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The Global Market for Antimicrobials and Antifungals: Challenging Resistance to 2016

Published by: Spectra Intelligence

Published: Dec. 1, 2006 - 329 Pages


Table of Contents



Contents List

List of Tables

List of Figures

List of Abbreviations

Executive Summary

Objective of the Report

Research Methodology

CHAPTER 1. INTRODUCTION TO ANTIBIOTICS AND ANTIFUNGALS

1.1 Pathogenic Bacteria and Fungi

1.1.1 Types of Bacteria and Morphological Characteristics

1.1.1.1 Gram-Positive versus Gram-Negative

1.1.1.2 Aerobes, Anaerobes, and Facultative Anaerobes

1.1.1.3 Morphological Characteristics

1.1.1.4 Virulence Factors and Antibiotic Resistance

1.1.1.5 Other Characteristics

1.1.1.6 Atypical Bacteria

1.1.1.7 Normal Human Flora

1.2 Types of Fungi

1.2.1 Candida

1.2.2 Dermatophytes

1.2.3 Aspergillus

1.2.4 Coccidiodes immitis

1.3 Antibiotic and Antifungal Evaluation

1.4 Epidemiology of Microbial Disease in the Developed and Developing World

1.5 The Challenge of Resistance

CHAPTER 2. BACTERIAL AND FUNGAL INFECTIONS AND DISEASES

2.1 Respiratory Tract Infections

2.1.1 Upper Respiratory Tract Infections

2.1.2 Less Common Upper Respiratory Tract Infections

2.1.2 Lower Respiratory Tract Infections

2.1.2.4 Hospital-Acquired Pneumonia

2.1.2.5 Staphylococcus aureus

2.1.2.6 Methicillin Resistant Staphylococcus aureus (MRSA)

2.1.3 Other Lower Respiratory Tract Infections

2.2 Invasive Infections

2.2.4 Intra-Abdominal Infections

2.2.5 Intra-Abdominal Abscesses

2.3 Skin, Eye, Soft Tissue, Joint and Bone Infections

2.3.7 Ophthalmic Infections

2.3.2 Bone and Joint Infections

2.4 Genito-Urinary Tract Infections

2.4.1 Urinary Tract Infections

2.4.1.3 Hospital Acquired Urinary Tract Infections

2.6 Sexually Transmitted Infections

2.7 Gastrointestinal Diseases and Infections

2.7.7 Other Gastrointestinal or Food-Borne Infections

2.9 Infectious Agents Potentially Utilised in Bioterrorism or Biowarfare

2.10 Bacterial Infections of the Tropical and Developing World

2.11 Fungal Diseases and Infections

2.11.1 Invasive Fungal Infections

2.11.2 Noninvasive Fungal Infections

CHAPTER 3. CLASSIC ANTIBIOTICS AND ANTIFUNGALS: PIPELINE INSIGHTS

3.0 Classic Antibiotics and Antifungals by Mechanism of Action

3.1 Cell Wall Synthesis Inhibitors

3.1.2.1 Penicillins

3.1.2.2 Cephalosporins

3.1.2.3 Beta-Lactamase Inhibitors

3.1.2.4 Carbapenems

3.1.4 Monobactams

3.1.5 Vancomycin

3.1.5.1 Vancomycin Descendents in the Pipeline

3.2 Cell Membrane Disruptors

3.2.5.5 Pipeline Triazoles

3.3 Protein Synthesis Inhibitors

3.3.1 Aminoglycosides

3.3.1.1 Pipeline Aminoglycosides

3.3.4 Macrolides

3.3.4.3 Pipeline Macrolides

3.3.6.1 Novel Tetracyclines

3.4 Transfer RNA Synthetase Inhibitors

3.5 Nucleic Acid Synthesis Inhibitors

3.5.1 Antifungal Agents

3.5.2 Fluoroquinolones

