New Frontiers in Point-of-Care/POC Infectious Disease Testing:
Business Challenges, Emerging Technologies, Competitive Landscape
Introduction
Executive Summary
Rationale for Testing Decentralization
1. Overview
2. Regulatory Trends
3. Economic Trends
4. Demographic Trends
5. Technological Trends
6. Social Trends
7. Quality of Care
8. Defensive Medicine
9. Quality Control Issues

Worldwide Market and Technology Overview
1. AIDS
2. Adenovirus
3. Campylobacter
4. Candida
5. Chlamydia
6. Clostridium Difficile
7. Cytomegalovirus
8. Enteroviruses
9. Epstein-Barr Virus
10. Gonorrhea
11. Helicobacter Pylori
12. Hepatitis a. Hepatitis A
b. Hepatitis B
c. Hepatitis C
d. Hepatitis D
13. Herpes Simplex Virus
14. Human Herpes Virus-6 (HHV-6)
15. Influenza Viruses
16. Legionella
17. Lyme Disease
18. Measles (Rubeola)
19. Meningitis
20. Mononucleosis
21. Mumps
22. Mycoplasma
23. Papillomaviruses
24. Pneumonia
25. Respiratory Syncytial Virus (RSV)
26. Rheumatoid Arthritis
27. Rotavirus (Reovirus)
28. Rubella (German Measles)
29. Salmonellosis
30. Shigellosis
31. Staphylococcus Aureus
32. Streptococci
33. Syphilis

Instrumentation: Infectious Disease Analyzers Manufactured by:
- Abbott
- Beckman Coulter/Danaher
- bioMeriuex
- Ortho-Clinical Diagnostics
- Roche
- Siemens
- Tosoh
- Wallac, and other suppliers
Current and Emerging Technologies
1. Monoclonal Antibodies
2. Immunoassays a. Technological Principle b. Enzyme Immunoassays (EIA)

Overview
ELISA
Dot Immunobinding Assays
Capillary Immunoassays
Particle-Membrane Capture Immunoassay
Enzyme Amplification c. Fluorescent Immunoassays
Fluorescent Polarization
Time-Resolved Pulse Fluorescence d. Luminescence
Chemiluminescence
Bioluminescence e. Latex Agglutination f. Immunoprecipitation
3. Dry Chemistry
4. Biosensors
5. IT and Automation
6. Molecular Diagnostics a. Technology Overview b. Amplification Methods

Polymerase Chain Reaction
Ligase Chain Reaction
Branched DNA
Q-Beta Replicase
Strand Displacement Activation
Self-Sustained Sequence Replicase
U.S.A.

A. Market Overview
1. Business Environment a. Health Care Expenditures b. Cost Consciousness c. Reimbursement d. Industry Consolidation e. Managed Care

PPO
HMO
f. Hospitals g. Admissions h. Length of Stay i. Industry Diversification j. Physician Demographics k. Aging Population
More Chronic Illness
Disease Incidence
Susceptibility to latrogenesis
Multiple Illnesses Cases l. Laboratory Regulations
2. Market Structure a. Hospitals b. Commercial/Private Laboratories

C. Physician Offices/Group Practices
1. Market Summary
2. Market Structure
3. Test Volume and Sales Forecasts

D. Ancillary Hospital Locations
1. Introduction a. Emergency Departments b. Operating Suites c. Intensive Care Units
2. Emergency Departments a. Market Summary b. Test volume and Sales Forecasts
3. Operating and Recovery Suites a. Market Summary b. Test Volume and Sales Forecasts
4. ICUs/CCUs a. Market Summary b. Test Volume and Sales Forecasts

E. Cancer Clinics
1. Introduction
2. Market Summary
3. Test Volume and Sales Forecasts

F. Ambulatory Care Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts

G. Surgery Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts

H. Nursing Homes
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts

I. Birth Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts

J. Major Suppliers Instrument Placements, Installed Base, Reagent Sales and Market Shares

Germany
A. Market Overview
B. Market Structure
C. Market Summary
D. Major Suppliers Reagent Sales and Market Shares

Spain
A. Business Environment
B. Market Structure
C. Market Summary
D. Major Suppliers Reagent Sales and Market Shares

Major Product Development Opportunities
Design Criteria for Decentralized Testing Products

Alternative Market Penetration Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts

D. Distribution Strategies for Decentralized Testing Markets
1. Marketing Approaches
2. Product complexity
3. Customer Preference
4. Established Suppliers
5. Emerging Suppliers
6. Major Types of Distributors
7. Market Segmentation

Potential Market Entry Barriers and Risks
A. Market Maturity
B. Cost Containment
C. Competition
D. Technological Edge and Limitations
E. Patent Protection
F. Regulatory Constraints
G. Decentralized Testing Market Challenges

Company Profile
- Abbott
- Affymetrix
- Beckman Coulter/Danaher
- Becton Dickinson
- bioMerieux
- Bio-Rad
- Cepheid
- Diamedix
- DiaSorin
- Eiken Chemical
- Enzo Biochem
- Fujirebio/Innogenetics
- Grifols/Novartis Diagnostics
- Hologic/Gen-Probe
- ID Biomedical/GSK
- Kreatech
- Lonza
- Nanogen/Elitech
- Ortho-Clinical Diagnostics
- Qiagen
- Roche
- Scienion
- Sequenom
- SeraCare
- Siemens
- Takara Bio
- Thermo Fisher/Life Technology
- Wallac/PE
- Wako

