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Published by: BCC Research
Published: Oct. 1, 2004 - 282 Pages
Table of Contents
Introduction
Study Goal And Objectives
Reasons For Doing The Study
Contributions Of The Study And For Whom
Scope And Format
Methodology
Information Sources
Analyst's Credentials
Related Bcc Work Credentials, Including Work Done By Other Authors
Bcc On-Line Services
Disclaimer
Summary
Summary Table:
Markets For 'New Antibiotics,' And Hiv/Aids Drugs By Category, Worldwide, Through 2009 ($ Millions)
Summary Figure:
Markets For 'New Antibiotics,' And Hiv/Aids Drugs By Category, Worldwide, 2001-2009 ($ Millions)
Overview
A Brief History Of Bugs And Man
Trends In Mortality From Infectious Diseases
Table 1 Trends In Mortality From Infectious Diseases: 1900-1990
Spanish Influenza Pandemic
Pathogenic Microbes And Infectious Diseases Recognized Between 1973 And 1997
Table 2 Disease-Causing Bacteria, Parasites And Viruses Identified Since 1973
Table 2 (Continued)
Setting The Stage For Pandemic Infectious Diseases
The Rapid Evolution Of Microbes
A Paradigm For A New Pandemic
Current Technologies For Addressing Potential Pandemic Threats
Table 3 Technologies To Address Potential Pandemic Threats
The New Antibiotic Market
The Greatest Challenge Facing The Anti-Infective Drug Market-Drug Resistance
The Crisis Of Antibiotic Resistance
The Microbiology Of Bacterial Resistance
Mechanisms Of Resistance
Beta-Lactamase Production
Importing Resistance Genes From Other Organisms
Alteration Of Binding Sites To Circumvent Anti-Infective Effectiveness
Antibiotic Efflux
Geographic Snapshot Of Resistance
The Primary Reasons For The Development Of Antibiotic Resistance
Broad Spectrum Prescriptions
Patient Pressure
Healthcare Policy
International Efforts To Address Microbial Resistance
Efforts By The World Health Organization
Efforts By The U.S. Congress
Strategies Implemented In The United Kingdom
No Advocates For Multidrug-Resistant Bacterial Diseases
The Impact Of Thinning Pipelines
The Impact Of Thinning Pipelines (Continued)
The Effect Of Drug Shortages
The Role Of Counterfeit Drugs
Insurers Get Involved
Resistance By Class Of Antibiotic
Fluoroquinolones
Mrsa Correlation
Expanded-Spectrum Fluoroquinolones
Median Mic90 Values Of Gram-Negative Organisms To Selected Fluoroquinolones
Table 4 Median Mic90 (Microgram/Ml) Values Of Gram-Negative Organisms To Selected Marketed And Development-Stage Fluoroquinolones
Table 5 Median Mic90 (Microgram/Ml) Values Of Gram-Positive Organisms To Selected Marketed And Development-Stage Fluoroquinolones
Macrolides
Prescription Use In Selected Countries
Table 6 Annual Macrolide Prescriptions Per 1,000 Inhabitants In Six Countries In 1980 And 1990
Antibiotic Use And Rate Of Macrolide-Resistant Streptococcus Pneumoniae In Selected Countries.
Table 7 Total Macrolide Use And Rate Of Macrolide-Resistant S. Pneumoniae In Selected Countries
Antibiotic Use And The Rate Of Macrolide-Resistant Streptococcus Pyogenes In Selected Countries
Table 8 Total Macrolide Use And Rate Of Macrolide-Resistant S. Pyogenes In Selected Countries
Penicillins
Table 9 Annual Beta-Lactam Prescriptions Per 1,000 Inhabitants In Six Countries In 1980 And 1990
Table 10 Total Antibiotic Use And Rate Of Penicillin-Nonsusceptible S. Pneumoniae In Selected Countries
Table 10 (Continued)
Selected Other Agents
Table 11 Percent Resistance To Ceftazidime, Ciprofloxacin, Imipenem And Piperacllin In P. Aeruginosa Isolates From Blood: San Francisco County, California, 1996-1999 (%)
The Leading Drug-Resistant Bacteria
Hospital And Community-Acquired Bacterial Pathogens In The U.S.
Table 12 Annual Incidence Of Infections Caused By Hospital- And Community-Acquired Bacterial Pathogens: U.S.
Disease Incidence By Bacterial Pathogen In U.S.
Table 13 Disease Incidence By Bacterial Pathogen (U.S.)
