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 34
2.5 Heart and Blood Vessels 38
2.5.1 Endocarditis 38
2.5.2 Acute Pericarditis 38
2.5.3 Myocarditis 38
2.5.4 Vascular Infection 38
2.6 Gastrointestinal Tract, Liver and Abdomen 39
2.6.1 Acute Viral Hepatitis 39
2.6.2 Chronic Hepatitis 39
2.6.3 Biliary Tract Infection 40
2.6.4 Pancreatitis 41
2.6.5 Esophageal Infections 41
2.6.6 Gastroenteritis 41
2.6.7 Peritonitis 42
2.7 Genitourinary Tract 43
2.7.1 Urethritis 43
2.7.2 Prostatitis 43
2.7.3 Urinary Tract Infection 44
2.7.4 Pelvic Inflammatory Disease 44
2.7.5 Candiduria 44
2.7.6 Human Papilloma Virus 44
2.8 Nervous System 45
2.8.1 Bacterial Meningitis 45
2.8.2 Viral Encephalitis 46
2.8.3 Reye’s Syndrome 46
2.8.4 Myelitis and Peripheral Neuropathy 46
2.9 Musculoskeletal System 46
2.9.1 Osteomyelitis 46
2.9.2 Polyarthritis 47
2.9.3 Bursitis 47
2.9.4 Psoas Abscess 47
2.10 Human Immunodeficiency Virus (HIV) Infection 47
2.11 Blood-borne Infections 53
2.11.1 Malaria 53
2.11.2 West Nile Virus 56
3. Anti-infective Agent Markets 58
3.1 FDA Approvals of New Anti-infective Therapy 60
3.2 Anti-infective Agents in Current Pharmaceutical Developmental Programs 68
3.3 Factors Determining Anti-infective Drug Development 71
3.4 Pharmaceutical R&D Expenditures 71
4. Description of Anti-infective Therapeutic Agents 73
4.1 Anti-bacterials 73
4.1.1 Anti-bacterial Therapeutic Agents in Current Formulation 77
4.1.1.1 ß-lactam Antibiotics 77
4.1.1.2 Fluoroquinones 79
4.1.1.3 Glycopeptides 80
4.1.1.4 Macrolides 80
4.1.1.5 Oxazolidinones 81
4.1.1.6 Other Classes of Anti-bacterial Agents 82
4.1.2 Older Classes of Antibiotics 82
4.2 Anti-virals 83
4.2.1 Overview 83
4.2.2 Anti-viral Therapy 83
4.2.3 Anti-viral Market Leaders 84
4.2.4 Principles of Anti-viral Therapy 84
4.3 Anti-fungals 91
4.3.1 Overview 91
4.3.2 Major Classes of Anti-fungal Therapy 91
4.3.3 Anti-fungal Agent Resistance 92
4.3.4 Anti-fungal Agent Market Leaders 93
4.4 Vaccines 93
4.4.1 Overview 93
4.4.2 Principles of Vaccine Therapy 95
4.4.3 Vaccine Market Leaders 97
5. Market for Anti-infective Agents and Vaccines 100
5.1 Molecular Diagnostics in Determining Demand 100
6. Decision-making Activity in the Anti-infective Market 104
6.1 Net Present Value in Making Decisions to Develop and Market Antibiotics 105
7. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials 107
7.1 Resistance and Antibiotic Usage 110
8. Global Market Analysis of Anti-infective Agents 112
8.1 Market Size 112
8.2 Market Share 112
8.3 Market Drivers 114
9. Global Market for Anti-bacterial Therapies 115
9.1 Amoxicillin 117
9.2 Nafcillin 117
9.3 Ticarcillin 117
9.4 Imipenem 118
9.5 Ceftriaxone 118
9.6 Cefotetan 118
9.7 Dalbavancin 119
9.8 Doripenem 120
10. Global Market for Anti-fungal Therapies 121
10.1 Amphotericin B 122
10.2 Azoles 122
10.3 Echinocandins 123
10.4 Flucytosine 123
11. Global Market for Anti-viral Therapies 124
11.1 Antiretroviral Market 124
11.1.1 The Viral Drug Resistance Crisis 124
11.1.2 Emtricitabine 127
11.1.3 CCR5 Receptor Antagonists 128
11.1.4 Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 128
11.2 HCV Infections 129
11.2.1 Pegintron Alpha 129
11.2.2 Ribavirin 130
11.2.3 Boceprevir 130
11.3 Acyclovir 130
11.4 Adefovir 130
11.5 Cidofovir 130
11.6 Entecavir 131
11.7 Fomivirsen 131
11.8 Foscarnet 131
11.9 Ganciclovir 131
12. Market, Demographic and Economic Trends 132
