Infectious Diseases Drugs Markets

Please note: The Infectious Diseases report has extensive coverage of the H1N1 virus (swine flu).

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").

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 -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