Provide an in-depth review of the global market for antibiotics resistance and antibiotics technologies

Offer an analysis of antibiotics resistance from an historical vantage point

Measure the current global market for antibiotics resistance and antibiotics technologies and provide market data for 2008, estimates for 2009, and compound annual growth rates (CAGRs) through 2014

Describe various products by classes, including penicillins and cephalsporins

Profile key players in the antibiotics market

Looks at government regulations adopted in various markets to combat antibiotics resistance.

Table Of Contents

Chapter- 1: INTRODUCTION -- Complimentary

STUDY GOAL AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 2
INTENDED AUDIENCE 2
SCOPE OF REPORT 3
INFORMATION SOURCES AND METHODOLOGY 3
ANANLYST’S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 4
BCC ONLINE SERVICES 4
DISCLAIMER 5

Chapter-2: EXECUTIVE SUMMARY

EXECUTIVE SUMMARY 6
SUMMARY TABLE CURRENT ANTIBIOTICS AND NEW PRODUCTS IN THE GLOBAL MARKET, THROUGH 2014 ($ BILLIONS) 7
SUMMARY FIGURE GLOBAL ANTIBIOTICS MARKET BY PRODUCT CLASSES, 2009 (%) 7

Chapter-3: OVERVIEW

MICROBIOLOGY OF INFECTION 8
ANTIBIOTICS AND THE PROBLEM OF ANTIBIOTIC RESISTANCE 8
TABLE 1 ANTIBIOTIC DISCOVERY AND RESISTANCE DEVELOPMENT 9
BACTERIA: CLASSIFICATION, IDENTIFICATION, AND RESISTANCE STATUS OF VARIOUS CLASSES 9
GRAM POSITIVE BACTERIA 10
Bacillus Anthracis 10
Clostridium 10
C. Botulinum 10
C. Difficle 11
C. Perfringens 11
C. Tetani 11
Corynebacterium Diphtheriae 11
Enterococci 12
Erysipelothrix Rhusiopathiae 12
Nocardia Asteroides 12
Pneumococcus 13
Staphylococcus 13
Streptococcus 14
GRAM-NEGATIVE BACTERIA 14
Bordetella Pertussis 15
Brucella 15
Campylobacter 15
Enterobacteriaceae 16
Cedecea 16
Citrobacter 16
Enterobacter 16
Escherichia coli 16
Klebsiella 17
Salmonella 17
Shigella 17
Haemophilus 18
Neisseria 18
Vibrio cholerae 19
MYCOBACTERIA 19
Mycobacterium Tuberculosis 20
TABLE 2 U.S. TUBERCULOSIS CASES AND DEATHS, 1998-2007 20
Mycobacterium Leprae 21
Mycobacteria other than Tuberculosis (MOTT) 21
SPIROCHETES 21
Borrelia Burgdorferi 22
Treponema Pallidum 22
PATHOGEN DISEASE DISTRIBUTION 22
TABLE 3 ESTIMATED DISEASE INCIDENCE BY BACTERIA IN SELECTED COUNTRIES, 2007 22
COMPARISON OF NOCOSOMIAL AND COMMUNITY INFECTIONS 23
Hospital-Acquired (HA)-MRSA 23
Community-Associated (CA)-MRSA 23
NATURAL DEFENSES PRESENT IN THE COMBAT OF INFECTION 24
ANTISEPTICS 24
BACTERIA AND OTHER MICROORGANISMS OF THE DIGESTIVE TRACT 25