12.1 Emerging Trends in Infectious Diseases Worldwide 132
12.2 Global Burden of Infectious Disease 133
12.3 The AIDS Model 134
12.4 Dead-end Transmission of Zoonotic and Vector-borne Diseases 134
12.5 Environmentally Persistent Organisms 135
12.6 Old Microbes Cause New Disease 135
12.7 Microbial Agents and Chronic Diseases 135
12.8 Remerging and Resurging Infections 136
12.9 Geographical Spread of Infectious Disease 136
12.10 Drug-resistant Microbes 137
12.11 Opportunistic Re-emerging Infections 137
12.12 Re-emerging Zoonotic and Vector-borne Diseases 137
12.13 Influenza 137
12.14 Deliberately Emerging Infections 138
12.15 Meeting the Challenge of Emerging Diseases 138
13. Political/Legal Trends 139
13.1 AATF and Legislation 139
13.2 Bioterrorism and Biowarfare 141
14. Technological Trends 142
14.1 Anti-microbial Discovery in the Post-genomic Era 142
14.1.1 Anti-bacterial Polypharmacology 142
14.1.2 Topology of Targets 143
14.1.3 Designer Polypharmacology and Designing HIV-Therapies 143
15. Socio-Cultural Trends 144
16. Competitive Landscape 145
16.1 Introduction 145
16.2 Strengths and Weaknesses in Anti-microbial Drug Discovery—Commercial 146
16.3 Strengths and Weaknesses in Anti-microbial Drug Discovery—Academic 147
16.4 Regulatory Hurdles 147
16.5 Business Hurdles 148
16.6 Strategic Alliances, Licensing Activity, and Mergers & Acquisitions in the Anti-infectives Landscape 149
17. Sales Performance amongst the Leading Players: Detailed Analysis of Leading Anti-infective Players 152
17.1 GlaxoSmithKline 152
17.1.1 Overview 152
17.1.2 Sales Focus by Drug Class 152
17.1.3 Marketed Product Portfolio 153
17.1.4 R&D Pipeline Analysis 155
17.1.5 Strategic and Growth Analysis 155
17.2 Merck 156
17.2.1 Overview 156
17.2.2 Sales Focus by Drug Class 156
17.2.3 Marketed Product Portfolio 157
17.2.4 R&D Pipeline Analysis 159
17.2.5 Strategic and Growth Analysis 159
17.3 Pfizer 160
17.3.1 Overview 160
17.3.2 Sales Focus by Drug Class 160
17.3.3 Marketed Product Portfolio 161
17.3.4 R&D Pipeline Analysis 163
17.3.5 Strategic and Growth Analysis 163
17.4 Novartis 164
17.4.1 Overview 164
17.4.2 Sales Focus by Drug Class 164
17.4.3 Marketed Product Portfolio 164
17.4.4 R&D Pipeline Analysis 165
17.4.5 Strategic and Growth Analysis 166
17.5 Gilead Sciences 167
17.5.1 Overview 167
17.5.2 Sales Focus by Drug Class 167
17.5.3 Marketed Product Portfolio 168
17.5.4 R&D Pipeline Analysis 169
17.5.5 Strategic and Growth Analysis 169
17.6 Abbott 170
17.6.1 Overview 170
17.6.2 Sales Focus by Drug Class 170
17.6.3 Marketed Product Portfolio 170
17.6.4 R&D Pipeline Analysis 171
17.6.5 Strategic and Growth Analysis 171
17.7 Wyeth 172
17.7.1 Overview 172
17.7.2 Sales Focus by Drug Class 172
17.7.3 Marketed Product Portfolio 172
17.7.4 R&D Pipeline Analysis 173
17.7.5 Strategic and Growth Analysis 173
17.8 Sanofi-Aventis 174
17.8.1 Overview 174
17.8.2 Sales Focus by Drug Class 175
17.8.3 Marketed Product Portfolio 175
17.8.4 R&D Pipeline Analysis 176
17.8.5 Strategic and Growth Analysis 176
17.9 Bristol-Myers Squibb 177
17.9.1 Overview 177
17.9.2 Sales Focus by Drug Class 177
17.9.3 Marketed Product Portfolio 177
17.9.4 R&D Pipeline Analysis 178
17.9.5 Strategic and Growth Analysis 178
17.10 Johnson & Johnson 179
17.10.1 Overview 179
17.10.2 Sales Focus by Drug Class 179
17.10.3 Marketed Product Portfolio 179
17.10.4 R&D Pipeline Analysis 180
