目次

Table of Contents
Introduction
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
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. Ferratin
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
- bioMerieux
- Carolina Chemistries
- Horiba
- Medica
- Nova Biomedical
- Ortho-Clinical Diagnostics
- Polymedco
- 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
- Roche
- Siemens Healthineers
- 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.
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
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
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 Profiles
Abbott
Agilent Technologies
Beckman Coulter/Danaher/Cepheid
Becton Dickinson
Bio/Data
bioMerieux
Bio-Rad
Chrono-Log
Corgenix
Decode Genetics
Diagnostica Stago
Diamedix
DiaSorin
Eiken Chemical
EKF Diagnostics
Fujifilm Wako
Fujirebio
Grifols
Helena Laboratories
Hologic
Horiba
Instrumentation Laboratory/Werfen
Kyowa Medex
Labcorp
Leica Biosystems
Lonza
Nihon Kohden
Polymedco
Qiagen
QuidelOrtho
Roche
SDIX
Sekisui Diagnostics
Siemens Healthineers
Sysmex
Takara Bio
Thermo Fisher
Tosoh

List of Tables
Major Companies Developing or Marketing
Albumin Tests
Major Companies Developing or Marketing
Alkaline Phosphatase Tests
Major Companies Developing or Marketing
ALT/SGPT Tests
Major Companies Developing or Marketing
Amylase Tests
Major Companies Developing or Marketing
AST/SGOT Tests
Major Companies Developing or Marketing
Bilirubin Tests
Major Companies Developing or Marketing
Blood Gas Analyzers
Major Companies Developing or Marketing
BUN Tests
Major Companies Developing or Marketing
Calcium Tests
Major Companies Developing or Marketing
Cholesterol Tests
Major Companies Developing or Marketing
Creatinine Tests
Major Companies Developing or Marketing
Electrolyte Tests
Major Companies Developing or Marketing
Ferritin Tests

