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Chapter- 1: INTRODUCTION

STUDY GOAL AND OBJECTIVES
REASONS FOR DOING THE STUDY
INTENDED AUDIENCE
SCOPE OF REPORT
INFORMATION SOURCES AND METHODOLOGY
ANANLYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC ONLINE SERVICES
DISCLAIMER

Chapter-2: EXECUTIVE SUMMARY

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

Chapter-3: OVERVIEW

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

Chapter-4: REGULATORY TRENDS

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

Chapter-5: PRODUCTS

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

Chapter-6: TECHNOLOGY TRENDS AND PATENT ANALYSIS

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

Chapter-7: INDUSTRY STRUCTURE

REVIVAL OF ANTIBIOTIC SECTOR
RISING PRESENCE OF BIOTECH COMPANIES
TABLE 42 SELECTED BIOTECH ANTIBACTERIALS IN DEVELOPMENT
REVIVAL OF THE SECTOR WITH RENEWED INTEREST OF BIG PHARMA
TABLE 43 RECENT INVESTMENTS OR PARTNERSHIPS BY BIG PHARMA COMPANIES TARGETING THE ANTIBIOTICS SECTOR
GLOBAL MARKET FOR ANTIBIOTICS AND FORECASTS
TABLE 44 GLOBAL GROWTH TRENDS FOR CARBAPENEM ANTIBIOTICS, THROUGH 2014 ($ MILLIONS)
FIGURE 1 GLOBAL GROWTH TRENDS FOR CARBAPENEM ANTIBIOTICS, 2008-2014 ($ MILLIONS)
TABLE 45 GLOBAL GROWTH TRENDS FOR CEPHALOSPORIN ANTIBIOTICS, THROUGH 2014 ($ MILLIONS)
FIGURE 2 GLOBAL GROWTH TRENDS FOR CEPHALOSPORIN ANTIBIOTICS, 2008-2014 ($ MILLIONS)
TABLE 46 GLOBAL GROWTH TRENDS OF MACROLID ANTIBIOTICS, THROUGH 2014 ($ MILLIONS)
FIGURE 3 GLOBAL GROWTH TRENDS OF MACROLID ANTIBIOTICS, 2008-2014 ($ MILLIONS)
TABLE 47 GLOBAL MARKET FOR BETA-LACTAM ANTIBIOTICS, THROUGH 2014 ($ MILLIONS)
FIGURE 4 GLOBAL MARKET FOR BETA-LACTAM ANTIBIOTICS, 2008-2014 ($ MILLIONS)
TABLE 48 GLOBAL MARKET FOR FLUOROQUINOLONES, THROUGH 2014 ($ MILLIONS)
FIGURE 5 GLOBAL MARKET FOR FLUOROQUINOLONES, 2008-2014 ($ MILLIONS)
TABLE 49 GLOBAL MARKET FOR BACTERIAL VACCINES, THROUGH 2014 ($ MILLIONS)
FIGURE 6 GLOBAL MARKET FOR BACTERIAL VACCINES, 2008-2014 ($ MILLIONS)
TABLE 50 GLOBAL ANTIBIOTIC MARKETS, THROUGH 2014 ($ MILLIONS)
FIGURE 7 GLOBAL ANTIBIOTIC MARKETS, 2008-2014 ($ MILLIONS)
LEADING COMPANIES IN THE ANTIBIOTICS MARKET
TABLE 51 TOP PLAYERS AND KEY PRODUCTS IN THE ANTIBIOTICS MARKET
COMPANY PROFILES
ACHAOGEN, INC.
ADVANCED LIFE SCIENCES
AFFINIUM PHARMACEUTICALS
ARPIDA, LTD.
BASILEA PHARMACEUTICA LTD.
BAYER SCHERING PLOUGH AG
BIOSYNEXUS INC.
CUBIST PHARMACEUTICALS, INC.
ENANTA PHARMACEUTICALS
GLAXO SMITHKLINE PLC
TABLE 52 GSK'S PIPELINE ANTIBIOTICS AND BACTERIAL VACCINE PRODUCTS
INTERCELL AG
TABLE 53 INTERCELL AG'S ANTI-BACTERIAL PIPELINE PRODUCTS
KALOBIOS PHARMACEUTICALS, INC.
KENTA BIOTECH LTD.
JOHNSON &JOHNSON
MERCK & CO. INC.
MPEX PHARMACEUTICALS
NABRIVA THERAPEUTICS AG
NOVABAY PHARMACEUTICALS, INC.
NOVARTIS INTERNATIONAL AG
TABLE 54 NOVARTIS' BACTERIAL VACCINE PIPELINE
NOVEXEL
OPTIMER PHARMACEUTICALS, INC.
OSCIENT PHARMACEUTICALS CORPORATION
PARATEK PHARMACEUTICALS, INC.
PFIZER, INC.
POLYMEDIX, INC.
REPLIDYNE, INC.
RIB-X PHARMACEUTICALS, INC.
SANOFI-AVENTIS
TABLE 55 SANOFI-AVENTIS'S BACTERIAL VACCINE CANDIDATES
TAIGEN BIOTECHNOLOGY CO., LTD.
THERAVANCE, INC.
TRIUS THERAPEUTICS
WYETH PHARMACEUTICALS
TABLE 56 WYETH'S ANTIBACTERIAL PIPELINE
APPENDIX
TABLE 57 ABBREVIATIONS