DIAGNOSTICS AND THERAPEUTICS FOR HIV: GLOBAL MARKETS

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1 DIAGNOSTICS AND THERAPEUTICS FOR HIV: GLOBAL MARKETS PHM058B April 2014 Kritika Chaudhari Project Analyst ISBN: X BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 3 STUDY GOALS AND OBJECTIVES 3 REASONS FOR DOING THE STUDY 3 INTENDED AUDIENCE 3 SCOPE AND FORMAT 3 METHODOLOGY 4 ANALYST'S CREDENTIALS 4 INFORMATION SOURCES 4 MARKET ANALYSES AND FORECASTS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH ONLINE SERVICES 5 DISCLAIMER 5 CHAPTER 2 SUMMARY 7 THE SKEWED MARKET 7 HIV THERAPEUTICS MARKET WILL BE WORTH $19.6 BILLION IN FIXED-DOSE COMBINATION DRUGS AND INTEGRASE INHIBITOR DRUGS WILL DRIVE THE MARKET 2013 WHO GUIDELINES WILL EXPAND THE GLOBAL HIV MARKET 8 STRICT ADHERENCE TO ARV TREATMENT REMAINS A CHALLENGE 8 DEMAND FOR ACCESS TO AFFORDABLE MEDICINE 8 SEVEN OF THE EIGHT LEADING ARV DRUGS ARE ON PATENT CLIFF 9 GILEAD SCIENCES WILL CONTINUE TO DOMINATE THE HIV THERAPEUTICS MARKET POC DEVICES FOR CD4 AND VIRAL LOAD TESTING WILL DRIVE THE HIV DIAGNOSTICS MARKET THE U.S. WILL REMAIN THE LEADING NATIONAL MARKET FOR HIV 10 EARLY PROPHYLAXIS IS THE KEY TO HIV MANAGEMENT 10 HIV VACCINES-A LONG ROAD AHEAD 11 TOWARDS AN AIDS-FREE GENERATION 11 SUMMARY TABLE GLOBAL HIV MARKET, THROUGH 2018 ($ 12 SUMMARY FIGURE GLOBAL HIV MARKET, ($ CHAPTER 3 OVERVIEW 14 GLOBAL BURDEN OF HIV 14 TABLE 1 TOP 10 LEADING CAUSES OF DEATHS IN THE WORLD, 2011 (MILLIONS) 14 TABLE 2 BURDEN OF HIV BY GEOGRAPHICAL REGIONS 15 GLOBAL RESPONSE TO HIV EPIDEMIC 16 MILESTONES IN HIV RESEARCH 16 TABLE 3 MILESTONES IN THE HISTORY OF HIV 16 TARGETING HIV LIFECYCLE 17 TABLE 4 LIFE CYCLE OF HIV-THERAPEUTICS TARGET POINTS 18 DIAGNOSTIC TOOLS FOR DETECTING HIV INFECTION 19 EFFORTS FOR HIV PROPHYLAXIS 19 FUTURE OF GLOBAL HIV MARKET 20 CONCLUSION 21

3 CHAPTER 4 GLOBAL MARKET 23 GLOBAL HIV MARKET GLOBAL HIV MARKET FORECAST TO TABLE 5 FORECASTED NUMBER OF PEOPLE RECEIVING ARV THERAPY, (MILLIONS) HIV MARKET BY GEOGRAPHICAL REGIONS 24 TABLE 6 ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, THROUGH 2018 ($ TABLE 7 ARV DRUGS MARKET SHARE BY GEOGRAPHIC REGIONS, (%) 24 FIGURE 1 ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, ($ NORTH AMERICAN HIV MARKET 25 REGULATIONS IMPACTING THE GROWTH OF NORTH AMERICAN HIV MARKET MARKET FORECAST 26 EUROPEAN HIV MARKET 26 TABLE 8 EUROPEAN COUNTRIES BY RATES OF HIV DIAGNOSIS (%) 27 TABLE 9 PATTERN OF