GLOBAL MARKETS FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES

Transcription

1 GLOBAL MARKETS FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES PHM005C January 2013 Peggy Lehr Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 1 REASONS FOR DOING THE STUDY 1 SCOPE OF REPORT 1 METHODOLOGY/INFORMATION SOURCES 1 INTENDED AUDIENCE 1 ANALYST CREDENTIALS 2 RELATED BCC REPORTS 2 BCC ONLINE SERVICES 2 DISCLAIMER 2 CHAPTER 2 SUMMARY 4 SUMMARY TABLE GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES, THROUGH 2017 ($ MILLIONS) SUMMARY FIGURE GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES, 2011 AND 2017 (%) 4 4 CHAPTER 3 INDUSTRY OVERVIEW 7 EPIDEMIOLOGY AND ETIOLOGY OF SEXUALLY TRANSMITTED DISEASES 7 TRENDS IN GLOBAL TRANSMISSION OF STDS 7 DIAGNOSIS OF STD 7 VISUAL OBSERVATION 7 BLOOD/TISSUE STAINING 8 AUTOMATED TESTING 8 TABLE 1 MAJOR MANUFACTURERS OF AUTOMATED STD TESTS, NONAUTOMATED STD DIAGNOSTIC TESTING 8 TABLE 2 MAJOR MANUFACTURERS OF RAPID AND LABORATORY DIAGNOSTIC STD KITS, 2012 VACCINES 9 TABLE 3 MAJOR MANUFACTURERS OF VACCINES FOR STDS 9 MARKET ANALYSIS BY DISEASE 9 HPV/GENITAL WARTS 10 Diagnostic Product Market 10 TABLE 4 HPV DIAGNOSTIC PRODUCTS, MANUFACTURER AND MARKET SHARE, 2011 (%) 10 GONORRHEA 10 Diagnostic Product Market 10 TABLE 5 GONORRHEA DIAGNOSTIC PRODUCT MANUFACTURERS AND PRODUCT NAMES 11 Treatment Market 11 TABLE 6 MAJOR GONORRHEA TREATMENT MANUFACTURERS AND PRODUCTS 11 HEPATITIS A, B AND C 12 Diagnostic Product Market 12 TABLE 7 HEPATITIS A, B AND C DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE OF TEST, 2011 ($ MILLIONS/%) Treatment Market 12 TABLE 8 MARKET STANDING OF MAJOR HEPATITIS B AND C TREATMENT MANUFACTURERS BY REVENUES, 2011 ($ MILLIONS) FIGURE 1 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS MARKET AND THEIR MARKET SHARE, 2011 (%)

3 HIV/AIDS 14 Diagnostic Market 14 TABLE 9 HIV DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE, 2011 ($ MILLIONS/%) Treatment Market 14 TABLE 10 HIV/AIDS TREATMENT MANUFACTURER MARKET STANDING BY REVENUES, 2011 ($ MILLIONS/%) FIGURE 2 MARKET SHARE OF LEADING COMPANIES IN THE HIV/AIDS TREATMENT MARKET, 2011 (%) MARKET SHARE, BY DISEASE 16 TABLE 11 NUMBER OF DIAGNOSTIC AND PHARMACEUTICAL MANUFACTURERS, BY DISEASE TREATED, WITH REVENUES AND MARKET SHARE, 2011 ($ MILLIONS/%) MERGERS AND ACQUISITIONS 16 TABLE 12 SELECTED MERGERS AND ACQUISITIONS, ($ MILLIONS) CHAPTER 4 DISEASE OVERVIEW 19 TABLE 13 CAUSATIVE ORGANISMS FOR SEXUALLY TRANSMITTED DISEASES 19 DIAGNOSTIC TESTING 19 FLUORESCENT IMMUNOASSAY (FIA) 20 Direct Fluorescent Antibody Testing 20 Indirect Fluorescent Antibody Testing 20 Chemiluminescent Microparticle Immunoassay 20 ENZYME IMMUNOASSAY 20 Basic EIA 21 Enzyme-linked Immunosorbent Assay (ELISA) 21 GENE PROBE ANALYSIS 21 Polymerase Chain Reaction Amplification 22 Nucleic Acid Amplification Test (NAT) 22 Transcription-Mediated Amplification (TMA) 22 Nucleic Acid Sequence-Based Amplification (NASBA) 22 Dual Kinetic Assay (DKA) 23 BACTERIAL VAGINOSIS 23 OVERVIEW 23 RISK FACTORS 23 INCIDENCE 24 DIAGNOSTIC PROCEDURES 24 TABLE 14 CURRENT DIAGNOSTIC TESTS FOR BACTERIAL VAGINITIS 24 TREATMENTS 24 TABLE 15 CURRENT TREATMENTS FOR BACTERIAL VAGINITIS 25 CANDIDIASIS 25 OVERVIEW 25 RISK FACTORS 25 INCIDENCE 25 DIAGNOSTIC PROCEDURES 25 TABLE 16 DIAGNOSTIC TESTS FOR CANDIDIASIS 25 TREATMENT 26 TABLE 17 TREATMENTS FOR VULVOVAGINAL CANDIDIASIS 26 CHANCROID (VENEREAL ULCERS) 27

