This 970-page report provides comprehensive analysis of the physician office/group practice diagnostics market, including its dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers.

This report will help diagnostic reagent and instrument suppliers develop more effective business, R&D and marketing strategies.

Rationale

The growing economic pressures on hospitals, coupled with advances in diagnostic technologies, intensifying competition among suppliers and physicians, and changing consumer demands are shifting diagnostic testing from hospitals and commercial laboratories closer to the patient.

Market Segmentation Analysis

– Review of the physician office/group practice diagnostics market, including its dynamics, trends, structure, size, growth and major suppliers.

– Five-year test volume and reagent sales forecasts for over 300 chemistry, immunodiagnostic, microbiology, hematology and coagulation procedures, including:

– Routine and Special Chemistry
– Microbiology/Infectious Diseases
– Hematology
– Flow Cytometry
– Coagulation
– Immunoproteins
– Drugs of Abuse
– TDM
– Endocrine Function
– Tumor Markers

Sales and Market Share Analysis

– Sales and market shares of major reagent and instrument suppliers.

Current and Emerging Products

– Analysis of over 130 diagnostic procedures.

– Review of leading chemistry, immunoassay, hematology and coagulation analyzers, both currently marketed and those in development, including their operating characteristics, features and selling prices.

Technology Review

– Emerging technologies and their applications for physician office/group practice diagnostic testing.

– Comprehensive listings of companies developing or marketing POC diagnostic technologies and products, by test.

Competitive Assessments

– Assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, joint ventures, and new products in R&D.

Strategic Recommendations

– Specific opportunities for new POC instruments and reagent systems with potentially significant market appeal during the next ten years.

– Design criteria for POC testing products.

– Alternative business expansion strategies.

– Potential market entry barriers and risks.

Methodology

This report is based on a combination of primary and secondary sources of information, including review of recent technical and business publications, manufacturer product literature, industry analyst reports, and VPGMarketResearch’s proprietary data files.

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
- ADI/American Diagnostica
- Agilent Technologies
- Alere/Biosite/Inverness
- Axis-Shield
- Beckman Coulter/Danaher
- Becton Dickinson
- Bio/Data
- Biomerieux
- Bio-Rad
- Cepheid
- Chrono-Log
- Corgenix
- Decode Genetics
- Diadexus
- Diagnocure
- Diagnostica Stago/Trinity Biotech
- Diamedix/Erba
- Diasorin
- Eiken Chemical
- EKF Diagnostics
- Fujirebio
- Grifols
- Helena Laboratories
- Hologic/Gen-Probe
- Horiba
- Instrumentation Laboratory
- International Technidyne/Nexus DX
- Kreatech/Leica
- Kyowa Medex
- Lonza
- Mackay Life Sciences
- Matritech
- Nihon Kohden
- Ortho-Clinical Diagnostics
- Polartechnics
- Polymedco
- Qiagen
- Roche
- SDIX
- Sequenom
- Siemens
- Sienco
- Sysmex
- Takara Bio
- ThermoFisher
- Tosoh
- Wako
- Zycare/Alere

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