3.5.2.1 Pipeline Fluoroquinolones

3.5.3.3 Rifamycins in the Pipeline

3.6 Folic Acid Synthesis Blockers

3.6.1 Antituberculosis Drugs

3.6.2.1 Pipeline Diaminopyrimidines

3.6.3 Sulphonamides and Sulphones

CHAPTER 4. NEW STRUCTURES AND/OR NOVEL TARGETS: APPROVED OR IN THE PIPELINE

4.0 New Structures and Novel Targets Recently Approved and in the Pipeline

4.1 Approved Products

4.2 Novel Antibiotics

4.3 Novel Antifungals

4.4 Novel Antibiotics - New Drug Applications Submitted

4.5 Novel Antibiotics in Clinical Trials

4.6 Antibiotics at Preclinical/Early Research Stage

4.6.1 Cationic Peptides

4.6.2 Defensins

4.6.3 DNA Replication Inhibitors

CHAPTER 5. THEWORLDMARKET FOR ANTI-INFECTIVES AND ANTIFUNGALS

5.1 Global Size of Antibiotic and Antifungal Markets

5.1.1 Generic Antibiotic and Antifungal Drug Sales

5.2 World Market Leaders in Branded Antibiotics

5.3 US Market Leaders in Branded and Generic Antibiotics and Antifungals

5.4 Market Shares of Branded and Generic Antibiotics by Class

5.5 Trends in Antibiotic and Antifungal Sales

5.6 Factors Affecting Worldwide Antibiotic and Antifungal Sales

5.6.1 Loss of Market Exclusivity/Generic Competition

5.6.2 Impact of Generic Sales on Individual Companies

5.6.4.1 Biodefense

5.6.5 Impact of Rising Levels of Antibiotic and Antifungal Resistance

5.6.5.1 Increase in Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections

5.6.9.1 Macrolides

5.6.9.2 Fluoroquinolones

5.6.9.3 Penicillins and Cephalosporins

5.9.6.4 Carbapenems and Linezolid

5.6.10 Impact of Toxicity and Adverse Side Effects

5.7 Market Predictions for Antibiotic and Antifungal Sectors to 2016

5.7.1 Predictions for Antibiotics and Antifungals Based on Current Sales Figures

5.7.2 Market Predictions Based on Trends in Infectious Disease Cases

5.8 Potential Impact of Competing Technologies

5.8.1 Therapeutic Antibodies and Vaccines

5.8.2 Summary on the Impact of Competing Technologies

5.8.3 Phage-Based Antibacterials

CHAPTER 6. CHALLENGES IN DEVELOPING ANDMARKETING NEW ANTIBIOTICS

6.1 Scientific Challenges and Solutions

6.1.2 The Ideal Antibiotic

6.1.2.1 Potential Solutions

6.2 Mechanisms of Antibiotic Resistance

6.2.4 Antibiotic Degradation or Modification

6.2.4.1 Beta-Lactamases

6.2.5 Target Modification

6.2.7 Failure to Modify Prodrug

6.3 Potential Solutions to Antibiotic Resistance

6.3.4 Overcoming Restricted Outer Membrane Permeability

6.3.5 New Drugs in Older Classes that are Poor Substrates for Efflux Pumps

6.3.6 Targeting Other Parts of the Resistance Mechanism

6.4 Discovery Approaches for New Molecules

6.4.1 Genomics Approaches

6.4.2 Computationally Intensive Approaches

6.4.3 New Sources of Natural Products

6.4.4 Chemical Biology Approaches

6.5 New Technology for Screening and Toxicological Analysis

6.6 Converting Limitations into Strengths

6.7.3 Novel Dosage Forms

6.7.5 Ophthalmic and Otic Preparations

