Table of Contents
Introduction
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. Fructosamine
16. Gamma-Glutamyl Transpeptidase (GGT)
17. Glucose
18. High Density Lipoprotein (HDL)
19. Iron
20. Lactate Dehydrogenase (LDH)
21. Magnesium
22. Phosphorus
23. Protein
24. Triglycerides
25. Uric Acid
26. Troponin
B. 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
C. 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
D. Tumor Markers And Special Chemistry Tests
1. Alpha-Fetoprotein (AFP)
2. Carcinoembrionic Antigen (CEA)
3. Ferritin
4. Follate/Folic Acid
5. Occult Blood
6. Prostatic Acid Phosphatase (PAP)
7. Prostate-Specific Antigen (PSA)
8. Vitamin B-12
E. Immunoprotein Tests
1. Complement
a. C3
b. C4
2. CRP
3. Immunoglobulins (IgA, IgE, IgG, IgM)
4. Protein Electrophoresis
F. 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
G. Instrumentation Review
Abaxis Piccolo
Abaxis Piccolo Xpress
Abbott AxSYM
Abbott Architect c4000
Abbott Architect i2000 Series
Abbott Architect ci8200 System
Abbott i-STAT
Alfa Wassermann ACE Alera
AMS Liasys
Awareness Technologies ChemWell
Awareness Technology STAT FAX 4500
Beckman Coulter Unicel Series
Beckman Coulter Access
Binding Site ESP600
bioMerieux Mini Vidas
Carolina Chemistries BioLis 24i
DiaSorin Liaison
Grifols Triturus
Horiba ABX Pentra 400
Inverness DS2
J&J DT System
J&J Vitros ECi/ECiO
J&J Vitros 3600
J&J Vitros 5600
Medica EasyRA
Nova Biomedical Critical Care Xpress
Olympus AU480
Olympus AU5400
Olympus AU53000i
Olympus AU2700
Polymedco Poly-Chem
Polymedco Spotchem EZ
Randox RX Daytona
Randox RX Imola
Roche Modular Analytics
Roche Cobas Integra 400
Roche Cobas Integra 400 Plus
Roche Elecsys
Roche Cobas c311
Roche Cardiac 200
Siemens ADVIA Centaur
Siemens Dimension
Siemens Dimension RxL Max
Siemens Dimension Vista 500
Siemens Immulite
Siemens Stratus
Tosoh AIA-Series
Vital Diagnostics ATAC 8000
Vital Diagnostics Envoy 500
H. Major In Vitro Diagnostic Technologies
And Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Radioimmunoassays (RIA)
c. Enzyme Immunoassays (EIA)
Overview
ELISA
EMIT
Immunofiltration
Dot Immunobinding Assays
Capillary Immunoassays
Particle-Membrane Capture Immunoassays
Enzyme Amplification
CEDIA
Electrochemical Immunoassays
d. Fluorescent Immunoassays
Fluorescence Polarization
Time-Resolved Pulse Fluorescence
e. Luminescence
Chemiluminescence
Bioluminescence
f. Latex Agglutination
g. Immunoprecipitation
h. Affinity Chromatography Immunoassays
i. Liposome Flow-Injection Immunoassays
3. IT and Automation
4. Dry Chemistry
5. Biosensors
6. Robotics
7. Chemometrics
8. Molecular Diagnostics
a. Sample Preparation
b. Hybridization
c. Separation
d. Detection/Measurement
Test Formats
a. Filter Hybridization
b. Southern Blot
c. Northern Blot
d. In Situ Hybridization
e. Others
Labeling Techniques
Amplification Methods
Polymerase Chain Reaction
Temperature Cyclers
PCR Variations
Immuno-PCR
QC-PCR.
