The Global Market for AIDS/HIV Testing and Treatment

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The Global Market for AIDS/HIV Testing and Treatment
Published on March 2011

Report Summary

REPORT HIGHLIGHTS

* The global HIV/AIDS market, including branded products and generics, was valued at $11.3 billion in 2010. This market is
expected to reach $11.8 billion in 2011 and increase at a 4.6% compound annual growth rate (CAGR) over the 2011-2016 forecast
period to reach $14.1 billion in 2016.
* Branded products to treat HIV/AIDS were worth nearly $10.7 billion in 2010 and should reach $11 billion in 2011. This sector is
expected to reach $13.2 billion in 2016, a compound annual growth rate (CAGR) of 4.6%.
* The market needs in the developing world are met by a number of generic suppliers. This sector is estimated to reach $690
million in 2011 and is expected to increase at a 4.4% compound annual growth rate (CAGR) to reach $830 million in 2016.

STUDY GOALS AND OBJECTIVES

The aim of this report is to provide detailed market, technology and industry analyses to help readers quantify and qualify the market
for products used in the management of HIV infection and AIDS. Important trends are identified and sales' forecasts by product
categories and major country markets are provided through 2016; these are based on industry sources and considered assessment
of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the HIV/AIDS market. The
wider economic environment is also taken into account.

REASONS FOR DOING THE STUDY

HIV/AIDS is one of the most catastrophic threats to human health throughout the world. Advanced treatment options and improved
methods of diagnosis have helped to moderate the growth of the epidemic and this has presented opportunities for companies
prepared to engage actively in this field. However, the management of HIV/AIDS is still, in many respects, an unfulfilled market and
there is an ongoing urgent need for promising new research directions as well as optimal exploitation of the treatment and diagnostic
options already developed. In this dynamic and continually evolving marketplace, there is a need for an up-to-date, comprehensive
appraisal covering both strategic and tactical options confronting the pharmaceutical industry.

SCOPE OF REPORT

This report summarizes knowledge of HIV/AIDS and discusses the present status and evolution of the global AIDS epidemic, with
analyses by selected major national markets. Latest treatment and diagnostic options and practices are described and their cost
implications clarified, especially in the context of treatment affordability in countries of widely varying economic status. The
emergence of a considerable generic medicine component in the marketplace, alongside the presence of original branded medicines,
is discussed; profiles of both originator companies and generic suppliers are included and the role of governmental and charitable
agencies explained. The current market for AIDS therapies is analyzed with breakdowns by major country and 5-year forecasts.
Finally, major ongoing research is summarized and promising directions identified.

MARKET ANALYSES AND FORECASTS

Market figures are based on revenues at the manufacturer level and are projected at 2011 dollar value without attempting to predict

The Global Market for AIDS/HIV Testing and Treatment (From Slideshare) Page 1/10


the effect of inflation/deflation.

National MARKET ANALYSES AND FORECASTS are provided for seven economically advanced countries and for five countries
classified as of low to medium economic advancement.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. Primary research included interviews with
leading individuals in pharmaceutical companies and industry associations. Primary sources of published data included company
annual reports, SEC filings, and government and industry publications. Secondary sources consisted of literature searches, industry
journals and other commercial publications. Data for market estimates and forecasts were pooled from a range of sources and
critically assessed by BCC.

INTENDED AUDIENCE

This report is designed to satisfy the information needs of a wide variety of individuals involved in the pharmaceutical marketplace,
including company senior management executives seeking to base their strategic decisions on the best available information on
market forces and trends. However, it is also aimed at managers and executives in marketing, research, planning and sales
departments who need readable, comprehensive and up-to-date background on the marketplace in which they are operating.

INFORMATION SOURCES

Sources of information included marketing strategists, industry executives, government agencies and regulatory bodies, and surveys
of physicians and pharmacists. Company annual reports and SEC filings, journal articles, and data from healthcare institutions were
also mined, as well as publications of relevant trade associations such as Pharmaceutical Journal and AIDS Research and Therapy.

ANALYST CREDENTIALS

Paul Evers has been involved in analyzing pharmaceutical and medical markets for 20 years. He is the author of previous reports on
the HIV/AIDS marketplace as well as analyses of major therapeutic categories and the pharmaceutical regulatory environment.

