Complete Guide to The Diagnostic Market 2007-2012
| Product Code | CLI00003 |
| Publication Date | January 2007 |
| Publisher | Clinica |
| Product Type | Report |
| Pages | 250 |
| ISBN Number | not applicable |
Complete Guide to The Diagnostic Market 2007-2012
The worldwide clinical diagnostics market, historically a market characterized by dynamic changes in competitive structure and technology, is continuing to undergo transitions on multiple fronts that are resulting in coalescence of in-vitro diagnostics with imaging, as well as expansion of segments such as molecular diagnostics and point-of-care testing. The industry is mature, although growth is continuing to outpace overall economic growth in the major countries worldwide.
Automation is becoming increasingly important in clinical laboratories worldwide, as shortages of laboratory technologists as well as cost constraints force labs to substitute automated systems for manual labor.Informatics is also growing in importance as laboratory results, which account for about 70% of all data used in clinical decision-making, are integrated with data from other modalities such as imaging and patient monitoring to provide a comprehensive and continuously updated view of patient status. New analytical technologies such as microarrays and microfluidic devices are playing an expanding role in the market, enabling new types of tests such as multi-marker molecular tests to be developed for applications in areas such as oncology, cardiovascular disease, pharmacogenetics, and genetic disease testing.
Key segments of the IVD market
This report analyses key segments of the clinical diagnostics market, with 2006 sales and forecast growth rates through 2011, including:
- Clinical chemistry
- Immunodiagnostics
- Microbiology
- Molecular diagnostics
- Haematology/flow cytometry
- Coagulation
- Other IVD products including toxicology, serology, histology/cytology
- testing products, and general laboratory equipment and supplies.
Expansion of the molecular diagnostics segment to include a variety of cancer-related tests, as well as pharmacogenetic tests used to guide drug therapy, is already well underway. Future advances in molecular diagnostics technology promise to enable development of tests that provide earlier detection of cancer, personalised drug treatments, non-invasive prenatal detection of genetic disorders, and advances in targeted therapy.
Overview of suppliers in the clinical diagnostics market
Key suppliers in the IVD products market include Roche Diagnostics, GE Healthcare (via its pending acquisition of Abbott's diagnostics business), Siemens Medical Solutions Diagnostics, Johnson & Johnson's Ortho Clinical Diagnostics and LifeScan divisions, Beckman Coulter, Dade Behring, BD, bioMrieux and Bio-Rad Laboratories. Niche suppliers include Gen-Probe in molecular diagnostics, Sysmex in haematology and cellular analysis, Cytyc in cytology and Ventana Medical in automated pathology. In addition, although Abbott Diagnostics is divesting the majority of its IVD business to GE Healthcare, it retains a significant IVD business focused in molecular diagnostics and whole blood glucose self-testing products. Likewise, while Bayer divested most of its IVD business to Siemens, it retains its whole blood glucose self-testing business, which was already established prior to the Siemens acquisition as an independent business unit. Mainly by virtue of their positions in the glucose self-testing market, both Abbott and Bayer continue to have significant positions in in-vitro diagnostics.
Recent acquisitions and mergers have begun to alter the competitive landscape in the clinical diagnostics market, exemplified by the entry of major competitors in the medical device and diagnostics industry including GE Healthcare and Siemens Medical in in-vitro diagnostics. The resulting competitive structure encompasses in-vitro diagnostics, diagnostic imaging, and clinical informatics, and raises the prospect that competition may become based on new factors such as strengths in automation technology, information technology, and biotechnology. In the central laboratory products segment, the size and scope of competitors is expected to become more important in the era of group purchasing in the US as well as to a growing extent in Europe.
Changes in the regulatory environment impact competition
Initiatives on the part of government agencies in the US, Europe and Japan are directed at creating a harmonized environment for regulatory clearance of IVD products, facilitating commercialization of new IVD products and lowering barriers to worldwide competition, particularly for smaller suppliers. While the pace of development of harmonized regulations has been slower than projected, progress is continuing to eliminate the need for multiple clinical trials in order to gain regulatory clearance in the major regions of the global market. This report provides an update on the current status and projected timelines for implementation of changes in the regulatory environment in the major regions of the market, including the status of global harmonisation efforts.