Selected Resistant Bacteria
Table 14 Selected Organisms And Agents To Which They Have Developed Resistance
Table 14 (Continued)
Enterococcal Infections
Vancomycin Resistance
Variant Esp Gene Vancomycin-Susceptible E. Faecium
Biofilm-Formation Capacity
Ampicillin Resistance
Table 15 Resistance Patterns Among Enterococcal Organisms Isolated From Bloodstream Infections
Escherichia Coli
Helicobacter Pylori
Hemophilus Influenzae
Klebsiella Pneumoniae
Pneumococcus
Pseudomonas Aeruginosa
Table 16 In Vitro Susceptibility Of P. Aeruginosa Isolates From Patients With Lower Respiratory Tract Infections
Staphylococcus Aureus
Mrsa
Community-Acquired Mrsa
Nursing Homes
Intensive Care Units And Medical Devices
Vancomycin Resistance
Streptococcal Infections
Streptococcus Pneumoniae
Penicillin And Other Drug Resistances
Geographic Specificity
Cephalosporin Resistance
Table 17 Comparison Of Percent Of Streptococcus Pneumoniae Isolates Nonsusceptible To Third-Generation Cephalosporins By Site: Antibiograms Versus Abcs
Erythromycin Resistance
Table 18 Comparison Of Percent Of Streptococcus Pneumoniae Isolates Nonsusceptible To Erythromycin By Site: Antibiograms Versus Abcs
Penicillin Resistance
Table 19 Comparison Of Percent Of Streptococcus Pneumoniae Isolates Nonsusceptible To Penicillin By Site: Antibiograms Versus Abcs
Serotype 3
New Developments
Foodborne Pathogens
Drug Resistance In Selected Diseases
Dysentery
Pneumonia
Leading Causes
Table 20 Frequency Of Occurrence Of Bacterial Pathogens Implicated In Pneumonia In Hospitalized Patients, Us.
Bacterial Versus Viral Infections
Penicillin-Resistant Cases In Selected Countries
Table 21 Percentage Of Hospitalized Patients In Selected Countries Infected With Penicillin-Resistant Pneumococci
Demand For Broad-Spectrum Drugs
Community-Acquired Pneumonia
Salmonella Infection
Tuberculosis
Tuberculosis (Continued)
The Who's Global Project On Anti-Tuberculosis Drug Resistance Surveillance
Geographic Specificity
Table 22 Percentage Of Drug-Resistant Strains Among New Cases Of Tuberculosis In Selected Countries, 2000
Geographic Specificity (Continued)
2004 Update On The Problem Of Mdr Tuberculosis
Applying Effective Treatment
The Dots Plan
Developing Effective Diagnostics For Detection Of Mdr Tuberculosis
Current Methods
Strategies To Combat Bacterial Resistance In The Hospital Setting
Development Of Narrow-Spectrum Agents
Avoidance Of Underdosing
Rotating Antibiotic Agents
Surgical Prophylaxis
Antibiograms
The Ideal Antibiotic
The Relationship Of Drug Resistance To The Use Of Antibiotics In Agriculture
Factors Contributing To Overuse Of Antimicrobials In Food Animals
Screening For Antibiotics In Food Animal Products
Drug-Resistant Bacteria In Livestock
Fluoroquinolone Resistance
Vancomycin Resistance
Avoparcin
Aquaculture
Government Regulation
Global Efforts To Address Antimicrobial Usage In Agriculture
Microbes In Livestock Manure
Technological Strategies To Combat Resistance
Efflux Pump Inhibitors
Mechanism
Efficacy
Research
Adverse Effects
Prions
Quorum Sensing
Quorum Sensing (Continued)
Sequencing Of Bacterial Genomes
The Market For Selected 'New Antibiotic' Products
Table 23 Worldwide Sales And Year Of Fda Approval Of Selected 'New Antibiotic' Prdocuts, Through 2009 ($ Millions)
Table 24 The Markets For Selected New Antibiotics And Existing Antibiotics, By Category: Worldwide Sales, Through 2009 ($ Millions)
Figure 1 The Markets For Selected New Antibiotics And Existing Antibiotics, By Category: Worldwide Sales, 2001-2009 ($ Millions)
Market Share By Company For New Antibiotics
Figure 2 Market Share By Company For New Antibiotics: 2004 And 2009 (%)
Products Targeted At Antibiotic Resistance
Products Introduced In 2001, 2002 And 2003
Table 25 Antibacterial Product Approvals, U.S.: 2001-2003
Table 25 (Continued)
Table 25 (Continued)
Selected Products Approved In 2001, 2002 And 2003
Cubicin
Mechanism
Indications
Market
Factive
Invanz
Levaquin
Spectracef
Tequin
Vigamox
Zithromax
Mechanism And Efficacy
Market
Zithromax Single Dose, Tri-Pak And Ivvial-Mate
Zosyn
Zymar
Zyvox
Selected Products Projected To Be Introduced In 2004 And 2005
Table 26 Projected Antibacterial Product Approvals, U.S.: 2004-2005
Table 26 (Continued)
Table 26 (Continued)
Table 26 (Continued)
Abt-773
Augmentin Xr
Choleragarde
Cubicin
Dalbavancin
Doripenem
Faropenem
Floxin Otic
Gracevit
Helicide
Iclaprim
Isv-401
Ketek
Ketek (Continued)
Mbi-226
Merrem I.V.
