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Introduction
Faced with limited growth opportunities in western markets, HIV drug developers are looking to expand into emerging markets, marked by a higher disease burden and greater medical unmet need. Efforts to improve treatment coverage coupled with a growing affluent middle class and private sector have turned countries like Brazil, Russia or India into a promising commercial opportunity.
Scope
*Analysis of current HIV market dynamics across Brazil, Russia and India
*Thorough assessment of underlying commercial and clinical factors, opportunities and threats shaping the antiretroviral market in these regions
*Review of sales trends and brand dynamics of key branded and generic agents
*Discussion of key domestic HIV drug makers as well as the position of major international players
Highlights
Brazil has one of most successful treatment programs for HIV-infected individuals, providing free access to HIV prevention and care. Despite challenges for international HIV drug makers arising from local competitors and compulsory licensing, growing concerns over drug resistance and intolerance are creating new revenue opportunities.
In Russia, HIV remained a low priority issue for several years but the situation has recently improved and the level of funding for treatment has increased. Given the lower level of generic incursion, there is significant opportunity for branded drugs due to the size of the epidemic, particularly as patients progress to late stage therapy.
Although the Indian HIV market is highly genericized, the introduction of the 2005 Patent Act could lead to improvements in intellectual property protection for global companies with branded products, illustrated by recent approvals for the patents of Selzentry, Isentress and Intelence in India.
Reasons to Purchase
*Identify key opportunities that will impact the use and uptake of new and existing HIV antiretrovirals
*Gain insight into the market environment for HIV antiretrovirals through a review of demographic, economic, regulatory and treatment trends
*Gain competitive advantage by identifying key HIV players, product characteristics and potential roles for new therapies
Table of Contents : Catalyst 1 Summary 1 About Datamonitor healthcare 2 About the Infectious Diseases pharmaceutical analysis team 2 Executive Summary 3 Scope of the analysis 3 Datamonitor insight into the HIV market 3 Related reports 6 Upcoming reports 6 Table of Contents 7 1. Brazil 7 Key findings 7 General characteristics 8 Demographics 8 Economics 10 Healthcare expenditure and access 11 Regulatory procedures 14 Drug approval process 14 New drug approvals must be registered with ANVISA 14 Imported pharmaceuticals have to be registered with ANVISA 15 Drug pricing 15 Pricing of new drugs is controlled by the CMED 15 Prices of marketed pharmaceuticals are controlled through price freezes and increases 16 Intellectual property protection 17 The HIV market in Brazil 17 Epidemiological trends 17 Current market situation 19 Historic development and access to antiretroviral therapy 25 Treatment guidelines and recommendations 26 Opportunities 28 Increase in number of patients accessing treatment 28 Resistance and intolerance creates a need for novel therapies 29 Increased financing for novel antiretroviral drugs 29 Threats 31 The threat of compulsory licensing reduces the attractiveness of the Brazilian market 31 Growing cost pressures may lead to a cut in the medication budget 32 Key HIV players in Brazil 32 General overview 32 Multinational corporations 35 Local manufacturers 36 Farmanguinhos 36 Blausiegel 37 Key conclusions for Brazil 37 2. Russia 38 Key findings 38 General characteristics 39 Demographics 39 Economics 41 Healthcare expenditure and access 42 Regulatory procedures 45 Drug approval process 45 Drug pricing 46 Intellectual property protection 47 The HIV market in Russia 47 Epidemiological trends 47 Current market situation 51 Historic development and access to antiretroviral therapy 54 Treatment guidelines and recommendations 56 Opportunities and threats 57 Opportunities 57 Level of funding for HIV programs has increased 57 The Russian market is dominated by branded antiretrovirals 57 Threats 58 Stigma associated with HIV infection restricts the number of patients accessing therapy 58 There is an increasing pressure on pharmaceutical companies to reduce antiretroviral prices 59 Key HIV players in the Russian Federation 60 General overview 60 Multinational corporations 61 GlaxoSmithKline dominates the Russian antiretrovirals market 61 Tibotec has strengthened its presence in the Russian market 62 Local manufacturers 62 Key conclusions for Russia 63 3. India 64 Key findings 64 General characteristics 65 Demographics 65 Economics 67 Healthcare expenditure and access 68 Regulatory procedures 70 Drug approval