HIV INFECTION BY EUROPEAN REGIONS, TRENDS IN EUROPEAN HIV MARKET 27 TABLE 10 SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES, THROUGH 2018 ($ TABLE 11 HIV THERAPEUTICS MARKET SHARE BY EU5 COUNTRIES, (%) 28 FIGURE 2 SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES ($ 28 TABLE 12 HIV PREVALENCE IN EU5 COUNTRIES, TABLE 13 RATE OF LATE DIAGNOSIS BY REGIONS OF THE U.K. (%) 30 MARKET FORECAST 30 THE ASIAN HIV MARKET 31 TABLE 14 HIV PREVALENCE AND INCIDENCE OF NEW INFECTIONS IN ASIAN COUNTRIES, 2012 TABLE 15 SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, THROUGH 2018 ($ TABLE 16 HIV MARKET SHARE BY LEADING ASIAN COUNTRIES, (%) 31 FIGURE 3 SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, ($ TRENDS IN THE ASIAN HIV MARKET 32 MARKET FORECAST 33 HIV MARKET IN ROW 33 HIV MARKET TRENDS IN THE ROW 33 MARKET FORECAST 33 GLOBAL INVESTMENT IN HIV RESEARCH 34 TABLE 17 FORECAST GLOBAL ANNUAL INVESTMENT IN HIV RESEARCH, THROUGH 2018 ($ TABLE 18 GLOBAL INVESTMENT SHARE BY AREA OF RESEARCH, (%) 34 TABLE 19 INVESTMENT BY DONOR TYPE (%) 35 INVESTMENT IN HIV THERAPEUTICS 35 TABLE 20 INVESTMENT IN HIV THERAPEUTICS BY DRUG SUBCATEGORIES IN 2012 (%) INVESTMENT IN HIV VACCINES

4 INVESTMENT IN HIV PROPHYLAXIS 36 TABLE 21 INVESTMENT BY MODE OF HIV PROPHYLAXIS (%) 37 INVESTMENT IN HIV DIAGNOSTICS 37 INVESTMENT FOR OTHER RESEARCH ASSOCIATED WITH HIV 37 GENERIC HIV DRUGS MARKET 37 FIGURE 4 GENERIC VS. BRANDED ARV DRUGS GLOBAL SALES REVENUE, ($ FIGURE 5 GENERIC ARV DRUGS GLOBAL SALES REVENUE GROWTH ($ MILLIONS/%) 38 DRIVERS FOR THE GROWTH OF GENERIC HIV DRUGS MARKET 39 TABLE 22 LEADING ARV DRUGS ON PATENT CLIFF 39 RESTRAINTS TO THE GROWTH OF GENERIC HIV DRUGS MARKET 40 TABLE 23 DRIVERS AND RESTRAINTS OF GENERIC HIV MARKET 40 CHAPTER SUMMARY 41 TABLE 24 DRIVERS AND RESTRAINTS OF GLOBAL HIV MARKET CHAPTER 5 HIV THERAPEUTICS MARKET: LEADING ARV DRUG CATEGORIES 43 THERAPY BY LINE-TREATMENT 43 TABLE 25 RECOMMENDED ARV TREATMENT BY THE WHO 44 FIRST-LINE TREATMENT REGIMEN 44 SECOND-LINE TREATMENT REGIMEN 44 THIRD-LINE/SALVAGE TREATMENT REGIMEN 45 ARV MARKET BY DRUG CATEGORIES 45 TABLE 26 HIV THERAPEUTICS MARKET BY DRUG CATEGORY, THROUGH 2018 ($ TABLE 27 HIV THERAPEUTICS MARKET SHARE BY DRUG CATEGORY, (%) 46 FIGURE 6 HIV THERAPEUTICS MARKET BY DRUG CATEGORY (%) 46 NRTIS 47 TABLE 28 LIST OF APPROVED NRTIS (AND TABLE UNITS) 47 Mechanism of Action: 48 Resistance to NRTIs 48 Market Status 48 Market Forecast 49 NNRTIS 49 