4 OVERVIEW 27 RISK FACTORS 27 INCIDENCE 27 DIAGNOSTIC PROCEDURES 28 TREATMENTS 28 TABLE 18 CURRENT MEDICATIONS USED TO TREAT CHANCROID ULCERS 28 CHLAMYDIA 28 OVERVIEW 28 RISK FACTORS 29 INCIDENCE 29 DIAGNOSTIC PROCEDURES 30 TABLE 19 CURRENTLY AVAILABLE CHLAMYDIA TESTS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 31 TABLE 20 CURRENT MEDICATIONS USED TO TREAT CHLAMYDIA 31 GENITAL HERPES 32 OVERVIEW 32 RISK FACTORS 32 INCIDENCE 32 DIAGNOSTIC PROCEDURES 32 TABLE 21 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF GENITAL HERPESBY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 33 TABLE 22 CURRENT TREATMENTS FOR GENITAL HERPESBY BRAND NAME, GENERIC NAME AND MANUFACTURER, 2012 GENITAL WARTS/HUMAN PAPILLOMAVIRUS 34 OVERVIEW 34 RISK FACTORS 34 INCIDENCE 35 DIAGNOSTIC PROCEDURES 35 TABLE 23 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HPV BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 35 TABLE 24 MEDICATIONS USED TO TREAT GENITAL WARTS BY BRAND NAME, GENERIC NAME AND MANUFACTURER GONORRHEA 36 OVERVIEW 36 RISK FACTORS 36 Age 15 to 24 Years 36 Black Heritage 37 Additional Risk Factors 37 INCIDENCE 37 DIAGNOSTIC PROCEDURES 37 TABLE 25 CURRENT PRODUCTS USED TO DIAGNOSE GONORRHEA 37 TREATMENTS 38 TABLE 26 CURRENT MEDICATIONS USED TO TREAT GONORRHEA 38 HEPATITIS B AND C 39 OVERVIEW

5 RISK FACTORS 39 INCIDENCE 39 DIAGNOSTIC PROCEDURES 40 TABLE 27 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HEPATITIS B AND C BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 41 TABLE 28 VACCINES AND MEDICATIONS FOR THE TREATMENT OF HEPATITIS, HERPES SIMPLEX VIRUS (SEE GENITAL HERPES) 43 HIV/AIDS 43 OVERVIEW 43 TABLE 29 CDC CLASSIFICATION OF HIV INFECTION 43 RISK FACTORS 44 Condoms and Preventing HIV 44 INCIDENCE/MORTALITY 44 DIAGNOSTIC PROCEDURES 45 TABLE 30 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HIV/AIDS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 46 TABLE 31 HIV LIFE CYCLE 46 Generic Treatments 46 TABLE 32 FDA-APPROVED GENERIC DRUGS FOR TREATMENT OF HIV, Brand Name HIV Treatments 48 TABLE 33 CURRENTLY APPROVED PHARMACEUTICAL PRODUCTS FOR TREATMENT OF HIV/AIDS BY BRAND NAME, GENERIC NAME AND MANUFACTURER, 2012 BRANDED TREATMENT MARKET, BY MAJOR MANUFACTURER 49 TABLE 34 HIV TREATMENT MARKET, BY MANUFACTURER ($ MILLIONS) 49 FIGURE MARKET SHARE FOR BRANDED HIV DRUGS, BY MANUFACTURER (%) 50 HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) 50 HAART Failure 51 Mega HAART 51 PEDIATRIC HIV 51 Smaller Pediatric Market 51 Complicated Treatment Regimen 52 PEDICULOSIS PUBIS 52 OVERVIEW 52 RISK FACTORS 52 INCIDENCE 52 DIAGNOSTIC PROCEDURES 52 TREATMENTS 53 TABLE 35 CURRENT TREATMENTS FOR PEDICULOSIS PUBIS BRAND NAME, GENERIC NAME AND MANUFACTURER PELVIC INFLAMMATORY DISEASE (PID) 53 OVERVIEW 53 RISK FACTORS 53 INCIDENCE 54 DIAGNOSIS 54 TREATMENT

