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IVD To Grow Nearly 7% Annually

US demand for in vitro diagnostic (IVD) reagents and instrumentation is expected to reach $12.2 billion in 2005. Spurred by novel technologies, an aging population and market penetration of personal monitoring devices, the industry is poised for annual gains approaching seven percent going forward. P>Cost-containment pressures in the healthcare industry will continue to be a source of concern; however, a plethora of new tests result-ing from the widespread availability of genomic information and the ongoing trend toward home-based products will more than offset managed care constraints. The insurance industry -- recognizing that accurate diagnosis can often minimize hospitalizations and more expensive treatment alterna-tives -- will continue to be a valuable ally of IVD manu-facturers.

Home Testing Kits Becoming Simpler, Faster

Laboratory-based clinical chemistry and immunoassays will remain the major revenue sources in IVD; however, many of these tests -- blood glucose monitoring and cholesterol monitoring, among others -- will continue to move out of the laboratory and into the home as new devices and simpler, more rapid test kits reach the marketplace.

Blood glucose monitoring among diabetics, for ex-ample, has been limited by cumbersome devices requir-ing frequent finger sticks in order to measure glucose in blood. The advent of portable, continuous, noninvasive monitors -- as demonstrated by FDA approval of the first such device in March 2001 -- is expected to lead to stellar growth in this segment.

Nucleic acid diagnostics will continue to experience the fastest growth in the IVD market. The development -- and more important, regula-tory approval -- of commer-cial DNA microarrays capable of analyzing thou-sands of genes and/or thousands of patients for genetic changes simulta-neously is expected to revolutionize diagnostics for diseases with strong genetic components, including cancer, heart disease and infectious diseases.

Human Genome Project To Open New Opportunities

The completion of the sequencing of the human genome in 2000 is antici-pated to lead to the identifica-tion of hundreds of additional mutations directly or indi-rectly culpable in disease.

Pharmacogenomic profiling -- the assessment of which therapeutic drugs are best suited patients based on their genetic makeup -- will also come to the fore in the next few years, as millions of single-nucleotide polymor-phisms are now available.

Industry Composition

The US IVD market remains highly concentrated, with the vast majority of products supplied by seven large, diversified firms -- Abbott Labs, Bayer, Beckman Coulter, Becton Dickinson, Dade Behring, Johnson & Johnson and Roche -- each of which is active in multiple technologies. Over the last few years, the trend toward consolidation has slowed somewhat, as the market leaders have sought to shore up existing markets and technology platforms.

Study Coverage

Details on these and other key findings are available in In Vitro Diagnostics, a new Freedonia study. Historical data plus forecasts to 2005 and 2010 are given in current dollars for in vitro diagnostic reagents and instrumentation demand by type, condition and point-of- care. In addition to disease diagnostics, the markets for drug testing and pregnancy and ovulation testing are covered as well. This study also evaluates market share and profiles key competitors.

Table of Contents

EXECUTIVE SUMMARY

MARKET ENVIRONMENT

• Demographic Trends
• Economic Factors
• Health Environment
  • Acute & Chronic Medical Conditions
  • Congenital Conditions
  • National Health Expenditures
  • Medical Resources & Patient Activity
• Diagnostics Market Overview
• In Vitro Diagnostic Market Trends
• International Markets
• Foreign Trade

IN VITRO DIAGNOSTIC TECHNOLOGIES

• Light-Based Methods
  • Blood Glucose Measurement
  • Lipid Profiles
  • Other
• Antigen-Antibody Reactions
• DNA- & RNA-Based Methods
  • Polymerase Chain Reaction
  • Chip Technologies
  • Other DNA & RNA Methods
• Other In Vitro Diagnostic Technologies

IN VITRO DIAGNOSTICS DEMAND BY TYPE

• Personal Monitoring & Clinical Chemistry
  • Personal Monitoring
  • Blood Glucose
  • Other
  • Clinical Chemistry
• Preliminary
  • Immunochemistry
  • Immunoassays
  • Other
• Cellular Analysis
  • Hematology
  • Flow Cytometry
• Microbiological Diagnostics
• Nucleic Acid Diagnostics
• Other

IN VITRO DIAGNOSTICS DEMAND BY CONDITION

• Diabetes
  • Epidemiology & Expenditures
  • Diagnostics Demand
• Infectious Diseases
  • Epidemiology & Expenditures
  • Sexually Transmitted Diseases
  • Hepatitis
  • Other
  • Diagnostics Demand
  • Sexually Transmitted Diseases
  • Hepatitis
  • Other
• Cancer
  • Epidemiology & Expenditures
  • Prostate Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Other
  • Diagnostics Demand
  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Other
• In Vitro Drug Testing
  • Drug Testing Trends
  • In Vitro Drug Testing Demand
• Cardiovascular Disease
  • Epidemiology & Expenditures
  • Diagnostics Demand
  • Risk Factors
  • Infarction Indicators
• Pregnancy & Ovulation
  • Reproductive Trends
  • Testing Demand
• Genetic Diseases
  • Epidemiology & Expenditures
  • Diagnostics Demand
• Other
  • Generic IVD Testing
  • Paternity Testing
  • Other Identity Testing

