Table of 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
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
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
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
- 5.4 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
- 5.7 Other IVD 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
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
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 bioMérieux
- 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
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