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
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. Physician Offices/Group Practices
1. Market Summary
2. Market Structure
3. Test Volume and Sales Forecasts
C. 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
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
Sienco
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
Antithrombin 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
U.S.A., Physician Offices/Group Practices
Total Diagnostic Sales Forecast
by Market Segment
U.S.A., Physician Offices/Group Practices
Reagent Sales Forecast by Market Segment
U.S.A., Physician Offices/Group Practices
Instrument Sales Forecast by Market Segment
U.S.A., Office-Based Physicians
Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Forecast by Type
U.S.A., Physician Office/Group Practice
Laboratories Forecast by Practice Size
U.S.A., Physician Offices/Group Practices
Routine and Special Chemistry Test
Volume Forecast
U.S.A., Physician Offices Laboratories
Major Infectious Disease Test Volume Forecast
U.S.A., Physician Offices/Group Practice
Microbiology Test Volume Forecast
by Market Segment
U.S.A., Physician Offices/Group Practices
Routine Hematology Test Volume Forecast
U.S.A., Physician Offices Laboratories
Flow Cytometry and Special Hematology
Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Coagulation Test Volume Forecast
U.S.A., Physician Offices/Group Practices
TDM Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Endocrine Function Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Major Tumor Marker Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Immunoprotien Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Drugs of Abuse Test Volume Forecast
U.S.A., Physician Offices/Group Practices
Routine and Special Chemistry Test Volume
Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Microbiology/Infectious Disease Test Volume
Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Hematology and Flow Cytometry Test Volume
Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
TDM Test Volume Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Endocrine Function Test Volume Forecast
by Practice Type
U.S.A., Physician Offices/Group Practices
Tumor Markers Test Volume Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Immunoprotein Test Volume Forecast by Practice Type
U.S.A., Physician Offices/Group Practices Drugs
of Abuse Test Volume Forecast by Practice Type
U.S.A., Physician Offices/Group Practices
Routine and Special Chemistry Reagent Market
Forecast by Test
U.S.A., Physician Offices Laboratories Major
Infectious Disease Reagent Market Forecast
by Test
U.S.A., Physician Offices/Group Practices
Microbiology Reagent Market Forecast
By Market Segment
U.S.A., Physician Offices/Group Practices
Hematology and Flow Cytometry Consumables
Market Forecast
U.S.A., Physician Offices/Group Practices
TDM Reagent Market Forecast by Test
U.S.A., Physician Offices/Group Practices
Endocrine Function Reagent Market Forecast
by Test
U.S.A., Physician Offices/Group Practices
Major Tumor Marker Reagent Market Forecast
by Test
U.S.A., Physician Offices/Group Practices
Coagulation Reagent Market Forecast
U.S.A., Physician Offices/Group Practices
Immunoprotein Reagent Market Forecast
by Test
U.S.A., Physician Offices/Group Practices
Drugs of Abuse Reagent Market Forecast
by Test
U.S.A., Major Suppliers of Clinical Chemistry
Reagents: Estimated Sales and Market Shares
U.S.A., Major Suppliers of Clinical Chemistry
Analyzers: Estimated Sales and Market Shares
U.S.A., Major Suppliers of Immunodiagnostic
Products: Estimated Sales and Market Shares
U.S.A., Major Suppliers of Immunoassay
Reagents: Estimated Sales and Market Shares
U.S.A., Major Suppliers of Immunoassay
Analyzers: Estimated Sales and Market Shares
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
U.S.A., AFP Testing Market by Major Suppliers
U.S.A., CA 15-3/27-29 Testing Market by Major Suppliers
U.S.A., CA 19-9 Testing Market by Major Suppliers
U.S.A., CEA Testing Market by Major Suppliers
U.S.A., PAP Testing Market by Major Suppliers
U.S.A., PSA Testing Market by Major Suppliers
U.S.A., Hematology Analyzers
Estimated Placements and Installed Base
U.S.A., Flow Cytometers
Estimated Placements and Installed Base
U.S.A., Hematology Diagnostics Market
Estimated Market Shares of Major Suppliers
U.S.A., Hematology Instrument Market
Estimated Market Shares of Major Suppliers
U.S.A., Hematology Consumable Market
Estimated Market Shares of Major Suppliers
U.S.A., Flow Cytometry Diagnostics Market
Estimated Market Shares of Major Suppliers
U.S.A., Flow Cytometry Consumable Market
Estimated Market Shares of Major Suppliers
U.S.A., Flow Cytometry Instruments Market
Estimated Market Shares of Major Suppliers
U.S.A., Market Major Suppliers of Coagulation
Diagnostic Products, Estimated Market Shares
of Major Suppliers