Technology continues to be a major driver of the market
The IVD market has historically been technology-driven, with examples being the introduction of multi-channel analysers that made high-volume chemistry testing practical, as well as the introduction of nucleic acid testing technologies that have created a new and rapidly growing segment of the market by enabling new types of tests to be offered. The development of sensor technologies and rapid testing technology spawned another new segment of the market for point-of-care testing. In the future, information and automation technology are expected to emerge as increasingly important market drivers, along with continued advances in molecular diagnostics technology. Biotechnology is also expected to become an important driver of the market, enabling the discovery and commercialization of new disease markers in multiple application segments including cardiovascular disease, oncology, infectious disease management, neurological disorders and guidance of targeted therapy. Informatics technology, including telecommunications technologies enabling a wider dissemination of diagnostic testing, is expected to play an important role in improving the utility of diagnostic data, allowing easier access to diagnostic services for patients, and improving the efficiency of patient management.
Contents
- Chapter 1 Introduction
- 1.1 Technology Trends in Clinical Diagnostics
- 1.1.1 Molecular Diagnostics
- 1.1.2 Point-of-Care Testing
- 1.1.3 Informatics
- 1.1.4 Microarrays and Lab-on-a-Chip Devices
- 1.1.5 Laboratory Automation
- 1.2 Drivers and Limiters of The Ivd Market
- 1.3 Major Trends in The Ivd Market
- 1.3.1 Targeted Therapeutics and Diagnostics
- 1.3.2 Workstation Consolidation
- 1.3.3 Supplier Consolidation
- 1.3.4 Segments of Opportunity and Risk in The Ivd Market
- 1.1 Technology Trends in Clinical Diagnostics
- Chapter 2 Industry Overview
- 2.1 Clinical Chemistry Segment
- 2.1.1 Trends in Serum/Plasma Chemistry Testing
- 2.1.2 Critical Care Testing
- 2.1.3 Urinalysis Testing
- 2.1.4 Whole Blood Glucose Testing
- 2.2 Immunodiagnostics Market and Sub-Segments
- 2.3 Microbiology Segment
- 2.4 Haematology, Flow Cytometry and Cell Imaging Segments
- 2.5 Molecular Diagnostics Segment
- 2.6 Other Ivd Market Segments
- 2.6.1 Coagulation Testing
- 2.6.2 Cytology and Histology
- 2.6.3 Other Sub-Segments
- 2.7 Regulatory Environment
- 2.8 The Eu Ivd Directive
- 2.9 US Regulatory Requirements
- 2.10 Regulatory Requirements in Japan
- 2.11 Regulatory Requirements in Other Regions
- 2.11.1 China
- 2.11.2 India
- 2.11.3 Other Asian Countries
- 2.11.4 South Africa
- 2.11.5 Canada
- 2.11.6 Australia
- 2.11.7 Latin America
- 2.12 Status of Harmonisation of Regulations between Countries
- 2.1 Clinical Chemistry Segment
- Chapter 3 Technology Developments
- 3.1 Poc Testing Technology
- 3.1.1 Impact of Device Miniaturization
- 3.1.2 Less Invasive and Non-Invasive Testing Technologies
- 3.2 Wireless Technologies and Poc Testing
- 3.3 Molecular Diagnostics Technologies
- 3.3.1 Microarrays in Molecular Diagnostics
- 3.3.2 Automation of Molecular Testing
- 3.3.3 Advances in Genotyping, Haplotyping and Sequencing
- Technology
- 3.4 Pharmacogenetic Testing
- 3.5 Advances in Informatics Technology
- 3.6 Proteomics Technology
- 3.1 Poc Testing Technology
- Chapter 4 Market Overview
- 4.1 Overview of Sales by Product Segment