6 TABLE 36 CURRENT TREATMENTS FOR PID BRAND NAME, GENERIC NAME AND MANUFACTURER SCABIES 55 OVERVIEW 55 RISK FACTORS 55 INCIDENCE 55 DIAGNOSTIC PROCEDURES 56 TREATMENTS 56 TABLE 37 CURRENT TREATMENTS FOR SCABIES BRAND NAME, GENERIC NAME AND MANUFACTURER SYPHILIS 56 OVERVIEW 56 TABLE 38 STAGES OF SYPHILIS 57 RISK FACTORS 57 INCIDENCE 57 U.S. 58 Western Europe, Russia 58 DIAGNOSTIC PROCEDURES 58 TABLE 39 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF SYPHILIS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TREATMENTS 59 TRICHOMONIASIS 59 OVERVIEW 59 RISK FACTORS 60 INCIDENCE 60 DIAGNOSTIC PROCEDURES 60 TABLE 40 DIAGNOSTIC ASSAYS FOR DETECTION OF TRICHOMONAS WITH BRAND NAME, TYPE AND MANUFACTURER TREATMENTS 60 TABLE 41 CURRENT MEDICATIONS FOR THE TREATMENT OF TRICHOMONAS 61 STD TRENDS 61 GLOBAL CONDOM USE 61 U.S. 61 Gonorrhea 61 Chlamydia 61 Syphilis 61 HIV/AIDs 62 EMRA 62 Gonorrhea 62 Chlamydia 62 Hepatitis B 62 Hepatitis C 63 HIV/AIDS 63 Syphilis 63 ASIA 64 Gonorrhea 64 Chlamydia 64 HIV/AIDS

7 Hepatitis 64 CHAPTER 5 STD DIAGNOSIS AND TREATMENT OPTIONS 66 DIAGNOSTIC OPTIONS, BY TYPE 66 FIGURE 4 MARKET SHARE FOR TYPES OF TESTS USED TO DIAGNOSE STDS, 2012 (%) 66 GLOBAL MARKET FOR STD DIAGNOSTIC PRODUCTS, BY DISEASE 67 TABLE 42 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED TO DETECT STDS BY DISEASE, THROUGH 2017 ($ MILLIONS) PROJECTED GLOBAL MARKET FOR STD DIAGNOSTIC PRODUCTS, BY REGION 68 TABLE 43 PROJECTED GLOBAL MARKET FOR STD DIAGNOSTIC PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) FIGURE 5 GLOBAL STD DIAGNOSTIC MARKET, BY REGION 2012 AND 2017 (%) 69 STD PHARMACEUTICAL PRODUCTS, BY DISEASE 69 TABLE 44 PROJECTED GLOBAL MARKET FOR STD PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) GLOBAL MARKET FOR STD PHARMACEUTICAL PRODUCTS, BY REGION 70 TABLE 45 PROJECTED GLOBAL MARKET FOR STD PHARMACEUTICAL PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) FIGURE 6 GLOBAL STD PHARMACEUTICAL MARKET BY REGION 2012 AND 2017 (%) 71 OPPORTUNITIES IN THE STD DIAGNOSIS AND TREATMENT MARKET 71 OPPORTUNITIES IN THE HIV/AIDS MARKET 72 Diagnostics 72 Pharmaceuticals 73 Immediate term 73 Medium-term priorities 73 OPPORTUNITIES IN THE HEPATITIS MARKET 74 Pharmaceutical Opportunities in the Hepatitis Market 74 OTHER STDS 74 Diagnostic Testing CHAPTER 6 THE AMERICAS MARKET 76 DIAGNOSTIC PRODUCTS IN THE AMERICAS 76 MARKET FOR DIAGNOSTIC PRODUCTS IN THE AMERICAS 76 TABLE 46 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) FIGURE 7 MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE AMERICAS BY DISEASE, 2012 AND 2017 (%) PHARMACEUTICAL TREATMENTS IN THE AMERICAS 78 TABLE 47 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE AMERICAS, BY DISEASE, THROUGH 2017 ($ MILLIONS) FIGURE 8 MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE AMERICAS BY DISEASE, 2012 AND 2017 (%) ANTIBIOTIC RESISTANCE IN TREATING STDS 79 THE U.S. 80 STD AND PREGNANCY 80 Problems for the Child at Birth 80 Treatments for STDs During Pregnancy 80 TABLE 48 ESTIMATED ANNUAL NUMBER OF PREGNANT WOMEN WITH AN STD IN THE U.S. 80 ANNUAL INCIDENCE OF STDS IN THE U.S