TABLE 29 LIST OF APPROVED NNRTIS 49 Mechanism of Action 50 Drug Resistance and Adverse Effects 50 Market Status 50 Market Forecast 50 PROTEASE INHIBITORS 51 TABLE 30 LIST OF APPROVED PROTEASE INHIBITORS 51 Pharmacokinetic Boosters 52 Market Forecast 52 INTEGRASE STRAND TRANSFER INHIBITORS 52 TABLE 31 LIST OF APPROVED INTEGRASE INHIBITOR DRUGS 52 Market Forecast 53 ENTRY INHIBITORS 53 TABLE 32 LIST OF APPROVED ENTRY INHIBITORS 53 Mechanism of Action 54 46

5 Market Forecast 54 SINGLE TABLET REGIMEN (STR) FIXED-DOSE COMBINATION (FDC) DRUGS 54 TABLE 33 LIST OF APPROVED STR FDC DRUGS 55 Market Forecast 55 CHAPTER SUMMARY 55 TABLE 34 MARKET DRIVERS AND RESTRAINTS OF ARV DRUGS, BY CLASS 57 CHAPTER 6 HIV THERAPEUTICS MARKET: LEADING DRUGS 59 LEADING EIGHT HIV DRUGS CLAIMED OVER 80% OF THE MARKET SHARE 59 TABLE 35 SALES REVENUE FORECAST OF LEADING HIV DRUGS, THROUGH 2018 ($ TABLE 36 HIV MARKET SHARE BY LEADING DRUGS (%) 60 FIGURE 7 HIV MARKET SHARE BY LEADING DRUGS (%) 60 ATRIPLA 61 Generic Atripla for PEPFAR Countries 61 Competitors 61 Market Forecast 61 TRUVADA 62 Truvada as a Prophylactic Drug 62 Market Forecast 62 EPZICOM 62 HLA-B*5701 Testing 63 Clinical Trials 63 Patents and Competition 63 Market Forecast 63 VIREAD 64 Viread Prodrug 64 Market Forecast 64 PREZISTA 64 Clinical Trials 64 Patents 65 Competitors 65 Market Forecast 65 REYATAZ 65 Competitors 65 Market Forecast 66 KALETRA 66 Competitors 66 Market Forecast 66 ISENTRESS 67 Clinical Trials 67 Competitors 67 Market Forecast 68 PROMISING EMERGING THERAPIES 68 STRIBILD 68 Clinical Trials 68 Competitors 69 Market Forecast 69 59

6 TIVICAY 69 Clinical Trials 70 Competitors 70 Market Forecast 70 COMPLERA 70 Clinical Trials 71 Patent 71 Market Forecast 71 INTELENCE 71 Market Forecast 72 OTHER DRUGS 72 COMBIVIR 72 Competition 72 SUSTIVA 72 NORVIR 73 SELZENTRY 73 Clinical Trials 73 Market Forecast 73 OTHER ARV DRUGS IN THE MARKET 73 CHAPTER SUMMARY 74 FIGURE 8 RANKING (BY MARKET SHARE) OF LEADING ARV DRUGS, TABLE 37 MARKET DRIVERS AND RESTRAINTS OF THE LEADING ARV DRUGS 75 CHAPTER 7 ARV DRUGS PIPELINE ANALYSIS 77 FIGURE 9 NUMBER OF CLINICAL TRIALS BY DEVELOPMENTAL PHASE 77 NRTI DRUGS IN DEVELOPMENT 78 TENOFOVIR ALAFENAMIDE (TAF) 78 Clinical Trials 78 Market Potential 78 NNRTIS IN DEVELOPMENT 79 TABLE 38 ONGOING CLINICAL TRIALS OF NNRTI DRUGS IN DEVELOPMENT 79 MK Clinical Trials 79 Market Potential 80 RILPIVIRINE (LA) 80 Clinical Trials 80 Market Potential 80 INTEGRASE INHIBITORS IN DEVELOPMENT 80 S/GSK Clinical Trials 81 Market Potential 82 ENTRY INHIBITORS IN DEVELOPMENT 82 CENICRIVIROC 82 Clinical Trials 82 Market Potential 83 ALBUVIRTIDE 83 Clinical Trials 83