- 4.2 Overview of Sales by Country
- 4.3 Analysis of Market by Application Segment
- 4.4 Role of IVDs in Healthcare
- 4.5 Sites for Ivd Testing
- 4.6 Major Trends in The Ivd Market
- 4.7 Characteristics of The Ivd Market by Region
- 4.7.1 US Market
- 4.7.2 Japanese Market
- 4.7.3 German Market
- 4.7.4 Italian Market
- 4.7.5 French Market
- 4.7.6 UK Market
- 4.7.7 Spanish Market
- 4.7.8 Chinese Market
- 4.7.9 Indian Market
- 4.8 Future Impact of Molecular Diagnostics, Pharmacogenetics and
- Proteomics
- 4.9 Segments of The Ivd Products Market
- Chapter 5 Product Segments
- 5.1 Clinical Chemistry Products
- 5.1.1 Integrated Testing Platforms
- 5.1.2 High-Throughput Chemistry Systems
- 5.1.3 Mid-Range Chemistry Systems
- 5.1.4 Low-Throughput/Alternate Site Chemistry Systems
- 5.1.5 Urinalysis Products
- 5.1.6 Critical Care Testing Products
- 5.1.7 Market Segmentation for Clinical Chemistry Products
- 5.2 Immunodiagnostic Products
- 5.2.1 General Purpose Immunodiagnostic Systems
- 5.2.2 Specialty Immunodiagnostic Systems
- 5.2.3 Immunoassay-Based Blood Screening Systems
- 5.2.4 Market Segmentation for Immunodiagnostic Products
- 5.3 Haematology/Cellular Analysis and Coagulation Testing Products
- 5.3.1 Conventional Haematology and Integrated
- Haematology/Flow Cytometry Systems
- 5.3.2 Dedicated Flow Cytometry Systems
- 5.3.3 Flow Cytometry Reagents
- 5.3.4 Coagulation Testing Products
- 5.3.5 Market Segmentation for Haematology and Coagulation
- Testing Products
- 5.3.1 Conventional Haematology and Integrated
- 5.4 Cancer Diagnostic Products
- 5.4.1 Tumour Marker Immunoassays
- 5.4.2 Occult Blood Test Kits
- 5.4.3 Immunohistochemistry Test Kits
- 5.4.4 Pap Smear Screening Systems and Computerised Image
- Analysers
- 5.4.5 Oncogene Test Kits
- 5.4.6 Detection of Circulating Tumour Cells
- 5.4.7 Cancer Diagnostics Market Segmentation
- 5.5 Molecular Diagnostic Products
- 5.5.1 Infectious Disease Testing Products
- 5.5.2 Blood Screening (Nat) Products
- 5.5.3 Genetic Testing Products
- 5.5.4 Pharmacogenetic Testing Products
- 5.5.5 Viral Load/Viral Genotyping Products
- 5.5.6 Molecular Diagnostics Market Segmentation
- 5.5.7 Poc Testing Products
- 5.5.8 Bedside Critical Care Testing Products
- 5.5.9 Alternate Site Coagulation/Platelet Function Monitoring
- Products
- 5.5.10 Drugs of Abuse Screening Kits
- 5.5.11 Professional-Use Whole Blood Chemistry Testing Systems
- 5.5.12 Poc Cardiac Marker Testing Products
- 5.5.13 Rapid Infectious Disease Test Kits
- 5.5.14 Other Poc Products
- 5.5.15 Poc Testing Market Segmentation
- 5.6 Home and Self-Testing Products
- 5.6.1 Whole Blood and Minimally Invasive Glucose Testing
- Products
- 5.6.2 Home Tests for Monitoring of Glycated Haemoglobin
- 5.6.3 Coagulation Self-Testing Products
- 5.6.4 Home Pregnancy and Fertility Products
- 5.6.5 Home Cholesterol Testing Products
- 5.6.6 Home Drugs of Abuse Test Kits
- 5.6.7 Home and Self-Testing Market Segmentation
- 5.6.1 Whole Blood and Minimally Invasive Glucose Testing
- 5.7 Other Ivd Products
- 5.1 Clinical Chemistry Products
- Chapter 6 Market Analysis by End User
- 6.1 Traditional Laboratory-Based Testing
- 6.2 Testing in Other Sites
- 6.3 Testing in The US
- 6.4 Testing in Europe
- 6.5 Testing in Japan
- 6.6 Testing in China
- 6.7 Testing in India
- 6.8 Testing in The Rest of World Region
- 6.9 Future Trends
- Chapter 7 Market Analysis by Country
- 7.1 US Market
- 7.1.1 Clinical Chemistry Market
