Stakeholder Opinions: HIV in Emerging Markets (Brazil, Russia, India) - Growing need for second- and third-line therapies boosts commercial opportunity

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

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Overview 1
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
Figure 29: India: overview of the HIV landscape, 2010 65
Figure 30: India: population growth, 1995-2020 66
Figure 31: India: population spread by age group, 2010 versus 2020 67
Figure 32: India : human immunodeficiency virus (HIV) infected population and prevalence rates, 1990-2007 73
Figure 33: India: modes of human immunodeficiency virus (HIV) transmission, 2009-2010 74
Figure 34: India: antiretroviral sales by class, 2005-09 76
Figure 35: India: market share of antiretrovirals by value, 2005-09 78
Figure 36: India: market share of antiretrovirals by volume, 2005-09 79
Figure 37: India: number of patients accessing antiretroviral (ART) treatment, 2007-09 81
Figure 38: India: antiretroviral sales by manufacturer, 2005-09 88
Figure 39: India: market share of leading antiretroviral companies, 2005 and 2009 90

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