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2017 POC/Point-of-Care Clinical Chemistry and Immunodiagnostic Testing: Physician Offices, Emergency Rooms, Operating Suites, ICUs/CCUs, Cancer Clinics, Ambulatory Care Centers, Surgery Centers, Nursing Homes, Birth Centers

March 2017 | 500 pages | ID: 273EE62B158EN
Venture Planning Group

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VPGMarketResearchs 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
  • AdnaGen
  • Agilent Technologies
  • Beckman Coulter/Danaher
  • Biomedical Diagnostics
  • Biomerieux
  • Bio-Rad
  • Diasorin
  • Eiken Chemical
  • Fujirebio
  • Grifols
  • Instrumentation Laboratory
  • Kyowa Medex
  • Matritech/Alere
  • Ortho-Clinical Diagnostics
  • Quest Diagnostics
  • Roche
  • Siemens
  • Sysmex
  • ThermoFisher
  • Tosoh
  • Wako
  • Wallac/PE
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 VPGMarketResearchs proprietary data files.

Contains 500 pages and 129 tables
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

1. INDUSTRY DIVERSIFICATION

j. Physician Demographics
k. Aging Population
? More Chronic Illness
? Disease Incidence
? Susceptibility t      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

1. 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
  AdnaGen
  Agilent Technologies
  Beckman Coulter/Danaher
  Biomedical Diagnostics
  BioMerieux
  Bio Rad
  DiaSorin
  Eiken
  Fujirebio
  Grifols
  INSTRUMENTATION Laboratory
  Kyowa Medex
  Matritech/Alere
  Ortho Clinical Diagnostics
  Quest Diagnostics
  Roche
  Siemens
  Sysmex
  ThermFisher
  Tosoh
  Wako
  Wallac/PE

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 b12/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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