CHAPTER 7. COMPANIES MARKETING OR DEVELOPING ANTIMICROBIALS AND ANTIFUNGALS

7.1 Abbott Laboratories

7.1.1 Product Review

7.2 Achaogen

7.2.1 Pipeline Review

7.3 Achillion

7.3.1 Pipeline Review

7.4 ActivBiotics

7.4.1 Pipeline Review

7.5 Advanced Life Sciences

7.5.1 Pipeline Review

7.6 Advancis

7.6.1 Pipeline and Technology Review

7.7 ADVENTRX Pharmaceuticals

7.7.1 Pipeline Review

7.8 Alcon Laboratories

7.8.1 Product Portfolio Review

7.8.2 Pipeline Review

7.9 AlphaRX

7.9.1 Pipeline Review

7.10 Arpida

7.10.1 Pipeline Review

7.11 Astellas Pharma

7.11.1 Product Portfolio Review

7.11.2 Pipeline Review

7.12 AstraZeneca Pharmaceuticals

7.12.1 Product Portfolio Review

7.12.2 Pipeline Review

7.13 Basilea Pharmaceutica

7.13.1 Pipeline Review

7.14 Bausch & Lomb

7.14.1 Product Review

7.15 Bayer

7.15.1 Product Portfolio Review

7.16 Biovertis

7.16.1 Pipeline Review

7.17 Boehringer Ingelheim

7.18 Bristol-Myers Squibb

7.18.1 Products Review

7.19 Centocor

7.20 Ceragenix Pharmaceuticals

7.20.1 Pipeline Review

7.21 Cerexa

7.21.1 Pipeline Review

7.22 Chiron

7.22.1 Products Review

7.23 Cubist Pharmaceuticals

7.23.1 Products Review

7.23.2 Pipeline Review

7.24 Cumbre Pharmaceuticals

7.24.1 Pipeline Review

7.25 Daiichi Sankyo

7.25.1 Product Portfolio Review

7.25.2 Pipeline Review

7.26 Eli Lilly

7.26.1 Product Portfolio Review

7.26.2 Pipeline Review

7.27 Enanta Pharmaceuticals

7.27.1 Pipeline Review

7.28 GlaxoSmithKline

7.28.1 Product Portfolio Review

7.28.2 Pipeline Review

7.28.2.1 GSK-TB Alliance Partnership

7.29 InSite Vision

7.29.1 Pipeline Product Review

7.30 InterMune

7.31 IntraBiotics Pharmaceuticals

7.32 Johnson & Johnson

7.32.1 Product Portfolio Review

7.32.1.1 Antibacterials

7.32.1.2 Antifungals

7.32.2 Pipeline Review

7.33 King Pharmaceuticals

7.33.1 Product Portfolio Review

7.34 Kyorin

7.34.1 Approved Product and Pipeline Review

7.35 Inhibitex

7.35.1 Pipeline Review

7.36 Intercell

7.37 Merck

7.37.1 Product Portfolio Review

7.37.2 Pipeline Review

7.38 MethylGene

7.38.1 Pipeline Review

7.39 Mpex Pharmaceuticals

7.39.1 Pipeline Review

7.40 Nabi Biopharmaceuticals

7.40.1 Pipeline Review

7.41 Nereus Pharmaceuticals

7.41.1 Pipeline Review

7.42 Novartis

7.42.1 Product Portfolio Review

7.42.2 Pipeline Review

7.43 Novexel

7.43.1 Pipeline Review

7.44 NovoBiotic Pharmaceuticals

7.45 Novozymes

7.46 Optimer Pharmaceuticals

7.46.1 Pipeline Review

7.47 Oragenics

7.47.1 Pipeline Review

7.48 Oscient Pharmaceuticals

7.48.1 Product Review

7.48.2 Pipeline Review

7.49 Paratek Pharmaceuticals

7.49.1 Pipeline Review

7.50 Pfizer

7.50.1 Product Portfolio Review

7.50.2 Pipeline Review

7.51 PolyMedix

7.51.1 Pipeline Review

7.52 Protez Pharmaceuticals

7.52.1 Pipeline Review

7.53 Purdue Pharmaceuticals

7.54 Quorex Pharmaceuticals

7.55 Replidyne

7.55.1 Pipeline Review

