New Frontiers in the Hospital ER, OR and ICU Diagnostic Testing Market 2017-2021: Supplier Shares, Business Challenges, Emerging Technologies, Competitive Landscape

New report provides comprehensive analysis of POC market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers.

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

- Review of POC market segments, including their dynamics, trends, structure, size, growth and major suppliers.

- Five-year test volume and reagent sales forecasts for chemistry, immunodiagnostic, microbiology, hematology and coagulation procedures by market segment:

- Emergency Rooms
- Operating/Recovery Suites
- ICUs/CCUs

and by test category:

- 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 Tests and Instrumentation

- Analysis of over 130 diagnostic procedures.

- Review of leading chemistry, immunoassay, hematology and coagulation analyzers market by Abaxis, Abbott, Alfa Wasserman, Awareness Technologies, Beckman Coulter/Danaher, Becton Dickinson, Behnk Elektronik, Biocode, Bio/Data, bioMerieux, Cardiovascular Diagnostics, Carolina Chemistries, Diagnostica Stago, Diesse Ves Matic, Drew-Scientific, Helena Laboratories, Horiba, Instrumentation Laboratory, Inverness, ITC Hemochron, Medica, Menarini, Nihon Kohden, Nova Biomedical, Ortho-Clinical Diagnostics, Polymedco, Randox, Roche, Siemens, Sysmex, Teco Medical Instruments, Trinity Biotech, and other suppliers.

Technology Review

- Emerging technologies and their applications for POC testing.

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

Strategic Recommendations

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

- Design criteria for POC testing products.

- Alternative business expansion strategies.

- Potential market entry barriers and risks.

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.

- The companies analyzed in the report include:

   - Abbott
   - Accriva
   - 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
   - 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
   - Thermo Fisher
   - Tosoh
   - Wako
   - Zycare/Alere

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 proprietary data files.

Contains 973 pages and 153 tables

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
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. Ferratin
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
Table of Contents (continued)
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
Table of Contents (continued)
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
Table of Contents (continued)
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
Table of Contents (continued)
- 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
Table of Contents (continued)
Worldwide Business Environment
U.S.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 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

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

List Of Tables

List of Table
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 Altithrombin 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
Ancillary Hospital Locations Estimated Number
Ancillary Hospital Locations Annual Utilization Hospital Emergency Departments Total Diagnostics Sales Forecast by Market Segment
Hospital Emergency Departments Reagent Sales Forecast by Market Segment
Hospital Emergency Departments Instrument Sales Forecast by Market Segment
Hospital Emergency Departments Routine and Special Chemistry Test Volume Forecast
Hospital Emergency Departments Profiles Panels and Individual Tests

Hospital Emergency Departments Drugs of Abuse Test Volume Forecast
Hospital Emergency Departments Routine Hematology Test Volume Forecast
Hospital Emergency Departments Coagulation Test Volume Forecast
Hospital Emergency Departments Selected Infectious Disease Test Volume Forecast
Hospital Emergency Departments Routine and Special Chemistry Reagent Market Forecast by Test
Hospital Emergency Departments Drugs of Abuse Reagent Market Forecast by Test
Hospital Emergency Departments Hematology Reagent Market Forecast
Hospital Emergency Departments Coagulation Reagent Market Forecast
Hospital Emergency Departments Selected Infectious Disease Reagent Market Forecast by Test
Hospital Operating and Recovery Suites Total Diagnostics Sales Forecast by Market Segment
Hospital Operating and Recovery Suites Reagent Sales Forecast by Market Segment
Hospital Operating and Recovery Suites Instrument Sales Forecast By Market Segment

Hospital Operating and Recovery Suites Routine and Special Chemistry Reagent Test Volume Forecast
Hospital Operating and Recovery Suites Routine Hematology Test Volume Forecast
Hospital Operating and Recovery Suites Coagulation Test Volume Forecast
Hospital Operating and Recovery Suites Routine and Special Chemistry Reagent Market Forecast by Test
Hospital Operating and Recovery Suites Hematology Reagent Market Forecast
Hospital Operating and Recovery Suites Coagulation Reagent Market Forecast
Hospital ICUs/CCUs Total Diagnostics Sales Forecast by Market Segment
Hospital ICUs/CCUs Reagent Sales Forecast by Market Segment
ICUs/CCUs Instrument Sales Forecast by Market Segment
Hospital ICUs/CCUs Routine and Special Chemistry Test Volume Forecast
Hospital ICUs/CCUs Routine Hematology Test Volume Forecast
Hospital ICUs/CCUs Coagulation Test Volume Forecast

Hospital ICUs/CCUs Routine and Special Chemistry Reagent Market Forecast by Test

Hospital ICUs/CCUs Hematology Reagent Market Forecast
Hospital ICUs/CCUs Coagulation Reagent Market Forecast
Major Suppliers of Clinical Chemistry Diagnostic Products, Estimated Sales and Market Shares
Major Suppliers of Clinical Chemistry Reagents, Estimated Sales and Market Shares
Major Suppliers of Clinical Chemistry Analyzers, Estimated Sales and Market Shares
Major Suppliers of Immunodiagnostic Products, Estimated Sales and Market Shares
Major Suppliers of Immunoassay Reagents, Estimated Sales and Market Shares
Major Suppliers of Immunoassay Analyzers, Estimated Sales and Market Shares
AIDS Testing Market Estimated Market Shares of Major Suppliers
Chlamydia Testing Market Estimated Market Shares of Major Suppliers
CMV Testing Market Estimated Market Shares of Major Suppliers
Gonorrhea Testing Market Estimated Market Shares of Major Suppliers
Helicobacter Pylori Testing Market Estimated Market Shares of Major Suppliers

Hepatitis Testing Market Estimated Market Shares of Major Suppliers
Herpes Testing Market Estimated Market Shares of Major Suppliers
Influenza Testing Market Estimated Market Shares of Major Suppliers
Lyme Disease Testing Market Estimated Market Shares of Major Suppliers
Mononucleosis Testing Market Estimated Market Shares of Major Suppliers
Rubella Testing Market Estimated Market Shares of Major Suppliers
Streptococci Testing Market Estimated Market Shares of Major Suppliers
Syphilis Testing Market Estimated Market Shares of Major Suppliers
AFP Testing Market by Major Supplier
CA 15-3/27-29 Testing Market by Major Supplier
CA 19-9 Testing Market by Major Supplier
CEA Testing Market by Major Supplier
PAP Testing Market by Major Supplier
PSA Testing Market by Major Supplier

Hematology Analyzers Estimated Placements and Installed Base
Flow Cytometers Estimated Placements and Installed Base
Hematology Diagnostics Market Estimated Market Shares of Major Suppliers
Hematology Instrument Market Estimated Market Shares of Major Suppliers
Hematology Consumable Market Estimated Market Shares of Major Suppliers
Flow Cytometry Diagnostics Market Estimated Market Shares of Major Suppliers
Flow Cytometry Consumable Market Estimated Market Shares of Major Suppliers
Flow Cytometry Instrument Market Estimated Market Shares of Major Suppliers
Major Suppliers of Coagulation Diagnostic Products, Estimated Market Shares of Major Suppliers

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