IN VITRO DIAGNOSTICS DEMAND BY POINT-OF-TESTING MARKET

• Laboratory Testing
  • Hospital
  • Independent
  • Physician Office
  • Other
• Home Testing

INDUSTRY STRUCTURE

• Market Share
• Regulatory Factors
  • FDA Regulations
  • CLIA Regulations
  • HCFA & Medicare Reimbursement
• Research & Development Trends
• Marketing Factors
• Competitive Strategies
• Mergers & Acquisitions
• Licensing & Related Agreements

Company Profiles

List of Tables and Charts

EXECUTIVE SUMMARY

• 1 Summary Table

MARKET ENVIRONMENT

• 1 Demographic Patterns
• 2 Macroeconomic Indicators
• 3 Acute & Chronic Medical Conditions
• 4 New Congenital Conditions
• 5 National Health Expenditures
• 6 Selected Health Care Resources & Patient Activity
• 7 Diagnostic Product Shipments
• 8 In Vitro Diagnostic Market Trends
• Chart In Vitro Diagnostic Market Trends, 1990-2000
• 9 In Vitro Diagnostics: US Foreign Trade

IN VITRO DIAGNOSTIC TECHNOLOGIES

• 1 In Vitro Diagnostics Demand by Technology
• Chart In Vitro Diagnostics Demand by Technology, 2000
• 2 In Vitro Diagnostics Demand for Light-Based Methods
• 3 In Vitro Diagnostics Demand for Antigen-Antibody Methods
• 4 In Vitro Diagnostics Demand for DNA- & RNA-Based Methods
• 5 In Vitro Diagnostics Demand for Other Technologies

IN VITRO DIAGNOSTICS DEMAND BY TYPE

• 1 In Vitro Diagnostics Demand by Type
• Chart In Vitro Diagnostics Demand by Type, 2000
• 2 Personal Monitoring & Clinical Chemistry Demand by Type & Condition
• 3 Personal Monitoring Demand by Type & Condition
• 4 Blood Glucose Monitoring Demand
• 5 Other Personal Monitoring Demand
• 6 Clinical Chemistry Demand
• 7 Immunochemistry Demand by Type & Condition
• 8 Immunoassay Demand
• 9 Other Immunochemistry Demand
• 10 Cellular Analysis Demand by Type & Condition
• 11 Hematology Demand
• 12 Flow Cytometry Demand
• 13 Microbiological Diagnostics Demand
• 14 Nucleic Acid Diagnostics Demand
• 15 Other In Vitro Diagnostics Demand

IN VITRO DIAGNOSTICS DEMAND BY CONDITION

• 1 In Vitro Diagnostics Demand by Condition
• Chart In Vitro Diagnostics Demand by Condition, 2000
• 2 Epidemiological & Expenditure Trends in Diabetes
• 3 Diabetes: In Vitro Diagnostics Demand
• 4 Epidemiological & Expenditure Trends in Infectious Disease
• 5 Infectious Disease: In Vitro Diagnostic Demand
• 6 Sexually Transmitted Disease: In Vitro Diagnostics Demand
• 7 Hepatitis: In Vitro Diagnostics Demand
• 8 Other Infectious Disease: In Vitro Diagnostics Demand
• 9 Epidemiological & Expenditure Trends in Cancer
• 10 Cancer: In Vitro Diagnostics Demand
• 11 Breast Cancer: In Vitro Diagnostics Demand
• 12 Prostate Cancer: In Vitro Diagnostics Demand
• 13 Colorectal Cancer: In Vitro Diagnostic Demand
• 14 Cervical Cancer: In Vitro Diagnostics Demand
• 15 Other Cancers: In Vitro Diagnostics Demand
• 16 Drug Testing Trends
• 17 In Vitro Drug Testing Demand
• 18 Epidemiological & Expenditure Trends in Cardiovascular Disease
• 19 Cardiovascular Disease: In Vitro Diagnostics Demand
• 20 Epidemiological & Expenditure Trends in Pregnancy & Reproduction
• 21 In Vitro Pregnancy & Ovulation Testing Demand
• 22 Epidemiological & Expenditure Trends in Genetic Disease
• 23 Genetic Disease: In Vitro Diagnostics Demand
• 24 Other In Vitro Diagnostics Demand

IN VITRO DIAGNOSTICS DEMAND BY POINT-OF-TESTING MARKET

• 1 In Vitro Diagnostics Demand by Point-of-Testing
• Chart In Vitro Diagnostics Demand by Point-of-Testing, 2000
• 2 Laboratory Testing Demand
• 3 Hospital Laboratory Testing Demand
• 4 Independent Laboratory Testing Demand
• 5 Physician Office Laboratory Testing Demand
• 6 Home Testing Demand

INDUSTRY STRUCTURE

• 1 US In Vitro Diagnostics Sales by Company, 2000
• Chart US In Vitro Diagnostics Market Share, 2000
• 2 Selected Acquisitions & Divestitures
• 3 Selected Cooperative Agreements