8 TABLE 49 ANNUAL INCIDENCE OF SEXUALLY TRANSMITTED DISEASES IN THE U.S., 2010 (PER 100,000 PEOPLE) Gonorrhea 81 Chlamydia 82 Syphilis 82 HIV 82 HIV and Women 82 Hepatitis B 82 Hepatitis C 82 LATIN/SOUTH AMERICA 83 HIV 83 HIV Treatment in Central/South America 83 CANADA 83 HIV IN CANADA 83 HEPATITIS IN CANADA 84 CHLAMYDIA IN CANADA 84 SYPHILIS IN CANADA 84 GONORRHEA IN CANADA CHAPTER 7 THE EMRA MARKET 86 STD DIAGNOSTIC PRODUCT MARKET IN THE EMRA 86 TABLE 50 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE EMRA, THROUGH 2017 ($ MILLIONS) FIGURE 9 MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE EMRA BY DISEASE, 2012 AND 2017 (%) STD PHARMACEUTICAL TREATMENTS IN THE EMRA 87 TABLE 51 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE EMRA BY DISEASE, THROUGH 2017 ($ MILLIONS) FIGURE 10 MARKET FOR STD TREATMENT PRODUCTS IN THE EMRA BY DISEASE, 2012 AND 2017 (%) ANNUAL INCIDENCES OF STD DISEASE IN THE EMRA 89 UNITED KINGDOM 89 Chlamydia 89 HSV 89 HPV 89 Syphilis 90 HIV IN EUROPE 90 HEPATITIS B, C IN EUROPE 90 Hepatitis C 90 CHLAMYDIA AND GONORRHEA IN EUROPE 90 Gonorrhea 91 SYPHILIS IN EUROPE 91 HIV IN AFRICA 91 Access to Therapeutics in Africa 92 Hepatitis in Africa 92 RUSSIA, EASTERN EUROPE, CENTRAL ASIA 92 HIV 92 HIV Treatments in the Region

9 Hepatitis 92 MIDDLE EAST 93 HIV 93 CHAPTER 8 THE ASIAN MARKET 95 DIAGNOSTIC PRODUCTS 95 TABLE 52 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN ASIA BY DISEASE, THROUGH 2017 ($ MILLIONS) FIGURE 11 MARKET FOR STD DIAGNOSTIC PRODUCTS IN ASIA BY DISEASE, 2012 AND 2017 (%) STD TREATMENT OPTIONS IN ASIA 96 TABLE 53 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN ASIA BY DISEASE, THROUGH 2017 ($ MILLIONS) FIGURE 12 MARKET FOR STD TREATMENT PRODUCTS IN ASIA BY DISEASE, 2012 AND 2017 (%) REGIONAL DISEASE PREVALENCE 98 CHINA 99 HIV 99 HIV Testing and Treatment 99 INDIA 99 HIV 99 Testing 100 Treatment 100 Hepatitis in India 100 AUSTRALIA 100 JAPAN 100 HIV 100 Hepatitis CHAPTER 9 REGULATIONS 103 CREATING DRUG TREATMENTS 103 TABLE 54 PROCESS OF CREATING DRUG TREATMENTS IN THE U.S. 103 REGIONAL REGULATIONS 104 THE AMERICAS 104 Surveys 104 Canada 104 EMRA 105 Diagnostic Products in EU 105 ASIA 105 Japan 105 Diagnostic Regulations 105 Pharmaceutical Regulations 106 China 106 India 106 CHAPTER 10 PHARMACEUTICAL TREATMENT PIPELINE 108 EMERGING TRENDS IN DIAGNOSTIC PRODUCTS 108 MICROFLUIDIC PAPER-BASED PRODUCTS 108

10 Microfluidic Detection and Telemedicine 108 EMERGING TRENDS IN PHARMACEUTICAL PRODUCTS 109 CHLAMYDIA 109 HERPES SIMPLEX VIRUS 109 Astellas Helicase Inhibitors 109 HIV/AIDS 109 Merck 110 Gilead Sciences 110 GlaxoSmithKline 110 HEPATITIS 111 Gilead Sciences 111 Janssen Pharmaceuticals/Tibotech Pharmaceuticals 111 Merck 111 Roche 111 Boehringer Ingelheim 112 Vertex Pharmaceuticals 112 PHARMACEUTICAL TREATMENT PRODUCT PIPELINE 112 TABLE 55 SEXUALLY TRANSMITTED DISEASE PHARMACEUTICAL PRODUCT PIPELINE, CHAPTER 11 PATENT ANALYSIS 118 PHARMACEUTICAL PATENTS ISSUED BY COMPANY, APPROVAL DATE AND DISEASE 118 TABLE 56 STD PHARMACEUTICAL PATENTS BY PATENT NUMBER, DISEASE, COMPANY, PRODUCT DESCRIPTION, AND APPROVAL DATE FEBRUARY 2006 OCTOBER 2012 DIAGNOSTIC PATENTS ISSUED BY COMPANY, APPROVAL DATE AND DISEASE 122 TABLE 57 STD DIAGNOSTIC PATENTS BY PATENT NUMBER, DISEASE, COMPANY, PRODUCT DESCRIPTION AND APPROVAL DATE MARCH 2005-OCTOBER 2012 PATENTS ISSUED BY COMPANY 124 TABLE 58 STD PHARMACEUTICAL PRODUCT PATENTS, BY MAJOR COMPANY JANUARY 2005 OCTOBER 2012 PATENTS ISSUED BY COUNTRY 125 TABLE 59 STD DIAGNOSIS AND TREATMENT PATENTS BY COUNTRY JANUARY 2005 OCTOBER 2012 PATENTS ISSUED BY DISEASE 126 TABLE 60 PATENTS ISSUED FOR DIAGNOSIS AND TREATMENT OF STDS BY DISEASE, MARCH 2005 OCTOBER CHAPTER 12 COMPANY PROFILES 128 ABBOTT LABORATORIES 128 TABLE 61 ABBOTT PHARMACEUTICAL PRODUCTS 128 TABLE 62 ABBOTT DIAGNOSTIC PRODUCTS 128 ALERE 129 TABLE 63 ALERE DIAGNOSTIC PRODUCTS 129 ALFA SCIENTIFIC DESIGNS 130 TABLE 64 ALFA SCIENTIFIC DESIGNS DIAGNOSTIC PRODUCTS 130 ATLAS LINK BIOTECH CO, LTD. 130 TABLE 65 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 131 BAYER AG 131 TABLE 66 BAYER PHARMACEUTICAL PRODUCTS 131

