2009 Worldwide Diagnostics Market Research Bundle

Table of Contents

IN VITRO DIAGNOSTICS IN A RECESSIONARY ECONOMY

CHAPTER ONE: Executive Summary

• Scope and Methodology
• Market Trends
• World Demand for Diagnostics
• Keys to Success

CHAPTER TWO: Introduction

• Background
• Marketing in a recession - what the experts say about the 4Ps
• Obama' s new deal - boom and bust
• Musings on what form a reformed U.S. system might take
• Status quo and future - impressing investors in a bear market

CHAPTER THREE: Market Trends/Demand Analysis

• Hospital financing
• The role of new deal for the insured, uninsured and underinsured
• Payer response to economic stress
• Demand for esoteric tests
• World market for IVD tests and services
  • 2009 Market Estimates (N. America, EU West Europe, Japan, China, Latin America, India, EU East Europe, ROW)
  • 2014 Market Forecasts (N. America, EU West Europe, Japan, China, Latin America, India, EU East Europe, ROW)
  • Economic Conditions in United States of America
  • Economic Conditions in Europe
  • Economic Conditions in Japan
  • Economic Conditions in China

CHAPTER FOUR: Market Overview/Supply Analysis

• Market Analysis, revenue estimates 2007 - 2015
• IVD Sectors Revenues
  • Clinical Chemistry,
  • Immunoassays - non isotopic Infectious Diseases
  • Other Immunos
  • Blood Bank Screening
  • Hematology
  • Microbiology (ID/AST)
  • Molecular Microbiology
  • Radioimmunoassays
  • Coagulation
  • Histology/Cytology
  • Nucleic Acid Assays
  • Blood Grouping/Typing
  • Blood Bank Molecular
  • Flow Cytometry
  • POC -OTC diabetes
  • POC -OTC other
  • POC -Professional/Hospital
• IVD Events
  • New Tests and Technologies
    • Abbott Diagnostics
    • Adnavance Technologies
    • Arbor Vita Corporation
    • Arcxis Biotechnologies and Roche
    • Assay Designs
    • Aureon Laboratories
    • Bayer Healthcare
    • BD Diagnostics
    • bioMerieux
    • BRAHMS
    • Caris Diagnostics
    • CISBIO Bioassays
    • Decision Biomarkers
    • DexCom
    • Diagnostic HYBRIDS
    • Fujirebio Diagnostics
    • GeneNews
    • InVivoScribe Technologies
    • Network Biosystems
  • Acquisitions, Mergers
    • Abbott Diagnostics-Ibis
    • Beckman Coulter-Nephromics
    • Exiqon A/S-Oncotech
    • GE Healthcare-Whatman
    • Others
  • Collaborations
  • Market Expansion Activities
  • Lab Services
  • Lab Information
    • Google
    • IBM
    • Intel Corporation
    • General Data Company Technology

CHAPTER FIVE: Company Profiles

• Abbott Diagnostics
• Beckman Coulter Inc.
• Becton, Dickinson and Company (BD)
• bioMerieux Inc.
• Celera Corporation
• Cellestis Ltd
• Cepheid
• Clarient Inc. (formerly ChromaVision)
• deCode Genetics Inc.
• Genomic Health
• Gen-Probe Inc.
• Immucor, Inc.
• Inverness Medical Innovations
• Luminex Corporation
• Monogram Biosciences, Inc.
• Nanogen
• Ortho Clinical Diagnostics (OCD)
• Qiagen N.V.
• Quidel Corporation
• Roche Diagnostics
• Seegene, Inc.
• Sequenom, Inc.
• Siemens Medical Solutions Diagnostics
• Sysmex Corporation
• Vermillion/Ciphergen Biosystems Inc.

CHAPTER SIX: Conclusion

• Pricing Strategy
• Marketing Strategy
• Supply and Demand

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Figure 1-1: Growth Rates Compared: World Regions

CHAPTER TWO: INTRODUCTION

• Table 2-1: Selected IVD Venture Investments

CHAPTER THREE: MARKET TRENDS/DEMAND ANALYSIS

• Table 3-1: Number of People Worldwide Who Get Chronic Diseases Every Year
• Table 3-2: Percent Change in Industrial Productivity, by Country or Region, December 2007 to December 2008
• Table 3-3: Worldwide In Vitro Diagnostic Reagent Sales by country, 2009-2014
• Table 3-4: Europe Unemployment Rates and % change in GDP

