Hospital Infection Testing August 2012

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CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

Overview .............................................................................................................................. 1
Infection Control Summary ............................................................................................... 3
Scope and Methodology ...................................................................................................... 4
Total Size and Growth of the Market ............................................................................... 4
Issues and Trends Affecting Market ................................................................................. 7
Leading Competitors .......................................................................................................... 8

CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS ....................10

Overview ............................................................................................................................ 10
Introduction to Pathogens ............................................................................................... 10
Classification of Antibacterial Organisms ...................................................................... 11
Common Hospital (nosocomial) Infections .................................................................... 12
Hospital Units and Infection Risks .................................................................................. 22
Burn Units....................................................................................................................... 22
Intensive Care Units ....................................................................................................... 23
Emergency Departments ................................................................................................. 24
General Infection Statistics ............................................................................................. 24
Nosocomial Infection Statistics ...................................................................................... 25
Hospital Length of Stay .................................................................................................. 27
Populations at Risk for Infection .................................................................................... 28
Demographics of the World ............................................................................................. 31
Life Expectancy .............................................................................................................. 32
Economic Trends .............................................................................................................. 35
Comparison Between Healthcare Spending and Real Health Outcomes ........................ 39
Infections and Drug Resistance ....................................................................................... 41
Causes of Drug Resistance ............................................................................................. 42
Drug Resistance in Select Populations ........................................................................... 43
Measures for Reducing Resistance ................................................................................. 44
Screening Hospitalized patients ...................................................................................... 45
Prevention Measures......................................................................................................... 46
Potential Use of Copper for Reducing Infections ........................................................... 47
Wide Area Disinfection Methods ................................................................................... 47
Software for Infection Detection and Control ................................................................ 48
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The American Recovery and Reinvestment Act of 2009 ................................................ 48

U.S. Government's National Action Plan to Prevent Healthcare
Associated Infections (HAIs) ........................................................................................... 49
U.S. Statewide Standardized Infection Ratio .................................................................. 50
State Level Case Study of HAI Admissions and Readmissions ..................................... 52
John T. Mather Memorial Hospital/Cepheid-Case Study ............................................... 53
Manufacturer and Marketer Trends ............................................................................... 54
Trends in Partnerships and Alliances .............................................................................. 54
Developers Trends .......................................................................................................... 54

CHAPTER THREE: HOSPITAL INFECTION TESTING PRODUCTS ..........56

Overview............................................................................................................................. 56
Methods of Transmission ................................................................................................ 56
Testing Methods ................................................................................................................ 57
Drug-Resistance/Susceptibility Testing .......................................................................... 58
Genotypic Methods ......................................................................................................... 59
Specific Nosocomial Disease Testing ................................................................................ 63
Acinetobacter Baumannii ................................................................................................ 63
Clostridium Difficile ....................................................................................................... 64
Hospital-Acquired Pneumonia ........................................................................................ 66
Pseudomonas Aeruginosa ............................................................................................... 67
Staphylococcus Aureus ................................................................................................... 68
Tuberculosis .................................................................................................................... 69
Urinary Tract Infections .................................................................................................. 71
Vancomycin-resistant Enterococcus ............................................................................... 72
Ventilator-Associated Pneumonia ................................................................................... 72
New Developments............................................................................................................. 74

CHAPTER FOUR: MARKET OPPORTUNITIES FOR HOSPITAL

INFECTION TESTING ............................................................................................76
Market Considerations ..................................................................................................... 76
Market Overview ...............................................................................................................77
Total Market Size and Forecast ....................................................................................... 78
Hospital Infection Testing Market by Geographical Region .......................................... 82
Competitive Analysis ......................................................................................................... 86

