 2008 Figure 7: Number of people receiving antiretroviral drugs for human immunodeficiency virus (HIV) infection in low- and middle-income countries, 2002-07 Figure 8: Annual global sales of antiretrovirals in the human immunodeficiency virus (HIV) market, 2004-08 Figure 9: Market share of leading brands in 2008 and 2018 across the seven major markets Figure 10: Datamonitor's 2008 and updated sales ($m) forecast for Atripla in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 11: Datamonitor's 2008 and updated sales ($m) forecast for Reyataz in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 12: Datamonitor's 2008 and updated sales ($m) forecast for Prezista in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 13: Datamonitor's 2008 and updated sales ($m) forecast for Isentress in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 14: Datamonitor's sales ($m) forecast for elvitegravir in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 15: Datamonitor's sales ($m) forecast for Quad Pill in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 Figure 16: Datamonitor's sales ($m) forecast for rilpivirine in human immunodeficiency virus (HIV) across the seven major markets, 2008-2018 AbstractIntroduction
In 2008, antiretroviral sales across the seven major markets totaled $10.7 billion, growing at a CAGR of 12.8% between 2005 and 2008. Datamonitor expects this expansion to slow down. Despite drivers such as new product launches, earlier treatment initiation, decreasing mortality and an increase in HIV prevalence, a series of patent expiries will impact branded sales from 2011.
Scope- Analysis of the current and future market dynamics for antiretrovirals across the US, EU, Japan, supported by KOL insights
- Detailed sales forecasts for the major antiretroviral classes, molecules and brands in each of the seven major markets.
- Assessments of the key marketed antiretroviral brands and late stage pipeline products.
- Snapshot of HIV drug sales in the Rest of World by region
Highlights
The highest selling drug in 2008 was Truvada, with revenues of $1.9 billion across the seven major markets, closely followed by Atripla with sales of $1.5 billion. Truvada's success has been driven by its popularity as the backbone of choice for highly active antiretroviral therapy (HAART) regimens across several lines of therapy.
Several drugs are currently in Phase III development, including Tibotec/Johnson & Johnson's rilpivirine, Schering-Plough's vicriviroc and Gilead's elvitegravir. In Datamonitor's opinion, rilpivirine and the Quad pill containing Truvada and elvitegravir have the strongest chance of commercial success.
Given the growing concerns over nucleoside toxicity, Datamonitor believes development of a nucleoside-sparing fixed dose combination, such as an integrase inhibitor and a protease inhibitor, may be the best strategy to challenge Gilead's market dominance.
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 antiretroviral market.
- Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2008 to 2018.
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