CLASSIFICATION OF ANTIBIOTICS 25
BACTERICIDAL AND BACTERIOSTATIC 26
CLASSIFICATION BASED ON STRUCTURE 26
Penicillins 26
Cephalosporins 27
Fluoroquinolones 27
Tetracyclines 28
Macrolides 28
TABLE 4 COMMONLY USED ANTIBIOTICS BY CLASS 29
CLASSIFICATION BASED ON THE MODE OF ACTION OF ANTIBIOTICS 29
Cell Wall Inhibitors 29
Cell Membrane Inhibitors 30
Nucleic Acid Inhibitors 30
Protein Synthesis Inhibitors 30
TABLE 5 COMMONLY USED PROTEIN SYNTHESIS INHIBITORS 31
Metabolic Inhibitors 31
Fatty Acid Biosynthesis (Fab) Inhibitors 31
ADMINISTRATION OF ANTIBIOTICS 32
DETERMINING THE POTENCY OF ANTIBIOTICS 32
ANTIBIOTIC SUSCEPTIBILITY TESTING 32
DRUG RESISTANCE: THE GREATEST CHALLENGE FACING THE ANTI-INFECTIVE DRUG MARKET 33
THE HISTORY OF ANTIBIOTIC RESISTANCE 33
CURRENT CRISIS OF ANTIBIOTIC RESISTANCE 34
THE MICROBIOLOGY OF ANTIBIOTIC RESISTANCE 34
MECHANISMS OF RESISTANCE DEVELOPED BY VARIOUS BACTERIA 35
Enzymatic Deactivation or Modification of Antibiotic 35
ESBL-Producing Organisms 35
Alteration of the Target Site of the Antibiotic 36
Alteration of the Metabolic Pathways 36
Reducing the Potential for Drug Accumulation 36
Biofilm Formation 37
TABLE 6 HUMAN INFECTIONS INVOLVING BIOFILMS 37
RESISTANCE IN GRAM-POSITIVE BACTERIA 37
Methicillin-Resistant Staphylococcus Aureus (MRSA) 38
Vancomycin-Intermediate S. aureus (VISA) 38
Vancomycin-Resistant Enterococci (VRE) 38
Multi-Drug-Resistant Clostridium difficile 39
RESISTANCE IN GRAM-NEGATIVE BACTERIA 39
Multi-Drug-Resistant Acinetobacter Baumannii 40
Enterobacteriacae- (Resistance by ESBL and AmpC-beta Lactamase Production) 41
Resistance in Pseudomonas Aeruginosa 42
Tetracycline-Resistant, Penicillin-Resistant Neisseria gonorrhoeae 42
ANTIBIOTIC RESISTANCE IN MYCOBACTERIUM 42
TABLE 7 MECHANISMS OF RESISTANCE BY BACTERIA REPORTED AGAINST VARIOUS ANTIBIOTIC CLASSES 43
COST OF ANTIBIOTIC RESISTANCE 43
TABLE 8 ECONOMIC PRESSURES DUE TO ANTIBIOTIC RESISTANCE, INSTITUTIONAL AND SOCIETAL 44
EFFECTS OF INCREASING ANTIBIOTIC RESISTANCE 44
TABLE 9 TREATMENT OPTIONS FOR RESISTANT BACTERIA 45
TABLE 9 (CONTINUED) 46
ANTIBIOTIC STEWARDSHIP PROGRAMS IN HOSPITALS 46
TABLE 10 ESSENTIAL COMPONENTS OF ANTIMICROBIAL STEWARDSHIP PROGRAMS 47
TRENDS IN GEOGRAPHIC DISTRIBUITION OF RESISTANCE 47
Europe 48
U.S. 48
TABLE 11 U.S. ANTIBIOTIC RESISTANCE TRENDS OF SOME CRITICAL INFECTIONS 48
TABLE 11 (CONTINUED) 49
Global Epidemiology Trends of Antibiotic Resistance: Rest of the World 49
TABLE 12 REST OF THE WORLD EPIDEMIOLOGY TRENDS OF ANTIBIOTIC RESISTANCE 50

