2020 POC Clinical Chemistry and Immunodiagnostic Markets: Physician Offices, Emergency Rooms, Operating Suites, ICUs/CCUs, Cancer Clinics, Ambulatory Care Centers, Surgery Centers, Nursing Homes, Birth Centers

s new report provides a comprehensive analysis of the POC clinical chemistry markets, 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 the POC clinical chemistry and immunodiagnostic market segments, including their dynamics, trends, structure, size, growth and major suppliers.

- Five-year test volume and reagent sales forecasts clinical chemistry procedures by market segment:

- Physician Offices/Group Practices
- Emergency Rooms
- Operating/Recovery Suites
- ICUs/CCUs
- Cancer Clinics
- Ambulatory Care Centers
- Surgery Centers
- Nursing Homes
- Birth Centers

Sales and Market Share Analysis

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

Routine Clinical Chemistry Tests

Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Blood Gases, BUN (Blood Urea Nitrogen), Calcium, Cholesterol, Cholinesterase, Creatinine, CK-MB, Electrolytes (Carbon Dioxide/Bicarbonate, Chloride, Potassium, Sodium), Ferritin, Follate/Folic Acid, Fructosamine,   GGT, Glucose, HDL, Iron, LDH, Magnesium, Phosphorus, Potassium, Protein, Sodium, Triglycerides, Troponin, Uric Acid, Urinalysis, Vitamin B12.

Endocrine Function Tests

Cortisol, Estradiol, FSH, HCG, Gastrin, LH, Progesterone, PTH/IO PTH, Prolactin, T3, T3 Uptake, Free T3, T4, Free T4, TBG, Testosterone, TSH.

Therapeutic Drug Monitoring (TDM) Tests

Amikacin, Carbamazepine, Digoxin, Gentamicin, Lidocaine, Lithium, Methotrexate, Phenobarbital, Phenytoin/Dilatin, NAPA/Procainamide, Quinidine, Theophylline, Tobramycin, Valproic Acid, Vancomycin.

Immunoprotein Tests

C3, C4, CRP, IgA, IgE Specific, IgE Total, IgG, Immunoglobulins, Protein Electrophoresis, and others.

Drugs of Abuse

Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids/Marijuana, Cocaine, LSD, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene, and others.

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 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

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 s proprietary data files.

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

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