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						目次
						
	Table of Contents
	
	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
	Review of Clinical Chemistry Immunodiagnostic 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
	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
	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: Chemistry Immunodiagnostic 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
	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
	B. Physician Offices/Group Practices
	1. Market Summary
	2. Market Structure
	3. Test Volume and Sales Forecasts
	C. 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
	D. Cancer Clinics
	1. Introduction
	2. Market Summary
	3. Test Volume and Sales Forecasts
	E. Ambulatory Care Centers
	1. Introduction
	2. Market Summary
	3. Market Structure
	4. Test Volume and Sales Forecasts
	F. Surgery Centers
	1. Introduction
	2. Market Summary
	3. Market Structure
	4. Test Volume and Sales Forecasts
	G. Nursing Homes
	1. Introduction
	2. Market Summary
	3. Market Structure
	4. Test Volume and Sales Forecasts
	H. Birth Centers
	1. Introduction
	2. Market Summary
	3. Market Structure
	4. Test Volume and Sales Forecasts
	I. Major Suppliers’ Sales and Market Shares
	Germany
	A. Market Overview
	B. Market Structure
	C. Market Summary
	D. Test Volume and Sales Forecasts
	E. Major Suppliers’ Sales and Market Shares
	Spain
	A. Business Environment
	B. Market Structure
	C. Market Summary
	D. Test Volume and Sales Forecasts
	E. Major Suppliers’ 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 Laboratories
	- Agilent Technologies
	- Beckman Coulter/Danaher
	- bioMerieux
	- Bio-Rad
	- DiaSorin
	- Eiken Chemical
	- Fujirebio
	- Grifols
	- Instrumentation Laboratory/Werfen
	- Kyowa Medex
	- Ortho-Clinical Diagnostics
	- PerkinElmer
	- Quest Diagnostics
	- Roche
	- Siemens Healthineers
	- Sysmex
	- Thermo Fisher
	- Tosoh
	- Wako
	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
	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
	Drugs of Abuse Tests
	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/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
	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/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
	Immunoprotein Reagent Market Forecast
	by Test
	U.S.A., Physician Offices/Group Practices
	Drugs of Abuse Reagent Market Forecast
	by Test
	U.S.A., Ancillary Hospital Locations Estimated Number
	U.S.A., Ancillary Hospital Locations Annual Utilization
	U.S.A., Hospital Emergency Departments Routine
	and Special Chemistry Test Volume Forecast
	U.S.A., Hospital Emergency Departments
	Profiles, Panels and Individual Tests
	U.S.A., Hospital Emergency Departments
	Drugs of Abuse Test Volume Forecast
	U.S.A., Hospital Emergency Departments
	Routine and Special Chemistry Reagent
	Market Forecast by Test
	U.S.A., Hospital Emergency Departments
	Drugs of Abuse Reagent Market Forecast
	by Test
	U.S.A., Hospital Operating and Recovery Suites
	Routine and Special Chemistry Reagent
	Test Volume Forecast
	U.S.A., Hospital Operating and Recovery Suites
	Routine and Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Hospital ICUs/CCUs Total Diagnostics
	Sales Forecast by Market Segment
	U.S.A., Hospital ICUs/CCUs
	Reagent Sales Forecast by Market Segment
	U.S.A., Hospital ICUs/CCUs
	Instrument Sales Forecast by Market Segment
	U.S.A., Hospital ICUs/CCUs Routine
	and Special Chemistry Test Volume Forecast
	U.S.A., Hospital ICUs/CCUs Routine
	and Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Cancer Clinics Routine And Special Chemistry
	Test Volume Forecast
	U.S.A., Cancer Clinics Endocrine
	Function Test Volume Forecast
	U.S.A., Cancer Clinics Routine and
	Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Cancer Clinics Endocrine
	Function Reagent Market 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 Routine