Chapter-4: REGULATORY TRENDS

POLITICS OF BACTERIAL RESISTANCE 51
AGRICULTURAL ANTIBIOTICS: REGULATORY TRENDS 51
TABLE 13 U.S.-APPROVED AGRICULTURAL ANTIMICROBIALS 51
TABLE 14 AGRICULTURAL ANTIBIOTICS THAT CAN CROSS-SELECT ANTIBIOTICS USED TO TREAT HUMANS 52
TABLE 15 COMMON ANTIBIOTICS IN USE IN LIVESTOCK AND HUMANS 53
REGULATORY ACTIONS AGAINST LARGE-SCALE USE OF AVOPARCIN 54
TABLE 16 REGULATORY ACTIONS TAKEN BY GOVERNMENTS TO CONTROL AGRICULTURAL USE OF AVOPARCIN 55
PREVALENCE OF FLUOROQUINOLONE RESISTANCE DUE TO AGRICULTURAL USAGE 55
TABLE 17 FLUOROQUINOLONES USED IN AGRICULTURE 56
TABLE 18 U.S. REGULATORY ACTIONS CONTROLLING AGRICULTURAL USE OF FLUOROQUINOLONES 56
INTERNATIONAL EFFORTS TO ADDRESS MICROBIAL RESISTANCE 57
ACTION ON ANTIBIOTIC RESISTANCE (REACT) 57
ALLIANCE FOR THE PRUDENT USE OF ANTIBIOTICS (APUA) 57
EFFORTS BY THE WORLD HEALTH ORGANIZATION (WHO) 57
TABLE 19 ANTIBIOTICS OF CRITICAL IMPORTANCE TO HUMAN MEDICINES CATEGORIZATION BY THE WORLD HEALTH ORGANIZATION 58
REGULATORY TRENDS IN U.S. 58
TABLE 20 U.S. REGULATORY BODIES AND OTHER AGENCIES INVOLVED IN MONITORING AGRICULTURAL ANTIBIOTICS 59
Role of the FDA 59
Impact of Regulations on Innovation 60
EFFORTS BY EUROPEAN REGULATORY AGENCIES 60
European Centre for Disease Prevention and Control (ECDC) 60
European Food Safety Authority (EFSA) 61
TABLE 21 E.U. KEY INITIATIVES TOWARD CONTAINING ANTIBIOTIC RESISTANCE 61
TABLE 22 PROJECTS UNDER DG-SANCO ADDRESSING ANTIBIOTIC RESISTANCE 62
TABLE 22 (CONTINUED) 63
REGULATORY TRENDS IN ASIA 63
Australia 64
China 64
India 64
Japan 65
South Korea 65
Taiwan 65
Taiwan (Continued) 66

Chapter-5: PRODUCTS

PRODUCTS TARGETED AT ANTIBIOTIC RESISTANCE 67
TABLE 23 KEY PRODUCTS TARGETING ANTIBIOTIC RESISTANCE 67
LEVAQUIN 68
ZOSYN/TAZOCIN 68
AVELOX 68
CUBICIN 68
ANTIBACTERIAL DRUGS IN DEVELOPMENT BY CLASS OF PRODUCT 69
BETA LACTAM ANTIBIOTICS 69
TABLE 24 ?-LACTAM ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 69
Doripenem 70
Tomopenem 70
PZ-601 70
Faropenem 71
Ceftaroline 71
Ceftobiprole 71
BAL-30072 72
FR-264205 72
TABLE 25 ?-LACTAM ANTIBIOTICS, IN DEVELOPMENT OR RECENTLY MARKETED 72
TABLE 25 (CONTINUED) 73
FLUOROQUINOLONES 73
TABLE 26 FLUOROQUINOLONE ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 74
Sitafloxacin 74
Garenoxacin 74
Delafloxacin 74
WCK-771 75
Zabofloxacin 75
DC-159a 75
GLYCOPEPTIDES 75
TABLE 27 GLYCOPEPTIDE ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 76
Dalbavancin 76
Oritavancin 77
Telavancin 77
Ramoplanin 77
MACROLIDES 78
TABLE 28 MACROLIDE ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 78
Cethromycin 78
EDP-420 79
Fidaxomicin 79
OXAZOLIDINONES 79
TABLE 29 OXAZOLIDINONE ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 80
Radezolid 80
Torezolid 80
OTHER CLASSES OF ANTIBIOTICS IN PIPELINE 81
TABLE 30 EMERGING CLASSES OF ANTIBIOTICS 81
TABLE 31 OTHER CLASSES OF ANTIBIOTICS, IN DEVELOPMENT OR NEWLY INTRODUCED 81
TABLE 31 (CONTINUED) 82
TABLE 31 (CONTINUED) 83
Iclaprim 83
PTK 0796 84
AFN-1252 84
Friulimicin 84
Rifalazil 84
Pagibaximab 85
Nemonoxacin 85
Platensimycin 85
NXL-103 85
BC-3205 and BC-3781 86
PMX-30063 86
KBPA-101 86
KB-001 87
ACHN-490 87
CB-182804 87
VACCINES 87
TABLE 32 VACCINES AGAINST BACTERIAL INFECTIONS IN DEVELOPMENT OR NEWLY INTRODUCED 88
Menveo 88
Prevnar 13vPnC 89
Synflorix 89
V710 89
IC43 90