Major Companies Developing or Marketing
GGT Tests
Major Companies Developing or Marketing
Glucose Tests
Major Companies Developing or Marketing
HDL Tests
Major Companies Developing or Marketing
Iron Tests
Major Companies Developing or Marketing
LDH Tests
Major Companies Developing or Marketing
Magnesium Tests
Major Companies Developing or Marketing
Phosphorus Tests
Major Companies Developing or Marketing
Protein Tests
Major Companies Developing or Marketing
Triglycerides Tests
Major Companies Developing or Marketing
Uric Acid Tests
Major Companies Developing or Marketing
Vitamin B-12/Folate Tests
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
Major Companies Developing or Marketing
AFP Tests
Major Companies Developing or Marketing
CEA Tests
Major Companies Developing or Marketing
Occult Blood Tests
Major Companies Developing or Marketing
Prostatic Acid Phosphatase Tests
Major Companies Developing or Marketing
PSA Tests
Major Companies Developing or Marketing
FSH Tests
Major Companies Developing or Marketing
HCG Tests
Major Companies Developing or Marketing
LH Tests
Major Companies Developing or Marketing
Prolactin Tests
Major Companies Developing or Marketing
T3 Tests
Major Companies Developing or Marketing
T4 Tests
Major Companies Developing or Marketing
TSH Tests
Major Companies Developing or Marketing
TDM Tests
Major Companies Developing or Marketing
Digoxin Tests
Major Companies Developing or Marketing
Lithium Tests
Major Companies Developing or Marketing
Phenytoin/Dilantin Tests
Major Companies Developing or Marketing
Theophylline Tests
Major Companies Developing or Marketing
Valproic Acid Tests
Major Companies Developing or Marketing
APTT Tests
Major Companies Developing or Marketing
Alpha-2 Antiplasmin Tests
Major Companies Developing or Marketing
Altithrombin III Tests
Major Companies Developing or Marketing
Bleeding Time Tests
Major Companies Developing or Marketing
D-Dimer Tests
Major Companies Developing or Marketing
Factor Assays Tests
Major Companies Developing or Marketing
Fibrin Degradation Product Tests
Major Companies Developing or Marketing
Fibrinogen Tests
Major Companies Developing or Marketing
Heparin Tests
Major Companies Developing or Marketing
Protein C Tests
Major Companies Developing or Marketing
Protein S Tests
Major Companies Developing or Marketing
PT Tests
Major Companies Developing or Marketing
Thrombin Time Tests
Major Companies Developing or Marketing
CRP Tests
Major Companies Developing or Marketing
Drugs of Abuse Tests
Ancillary Hospital Locations Estimated Number
Ancillary Hospital Locations
Annual Utilization
Hospital Emergency Departments
Total Diagnostics Sales Forecast
by Market Segment
Hospital Emergency Departments
Reagent Sales Forecast by Market Segment
Hospital Emergency Departments
Instrument Sales Forecast by Market Segment
Hospital Emergency Departments Routine
and Special Chemistry Test Volume Forecast
Hospital Emergency Departments
Profiles Panels and Individual Tests
Hospital Emergency Departments
Drugs of Abuse Test Volume Forecast
Hospital Emergency Departments
Routine Hematology Test Volume Forecast
Hospital Emergency Departments
Coagulation Test Volume Forecast
Hospital Emergency Departments
Selected Infectious Disease
Test Volume Forecast
Hospital Emergency Departments
Routine and Special Chemistry Reagent
Market Forecast by Test
Hospital Emergency Departments
Drugs of Abuse Reagent Market Forecast
by Test
Hospital Emergency Departments
Hematology Reagent Market Forecast
Hospital Emergency Departments
Coagulation Reagent Market Forecast
Hospital Emergency Departments
Selected Infectious Disease Reagent Market
Forecast by Test
Hospital Operating and Recovery Suites
Total Diagnostics Sales Forecast by Market Segment
Hospital Operating and Recovery Suites
Reagent Sales Forecast by Market Segment
Hospital Operating and Recovery Suites
Instrument Sales Forecast By Market Segment
Hospital Operating and Recovery Suites
Routine and Special Chemistry Reagent
Test Volume Forecast
Hospital Operating and Recovery Suites
Routine Hematology Test Volume Forecast
Hospital Operating and Recovery Suites
Coagulation Test Volume Forecast
Hospital Operating and Recovery Suites
Routine and Special Chemistry Reagent Market
Forecast by Test
Hospital Operating and Recovery Suites
Hematology Reagent Market Forecast
Hospital Operating and Recovery Suites
Coagulation Reagent Market Forecast
Hospital ICUs/CCUs Total Diagnostics
Sales Forecast by Market Segment
Hospital ICUs/CCUs
Reagent Sales Forecast by Market Segment
ICUs/CCUs
Instrument Sales Forecast by Market Segment
Hospital ICUs/CCUs Routine
and Special Chemistry Test Volume Forecast
Hospital ICUs/CCUs Routine
Hematology Test Volume Forecast
Hospital ICUs/CCUs
Coagulation Test Volume Forecast
Hospital ICUs/CCUs Routine
and Special Chemistry Reagent Market
Forecast by Test
Hospital ICUs/CCUs
Hematology Reagent Market Forecast
Hospital ICUs/CCUs
Coagulation Reagent Market Forecast
Major Suppliers of Clinical Chemistry
Diagnostic Products, Estimated Sales
and Market Shares
Major Suppliers of Clinical Chemistry
Reagents, Estimated Sales and Market Shares
Major Suppliers of Clinical Chemistry
Analyzers, Estimated Sales and Market Shares
Major Suppliers of Immunodiagnostic
Products, Estimated Sales and Market Shares
Major Suppliers of Immunoassay
Reagents, Estimated Sales and Market Shares
Major Suppliers of Immunoassay
Analyzers, Estimated Sales and Market Shares
AIDS Testing Market
Estimated Market Shares of Major Suppliers
Chlamydia Testing Market
Estimated Market Shares of Major Suppliers
CMV Testing Market
Estimated Market Shares of Major Suppliers
Gonorrhea Testing Market
Estimated Market Shares of Major Suppliers
Helicobacter Pylori Testing Market
Estimated Market Shares of Major Suppliers
Hepatitis Testing Market
Estimated Market Shares of Major Suppliers
Herpes Testing Market
Estimated Market Shares of Major Suppliers
Influenza Testing Market
Estimated Market Shares of Major Suppliers
Lyme Disease Testing Market
Estimated Market Shares of Major Suppliers
Mononucleosis Testing Market
Estimated Market Shares of Major Suppliers
Rubella Testing Market
Estimated Market Shares of Major Suppliers
Streptococci Testing Market
Estimated Market Shares of Major Suppliers
Syphilis Testing Market
Estimated Market Shares of Major Suppliers
AFP Testing Market by Major Supplier
CA 15-3/27-29 Testing Market by Major Supplier
CA 19-9 Testing Market by Major Supplier
CEA Testing Market by Major Supplier
PAP Testing Market by Major Supplier
PSA Testing Market by Major Supplier
Hematology Analyzers
Estimated Placements and Installed Base
Flow Cytometers
Estimated Placements and Installed Base
Hematology Diagnostics Market
Estimated Market Shares of Major Suppliers
Hematology Instrument Market
Estimated Market Shares of Major Suppliers
Hematology Consumable Market
Estimated Market Shares of Major Suppliers
Flow Cytometry Diagnostics Market
Estimated Market Shares of Major Suppliers
Flow Cytometry Consumable Market
Estimated Market Shares of Major Suppliers
Flow Cytometry Instrument Market
Estimated Market Shares of Major Suppliers
Major Suppliers of Coagulation
Diagnostic Products, Estimated Market Shares
of Major Suppliers