A hospital-acquired infection (HAI)is a new infection that develops in a patient during hospitalization. It is usually defined as an infection that is identified at least forty-eight to seventy-two hours following admission, so infections incubating, but not clinically apparent, at admission are excluded. This type of infection is also known as a nosocomial infection (or more generically healthcare-associated infections).

The following market data is provided in this report:

• Market for HAI Diagnostics

• Forecast for HAI Diagnostics to 2015

• HAI Tests on the Market

• Market for Diagnostics by Infection Type (C. Diff., MRSA, Pneumonia, Other)

• Molecular HAI Market vs. Conventional HAI Market, Present and in 2015

• Geographic Breakdown of Testing (U.S., Europe, Asia, ROW)

• New Hospital Infection Product Testing Products in the Market

• Company Profiles

• Treatment Products on the Market, HAI Antibiotic market Size and Forecast

Both diagnostics and treatment segments have unique circumstances for growth which are discussed in detail in the report. Worldwide, both segments combined are worth more than $9 billion for 2010 with 2015 sales expected to reach $10.3 billion. The market has shown an increase of 3% annually with sales increasing from $7.9 billion in 2005. Although the treatment segment will continue to struggle to maintain growth, the testing segment will offset declines beginning in 2012.

This report primarily focuses on bacterial nosocomial infections with some mention of viral infections. The major consideration is given to bacterial nosocomial infections because a) they are the most frequent type of infections spread in the hospital setting, and b) the practical aspects of diagnosis and therapy are more meaningful based both on medical considerations and on market considerations.

Some of the issues discussed in this report include:

• Development of Potential Life-Saving Products

• Development of Fast Testing Systems

• Growing Drug Resistance

• Development of Better Pharmacodiagnostics

• Market Opportunity and Growth Rates Expected in Diagnostics versus Treatment

• Hospital Procedures for Use of Testing and Antibiotics

• Attention to Special Population Issues

• Demographics and Epidemiology

• New Government Guidelines and Requirements for Preventing Infection

• Focus on Alliances and Partnerships

Market analysis in this report considers primarily the epidemiological considerations and the size of patient groups both in the United States and globally, where available. We have accumulated the most recent data available, understanding that virtually no organization does extensive studies on these applications on a regular basis. Many studies are highly localized and may only apply to a community, state or country (more often countries that are not a part of the major markets for nosocomial diagnostic and therapeutic products). In many instances, we have had to draw from broader epidemiologic data, that is, on data that reach outside of the hospital environment in order to try and construct a picture of the nosocomial testing and treatment needs.

The primary focus of this report is on the bacterial form of nosocomial infections, and those with significant impact on the hospital setting and markets. In looking at these infections, we consider the diagnostic and therapeutic technologies that are currently available and attempt to project trends in these product areas. To some extent, we are limited by the activity of the industries associated with the diagnosis and treatment of these infections. For the most part, these activities are limited and the advanced technologies seen in other areas of medical application are not necessarily present in terms of microbiology.

The analysis presented in this report is based on data from a combination of company, government, industry, institutional and private sources. It includes information from extensive literature reviews and discussions with experts in the field, including microbiologists, pathologists, hospital authorities, research scientists, business development managers and marketing managers.

Companies profiled in this report are:

• Abbott Laboratories

• AdvanDX

• Alere

• AstraZeneca

• Bayer Schering Pharma

• Becton Dickinson

• Cepheid

• Cubist

• Daiichi Sankyo

• Gen-Probe

• GlaxoSmithKline

• Johnson & Johnson

• Merck & Co.