7 Market Potential 83 BMS COMBINATION THERAPIES 83 TABLE 39 ONGOING CLINICAL TRIALS OF STR FDC DRUGS TRII 84 Clinical Trials 85 Market Potential 85 OTHER STR FDC DRUGS IN DEVELOPMENT 85 PHARMACOKINETIC BOOSTERS IN DEVELOPMENT 85 EMERGING THERAPIES 86 TABLE 40 ONGOING CLINICAL TRIALS OF EMERGING THERAPIES 86 SB-728-T 86 Clinical Trials 87 Market Potential 87 KP Clinical Trials 87 LEXGENLEUCEL-T (VRX-496) 88 Clinical Trials 88 Market Potential 88 SL9-TCR GENE THERAPY 88 Clinical Trials 89 IMMUNOMODULATORS 89 MONOCLONAL ANTIBODIES AGAINST HIV 89 CHAPTER SUMMARY 90 TABLE 41 OVERVIEW OF ARV DRUGS IN DEVELOPMENT 90 CHAPTER 8 HIV TESTING AND DIAGNOSTICS 93 EARLY DETECTION 93 PATIENT STAGING 93 TREATMENT SWITCHING 93 HIV SCREENING TESTS 94 HIV CONFIRMATORY TESTS 94 HIV MONITORING TESTS 94 TYPES OF HIV TESTS 94 ANTIGEN- AND ANTIBODY-BASED TESTS FOR HIV 94 TABLE 42 HIV RAPID TESTS ADVANTAGES AND DISADVANTAGES BY CLIA* COMPLEXITY AND GENERATION TABLE 43 FDA APPROVED ANTIBODY HIV TESTS 96 TABLE 44 FDA APPROVED ANTIGEN-ANTIBODY COMBO TESTS 97 CD4 TESTING 97 TABLE 45 CD4 TESTS IN THE MARKET 98 VIRAL LOAD TESTING 98 TABLE 46 LIST OF MARKETED VIRAL LOAD TESTS 99 SELECTED RAPID HIV TESTS 99 ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST 99 CHEMBIO'S DPP(R) HIV 1/2 ASSAY 100 CLEARVIEW HIV 1/2 STAT-PAK 100 REVEAL G3 RAPID HIV-1 ANTIBODY TEST

8 PRISM HIV AG/AB COMBO ASSAY 100 SELECTED CD4 TESTS 100 BD FACSCALIBUR FLOW CYTOMETER 101 CYTOMICS FC 500 MCL/MPL SYSTEM 101 CYFLOW COUNTER 101 MILLIPORE-GUAVA AUTO CD4/CD4% SYSTEM 102 APOGEE AUTO40 FLOW CYTOMETER 102 AQUIOS CL 102 POINT OF CARE CD4 TESTING ASSAYS 102 PointCare NOW 102 Pima CD4 Analyser 102 CyFlowTM CD4 minipoc 103 SELECTED VIRAL LOAD TESTS 103 COBAS AMPLIPREP/COBAS TAQMAN HIV-1 SYSTEM 103 ABBOTT REALTIME HIV VERSANT HIV RNA 1.0 (KPCR) 104 ARTUS HIV-1 RS/QS-RGQ KIT 104 NUCLISENS EASYQ HIV VERSANT HIV-1 RNA 3.0 ASSAY 104 NON-NUCLEIC ACID-BASED VIRAL LOAD ASSAYS 104 ExaVir Load Version HIV DIAGNOSTICS PIPELINE 105 TABLE 47 HIV/AIDS DIAGNOSTICS PIPELINE 105 DAKTARI CD4 COUNTER 106 MBIO CD4 SYSTEM 106 VISITECT CD4 107 ZYOMYX MYT4 TEST 107 ALERE'S NAT SYSTEM 107 LIAT ANALYSER 108 SAMBA 108 EOSCAPE-HIV RAPID RNA ASSAY SYSTEM 109 LYNX HIV P24 ANTIGEN ASSAY 109 PANNAT