米国のインビトロ診断（IVD）製品市場

Abstract

Clinical chemistry, immunoassays to remain dominant product groups

The US market for in vitro diagnostic (IVD) products will grow 5.1 percent annually to $20 billion in 2011. Based on extensive use in pre-hospital admission screening, basic physical examinations and diabetes self-monitoring, clinical chemistry will remain the top-selling product group through 2011 and beyond. However, clinical chemistry diagnostics will generate below-average growth in demand. While sales of blood glucose test strips will increase at a strong pace as the number of diabetic patients expands, the market for clinical chemistry reagents and instruments employed in basic patient screening will grow slowly due to consolidation in the clinical laboratory market and decreasing consumable requirements per test.

Established uses in metabolic and infectious disease detection and therapeutic drug monitoring, coupled with increasing applications in cancer, cardiovascular disease and congenital marker testing, will keep immunoassays the second-largest selling IVD product group. However, overall growth opportunities for immunoassay diagnostics will decelerate over the next decade due to increasing competition from nucleic acid and cellular analysis testing products. Competitive and market trends will also weaken growth prospects for IVD products used in blood testing applications. Advances in immunoassays, PCR and microarray technologies will moderate gains in demand for hematology reagents and instruments. Trends toward less invasive surgery will soften growth prospects for blood banking diagnostics. Improvements in the safety of anticoagulant and thrombolytic therapies will slow gains in sales of hemostasis testing products.

Table of Contents

INTRODUCTION

I. EXECUTIVE SUMMARY

II. MARKET ENVIRONMENT

• General
• Macroeconomic Environment
• Population & Demographic Trends
• Health Care Trends
  • Acute Conditions
  • Chronic Conditions
  • Cancer & AIDS
  • Health Insurance Trends
  • National Health Expenditures
  • Medical Providers
    • Hospitals
    • Physicians
    • Outpatient Facilities
    • Home Health Care Agencies
    • Clinical Laboratories
    • Blood & Organ Banks
  • Patient Activity
    • Hospital Activity
    • Surgical Procedures
    • Outpatient Visits
• IVD Product Overview
  • Regulations
  • Technology
  • Diagnostic Testing Volume
  • Clinical Laboratory Testing Services
  • Pricing Trends
  • Product Demand Patterns 1996-2006
  • US Trade
  • International Markets

III. PRODUCTS

• General
• Product Segments
  • Reagents & Consumables
  • Instruments & Systems
• Clinical Chemistry Products
  • Professional Products
    • Reagents & Test Kits
    • Standards & Controls
    • Instruments & Systems
    • Applications
    • Producers
  • Self-Testing Products
    • Blood Glucose Monitoring Products
    • Test Strips & Discs
    • Monitors
    • Other Self-Testing Products
• Immunoassay Products
  • Technology Overview
    • Competitive Immunoassays
    • Noncompetitive Immunoassays
    • Heterogeneous & Homogeneous Immunoassays
    • Labeling Techniques
    • ELISA
    • FPIA
    • MEIA
    • CMIA
    • Manual Immunoassays
  • Reagents & Test Kits
    • Enzyme Immunoassays
    • Chemiluminescent Immunoassays
    • Fluorescent Immunoassays
    • Radioimmunoassays
  • Instruments & Systems
  • Applications
    • Drug Testing
    • Therapeutic Drugs
    • Illicit Drugs
    • Infectious Disease Testing
    • Endocrine Conditions
    • Cancer
    • Heart Disease
    • Other Applications
  • Producers
• Blood Testing Products
  • Hematology Products
    • Reagents & Consumables
    • Instruments & Systems
    • Applications
    • Producers
  • Blood Banking Products
    • Reagents & Consumables
    • Instruments & Systems
    • Applications
    • Producers
  • Hemostasis Products
    • Reagents & Consumables
    • Instruments & Systems
    • Applications
    • Producers
• Nucleic Acid Testing Products
  • Technology Overview
    • Polymerase Chain Reaction
    • Microarrays
    • DNA Sequencing
    • In Situ Hybridization (ISH)
    • Restriction Fragment Length Polymorphisms (RFLPs)
  • Amplified DNA Probes
  • Direct DNA Probes
  • Microarray Products
    • Types of Microarrays
    • IVD Applications
    • Disease Management
    • Forensic Medicine
    • Illicit Drug Testing
  • Instruments & Systems
  • Consumables
  • Applications
  • Producers
• Microbiology Products
  • Culture Media
  • Reagents & Consumables
  • Instruments & Systems
  • Applications
  • Producers
• Cellular Analysis Products
  • Flow Cytometry Products
    • Reagents & Consumables
    • Instruments & Systems
    • Applications
    • Producers
  • Other Cellular Analysis Products
    • Reagents & Consumables
    • Instruments & Systems
    • Applications
    • Producers
• Other IVD Products
  • Anatomical Pathology Products
    • Histology Products
    • Immunohistochemistry Products
  • Effusion & Visual Inspection Products
    • Visual Inspection Tests
    • Effusion Testing
    • Applications
    • Producers
  • Cytology Products
    • Reagents & Instruments
    • Applications

