体外診断薬 (IVD) の市場調査パッケージ

October 2001

In recent years molecular diagnostics has become a growing part of the clinical laboratory. The trend will not only continue but will show significant growth in the future. This report from Kalorama Information examines the current and future opportunities associated with Molecular Diagnostic Technologies. Areas covered include:

• Applications
• DNA-Based Technologies
  • Genomics
  • Amplification systems
  • Probe technologies
  • Chip-based technologies
• Protein-Based Technologies
  • Proteomics
  • Protein probes
  • Chip-based technologies

Market size and share for traditional Molecular Diagnostic products and the commercial outlook for new and/or emerging technologies.

The Worldwide Market for In Vitro Diagnostics

April 2002

This comprehensive report is a thorough overview of the in vitro diagnostics (IVD) industry worldwide, covering the breadth of traditional IVD testing (Kalorama released a report dedicated to the molecular diagnostics segment in the Fall of 2001). The Worldwide Market for In Vitro Diagnostic Tests will contain complete market statistics and analysis for all areas of IVD, including:

• Point-of-Care
• Clinical Chemistry
• Immunoassays
• Molecular Assays
• Hematology
• Coagulation
• Microbiology and Virology
• Blood Banking
• Tissue Banking and Transplantation, and
• Histology and Cytology

Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments will be discussed.

Asian In Vitro Diagnostics

October 2002

This report covers the five most important markets for in vitro diagnostics in Asia: Japan, China, India, Korea and Taiwan. The total market for diagnostics is broken down into six segments: Routine chemistry, critical care chemistry, hematology, urinalysis, coagulation and immunochemistry. The instruments working in each of the segments is summarized by company.

In chemistry, instrumentation is broken down by three levels of throughput. In critical care, instruments are divided by combination units and those doing blood gasses and those doing electrolytes. In hematology, cell counters are broken down by 5, 3, and no-diff systems. In urinalysis, strip readers are broken down by large and small instruments. In coagulation, instruments are broken down by automated and semi-automated. In immunochemistry, instruments are broken down by open and closed systems.

Market shares are provided for both instruments and reagents in all sectors. Profiles of the top ten players in each sector show the presence of that firm in the country; either by their own office or their local distributor. Finally, the report forecasts growth in both instrument and reagent sales.

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