- 7.1.2 Critical Care Testing Market
- 7.1.3 Urinalysis Market
- 7.1.4 Blood Glucose Market
- 7.1.5 Immunodiagnostics Market
- 7.1.6 Haematology/Flow Cytometry Market
- 7.1.7 Microbiology Market
- 7.1.8 Coagulation/Platelet Function Testing Market
- 7.1.9 Molecular Diagnostics Market
- 7.1.10 Other Product Market Segments
- 7.2 Japanese Market
- 7.2.1 Clinical Chemistry Market
- 7.2.2 Critical Care Testing Market
- 7.2.3 Urinalysis Market
- 7.2.4 Blood Glucose Market
- 7.2.5 Immunodiagnostics Market
- 7.2.6 Haematology/Flow Cytometry Market
- 7.2.7 Microbiology Market
- 7.2.8 Coagulation/Platelet Function Testing Market
- 7.2.9 Molecular Diagnostics Market
- 7.2.10 Other Product Market Segments
- 7.3 German Market
- 7.3.1 Clinical Chemistry Market
- 7.3.2 Critical Care Testing Market
- 7.3.3 Urinalysis Market
- 8.1.1 Blood Glucose Market
- 7.3.4 Immunodiagnostics Market
- 7.3.5 Haematology/Flow Cytometry Market
- 7.3.6 Microbiology Market
- 7.3.7 Coagulation/Platelet Function Testing Market
- 7.3.8 Molecular Diagnostics Market
- 7.3.9 Other Product Market Segments
- 7.4 French Market
- 7.4.1 Clinical Chemistry Market
- 7.4.2 Critical Care Testing Market
- 7.4.3 Urinalysis Market
- 7.4.4 Blood Glucose Market
- 7.4.5 Immunodiagnostics Market
- 7.4.6 Haematology/Flow Cytometry Market
- 7.4.7 Microbiology Market
- 7.4.8 Coagulation/Platelet Function Testing Market
- 8.1.2 Molecular Diagnostics Market
- 7.4.9 Other Product Market Segments
- 7.5 Italian Market
- 7.5.1 Clinical Chemistry Market
- 7.5.2 Critical Care Testing Market
- 7.5.3 Urinalysis Market
- 7.5.4 Blood Glucose Market
- 7.5.5 Immunodiagnostics Market
- 7.5.6 Haematology/Flow Cytometry Market
- 7.5.7 Microbiology Market
- 7.5.8 Coagulation/Platelet Function Testing Market
- 7.5.9 Molecular Diagnostics Market
- 7.5.10 Other Product Market Segments
- 7.6 UK Market
- 7.7 Rest of Europe and Rest of World Markets
- 7.7.1 Rest of Europe
- 7.7.2 China
- 7.7.3 India
- 7.7.4 Rest of World
- 7.8 Country Markets by Testing Discipline
- 7.1 US Market
- Chapter 8 Company Analysis
- 8.1 Overview of Ivd Product Suppliers
- 8.1.1 Industry Leaders
- 8.1.2 Niche Suppliers and Emerging Companies
- 8.2 Mergers and Acquisitions in The Ivd Industry
- 8.3 Perspectives and Strategies of Key Suppliers
- 8.3.1 Siemens Medical Solutions Diagnostics
- 8.3.2 Ge Healthcare
- 8.3.3 Roche Diagnostics
- 8.1 Overview of Ivd Product Suppliers
- Chapter 9 Company Profiles
- 9.1 Abbott Laboratories/Ge Healthcare
- 9.2 A Menarini Diagnostics
- 9.3 Bayer Diabetes Care
- 9.4 Beckman Coulter
- 9.5 Bd
- 9.6 Biomrieux
- 9.7 Bio-Rad Laboratories
- 9.8 Biosite
- 9.9 Cytyc
- 9.10 Dade Behring
- 9.11 Digene
- 9.12 Gen-Probe
- 9.13 Home Diagnostics
- 9.14 Instrumentation Laboratory
- 9.15 Inverness Medical Innovations
- 9.16 Meridian Bioscience
- 9.17 Olympus Clinical Instruments
- 9.18 Ortho Clinical Diagnostics/LifeScan
- 9.19 Radiometer Medical
- 9.20 Roche Diagnostics
- 9.21 Siemens Medical Solutions/Bayer Diagnostics/Dpc
- 9.22 DiaSorin Spa
- 9.23 Stago
- 9.24 Sysmex
- 9.25 Tosoh
- Chapter 10 Strategies for Success
- 10.1 Consolidation and Information Technology
- 10.2 Targeting of High Growth/High-Value Segments
- 10.3 Technology Strategies
- 10.4 Marketing and Distribution Strategies for The Clinical Diagnostics
- Market
- List of Tables
- Table 1.1 2006 Global Diagnostic and Electromedical Device Market