PLATFORM 109 HIV DIAGNOSTICS MARKET 109 TABLE 48 HIV DIAGNOSTICS MARKET BY TYPES OF TESTS, THROUGH 2018 ($ TABLE 49 HIV DIAGNOSTICS MARKET SHARE BY TYPES OF TESTS, (%) 110 RAPID HIV TESTING MARKET 110 Forecast for Rapid HIV Testing Market 111 CD4 TESTING MARKET 111 TABLE 50 CD4 TESTING MARKET SHARE IN SEVEN SUB-SAHARAN AFRICAN COUNTRIES, 2012 (%) Forecast for CD4 Testing Market 112 TABLE 51 GLOBAL DEMAND FOR CD4 TESTING, (MILLIONS) 112 VIRAL LOAD TESTING MARKET 112 Forecast for Viral Load Testing Market 112 TABLE 52 GLOBAL DEMAND FOR VIRAL LOAD TESTING, (MILLIONS) 113 CHAPTER SUMMARY

9 TABLE 53 MARKET DRIVERS AND RESTRAINTS FOR HIV TESTING PRODUCTS 114 CHAPTER 9 HIV PROPHYLAXIS 116 HIV PROPHYLAXIS BASED ON EXPOSURE 116 EARLY PROPHYLAXIS 116 PRE-EXPOSURE PROPHYLAXIS 116 CLINICAL STUDIES IN SUPPORT OF HIV PREP 117 Bangkok Tenofovir Study 117 HPTN PopART Study 117 LONG ACTING FORMULATIONS OF EXISTING ARV DRUGS 118 TABLE 54 CLINICAL TRIALS TESTING DRUG-BASED PREP, 2014 AND MICROBICIDES AND VAGINAL RINGS 119 Centers for Disease Control and Prevention 119 Failure of the VOICE Trial 120 CAPRISA 120 ASPIRE and "IPM 027" 120 TABLE 55 ONGOING CLINICAL TRIALS OF MICROBICIDES, 2014 AND MALE CIRCUMCISION 122 POST-EXPOSURE PROPHYLAXIS (PEP) 122 PREVENTING TRANSMISSION FROM MOTHER TO CHILD 123 TABLE 56 EVOLUTION OF WHO GUIDELINES WITH REGARDS TO PMTCT, TABLE 57 SELECTED ON-GOING TRIALS ON PMTCT, CHAPTER SUMMARY 127 CHAPTER 10 HIV VACCINES 129 HURDLES FOR DEVELOPING HIV VACCINES 129 PROPHYLACTIC VS. THERAPEUTIC HIV VACCINES 129 TYPES OF HIV VACCINES 130 TABLE 58 TYPE OF HIV VACCINES 130 THE HISTORIC RV144 TRIAL 131 RECENT ADVANCES IN HIV VACCINE RESEARCH 132 GEOVAX'S PROPHYLACTIC AND THERAPEUTIC VACCINE DUAL TECHNOLOGY TABLE 59 ONGOING CLINICAL TRIALS OF PROPHYLACTIC HIV VACCINES 132 TABLE 60 ONGOING CLINICAL TRIALS FOR THERAPEUTIC HIV VACCINES 133 FUTURE HOPES OF A SUCCESSFUL HIV VACCINE CHAPTER 11 QUALITATIVE ANALYSIS 137 PORTER'S 5 ANALYSIS 137 FIGURE 10 GLOBAL HIV THERAPEAUTICS MARKET ANALYSIS 137 COMPETITIVE RIVALRY WITHIN INDUSTRY 137 THREAT OF NEW ENTRANTS 138 THREAT OF SUBSTITUTE PRODUCTS 138 Leading Drugs on Patent Cliff 138 Drug Counterfeiting 138 BARGAINING POWER OF SUPPLIERS 139 BARGAINING POWER OF CUSTOMERS 139