DAP-PCR
Strand Displacement Activation
TMA
Ligase Chain Reaction
Branched DNA
Hybridization Protection Assay
Nucleic-Acid Sequence-Based Amplification
Self-Sustained Sequence Replicase
Others
Ampliprobe
CAR
CAS
CPT
Dendritic Polymer Technology
ISO-CR
LAT
Probe Networks
RAMP
Repair Chain Reaction
Rolling Circles
Sequence Independent Gene Amplification
Sequence Initiation Reaction
SISPA
Solid Phase Amplification
Detection Technologies
a. Radioactive Methods
Overview
Major Isotopes
P-32
S-35
H-3
I-125
b. Non-Isotopic Methods
Enzymatic Labels
Chemical Labeling
Indirect Chemical Labeling
Direct Chemical Labeling
Fluorescence
Chemiluminescence
Electrical Conductivity
Instrumentation Review
a. Abbott LCx
b. Beckman Coulter/Biomek FK
c. Becton Dickinson SDA
d. Bio-Rad GeneScope
e. Gen-Probe Tigris
f. Roche Cobas Amplicor
g. Tecan LS Series
Biochips: Genosensors, Microarrays, and
Labs-on-the-chip
Liquid Transportation and Mixing
Separation
Reaction
Detection
Worldwide Market Overview
1. Business Environment
2. Market Structure
3. Market Size and Growth
Germany
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and 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
Competitive Assessments
Abbott Laboratories
AdnaGen
Ambrilia
AMDL
Beckman Coulter
Biomedical Diagnostics
BioMerieux
Bio-Rad
Canag Diagnostics
Dako
DiaSorin
Eiken
Fujirebio
Instrumentation Laboratory
J&J
Kyowa Medex
Matritech
Roche
Siemens
Sysmex
Thermo Fisher
Trinity Biotech
Tosoh
Wako
Wallac
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
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
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
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
AFP Tests
Major Companies Developing or Marketing
CEA Tests
Major Companies Developing or Marketing
Ferritin 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
Vitamin B-12/Folate Tests
Major Companies Developing or Marketing
CRP Tests
Major Companies Developing or Marketing
Drugs of Abuse Tests
Major Companies Developing or Marketing
Biosensors for Clinical Chemistry Testing
Major Companies Developing or Marketing
Biosensors for Immunological Testing
Major Companies Developing or Marketing
DNA Probes for Cancer Testing
Major Companies Developing or Marketing
DNA Probes for Genetic Disease Testing
Worldwide, All Market Segments, Estimated
Laboratory Universe Performing Chemistry
and Immunodiagnostics Tests By Country
Worldwide, All Market Segments, Estimated
Chemistry and Immunodiagnostics Consumable
Market By Country
Worldwide, All Market Segments, Estimated
Chemistry and Immunodiagnostics Instrument Sales
By Country
Worldwide, All Market Segments, Estimated Total
Chemistry and Immunodiagnostics Market
By Country
Executive Summary Table: Germany, Clinical
Chemistry and Immunoassay Test Volume and
Diagnostics Sales Forecast By Test Category
Germany, Laboratories Performing Chemistry
and Immunoassay Tests By Market Segment
Germany, Hospital Laboratories Performing
Chemistry and Immunoassay Tests By Bed Size
Germany, Commercial/Private Laboratories
Performing Chemistry and Immunoassay
Tests By Annual Test Volume
Germany, Total Chemistry and Immunoassay
Specimen Volume Forecast
Germany, All Market Segments, Specimen
Volume Forecast By Test Category
Germany, Total Clinical Chemistry and
Immunoassay Test Volume Forecast By Test Category
Germany, Routine Chemistry Test Volume
Forecast By Market Segment
Germany, Endocrine Function Test Volume
Forecast By Market Segment
Germany, Tumor Markers and Special
Chemistry Test Volume Forecast By Market
Segment
Germany, Immunoprotein Test Volume
Forecast By Market Segment
Germany, TDM Test Volume Forecast By Market
Segment
Germany, Drugs of Abuse Test Volume
Forecast By Market Segment
Germany, All Market Segments, Profiles,
Panels and Individual Tests Forecast
Germany, Hospital Laboratories, Profiles,
Panels and Individual Tests Forecast
Germany, Commercial/Private Laboratories,
Profiles, Panels and Individual Tests Forecast
Germany, Physician Offices/Group Practices,
Profiles, Panels and Individual Tests Forecast
Germany, All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
Germany, Hospital Laboratories, Routine
Chemistry Test Volume Forecast by Assay
Germany, Commercial/Private Laboratories,
Routine Chemistry Test Volume Forecast by Assay
Germany, Physician Offices/Group Practices,
Routine Chemistry Test Volume Forecast by Assay
Germany, All Market Segments, Endocrine
Function Test Volume Forecast by Assay
Germany, Hospital Laboratories, Endocrine
Function Test Volume Forecast by Assay
Germany, Commercial/Private Laboratories,
Endocrine Function Test Volume Forecast by Assay
Germany, Physician Offices/Group Practices,