Table of Content

CHAPTER ONE: INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 1
MARKET ANALYSES AND FORECASTS 2
INTENDED AUDIENCE 2
INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER TWO: SUMMARY 4
HIV/AIDS 4
ECONOMIC REALITIES 4



PHARMACEUTICAL SUPPLIERS 5
SUMMARY TABLE ARV MARKET ESTIMATES AND FORECASTS,
THROUGH 2016 ($ MILLIONS) 5
SUMMARY FIGURE ARV MARKET ESTIMATES AND FORECASTS,
2010-2016 ($ MILLIONS) 6
CHAPTER THREE: OVERVIEW: BRIEFING ON HIV AND AIDS 7
ORIGINS OF HIV 7
THE VIRUS 8
SUBTYPES OF HIV-1 9
THE STRUCTURE OF HIV 9
NINE GENES 9
VIRAL LIFE-CYCLE 10
REVERSE TRANSCRIPTION AND INTEGRATION 10
TRANSCRIPTION AND TRANSLATION 10
FROM HIV TO AIDS 11
TABLE 1 RELATIONSHIP BETWEEN VIRAL LOAD AND AIDS RISK 12
DIAGNOSIS 12
DIAGNOSIS (CONTINUED) 13
TREATMENT 14
TREATMENT (CONTINUED) 15
DISEASE PROGRESSION 16
SYMPTOMS AND SIGNS 16
A NOTE ON TRANSMISSION 17
A NOTE ON TRANSMISSION (CONTINUED) 18
CHAPTER FOUR: UPDATE ON THE AIDS PANDEMIC 19
TABLE 2 MILESTONES IN THE HISTORY OF HIV/AIDS 19
TABLE 2 (CONTINUED) 20
REGIONAL OVERVIEW 20
SUB-SAHARAN AFRICA 21
ASIA 21
CARIBBEAN 22
EASTERN EUROPE AND CENTRAL ASIA 22
NORTH AFRICA AND THE MIDDLE EAST 22
CENTRAL AND SOUTH AMERICA 22
NORTH AMERICA, OCEANIA AND WESTERN AND
CENTRAL EUROPE 23
FIGURE 1 DISTRIBUTION OF HIV BY REGION, 2009 24
CHAPTER FIVE: CURRENT TREATMENT AND PIPELINE 25
CURRENT ARV DRUGS 25
TABLE 3 APPROVED ANTI-HIV DRUGS 26
CHOOSING THE COMBINATION 27
FIRST- AND SECOND-LINE THERAPY 27
RECENTLY APPROVED DRUGS AND THE RESEARCH PIPELINE 28
ENTRY INHIBITORS 28
INTEGRASE INHIBITORS 29
MATURATION INHIBITORS 29
NNRTIS 29
NRTI 30



NRTI (Continued) 31
AN INTRIGUING POSSIBILITY 32
BUT A MYSTERY REMAINS 32
But a Mystery Remains (Continued) 33
CHAPTER SIX: GLOBAL AND NATIONAL MARKETS 34
EVOLUTION OF THE MARKET 34
THE GLOBAL FUND 34
ENTER THE GENERICS 35
FIGURE 2 EFFECT OF GENERIC COMPETITION ON ARV BRAND
PRICES 36
WHAT PRICE PATENTS' 36
AVOIDING CONFRONTATION WITH PHARMA MAJORS 37
Tiered Pricing 38
Voluntary and Compulsory Licensing 39
MARKET ESTIMATES AND FORECASTS 39
THE HIV/AIDS MARKET BY REGIONS AND COUNTRIES 40
NORTH AMERICA 40
United States 40
United States (Continued) 41
Current Status 42
FIGURE 3 DISTRIBUTION OF AIDS CASES ACROSS THE US 43
TABLE 4 CURRENT AND FORECAST ARV MARKET IN THE US,
THROUGH 2016 ($000) 44
LATIN AMERICA 44
Latin America (Continued) 45
Brazil 46
Current Status 46
TABLE 5 CURRENT AND FORECAST ARV MARKET IN BRAZIL,
THROUGH 2016 ($000) 47
Argentina 47
TABLE 6 CURRENT AND FORECAST ARV MARKET IN ARGENTINA,
THROUGH 2016 ($000) 48
Mexico 48
TABLE 7 CURRENT AND FORECAST ARV MARKET IN MEXICO,
THROUGH 2016 ($000) 49
SOURCE: BCC RESEARCH 49
ASIA 49
Japan 50
TABLE 8 CURRENT AND FORECAST ARV MARKET IN JAPAN,
THROUGH 2016 ($000) 51
Source: BCC Research 51
Republic of Korea 51
TABLE 9 CURRENT AND FORECAST ARV MARKET IN REPUBLIC
OF KOREA, THROUGH 2016 ($000) 52
India 52
Distribution 53
Andhra Pradesh 53
Goa 54