CHAPTER FIVE: COMPANY PROFILES ...........................................................90

Introduction ....................................................................................................................... 90
Abbott Laboratories .......................................................................................................... 91
Alere .................................................................................................................................... 93
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Becton, Dickinson .............................................................................................................. 95

bioMerieux ......................................................................................................................... 97
Cepheid .............................................................................................................................. 99
Gen-Probe ........................................................................................................................ 101
Meridian Bioscience, Inc. ............................................................................................... 103
Qiagen GmbH.................................................................................................................. 105
Roche ................................................................................................................................ 107
Siemens AG...................................................................................................................... 109

LIST OF MAJOR PROVIDERS............................................................................111

L

EXECUTIVE SUMMARY .........................................................................................1

Table 1-1: Frequency of the Most Common Nosocomial Infections .............................. 3
Table 1-2: The World Market for Hospital Infection
Testing/Diagnostics 2007-2016 ........................................................................................... 6
Figure 1-1: The World Market for Hospital Infection
Testing/Diagnostics 2007-2016 ........................................................................................... 7

CHAPTER TWO: INTRODUCTION AND INDUSTRY TRENDS ....................10

Table 2-1: Burn Statistics ................................................................................................. 23
Figure 2-1: U.S. Hospital Admissions and Percent of
Hospital-acquired Infections (HAIs) .............................................................................. 26
Table 2-2: U.S. Hospital Length of Stay, Average by Age Group ................................ 27
Table 2-3: Average International Length of Stay, by Country 2010 ............................ 28
Table 2-4: World Population at Risk for Serious Bacterial Infections,
Secondary to Chronic Diseases by Selected Geographical Region, 2010 ..................... 29
Figure 2-2: World Population at Risk for Serious Bacterial Infections,
Secondary to Chronic Diseases by Selected Geographical Region, 2010 .................... 30
Table 2-5: Estimated World Population by Age and Geographical Region, 2010 ...... 31
Figure 2-3: Estimated World Population by Age and Geographical Region, 2010 .... 32
Table 2-6: Average Life Expectancy in Years by Country 1980, 2004 and 2011 ........ 34
Figure 2-4: Average Life Expectancy in Years by Country 1980 and 2011................. 35

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Table 2-7: Total Healthcare Expenditures as a Percent of GDP by

Country 1990, 2000 and 2010 .......................................................................................... 37
Figure 2-5: Total Healthcare Expenditures as a Percent of GDP by
Country 1990, 2000, and 2010 .......................................................................................... 38
Table 2-8: Healthcare Spending, Obesity and Life Expectancy, 2011 .......................... 39
Table 2-9: U.S. States Hospital Acquired Infection Standardized Infection
Ratio (SIR) ......................................................................................................................... 50
Table 2-10: Pennsylvania State Analysis of HAI Readmissions and
Related Costs, 2009........................................................................................................... 52
Table 2-11: Pennsylvania State Analysis of HAIs, 2009 ................................................. 53

CHAPTER THREE: HOSPITAL INFECTION TESTING PRODUCTS ..........56

Table 3-1: Recent Approvals for Hospital Infection Testing ......................................... 73
Table 3-2: New Developments, Hospital Infection Testing, as of July 2012 ................. 75

CHAPTER FOUR: MARKET OPPORTUNITIES FOR

HOSPITAL INFECTION TESTING .....................................................................76
Table 4-1: The World Market for Hospital Infection
Testing/Diagnostics 2007-2016 ......................................................................................... 79
Figure 4-1: The World Market for Hospital Infection
Testing/Diagnostics 2007-2016 ......................................................................................... 80
Figure 4-2: The World Market for Hospital Infection
Testing/Diagnostics Estimated Market Share by Test Indication, 2011 ....................... 81
Table 4-2: The World Market for Hospital Infection
Testing/Diagnostics Estimated Products Sales by Geographic Region 2007-2016 ..... 83
Figure 4-3: The World Market for Hospital Infection Testing/Diagnostics
Estimated Product Sales by Geographic Region 2007-2016 ........................................ 84
Figure 4-4: The World Market for Hospital Infection Testing/Diagnostics
Estimated Market Share by Region, 2011 ....................................................................... 85
Table 4-3: The World Market for Hospital Infection Testing/Diagnostics
Leading Suppliers Shares Estimates for 2011 .............................................................. 88
Figure 4-5: The World Market for Hospital Infection Testing/Diagnostics
Leading Suppliers Shares Estimates for 2011 .............................................................. 89

