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
A. Major Routine Chemistry Tests
1. Albumin
2. Alkaline Phosphatase
3. ALT/SGPT
4. Ammonia
5. Amylase
6. AST/SGOT
7. Bilirubin
8. Blood Gases
9. Blood Urea Nitrogen (BUN)
10. Calcium
11. Cholesterol
12. Cholinesterase
13. Creatinine
14. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
15. Ferritin
16. Follate/Folic Acid

17. Fructosamine
18. Gamma-Glutamyl Transpeptidase (GGT)
19. Glucose
20. High Density Lipoprotein (HDL)
21. Iron
22. Lactate Dehydrogenase (LDH)
23. Magnesium
24. Phosphorus
25. Protein
26. Triglycerides
27. Troponin
28. Uric Acid
29. Urinalysis
30. Vitamin B12
Infectious Disease Tests
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
Tumor Markers
1. Alpha-Fetoprotein (AFP)
2. Carcinoembrionic Antigen (CEA)
3. Occult Blood
4. Prostatic Acid Phosphatase (PAP)
5. Prostate-Specific Antigen (PSA)
Major Routine and Special Hematology Tests
1. CBC Analysis
a. Hemoglobin Concentration
b. Hematocrit Determination
c. Red Blood Cell Count
d. Platelets
Endocrine Function Tests
1. Cortisol
2. Follicle-Stimulating Hormone (FSH)
3. Gastrin
4. Human Chorionic Gonadotropin (HCG)
5. LH
6. Prolactin
7. T3
8. T3 Uptake
9. Free T3
10. Thyroxine (T4)
11. Free T4
12. TBG
13. TSH

Therapeutic Drug Monitoring (TDM)
1. Overview
2. Carbamazepine
3. Digoxin
4. Gentamicin
5. Lidocaine
6. Lithium
7. Phenytoin/Dilantin
8. Procainamide
9. Quinidine
10. Theophylline
11. Valproic Acid
Coagulation Tests
1. Introduction
2. Activated Partial Thromboplastin Time (APTT)
3. Alpha-2 Antiplasmin
4. Antithrombin III
5. Bleeding Time
6. D-Dimer
7. Factor VIII
8. Fibrin Degradation Products
9. Fibrinogen
10. Heparin
11. Proteins C and S
12. Prothrombin Time (PT)
13. Thrombin Time
Immunoprotein Tests
1. CRP
2. Immunoglobulins
Drugs of Abuse
1. Overview
2. Test Methodologies
3. Amphetamines
4. Barbiturates
5. Benzodiazepines
6. Cannabinoids/Marijuana
7. Cocaine

8. Lysergic Acid Diethylamide (LSD)
9. Methadone
10. Methaqualone
11. Opiates
12. Phencyclidine
Instrumentation
1. Chemistry Analyzers Manufactured by:
- Abaxis
- Abbott
- Alfa Wassermann
- Awareness Technologies
- Beckman Coulter/Danaher
- bioMeriuex
- Carolina Chemistries
- Horiba
- Inverness
- Medica
- Nova Biomedical
- Ortho-Clinical Diagnostics
- Polimedco
- Randox
- Roche
2. Hematology Analyzers Manufactured by:
- Abbott
- Becton Dickinson
- Beckman Coulter/Danaher
- Biocode
- Drew-Scientific
- Diesse Ves Matic
- Horiba
- Menarini
- Nihon Kohden
- Polymedco
- Sysmex
3. Coagulation Analyzers Manufactured by:
- Behnk Elektronik
- Bio/Data
- Cardiovascular Diagnostics

- Diagnostica Stago
- Helena Laboratories
- Instrumentation Laboratory
- ITC Hemochron
- Roche
- Siemens
- Sysmex
- Teco Medical Instruments
- Trinity Biotech
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

Worldwide Business Environment
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
B. Personal Testing
1. Glucose Monitoring
? Market and Technology Overview
? Invasive Testing
? Non-Invasive Testing
? Genetic Testing
2. Pregnancy Tests
3. Occult Blood Tests
4. Market Size and Growth
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, Consumables Sales and Market Shares

Germany
A. Market Overview
B. Market Structure
C. Market Summary
D. Test Volume and Sales Forecasts
E. Major Suppliers' Instrument Placements,
Installed Base, Consumables Sales and Market Shares
Spain
A. Business Environment
B. Market Structure
C. Market Summary
D. Test Volume and Sales Forecasts
E. Major Suppliers' Instrument Placements,
Installed Base, Consumables Sales and Market Shares
Major Product Development Opportunities
A. Routine and Special Chemistry
B. Microbiology/Infectious Diseases
C. Hematology and Flow Cytometry
D. Coagulation
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
- ADI/American Diagnostica
- Agilent Technologies
- Alere/Biosite/Inverness
- Axis-Shield
- Beckman Coulter/Danaher
- Becton Dickinson
- Bio/Data
- Biomerieux
- Bio-Rad
- Cepheid
- Chrono-Log
- Corgenix
- Decode Genetics
- Diadexus
- Diagnocure
- Diagnostica Stago/Trinity Biotech
- Diamedix
- Diasorin
- Eiken Chemical
- EKF Diagnostics
- Fujirebio
- Grifols
- Helena Laboratories
- Hologic/Gen-Probe
- Horiba
- Instrumentation Laboratory
- International Technidyne/Nexus DX
- Kreatech
- Kyowa Medex

- Lonza
- Mackay Life Sciences
- Matritech
- Nihon Kohden
- Ortho-Clinical Diagnostics
- Polartechnics
- Polymedco
- Qiagen
- Roche
- SDIX
- Sequenom
- Siemens
- Sienco
- Sysmex
- Takara Bio
- ThermoFisher
- Tosoh
- Wako
- Zycare/Alere