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Forecast Insight: HIV - Cross-Class Fixed Dose Combinations Drive Continued Growth

Published by: Datamonitor

Published: Jun. 17, 2009 - 56 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About 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

Abstract

Introduction

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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