7.56 Rib-X Pharmaceuticals

7.56.1 Pipeline Review

7.57 Roche

7.57.1 Product Review

7.57.2 Pipeline Review

7.58 Salix Pharmaceuticals

7.58.1 Product Review

7.59 Sanofi-Aventis

7.59.1 Product Review

7.59.2 Pipeline Review

7.60 Schering-Plough

7.60.1 Products Review

7.61 Shionogi and Co.

7.61.1 Product Review

7.61.2 Pipeline Review

7.62 TAP Pharmaceutical Products

7.63 Targanta Therapeutics

7.63.1 Pipeline Review

7.64 Theravance

7.64.1 Pipeline Review

7.65 Toyama Chemical

7.65.1 Products Review

7.65.2 Pipeline Review

7.66 Vertex Pharmaceuticals

7.66.1 Pipeline Review

7.67 ViroPharma

7.67.1 Product Review

7.67.2 Pipeline Review

7.68 Wyeth Pharmaceuticals

7.68.1 Products Review

7.68.2 Pipeline Review

LIST OFTABLES

Table 1.1 Common Bacterial Pathogens

Table 1.2 Common Fungal Pathogens

Table 2.1 Bacterial Respiratory Tract Infections and Causative Organisms

Table 2.2 Invasive Infections and Causative Organisms

Table 2.3 Skin, Eye, Soft Tissue, Joint and Bone Infections and Causative Organisms

Table 2.4 Genito-Urinary Tract Infections and Causative Organisms

Table 2.5 Gastrointestinal and Food-Borne Bacterial Infections and Causative Organisms

Table 2.6 Soil and Insect-Borne Bacterial Diseases and Causative Organisms

Table 2.7 The US National Institute of Allergy and Infectious Disease (NIAID) Category A, B and C Priority Bacterial Pathogens for Biodefense Research

Table 2.8 Common Fungal Infections and Causative Organisms

Table 3.1 Recently Approved and Pipeline Cephalosporins

Table 3.2 Beta-Lactam/Beta-Lactamase Inhibitors in the Pipeline

Table 3.3 Recently Approved and Pipeline Carbapenems

Table 3.4 Glycopeptide-Based Anti-Infectives and Descendants in the Pipeline

Table 3.5 Recently Approved and Pipeline Azoles

Table 3.6 Pipeline Aminoglycosides

Table 3.7 Pipeline Macrolides

Table 3.8 Recently Approved and Pipeline Tetracyclines

Table 3.9 Recently Approved and Pipeline Fluoroquinolones

Table 3.10 Recently Approved and Pipeline Rifamycins

Table 4.1 New Antibiotics and Antifungals Approved Since 1999

Table 4.2 New Drug Applications, 2004-2006

Table 4.3 Classic and Novel Antibiotics and Antifungals in Phase-III Clinical Trials

Table 4.4 Classic and Novel Antibiotics and Antifungals in Phase-II Clinical Trials

Table 4.5 Classic and Novel Antibiotics and Antifungals in Phase-I Clinical Trials

Table 4.6 Summary of Antibiotics and Antifungals in Preclinical/Early Research Stage Drug Development

Table 5.1 Worldwide Sales Data for Major Branded Antibiotics, 2005

Table 5.2 Worldwide Sales Data for Major Branded Antifungals, 2005

Table 5.3 US Retail and Hospital Sales Data for Branded and Generic Antibiotics, 2005

Table 5.4 US Retail and Hospital Sales Data for Branded and Generic Antifungals, 2005

Table 5.5 Past, Current, and Future Losses of Patent Protection for Key Antibiotic and Antifungals