Karnataka 54
Maharashtra 54
Tamil Nadu 54
Manipur 54
ARV Availability 55
TABLE 10 CURRENT AND FORECAST ARV MARKET IN INDIA,
THROUGH 2016 ($000) 56
China 56
FIGURE 4 REGIONAL DISTRIBUTION OF HIV IN CHINA 57
Treatment 58
Current Situation 58
TABLE 11 CURRENT AND FORECAST ARV MARKET IN CHINA,
THROUGH 2016 ($000) 59
Thailand 59
TABLE 12 CURRENT AND FORECAST ARV MARKET IN THAILAND,
THROUGH 2016 ($000) 60
EUROPE 61
FIGURE 5 HIV RATES ACROSS EUROPE 61
Germany 62
Challenges 63
TABLE 13 CURRENT AND FORECAST ARV MARKET IN GERMANY,
THROUGH 2016 ($000) 64
France 64
TABLE 14 CURRENT AND FORECAST ARV MARKET IN FRANCE,
THROUGH 2016 ($000) 65
Italy 65
TABLE 15 CURRENT AND FORECAST ARV MARKET IN ITALY,
THROUGH 2016 ($000) 66
United Kingdom 66
TABLE 16 CURRENT AND FORECAST ARV MARKET IN UK,
THROUGH 2016 ($000) 67
Spain 67
TABLE 17 CURRENT AND FORECAST ARV MARKET IN SPAIN,
THROUGH 2016 ($000) 68
CENTRAL AND EASTERN EUROPE 69
Czech Republic 69
TABLE 18 CURRENT AND FORECAST ARV MARKET IN CZECH
REPUBLIC, THROUGH 2016 ($000) 70
Poland 70
TABLE 19 CURRENT AND FORECAST ARV MARKET IN POLAND,
THROUGH 2016 ($000) 71
Hungary 72
TABLE 20 CURRENT AND FORECAST ARV MARKET IN HUNGARY,
THROUGH 2016 ($000) 72
Russian Federation 72
Russian Federation (Continued) 73
TABLE 21 CURRENT AND FORECAST ARV MARKET IN RUSSIA,
THOUGH 2016 ($000) 74



AFRICA 74
South Africa 74
TABLE 22 CURRENT AND FORECAST ARV MARKET IN SOUTH
AFRICA, THROUGH 2016 ($000) 75
CHAPTER SEVEN: MARKET ANALYSIS BY PRODUCTS AND
COMPANIES 76
PRODUCTS 76
TABLE 23 PRODUCT PROFILE: RETROVIR 76
TABLE 24 PRODUCT PROFILE: VIRAMUNE 77
TABLE 25 PRODUCT PROFILE: ZERIT 78
TABLE 26 PRODUCT PROFILE: EPIVIR 78
TABLE 27 PRODUCT PROFILE: INVIRASE 79
TABLE 28 PRODUCT PROFILE: NORVIR 80
TABLE 29 PRODUCT PROFILE: CRIXIVAN 81
TABLE 30 PRODUCT PROFILE: VIRACEPT 81
TABLE 31 PRODUCT PROFILE: RESCRIPTOR 82
TABLE 32 PRODUCT PROFILE: SUSTIVA 83
TABLE 33 PRODUCT PROFILE: ZIAGEN 84
TABLE 34 PRODUCT PROFILE: VIDEX 84
TABLE 35 PRODUCT PROFILE: VIREAD 85
TABLE 36 PRODUCT PROFILE: FUZEON 86
TABLE 37 PRODUCT PROFILE: REYATAZ 86
TABLE 38 PRODUCT PROFILE: EMTRIVA 87
TABLE 39 PRODUCT PROFILE: LEXIVA 88
TABLE 40 PRODUCT PROFILE: APTIVUS 88
TABLE 41 PRODUCT PROFILE: PREZISTA 89
TABLE 42 PRODUCT PROFILE: SELZENTRY 89
TABLE 43 PRODUCT PROFILE: ISENTRESS 90
TABLE 44 PRODUCT PROFILE: INTELENCE 91
COMBINATION ANTIVIRALS 91
TABLE 45 PRODUCT PROFILES: ANTIVIRAL COMBINATIONS 92
MARKET PENETRATION BY PRODUCT 92
TABLE 46 SALES OF ANTIRETROVIRAL PRODUCTS, 2008-2010 ($
MILLIONS, % CHANGE) 93
TABLE 47 FIRST PATENT EXPIRIES ON ARV PRODUCTS, 2011-2016 94
TABLE 48 MARKET FOR ARV PRODUCTS, THROUGH 2016 ($
MILLIONS) 95
MARKET SHARE BY COMPANY 95
FIGURE 6 ARV COMPANY SHARES, 2010 (%) 96
THE GENERIC SECTOR 96
The Generic Sector (Continued) 97
CHAPTER EIGHT: COMPANY PROFILES 98
MAJOR PHARMACEUTICAL COMPANIES 98
ABBOTT LABORATORIES 98
BOEHRINGER INGELHEIM GMBH 99
BRISTOL-MYERS SQUIBB 100
GILEAD SCIENCES INC 101
GLAXOSMITHKLINE PLC 102



