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

July 2016 | 973 pages | ID: N97A889F327EN
Venture Planning Group

Abstracts

VPGMarketResearch’s 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
• ADI/American Diagnostica/Sekisui
• Agilent Technologies
• Alere/Biosite/Inverness
• Axis-Shield
• Beckman Coulter/Danaher
• Becton Dickinson
• Bio/Data
• Biomerieux
• Bio-Rad
• Cepheid
• Chrono-Log
• Corgenix/Orgentec
• 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
• 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 VPGMarketResearch's proprietary data files.

Contains 973 pages and 153 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

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. EPSTEInBARR 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
  TeC     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. 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

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/GenProbe
  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 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 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