Emerging US Point-of-Care Testing Market 2015: Cancer Clinics, Ambulatory Centers, Surgery Centers, Nursing Homes, Birth Centers

April 2015 | 1007 pages | ID: E50E4AB4FCAEN
Venture Planning Group

Abstracts

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 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 Venture Planning Group's proprietary data files.

Contains 1,007 pages and 180 tables

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. 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
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
Helena Laboratories
Hologic/Gen-Probe
Horiba
Instrumentation Laboratory
International Technidyne/Nexus DX
Kreatech
Kyowa Medex
Life Technologies
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

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@List of Tables
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