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The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 8th
Edition
This year, Kalorama has published its eighth edition of this informative volume based on the
market events of 2011. The report is over 1400 pages, reflecting the dramatic change in
IVD. New entrants, net technologies have entered the stage and all important events are
cataloged in this report. The idea behind Kalorama's unique report is that the entire market can
be captured in one volume and business planners avoid multiple purchases. Published every two
years, this volume includes coverage of the most important aspects of all of the major segments
of clinical lab testing, including:

      Point of Care (POC), (Professional and Self-Testing)
      Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)
      Core Lab (General Chemistries, Workstations, Analyzers)
      Immunoassays (Blood Gases, Urinalysis, Critical Care)
      Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology,
       Pharmacodiagnostics, Tissue Typing, Prenatal)
      Hematology
      Coagulation (Lab-Based, POC, Genetic Markers)
      Microbiology and Virology
      Blood Banking (Grouping, Immunoassay Screens, NAT Screens)

Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the
segments, where possible. Changes in technology development, regulatory and reimbursement
issues, clinical care, and business environments are discussed. Current market numbers are
presented for 2011, with projections given through 2016.

The "Bible of the IVD Industry"

Now in 8 editions, this report has become the go-to market research reference for the
industry. Many of the top IVD companies use this product for business planning, which means
that this volume can provide a uniform standard for in vitro diagnostic market numbers. This
edition greatly expands coverage of the field and tracks the most important developments. See
aspects of the industry that might not be available in your company's internal resources. View
the market from an independent point of view. Learn about competitors in away that may be
invisible to internal personnel. Know the market players - your competitors and potential
partners, in proper context and classification. Save countless hours of staff time and other
research expenses with the authoritative guide for IVD market estimates and forecasts.

A Global Report

From the first edition, this report was designed as a global resource in order to give market-
watchers a true picture of the industry. IVD is a worldwide business. While the US is a large
healthcare market, much of the dynamism, the growth, and also competition is occurring in other
areas. Many of the most interesting opportunities for companies are occurring in emerging
markets. As part of its coverage, the report breaks down the entire IVD market for the following
regions.

      North America
      Europe (EU countries, incl. IVD market sizes by country)
      Eastern Europe
      South America
      Asia (Japan, China and India)
      Rest of World

A Report Designed for a Changing Industry

A number of totally disparate phenomena have come together to change the IVD industry.
Human genome research is finding links between a person’s genome and several lifestyle
situations such as nutrition, dieting, skin conditions and other essentially non-medical conditions.
This has attracted consumer product companies such as Proctor & Gamble and Nestlé to develop
products and services based on IVD technologies. Decreases in life science grants has
encouraged companies active in this space to migrate their technologies for clinical applications.

 The result is the entry of companies such as Caliper Life Sciences, Illumina, Affymetrix and
Life Technologies to the diagnostics market with products and test services. Miniaturization of
traditional immunoassay and molecular test technologies has finally matured to the point where
they may be ready for scale-up and then commercialization into products. Here electronics
companies such as Sony, Samsung, Dell Computers and Intel Corp. have invested in clinical
diagnostics ventures. These exciting developments join expansion into new market segments by
companies already involved in the IVD industry.

In 2010 and 2011, there were at least 74 acquisitions and some 36 distribution agreements. And
this is only a small portion of what is really happening. There are many more deals that have not
been announced. The goal is to build better tests and stronger companies. The future of the
industry lies in the development of more sensitive, faster, user-friendly, IT capable devices for a
host of new protein and molecular markers.

In this eighth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama
Information addresses all of the key issues affecting the diagnostic industry in 2012 and how
competitors are faring. Among the topics tackled in this report:

Molecular diagnostics including infectious disease mdx, pharmacodiagnostics, molecular poc
and test services are put in a context.
   Merging IT and IVD: Establishing the EMR Record from IVD Tests
      Healthcare Reform and its Possible Impact on IVD.
      The Status of Automation in the Lab; Core Lab Section Includes Both Workstation and
       Automated Panel Revenues.
      Mass Spec, Next Gen Sequencing and Other Technology Entrants
      Hospital Infection Testing - the latest
      Several Hundred Company profiles. Top tier companies, Second and Third Tier
       companies but also Smaller Innovators. The report‘s profiles distinguish between
       companies that are leaders in all aspects of IVD, those that are Specialists in one
       particular area or a few.
      Major Mergers as well as Partnerships, Distribution Agreements.
      Brazil, India and China - Important Emerging Markets for IVD.
      Innovations in Blood Banking
      Histology/Cytology innovations; the role of FISH testing and Digital Images
      Healthcare statistics for various countries -healthcare spending as a percent of GDP, new
       hospitals, cost increases and other information.
      Tables that document the most competitive products on the market and under
       development in each area of IVD.
      Country-level Breakout of IVD market for major European and Asian countries.
      The Current Economic Situation
      Update on the Regulation of Novel Devices