	and Special Chemistry Test Volume Forecast
	U.S.A., Ambulatory Care Centers
	Drugs of Abuse Test Volume Forecast
	U.S.A., Ambulatory Care Centers Routine
	and Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Ambulatory Care Centers Drugs
	of Abuse Reagent Market Forecast by Test
	U.S.A., Surgery Centers Most
	Frequently Performed Procedures
	U.S.A., Surgery Centers Routine and
	Special Chemistry Test Volume Forecast
	U.S.A., Surgery Centers Routine and
	Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Nursing Homes
	Estimated Number of Facilities,
	Beds and Occupancy Rate
	U.S.A., Nursing Homes Routine and
	Special Chemistry Test Volume Forecast
	U.S.A., Nursing Homes Routine and
	Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Birth Centers Facilities,
	Patient Visits, and Births
	U.S.A., Birth Centers Routine and
	Special Chemistry Test Volume Forecast
	U.S.A., Birth Centers Profiles,
	Panels and Individual Tests
	U.S.A., Birth Centers Routine and
	Special Chemistry Reagent Market
	Forecast by Test
	U.S.A., Major Suppliers of Clinical Chemistry
	Diagnostics Products, Estimated Sales
	and Market Shares
	U.S.A., Major Suppliers of Clinical Chemistry
	Reagents, Estimated Market Shares
	U.S.A., Major Suppliers of Clinical Chemistry
	Analyzers, Estimated Market Shares
	U.S.A., Major Suppliers of Immunodiagnostic
	Products, Estimated Market Shares
	U.S.A., Major Suppliers of Immunoassay
	Reagents, Estimated Market Shares
	U.S.A., Major Suppliers of Immunoassay
	Analyzers, Estimated Market Shares
	Germany, Physician Offices/Group Practices
	Routine and Special Chemistry
	Test Volume Forecast
	Germany, Physician Offices/Group Practices
	Endocrine Function Test Volume Forecast
	Germany, Physician Offices/Group Practices
	Major Cancer Diagnostic Test Volume Forecast
	Germany, Physician Offices/Group Practices
	Immunoprotein Test Volume Forecast
	Germany, Physician Offices/Group Practices
	TDM Test Volume Forecast
	Germany, Physician Offices/Group Practices
	Routine Chemistry Reagent Market Forecast
	Germany, Physician Offices/Group Practices
	Cancer Diagnostics Market Forecast by Test
	Germany, Physician Offices/Group Practices
	Endocrine Function Diagnostics Market Forecast
	Germany, Physician Offices/Group Practices
	TDM Reagent Market Forecast
	Germany, Physician Offices/Group Practices
	Immunoprotein Reagent Market Forecast
	Germany, Physician Offices/Group Practices
	Drugs of Abuse Reagent Market Forecast
	Germany, Major Suppliers of Clinical Chemistry
	Diagnostic Products Estimated Market Shares
	Germany, Major Suppliers of Clinical Chemistry
	Reagent Estimated Market Shares
	Germany, Major Suppliers of Clinical Chemistry
	Analyzers Estimated Market Shares
	Germany, Major Suppliers of Immunodiagnostic
	Products Estimated Market Shares
	Germany, Major Suppliers of Immunodiagnostic
	Reagent Estimated Market Shares
	Germany, Major Suppliers of Immunoassay
	Analyzers Estimated Market Shares
	Spain, Laboratory Performing Chemistry
	and Immunoassay Tests Forecast by Market Segment
	Spain, Ambulatory Care Centers Routine
	and Special Chemistry Test Volume Forecast
	Spain, Ambulatory Care Centers
	Endocrine Function Test Volume Forecast
	Spain, Ambulatory Care Centers
	TDM Test Volume Forecast
	Spain, Ambulatory Care Centers
	Immunoprotein Test Volume Forecast
	Spain, Ambulatory Care Centers
	Drugs of Abuse Test Volume Forecast
	Spain, Ambulatory Care Centers
	Routine and Special Chemistry
	Reagent Market Forecast
	Spain, Ambulatory Care Centers Endocrine
	Function Reagent Market Forecast
	Spain, Ambulatory Care Centers
	TDM Reagent Market Forecast
	Spain, Ambulatory Care Centers
	Immunoprotein Reagent Market Forecast
	Spain, Ambulatory Care Centers Drugs
	of Abuse Reagent Market Forecast
	Spain, Major Suppliers of Clinical Chemistry
	Diagnostic Products Estimated Market Shares
	Spain, Major Suppliers of Immunodiagnostics
	Products Estimated Market Shares