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Two: Introduction
18

While it is classified as an aerobic (requiring air) organism, P. aeruginosa is considered by

many as a facultative anaerobe, adaptive to proliferate in conditions of partial or total oxygen
depletion as well. Adaptation to microaerobic or anaerobic environments is essential for certain
lifestyles of P. aeruginosa, as seen in lung infections in cystic fibrosis patients, where thick layers
of alginate surrounding bacterial mucoid cells can limit the diffusion of oxygen.

Staphylococcus Aureus/Methicillin-Resistant Staphylococcus Aureus

Staphylococcus aureus is the single most common cause of staph infections. It is a
bacterium that is frequently found in the nose and skin of a person. S. aureus can cause a range
of illnesses from minor skin infections (e.g., pimples, impetigo, boils, cellulitis, folliculitis,
furuncles, carbuncles, scalded skin syndrome and abscesses) to life-threatening diseases such as
pneumonia, meningitis, osteomyelitis endocarditis, toxic shock syndrome (TSS), and septicemia.
Its incidence is from skin, soft tissue, respiratory, bone, joint, endovascular to wound infections.
It is still one of the four most common causes of nosocomial infections, often causing
postsurgical wound infections.
Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium that is responsible for
difficult-to-treat infections in humans. (The continued use of the term methicillin-resistant, has
carried on even though methicillin is not longer on the market.) MRSA is, by definition, a strain
of S. aureus that is resistant to a large group of antibiotics called the -lactams, which include the
penicillins and the cephalosporins.

Stenotrophomonas Maltophilia
Stenotrophomonas maltophilia is an aerobic, nonfermentative, Gram-negative bacterium that
causes uncommon but difficult to treat opportunistic infections in humans. In immunocompetent
individuals, S. maltophilia is a relatively unusual cause of pneumonia, urinary tract infection, or
blood stream infection. In immunocompromised patients, however, S. maltophilia is a growing
source of latent pulmonary infections. S. maltophilia colonization rates in individuals with cystic
fibrosis have been increasing.
S. maltophilia frequently colonizes breathing tubes such as endotracheal or tracheotomy
tubes, the respiratory tract and indwelling urinary catheters. Infection is usually facilitated by the
presence of prosthetic material (plastic or metal) and the most effective treatment is removal of
the prosthetic material (usually a central venous catheter or similar device).

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Two: Introduction
37

Table 2-7

Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000

and 2010

Country

Total Health Expenditures as Percent of GDP by

Country
1990
2000
2010

*2009 data
Source: Organization for Economic Cooperation and Development; U.S. Census Bureau; British
Medical Journal; U.S. National Coalition on Healthcare; Canadian Institute for Health Information;
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Three: Infections
57

Contact
This is the most frequent mode of transmission for nosocomial infections. There are two
general classifications of contact transmission:
Direct-Contact Transmission
This involves direct body surface-to-body transmission.
patients, source to host transfer.

This can occur between two

Indirect-Contact Transmission
This involves contact with a contaminated object with a viable host.
contaminated needles, dressings and gloves.

For example,

Droplet
Droplet transmission involves the act of sneezing, coughing and talking from an infected
source to a viable host. These require short distance transmission.

Vehicle
Vehicle transmission includes microorganisms transmitted to the host by contaminated items,
typically medical devices, equipment and other objects.

TESTING METHODS
In recent years there have been improved methods for testing infected patients. For MRSA
infections, a nostril swab has been effective in detecting bacteria. Admission screening has been
effective in some areas and has reduced the spread of MRSA infections in hospitals in the United
States and some European countries.
In some European countries, including the United Kingdom, screening for aggressive
infections such as MRSA is performed in many hospitals upon admission.

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in whole or in any part, is strictly prohibited