Buy your copy of this report @ http://www.reportsnreports.com/reports/183811-the-worldwide-
market-for-in-vitro-diagnostic-ivd-tests-8th-edition.html


Report Details:
Published: July 2012
No. of Pages: 1400
Price : Single User License: US$ 6500       Price : Corporate User License: US$ 13000




Table of contents

CHAPTER ONE: EXECUTIVE SUMMARY
Introduction – Doing more with less
Scope and Methodology
Size and Growth of the Market
Market Trends

CHAPTER TWO: INTRODUCTION
Background
Report Design
Lab Medicine Disciplines And Applications
Market Analysis of IVD Market Segments
The lure of IVD – new majors and entrants
Licenses and distribution agreements
Test Services
Top Suppliers and Niche players
Point of View

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Background
Population and Disease Demographics, Worldwide
Chronic Diseases as a Market Driver
Cancer
Diabetes
Allergy
The BRIC Effect
World Segments of the IVD Market and IVD Market Evolution
Specific Country Information
The United States of America – a world in flux
RUO/IUO Issues
The Patient Protection and Affordable Care Act
Accountable Care Organizations
LDT Oversight
Accent on Preventative Care
In Patient Bundling
Molecular test reimbursement
Japan
Europe – effects of austerity
IVD Directive Update
China
India
Brazil
Russia

CHAPTER FOUR: TRENDS AND INNOVATION
Background
Looking to the East
Looking Past the Hospital ER
Telemedicine and Home Care Trends
Commercialization of Novel Tests
EMR Update
Wireless Connectivity and Healthcare Efficiencies
Apps everywhere
The search for non-invasive tools

CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS
Overview of POC Tests
The Major POC Test Players
Market Analysis
Blood Glucose Monitoring
Blood Glucose Self Testing
Continuous Self Testing
Blood Glucose Testing by Professionals
Diabetes Testing – Glycated Hemoglobin
The Genetics of Diabetes
The Commercial Outlook for POC Tests

CHAPTER SIX: THE CORE LAB
Core Lab Overview
Overview of Chemistry Tests
Market Analysis : Leading Suppliers and Growth Potential
Lab-based Chemistries
Critical Care Analysis
Urinalysis
The Commercial Outlook for the Core Lab

CHAPTER SEVEN: IMMUNOASSAYS
Overview of Immunoassays
Market Analysis
Immunoassay Test Segments - Mature and Emerging
Point-of-care OTC and Professional Use
The Commercial Outlook for Immunoassays

CHAPTER EIGHT: MOLECULAR ASSAY PLATFORMS
Overview of Molecular Assays
Worldwide Opportunities for Molecular Tests
Molecular Test User Markets
Next generation Sequencing
Mass Spectroscopy
Molecular Technologies And Players
Market Analysis
Oncology
Inherited Diseases
Pharmacodiagnostics
Prenatal Chromosome Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests

CHAPTER NINE: HEMATOLOGY
Overview of Hematology
Automation and IT
Digital Evolution
Decentralized Hematology Testing
Market Analysis : Leading Suppliers
The Commercial Outlook for Hematology Tests

CHAPTER TEN: COAGULATION
Overview of Coagulation / Immunohematology Tests
Special Topic
Genetics and Personalized Medicine
Warfarin
Plavix
Market Analysis
Lab-based Testing
Genetic markers of hypercoagulopathies
Decentralized Coagulation testing – Professional Use
Decentralized Coagulation testing – OTC
Platelet Testing
Leading Suppliers
The Commercial Outlook for Coagulation Tests

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
Overview of Microbiology / Virology Tests
Special Topics
Antimicrobial Drug Resistance
Genome Sequencing and Mass Spectrometry
Sepsis Serology
Market Analysis
Supplies
Chromogenic Media
Microbial Identification and Antimicrobial Sensitivity Tests
Liquid Microbiology
Blood Culture
Immunoassays – lab based
Immunoassays – rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology Tests

