CHAPTER FOUR: UPDATE ON THE AIDS PANDEMIC TABLE 2 MILESTONES IN THE HISTORY OF HIV/AIDS TABLE 2 (CONTINUED) REGIONAL OVERVIEW...

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Peter Jerome Howard
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1 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, ($ MILLIONS)... 6 CHAPTER THREE: OVERVIEW: BRIEFING ON HIV AND AIDS... 7 ORIGINS OF HIV... 7 THE VIRUS... 8 SUBTYPES OF HIV THE STRUCTURE OF HIV... 9 NINE GENES... 9 VIRAL LIFE-CYCLE REVERSE TRANSCRIPTION AND INTEGRATION TRANSCRIPTION AND TRANSLATION FROM HIV TO AIDS TABLE 1 RELATIONSHIP BETWEEN VIRAL LOAD AND AIDS RISK DIAGNOSIS DIAGNOSIS (CONTINUED) TREATMENT TREATMENT (CONTINUED) DISEASE PROGRESSION SYMPTOMS AND SIGNS A NOTE ON TRANSMISSION A NOTE ON TRANSMISSION (CONTINUED) CHAPTER FOUR: UPDATE ON THE AIDS PANDEMIC TABLE 2 MILESTONES IN THE HISTORY OF HIV/AIDS TABLE 2 (CONTINUED) REGIONAL OVERVIEW... 20

2 SUB-SAHARAN AFRICA ASIA CARIBBEAN EASTERN EUROPE AND CENTRAL ASIA NORTH AFRICA AND THE MIDDLE EAST CENTRAL AND SOUTH AMERICA NORTH AMERICA, OCEANIA AND WESTERN AND CENTRAL EUROPE FIGURE 1 DISTRIBUTION OF HIV BY REGION, CHAPTER FIVE: CURRENT TREATMENT AND PIPELINE CURRENT ARV DRUGS TABLE 3 APPROVED ANTI-HIV DRUGS CHOOSING THE COMBINATION FIRST- AND SECOND-LINE THERAPY RECENTLY APPROVED DRUGS AND THE RESEARCH PIPELINE ENTRY INHIBITORS INTEGRASE INHIBITORS MATURATION INHIBITORS NNRTIS NRTI NRTI (Continued) AN INTRIGUING POSSIBILITY BUT A MYSTERY REMAINS But a Mystery Remains (Continued) CHAPTER SIX: GLOBAL AND NATIONAL MARKETS EVOLUTION OF THE MARKET THE GLOBAL FUND ENTER THE GENERICS FIGURE 2 EFFECT OF GENERIC COMPETITION ON ARV BRAND PRICES WHAT PRICE PATENTS? AVOIDING CONFRONTATION WITH PHARMA MAJORS Tiered Pricing Voluntary and Compulsory Licensing MARKET ESTIMATES AND FORECASTS THE HIV/AIDS MARKET BY REGIONS AND COUNTRIES NORTH AMERICA United States United States (Continued) Current Status FIGURE 3 DISTRIBUTION OF AIDS CASES ACROSS THE U.S TABLE 4 CURRENT AND FORECAST ARV MARKET IN THE U.S., THROUGH 2016 ($000)... 44

3 LATIN AMERICA Latin America (Continued) Brazil Current Status TABLE 5 CURRENT AND FORECAST ARV MARKET IN BRAZIL, THROUGH 2016 ($000) Argentina TABLE 6 CURRENT AND FORECAST ARV MARKET IN ARGENTINA, THROUGH 2016 ($000) Mexico TABLE 7 CURRENT AND FORECAST ARV MARKET IN MEXICO, THROUGH 2016 ($000) SOURCE: BCC RESEARCH ASIA Japan TABLE 8 CURRENT AND FORECAST ARV MARKET IN JAPAN, THROUGH 2016 ($000) Source: BCC Research Republic of Korea TABLE 9 CURRENT AND FORECAST ARV MARKET IN REPUBLIC OF KOREA, THROUGH 2016 ($000) India Distribution Andhra Pradesh Goa Karnataka Maharashtra Tamil Nadu Manipur ARV Availability TABLE 10 CURRENT AND FORECAST ARV MARKET IN INDIA, THROUGH 2016 ($000) China FIGURE 4 REGIONAL DISTRIBUTION OF HIV IN CHINA Treatment Current Situation TABLE 11 CURRENT AND FORECAST ARV MARKET IN CHINA, THROUGH 2016 ($000) Thailand TABLE 12 CURRENT AND FORECAST ARV MARKET IN THAILAND, THROUGH 2016 ($000) EUROPE FIGURE 5 HIV RATES ACROSS EUROPE Germany... 62

