Special In Vitro Diagnostics Research Package

Executive Summary

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trends
• The Nature of the Industry

Introduction

• Background
• Market Erosion
• Clinical Relevance
• Cost-Benefit Relationships
• Scientific Limitations
• Fitting the Environment
• Genomics
• The Relationship of Genes to Disease
• The Spread of Functional Genomics

Molecular Diagnostics Technologies

• Background
• Amplification Technologies
• Probe Technologies
• Microchip Technologies
• Electrophoretic Technologies
• Blotting Technologies

Applications Of Molecular Diagnostics

• The Testing Environment
• Infectious Diseases
• Blood Banking
• Genetic Diseases
• Cancer
• Pharmacogenetics
• Commercial Efforts

The Market Dynamics Of Molecular Diagnostics

• Market Size and Trending
• Competition
• The Future Revival?

Company Profiles

• Abbott Diagnostics, Inc
• Affymetrix Inc
• Agilent Technologies, Inc
• Applied Biosystems Group
• Cepheid, Inc
• Chiron Corporation
• diaDexus, LLC
• Digene Corp
• Gene Logic, Inc
• Gen-Probe, Incorporated
• Innogenetics NV
• MitoKor, Inc
• Myriad Genetics, Inc
• Nanogen, Inc
• Orchid Biosciences, Inc
• Perkin-Elmer Corp
• Roche Diagnostics Division/Roche Molecular Systems
• Visible Genetics
• Vysis

Chapter One: Executive Summary

• Table 1-1: Molecular Diagnostics Testing Potential in the United States: 1999 - 2007
• Figure 1-1: Distribution of Molecular Diagnostics Testing Potential by Application in the United States: 2001
• Table 1-2: Common Molecular Diagnostics Tests
• Table 1-3: Historic and Forecast Total Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 1-2: Trending of the Historic and Forecast Total Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Table 1-4: Historic and Forecast Serviceable Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 1-3: Trending of the Historic and Forecast Serviceable Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Table 1-5: Key Molecular Diagnostics Companies

Chapter Three: Molecular Diagnostics Technologies

• Table 3-1: Molecular Diagnostics Technologies
• Table 3-2: Gene Amplification Technologies
• Table 3-3: Signal Amplification Technologies

Chapter Four: Applications Of Molecular Diagnostics

• Table 4-1: Home-Brew Molecular Diagnostics Assays at the Johns Hopkins University Hospital
• Table 4-2: Home-Brew Molecular Diagnostics Assays at the Magee-Womens Hospital/University of Pittsburgh
• Table 4-3: Home-Brew Molecular Diagnostics Assays at the University of Nebraska Medical Center
• Table 4-4: Home Brew Molecular Diagnostics Assays at the City of Hope National Medical Center
• Figure 4-1: Distribution of Molecular Diagnostics Testing by Application in the United States: 2001
• Table 4-5: Important Infectious Disease Testing Opportunities for Molecular Diagnostics in the United States: 1999 - 2007
• Figure 4-2: Trends in Molecular US Infectious Disease Testing in the United States: 1999 - 2007
• Table 4-6: Important Blood Banking Testing Opportunities for Molecular Diagnostics in the United States: 1999 - 2007
• Figure 4-3: Trends in Molecular Blood Banking Testing in the United States: 1999 - 2007
• Table 4-7: Common Hereditary Diseases
• Table 4-8: Important Genetic Disease Testing Opportunities for Molecular Diagnostics in the United States: 1999 - 2007
• Figure 4-4: Trends in Molecular Genetic Disease Testing in the United States: 1999 - 2007
• Table 4-9: Important Cancer Testing Opportunities for Molecular Diagnostics in the United States: 1999 - 2007
• Figure 4-5: Trends in Molecular Cancer Testing in the United States: 1999 - 2007
• Table 4-10: Important Pharmacogenetic Testing Opportunities for Molecular Diagnostics in the United States: 1999 - 2007
• Figure 4-6: Trends in Molecular Pharmacogenetics Testing in the United States: 1999 - 2007

Chapter Five: The Market Dynamics Of Molecular Diagnostic

• Table 5-1: Historic and Forecast Total Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 5-1: Trending of the Historic and Forecast Total Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 5-2: Composition of the Historic and Forecast Total Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Table 5-2: Breakdown of the Historic and Forecast Total Available United States Market for Molecular Diagnostics by Dollar Volume, Test Volume and Average Price Per Test: 1999 - 2007
• Table 5-3: Historic and Forecast Serviceable United States Markets for Molecular Diagnostics: 1999 - 2007
• Table 5-4: Comparison of the Total Available and Serviceable Available United States Markets for Molecular Diagnostics by Application Segment: 1999 - 2007
• Figure 5-3: Trending of the Historic and Forecast Serviceable United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 5-4: Composition of the Historic and Forecast Serviceable Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Figure 5-5: Closing the Gap Between the Total Available and Serviceable Available United States Markets for Molecular Diagnostics: 1999 - 2007
• Table 5-5: Active Competitors in the United States Molecular Diagnostics Markets
• Figure 5-6: Estimated Market Shares in Molecular Diagnostics By Technology Segment: 2001