17.10.5 Strategic and Growth Analysis 180
17.11 Roche Pharma AG 181
17.11.1 Overview 181
17.11.2 Sales Focus by Drug Class 182
17.11.3 Marketed Product Portfolio 182
17.11.4 R&D Pipeline Analysis 182
17.11.5 Strategic and Growth Analysis 183
18. Company Profiles 184
18.1 Abraxis BioScience, Inc. 184
18.2 Acambis 184
18.3 Achillion Pharmaceuticals, Inc. 184
18.4 Adlyfe, Inc. 185
18.5 Advanced Life Sciences Holdings, Inc. 186
18.6 Affinium Pharmaceuticals 186
18.7 Akonni Biosystems 186
18.8 Alnylam Pharmaceuticals 186
18.9 APP Pharmaceuticals 187
18.10 Aquapharm Biodiscovery 187
18.11 Arbor Vita Corporation 187
18.12 Arpida Ltd. 187
18.13 Avexa Ltd. 188
18.14 Basilea Pharmaceutica AG 188
18.15 Baxter International, Inc. 188
18.16 Biophage Pharma, Inc. 189
18.17 CEL-SCI Corporation 189
18.18 Cerexa, Inc. (Subsidiary of Forest Laboratories) 190
18.19 CombiMatrix Corporation 190
18.20 Cubist Pharmaceuticals, Inc. 191
18.21 Daiichi Sankyo Co., Ltd. 191
18.22 Hospira, Inc. 191
18.23 Incyte Corporation 192
18.24 Idenix Pharmaceuticals, Inc. 193
18.25 Medivir AB 194
18.26 Meiji Holdings Co., Ltd. 194
18.27 MerLion Pharmaceuticals 194
18.28 Mutabilis 194
18.29 NanoBio Corporation 195
18.30 Nanosphere, Inc. 195
18.31 Nanoviricides, Inc. 195
18.32 Novabay Pharmaceuticals, Inc. 196
18.33 Obetech, LLC 196
18.34 Optimer Pharmaceuticals, Inc. 196
18.35 Panacos Pharmaceuticals, Inc. 197
18.36 Paratek Pharmaceuticals, Inc. 197
18.37 Pharmasset, Inc. 197
18.38 Pico Pharmaceuticals, Inc. 198
18.39 PolyMedix, Inc. 198
18.40 PowderMed Ltd. (Subsidiary of Pfizer) 199
18.41 Presidio Pharmaceuticals, Inc. 199
18.42 Progenics Pharmaceuticals, Inc. 199
18.43 Protez Pharmaceuticals (a Novartis Subsidiary) 200
18.44 Ribomed Biotechnologies, Inc. 200
18.45 Rib-X Pharmaceuticals, Inc. 200
18.46 Targanta Therapeutics Corporation, Inc. 201
18.47 Theravance, Inc. 201
18.48 Trius Therapeutics 201
18.49 Vertex Pharmaceuticals, Inc. 201
18.50 X-GEN Pharmaceuticals, Inc. 202
Appendix 1: FDA Compliance Policies Regarding Approved New Drug and Antibiotic Drug Products 203
Appendix 2: Anti-HCV Drugs in Development 205
Appendix 3: The Market for Anti-infectives in Animal Health 208
Appendix 4: Diagnostics for Infectious Agents 214
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 Methicillin-resistant S. aureus (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, 2005 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 33
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 35
Figure 2.13: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008 36
Figure 2.14: U.S.-born TB Cases by Ethnicity, 2008 37
Figure 2.15: Rate of New Hepatitis A, Hepatitis B and Hepatitis C Infections in the U.S., 1982-2006 39
Figure 2.16: Countries Reporting Outbreaks of Cholera, 2006-2008 42
Figure 2.17: U.S. Rates of Sexually-Transmitted Diseases, 1940-2007 43
Figure 2.18: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008 45
Figure 2.19: Global Trend of HIV Infection, 1991-2007 48
Figure 2.20: Worldwide Percentage of Adults Living with HIV, 1990-2006 48
Figure 2.21: Worldwide Rate of New HIV Cases, 1990-2007 49
Figure 2.22: Percentage of Adult Population in African Countries with HIV, 2007 49
Figure 2.23: Ethnic Distribution of AIDS Patients in the U.S., 2007 51
Figure 2.24: Ten Best Selling AIDS Drugs in the U.S., 2008 51
Figure 2.25: U.S. Rates for New HIV Cases, 2008 52