4 Challenges TABLE 13 CURRENT AND FORECAST ARV MARKET IN GERMANY, THROUGH 2016 ($000) France TABLE 14 CURRENT AND FORECAST ARV MARKET IN FRANCE, THROUGH 2016 ($000) Italy TABLE 15 CURRENT AND FORECAST ARV MARKET IN ITALY, THROUGH 2016 ($000) United Kingdom TABLE 16 CURRENT AND FORECAST ARV MARKET IN U.K, THROUGH 2016 ($000) Spain TABLE 17 CURRENT AND FORECAST ARV MARKET IN SPAIN, THROUGH 2016 ($000) CENTRAL AND EASTERN EUROPE Czech Republic TABLE 18 CURRENT AND FORECAST ARV MARKET IN CZECH REPUBLIC, THROUGH 2016 ($000) Poland TABLE 19 CURRENT AND FORECAST ARV MARKET IN POLAND, THROUGH 2016 ($000) Hungary TABLE 20 CURRENT AND FORECAST ARV MARKET IN HUNGARY, THROUGH 2016 ($000) Russian Federation Russian Federation (Continued) TABLE 21 CURRENT AND FORECAST ARV MARKET IN RUSSIA, THOUGH 2016 ($000) AFRICA South Africa TABLE 22 CURRENT AND FORECAST ARV MARKET IN SOUTH AFRICA, THROUGH 2016 ($000) CHAPTER SEVEN: MARKET ANALYSIS BY PRODUCTS AND COMPANIES PRODUCTS TABLE 23 PRODUCT PROFILE: RETROVIR TABLE 24 PRODUCT PROFILE: VIRAMUNE TABLE 25 PRODUCT PROFILE: ZERIT TABLE 26 PRODUCT PROFILE: EPIVIR TABLE 27 PRODUCT PROFILE: INVIRASE TABLE 28 PRODUCT PROFILE: NORVIR TABLE 29 PRODUCT PROFILE: CRIXIVAN TABLE 30 PRODUCT PROFILE: VIRACEPT... 81

5 TABLE 31 PRODUCT PROFILE: RESCRIPTOR TABLE 32 PRODUCT PROFILE: SUSTIVA TABLE 33 PRODUCT PROFILE: ZIAGEN TABLE 34 PRODUCT PROFILE: VIDEX TABLE 35 PRODUCT PROFILE: VIREAD TABLE 36 PRODUCT PROFILE: FUZEON TABLE 37 PRODUCT PROFILE: REYATAZ TABLE 38 PRODUCT PROFILE: EMTRIVA TABLE 39 PRODUCT PROFILE: LEXIVA TABLE 40 PRODUCT PROFILE: APTIVUS TABLE 41 PRODUCT PROFILE: PREZISTA TABLE 42 PRODUCT PROFILE: SELZENTRY TABLE 43 PRODUCT PROFILE: ISENTRESS TABLE 44 PRODUCT PROFILE: INTELENCE COMBINATION ANTIVIRALS TABLE 45 PRODUCT PROFILES: ANTIVIRAL COMBINATIONS MARKET PENETRATION BY PRODUCT TABLE 46 SALES OF ANTIRETROVIRAL PRODUCTS, ($ MILLIONS, % CHANGE) TABLE 47 FIRST PATENT EXPIRIES ON ARV PRODUCTS, TABLE 48 MARKET FOR ARV PRODUCTS, THROUGH 2016 ($ MILLIONS) MARKET SHARE BY COMPANY FIGURE 6 ARV COMPANY SHARES, 2010 (%) THE GENERIC SECTOR The Generic Sector (Continued) CHAPTER EIGHT: COMPANY PROFILES MAJOR PHARMACEUTICAL COMPANIES ABBOTT LABORATORIES BOEHRINGER INGELHEIM GMBH BRISTOL-MYERS SQUIBB GILEAD SCIENCES INC GLAXOSMITHKLINE PLC MERCK & CO INC PFIZER INC TIBOTEC BABE VIIV HEALTHCARE THE GENERICS SECTOR AJANTA PHARMA (MAURITIUS) LIMITED CIPLA LTD THE GOVERNMENT PHARMACEUTICAL ORGANIZATION HETERO DRUGS LTD KOREA UNITED PHARMACEUTICALS INC LABORATORIOS RICHMOND S.A

