I. Introduction

II. 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, Total
8. Blood Gases
9. Blood Urea Nitrogen (BUN)
10. Calcium
11. Cardio CRP
12. Cholesterol
13. Cholinesterase
14. CRP
15. Creatinine
16. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride
c. Potassium
d. Sodium
17. Ferritin
18. Fructosamine
19. Gamma-Glutamyl Transpeptidase (GGT)
20. Glucose
21. High Density Lipoprotein (HDL)
22. Homocysteine
23. Iron
24. Lactate Dehydrogenase (LDH)
25. Magnesium
26. Phosphorus
27. Protein
28. Triglycerides
29. Uric Acid
30. Troponin

B. Therapeutic Drug Monitoring (TDM)
1. Overview
2. Carbamazepine
3. Cyclosporin
4. Digoxin
5. Everolimus
6. Gentamicin
7. Lamotrigine/Lamictal
8. Levetiracetam
9. Lidocaine
10. Lithium
11. NAPA/Procainamide
12. Phenytoin
13. Quinidine
14. Sirolimus
15. Tacrolimus
16. Theophylline
17. Topirimate
18. Valproic Acid

C. Endocrine Function Tests
1. Cortisol
2. Estradiol
3. Follicle-Stimulating Hormone (FSH)
4. Gastrin
5. Growth Hormone/IGF-1
6. Human Chorionic Gonadotropin (HCG)
7. LH
8. Progesterone
9. PTH/IO PTH
10. Prolactin
11. T3
12. T3 Free
13. T3 Uptake
14. T4 (Thyroxine)
15. T4 Free
16. TBG
17. Testosterone
18. Thyroglobulin Ab
19. TPO Ab
20. TSH

D. Tumor Markers and Special Chemistry Tests
1. AFP
2. CA 15-3
3. CA 19-9
4. CA 27-29
5. Carcinoembrionic Antigen (CEA)
6. Folate/Folic Acid
7. HCG
8. 25-Hydroxy Vitamin D2 and D3
9. Occult Blood
10. Prostate-Specific Antigen (PSA)
11. Thyroglobulin
12. Vitamin B-12

E. Immunoprotein Tests
1. Complement
a. C3
b. C4
2. Free Light Chains
3. Immunofixation
4. Immunoglobulins (IgA, IgE, IgG, IgM)
5. Haptoglobin
6. Prealbumin
7. 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
13. Tricyclic Antidepressants
G. Instrumentation Review: Operating characteristics
and features of high-, medium-, and low-volume/POC analyzers
H. Major In Vitro Diagnostic Technologies
and Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Chemiluminescence
c. Enzyme Immunoassays (EIA)
- Overview
- ELISA
- EMIT
- Electrochemical
d. Radioimmunoassays (RIA)
e. Immunoprecipitation
f. Affinity Chromatography
3. Tandem Mass Spec
4. IT and Automation
5. Dry Chemistry
6. Biosensors

VI. Market Size, Growth and Sales Forecasts by Test

VII. Major Product Development Opportunities

VIII. Design Criteria for Decentralized Testing Products

IX. 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

X. 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

XI. Competitive Assessments
- Abbott Laboratories
- AdnaGen
- Agilent Technologies
- Beckman Coulter/Danaher
- Biomedical Diagnostics
- BioMerieux
- Bio-Rad
- DiaSorin
- Eiken
- Fujirebio/Innogenetics
- Instrumentation Laboratory
- Kyowa Medex
- Matritech/Alere
- Ortho-Clinical Diagnostics
- Quest Diagnostics
- Roche
- Siemens
- Sysmex
- Thermo Fisher
- Tosoh
- Wako
- Wallac/PE

List of Tables
Executive Summary Table: Clinical Chemistry
and Immunoassay Test Volume and Diagnostics
Sales Forecast by Test Category
Total Chemistry and Immunoassay
Specimen Volume Forecast
All Market Segments, Specimen
Volume Forecast by Test Category
Total Clinical Chemistry and Immunoassay
Test Volume Forecast by Test Category
All Market Segments, Profiles, Panels and Individual Tests Forecast
All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
All Market Segments, Endocrine
Function Test Volume Forecast by Assay
All Market Segments, Tumor Markers and
Special Chemistry Test Volume Forecast by Assay
All Market Segments, Immunoprotein
Test Volume Forecast by Assay
All Market Segments, TDM
Test Volume Forecast by Assay
All Market Segments, Drugs of Abuse
Test Volume Forecast by Assay
Total Clinical Chemistry and Immunoassay
Reagent Market Forecast by Test Category
Clinical Chemistry and Immunoassay
Calibrator and Control Market
Forecast by Test Category
All Market Segments, Routine Chemistry
Reagent Market Forecast by Assay
All Market Segments, Endocrine Function
Reagent Market Forecast by Assay
All Market Segments, Tumor Markers and
Special Chemistry Reagent Market Forecast by Assay
All Market Segments, Immunoprotein
Reagent Market Forecast by Assay
All Market Segments, TDM
Reagent Market Forecast by Assay
All Market Segments, Drugs of Abuse
Reagent Market Forecast by Assay
Clinical Chemistry and Immunoassay
Instrument Market Forecast by Analyzer Type
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 Immunological Testing by Assay