Endocrine Function Test Volume Forecast by Assay
Germany, All Market Segments, Tumor Markers
and Special Chemistry Test Volume Forecast by Assay
Germany, Hospital Laboratories, Tumor Markers
and Special Chemistry Test Volume Forecast by Assay
Germany, Commercial/Private Laboratories, Tumor
Markers and Special Chemistry Test Volume
Forecast by Assay
Germany, Physician Offices/Group
Practices, Tumor Markers and Special
Chemistry Test Volume Forecast by Assay
Germany, All Market Segments,
Immunoprotein Test Volume Forecast by Assay
Germany, Hospital Laboratories,
Immunoprotein Test Volume Forecast by Assay
Germany, Commercial/Private Laboratories,
Immunoprotein Test Volume Forecast by Assay
Germany, Physician Offices/Group Practices,
Immunoprotein Test Volume Forecast by Assay
Germany, All Market Segments, TDM
Test Volume Forecast by Assay
Germany, Hospital Laboratories, TDM
Test Volume Forecast
Germany, Commercial/Private Laboratories,
TDM Test Volume Forecast by Assay
Germany, Physician Offices/Group
Practices, TDM Test Volume Forecast by Assay
Germany, All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
Germany, Hospital Laboratories, Drugs
of Abuse Test Volume Forecast by Assay
Germany, Commercial/Private Laboratories,
Drugs of Abuse Test Volume Forecast by Assay
Germany, Physician Offices/Group Practices,
Drugs of Abuse Test Volume Forecast by Assay
Germany, Total Clinical Chemistry and Immunoassay
Reagent Market Forecast By Test Category
Germany, Clinical Chemistry and
Immunoassay Calibrator and Control Market
Forecast By Test Category
Germany, Routine Chemistry Reagent Market
Forecast By Market Segment
Germany, Endocrine Function Reagent Market
Forecast By Market Segment
Germany, Tumor Markers and Special Chemistry
Reagent Market Forecast By Market Segment
Germany, TDM Reagent Market Forecast By
Market Segment
Germany, Immunoprotein Reagent Market
Forecast By Market Segment
Germany, Drugs of Abuse Reagent Market
Forecast By Market Segment
Germany, All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
Germany, Hospital Laboratories, Routine
Chemistry Reagent Market Forecast by Assay
Germany, Commercial/Private Laboratories,
Routine Chemistry Reagent Market Forecast by Assay
Germany, Physician Offices/Group Practices,
Routine Chemistry Reagent Market Forecast by Assay
Germany, All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
Germany, Hospital Laboratories, Endocrine
Function Reagent Market Forecast by Assay
Germany, Commercial/Private Laboratories,
Endocrine Function Reagent Market Forecast by Assay
Germany, Physician Offices/Group Practices,
Endocrine Function Reagent Market Forecast by Assay
Germany, All Market Segments, Tumor Markers
and Special Chemistry Reagent Market Forecast by Assay
Germany, Hospital Laboratories, Tumor Markers
and Special Chemistry Reagent Market Forecast by Assay
Germany, Commercial/Private Laboratories,
Tumor Markers and Special Chemistry Reagent
Market Forecast by Assay
Germany, Physician Offices/Group Practices,
Tumor Markers and Special Chemistry Reagent
Market Forecast by Assay
Germany, All Market Segments, TDM
Reagent Market Forecast by Assay
Germany, Hospital Laboratories, TDM
Reagent Market Forecast by Assay
Germany, Commercial/Private Laboratories,
TDM Reagent Market Forecast by Assay
Germany, Physician Offices/Group
Practices, TDM Reagent Market Forecast by Assay
Germany, All Market Segments,
Immunoprotein Reagent Market Forecast by Assay
Germany, Hospital Laboratories,
Immunoprotein Reagent Market Forecast
Germany, Commercial/Private Laboratories,
Immunoprotein Reagent Market Forecast by Assay
Germany, Physician Offices/Group Practices,
Immunoprotein Reagent Market Forecast by Assay
Germany, All Market Segments, Drugs of
Abuse Reagent Market Forecast by Assay
Germany, Hospital Laboratories, Drugs of
Abuse Reagent Market Forecast by Assay
Germany, Commercial/Private Laboratories,
Drugs of Abuse Reagent Market Forecast by Assay
Germany, Physician Offices/Group Practices,
Drugs of Abuse Reagent Market Forecast by Assay
Germany, Major Suppliers of Clinical
Chemistry Reagents, Estimated Sales and
Market Shares
Germany, Major Suppliers of Clinical
Chemistry Analyzers, Estimated Instrument
Sales and Market Shares
Germany, Major Suppliers of Clinical
Chemistry Diagnostics Products, Estimated Sales
and Market Shares
Germany, Major Suppliers of
Immunoassay Reagents, Estimated Sales
and Market Shares
Germany, Major Suppliers of Immunoassay
Analyzers, Estimated Instrument Sales and
Market Shares
Germany, Major Suppliers of Immunoassay
Diagnostic Products, Estimated Sales and
Market Shares
Germany, Clinical Chemistry and Immunoassay
Instrument Market Forecast By Analyzer Type