- Table 1.2 Key Factors Driving Adoption of Poc Testing
- Table 1.3 Expansion of Clinical Lab Automation
- Table 1.4 High and Low-Growth Product Segments in The Ivd Market
- Table 2.1 Highest Volume Laboratory Tests Performed in The US Medicare Population, 2003
- Table 2.2 Chemistry Testing Products
- Table 2.3 Critical Care Testing Products
- Table 2.4 Diabetes Prevalence Trends
- Table 2.5 Development-Stage Non-Invasive Glucose Monitoring Devices
- Table 2.6 Automated and Semi-Automated Immunoassay Analysers
- Table 2.7 Microbiology Test Systems
- Table 2.8 Haematology/Flow Cytometry Products
- Table 2.9 Molecular Diagnostics Products
- Table 2.10 Coagulation Testing Products
- Table 3.1 Minimally Invasive and Non-Invasive Glucose Monitoring Technologies
- Table 3.2 Microarrays for Molecular Diagnostics
- Table 4.1 Global Ivd Products Market by Product Segment, 2005-2011($Million)
- Table 4.2 Global Ivd Products Market by Country/Region, 2005-2011($Million)
- Table 4.3 Global Ivd Products Market Size and Growth by Application Segment, 2006-2011
- Table 4.4 Segmentation of Healthcare Costs in The US
- Table 4.5 Number of Clia-Registered Clinical Laboratories by Type, 1996 and 2005
- Table 4.6 Size of The Worldwide Clinical Diagnostic Products Market by Segment
- Table 4.7 Size of The Worldwide Clinical Chemistry Market Segments
- Table 4.8 Size of The Worldwide Immunodiagnostics Market Segments
- Table 4.9 Microbiology Products Market
- Table 4.10 Haematology/Flow Cytometry and Coagulation Testing Products Market
- Table 4.11 Worldwide Molecular Diagnostics Products Market
- Table 4.12 Leading Suppliers in The Global Ivd Market, 2006
- Table 4.13 Niche and Emerging Suppliers in The Global Ivd Market, 2006
- Table 5.1 Clinical Chemistry Products
- Table 5.2 Clinical Chemistry Market Segmentation by Product Type, 2006
- Table 5.3 General Purpose Immunodiagnostic Products
- Table 5.4 Immunodiagnostics Market by Product Segment, 2006
- Table 5.5 Haematology and Coagulation Products
- Table 5.6 Haematology/Flow Cytometry/Coagulation Testing Market by Product Segment, 2006
- Table 5.7 Cancer Diagnostic Products
- Table 5.8 Serum Tumour Markers and Their Clinical Applications
- Table 5.9 Cancer Ivd Testing Products Market by Product Segment, 2006
- Table 5.10 Molecular Diagnostic Products
- Table 5.11 Molecular Diagnostics Testing Products Market by Product Segment, 2006
- Table 5.12 Poc Testing Products
- Table 5.13 Point-of-Care (Poc) Testing Products Market by Product Segment, 2006
- Table 5.14 Home and Self-Testing Products
- Table 5.15 Home and Self-Testing Products Market by Product Segment,2006
- Table 5.16 Other Ivd Products
- Table 6.1 Changes to The Clinical Laboratory Fee Schedule in The US,1995-2004
- Table 6.2 Number of Hospital and Private Laboratories in Selected Countries, 2005
- Table 6.3 Segmentation of Laboratory-Based Testing in The US, 2006
- Table 6.4 Trends in The Site of Laboratory-Based Testing in The US, 1996-2006
- Table 6.5 Estimated Distribution of Hospital and Clinic Laboratories in Major European Countries, 2006
- Table 6.6 Trends in Healthcare Expenditure as a Percentage of Gdp,1994-2004
- Table 6.7 Number of Medical Institutions in China
- Table 7.1 Breakdown of The Global Ivd Market by Country/Region, 2006