Table 5.6 Annual US Disease Cases (Clinic or Hospital Visits), 2006 & 2016

Table 6.1 Mechanisms of Antibiotic and Antifungal Resistance

Table 6.2 Classification of Beta-Lactamases

Table 7.1 Abbott Laboratories’ Anti-Infectives Product Portfolio, 2006

Table 7.2 Achaogen’s Anti-Infective and Antifungal Product Pipeline, 2006

Table 7.3 Achillion’s Anti-Infective Product Pipeline, 2006

Table 7.4 ActivBiotics’ Anti-Infective Product Pipeline, 2006

Table 7.5 Advanced Life Sciences’ Anti-Infective Product Pipeline, 2006

Table 7.6 Advancis’ Current and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.7 ADVENTRX Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.8 Alcon’s Anti-Infective Product Portfolio, 2006

Table 7.9 AlphaRX’s Anti-Infective Product Pipeline, 2006

Table 7.10 Arpida’s Anti-Infective Product Pipeline, 2006

Table 7.11 Astellas Pharma’s Current and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.12 AstraZeneca’s Current and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.13 Basilea Pharmaceutica’s Anti-Infective and Antifungal Product Pipeline, 2006

Table 7.14 Bayer’s Anti-Infective Product Portfolio, 2006

Table 7.15 Biovertis’ Anti-Infective Product Pipeline, 2006

Table 7.16 Bristol-Myers Squibb’s Anti-Infective Product Portfolio, 2006

Table 7.17 Ceragenix Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.18 Chiron’s Anti-Infective Product Portfolio, 2006

Table 7.19 Cubist Pharmaceutical’s Approved and Pipeline Anti-Infective Product Portfolio,

Table 7.20 Cumbre Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.21 Daiichi Sankyo’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.22 Eli Lilly’s Anti-Infective Product Portfolio, 2006

Table 7.23 GlaxoSmithKline’s Approved and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.24 Johnson & Johnson’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.25 King Pharmaceuticals’ Anti-Infective Product Portfolio, 2006

Table 7.26 Kyorin’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.27 Inhibitex’s Anti-Infective Product Pipeline, 2006

Table 7.28 Merck’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.29 MethylGene’s Anti-Infective and Antifungal Product Pipeline, 2006

Table 7.30 Mpex Pharmaceutical’s Anti-Infective Product Pipeline, 2006

Table 7.31 Nabi Biopharmaceutical’s Anti-Infective Product Pipeline, 2006

Table 7.32 Novartis’ Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.33 Novexel’s Anti-Infective and Antifungal Product Pipeline, 2006

Table 7.34 Optimer Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.35 Oscient Pharmaceuticals’ Approved and Pipeline Anti-Infective Product Portfolio,

Table 7.36 Paratek Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.37 Pfizer’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.38 Protez Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.39 Replidyne’s Anti-Infective Product Pipeline, 2006

Table 7.40 Rib-X Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.41 Roche’s Approved and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.42 Sanofi-Aventis’ Approved and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.43 Schering-Plough’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.44 Targanta Therapeutics’ Anti-Infective Product Pipeline, 2006

Table 7.45 Toyama Chemical’s Approved and Pipeline Anti-Infective and Antifungal Product Portfolio,

Table 7.46 Vertex Pharmaceuticals’ Anti-Infective Product Pipeline, 2006

Table 7.47 ViroPharma’s Approved and Pipeline Anti-Infective Product Portfolio, 2006

Table 7.48 Wyeth’s Approved and Pipeline Anti-Infective Product Portfolio, 2006

LIST OF FIGURES

Figure 1.1 Worldwide Causes of Death, 2005

Figure 1.2 Comparison of Causes of Death in High versus Low Income Countries, 2005

