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Diagnostics

Complete Guide to the Diagnostic Market 2007-2012

 

Publication Date January 2007
Publisher Clinica
Product Type Report
Pages 250
ISBN Number not applicable
Product Code CLI00005

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Summary

This report provides a comprehensive analysis of the global market for in-vitro diagnostics and projects that this market will continue to show solid growth over the next five years.

It will help you:

- Plan your market entry strategy
- Identify partnerships/investment opportunities
- Analyse the market position of your competitors
- Identify new technologies for licensing
- Assess the competitive landscape for your products

This report will provide you information on:

- Primary segments of the IVD market
- Overview of the suppliers in the IVD market
- Mergers and acquisitions in the IVD industry
- Regulatory framework and issues for in-vitro diagnostics
- Technology developments and trends
- Market applications segments
- Trends in individual country markets
- Impact of emerging technologies

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 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:
    • 1.1 2006 Global diagnostic and electromedical device market 12 Table
    • 1.2 Key factors driving adoption of POC testing 13 Table
    • 1.3 Expansion of clinical lab automation 15 Table
    • 1.4 High and low-growth product segments in The IVD market 19 Table
    • 2.1 Highest volume laboratory tests performed in The US Medicare population, 2003 22 Table
    • 2.2 Chemistry testing products 23 Table
    • 2.3 Critical care testing products 28 Table
    • 2.4 Diabetes prevalence trends 30 Table
    • 2.5 Development-stage non-invasive glucose monitoring devices 33 Table
    • 2.6 Automated and semi-automated immunoassay analysers 35 Table
    • 2.7 Microbiology Test Systems 39 Table
    • 2.8 Haematology/flow cytometry products 41 Table
    • 2.9 Molecular diagnostics products 43 Table
    • 2.10 Coagulation testing products 45 Table
    • 3.1 Minimally invasive and non-invasive glucose monitoring technologies 63 Table
    • 3.2 Microarrays for molecular diagnostics 66 Table
    • 4.1 Global IVD products market by product segment, 2005-2011 ($million) 74 Table
    • 4.2 Global IVD products market by country/region, 2005-2011 ($million) 78 Table
    • 4.3 Global IVD products market size and growth by application segment, 2006-2011 80 Table
    • 4.4 Segmentation of healthcare costs in The US 83 Table
    • 4.5 Number of CLIA-registered clinical laboratories by type, 1996 and 2005 84 Table
    • 4.6 Size of The worldwide clinical diagnostic products market by segment 97 Table
    • 4.7 Size of The worldwide clinical chemistry market segments 98 Table
    • 4.8 Size of The worldwide immunodiagnostics market segments 98 Table
    • 4.9 Microbiology products market 99 Table
    • 4.10 Haematology/flow cytometry and coagulation testing products market 99 Table
    • 4.11 Worldwide molecular diagnostics products market 100 Table
    • 4.12 Leading suppliers in The global IVD market, 2006 101 Table
    • 4.13 Niche and emerging suppliers in The global IVD market, 2006 101 Table
    • 5.1 Clinical chemistry products 105 Table
    • 5.2 Clinical chemistry market segmentation by product type, 2006 109 Table
    • 5.3 General purpose immunodiagnostic products 112 Table
    • 5.4 Immunodiagnostics market by product segment, 2006 115 Table
    • 5.5 Haematology and coagulation products 117 Table
    • 5.6 Haematology/flow cytometry/coagulation testing market by product segment, 2006 121 Table
    • 5.7 Cancer diagnostic products 122 Table
    • 5.8 Serum tumour markers and Their clinical applications 124 Table
    • 5.9 Cancer IVD testing products market by product segment, 2006 128 Table
    • 5.10 Molecular diagnostic products 131 Table
    • 5.11 Molecular diagnostics testing products market by product segment, 2006 135 Table
    • 5.12 POC testing products 137 Table
    • 5.13 Point-of-Care (POC) testing products market by product segment, 2006 143 Table
    • 5.14 Home and self-testing products 145 Table
    • 5.15 Home and self-testing products market by product segment, 2006 149 Table
    • 5.16 OTher IVD products 150 Table
    • 6.1 Changes to The Clinical Laboratory Fee Schedule in The US, 1995-2004 154 Table
    • 6.2 Number of Hospital and Private Laboratories in Selected Countries, 2005 155 Table