Oritavancin
Ramoplanin
Rifaximin
Segard
Staphvax
Tifacogin
Tigecycline
Zithromax
Selected Promising Products In Earlier Stages Of Development
Altastaph
Glycodendriprotein
Iseganan
Lysostaphin
Oligosaccharides
Oxazolidinones
Zyvox
Streptogramins
Synercid
Synercid (Continued)
Innovative Technologies In Early Research
Antibiotic-Producing Bacteria
Bacteriophages
Bacteriophages (Continued)
Q Beta
Natural Protective Mechanisms Of Bacteria
Natural Protective Mechanisms Of Bacteria (Continued)
Nubiotics
Peptide Drugs
Peptide Deformylase Inhibitors
Viral Pandemic Threats
What Is A Virus?
The Viral Pandemic Of 2004 - Human Immunodeficiency Virus (Hiv) Infection And Acquired Immune Deficiency Syndrome (Aids)
The Viral Pandemic Of 2004.. (Continued)
Transmission Of Hiv
Early Symptoms And Progress Of Hiv Infection
The Expanded Definition Of Aids
The Pandemic
Hiv And Aids In Africa - A Timeline Of Death
Leading Causes Of Death
Table 27 Leading Causes Of Death In Africa: 2000
Life Expectancy
Table 28 Life Expectancy In Selected African Countries: 1950-2000
Table 28 (Continued)
Hiv And Aids In The Ex-Soviet Bloc-An Africa In The Making?
Mathematical Models For The Aids Epidemic
Mathematical Models For The Aids Epidemic (Continued)
Hiv And Aids Statistics
Number Of Hiv/Living With Aids Cases In 2003 By Geographic Region
Table 29 Estimated Number Of Persons Infected With Hiv/Living With Aids, Adults And Children, By Geographic Region: 2003
Geographic Region 2003 Percentage Of Global Hiv Cases By Geographic Region
Table 30 Percent Of Global Hiv Cases By Geographic Region: 2003
New Hiv Cases In 2003 By Region
Table 31 Estimated Number Of People Newly Infected With Hiv, Adults And Children, By Geographic Region: 2003
Increase Of Hiv Cases By Region From 1999 To 2002
Table 32 Increase In Number Of People Newly Infected With Hiv, Adults And Children, By Geographic Region: 1999-2002
2003 Aids Deaths By Region
Table 33 Estimated Number Of Deaths From Aids, Adults And Children, By Geographic Region: 2003
Estimated Number Of Hiv Cases By Country In 2002 And 2010
Table 34 Estimated Number Of People Infected With Hiv In Selected Countries: 2002 And 2010
Hiv Infection And Aids Cases In The U.S.