CHAPTER TWELVE: BLOOD BANKING SERVICES
Overview of Blood Banking
Blood Management – are all these transfusions good medicine
Blood Tracking
Chagas Disease
Platelet Safety
Market Analysis
Blood Grouping
Immunoassay Screens
Nucleic Acid Testing Continues to Grow
Leading Suppliers
The Commercial Outlook for Blood Banking

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
Overview of Histology / Cytology
Special Topics
Companies expand with test services
Market Analysis
Histology/Cytology
Traditional Stains
Pap and HPV Tests
Immunochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging
Tissue Microarrays
Circulating Tumor Cells
Chromosome Analysis
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests

COMPANIES PROFILED

CHAPTER FOURTEEN: The Top Tier
Abbott Diagnostics
Alere
Arkray
Beckman Coulter Inc.
Becton, Dickinson and Company (BD)
bioMérieux Inc.
Bio-Rad Laboratories Inc.
Danaher Corporation
Gen-Probe Inc.
Hologic, Inc.
Horiba Medical
Instrumentation Laboratory (IL)
Ortho Clinical Diagnostics
QIAGEN N.V.
Radiometer A/S
Roche Diagnostics
Siemens Healthcare Diagnostics
Sysmex Corporation
Thermo Fisher Scientific Inc.

CHAPTER FIFTEEN: The Second Tier
Affymetrix, Inc.
Agilent Technologies Inc.
Axis-Shield plc
Bruker BioSciences Corporation
Celera Diagnostics
Cepheid
China Medical Technologies
Dako A/S
DiaSorin S.p.A.

Eiken Chemical Co., Ltd
ELITech Group
Fujirebio Diagnostics, Inc.
General Electric - GE Healthcare
Grifols, S.A.
Illumina Inc.
IRIS International, Inc.
Life Technologies
Luminex Corporation
Magellan Biosciences
A. Menarini Diagnostics
Mindray Bio-Medical Electronics Co., Ltd
Nanosphere, Inc.
Nova Biomedical
Novartis Diagnostics
PerkinElmer, Inc.
Phadia AB
Quidel Corporation
Randox Laboratories Ltd.
Sequenom
Tosoh Corporation
Transasia Bio-Medicals Ltd.
Trinity Biotech plc
Ventana Medical Systems Inc.
Veridex, LLC
Wako Pure Chemical Industries, Ltd.
Werfen Group S.A


Contact: sales@reportsandreports.com for further details.

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The worldwide market for in vitro diagnostic (ivd) tests, 8th edition