THE WORLDWIDE MARKET FOR IN VITRO DIAGNOSTICS

Table of Contents

Chapter one: Executive Summary

• Scope and Methodology
• Size and Growth of the Market
• Market Trends

Chapter Two: Introduction

• Background
• Lab Medicine Disciplines and Applications
• Market Analysis of IVD Market Segments
• Top Suppliers and Niche Players
• Tests, Bioinformatics, and Drugs—The 21st Century Diagnostics Paradigm
• Point of View

Chapter Three: Overview Of Global In Vitro Diagnostic Markets

• Background
• World Segments of the IVD Market—Healthcare and Geography
• Population Trends and IVD Market Evolution
• IVD Market Growth—Emerging and Developed Country Potentials
• The United States
• Japan
• Western Europe
• China
• India
• The Tiger Economies
• Privatization To Spur Demand For IVD Products
• End-Users of Clinical IVD Products
• End-Users of IVD Products Outside the Healthcare System

Chapter Four: Trends In Healthcare Delivery And In Vitro Diagnostics

• Background
• Outpatient/Inpatient Product Mix
• Miniaturization and Chip Progress
• Non-Invasive Techniques and Alternative Samples
• Nearer-the-Patient Testing and Decentralization
• Commercialization Issues: Globalization and Distribution Channels
• Consumer Power
• Provider Group Consolidations
• Outcomes-Based Medicine
• Emergence of New Technologies
• Test Implications from The Human Genome Project
• Growing Globalization of Public Health Crises
• Regulatory and Reimbursement Issues and Novel Devices

Chapter Five: Point-Of-Care Tests

• Overview
• POC Test Segments
• Market Analysis: Leading Suppliers
• Cost Pressures and Perceived Barriers for POC Tests
• Institutional Users of POC Tests
• The Commercial Outlook for POC Tests

Chapter Six: Clinical Chemistry

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Lab Automation and Workstation Consolidation
• The Commercial Outlook for Chemistry Tests

Chapter Seven: Immunoassays

• Overview of Immunoassays
• Market Analysis: Leading Suppliers and Growth Potential
• Immunoassay Test Segments-Mature and Emerging
• New Antibodies, Labels, and Homogeneous Assay Designs
• Growth Opportunities Derived from Trends in Functional Genomics
• The Commercial Outlook for Immunoassays

Chapter Eight: Molecular Assays

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Genomic Medicine and the Role of In Vitro Diagnostics
• Molecular Testing Initiatives- Technology and Players
• Biochips, Arrays, and Instrumentation
• The Commercial Outlook for Molecular Tests

Chapter Nine: Hematology

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Rare Event Cell Counting Techniques
• Decentralized Hematology Testing
• The Commercial Outlook for Hematology Tests

Chapter Ten: Coagulation

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Hypercoagulopathies and Cardiac Disease
• POC and Self-Testing Coagulation Systems
• The Commercial Market for Coagulation Tests

Chapter Eleven: Microbiology And Virology

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Antimicrobial Resistance Testing
• Tradition Is Challenged by Molecular Techniques
• The Commercial Outlook for Microbiology/Virology Tests

Chapter Twelve: Blood Banking Services

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
  • Blood Grouping and Typing Reagents
  • Immunoassays
  • Nucleic Acid Testing
• Artificial Blood Products Begin to Appear
• The Commercial Outlook for Blood Banking

Chapter Thirteen: Histology And Cytology

• Overview
• Market Analysis: Leading Suppliers and Growth Potential
• Traditional Testing
• Immunohistochemical Stains and In Situ Hybridization
• New Technologies for Monolayer and Sample Preparation
• Genomic Medicine Fuels Automated Techniques and FISH
• The Commercial Outlook for Histology and Cytology Tests

Chapter Fourteen: Company Profiles, Top 15 Competitors

• Roche Diagnostics
• Abbott Laboratories
• Ortho Clinical Diagnostics & LifeScan
• Bayer Corporation, Diagnostics Division
• Beckman Coulter Inc.
• Dade Behring Inc.
• BD Biosciences
• bioMérieux-Pierre Fabre
• Bio-Rad Laboratories Inc.
• Sysmex Corporation
• Instrumentation Laboratory (IL)
• Diagnostic Product Corporation (DPC)
• Fujirebio, Inc.
• Olympus America Inc.
• Thermo Electron Corp.