10 TRIPS Flexibilities 139 Compulsory Licensing and Parallel Imports 139 Negotiations for Low-Priced Drugs 139 Promoting Free Trade 139 Patents for Public Health 140 CHALLENGES OF THE HIV MARKET 140 ACCESSIBILITY TO ARV THERAPY 140 ADHERENCE TO DRUG REGIMENS 140 TABLE 61 RETENTION TO TREATMENT (%) 141 P4P4P 141 Combination Pills 141 HIGH COST OF TREATMENT 142 First-Line vs. Second-Line Treatment 142 TABLE 62 FIRST-LINE VS. SECOND-LINE TREATMENT MEDIAN PRICE, 2012 (IN $US PER PERSON PER YEAR) Cost of STR FDC Pills 142 PEDIATRIC FORMULATIONS OF ARV DRUGS 143 LATE DIAGNOSIS OF HIV INFECTION 143 ACCESSIBILITY TO HIV DIAGNOSTICS 144 COMPLEXITY OF VIRAL LOAD TESTING 144 ADHERENCE CHALLENGES IN PRE-EXPOSURE PROPHYLAXIS 145 REGULATORY AND POLITICAL CHALLENGES 145 HIGH VARIABILITY OF HIV 145 OPPORTUNITIES FOR REVENUE GENERATION 146 DRUGS FOR TREATMENT-EXPERIENCED PATIENTS 146 DRUGS WITH LONG HALF-LIFE 146 EARLY INFANT DIAGNOSIS 146 PREVENTING TREATMENT SWITCHES 147 DECENTRALIZATION OF HIV TESTING 147 DEMAND FOR SIMPLE, IMPROVED LOW-COST TESTING DEVICES 147 DRIVERS OF THE HIV MARKET 148 LONGEVITY OF HIV-INFECTED PATIENTS 148 INCREASE IN AWARENESS PROGRAMS 148 INCREASE IN ACCESS TO THERAPEUTICS AND DIAGNOSTICS 148 FOURTH-GENERATION RAPID HIV TESTING 148 POINT-OF-CARE DIAGNOSTICS 149 IMPLICATIONS OF RECENT REGULATORY GUIDELINES 149 RESTRAINTS TO THE GROWTH OF HIV MARKET 150 SOCIAL STIGMA ASSOCIATED WITH HIV TESTING 150 HIGH PRICE FOR NEW DRUGS EVENTUALLY REDUCING THEIR UPTAKE 150 PMTCT WILL REDUCE PEDIATRIC HIV MARKET 150 ECONOMIC SLOWDOWN 150 HARMONIZATION 151 PUBLIC-PRIVATE PARTNERSHIPS 151 CORPORATE RESPONSIBILITY 152 HARMONY AMONG REGULATORY AGENCIES 152 CHAPTER SUMMARY 153 TABLE 63 CHALLENGES AND OPPORTUNITIES IN THE GLOBAL HIV MARKET

11 TABLE 64 MAJOR DRIVERS AND RESTRAINTS IN THE GLOBAL HIV MARKET 155 CHAPTER 12 COMPANY PROFILES 157 HIV THERAPEUTICS-LEADING COMPANIES 157 TABLE 65 HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES, ($ FIGURE 11 HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES (%) 157 ABBVIE INC 158 BRISTOL-MYERS SQUIBB 159 Bristol-Myers Squibb Pharmaceuticals Limited (Uxbridge) 159 GILEAD SCIENCES 159 JANSSEN THERAPEUTICS 160 MERCK & CO. INC 161 VIIV HEALTHCARE 162 U.S. headquarters 162 HIV DIAGNOSTICS: LEADING COMPANIES 163 ABBOTT LABORATORIES 163 ALERE 163 BD BIOSCIENCES 164 BD 164 ROCHE 165 SIEMENS HEALTHCARE DIAGNOSTICS 165 SELECTED EMERGING AND GENERIC COMPANIES IN THE GLOBAL HIV MARKET 166 ASPEN GROUP 166 KORONIS PHARMACEUTICALS (VDA PHARMA) 167 MYLAN 167 SANGAMO BIOSCIENCES CHAPTER 13 APPENDIX A: GLOSSARY 170 TABLE 66 GLOSSARY 170 CHAPTER 14 APPENDIX B: DRUG ACRONYMS 176 CHAPTER 15 APPENDIX C: ABBREVIATIONS 178 TABLE 67 ABBREVIATIONS 178