process 71 Drug pricing 71 Intellectual property protection 72 The HIV market in India 72 Epidemiological trends 72 Current market overview 74 Historic development and access to antiretroviral therapy 79 Treatment guidelines 82 First-line therapy recommendations 82 Recommendations for switching therapy due to intolerance or treatment failure 83 Opportunities and threats 84 Opportunities 84 Patents granted for Selzentry, Isentress and Intelence indicating a potential shift in IP environment 84 Voluntary licenses and patent pooling 84 Growing need for second-line treatment 85 Threats 86 Low treatment coverage rates 86 India is benefiting from compulsory licenses for HIV/AIDS drugs in other countries 86 Key HIV players in India 87 General overview 87 Multinational corporations 88 Gilead Sciences 89 GlaxoSmithKline 89 Bristol-Myers Squibb 89 Local manufacturers 90 Cipla 90 Emcure 92 Genx Pharma 93 Key conclusions for India 94 Bibliography 95 Journals 95 Websites 96 Others 99 Datamonitor reports 102 Appendix A 103 Data definitions, limitations and assumptions 103 Standard units 103 Country group definitions 103 Rest of European Union 103 Middle East and North Africa (MENA) 103 Rest of World 103 Appendix B 104 Contributing experts 104 Conferences attended 104 Report methodology 104 About Datamonitor 105 About Datamonitor Healthcare 105 About the Infectious Diseases analysis team 106 Disclaimer 108 List of Tables Table 1: Brazil: key economic indicators, 2007-09 11 Table 2: Brazil: healthcare expenditure indicators, 2006 12 Table 3: Brazil: key health system indicators, 2006 13 Table 4: Brazil: top 10 causes of mortality, 2004 14 Table 5: Brazil: cost of different antiretroviral regimens for adult formulations per patient per year (US$), 2006 26 Table 6: Brazil: Farmanguinhos antiretrovirals portfolio 36 Table 7: Russia: key economic indicators, 2007-09 42 Table 8: Russia: healthcare expenditure indicators, 2006 44 Table 9: Russia: key health system indicators, 2006 44 Table 10: Russia: top 10 causes of mortality, 2004 45 Table 11: India: key economic indicators, 2007-09 68 Table 12: India: healthcare expenditure indicators, 2006 69 Table 13: India: key health system indicators, 2006 69 Table 14: India: top 10 causes of mortality, 2004 70 Table 15: India: Cipla's antiretroviral portfolio, 2010 91 Table 16: India: Emcure's antiretroviral portfolio, 2010 93 List of Figures Figure 1: Brazil: overview of the HIV landscape, 2010 8 Figure 2: Brazil: population growth, 1995-2020 9 Figure 3: Brazil: population spread by age group, 2010 versus 2020 10 Figure 4: Brazil : human immunodeficiency virus (HIV) infected population and prevalence rates, 1990-2007 18 Figure 5: Brazil: acquired immune deficiency syndrome (AIDS)-related morality rates, 1990-2007 19 Figure 6: Brazil: antiretroviral sales by class, 2005-09 20 Figure 7: Brazil: market share of antiretrovirals, 2005-09 21 Figure 8: Brazil: prescription trends for nucleoside reverse transcriptase inhibitors, 1997-2005 23 Figure 9: Brazil: prescription trends for non-nucleoside reverse transcriptase inhibitors, 1997-2005 24 Figure 10: Brazil: prescription trends for protease inhibitors, 1997-2005 25 Figure 11: Brazil: number of patients accessing human immunodeficiency virus (HIV) infection treatment, 1997-2008 26 Figure 12: Brazil: recommendations for first-line regimens in the treatment of human immunodeficiency virus (HIV) infection, 2010 28 Figure 13: Brazil: total investment in antiretroviral drugs and average number of patients on therapy (US$m) , 1997-2005 30 Figure 14: Brazil: trends in the distribution of antiretroviral drug costs between local and multinational production, 1999-2005 33 Figure 15: Brazil: antiretroviral sales by manufacturer, 2005-09 34 Figure 16: Brazil: market share of leading antiretroviral companies, 2005 and 2009 35 Figure 17: Russia: overview of the HIV landscape, 2010 39 Figure 18: Russia: population growth, 1995-2020 40 Figure 19: Russia: population spread by age group, 2010 versus 2020 41 Figure 20: Russia: human immunodeficiency virus (HIV) infected population and prevalence rates, 1990-2007 48 Figure 21: Russia: acquired immune deficiency syndrome (AIDS)-related morality rates, 1990-2007 49 Figure 22: Russia: distribution of registered human immunodeficiency virus (HIV) cases by main risk factors, 1987-2007 50 Figure 23: Russia: antiretroviral sales by class, 2005-09 52 Figure 24: Russia: market share of antiretrovirals by sales, 2005-09 53 Figure 25: Russia: market share of antiretrovirals by volume, 2005-09 54 Figure 26: Russia: number of patients accessing human immunodeficiency virus (HIV) infection treatment, 2004-08 59 Figure 27: Russia: antiretroviral sales by manufacturer, 2005-09 60 Figure 28: Russia: market share of leading antiretroviral companies, 2005 and 2009 61
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