  • 1. The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 8th Edition This year, Kalorama has published its eighth edition of this informative volume based on the market events of 2011. The report is over 1400 pages, reflecting the dramatic change in IVD. New entrants, net technologies have entered the stage and all important events are cataloged in this report. The idea behind Kalorama's unique report is that the entire market can be captured in one volume and business planners avoid multiple purchases. Published every two years, this volume includes coverage of the most important aspects of all of the major segments of clinical lab testing, including:  Point of Care (POC), (Professional and Self-Testing)  Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)  Core Lab (General Chemistries, Workstations, Analyzers)  Immunoassays (Blood Gases, Urinalysis, Critical Care)  Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)  Hematology  Coagulation (Lab-Based, POC, Genetic Markers)  Microbiology and Virology  Blood Banking (Grouping, Immunoassay Screens, NAT Screens) Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the segments, where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market numbers are presented for 2011, with projections given through 2016. The "Bible of the IVD Industry" Now in 8 editions, this report has become the go-to market research reference for the industry. Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments. See aspects of the industry that might not be available in your company's internal resources. View the market from an independent point of view. Learn about competitors in away that may be invisible to internal personnel. Know the market players - your competitors and potential partners, in proper context and classification. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts. A Global Report From the first edition, this report was designed as a global resource in order to give market-
  • 2. watchers a true picture of the industry. IVD is a worldwide business. While the US is a large healthcare market, much of the dynamism, the growth, and also competition is occurring in other areas. Many of the most interesting opportunities for companies are occurring in emerging markets. As part of its coverage, the report breaks down the entire IVD market for the following regions.  North America  Europe (EU countries, incl. IVD market sizes by country)  Eastern Europe  South America  Asia (Japan, China and India)  Rest of World A Report Designed for a Changing Industry A number of totally disparate phenomena have come together to change the IVD industry. Human genome research is finding links between a person’s genome and several lifestyle situations such as nutrition, dieting, skin conditions and other essentially non-medical conditions. This has attracted consumer product companies such as Proctor & Gamble and Nestlé to develop products and services based on IVD technologies. Decreases in life science grants has encouraged companies active in this space to migrate their technologies for clinical applications. The result is the entry of companies such as Caliper Life Sciences, Illumina, Affymetrix and Life Technologies to the diagnostics market with products and test services. Miniaturization of traditional immunoassay and molecular test technologies has finally matured to the point where they may be ready for scale-up and then commercialization into products. Here electronics companies such as Sony, Samsung, Dell Computers and Intel Corp. have invested in clinical diagnostics ventures. These exciting developments join expansion into new market segments by companies already involved in the IVD industry. In 2010 and 2011, there were at least 74 acquisitions and some 36 distribution agreements. And this is only a small portion of what is really happening. There are many more deals that have not been announced. The goal is to build better tests and stronger companies. The future of the industry lies in the development of more sensitive, faster, user-friendly, IT capable devices for a host of new protein and molecular markers. In this eighth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information addresses all of the key issues affecting the diagnostic industry in 2012 and how competitors are faring. Among the topics tackled in this report: Molecular diagnostics including infectious disease mdx, pharmacodiagnostics, molecular poc and test services are put in a context.
  • 3. Merging IT and IVD: Establishing the EMR Record from IVD Tests  Healthcare Reform and its Possible Impact on IVD.  The Status of Automation in the Lab; Core Lab Section Includes Both Workstation and Automated Panel Revenues.  Mass Spec, Next Gen Sequencing and Other Technology Entrants  Hospital Infection Testing - the latest  Several Hundred Company profiles. Top tier companies, Second and Third Tier companies but also Smaller Innovators. The report‘s profiles distinguish between companies that are leaders in all aspects of IVD, those that are Specialists in one particular area or a few.  Major Mergers as well as Partnerships, Distribution Agreements.  Brazil, India and China - Important Emerging Markets for IVD.  Innovations in Blood Banking  Histology/Cytology innovations; the role of FISH testing and Digital Images  Healthcare statistics for various countries -healthcare spending as a percent of GDP, new hospitals, cost increases and other information.  Tables that document the most competitive products on the market and under development in each area of IVD.  Country-level Breakout of IVD market for major European and Asian countries.  The Current Economic Situation  Update on the Regulation of Novel Devices Buy your copy of this report @ http://www.reportsnreports.com/reports/183811-the-worldwide- market-for-in-vitro-diagnostic-ivd-tests-8th-edition.html Report Details: Published: July 2012 No. of Pages: 1400 Price : Single User License: US$ 6500 Price : Corporate User License: US$ 13000 Table of contents CHAPTER ONE: EXECUTIVE SUMMARY Introduction – Doing more with less Scope and Methodology Size and Growth of the Market Market Trends CHAPTER TWO: INTRODUCTION Background Report Design Lab Medicine Disciplines And Applications