IV. APPLICATIONS

• General
• Endocrine Conditions
  • Blood Glucose Monitoring Products
    • Blood Glucose Test Strips
    • Blood Glucose Monitors
    • Other Diabetes Testing
  • Pregnancy & Ovulation Testing
  • Other Endocrine Conditions
• Infectious Diseases
  • Sexually Transmitted Diseases
    • IVD Demand by Methodology
    • IVD Demand by Condition
  • Other Infectious Diseases
    • IVD Demand by Methodology
    • IVD Demand by Condition
• Cancer
  • IVD Demand by Methodology
  • IVD Demand by Condition
    • Cervical Cancer
    • Breast Cancer
    • Prostate Cancer
    • Colorectal Cancer
    • Other Cancers
• Drug Testing
  • Therapeutic Drug Monitoring (TDM)
  • Illicit Drug Testing
• Heart Disease Testing
  • Lipid Profiling
  • Cardiac Markers
  • Blood Proteins
• Blood Grouping & Screening
  • Blood Typing & Matching
  • Blood & Bleeding Disorders
• Forensic Medicine & Related Testing
  • Forensic Testing
  • Genetic Testing
  • Identity Testing
• General Health Screening & Other IVD Applications
  • General Health Screening
  • Disease Detection & Other

V. MARKETS

• General
• Hospitals
• Independent Clinical Laboratories
• Outpatient Facilities
• Home Health Care
• Other Markets

VI. INDUSTRY STRUCTURE

• General
• Market Share
  • Johnson & Johnson
  • Roche Holding
  • Abbott Laboratories
  • Siemens Medical Solutions
  • Beckman Coulter
  • Dade Behring Holdings
  • Becton Dickinson
• Competitive Strategies
• Mergers & Acquisitions
• Licensing Agreements
• Research & Development Activities
• Marketing & Distribution
• Manufacturing

• COMPANY PROFILES
  • Abbott Laboratories
  • Agilent Technologies Incorporated
  • Applera Corporation
  • Applied Biosystems, see Applera Corporation
  • ARKRAY Incorporated
  • Bayer AG
  • Beckman Coulter Incorporated
  • Becton, Dickinson and Company
  • Binax Incorporated, see Inverness Medical Innovations
  • Bio-Rad Laboratories Incorporated
  • bioMerieux SA
  • Biosite Incorporated
  • Celera Diagnostics, see Applera Corporation
  • Cytyc Corporation
  • Dade Behring Holdings Incorporated
  • Diagnostic Products Corporation, see Siemens AG
  • Diagnostic Systems Laboratories, see Beckman Coulter
  • Digene Corporation
  • First Check Diagnostics, see Inverness Medical Innovations
  • GE Healthcare, see General Electric Company
  • GeneOhm Sciences, see Becton, Dickinson and Company
  • Gen-Probe Incorporated
  • General Electric Company
  • Hypoguard USA, see ARKRAY Incorporated
  • Inverness Medical Innovations Incorporated
  • Invitrogen Corporation
  • Ischemia Technologies, see Inverness Medical Innovations
  • Johnson & Johnson
  • LifeScan Incorporated, see Johnson & Johnson
  • Lumigen Incorporated, see Beckman Coulter Incorporated
  • MDY Healthcare plc
  • Medisys plc, see MDY Healthcare plc
  • Metrika Incorporated, see Bayer AG
  • Myriad Genetics Incorporated
  • Nova Biomedical Corporation
  • Olympus Corporation
  • Oncogene Science Biomarker Group, see Siemens AG
  • Ortho-Clinical Diagnostics, see Johnson & Johnson
  • PerkinElmer Incorporated
  • Primus Corporation, see Trinity Biotech plc
  • QIAGEN NV
  • Roche Holding Limited
  • Siemens AG
  • Thermo BioStar, see Inverness Medical Innovations
  • Trinity Biotech plc
  • TriPath Imaging Incorporated, see Becton, Dickinson and Company
  • Veridex LLC, see Johnson & Johnson
  • Vysis Incorporated, see Abbott Laboratories