11 BECTON DICKINSON 131 TABLE 67 BECTON DICKINSON DIAGNOSTIC PRODUCTS 132 BIOMERIEUX, INC. 132 TABLE 68 BIOMERIEUX DIAGNOSTIC PRODUCTS 132 BIO-RAD LABORATORIES 132 TABLE 69 BIO-RAD LABORATORIES DIAGNOSTIC PRODUCTS 133 BOEHRINGER INGELHEIM GMBH 133 TABLE 70 BOEHRINGER INGELHEIM PHARMACEUTICAL PRODUCTS 133 BRISTOL-MYERS SQUIBB COMPANY 134 TABLE 71 BRISTOL-MEYERS SQUIBB PHARMACEUTICAL PRODUCTS 134 CREATIVE DIAGNOSTICS 134 TABLE 72 CREATIVE DIAGNOSTICS DIAGNOSTIC PRODUCTS 135 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS, INC. 135 TABLE 73 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC PRODUCTS 135 DIASORIN 136 TABLE 74 DIASORIN DIAGNOSTIC PRODUCTS 136 ENZO BIOCHEM 136 TABLE 75 ENZO BIOCHEM DIAGNOSTIC PRODUCTS 137 FIRST DIAGNOSTIC LLC 137 TABLE 76 FIRST DIAGNOSTIC DIAGNOSTIC PRODUCTS 137 GENENTECH (SEE ROCHE) 138 GEN-PROBE, INC. (SEE HOLOGIC) 138 GILEAD SCIENCES, INC. 138 TABLE 77 GILEAD SCIENCES PHARMACEUTICAL PRODUCTS 138 GLAXOSMITHKLINE 138 TABLE 78 GLAXOSMITHKLINE PHARMACEUTICAL PRODUCTS 139 HOLOGIC/GEN-PROBE 139 TABLE 79 HOLOGIC/GEN-PROBE DIAGNOSTIC PRODUCTS 139 HOME ACCESS HEALTH, INC. 140 TABLE 80 HOME ACCESS HEALTH DIAGNOSTIC PRODUCTS 140 IMMUNOSTICS 140 TABLE 81 IMMUNOSTICS DIAGNOSTIC PRODUCTS 140 IND DIAGNOSTIC, INC. 141 TABLE 82 IND DIAGNOSTIC, INC DIAGNOSTIC PRODUCTS 141 INVERNESS MEDICAL INNOVATIONS (SEE ALERE) 141 JANSSEN THERAPEUTICS (FORMERLY TIBOTEC THERAPEUTICS) 141 TABLE 83 JANSSEN THERAPEUTICS PHARMACEUTICAL PRODUCTS 142 MERCK & COMPANY, INC. 142 TABLE 84 MERCK PHARMACEUTICAL PRODUCTS 142 MERIDIAN BIOSCIENCE 143 TABLE 85 MERIDIAN BIOSCIENCE DIAGNOSTIC PRODUCTS 143 NOVARTIS PHARMACEUTICAL CORPORATION 143 TABLE 86 NOVARTIS DIAGNOSTIC PRODUCTS 144 ORASURE TECHNOLOGIES, INC. 144 TABLE 87 ORASURE TECHNOLOGIES DIAGNOSTIC PRODUCTS 144 ORTHO CLINICAL DIAGNOSTICS 144 TABLE 88 ORTHO CLINICAL DIAGNOSTICS DIAGNOSTIC PRODUCTS 145

12 PFIZER, INC. 145 TABLE 89 PFIZER PHARMACEUTICAL PRODUCTS 145 PRINCETON BIOMEDITECH CORPORATION 146 TABLE 90 PRINCETON BIOMEDITECH DIAGNOSTIC PRODUCTS 146 QIAGEN BENELUX BV 146 TABLE 91 QIAGEN DIAGNOSTIC PRODUCTS 146 QUIDEL 147 TABLE 92 QUIDEL DIAGNOSTIC PRODUCTS 147 REMEL/THERMOFISHER SCIENTIFIC 147 TABLE 93 REMEL/THERMOFISHER SCIENTIFIC DIAGNOSTIC PRODUCTS 148 ROCHE LABORATORIES (HOFFMANN-LA ROCHE INC.) 148 TABLE 94 ROCHE PHARMACEUTICAL PRODUCTS 148 TABLE 95 ROCHE DIAGNOSTIC PRODUCTS 148 SEKISUI DIAGNOSTICS 149 TABLE 96 SEKISUI DIAGNOSTICS DIAGNOSTIC PRODUCTS 149 SHANGHAI KEHUA BIO-ENGINEERING CO, LTD. 149 TABLE 97 SHANGHAI KEHUA BIO-ENGINEERING DIAGNOSTIC PRODUCTS 149 STANDARD DIAGNOSTICS, INC. 150 TABLE 98 STANDARD DIAGNOSTICS DIAGNOSTIC PRODUCTS 150 TRINITY BIOTECH PLC 151 TABLE 99 TRINITY BIOTECH DIAGNOSTIC PRODUCTS 151 VERTEX PHARMACEUTICALS 152 TABLE 100 VERTEX PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 152 VIIV HEALTHCARE 152 TABLE 101 VIIV HEALTHCARE PHARMACEUTICAL PRODUCTS 152

13 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES, THROUGH 2017 ($ MILLIONS) TABLE 1 MAJOR MANUFACTURERS OF AUTOMATED STD TESTS, TABLE 2 MAJOR MANUFACTURERS OF RAPID AND LABORATORY DIAGNOSTIC STD KITS, TABLE 3 MAJOR MANUFACTURERS OF VACCINES FOR STDS 9 TABLE 4 HPV DIAGNOSTIC PRODUCTS, MANUFACTURER AND MARKET SHARE, 2011 (%) 10 TABLE 5 GONORRHEA DIAGNOSTIC PRODUCT MANUFACTURERS AND PRODUCT NAMES 11 TABLE 6 MAJOR GONORRHEA TREATMENT MANUFACTURERS AND PRODUCTS 11 TABLE 7 HEPATITIS A, B AND C DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE OF TEST, 2011 ($ MILLIONS/%) TABLE 8 MARKET STANDING OF MAJOR HEPATITIS B AND C TREATMENT MANUFACTURERS BY REVENUES, 2011 ($ MILLIONS) TABLE 9 HIV DIAGNOSTIC PRODUCT MARKET SHARE AND REVENUES BY TYPE, 2011 ($ MILLIONS/%) TABLE 10 HIV/AIDS TREATMENT MANUFACTURER MARKET STANDING BY REVENUES, 2011 ($ MILLIONS/%) TABLE 11 NUMBER OF DIAGNOSTIC AND PHARMACEUTICAL MANUFACTURERS, BY DISEASE TREATED, WITH REVENUES AND MARKET SHARE, 2011 ($ MILLIONS/%) TABLE 12 SELECTED MERGERS AND ACQUISITIONS, ($ MILLIONS) 16 TABLE 13 CAUSATIVE ORGANISMS FOR SEXUALLY TRANSMITTED DISEASES 19 TABLE 14 CURRENT DIAGNOSTIC TESTS FOR BACTERIAL VAGINITIS 24 TABLE 15 CURRENT TREATMENTS FOR BACTERIAL VAGINITIS 25 TABLE 16 DIAGNOSTIC TESTS FOR CANDIDIASIS 25 TABLE 17 TREATMENTS FOR VULVOVAGINAL CANDIDIASIS 26 TABLE 18 CURRENT MEDICATIONS USED TO TREAT CHANCROID ULCERS 28 TABLE 19 CURRENTLY AVAILABLE CHLAMYDIA TESTS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 20 CURRENT MEDICATIONS USED TO TREAT CHLAMYDIA 31 TABLE 21 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF GENITAL HERPESBY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 22 CURRENT TREATMENTS FOR GENITAL HERPESBY BRAND NAME, GENERIC NAME AND MANUFACTURER, 2012 TABLE 23 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HPV BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 24 MEDICATIONS USED TO TREAT GENITAL WARTS BY BRAND NAME, GENERIC NAME AND MANUFACTURER TABLE 25 CURRENT PRODUCTS USED TO DIAGNOSE GONORRHEA 37 TABLE 26 CURRENT MEDICATIONS USED TO TREAT GONORRHEA 38 TABLE 27 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HEPATITIS B AND C BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 28 VACCINES AND MEDICATIONS FOR THE TREATMENT OF HEPATITIS, TABLE 29 CDC CLASSIFICATION OF HIV INFECTION 43 TABLE 30 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HIV/AIDS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 31 HIV LIFE CYCLE 46 TABLE 32 FDA-APPROVED GENERIC DRUGS FOR TREATMENT OF HIV, TABLE 33 CURRENTLY APPROVED PHARMACEUTICAL PRODUCTS FOR TREATMENT OF HIV/AIDS BY BRAND NAME, GENERIC NAME AND MANUFACTURER, 2012 TABLE 34 HIV TREATMENT MARKET, BY MANUFACTURER ($ MILLIONS)

14 TABLE HEADING TABLE 35 CURRENT TREATMENTS FOR PEDICULOSIS PUBIS BRAND NAME, GENERIC NAME AND MANUFACTURER TABLE 36 CURRENT TREATMENTS FOR PID BRAND NAME, GENERIC NAME AND MANUFACTURER TABLE 37 CURRENT TREATMENTS FOR SCABIES BRAND NAME, GENERIC NAME AND MANUFACTURER TABLE 38 STAGES OF SYPHILIS 57 TABLE 39 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF SYPHILIS BY BRAND NAME, TYPE AND MANUFACTURER, 2012 TABLE 40 DIAGNOSTIC ASSAYS FOR DETECTION OF TRICHOMONAS WITH BRAND NAME, TYPE AND MANUFACTURER TABLE 41 CURRENT MEDICATIONS FOR THE TREATMENT OF TRICHOMONAS 61 TABLE 42 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED TO DETECT STDS BY DISEASE, THROUGH 2017 ($ MILLIONS) TABLE 43 PROJECTED GLOBAL MARKET FOR STD DIAGNOSTIC PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) TABLE 44 PROJECTED GLOBAL MARKET FOR STD PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) TABLE 45 PROJECTED GLOBAL MARKET FOR STD PHARMACEUTICAL PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) TABLE 46 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) TABLE 47 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE AMERICAS, BY DISEASE, THROUGH 2017 ($ MILLIONS) TABLE 48 ESTIMATED ANNUAL NUMBER OF PREGNANT WOMEN WITH AN STD IN THE U.S. 80 TABLE 49 ANNUAL INCIDENCE OF SEXUALLY TRANSMITTED DISEASES IN THE U.S., 2010 (PER 100,000 PEOPLE) TABLE 50 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE EMRA, THROUGH 2017 ($ MILLIONS) TABLE 51 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE EMRA BY DISEASE, THROUGH 2017 ($ MILLIONS) TABLE 52 PROJECTED MARKET FOR STD DIAGNOSTIC PRODUCTS IN ASIA BY DISEASE, THROUGH 2017 ($ MILLIONS) TABLE 53 PROJECTED MARKET FOR STD PHARMACEUTICAL PRODUCTS IN ASIA BY DISEASE, THROUGH 2017 ($ MILLIONS) TABLE 54 PROCESS OF CREATING DRUG TREATMENTS IN THE U.S. 103 TABLE 55 SEXUALLY TRANSMITTED DISEASE PHARMACEUTICAL PRODUCT PIPELINE, TABLE 56 STD PHARMACEUTICAL PATENTS BY PATENT NUMBER, DISEASE, COMPANY, PRODUCT DESCRIPTION, AND APPROVAL DATE FEBRUARY 2006 OCTOBER 2012 TABLE 57 STD DIAGNOSTIC PATENTS BY PATENT NUMBER, DISEASE, COMPANY, PRODUCT DESCRIPTION AND APPROVAL DATE MARCH 2005-OCTOBER 2012 TABLE 58 STD PHARMACEUTICAL PRODUCT PATENTS, BY MAJOR COMPANY JANUARY 2005 OCTOBER 2012 TABLE 59 STD DIAGNOSIS AND TREATMENT PATENTS BY COUNTRY JANUARY 2005 OCTOBER 2012 TABLE 60 PATENTS ISSUED FOR DIAGNOSIS AND TREATMENT OF STDS BY DISEASE, MARCH 2005 OCTOBER 2012 TABLE 61 ABBOTT PHARMACEUTICAL PRODUCTS 128 TABLE 62 ABBOTT DIAGNOSTIC PRODUCTS 128 TABLE 63 ALERE DIAGNOSTIC PRODUCTS 129 TABLE 64 ALFA SCIENTIFIC DESIGNS DIAGNOSTIC PRODUCTS

