Point-of-Care (POC) Testing, 2019-2023: Market Share Analysis, Country Segment Forecasts, Competitive Intelligence, Technology Trends, Opportunities for Suppliers

This 1,007-page report provides comprehensive analysis of the emerging POC market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers.  This report will help diagnostic instrument and reagent 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 emerging 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:

- Cancer Clinics
- Ambulatory Care Centers
- Surgery Centers
- Nursing Homes
- Birth Centers

  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 Products

- Analysis of over 130 diagnostic procedures.

- Review of the leading POC 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 POC 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 five 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 the proprietary data files.

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. Cancer Clinics
1. Introduction
2. Market Summary
3. Test Volume and Sales Forecasts
C. Ambulatory Care Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts
D. Surgery Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts

E. Nursing Homes
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts
F. Birth Centers
1. Introduction
2. Market Summary
3. Market Structure
4. Test Volume and Sales Forecasts
G. 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/America 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/Alere
- 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
Cancer Clinics Total Diagnostics
Sales Forecast by Market Segment
Cancer Clinics Reagent
Sales Forecast by Market Segment
Cancer Clinics Instrument
Sales Forecast by Market Segment
Cancer Clinics Major Tumor Markers Test
Volume Forecast
Cancer Clinics Routine And Special Chemistry
Test Volume Forecast
Cancer Clinics Routine Hematology/Flow Cytometry
Test Volume Forecast
Cancer Clinics Endocrine Function Test Volume Forecast
Cancer Clinics Coagulation Test Volume Forecast

Cancer Clinics Major Tumor
Marker Sales Forecast by Test
Cancer Clinics Routine and Special Chemistry
Reagent Market Forecast by Test
Cancer Clinics Hematology And Flow Cytometry
Reagent Market Forecast
Cancer Clinics Endocrine
Function Reagent Market Forecast
Cancer Clinics Coagulation
Reagent Market Forecast
Ambulatory Care Centers Total
Diagnostics Sales Forecast by Market Segment
Ambulatory Care Centers Reagent
Sales Forecast by Market Segment
Ambulatory Care Centers
Instrument Sales Forecast by Market Segment
Ambulatory Care Centers Estimated
Number of Facilities and Patient Visits
Ambulatory Care Centers Most Frequent Diagnoses
Ambulatory Care Centers Routine
and Special Chemistry Test Volume Forecast
Ambulatory Care Centers Routine
Hematology Test Volume Forecast
Ambulatory Care Centers Microbiology
and Serology Test Volume Forecast

Ambulatory Care Centers
Drugs of Abuse Test Volume Forecast
Ambulatory Care Centers
Coagulation Test Volume Forecast
Ambulatory Care Centers Routine
and Special Chemistry Reagent Market
Forecast by Test
Ambulatory Care Centers Drugs
of Abuse Reagent Market Forecast by Test
Ambulatory Care Centers
Hematology Reagent Market Forecast
Ambulatory Care Centers Microbiology
and Serology Reagent Market Forecast by Test
Ambulatory Care Centers
Coagulation Reagent Market Forecast
Surgery Centers Total Diagnostics
Sales Forecast by Market Segment
Surgery Centers Reagent
Sales Forecast by Market Segment
Surgery Centers Instrument
Sales Forecast by Market Segment
Surgery Centers Most Frequently Performed Procedures
Surgery Centers Routine
And Special Chemistry Test Volume Forecast
Surgery Centers Routine Hematology Test Volume Forecast

Surgery Centers Coagulation Test Volume Forecast
Surgery Centers Microbiology
and Serology Test Volume Forecast
Surgery Centers Routine and Special Chemistry
Reagent Market Forecast by Test
Surgery Centers Hematology
Consumable Market Forecast
Surgery Centers Coagulation Reagent Market Forecast
Nursing Homes Total Diagnostics
Sales Forecast by Market Segment
Nursing Homes Reagent Sales Forecast
by Market Segment
Nursing Homes Instrument Sales Forecast
by Market Segment
Nursing Homes Estimated Number of Facilities,
Beds and Occupancy Rate
Nursing Homes Routine and Special Chemistry
Test Volume Forecast
Nursing Homes Coagulation Test Volume Forecast
Nursing Homes Routine Hematology Test Volume Forecast

Nursing Homes Routine And Special Chemistry
Reagent Market Forecast by Test
Nursing Homes Coagulation Reagent Market Forecast
Nursing Homes Hematology Reagent Market Forecast
Birth Centers Total Diagnostics Sales Forecast
by Market Segment
Birth Centers Reagent Sales Forecast
by Market Segment
Birth Centers Instrument Sales Forecast
by Market Segment
Birth Centers Facilities, Patient Visits, and Births
Birth Centers Routine And Special Chemistry Test
Volume Forecast
Birth Centers Profiles, Panels and Individual Tests
Birth Centers Microbiology
and Serology Test Volume Forecast
Birth Centers Coagulation Test Volume Forecast
Birth Centers Routine Hematology Test Volume Forecast
Birth Centers Routine and Special Chemistry
Reagent Market Forecast by Test

Birth Centers Microbiology
and Serology Testing Market Forecast
Birth Centers Hematology Reagent Market Forecast
Birth Centers Coagulation Reagent Market Forecast
Major Suppliers of Clinical Chemistry
Diagnostics 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 Suppliers
CA 15-3/27-29 Testing Market by Major Suppliers
CA 19-9 Testing Market by Major Suppliers
CEA Testing Market by Major Suppliers
PAP Testing Market by Major Suppliers
PSA Testing Market by Major Suppliers

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 Instruments Market
Estimated Market Shares of Major Suppliers
Major Suppliers of Coagulation Diagnostic Products,
Estimated Market Shares of Major Suppliers

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