The Dire Need For Better Access To Treatment
Table 35 Percent Of Patients By Geographic Region Receiving Antiretroviral Treatment For Hiv Infection
The Impact Of The Availability Of Antiretroviral Therapy
The Introduction Of Haart
Table 36 Number Of Deaths From Aids In The U.S., 1988-2002
Efforts To Reduce The Cost Of Hiv Drugs In The Developing World
Boehringer Ingelheim And Glaxosmithkline Sign Agreements
Aids Healthcare Foundation Lawsuit
Government Lawsuits
Sub-Saharan Africa Generic Production Agreement
Merck Announces Reduction Of The Cost Of Stocrin
Council Of Ministers Program Slow To Recruit Participants
Efforts To Make Generic Hiv Drugs Available In Developing Countries
The World Trade Organization Steps In
Generic Manufacturers Make A Bold Play
A Strategy To Gain A Foothold In The World Market
The Bush Administration Moves To Restrict Access To Generic Hiv Drugs
Clinton Foundation Negotiates Lower Drug Prices For Poor Countries
Other Struggles To Gain Access To Generic Hiv Drugs
'The 3 By 5 Initiative'
Near-Term Objectives
Main Plan Objectives
Drug Resistance In Hiv/Aids
Definition Of Antiviral Drug Resistance
How Resistance Develops
Locations Of Mutations
Current Status Of Resistance
2003 Catch Study
Resistance Among Hiv Cases In Europe
Table 37 Resistance Among Hiv-Positive Patients In Europe As Determined By The Catch Study
Conclusions
Acute Infection And Early Disease Research Program
2nd International Aids Society Conference
San Francisco Study Of Pockets Of Resistance Epidemics
Epidemic Control Recommendations
Types Of Drug Resistance Testing
Genotypic And Phenotypic Testing
Table 38 Protease Mutations
Table 39 Reverse Transcriptase Mutations
Genotypic And Phenotypic Testing (Continued)
Table 40 Advantages And Disadvantages Of Genotypic Versus Phenotypic Testing
Reimbursement For Hiv Drug Resistance Testing
Guidelines For Hiv Drug Resistance Testing
The Special Case Of Protease Inhibitors
The Rationale For Genotypic Testing For Hiv-I Drug Resistance
Available Hiv Drug Resistance Tests
New Saliva Test Approved To Detect Hiv
Cost Of Hiv/Aids Treatment
Table 41 Estimated Annual Costs For Haart In U.S. And Sub-Saharan Africa
Abbott Increases The Cost Of Norvir Five-Fold
Table 42 Comparison Of Average Annual Cost Of Boosted* Protease Inhibitor-Based Hiv Treatment Regimens Before And After Norvir Price Increase
Available Products For The Treatment Of Hiv Infection And Aids
Table 43 Fda-Approved Drugs For The Treatment Of Hiv Infection/Aids
Table 43 (Continued)
Products For The Prevention/Treatment Of Antiviral Diseases Introduced In 2001, 2002 And 2003
Table 44 Antiviral And Vaccine Product Introductions, U.S.: 2001-2003
Table 44 (Continued)
Table 44 (Continued)
The Market For Products To Treat Hiv Infection And Aids
Table 45 The Market For Selected Hiv/Aids Therapeutics: Worldwide Sales, Through 2009 ($ Millions)
Table 46 The Market For Selected Hiv/Aids Therapeutics By Product Category: Worldwide Sales, Through 2009 ($ Millions)
Figure 3 The Market For Selected Hiv/Aids Therapeutics By Product Category: Worldwide Sales, 2001-2009 ($ Millions)
Figure 4 Market Share Of Hiv/Aids Drugs By Product Category, Worldwide Sales, 2003 And 2009 ($ Millions)
The U.S. Market For Hiv/Aids Drugs
Table 47 The Market For Selected Hiv Therapeutics: U.S. Sales, Through 2009 ($ Millions)
Combination Products Emerge As Preferred Treatment
Leading Marketers Of Hiv/Aids Drugs
Leaders In The Nucleoside Reverse Transcriptase Inhibitor Class
Categories Of Drugs Available For The Treatment Of Hiv/Aids
Entry Inhibitors, Fusion Inhibitors And Receptor Inhibitors
Entry Inhibitors, Fusion Inhibitors And Receptor Inhibitors (Continued)
Immunotherapies
Nonnucleoside Reverse Transcriptase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Nucleotide Reverse Transcriptase Inhibitors
Protease Inhibitors
Selected Hiv/Aids Drugs Introduced To The U.S. Market In 2001, 2002 And 2003
Fusion Inhibitors
Nonnucleoside Reverse Transcriptase Inhibitors
Sustiva
Nucleoside Reverse Transcriptase Inhibitors
Emtriva
Nucleotide Reverse Transcriptase Inhibitors
Protease Inhibitors
Lexiva/Telzir
Reyataz
Reyataz (Continued)
Kaletra
Table 48 Protease Inhibitor Prescription Market Share, By Product, June 1, 2003 To November 30, 2003: U.S.