MERCK & CO INC 103
PFIZER INC 104
TIBOTEC BABE 105
VIIV HEALTHCARE 106
THE GENERICS SECTOR 107
AJANTA PHARMA (MAURITIUS) LIMITED 107
CIPLA LTD 108
THE GOVERNMENT PHARMACEUTICAL ORGANIZATION 109
HETERO DRUGS LTD 110
KOREA UNITED PHARMACEUTICALS INC 111
LABORATORIOS RICHMOND SA 111
MEDOPHARM 112
RANBAXY LABORATORIES LIMITED 113
SRS PHARMACEUTICALS 114
STRIDES ARCOLAB 115
TABLE 49 STRIDES ARV PRODUCTS 115
VAISHNAVI LIFESCIENCE PVT LTD 116
CHAPTER NINE: VACCINE DEVELOPMENTS 117
VAXGEN 117
CELL-MEDIATED IMMUNITY 118
MERCK CANDIDATE 118
THAILAND STUDY 119
REASONS FOR OPTIMISM' 120
GEOVAX CANDIDATE 120
BIO-NOR CANDIDATE 120
FIT BIOTECH APPROACH 121
TIME IS NOT ON OUR SIDE 122
TIME IS NOT ON OUR SIDE (CONTINUED) 123
CHAPTER TEN: HIV TESTING: BACKGROUND AND MARKET 124
ANTIBODY TESTS 124
ELISA 124
WESTERN BLOT 124
INTERPRETING ANTIBODY TESTS 125
OTHER TESTS 126
P24 ANTIGEN TEST 126
NUCLEIC ACID BASED TESTS (NAT) 126
CD4 TEST 127
HOME TESTING 128
Home Access Express HIV-1 Test 128
OraQuick 129
Orasure 129
Uni-Gold 129
Clearview Complete HIV 1/2 and Clearview HIV 1/2 Stat-
Pak 129
INSTI HIV-1/HIV-2* Rapid Antibody Test 129
Reveal HIV 129
TABLE 50 COMPARISON OF HIV HOME SAMPLING AND HOME



TESTING SERVICES 130
THE TESTING MARKET 130
TABLE 51 RAPID HIV TEST PRODUCTS 131
TABLE 52 HIV TESTING MARKET FORECAST, THROUGH 2016 ($
MILLIONS) 133
TABLE 53 REGIONAL SHARES OF HIV TESTING MARKET,
THROUGH 2016 ($ MILLIONS) 133
COMPANIES INVOLVED IN HIV TESTING 134
ABBOTT DIAGNOSTICS 134
BIOMÉRIEUX SA 135
Prevention/Diagnosis 135
Monitoring 136
BIO-RAD LABORATORIES INC 136
CALYPTE BIOMEDICAL CORPORATION 137
CELERA GROUP 137
GEN-PROBE INC 138
INNOGENETICS NV 139
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 140
MEDMIRA LABORATORIES INC 140
ORASURE TECHNOLOGIES INC 141
ORTHO-CLINICAL DIAGNOSTICS INC 142
ROCHE DIAGNOSTICS 143
SIEMENS HEALTHCARE DIAGNOSTICS INC 144
APPENDIX ONE: GLOSSARY 145
APPENDIX ONE 145
APPENDIX ONE (CONTINUED) 146
APPENDIX ONE (CONTINUED) 147
APPENDIX TWO: THE HUMAN IMMUNE SYSTEM 148
APPENDIX TWO 148
LYMPHOCYTES 149
KILLER AND HELPER T CELLS 149
IMMUNODEFICIENCY 150
APPENDIX THREE: VIRUSES 151
APPENDIX THREE 151
DNA VIRUSES 152
RNA VIRUSES 152
REVERSE TRANSCRIBING VIRUSES 153
HOST DEFENSE MECHANISMS 153
PREVENTION AND TREATMENT 154


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