Chapter-6: TECHNOLOGY TRENDS AND PATENT ANALYSIS

DECLINING TRENDS OF INNOVATION IN THE DEVELOPMENT OF NEW ANTIBIOTICS 91
TABLE 33 U.S. FDA-APPROVED SYSTEMIC ANTIBACTERIAL NMES, 1983-2008 91
BROAD-SPECTRUM VERSUS NARROW-SPECTRUM ANTIBIOTICS 91
TABLE 34 SYSTEMIC ANTIBIOTICS TARGETING MRSA IN CLINICAL DEVELOPMENT 92
TABLE 34 (CONTINUED) 93
TABLE 35 ANTIBACTERIALS AGAINST MDR-GRAM-NEGATIVE BACTERIA IN CLINICAL DEVELOPMENT 93
TABLE 35 (CONTINUED) 94
NEW FOCUS ON GRAM-NEGATIVE PATHOGENS 94
ANALOGUES OF EXISTING ANTIBIOTICS VS NOVEL MOLECULES/ TARGETS 95
TABLE 36 ANALOGUES OF EXISTING DRUGS AND NEW MOLECULES 95
CATIONIC PEPTIDES AS NEW GENERATION ANTIBACTERIALS FOR THERAPEUTIC USE 96
TABLE 37 COMPARISON OF CATIONIC PEPTIDE ANTIBIOTICS AND CONVENTIONAL ANTIBIOTICS 96
TABLE 38 CATIONIC ANTIBACTERIAL PEPTIDES FOR SYSTEMIC ADMINISTRATION, UNDER DEVELOPMENT 97
BACTERIAL INTERFERENCE: A NEW APPROACH FOR THE TREATMENT OF BACTERIAL INFECTIONS 97
BACTERIOPHAGE THERAPY 98
PATENT ANALYSIS 98
TABLE 39 U.S. PTO-GRANTED PATENTS BY ANTIBIOTIC STRUCTURAL CLASSES, 1976-SEPTEMBER 8, 2009 99
TABLE 40 TRENDS IN PATENTING OF BIG PHARMA COMPANIES RELATED TO ANTIBIOTICS* 100
TABLE 41 PATENTS IN ANTIBIOTICS BY NEW AND EMERGING COMPANIES, 1976-SEPTEMBER 8, 2009 100
TABLE 41 (CONTINUED) 101