- Table 7.2 The US Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.3 The Japan Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.4 The German Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.5 The French Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.6 The Italian Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.7 The UK Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.8 The Rest of Europe Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.9 The Rest of World Ivd Market Analysed by Segment (Sales in $Million)
- Table 7.10 Country/Regional Markets, Clinical Chemistry (Sales in $Million)*
- Table 7.11 Country/Regional Markets, Critical Care Testing (Sales in $Million)*
- Table 7.12 Country/Regional Markets, Urinalysis (Sales in $Million)*
- Table 7.13 Country/Regional Markets, Whole Blood Glucose (Sales in $Million)*
- Table 7.14 Country/Regional Markets, Immunodiagnostics (Sales in $Million)*
- Table 7.15 Country/Regional Markets, Haematology/Flow Cytometry (Sales in $Million)*
- Table 7.16 Country/Regional Markets, Microbiology (Sales in $Million)*
- Table 7.17 Country/Regional Markets, Molecular Diagnostics (Sales in $Million)*
- Table 7.18 Country/Regional Markets, Coagulation (Sales in $Million)*
- Table 7.19 Country/Regional Markets, Other (Sales in $Million)*
- Table 8.1 Worldwide Sales of Emerging and Niche Suppliers in The Ivd Market, 2006
- Table 8.2 Worldwide Sales of Leading Suppliers in The Ivd Market, 2006
- Table 10.1 Market Segment Participation of The Top Ten Ivd Companies,2006
- List of Figures
- Figure 4.1 Global Ivd Products Market Distribution by Product Segment, 2006 and 2011
- Figure 4.2 Global Ivd Products Market Distribution by Country/Region, 2006 and 2011
- Figure 4.3 Distribution of Global Ivd Products Market by Application Segment, 2006 and 2011
- Figure 4.4 Worldwide Clinical Diagnostic Products Market by Region
- Figure 5.1 Product Segmentation of The Clinical Chemistry Market, 2006
- Figure 5.2 Product Segmentation of The Clinical Chemistry Market, 2006
- Figure 5.3 Product Segmentation of The Haematology/Flow Cytometry/Coagulation Testing Market, 2006
- Figure 5.4 Product Segmentation of The Cancer Ivd Testing Products Market, 2006
- Figure 5.5 Product Segmentation of The Molecular Diagnostics Products Market, 2006
- Figure 5.6 Product Segmentation of The Point-of-Care Testing Products Market, 2006
- Figure 5.7 Product Segmentation of The Home and Self-Testing Products Market, 2006
- Figure 7.1 Percentage Share per Country/Region of The Global Clinical Chemistry Market, 2006
- Figure 7.2 Percentage Share per Country/Region of The Global Critical Care Testing Market, 2006
- Figure 7.3 Percentage Share per Country/Region of The Global Urinalysis Market, 2006
- Figure 7.4 Percentage Share per Country/Region of The Global Whole Blood Glucose Testing Products Market, 2006
- Figure 7.5 Percentage Share per Country/Region of The Global Immunodiagnostics Products Market, 2006
- Figure 7.6 Percentage Share per Country/Region of The Global Haematology/Flow Cytometry Products Market, 2006
- Figure 7.7 Percentage Share per Country/Region of The Global Microbiology Products Market, 2006
- Figure 7.8 Percentage Share per Country/Region of The Global Molecular Diagnostics Market, 2006
- Figure 7.9 Percentage Share per Country/Region of The Global Coagulation Testing Products Market, 2006
- Figure 7.10 Percentage Share per Country/Region of The Global Other Ivd Products Market, 2006
- Figure 8.1 Worldwide Ivd Market Shares under Various Scenarios, 2006