• Meridien

• Pfizer

• Roche

• Seegene

CHAPTER ONE: EXECUTIVE SUMMARY

• Overview

• Infection Control Summary

• Scope and Methodology

• Total Size and Growth of the Market

• Issues and Trends Affecting Market

  • Molecular Testing vs. Conventional Testing

• Leading Competitors

CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS

• Overview

• Introduction to Pathogens

• Classification of Antibacterial Organisms

• Common Hospital (nosocomial) Infections

  • Description of Infections

  • Acinetobacter Baumannii

  • Clostridium Difficile

  • Gastroenteritis

  • Hospital-Acquired Pneumonia (HAP)

  • Pseudomonas Aeruginosa

  • Staphylococcus Aureus/Methicillin-Resistant Staphylococcus Aureus

  • Stenotrophomonas Maltophilia

  • Tuberculosis

  • Urinary Tract Infections

  • Vancomycin-Resistant Enterococcus

• Hospital Units and Infection Risks

  • Burn Units

  • Intensive Care Units

  • Emergency Departments

• Principles of Anti-bacterial Therapy

• Infecting Organism

• Antibiotic Sensitivity Testing

• Site of Infection

• Host Defenses and Organ Function

• Antibiotic Pharmacokinetics

• Monitoring Therapy

• General Infection Statistics

• Nosocomial Infection Statistics

• Populations at Risk for Infection

• Demographics of the World

• Infections and Drug Resistance

• Causes of Drug Resistance

• Antibiotic Abuse

• Antibiotic Use in Agriculture

• Drug Resistance in Select Populations

• Children

• The Elderly

• Compromised Individuals

• Measures for Reducing Resistance

• Antibiotic Cycling

• Antibiotic Education

• Screening Hospitalized patients

• The American Recovery and Reinvestment Act of 2009

• Financial Impact of Hospital Infections

• State Level Case Study of HAI Admissions and Readmissions

• Manufacturer and Marketer Trends

• Trends in Partnerships and Alliances

• Developers Trends

CHAPTER THREE: HOSPITAL INFECTION DIAGNOSTICS

• Overview

• Methods of Transmission

  • Airborne

  • Contact

  • Direct-Contact Transmission

  • Indirect-Contact Transmission

  • Droplet

  • Vehicle

  •  

  Prevention Measures

• Testing

  Drug-Resistance/Susceptibility Testing

  • Genotypic Methods

  • DNA Sequencing

  • Solid-phase Hybridization Techniques

  • Microarrays

  • Real-time Polymerase Chain Reaction Techniques

  • Phenotypic Methods

  • Phage-based Assays

  • Colorimetric Methods

  • The Nitrate Reductase Assay

• Nosocomial Disease Testing

  • Acinetobacter Baumannii

  • Clostridium Difficile

  • Hospital-Acquired Pneumonia

  • Ventilator-Associated Pneumonia

  • Pseudomonas Aeruginosa

  • Staphylococcus Aureus

  • Tuberculosis

  • Urinary Tract Infections

• New Developments

• Market Overview

• Total Market Size and Forecast

• HAI Testing by Infection Type

• Hospital Infection Testing Market by Geographical Region

• Molecular Testing vs. Conventional Testing.

• Market and Forecast for Molecular HAI

• Competitors in HAI Testing

CHAPTER FOUR: TREATING HOSPITAL INFECTIONS

• Overview

• Treatment Guidelines

• Clostridium Difficile

• Gastroenteritis

• Hospital-Acquired Pneumonia

• Ventilator-associated Pneumonia

• Pseudomonas Aeruginosa

• Staphylococcus Aureus

• Stenotrophomonas maltophilia

• Tuberculosis

• Urinary Tract Infections

• Recent Drug Approvals

• Market Overview

CHAPTER FIVE: MARKET SUMMARY

• Market Considerations

• Market Overview

• Regional Breakdown of Market

• Competitive Summary

CHAPTER SIX: COMPANY PROFILES

• Introduction

• Abbott Laboratories

• AdvanDx, Inc.

• Alere

• AstraZeneca

• Bayer Healthcare Pharmaceuticals (Bayer Schering Pharma) v Becton, Dickinson

• Cepheid

• Cubist Pharmaceuticals

• Daiichi Sankyo

• Diatherix Laboratories Inc.

• Gen-Probe Inc.