    • 6.3 Segmentation of laboratory-based testing in The US, 2006 156 Table
    • 6.4 Trends in The site of laboratory-based testing in The US, 1996- 2006 157 Table
    • 6.5 Estimated distribution of hospital and clinic laboratories in major European countries, 2006 158 Table
    • 6.6 Trends in healthcare expenditure as a percentage of GDP, 1994-2004 158 Table
    • 6.7 Number of medical institutions in China 160 Table
    • 7.1 Breakdown of The global IVD market by country/region, 2006 166 Table
    • 7.2 The US IVD market analysed by segment (sales in $million) 167 Table
    • 7.3 The Japan IVD market analysed by segment (sales in $million) 172 Table
    • 7.4 The German IVD market analysed by segment (sales in $million) 177 Table
    • 7.5 The French IVD market analysed by segment (sales in $million) 182 Table
    • 7.6 The Italian IVD market analysed by segment (sales in $million) 186 Table
    • 7.7 The UK IVD market analysed by segment (sales in $million) 191 Table
    • 7.8 The rest of Europe IVD market analysed by segment (sales in $million) 193 Table
    • 7.9 The rest of world IVD market analysed by segment (sales in $million) 194 Table
    • 7.10 Country/regional markets, clinical chemistry (sales in $million)* 197 Table
    • 7.11 Country/regional markets, critical care testing (sales in $million)* 197 Table
    • 7.12 Country/regional markets, urinalysis (sales in $million)* 197 Table
    • 7.13 Country/regional markets, whole blood glucose (sales in $million)* 198 Table
    • 7.14 Country/regional markets, immunodiagnostics (sales in $million)* 198 Table
    • 7.15 Country/regional markets, haematology/flow cytometry (sales in $million)* 198 Table
    • 7.16 Country/regional markets, microbiology (sales in $million)* 199 Table
    • 7.17 Country/regional markets, molecular diagnostics (sales in $million)* 199 Table
    • 7.18 Country/regional markets, coagulation (sales in $million)* 199 Table
    • 7.19 Country/regional markets, oTher (sales in $million)* 200 Table
    • 8.1 Worldwide sales of emerging and niche suppliers in The IVD market, 2006 208 Table
    • 8.2 Worldwide sales of leading suppliers in The IVD market, 2006 208 Table
    • 10.1 Market segment participation of The top ten IVD companies, 2006 241
  • List of Figures:
    • Figure 4.1 Global IVD products market distribution by product segment, 2006 and 2011 75 Figure
    • 4.2 Global IVD products market distribution by country/region, 2006 and 2011 79 Figure
    • 4.3 Distribution of global IVD products market by application segment, 2006 and 2011 80 Figure
    • 4.4 Worldwide clinical diagnostic products market by region 86 Figure
    • 5.1 Product segmentation of The clinical chemistry market, 2006 110 Figure
    • 5.2 Product segmentation of The clinical chemistry market, 2006 115 Figure
    • 5.3 Product segmentation of The haematology/flow cytometry/coagulation testing market, 2006 121 Figure
    • 5.4 Product segmentation of The cancer IVD testing products market, 2006 129 Figure
    • 5.5 Product segmentation of The molecular diagnostics products market, 2006 135 Figure
    • 5.6 Product segmentation of The point-of-care testing products market, 2006 143 Figure
    • 5.7 Product segmentation of The home and self-testing products market, 2006 149 Figure
    • 7.1 Percentage share per country/region of The global clinical chemistry market, 2006 200 Figure
    • 7.2 Percentage share per country/region of The global critical care testing market, 2006 200 Figure
    • 7.3 Percentage share per country/region of The global urinalysis market, 2006 200 Figure
    • 7.4 Percentage share per country/region of The global whole blood glucose testing products market, 2006 201 Figure
    • 7.5 Percentage share per country/region of The global immunodiagnostics products market, 2006 201 Figure
    • 7.6 Percentage share per country/region of The global haematology/flow cytometry products market, 2006 201 Figure
    • 7.7 Percentage share per country/region of The global microbiology products market, 2006 201 Figure
    • 7.8 Percentage share per country/region of The global molecular diagnostics market, 2006 202 Figure
    • 7.9 Percentage share per country/region of The global coagulation testing products market, 2006 202 Figure
    • 7.10 Percentage share per country/region of The global oTher IVD products market, 2006 202 Figure
    • 8.1 Worldwide IVD market shares under various scenarios, 2006