薬剤耐性菌：診断における機会と作用

Abstract

Introduction

Antibiotic drug resistance is a perpetual and growing source of medical need; however, diagnostics that can identify drug-resistant pathogens are limited in number. As bacteria develop resistance to more agents and classes of antibiotics, the need for rapid diagnostics that can provide diagnostic accuracy and help in patient management (i.e., by helping physicians administer appropriate therapy quickly) will grow urgent. Diagnostics companies should take heed of the significant market opportunity thus presented.

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Antibiotic drug resistance continues to plague the community and hospital settings. Which setting is more lucrative for the uptake of diagnostics? What features are needed to penetrate these settings? Currently, most diagnostics identifying drug-resistant pathogens are designed to detect methicillin-resistant Staphylococcus aureus (MRSA). Which pathogens represent future opportunities? Many diagnostics (e.g., phenotypic tests, molecular tests) are now available to detect pathogens and determine antibiotic susceptibility. Where do future opportunities lie? What challenges must be overcome? With the availability of better diagnostics for identification of resistant pathogens, treatment practices in the community and the hospital are likely to be impacted. How will the widespread use of diagnostics affect drug development and use of current drugs? Will it increase or decrease use of drugs such as daptomycin, linezolid, and tigecycline?

Decision Resources, Inc. 4-2

Scope

• Impact of drug resistance and role of diagnostics: overview of resistance issues in the hospital and community settings and the crucial but limited role diagnostics play.
• Key antibacterial drug-resistant pathogens: overview of key drug-resistant pathogens in the community and hospital settings, and their drug-resistance mechanisms.
• Antibacterial diagnostic technologies: a review of technologies, including phenotypic and molecular tests as well as biological markers.
• Key players: valuable profiles of important companies in the antibacterial diagnostics arena, including information on their current and emerging products.
• Outlook: opportunities and challenges to developing antibacterial diagnostics and the effect of new antibacterial diagnostics on the pharmaceutical industry.

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Impact of Drug Resistance
• Role of Diagnostics in Guiding Treatment
• Key Antibacterial Drug-Resistant Pathogens
• Staphylococcus
• Sites of Infection
• Mechanism of Resistance
• Enterobacteriaceae
• Sites of Infection
• Mechanism of Resistance
• Streptococcus
• Sites of Infection
• Mechanism of Resistance
• Antibacterial Diagnostic Technologies: Status and Next Steps
• Phenotypic Test Technology
• Molecular Test Technology
• Biological Markers
• C-Reactive Protein
• Procalcitonin
• Other Biomarkers
• Select Key Players in Antibacterial Diagnostics
• Accelr8 Technology
• Acolyte Biomedica
• AdvanDx
• Becton Dickinson
• BioMerieux
• Cepheid
• HandyLab
• Roche
• Outlook for Diagnostics
• Point-of-Care Testing
• Impact of Diagnostics on Drug Development
• Remaining Challenges
• Bibliography

Tables

• 1. Mechanisms of Bacterial Resistance to Select Antibiotic Classes of Drugs
• 2. Key Outcome Parameters of Methicillin-Resistant and Methicillin-Susceptible Staphylococcus aureus (MRSA and MSSA)
• 3. Select Existing and Emerging Bacterial Detection and Susceptibility Diagnostic Technologies
• 4. Select Companies and Their Diagnostic Products
• 5. Advantages and Disadvantages of Developing Diagnostics for Antibacterial Resistance

Figures

• 1. Timeline of Discovery of New Classes of Antibiotics
• 2. Common Pathogens Implicated in Hospital-Acquired Infections
• 3. Mechanisms of Antibiotic Drug Resistance
• 4. Mechanisms of Transferring or Spreading Drug Resistance