12 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL HIV MARKET, THROUGH 2018 ($ 11 TABLE 1 TOP 10 LEADING CAUSES OF DEATHS IN THE WORLD, 2011 (MILLIONS) 13 TABLE 2 BURDEN OF HIV BY GEOGRAPHICAL REGIONS 14 TABLE 3 MILESTONES IN THE HISTORY OF HIV 15 TABLE 4 LIFE CYCLE OF HIV-THERAPEUTICS TARGET POINTS 17 TABLE 5 FORECASTED NUMBER OF PEOPLE RECEIVING ARV THERAPY, (MILLIONS) TABLE 6 ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, THROUGH 2018 ($ TABLE 7 ARV DRUGS MARKET SHARE BY GEOGRAPHIC REGIONS, (%) 23 TABLE 8 EUROPEAN COUNTRIES BY RATES OF HIV DIAGNOSIS (%) 26 TABLE 9 PATTERN OF HIV INFECTION BY EUROPEAN REGIONS, TABLE 10 SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES, THROUGH 2018 ($ TABLE 11 HIV THERAPEUTICS MARKET SHARE BY EU5 COUNTRIES, (%) 27 TABLE 12 HIV PREVALENCE IN EU5 COUNTRIES, TABLE 13 RATE OF LATE DIAGNOSIS BY REGIONS OF THE U.K. (%) 29 TABLE 14 HIV PREVALENCE AND INCIDENCE OF NEW INFECTIONS IN ASIAN COUNTRIES, 2012 TABLE 15 SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, THROUGH 2018 ($ TABLE 16 HIV MARKET SHARE BY LEADING ASIAN COUNTRIES, (%) 30 TABLE 17 FORECAST GLOBAL ANNUAL INVESTMENT IN HIV RESEARCH, THROUGH 2018 ($ TABLE 18 GLOBAL INVESTMENT SHARE BY AREA OF RESEARCH, (%) 33 TABLE 19 INVESTMENT BY DONOR TYPE (%) 34 TABLE 20 INVESTMENT IN HIV THERAPEUTICS BY DRUG SUBCATEGORIES IN 2012 (%) 35 TABLE 21 INVESTMENT BY MODE OF HIV PROPHYLAXIS (%) 36 TABLE 22 LEADING ARV DRUGS ON PATENT CLIFF 38 TABLE 23 DRIVERS AND RESTRAINTS OF GENERIC HIV MARKET 39 TABLE 24 DRIVERS AND RESTRAINTS OF GLOBAL HIV MARKET 40 TABLE 25 RECOMMENDED ARV TREATMENT BY THE WHO 43 TABLE 26 HIV THERAPEUTICS MARKET BY DRUG CATEGORY, THROUGH 2018 ($ TABLE 27 HIV THERAPEUTICS MARKET SHARE BY DRUG CATEGORY, (%) 45 TABLE 28 LIST OF APPROVED NRTIS (AND TABLE UNITS) 46 TABLE 29 LIST OF APPROVED NNRTIS 48 TABLE 30 LIST OF APPROVED PROTEASE INHIBITORS 50 TABLE 31 LIST OF APPROVED INTEGRASE INHIBITOR DRUGS 51 TABLE 32 LIST OF APPROVED ENTRY INHIBITORS 52 TABLE 33 LIST OF APPROVED STR FDC DRUGS 54 TABLE 34 MARKET DRIVERS AND RESTRAINTS OF ARV DRUGS, BY CLASS 56 TABLE 35 SALES REVENUE FORECAST OF LEADING HIV DRUGS, THROUGH 2018 ($ TABLE 36 HIV MARKET SHARE BY LEADING DRUGS (%) 59 TABLE 37 MARKET DRIVERS AND RESTRAINTS OF THE LEADING ARV DRUGS 74 TABLE 38 ONGOING CLINICAL TRIALS OF NNRTI DRUGS IN DEVELOPMENT 78 TABLE 39 ONGOING CLINICAL TRIALS OF STR FDC DRUGS