Dosing And Compliance Challenges
Table 49 Daily Dosage Requirements For Selected Hiv/Aids Therapies
Table 50 Relationship Between Compliance And Dosing Frequency
The Ideal Treatment Regimen
The Number Of Salvage Patients Continues To Increase
Drugs In Development For The Treatment And/Or Prevention Of Hiv Infection And Aids
Table 51 Products In Phase Ii Or Later Development For The Treatment And/Or Prevention Of Hiv Infection/Aids
Table 51 (Continued)
The Four Main Targets For Antiretroviral Drugs
Entry Mechanisms
Integrase
Protease
Reverse Transcriptase
Antiviral Products Projected To Be Introduced In 2004 And 2005
Table 52 Projected Product Introductions To Address Viral Diseases: 2004-2005
Table 52 (Continued)
C31g 1% Vaginal Gel
Capravirine
Remune
Viread/Emtriva Combination Product
Other Products In Late-Stage Development
Tmc-114
Tipranavir
Other Selected Products In Earlier Development
Ccr5 Antagonists
Hiv-Hemopurifier
Pro-542
Vgx-410
Viread
Aids Vaccines In Development
Status Of Selected Products
Table 53 Selected Hiv And Aids Vaccines In Development
Table 53 (Continued)
Class And Vector Of Selected Products
Table 54 Vaccine Type And Vectors For Hiv Vaccines In Phase I/Ii Trials
Development Strategies
Barriers
Vaccine Candidates And Target Market
Results Of Early Trials With Hiv/Aids Vaccines
Aidsvax
Alvac Hiv
Gp120 Vaccines
Gp160 Vaccines
Live Virus Hiv Vaccine
Other Emerging Viral Disease Threats
Dengue Virus
Ebola Virus
Outbreak Locales
Infection And Transmission
Recovery Factors
Diagnosis
Treatment
Enteroviruses
Hantaviruses
Influenza
The Algorithm Of The Pandemic
Avian Influenza
The Concern About The H5n1 Subtype
Influenza Type A
Progress Made Since The 1918-1919 Pandemic
Diagnostic And Therapeutic Products For Influenza
Flumadine
Relenza
Symmetrel
Tamiflu
Vaccines
Marburg Virus
Outbreak Locales
Infection And Transmission
Diagnosis
Recovery Factors
Treatment
Nipah Virus
Outbreak Locales
Infection And Transmission
Treatment
Norwalk Virus
Severe Acute Respiratory Syndrome
Variant Creutzfeldt-Jakob Disease
Infection And Transmission
Mbm And Export Bans
Outbreak Locales
West Nile Virus
Yellow Fever
Infection And Transmission
Outbreak Locales
Recovery Factors
Diagnosis
Treatment
Company Profiles
Avant Immunotherapeutics, Inc.
Business Overview
Financial Information
Products
Table 55 Avant Immunotherapeutics' Product Pipeline
Corporate Strategy
Biosynexus, Inc.
Business Overview
Products
Corporate Strategy
Bristol-Myers Squibb
Business Overview
Financial Information
Products
Corporate Strategy
Chiron Corp.
Business Overview
Financial Information
Products
Table 56 Selected Vaccines And Biopharmaceuticals In Chiron's Product Pipeline
Corporate Strategy
Cubist Pharmaceuticals, Inc.
Business Overview
Financial Information
Products
Products (Continued)
Corporate Strategy
Gilead Sciences, Inc.
Business Overview
Financial Information
Products
Table 57 Gilead's Product Pipeline
Corporate Strategy
Glaxosmithkline Plc
Business Overview
Financial Information
Table 58 Glaxosmithkline's Antibacterial And Hiv/Aids Product Sales, 2002 And 2003 ($ Millions)
Products
Table 59 Glaxosmithkline's Antibacterial, Hiv/Aids Drugs And Antiviral Vaccine Product Pipeline
Corporate Strategy
Intermune, Inc.
Business Overview
Financial Information
Products
Corporate Strategy
Micrologix Biotech Inc.
Business Overview
Financial Information
Products
Table 60 Micrologix's Product Pipeline
Company Strategy
Oscient Pharmaceuticals, Inc. (Formerly Genome Therapeutics Corp.)
Business Overview
Financial Information
Products
Table 61 Oscientoscient Pharmaceuticals' Product Pipeline
Corporate Strategy
Table 62 Oscient Pharmaceuticals' Corporate Partnerships
Pfizer Corp.
Business Overview
Financial Information
Products
Corporate Strategy
Salix Pharmaceuticals, Inc.
Business Overview
Financial Information
Products
Corporate Strategy
Vicuron, Inc.
Business Overview
Financial Information
Products
Table 63 Vicuron's Product Pipeline
Corporate Strategy
Virologic, Inc.
Business Overview
Financial Information
Products
Corporate Strategy
AbstractThe report provides: A focuses on products in development to treat bacterial diseases, especially those caused by drug-resistant organisms, and HIV/AIDS; Clarification of the HIV/AIDS pandemic and ongoing efforts to control it; Discussion of emerging threats, such as multidrug-resistant tuberculosis, West Nile virus and other serious viral diseases; Sales for 2003 of new antibiotics and HIV/AIDS drugs, with forecasts through 2008; Trends based on projected sales through 2008 for new products, including supporting analyses for projections.
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