6 MEDOPHARM RANBAXY LABORATORIES LIMITED SRS PHARMACEUTICALS STRIDES ARCOLAB TABLE 49 STRIDES ARV PRODUCTS TABLE 49 (CONTINUED) VAISHNAVI LIFESCIENCE PVT LTD CHAPTER NINE: VACCINE DEVELOPMENTS VAXGEN CELL-MEDIATED IMMUNITY MERCK CANDIDATE THAILAND STUDY REASONS FOR OPTIMISM? GEOVAX CANDIDATE BIO-NOR CANDIDATE FIT BIOTECH APPROACH TIME IS NOT ON OUR SIDE TIME IS NOT ON OUR SIDE (CONTINUED) CHAPTER TEN: HIV TESTING: BACKGROUND AND MARKET ANTIBODY TESTS ELISA WESTERN BLOT INTERPRETING ANTIBODY TESTS OTHER TESTS P24 ANTIGEN TEST NUCLEIC ACID BASED TESTS (NAT) CD4 TEST HOME TESTING Home Access Express HIV-1 Test OraQuick Orasure Uni-Gold Clearview Complete HIV 1/2 and Clearview HIV 1/2 Stat- Pak INSTI HIV-1/HIV-2* Rapid Antibody Test Reveal HIV TABLE 50 COMPARISON OF HIV HOME SAMPLING AND HOME TESTING SERVICES THE TESTING MARKET TABLE 51 RAPID HIV TEST PRODUCTS TABLE 51 (CONTINUED) TABLE 52 HIV TESTING MARKET FORECAST, THROUGH 2016 ($ MILLIONS)

7 TABLE 53 REGIONAL SHARES OF HIV TESTING MARKET, THROUGH 2016 ($ MILLIONS) COMPANIES INVOLVED IN HIV TESTING ABBOTT DIAGNOSTICS BIOMÉRIEUX SA Prevention/Diagnosis Monitoring BIO-RAD LABORATORIES INC CALYPTE BIOMEDICAL CORPORATION CELERA GROUP GEN-PROBE INC INNOGENETICS NV INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS MEDMIRA LABORATORIES INC ORASURE TECHNOLOGIES INC ORTHO-CLINICAL DIAGNOSTICS INC ROCHE DIAGNOSTICS SIEMENS HEALTHCARE DIAGNOSTICS INC APPENDIX ONE: GLOSSARY APPENDIX ONE APPENDIX ONE (CONTINUED) APPENDIX ONE (CONTINUED) APPENDIX TWO: THE HUMAN IMMUNE SYSTEM APPENDIX TWO LYMPHOCYTES KILLER AND HELPER T CELLS IMMUNODEFICIENCY APPENDIX THREE: VIRUSES APPENDIX THREE DNA VIRUSES RNA VIRUSES REVERSE TRANSCRIBING VIRUSES HOST DEFENSE MECHANISMS PREVENTION AND TREATMENT

HIV Drug Market by Medication class (multi-class combination drugs, nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse

HIV Drug Market by Medication class (multi-class combination drugs, nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs),