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According to the World Health Organization (WHO), six infectious diseases--pneumonia, tuberculosis, diarrheal diseases, malaria, measles and HIV/AIDS--account for half of all premature deaths worldwide, killing mostly children and young adults. What’s more, threatening pandemics such as swine flu (H1N1 influenza A virus) are adding significant pressure to already strained healthcare budgets of governments around the world. This report provides a detailed description of the current infectious diseases drugs market and highlights the existing and developing anti-infective agents used to ameliorate diseases’ afflictions on humankind. Anti-infective agents include: anti-viral therapeutics, antibiotics, anti-fungal agents and prophylactic treatments such as vaccines. Particular attention is paid to the clinical market segment and the pharmaceutical/biotechnology companies involved in anti-infective agents, with specific emphasis on each company’s sales focus, product portfolio and R&D pipeline. To date, the most successful anti-infective agents target the human immunodeficiency virus (HIV, the virus that causes AIDS), the herpes virus (HSV-1 and HSV-2), bacterial infections and hepatitis C (HCV). A number of exciting novel anti-viral and antibiotic compounds are currently revolutionizing the infectious diseases drugs market, including Truvada and Valtrex, which are anti-HIV and anti-herpes therapies, respectively. Significant resources are also being dedicated toward hepatitis A (HAV), hepatitis B (HBV) and Staph infections, including MRSA. What’s more, this study will examine the existing and developing anti-infective agents targeted at infectious diseases that continue to devastate developing countries, including: cholera, dengue fever, meningitis, rotavirus, typhoid, yellow fever and onchocerciasis (“river blindness”).
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TABLE OF CONTENTS :
1. Overview 9 1.1 Statement of Report 9 1.2 Scope of the Report 9 1.3 Methodology 10 1.4 Executive Summary 11
2. Clinical Syndromes and Therapy 20 2.1 Head and Neck 22 2.1.1 Sinusitis 22 2.1.2 Pharyngotonsillitis 23 2.1.3 Deep Neck Infections 23 2.1.4 Otitis Media and Externa 23 2.1.5 Acute Suppurative Thyroiditis 23 2.2 Eye 24 2.2.1 Conjunctivitis 24 2.2.2 Keratitis 24 2.2.3 Iritis 24 2.2.4 Retinitis 25 2.2.5 Endophthalmitis 25 2.3 Skin and Lymph Nodes 25 2.3.1 Complicated Skin and Skin Structure Infections (cSSSI) 25 2.3.2 Lymphadenitis 25 2.4 Respiratory Tract 26 2.4.1 Bronchitis 26 2.4.2 Laryngitis 26 2.4.3 Pneumonia 26 2.4.4 Influenza 28 2.4.5 Avian Bird Flu 29 2.4.6 Swine Flu 29 2.4.7 Respiratory Syncytial Virus 33 2.4.8 Tuberculosis 33 2.5 Heart and Blood Vessels 37 2.5.1 Endocarditis 37 2.5.2 Acute Pericarditis 37 2.5.3 Myocarditis 37 2.5.4 Vascular Infections 37 2.6 Gastrointestinal Tract, Liver and Abdomen 38 2.6.1 Acute Viral Hepatitis 38 2.6.2 Chronic Hepatitis 38 2.6.3 Biliary Tract Infections 39 2.6.4 Pancreatitis 40 2.6.5 Esophageal Infections 40 2.6.6 Gastroenteritis 40 2.6.7 Peritonitis 41 2.7 Genitourinary Tract 42 2.7.1 Urethritis 42 2.7.2 Prostatitis 42 2.7.3 Urinary Tract Infections 43 2.7.4 Pelvic Inflammatory Disease 43 2.7.5 Candiduria 43 2.7.6 Human Papilloma Virus 43 2.8 Nervous System 44 2.8.1 Bacterial Meningitis 44 2.8.2 Viral Encephalitis 45 2.8.3 Reye’s Syndrome 45 2.8.4 Myelitis and Peripheral Neuropathy 45 2.9 Musculoskeletal System 45 2.9.1 Osteomyelitis 45 2.9.2 Polyarthritis 46 2.9.3 Bursitis 46 2.9.4 Psoas Abscess 46 2.10 Human Immunodeficiency Virus (HIV) Infection 46 2.11 Blood-borne Infections 52 2.11.1 Malaria 52 2.11.2 West Nile Virus 55
3. Anti-infective Agents Market 57 3.1 FDA Approvals of New Anti-infective Therapy 59 3.2 Anti-infective Agents in Current Pharmaceutical Developmental Programs 67 3.3 Factors Determining Anti-infective Drug Development 69 3.4 Pharmaceutical R&D Expenditures 69
4. Description of Anti-infective Therapeutic Agents 71 4.1 Anti-bacterials 71 4.1.1 Anti-bacterial Therapeutic Agents in Current Formulation 74 4.1.1.1 ß-lactam Antibiotics 75 4.1.1.2 Fluoroquinones 76 4.1.1.3 Glycopeptides 77 4.1.1.4 Macrolides 78 4.1.1.5 Oxazolidinones 79 4.1.1.6 Other Classes of Anti-bacterial Agents 80 4.1.2 Older Classes of Antibiotics 80 4.2 Anti-virals 81 4.2.1 Overview 81 4.2.2 Anti-viral Therapy 81 4.2.3 Anti-viral Market Leaders 82 4.2.4 Principles of Anti-viral Therapy 82 4.3 Anti-fungals 88 4.3.1 Overview 88 4.3.2 Major Classes of Anti-fungal Therapy 88 4.3.3 Anti-fungal Agent Resistance 89 4.3.4 Anti-fungal Agent Market Leaders 90 4.4 Vaccines 90 4.4.1 Overview 90 4.4.2 Principles of Vaccine Therapy 92 4.4.3 Vaccine Market Leaders 93
5. Market for Anti-infective Agents and Vaccines 96 5.1 Molecular Diagnostics in Determining Demand 96
6. Decision-making Activity in the Anti-infective Market 100 6.1 Net Present Value in Making Decisions to Develop and Market Antibiotics 101
7. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials 103 7.1 Resistance and Antibiotic Usage 106
8. Global Market Analysis of Anti-infective Agents 108 8.1 Market Size 108 8.2 Market Share 108 8.3 Market Drivers 110
9. Global Market for Anti-bacterial Therapies 111 9.1 Amoxicillin 113 9.2 Nafcillin 113 9.3 Ticarcillin 113 9.4 Imipenem 114 9.5 Ceftriaxone 114 9.6 Cefotetan 114 9.7 Dalbavancin 115 9.8 Doripenem 115
10. Global Market for Anti-fungal Therapies 117 10.1 Amphotericin B 118 10.2 Azoles 118 10.3 Echinocandins 119 10.4 Flucytosine 119
11. Global Market for Anti-viral Therapies 120 11.1 Antiretroviral Market 120 11.1.1 The Viral Drug Resistance Crisis 120 11.1.2 Emtricitabine 123 11.1.3 CCR5 Receptor Antagonists 124 11.1.4 Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 124 11.2 HCV Infections 125 11.2.1 Pegintron Alpha 125 11.2.2 Ribavirin 126 11.2.3 Boceprevir 126 11.3 Acyclovir 126 11.4 Adefovir 126 11.5 Cidofovir 127 11.6 Entecavir 127 11.7 Fomivirsen 127 11.8 Foscarnet 127 11.9 Ganciclovir 127
12. Market, Demographic and Economic Trends 128 12.1 Emerging Trends in Infectious Diseases Worldwide 128 12.2 Global Burden of Infectious Disease 129 12.3 The AIDS Model 130 12.4 Dead-end Transmission of Zoonotic and Vector-borne Diseases 130 12.5 Environmentally Persistent Organisms 131 12.6 Old Microbes Cause New Disease 131 12.7 Microbial Agents and Chronic Diseases 131 12.8 Remerging and Resurging Infections 132 12.9 Geographical Spread of Infectious Disease 132 12.10 Drug-resistant Microbes 133 12.11 Opportunistic Re-emerging Infections 133 12.12 Re-emerging Zoonotic and Vector-borne Diseases 133 12.13 Influenza 133 12.14 Deliberately Emerging Infections 134 12.15 Meeting the Challenge of Emerging Diseases 134
13. Political/Legal Trends 135 13.1 AATF and Legislation 135 13.2 Bioterrorism and Biowarfare 137
14. Technological Trends 138 14.1 Anti-microbial Discovery in the Post-genomic Era 138 14.1.1 Anti-bacterial Polypharmacology 138 14.1.2 Topology of Targets 139 14.1.3 Designer Polypharmacology and Designing HIV-Therapies 139
15. Socio-Cultural Trends 140
16. Competitive Landscape 141 16.1 Introduction 141 16.2 Strengths and Weaknesses in Anti-microbial Drug Discovery—Commercial 142 16.3 Strengths and Weaknesses in Anti-microbial Drug Discovery—Academic 143 16.4 Regulatory Hurdles 143 16.5 Business Hurdles 144 16.6 Strategic Alliances, Licensing Activity, and Mergers & Acquisitions in the Anti-infectives Landscape 145
17. Sales Performance amongst the Leading Players: Detailed Analysis of Leading Anti-infective Players 148 17.1 GlaxoSmithKline 148 17.1.1 Overview 148 17.1.2 Sales Focus by Drug Class 148 17.1.3 Marketed Product Portfolio 149 17.1.4 R&D Pipeline Analysis 151 17.1.5 Strategic and Growth Analysis 151 17.2 Merck 152 17.2.1 Overview 152 17.2.2 Sales Focus by Drug Class 152 17.2.3 Marketed Product Portfolio 153 17.2.4 R&D Pipeline Analysis 155 17.2.5 Strategic and Growth Analysis 155 17.3 Pfizer 156 17.3.1 Overview 156 17.3.2 Sales Focus by Drug Class 156 17.3.3 Marketed Product Portfolio 157 17.3.4 R&D Pipeline Analysis 159 17.3.5 Strategic and Growth Analysis 159 17.4 Novartis 160 17.4.1 Overview 160 17.4.2 Sales Focus by Drug Class 160 17.4.3 Marketed Product Portfolio 160 17.4.4 R&D Pipeline Analysis 161 17.4.5 Strategic and Growth Analysis 162 17.5 Gilead Sciences 163 17.5.1 Overview 163 17.5.2 Sales Focus by Drug Class 163 17.5.3 Marketed Product Portfolio 164 17.5.4 R&D Pipeline Analysis 165 17.5.5 Strategic and Growth Analysis 165 17.6 Abbott 165 17.6.1 Overview 165 17.6.2 Sales Focus by Drug Class 166 17.6.3 Marketed Product Portfolio 166 17.6.4 R&D Pipeline Analysis 167 17.6.5 Strategic and Growth Analysis 167 17.7 Wyeth 167 17.7.1 Overview 167 17.7.2 Sales Focus by Drug Class 168 17.7.3 Marketed Product Portfolio 168 17.7.4 R&D Pipeline Analysis 169 17.7.5 Strategic and Growth Analysis 169 17.8 Sanofi-Aventis 170 17.8.1 Overview 170 17.8.2 Sales Focus by Drug Class 170 17.8.3 Marketed Product Portfolio 171 17.8.4 R&D Pipeline Analysis 172 17.8.5 Strategic and Growth Analysis 172 17.9 Bristol-Myers Squibb 173 17.9.1 Overview 173 17.9.2 Sales Focus by Drug Class 173 17.9.3 Marketed Product Portfolio 173 17.9.4 R&D Pipeline Analysis 174 17.9.5 Strategic and Growth Analysis 174 17.10 Johnson & Johnson 175 17.10.1 Overview 175 17.10.2 Sales Focus by Drug Class 175 17.10.3 Marketed Product Portfolio 175 17.10.4 R&D Pipeline Analysis 176 17.10.5 Strategic and Growth Analysis 176 17.11 Roche Pharma AG 177 17.11.1 Overview 177 17.11.2 Sales Focus by Drug Class 177 17.11.3 Marketed Product Portfolio 178 17.11.4 R&D Pipeline Analysis 178 17.11.5 Strategic and Growth Analysis 179
18. Company Profiles 180 18.1 Abraxis BioScience, Inc. 180 18.2 Acambis 180 18.3 Achillion Pharmaceuticals, Inc. 180 18.4 Adlyfe, Inc. 181 18.5 Advanced Life Sciences Holdings, Inc. 182 18.6 Affinium Pharmaceuticals 182 18.7 Akonni Biosystems 182 18.8 Alnylam Pharmaceuticals 182 18.9 APP Pharmaceuticals 183 18.10 Aquapharm Biodiscovery 183 18.11 Arbor Vita Corporation 183 18.12 Arpida Ltd. 183 18.13 Avexa Ltd. 184 18.14 Basilea Pharmaceutica AG 184 18.15 Baxter International, Inc. 184 18.16 Biophage Pharma, Inc. 185 18.17 CEL-SCI Corporation 185 18.18 Cerexa, Inc. (Subsidiary of Forest Laboratories) 186 18.19 CombiMatrix Corporation 186 18.20 Cubist Pharmaceuticals, Inc. 187 18.21 Daiichi Sankyo Co., Ltd. 187 18.22 Hospira, Inc. 187 18.23 Incyte Corporation 188 18.24 Idenix Pharmaceuticals, Inc. 189 18.25 Medivir AB 189 18.26 Meiji Holdings Co., Ltd. 190 18.27 MerLion Pharmaceuticals 190 18.28 Mutabilis 190 18.29 NanoBio Corporation 191 18.30 Nanosphere, Inc. 191 18.31 Nanoviricides, Inc. 191 18.32 Novabay Pharmaceuticals, Inc. 191 18.33 Obetech, LLC 192 18.34 Optimer Pharmaceuticals, Inc. 192 18.35 Panacos Pharmaceuticals, Inc. 193 18.36 Paratek Pharmaceuticals, Inc. 193 18.37 Pharmasset, Inc. 193 18.38 Pico Pharmaceuticals, Inc. 194 18.39 PolyMedix, Inc. 194 18.40 PowderMed Ltd. (Subsidiary of Pfizer) 195 18.41 Presidio Pharmaceuticals, Inc. 195 18.42 Progenics Pharmaceuticals, Inc. 195 18.43 Protez Pharmaceuticals (a Novartis Subsidiary) 196 18.44 Ribomed Biotechnologies, Inc. 196 18.45 Rib-X Pharmaceuticals, Inc. 196 18.46 Targanta Therapeutics Corporation, Inc. 197 18.47 Theravance, Inc. 197 18.48 Trius Therapeutics 197 18.49 Vertex Pharmaceuticals, Inc. 197 18.50 X-GEN Pharmaceuticals, Inc. 198
Appendix 1: FDA Compliance Policies Regarding Approved New Drug and Antibiotic Drug Products 199 Appendix 2: Anti-HCV Drugs in Development 201 Appendix 3: The Market for Anti-infectives in Animal Health 204 Appendix 4: Diagnostics for Infectious Agents 210
INDEX OF FIGURES
Figure 1.1: Leading Causes of Death in the U.S., 1958-2005 12 Figure 1.2: Global Distribution of Anti-infective Agent Sales by Geography 15 Figure 2.1: Incidence Rates of Invasive MRSA Infections by Age 20 Figure 2.2: U.S. Child Death Rate from Preventable Diseases, 2007 22 Figure 2.3: Infection Rate of Serotype 19A by Age Group in the U.S., 1998-2006 27 Figure 2.4: U.S. Hospitalizations for Types of Respiratory Diseases in Children Under 15 Years of Age 27 Figure 2.5: Economic Burden of Select Lung Diseases in the U.S., 2007 28 Figure 2.6: Infection Rate of Invasive Pneumococcal Disease in the U.S., 1998-2006 28 Figure 2.7: Status of H5N1 Avian Influenza, 2009 29 Figure 2.8: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009 31 Figure 2.9: Distribution of H1N1 Flu in the U.S., August 2009 32 Figure 2.10: Novel H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group 32 Figure 2.11: Number of Tuberculosis (TB) Cases among U.S. - and Foreign-born Persons, by Year Reported in the U.S., 1993-2008 34 Figure 2.12: Rate of Tuberculosis (TB) Cases among U.S. - and Foreign-born Persons, by Year Reported in the U.S., 1993-2008 34 Figure 2.13: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008 35 Figure 2.14: U.S.-born TB Cases by Ethnicity, 2008 36 Figure 2.15: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006 38 Figure 2.16: Countries Reporting Outbreaks of Cholera, 2006-2008 41 Figure 2.17: U.S. Rates of Sexually-Transmitted Diseases, 1940-2007 42 Figure 2.18: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008 44 Figure 2.19: Global Trend of HIV Infection, 1991-2007 47 Figure 2.20: Worldwide Percentage of Adults Living with HIV, 1990-2006 47 Figure 2.21: Worldwide Rate of New HIV Cases, 1990-2007 48 Figure 2.22: Percentage of Adult Population in African Countries with HIV, 2007 48 Figure 2.23: Ethnic Distribution of AIDS Patients in the U.S., 2007 50 Figure 2.24: Ten Best Selling AIDS Drugs in the U.S., 2008 50 Figure 2.25: U.S. Rates for New HIV Cases, 2008 51 Figure 2.26: Global Malaria-Endemic Areas in the Eastern Hemisphere 53 Figure 2.27: Anti-Malarial Vaccine Pipeline, 2009 54 Figure 2.28: Global