15 TABLE HEADING TABLE 65 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 131 TABLE 66 BAYER PHARMACEUTICAL PRODUCTS 131 TABLE 67 BECTON DICKINSON DIAGNOSTIC PRODUCTS 132 TABLE 68 BIOMERIEUX DIAGNOSTIC PRODUCTS 132 TABLE 69 BIO-RAD LABORATORIES DIAGNOSTIC PRODUCTS 133 TABLE 70 BOEHRINGER INGELHEIM PHARMACEUTICAL PRODUCTS 133 TABLE 71 BRISTOL-MEYERS SQUIBB PHARMACEUTICAL PRODUCTS 134 TABLE 72 CREATIVE DIAGNOSTICS DIAGNOSTIC PRODUCTS 135 TABLE 73 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC PRODUCTS 135 TABLE 74 DIASORIN DIAGNOSTIC PRODUCTS 136 TABLE 75 ENZO BIOCHEM DIAGNOSTIC PRODUCTS 137 TABLE 76 FIRST DIAGNOSTIC DIAGNOSTIC PRODUCTS 137 TABLE 77 GILEAD SCIENCES PHARMACEUTICAL PRODUCTS 138 TABLE 78 GLAXOSMITHKLINE PHARMACEUTICAL PRODUCTS 139 TABLE 79 HOLOGIC/GEN-PROBE DIAGNOSTIC PRODUCTS 139 TABLE 80 HOME ACCESS HEALTH DIAGNOSTIC PRODUCTS 140 TABLE 81 IMMUNOSTICS DIAGNOSTIC PRODUCTS 140 TABLE 82 IND DIAGNOSTIC, INC DIAGNOSTIC PRODUCTS 141 TABLE 83 JANSSEN THERAPEUTICS PHARMACEUTICAL PRODUCTS 142 TABLE 84 MERCK PHARMACEUTICAL PRODUCTS 142 TABLE 85 MERIDIAN BIOSCIENCE DIAGNOSTIC PRODUCTS 143 TABLE 86 NOVARTIS DIAGNOSTIC PRODUCTS 144 TABLE 87 ORASURE TECHNOLOGIES DIAGNOSTIC PRODUCTS 144 TABLE 88 ORTHO CLINICAL DIAGNOSTICS DIAGNOSTIC PRODUCTS 145 TABLE 89 PFIZER PHARMACEUTICAL PRODUCTS 145 TABLE 90 PRINCETON BIOMEDITECH DIAGNOSTIC PRODUCTS 146 TABLE 91 QIAGEN DIAGNOSTIC PRODUCTS 146 TABLE 92 QUIDEL DIAGNOSTIC PRODUCTS 147 TABLE 93 REMEL/THERMOFISHER SCIENTIFIC DIAGNOSTIC PRODUCTS 148 TABLE 94 ROCHE PHARMACEUTICAL PRODUCTS 148 TABLE 95 ROCHE DIAGNOSTIC PRODUCTS 148 TABLE 96 SEKISUI DIAGNOSTICS DIAGNOSTIC PRODUCTS 149 TABLE 97 SHANGHAI KEHUA BIO-ENGINEERING DIAGNOSTIC PRODUCTS 149 TABLE 98 STANDARD DIAGNOSTICS DIAGNOSTIC PRODUCTS 150 TABLE 99 TRINITY BIOTECH DIAGNOSTIC PRODUCTS 151 TABLE 100 VERTEX PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 152 TABLE 101 VIIV HEALTHCARE PHARMACEUTICAL PRODUCTS 152

16 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR TREATMENT AND DIAGNOSIS OF SEXUALLY TRANSMITTED DISEASES, 2011 AND 2017 (%) FIGURE 1 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS MARKET AND THEIR MARKET SHARE, 2011 (%) FIGURE 2 MARKET SHARE OF LEADING COMPANIES IN THE HIV/AIDS TREATMENT MARKET, 2011 (%) FIGURE MARKET SHARE FOR BRANDED HIV DRUGS, BY MANUFACTURER (%) 50 FIGURE 4 MARKET SHARE FOR TYPES OF TESTS USED TO DIAGNOSE STDS, 2012 (%) 66 FIGURE 5 GLOBAL STD DIAGNOSTIC MARKET, BY REGION 2012 AND 2017 (%) 69 FIGURE 6 GLOBAL STD PHARMACEUTICAL MARKET BY REGION 2012 AND 2017 (%) 71 FIGURE 7 MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE AMERICAS BY DISEASE, 2012 AND 2017 (%) FIGURE 8 MARKET FOR STD PHARMACEUTICAL PRODUCTS IN THE AMERICAS BY DISEASE, 2012 AND 2017 (%) FIGURE 9 MARKET FOR STD DIAGNOSTIC PRODUCTS IN THE EMRA BY DISEASE, 2012 AND 2017 (%) FIGURE 10 MARKET FOR STD TREATMENT PRODUCTS IN THE EMRA BY DISEASE, 2012 AND 2017 (%) FIGURE 11 MARKET FOR STD DIAGNOSTIC PRODUCTS IN ASIA BY DISEASE, 2012 AND 2017 (%) FIGURE 12 MARKET FOR STD TREATMENT PRODUCTS IN ASIA BY DISEASE, 2012 AND 2017 (%)