13 TABLE HEADING TABLE 40 ONGOING CLINICAL TRIALS OF EMERGING THERAPIES 85 TABLE 41 OVERVIEW OF ARV DRUGS IN DEVELOPMENT 89 TABLE 42 HIV RAPID TESTS ADVANTAGES AND DISADVANTAGES BY CLIA* COMPLEXITY AND GENERATION TABLE 43 FDA APPROVED ANTIBODY HIV TESTS 95 TABLE 44 FDA APPROVED ANTIGEN-ANTIBODY COMBO TESTS 96 TABLE 45 CD4 TESTS IN THE MARKET 97 TABLE 46 LIST OF MARKETED VIRAL LOAD TESTS 98 TABLE 47 HIV/AIDS DIAGNOSTICS PIPELINE 104 TABLE 48 HIV DIAGNOSTICS MARKET BY TYPES OF TESTS, THROUGH 2018 ($ TABLE 49 HIV DIAGNOSTICS MARKET SHARE BY TYPES OF TESTS, (%) 109 TABLE 50 CD4 TESTING MARKET SHARE IN SEVEN SUB-SAHARAN AFRICAN COUNTRIES, 2012 (%) TABLE 51 GLOBAL DEMAND FOR CD4 TESTING, (MILLIONS) 111 TABLE 52 GLOBAL DEMAND FOR VIRAL LOAD TESTING, (MILLIONS) 112 TABLE 53 MARKET DRIVERS AND RESTRAINTS FOR HIV TESTING PRODUCTS 113 TABLE 54 CLINICAL TRIALS TESTING DRUG-BASED PREP, 2014 AND TABLE 55 ONGOING CLINICAL TRIALS OF MICROBICIDES, 2014 AND TABLE 56 EVOLUTION OF WHO GUIDELINES WITH REGARDS TO PMTCT, TABLE 57 SELECTED ON-GOING TRIALS ON PMTCT, TABLE 58 TYPE OF HIV VACCINES 129 TABLE 59 ONGOING CLINICAL TRIALS OF PROPHYLACTIC HIV VACCINES 131 TABLE 60 ONGOING CLINICAL TRIALS FOR THERAPEUTIC HIV VACCINES 132 TABLE 61 RETENTION TO TREATMENT (%) 140 TABLE 62 FIRST-LINE VS. SECOND-LINE TREATMENT MEDIAN PRICE, 2012 (IN $US PER PERSON PER YEAR) TABLE 63 CHALLENGES AND OPPORTUNITIES IN THE GLOBAL HIV MARKET 153 TABLE 64 MAJOR DRIVERS AND RESTRAINTS IN THE GLOBAL HIV MARKET 154 TABLE 65 HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES, ($ TABLE 66 GLOSSARY 169 TABLE 67 ABBREVIATIONS

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL HIV MARKET, ($ 11 FIGURE 1 ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, ($ FIGURE 2 SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES ($ 27 FIGURE 3 SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, ($ FIGURE 4 GENERIC VS. BRANDED ARV DRUGS GLOBAL SALES REVENUE, ($ FIGURE 5 GENERIC ARV DRUGS GLOBAL SALES REVENUE GROWTH ($ MILLIONS/%) 37 FIGURE 6 HIV THERAPEUTICS MARKET BY DRUG CATEGORY (%) 45 FIGURE 7 HIV MARKET SHARE BY LEADING DRUGS (%) 59 FIGURE 8 RANKING (BY MARKET SHARE) OF LEADING ARV DRUGS, FIGURE 9 NUMBER OF CLINICAL TRIALS BY DEVELOPMENTAL PHASE 76 FIGURE 10 GLOBAL HIV THERAPEAUTICS MARKET ANALYSIS 136 FIGURE 11 HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES (%)

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