Anti-Malarial Drug Pipeline, 2008 55 Figure 2.29: West Nile Virus Activity in the U.S., 2009 56 Figure 3.1: Anti-infective Drug Market Projections, 2006-2013 57 Figure 3.2: Leading Companies in Anti-infectives Market Share, 2008 58 Figure 3.3: Number of New Anti-bacterial Agents Approved by the FDA in the U.S., 1983-2008 61 Figure 3.4: Total Spending on Healthcare in the U.S., 1960-2008 63 Figure 3.5: Percentage Breakdown of U.S. Healthcare Spending, 2008 64 Figure 3.6: International per Capita Healthcare Spending by Country, 2006 64 Figure 3.7: Generic Drug Applications and Approvals in the U.S., 1995-2006 65 Figure 3.8: Savings Generated by Generic Use in the U.S., by Therapeutic Category, 1999-2008 66 Figure 3.9: Anti-bacterial and Anti-HIV New Molecular Entities (NMEs) Approved by the FDA, 1993-2007 69 Figure 3.10: Cost for New Drugs by Primary Indication, 2007 70 Figure 4.1: Market Share by Leading Anti-bacterial Drug Class 72 Figure 4.2: Anti-virals in the Marketplace 81 Figure 4.3: Anti-viral Market by Indication, Excluding HIV and HCV 82 Figure 4.4: Anti-viral Therapeutics Market, by Drug Class 83 Figure 4.5: Global Distribution of the Lack of Childhood Vaccination 91 Figure 4.6: GAVI Alliance Members 92 Figure 4.7: Global Vaccines Market, 2008 93 Figure 4.8: GlaxoSmithKline’s Vaccine Pipeline, 2008 94 Figure 4.9: The Vaccine Market by Geographical Area, 2008 94 Figure 5.1: Global Market for Molecular Diagnostics, 2002-2013 97 Figure 6.1: Number of Non-elderly Americans without Health Insurance Coverage, 1994-2007 101 Figure 6.2: Percentage of Non-elderly Americans without Health Insurance Coverage, 1994-2007 101 Figure 7.1: Global Multidrug Susceptibility in P. aeruginosa 105 Figure 7.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 105 Figure 7.3: MRSA Trends According to Patient Location, 1998-2005 106 Figure 9.1: Projected Growth in Market for Injectable Anti-bacterials, 2008 and 2013 112 Figure 9.2: Real and Projected Market Shares for Major Anti-bacterial Classes, 2008 and 2013 112 Figure 9.3: Frequency of S. aureus in Skin and Soft Tissue Infections 115 Figure 11.1: Current and Projected Market Size for Injectable Antiretrovirals by Class, 2008 and 2013 120 Figure 11.2: Market Share for Injectable Antiretrovirals by Drug Class, 2008 121 Figure 11.3: The Changing Face of the HCV Market: Growth and Projections by Drug Class, 2008 and 2013 125 Figure A3.1: Growth in Global Sales of Antibiotic Products in Animal Health, 2005-2012 204 Figure A4.1: FIND Pipeline for TB Diagnostics 221
INDEX OF TABLES
Table 1.1: Top Ten Causes of Death Worldwide 12 Table 1.2: Leading Pharmaceutical Companies in the Anti-infective Market—Total Global Sales, 2008 16 Table 2.1: Annual Rates of Global Infectious Diseases 21 Table 2.2: Drugs in Development for Chronic Hepatitis B, 2009 39 Table 2.3: Global HIV Statistics, 2007 49 Table 3.1: Top Selling Anti-infective Agents, 2008 58 Table 3.2: Sales for Leading Companies’ Infectious Diseases Segments, 2008 59 Table 3.3: Current Drug Development Times and Rates, by Therapeutic Indication 60 Table 3.4: Emerging Therapeutic Approaches 60 Table 3.5: New Drug Approvals in All Categories from FDA, 2000-2008 61 Table 3.6: Top Ten Global Pharmaceutical Markets, 2008 62 Table 3.7: BRIC Countries, Percentage of GDP Spent on Healthcare, 2008 62 Table 3.8: Percentage of GDP Healthcare Spending by Country, 2008 63 Table 3.9: Top 20 Generic Drugs by Prescriptions, 2008 