List of Tables
Major Companies Developing or Marketing
AIDS Tests
Major Companies Developing or Marketing
Adenovirus Tests
Major Companies Developing or Marketing
Campylobacter Tests
Major Companies Developing or Marketing
Candida Tests
Major Companies Developing or Marketing
CMV Tests
Major Companies Developing or Marketing
EBV Tests
Major Companies Developing or Marketing
Gonorrhea Tests
Major Companies Developing or Marketing
Helicobacter Pylori Tests
Major Companies Developing or Marketing
Hepatitis Tests
Major Companies Developing or Marketing
Herpes Tests
Major Companies Developing or Marketing
Influenza Tests
Major Companies Developing or Marketing
Legionella Tests
Major Companies Developing or Marketing
Lyme Disease Tests
Major Companies Developing or Marketing
Measles Tests
Major Companies Developing or Marketing
Meningitis Tests
Major Companies Developing or Marketing
Mononucleosis Tests
Major Companies Developing or Marketing
Mumps Tests
Major Companies Developing or Marketing
Mycoplasma Tests
Major Companies Developing or Marketing
Pneumonia Tests
Major Companies Developing or Marketing
RSV Tests
Major Companies Developing or Marketing
Rotavirus Tests
Major Companies Developing or Marketing
Rubella Tests
Major Companies Developing or Marketing
Salmonella Tests
Major Companies Developing or Marketing
Shigella Tests
Major Companies Developing or Marketing
Streptococci Tests
Major Companies Developing or Marketing
Syphilis Tests
U.S.A., Physician Office/Group Practice
Laboratories Forecast by Practice Size
U.S.A., Physician Offices/Group Practices
Forecast by Type
U.S.A., Office-Based Physicians
Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Infectious Disease Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Microbiology Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Infectious Disease Reagent and Instrument Sales Forecast
U.S.A., Physician Offices/Group Practices
Microbiology Reagent and Instrument Sales Forecast
U.S.A., Ancillary Hospital Locations Estimated Number
U.S.A., Ancillary Hospital Locations Annual Utilization
U.S.A., Hospital Emergency Departments
Infectious Disease Test Volume Forecast
U.S.A., Hospital Emergency Departments
Infectious Disease Reagent and Instrument Sales Forecast
U.S.A., Ambulatory Care Centers Estimated
Number of Facilities and Patient Visits
U.S.A., Ambulatory Care Centers
Most Frequent Diagnoses
U.S.A., Ambulatory Care Centers
Infectious Disease Test Volume Forecast
U.S.A., Ambulatory Care Centers Microbiology
And Serology Test Volume Forecast
U.S.A., Ambulatory Care Centers
Infectious Disease Reagent and Instrument Sales Forecast
U.S.A., Ambulatory Care Centers Microbiology and Serology Reagent and Instrument Sales Forecast
U.S.A., Surgery Centers Most
Frequently Performed Procedures
U.S.A., Surgery Centers Microbiology and Serology Test Volume Forecast
U.S.A., Surgery Centers Microbiology
And Serology Reagent and Instrument Sales Forecast
U.S.A., Birth Centers Facilities, Patient Visits, and Births
U.S.A., Birth Centers Microbiology and Serology Test Volume Forecast
U.S.A., AIDS Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Chlamydia Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., CMV Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Gonorrhea Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Helicobacter Pylori Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Hepatitis Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Herpes Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Influenza Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Lyme Disease Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Mononucleosis Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Rubella Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Streptococci Testing Market
Estimated Market Shares of Major Suppliers
U.S.A., Syphilis Testing Market
Estimated Market Shares of Major Suppliers
Germany, Laboratory Performing Diagnostic Tests by Market Segment
Germany, AIDS Testing Market
Estimated Market Share of Major Suppliers
Germany, Gonorrhea Testing Market
Estimated Market Share of Major Suppliers
Germany, Hepatitis Testing Market
Estimated Market Share of Major Suppliers
Germany, Herpes Testing Market
Estimated Market Share of Major Suppliers
Germany, Influenza Testing Market
Estimated Market Share of Major Suppliers
Germany, Mononucleosis Testing Market
Estimated Market Share of Major Suppliers
Germany, Septicemia Testing Market
Estimated Market Share of Major Suppliers
Germany, Streptococci Testing Market
Estimated Market Share of Major Suppliers
Spain, Laboratory Performing Infectious Disease Tests by Market Segment
Spain, AIDS Testing Market
Estimated Market Shares of Major Suppliers
Spain, Chlamydia Testing Market
Estimated Market Shares of Major Suppliers
Spain, Hepatitis Testing Market
Estimated Market Shares of Major Suppliers
Spain, Herpes Testing Market
Estimated Market Shares of Major Suppliers
Spain, Influenza Testing Market
Estimated Market Shares of Major Suppliers
Spain, Mononucleosis Testing Market
Estimated Market Shares of Major Suppliers
Spain, Rubella Testing Market
Estimated Market Shares of Major Suppliers
Spain, Streptococci Testing Market
Estimated Market Shares of Major Suppliers
Spain, Syphilis Testing Market
Estimated Market Shares of Major Suppliers