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY

• Summary Table

SECTION II -- MARKET ENVIRONMENT

• 1 Macroeconomic Indicators
• 2 Population & Demographics
• 3 Acute Conditions by Type
• 4 Chronic Conditions by Type
• 5 Cancer & Aids Indicators
• 6 National Health Expenditures by Type
• 7 Selected Medical Providers
• 8 Selected Patient Activity
• 9 Diagnostic Testing Volume
• 10 Clinical Laboratory Testing Sites & Revenues
• 11 IVD Product Demand, 1996-2006
• 12 US Trade in IVD Products
• 13 World IVD Product Demand

SECTION III -- PRODUCTS

• 1 IVD Product Demand by Product Group
• 2 IVD Product Demand by Methodology
• 3 IVD Reagent & Consumable Demand by Methodology
• 4 IVD Instrument & System Demand by Methodology
• 5 Clinical Chemistry Product Demand by Segment
• 6 Professional Clinical Chemistry Product Demand by Type
• 7 Common Clinical Chemistry Tests
• 8 Professional Clinical Chemistry Product Demand by Application
• 9 Self-Testing Clinical Chemistry Product Demand by Type
• 10 Self-Testing Clinical Chemistry Product Demand by Application
• 11 Immunoassay Product Demand by Type
• 12 Immunoassay Product Demand by Application
• 13 Blood Testing Product Demand by Methodology
• 14 Hematology Product Demand by Type
• 15 Hematology Product Demand by Application
• 16 Blood Banking Product Demand by Type
• 17 Blood Banking Product Demand by Application
• 18 Hemostasis Product Demand by Type
• 19 Hemostasis Product Demand by Application
• 20 Nucleic Acid Testing Product Demand by Type
• 21 Nucleic Acid Testing Product Demand by Application
• 22 Microbiology Product Demand by Type
• 23 Microbiology Product Demand by Application
• 24 Cellular Analysis Product Demand by Methodology
• 25 Flow Cytometry Product Demand by Type
• 26 Flow Cytometry Product Demand by Application
• 27 Other Cellular Analysis Product Demand by Type
• 28 Other Cellular Analysis Product Demand by Application
• 29 Other IVD Product Demand by Methodology
• 30 Anatomical Pathology Product Demand by Type
• 31 Pathology Product Demand by Application
• 32 Effusion & Visual Testing Product Demand by Type
• 33 Effusion & Visual Testing Product Demand by Application
• 34 Cytology Product Demand by Type
• 35 Cytology Product Demand by Application

SECTION IV -- APPLICATIONS

• 1 IVD Product Demand by Application
• 2 Endocrine Testing - IVD Demand by Methodology & Condition
• 3 Infectious Disease Testing - IVD Demand by Condition
• 4 Sexually Transmitted Disease (STD) Testing - IVD Demand by Methodology
• 5 Sexually Transmitted Disease (STD) Testing - IVD Demand by Condition
• 6 Other Infectious Disease Testing - IVD Demand by Methodology
• 7 Cancer Testing - IVD Demand by Methodology
• 8 Cancer Testing - IVD Demand by Condition
• 9 Drug Testing - IVD Demand by Methodology & Type
• 10 Heart Disease Testing - IVD Demand by Methodology
• 11 Blood Grouping & Screening - IVD Demand by Methodology
• 12 Forensic Medicine & Related Testing - IVD Demand by Methodology
• 13 General Health Screening (GHS) & Other Applications - IVD Demand by Methodology & Procedure

SECTION V -- MARKETS

• 1 IVD Product Demand by Market
• 2 Hospital IVD Product Demand
• 3 Independent Clinical Laboratory IVD Product Demand
• 4 Outpatient IVD Product Demand
• 5 Home IVD Product Demand
• 6 IVD Product Demand in Other Markets

SECTION VI -- INDUSTRY STRUCTURE

• 1 IVD Product Sales by Company, 2006
• 2 Selected Acquisitions & Divestitures
• 3 Selected Cooperative Agreements

LIST OF CHARTS

SECTION III -- PRODUCTS

• 1 IVD Product Demand by Methodology, 2006

SECTION IV -- APPLICATIONS

• 1 IVD Product Demand by Application, 2006

SECTION V -- MARKETS

• 1 IVD Product Demand by Market, 2006

SECTION VI -- INDUSTRY STRUCTURE

• 1 IVD Products US Market Share by Company, 2006