66 Table 3.10: Anti-bacterial Agents Undergoing Clinical Development 67 Table 3.11 Leading Tuberculosis R&D Candidates 68 Table 3.12: Pipeline for Repositioned Drugs 68 Table 4.1: Potential Anti-bacterial Protein Drug Targets 73 Table 4.2: In vitro Susceptibility of Staphylococci to New Agents in Development 73 Table 4.3: Anti-staphylococcal Vaccines and Immunoglobulins in the Late Stage Pipeline, 2009 74 Table 4.4: Bacterial Targets of Antibiotics and Resistance Mechanisms 74 Table 4.5: Guideline Summary for Antibiotic Selection for Skin and Soft Tissue Infections 75 Table 4.6: Selected Anti-viral Drugs 83 Table 4.7: Anti-reterovirals in Development, 2008 83 Table 4.8: New Types of HIV Drugs 84 Table 4.9: Recommended Daily Dosage of Seasonal Influenza Anti-viral Medications for Treatment and Chemoprophylaxis in the U.S., 2008-2009 85 Table 4.10: Percentage Drug Resistance for Common Influenza Virus Strains, 2009 86 Table 4.11: Selected HCV Drugs in Development, 2009 87 Table 4.12: Therapeutic Agents in Development for Treating Hepatitis B, 2008 88 Table 4.13: Anti-fungal Compounds in Late Stage Development 89 Table 4.14: New Vaccines Licensed, 2005-2008 91 Table 4.15: Global Top Selling Blockbuster Vaccines, 2008 95 Table 4.16: Selected Anti-infective Monoclonal Antibodies in Clinical Development, 2009 95 Table 5.1: FDA-approved Commercial Kits for the Detection of Infectious Agents 97 Table 5.2: Examples of Personalized Medicine in Treatment of Infectious Disease 98 Table 6.1: Competitive Landscape for Anti-viral Drugs in Development, 2009 102 Table 6.2: Competitive Landscape for Anti-biotic Drugs in Development, 2009 102 Table 8.1 Anti-HIV Therapeutics Approved by the FDA 109 Table 9.1: Major Classes of Antibiotics 111 Table 10.1: Major Classes of Anti-fungals 117 Table 11.1: CCR-5 Receptor Agonists in Development, 2009 124 Table 12.1: Major Pathogens Identified in the Last 30 Years 129 Table 12.2: Emerging and Re-emerging Infectious Diseases and their Geographical Location 132 Table 16.1: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2008 142 Table 16.2: International Regulatory Measures Indicated by International Forum of Anti-bacterial Resistance 144 Table A2.1: Anti-HCV Pipeline, 2009 201 Table A3.1: U.S. Volume of Animal Health Antibiotics Used, 2000-2006 205 Table A3.2: European Sales of Animal Health Antibiotics, 2005-2012 205 Table A3.3: Use of Antibiotics as Growth Promotants 207 Table A4.1: The Market Structure for Infectious Disease Diagnostics 211 Table A4.2: Rapid Strep Tests on the Market 212 Table A4.3: Rapid Tests for Chlamydia 214 Table A4.4: Rapid Tests for Gonorrhea 216 Table A4.5: The Burden of Influenza 217 Table A4.6: Global Market Potential for TB Diagnostic Testing, 2000-2010 222 Table A4.7: Global Market for HBV Diagnostic Testing, 2000-2012 225 Table A4.8: U.S. Market for HBV Diagnostic Testing, 2000-2012 225 Table A4.9: Serological Diagnosis of Hepatitis B Virus Infections 227 Table A4.10: Lower Detection Limits of HBV DNA Assays 228 Table A4.11: Type of Test: Lateral Flow 231 Table A4.12: Type of Test: Flow-through 232 Table A4.13: Type of Test: Agglutination 232 Table A4.14: Type of Test: Immunoblot 232 Table A4.15: Global Market for HCV Diagnostic Testing, 2000-2009 235 Table A4.16: Efficiency of Available HCV Screening Tests 236 Table A4.17: Recommendations for Diagnostic Testing for Hepatitis C 238
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