Chapter Fifteen: Company Profiles: Niche Player Summaries

• AccuMed International, Inc.
• Affymetrix, Inc.
• AstraZeneca Diagnostics
• Avitar Inc.
• Avocet Medical Inc.
• Beacon Diagnostics Inc.
• Biosite Diagnostics Incorporated
• Caliper Technologies Corporation
• Calypte Biomedical Corporation
• Cholestech Corporation
• Cygnus, Inc.
• Cytyc Corporation
• DiagnoCure Inc.
• Digene Corporation
• Enzo Diagnostics
• Epitope, Inc.
• Genicon Sciences Corporation
• Gen-Probe Inc.
• Genzyme Diagnostics
• Igen, Inc.
• International Remote Imaging Systems, Inc. (IRIS)
• i-STAT Corporation
• Luminex Corporation
• LungCheck Inc. / CellMetrix
• Matritech, Inc.
• Mediators Diagnostika
• Motorola Life Sciences
• Myriad Genetics, Inc.
• Nanogen Inc.
• National Genetics Institute (NGI)
• Non-Invasive Monitoring Systems, Inc. (NIMS)
• OraSure Technologies, Inc.
• PharmaNetics, Inc.
• PicoQuant GmbH
• Quantum Dot Corporation
• Rapigene Inc.
• Saliva Diagnostic Systems Inc.
• Spectral Diagnostics Inc.
• SpectRx, Inc.
• Third Wave Technologies Inc.
• Visible Genetics Inc.
• Vysis Inc.
• World Diagnostics Inc. (WDI)
• Xtrana, Inc.

List of Exhibits

Table 1-1: Worldwide In Vitro Diagnostic Sales by Product Market, 2000-2005

Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market, 2000-2005

Table 2-2: Revenues of Selected IVD Companies, 1999-2001

Table 3-1: Worldwide In Vitro Diagnostics Sales by Geographic Region, 2000-2005

Table 3-2: Selected Companies Involved in International Collaborations

Table 3-3: Selected Company Product Collaborations

Table 4-1: Percent of Selected Surgical Procedures to be Performed by Minimally Invasive Methods

Table 4-2: Selected Clinical Biochip Systems

Table 4-3: Selected Tests using Alternative Samples

Table 4-4: Selected Non-Invasive Devices (Nonglucose)

Table 4-5: Selected International Distribution Agreements

Table 4-6: Selected OTC Self-Test Types Available, 2001

Table 4-7: Selected Home Test Products, Non-glucose

Table 4-8: Selected IVD Company Mergers and Acquisitions, 1998-2001

Table 4-9: Selected POC Infectious Disease Tests

Table 5-1: Selected POC Connectivity Solutions

Table 5-2: POC Sales by Test Category, Worldwide 2000-2005

Table 5-3: World Rapid Infectious Disease Sales by Test, 2000

Table 5-4: Selected New Professional POC Devices

Table 6-1: Worldwide Clinical Chemistry Sales by Test Category, 2000-2005

Table 6-2: General Chemistry Sales for Top Competitors, 2000-2001

Table 6-3: Selected Clinical Chemistry Innovations

Table 7-1: Worldwide Lab-Based Immunoassay Sales, 2000-2005

Table 7-2: Worldwide Immunoassays Average Cost per Test, 2000

Table 7-3: Selected Cancer Immunoassays

Table 7-4: Selected Immunoassay Innovations

Table 8-1: Worldwide Molecular Test Sales, 2000-2005

Table 8-2: Molecular Assays Currently Available

Table 8-3: Selected Molecular Assay Innovations

Table 9-1: Selected Hematology and Flow Cytometry Innovations

Table 10-1: Worldwide Coagulation Sales, 2000-2005

Table 10-2: Selected Procoagulation and Thrombolytic Markers

Table 10-3: Selected Coagulation Test Innovations

Table 11-1: Worldwide Microbiology/Virology Sales, 2000-2005

Table 11-2: Selected Prion Test Innovations

Table 11-3: Selected Biowarfare Agent Tests

Table 12-1: Selected Artificial Blood Products

Table 12-2: Selected Blood Bank Product Innovations

Table 13-1: Worldwide Histology and Cytology Sales, 2000-2005

Table 13-2: Selected Histology Stains

Table 13-3: Companies Marketing Fluorescent and Colorimetric Labeled Probes for ISH