• GlaxoSmithKline

• Johnson & Johnson

• Merck & Co.

• Meridian Bioscience, Inc.

• Pfizer

• Roche

• Seegene, Inc.

APPENDIX: LIST OF MAJOR PROVIDERS

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-2: The Global Market for Hospital Infections by Product Segment (Diagnostics, Treatment), 2005-2015

• Figure 1-1: The Global Market for Hospital Infections 2005-2015

• Figure 1-2: Growth Rate - HAI Diagnostic Market vs. HAI Treatment Market

• Table 1-3: MRSA Risk and Testing Priority

CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS

• Table 2-1: Antibiotics with Difficult Penetration

• Table 2-2: Common Nosocomial Infections

• Table 2-3: Risk Factors for M. tuberculosis

• Table 2-4: Common ICU Infections

• Table 2-5: Estimated World and U.S. Incidence of Bacterial Infections

• Figure 2-1: Estimated World and U.S. Incidence of Bacterial Infections

• Figure 2-2: U.S. Hospital Admissions, Percent Acquiring HAIs

• Table 2-6: World Population at Risk for Serious Bacterial Infections, Secondary to Chronic Diseases by Selected Geographical Region (World, U.S., Europe), 2010

• Figure 2-3: World Population at Risk for Serious Bacterial Infections, Secondary to Chronic Diseases by Selected Geographical Region, 2010

• Table 2-4: Estimated World Population by Age and Geographical Region, 2010

• Figure 2-4: Estimated World Population by Age and Geographical Region, 2010

• Table 2-5: Pennsylvania State Analysis of HAI Readmissions and Related Costs, 2009

• Table 2-6: Pennsylvania State Analysis of HAIs, 2009

CHAPTER THREE: HOSPITAL INFECTION DIAGNOSTICS

• Table 3-1: CDC Healthcare Setting Guidelines

• Table 3-2: MRSA Risk and Testing Priority

• Table 3-3: Recent Approvals for Hospital Infection Testing (Product, Company, Description of Test, Approved Regions)

• Table 3-4: New Developments, Hospital Infection Testing (Developer, Description, Status, Indication)

• Table 3-5: The World Market for Hospital Infection Testing/Diagnostics 2005-2015 (Revenues, Percent Change)

• Figure 3-1: The World Market for Hospital Infection Testing/Diagnostics 2005-2015

• Figure 3-2: Distribution of Revenues for HAI Testing by Infection Type, 2010 Estimates (MRSA, Cdiff, Other HAIs)

• Table 3-6: The World Market for Hospital Infection Testing/Diagnostics Estimated Products Sales by Geographic Region (US, Europe, ROW) 2005-2015

• Figure 3-3: The World Market for Hospital Infection Testing/Diagnostics Estimated Product Sales by Geographic Region (US, Europe, ROW) 2005-2015

• Table 3-7: Detection Time for MRSA by Screening Method (Test Type, Turnaround Time, Average Cost)

• Figure 3-4: Molecular vs. Conventional Diagnostic Market for HAIs in 2010 and Projected to 2015

• Table 3-8: The World Market for Hospital Infection Diagnostics (Top 9 Leading Suppliers vs. Others) 2010

CHAPTER FOUR: TREATING HOSPITAL INFECTIONS

• Table 4-1: Treatment Options for Bacterial Infections (Type, Brand, and Manufacturer)

• Table 4-3: Recent Approvals for Hospital Infection Treatments

• Table 4-5: The World Market for Hospital Infection Treatment 2005-2015

• Figure 4-3: The World Market for Hospital Infection Treatment Estimated Market Share by Region, 2010

CHAPTER FIVE: MARKET SUMMARY

• Table 5-1: The Global Market for Hospital Infections by Product Segment, 2005-2015

• Figure 5-1: The Global Market for Hospital Infection Products 2005-2015

• Figure 5-2: The Global Market for Hospital Infection Products by Product Segment, 2010 (Diagnostics, Treatment)