Figure 2.26: Global Malaria-Endemic Areas in the Eastern Hemisphere 54
Figure 2.27: Anti-Malarial Vaccine Pipeline, 2009 55
Figure 2.28: Global Anti-Malarial Drug Pipeline, 2008 56
Figure 2.29: West Nile Virus Activity in the U.S., 2009 57
Figure 3.1: Anti-infective Drug Market Projections, 2006-2013 58
Figure 3.2: Leading Companies in Anti-infectives Market Share, 2008 59
Figure 3.3: Number of New Anti-bacterial Agents Approved by the FDA in the U.S., 1983-2008 62
Figure 3.4: Total Spending on Healthcare in the U.S., 1960-2008 64
Figure 3.5: Percentage Breakdown of U.S. Healthcare Spending, 2008 65
Figure 3.6: International per Capita Healthcare Spending by Country, 2006 65
Figure 3.7: Generic Drug Applications and Approvals in the U.S., 1995-2006 67
Figure 3.8: Savings Generated by Generic Use in the U.S., by Therapeutic Category, 1999-2008 67
Figure 3.9: Anti-bacterial and Anti-HIV New Molecular Entities (NMEs) Approved by the FDA, 1993-2007 71
Figure 3.10: Cost for New Drugs by Primary Indication, 2007 72
Figure 4.1: Market Share by Leading Anti-bacterial Drug Class 74
Figure 4.2: Anti-virals in the Marketplace, 2004 83
Figure 4.3: Anti-viral Market by Indication, Excluding HIV and HCV 85
Figure 4.4: Anti-viral Therapeutics Market, by Drug Class 85
Figure 4.5: Global Distribution of the Lack of Childhood Vaccination 93
Figure 4.6: GAVI Alliance Members 95
Figure 4.7: Global Vaccines Market, 2008 97
Figure 4.8: GlaxoSmithKline’s Vaccine Pipeline, 2008 98
Figure 4.9: The Vaccine Market by Geographical Area, 2008 98
Figure 5.1: Global Market for Molecular Diagnostics, 2002-2013 101
Figure 6.1: Number of Non-elderly Americans without Health Insurance Coverage, 1994-2007 105
Figure 6.2: Percentage of Non-elderly Americans without Health Insurance Coverage, 1994-2007 105
Figure 7.1: Global Multidrug Susceptibility in P. aeruginosa 109
Figure 7.2: Global Frequency of Vancomycin-resistant Enterococci, 2006 109
Figure 7.3: MRSA Trends According to Patient Location, 1998-2005 110
Figure 9.1: Projected Growth in Market for Injectable Anti-bacterials, 2008 and 2013 116
Figure 9.2: Real and Projected Market Shares for Major Anti-bacterial Classes, 2008 and 2013 116
Figure 9.3: Frequency of S. aureus in Skin and Soft Tissue Infections 119
Figure 11.1: Current and Projected Market Size for Injectable Antiretrovirals by Class, 2008 and 2013 124
Figure 11.2: Market Share for Injectable Antiretrovirals by Drug Class, 2008 125
Figure 11.3: The Changing Face of the HCV Market: Growth and Projections by Drug Class, 2008 and 2013 129
Figure A3.1: Growth in Global Sales of Antibiotic Products in Animal Health, 2005-2012 208
Figure A4.1: FIND Pipeline for TB Diagnostics 225
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 15
Table 2.1: Annual Rates of Global Infectious Diseases 21
Table 2.2: Drugs in Development for Chronic Hepatitis B, 2009 40
Table 2.3: Global HIV Statistics, 2007 50
Table 3.1: Top Selling Anti-infective Agents, 2008 59
Table 3.2: Sales for Leading Companies’ Infectious Diseases Segments, 2008 60
Table 3.3: Current Drug Development Times and Rates, by Therapeutic Indication 61
Table 3.4: Emerging Therapeutic Approaches 61
Table 3.5: New Drug Approvals in all Categories from FDA, 2000-2008 62
Table 3.6: Top Ten Global Pharmaceutical Markets, 2008 63
Table 3.7: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 63