Table 13-4: Selected Histology/Cytology Innovations

Figure 5-1: Competitive Share or the Flushable Fecal Occult Blood Test Market, 2001

Figure 9-1: Share of the Hematology Market by Competitor

ASIAN IN VITRO DIAGNOSTICS

Table of Contents

Executive Summary

• Scope
• Analysts and Methodology

Clinical Diagnostics in China

Market Size and Growth

Issues & Trends

• The WTO
• Who Are the End-Users?
• Will There Ever Be Private Practice?
• Payment for Testing

Leading Competitors

What to Expect from the Future

Routine Chemistry

Immunochemistry

Hematology

Coagulation

Critical Care Chemistry

Urinalysis

Foreign Manufacturers

• Abbott Laboratories
• Bayer Diagnostics
• Beckman Coulter
• Hitachi High Technologies Corporation
• Olympus
• Roche Diagnostics
• Sysmex Ltd.

Domestic Manufacturers

• Kehua Biotech (Shanghai Kehua)
• Shanghai Fosun Industrial / Long March
• ZhongSheng High-Tech Bioengineering (Beijing ZhongSheng)

Clinical Diagnostics in India

Market Size and Growth

Issues & Trends

• Who are the end-users?
• Payment for Testing

Leading Competitors

What to Expect from the Future?

Routine Chemistry

Immunochemistry

Hematology

Coagulation

Critical Care Chemistry

Urinalysis

Foreign Manufacturers

• Abbott Laboratories ( India ) Ltd
• Bayer Diagnostics India
• bioMérieux India Pvt. Ltd.
• Thermo Labsystems

Domestic Manufacturers

• Accurex Biomedical Pvt. Ltd.
• Span Diagnostics Ltd.
• Transasia Bio-Medicals Ltd.
• Tulip Group

Distributors

• Nicholas Piramal India Limited
• Wipro

Clinical Diagnostics in Japan

Market size and growth

Issues & Trends

• Who Are the End-Users?
• Historical Background—IVD Reimbursement in Japan
• The Unique Role of Wholesalers

Leading Competitors

What to Expect from the Future

Routine Chemistry

Immunochemistry

Hematology

Coagulation

Critical Care Chemistry

Urinalysis

Manufacturers

• ARKRAY, Inc. (formerly Kyoto Daiichi)
• Denka Seiken Co., Ltd.
• Denka Seiken Co., Ltd.
• Dia-Iatron Co., Ltd.
• Eiken Chemical Co., Ltd.
• Fujirebio Inc.
• Hitachi High-Technologies Corporation
• Kyowa Medex Co., Ltd.
• Olympus Optical
• Sysmex Corporation
• Tosoh Corporation
• Wako Pure Chemical Industries, Ltd.

Clinical Diagnostics in Korea

Market Size and Growth

Issues & Trends

• Who Are the End-Users?
• What About the Doctors?
• Payment for Testing

Leading competitors

What to Expect from the Future

Routine Chemistry

Immunochemistry

Hematology

Coagulation

Critical Care Chemistry

Urinalysis

Foreign Manufacturers

• Abbott Laboratories
• Bayer Diagnostics Korea
• Beckman Coulter
• Roche Diagnostics Korea

Domestic Manufacturers

• Asan Pharmaceutical/Sam Kwang Chemical
• Shin Yang Chemical
• YD Diagnostics (Yeongdong)

Distributors

• ChoongWae Medical
• Dong Kang Medipia
• Handok Pharmaceuticals

Clinical Diagnostics in Taiwan

Market Size and Growth

Issues & Trends

• The WTO
• Who are the End-Users?
• Payment for Testing

Leading Competitors

What to Expect from the Future

Routine Chemistry

Immunochemistry

Hematology

Coagulation

Critical Care Chemistry

Urinalysis

Foreign Manufacturers

• Abbott Laboratories
• Bayer-Sankyo
• Beckman Coulter Taiwan
• Bio-Rad
• General Biologicals
• Ortho-Clinical Diagnostics
• Roche Products

Distributors

• Beam International/Medicare Products/SSAGA
• Grant Technology
• San Tung Instruments/San-Yih

Company Directory

List of Exhibits

• Exhibit 1-1: Revenues in the Top 5 Asian IVD Markets
• Exhibit 2-1: Size and Composition of the Clinical Laboratory Market in China
• Exhibit 3-1: Size and Composition of the Clinical Laboratory Market in India
• Exhibit 4-1: Size and Composition of the Clinical Laboratory Market in Japan
• Exhibit 5-1: Size and Composition of the Clinical Laboratory Market in Korea
• Exhibit 6-1: Size and Composition of the Clinical Laboratory Market in Taiwan