Figure 5.1 World Market Shares of Antibiotics, 2005

Figure 5.2 World Market Shares of Antibiotics by Company, 2005

Figure 5.3 US Market Shares of Branded Antibiotics, 2005

Figure 5.4 US Market Shares of Top 10 Generic Antibiotics, 2005

Figure 5.5 US Market Shares of Antifungals, 2005

Figure 5.6 US Market Shares of Branded Antibiotics by Class, 2005

Figure 5.7 US Market Shares of Generic Antibiotics by Class, 2005

Figure 5.8 World Market Shares of Branded Antibiotics by Class, 2005

Figure 5.9 Antibiotics with Increasing Sales Worldwide, 2003-2006

Figure 5.10 Antibiotics with Decreasing Sales Worldwide, 2003-2006

Figure 5.11 Trends in Worldwide Sales of Antifungals, 2003-2006

Figure 5.12 Impact of Four Key Branded Antibiotics Losing Patent Protection in 2005

Figure 5.13 Resistance Rates of Nosocomial Infections, 1998-2003

Figure 5.14 US Methicillin-Resistant Staphylococcus aureus (MRSA) Pneumonia and Septicaemia Rates by Age Groups, 1999-

Figure 5.15 Rates of Prescriptions Written for Antimicrobial Drugs, 1992-2000

Figure 5.16 Changes in Prescription Rates by Class of Antibiotic, 1992-2000

Figure 5.17 US Rates of Clinic Visits for Infections, 1993-2005

Figure 5.18 Declining Rates of Prescriptions for Respiratory Infections in Children in the US, 1996-

Figure 5.19 US Trends in Infections Requiring Hospitalisation, 1994-2004

Figure 5.20 Changes in Reportable Infection Rates in the US, 1993-2003

Figure 5.21 US Rates of Sexually Transmitted Diseases, 1993-2003

Figure 5.22 US Rates of Clinic Visits (A) or Hospitalisations (B) for per Annum for Common Infections

Figure 5.23 Worldwide Trends in Sales of Macrolides, 2003-2006

Figure 5.24 Worldwide Trends in Sales of Fluoroquinolones, 2003-2006

Figure 5.25 Worldwide Trends in Sales of Penicillins and Cephalosporins, 2003-2006

Figure 5.26 Worldwide Trends in Sales of Carbapenems and Linezolid, 2003-

Abstract

Antibiotic resistance is a significant problem which is negatively impacting prescribing patterns, consequently reducing antibiotic usage. The total worldwide market for antibiotics and antifungals was US$25 billion in 2005, but is predicted to fall to between US$15 and US$20 billion by 2016. This forecast is based on a number of factors, but largely due to declining rates of antibiotic prescriptions for respiratory infections - a major segment of the market. Other contributing factors include the loss of market exclusivity for a number of popular branded antibiotics, including Abbott's Biaxin and Pfizer's Zithromax in 2005. Generic competitors of these drugs have already been launched and are set to make serious inroads on the branded market in the years to come.

In this unique market analysis report, The Global Market for Antimicrobials and Antifungals: Challenging Resistance to 2016, the reader will be presented with a comprehensive asessment of the global market for anti-infectives and antifungals. Included in the analysis are therapeutics to combat the lethal microorganisms MRSA, C. difficile, and the highly infectious agents potentially used in bioterrorism. The report also provides current sales and prescription trends for antibiotics and antifungals and a detailed review of the current armamentarium of marketed antibiotics and antifungals. Resistance mechanisms and efforts to target those mechanisms in drug discovery are also discussed. Furthermore, mechanisms of action of current and novel anti-infective therapeutics, side effects, and how differences in dosage formulations can affect their attractiveness to physicians and patients are also detailed. The report also provides an up-to-date extensive list of companies engaged in antibacterial and antifungal drug discovery and lists some of the novel scientific approaches being taken, including chemical biology, toxicogenomics, and computational approaches. It further documents efforts by companies to extend profits on drugs that are off-patent by developing new formulations with additional advantages benefiting patient compliance. Pipeline products and their advantages and disadvantages are also covered in-depth in the market analysis.

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