Chapter-7: INDUSTRY STRUCTURE

REVIVAL OF ANTIBIOTIC SECTOR 102
RISING PRESENCE OF BIOTECH COMPANIES 102
TABLE 42 SELECTED BIOTECH ANTIBACTERIALS IN DEVELOPMENT 102
TABLE 42 (CONTINUED) 103
REVIVAL OF THE SECTOR WITH RENEWED INTEREST OF BIG PHARMA 103
TABLE 43 RECENT INVESTMENTS OR PARTNERSHIPS BY BIG PHARMA COMPANIES TARGETING THE ANTIBIOTICS SECTOR 103
TABLE 43 (CONTINUED) 104
GLOBAL MARKET FOR ANTIBIOTICS AND FORECASTS 104
TABLE 44 GLOBAL GROWTH TRENDS FOR CARBAPENEM ANTIBIOTICS, THROUGH 2014 ($ MILLIONS) 104
FIGURE 1 GLOBAL GROWTH TRENDS FOR CARBAPENEM ANTIBIOTICS, 2008-2014 ($ MILLIONS) 105
TABLE 45 GLOBAL GROWTH TRENDS FOR CEPHALOSPORIN ANTIBIOTICS, THROUGH 2014 ($ MILLIONS) 105
FIGURE 2 GLOBAL GROWTH TRENDS FOR CEPHALOSPORIN ANTIBIOTICS, 2008-2014 ($ MILLIONS) 106
TABLE 46 GLOBAL GROWTH TRENDS OF MACROLID ANTIBIOTICS, THROUGH 2014 ($ MILLIONS) 106
FIGURE 3 GLOBAL GROWTH TRENDS OF MACROLID ANTIBIOTICS, 2008-2014 ($ MILLIONS) 107
TABLE 47 GLOBAL MARKET FOR BETA-LACTAM ANTIBIOTICS, THROUGH 2014 ($ MILLIONS) 107
FIGURE 4 GLOBAL MARKET FOR BETA-LACTAM ANTIBIOTICS, 2008-2014 ($ MILLIONS) 108
TABLE 48 GLOBAL MARKET FOR FLUOROQUINOLONES, THROUGH 2014 ($ MILLIONS) 108
FIGURE 5 GLOBAL MARKET FOR FLUOROQUINOLONES, 2008-2014 ($ MILLIONS) 109
TABLE 49 GLOBAL MARKET FOR BACTERIAL VACCINES, THROUGH 2014 ($ MILLIONS) 109
FIGURE 6 GLOBAL MARKET FOR BACTERIAL VACCINES, 2008-2014 ($ MILLIONS) 110
TABLE 50 GLOBAL ANTIBIOTIC MARKETS, THROUGH 2014 ($ MILLIONS) 111
FIGURE 7  GLOBAL ANTIBIOTIC MARKETS, 2008-2014 ($ MILLIONS) 111
LEADING COMPANIES IN THE ANTIBIOTICS MARKET 112
TABLE 51 TOP PLAYERS AND KEY PRODUCTS IN THE ANTIBIOTICS MARKET 112
TABLE 51 (CONTINUED) 113
COMPANY PROFILES 113
ACHAOGEN, INC. 113
ADVANCED LIFE SCIENCES 113
AFFINIUM PHARMACEUTICALS 114
ARPIDA, LTD. 115
BASILEA PHARMACEUTICA LTD. 115
BAYER SCHERING PLOUGH AG 116
BIOSYNEXUS INC. 116
CUBIST PHARMACEUTICALS, INC. 116
ENANTA PHARMACEUTICALS 117
GLAXO SMITHKLINE PLC 117
TABLE 52 GSK’S PIPELINE ANTIBIOTICS AND BACTERIAL VACCINE PRODUCTS 118
TABLE 52 (CONTINUED) 119
INTERCELL AG 119
TABLE 53 INTERCELL AG’S ANTI-BACTERIAL PIPELINE PRODUCTS 120
KALOBIOS PHARMACEUTICALS, INC. 120
KENTA BIOTECH LTD. 121
JOHNSON andJOHNSON 121
MERCK and CO. INC. 122
MPEX PHARMACEUTICALS 122
NABRIVA THERAPEUTICS AG 123
NOVABAY PHARMACEUTICALS, INC. 123
NOVARTIS INTERNATIONAL AG 124
TABLE 54 NOVARTIS’ BACTERIAL VACCINE PIPELINE 125
NOVEXEL 125
OPTIMER PHARMACEUTICALS, INC. 126
OSCIENT PHARMACEUTICALS CORPORATION 126
PARATEK PHARMACEUTICALS, INC. 127
PFIZER, INC. 127
POLYMEDIX, INC. 128
REPLIDYNE, INC. 129
RIB-X PHARMACEUTICALS, INC. 129
SANOFI-AVENTIS 130
TABLE 55 SANOFI-AVENTIS’S BACTERIAL VACCINE CANDIDATES 131
TAIGEN BIOTECHNOLOGY CO., LTD. 131
THERAVANCE, INC. 131
TRIUS THERAPEUTICS 132
WYETH PHARMACEUTICALS 132
TABLE 56 WYETH’S ANTIBACTERIAL PIPELINE 133
APPENDIX 134
TABLE 57 ABBREVIATIONS 134
TABLE 57 (CONTINUED) 135
TABLE 57 (CONTINUED) 136

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