  • 4. Market Analysis of IVD Market Segments The lure of IVD – new majors and entrants Licenses and distribution agreements Test Services Top Suppliers and Niche players Point of View CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS Background Population and Disease Demographics, Worldwide Chronic Diseases as a Market Driver Cancer Diabetes Allergy The BRIC Effect World Segments of the IVD Market and IVD Market Evolution Specific Country Information The United States of America – a world in flux RUO/IUO Issues The Patient Protection and Affordable Care Act Accountable Care Organizations LDT Oversight Accent on Preventative Care In Patient Bundling Molecular test reimbursement Japan Europe – effects of austerity IVD Directive Update China India Brazil Russia CHAPTER FOUR: TRENDS AND INNOVATION Background Looking to the East Looking Past the Hospital ER Telemedicine and Home Care Trends Commercialization of Novel Tests EMR Update Wireless Connectivity and Healthcare Efficiencies Apps everywhere The search for non-invasive tools CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS Overview of POC Tests
  • 5. The Major POC Test Players Market Analysis Blood Glucose Monitoring Blood Glucose Self Testing Continuous Self Testing Blood Glucose Testing by Professionals Diabetes Testing – Glycated Hemoglobin The Genetics of Diabetes The Commercial Outlook for POC Tests CHAPTER SIX: THE CORE LAB Core Lab Overview Overview of Chemistry Tests Market Analysis : Leading Suppliers and Growth Potential Lab-based Chemistries Critical Care Analysis Urinalysis The Commercial Outlook for the Core Lab CHAPTER SEVEN: IMMUNOASSAYS Overview of Immunoassays Market Analysis Immunoassay Test Segments - Mature and Emerging Point-of-care OTC and Professional Use The Commercial Outlook for Immunoassays CHAPTER EIGHT: MOLECULAR ASSAY PLATFORMS Overview of Molecular Assays Worldwide Opportunities for Molecular Tests Molecular Test User Markets Next generation Sequencing Mass Spectroscopy Molecular Technologies And Players Market Analysis Oncology Inherited Diseases Pharmacodiagnostics Prenatal Chromosome Analysis Tissue Typing The Commercial Outlook for Molecular Tests CHAPTER NINE: HEMATOLOGY Overview of Hematology Automation and IT Digital Evolution Decentralized Hematology Testing
  • 6. Market Analysis : Leading Suppliers The Commercial Outlook for Hematology Tests CHAPTER TEN: COAGULATION Overview of Coagulation / Immunohematology Tests Special Topic Genetics and Personalized Medicine Warfarin Plavix Market Analysis Lab-based Testing Genetic markers of hypercoagulopathies Decentralized Coagulation testing – Professional Use Decentralized Coagulation testing – OTC Platelet Testing Leading Suppliers The Commercial Outlook for Coagulation Tests CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY Overview of Microbiology / Virology Tests Special Topics Antimicrobial Drug Resistance Genome Sequencing and Mass Spectrometry Sepsis Serology Market Analysis Supplies Chromogenic Media Microbial Identification and Antimicrobial Sensitivity Tests Liquid Microbiology Blood Culture Immunoassays – lab based Immunoassays – rapid Molecular Tests The Commercial Outlook for Microbiology / Virology Tests CHAPTER TWELVE: BLOOD BANKING SERVICES Overview of Blood Banking Blood Management – are all these transfusions good medicine Blood Tracking Chagas Disease Platelet Safety Market Analysis Blood Grouping Immunoassay Screens Nucleic Acid Testing Continues to Grow Leading Suppliers
  • 7. The Commercial Outlook for Blood Banking CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY Overview of Histology / Cytology Special Topics Companies expand with test services Market Analysis Histology/Cytology Traditional Stains Pap and HPV Tests Immunochemistry and In Situ Hybridization Pharmacodiagnostic Histology Digital Imaging Tissue Microarrays Circulating Tumor Cells Chromosome Analysis Flow Cytometry The Commercial Outlook for Histology and Cytology Tests COMPANIES PROFILED CHAPTER FOURTEEN: The Top Tier Abbott Diagnostics Alere Arkray Beckman Coulter Inc. Becton, Dickinson and Company (BD) bioMérieux Inc. Bio-Rad Laboratories Inc. Danaher Corporation Gen-Probe Inc. Hologic, Inc. Horiba Medical Instrumentation Laboratory (IL) Ortho Clinical Diagnostics QIAGEN N.V. Radiometer A/S Roche Diagnostics Siemens Healthcare Diagnostics Sysmex Corporation Thermo Fisher Scientific Inc. CHAPTER FIFTEEN: The Second Tier Affymetrix, Inc. Agilent Technologies Inc. Axis-Shield plc
  • 8. Bruker BioSciences Corporation Celera Diagnostics Cepheid China Medical Technologies Dako A/S DiaSorin S.p.A. Eiken Chemical Co., Ltd ELITech Group Fujirebio Diagnostics, Inc. General Electric - GE Healthcare Grifols, S.A. Illumina Inc. IRIS International, Inc. Life Technologies Luminex Corporation Magellan Biosciences A. Menarini Diagnostics Mindray Bio-Medical Electronics Co., Ltd Nanosphere, Inc. Nova Biomedical Novartis Diagnostics PerkinElmer, Inc. Phadia AB Quidel Corporation Randox Laboratories Ltd. Sequenom Tosoh Corporation Transasia Bio-Medicals Ltd. Trinity Biotech plc Ventana Medical Systems Inc. Veridex, LLC Wako Pure Chemical Industries, Ltd. Werfen Group S.A Contact: sales@reportsandreports.com for further details.