Table 3.8: Percentage of GDP Healthcare Spending by Country, 2008 64
Table 3.9: Top 20 Generic Drugs by Prescriptions, 2008 68
Table 3.10: Anti-bacterial Agents Undergoing Clinical Development 69
Table 3.11 Leading Tuberculosis R&D Candidates 69
Table 3.12: Pipeline for Repositioned Drugs 70
Table 4.1: Potential Anti-bacterial Protein Drug Targets 75
Table 4.2: In vitro Susceptibility of Staphylococci to New Agents in Development 75
Table 4.3: Anti-staphylococcal Vaccines and Immunoglobulins in the Late Stage Pipeline, 2009 76
Table 4.4: Bacterial Targets of Antibiotics and Resistance Mechanisms 76
Table 4.5: Guideline Summary for Antibiotic Selection for Skin and Soft Tissue Infections 77
Table 4.6: Selected Anti-viral Drugs 86
Table 4.7: Anti-reterovirals in Development, 2008 86
Table 4.8: New Types of HIV Drugs 87
Table 4.9: Recommended Daily Dosage of Seasonal Influenza Anti-viral Medications for Treatment and Chemoprophylaxis in the U.S., 2008-2009 88
Table 4.10: Percentage Drug Resistance for Common Influenza Virus Strains, 2009 89
Table 4.11: Selected HCV Drugs in Development, 2009 90
Table 4.12: Therapeutic Agents in Development for Treating Hepatitis B, 2008 91
Table 4.13: Anti-fungal Compounds in Late Stage Development 92
Table 4.14: New Vaccines Licensed, 2005-2008 94
Table 4.15: Global Top Selling Blockbuster Vaccines, 2008 99
Table 4.16: Selected Anti-infective Monoclonal Antibodies in Clinical Development, 2009 99
Table 5.1: FDA-approved Commercial Kits for the Detection of Infectious Agents 101
Table 5.2: Examples of Personalized Medicine in Treatment of Infectious Disease 102
Table 6.1: Competitive Landscape for Anti-viral Drugs in Development, 2009 106
Table 6.2: Competitive Landscape for Anti-biotic Drugs in Development, 2009 106
Table 8.1 Anti-HIV Therapeutics Approved by the FDA 113
Table 9.1: Major Classes of Antibiotics 115
Table 10.1: Major Classes of Anti-fungals 121
Table 11.1: CCR-5 Receptor Agonists in Development, 2009 128
Table 12.1: Major Pathogens Identified in the Last 30 Years 133
Table 12.2: Emerging and Re-emerging Infectious Diseases and their Geographical Location 136
Table 16.1: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2008 146
Table 16.2: International Regulatory Measures Indicated by the International Forum of Anti-bacterial Resistance 148
Table A2.1: Anti-HCV Pipeline, 2009 205
Table A3.1: U.S. Volume of Animal Health Antibiotics Used, 2000-2006 209
Table A3.2: European Sales of Animal Health Antibiotics, 2005-2012 209
Table A3.3: Use of Antibiotics as Growth Promotants 211
Table A4.1: The Market Structure for Infectious Disease Diagnostics 215
Table A4.2: Rapid Strep Tests on the Market 216
Table A4.3: Rapid Tests for Chlamydia 218
Table A4.4: Rapid Tests for Gonorrhea 220
Table A4.5: The Burden of Influenza 221
Table A4.6: Global Market Potential for TB Diagnostic Testing 226
Table A4.7: Global Market for HBV Diagnostic Testing 228
Table A4.8: U.S. Market for HBV Diagnostic Testing 228
Table A4.9: Serological Diagnosis of Hepatitis B Virus Infections 231
Table A4.10: Lower Detection Limits of HBV DNA Assays 232
Table A4.11: Summary of Hepatitis B Test Technology 235
Table A4.12: Global Market for HCV Diagnostic Testing 239
Table A4.13: Efficiency of Available HCV Screening Tests 240
Table A4.14: Recommendations for Diagnostic Testing for Hepatitis C 241 |
