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Introduction
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

For more information please visit :

http://www.aarkstore.com/reports/Stakeholder-Opinions-HIV-in-Emerging-Markets-Brazil-Russia-India-Growing-need-for-second-and-third-line-therapies-boosts-commercial-opportunity-45614.html

by: Aarkstore Enterprise




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