CHAPTER FOUR: Market Overview/Supply Analysis

• Table 4-1: Worldwide In Vitro Diagnostic Reagent Sales by Product Segment, 2009-2014 (Clinical Chemistry, Immunoassays, Blood Bank Screening, Hematology, Microbiology, Radioimmunoassays, Coagulation, Histology/Cytology, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, POC OTC diabetes, POC, OTC Other, POC, Professional/Hospital)

CHAPTER SIX: Conclusion

• Table 6-1: Pricing Structures That Create Value for the Customer

WORLDWIDE MARKET FOR IN VITRO DIAGNOSTICS, 6th EDITION

Chapter one: Executive Summary

• Overview
• Size and Growth of the Market
  • Important Changes in the IVD Market
  • IVD Growth in Developed Countries
  • Privatization of Healthcare
  • Newly Aggressive Foundations and Initiatives

• Positive and Negative Market Trends
  • Human Genome Project Applications
  • Remote Patient Monitoring
  • Demand for Data
  • The Informed Medical Consumer
  • Price Point of New Products
  • Focus On Home Care Raises Questions

• Top Suppliers and Niche Players
• Scope and Methodology
  • Exchange Rates
  • Scope
  • Methodology

Chapter two: Introduction

• New Report Design
• Lab Medicine Disciplines and Applications
  • Core Lab

• Market Analysis of IVD Market Segments
• Age of the Giants and Smaller Colossuses
• Licenses and Distribution Agreements
• Top Suppliers and Niche Players
• Point of View

Chapter three: Overview of Global In Vitro Diagnostic Markets

• The Boomers and Aging Worldwide
• Healthcare Spending Worldwide
• World Segments of the IVD Market and IVD Market Evolution
  • The United States
  • Japan Just Barely Holding Its Own
  • Europe
  • China
  • India
  • Africa

CHAPTER FOUR: TRENDS AND INNOVATIONS:

• Background
• Diabetes innovation
• Miniaturization And Chip Progress
• Non-Invasive Techniques And Alternative Samples
• Commercialization Issues : Patents and market innovation
• Direct to Consumer marketing
• Patient Management and Outcomes-Based Medicine
• Economics of New Tests and Technologies - the old don' t disappear
• Post Genomics and Pharmacogenomics - reality check
• Growing Globalization of Public Health Crises - SARS, West Nile, Biowar impact
• Regulatory and Reimbursement Issues And Novel Devices

CHAPTER FIVE: Point-of-Care Tests

• Overview
• Special Topics
  • POC in world market
  • The pros and cons of POC testing
  • Telemedicine Goes Wireless

• Market Analysis
  • Blood Glucose Monitoring

• The Commercial Outlook for POC Tests
• Companies to Watch

Chapter six: The Core Lab

• Core Lab Overview
• Overview of Chemistry Tests
• Special Topics
  • Competing for Customer Loyalty
  • Client Side
  • Vendor Side
  • Managed Service Plans

• Market Analysis
  • Lab-based Chemistries
  • Critical Care Chemistries
  • Responses to Cost Pressures

• The Commercial Outlook for Chemistry Tests
• Companies to Watch
• Abaxis, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Abbott Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details

• Beckman Coulter Inc.
• Beckman Coulter Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Instrumentation Laboratory (IL)
  • Recent Revenue History
  • Key Comment
  • Details

• IRIS International, Inc.
• IRIS International, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Maxmat S.A.
• Maxmat S.A.
  • Recent Revenue History
  • Key Comment
  • Details

• Nova Biomedical
  • Recent Revenue History
  • Key Comment
  • Details

• Olympus America Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• OPTI Medical Systems, Inc.
• OPTI Medical Systems, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Ortho Clinical Diagnostics (OCD)
  • Recent Revenue History
  • Key Comment
  • Details

• Probe Scientific
  • Recent Revenue History
  • Key Comment
  • Details

• Radiometer A/S
  • Recent Revenue History
  • Key Comment
  • Details

• Randox Laboratories
  • Recent Revenue History
  • Key Comment
  • Details

• Roche Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details

• Siemens Medical Solutions Diagnostics
  • Recent Revenue History
  • Key Comment

• Sphere Medical Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

Chapter seven: Immunoassays

• Overview of Immunoassays
  • New Immunoassays
  • Changes in the Immunoassay Market

• Special Topics
  • Proteins: How Low Can You Go
  • New Platforms
  • immunoPCR
  • FACTT
  • NADIA
  • ELISA
  • Role of Immunoassays in Disease Management

• Market Analysis: Leading Suppliers and Growth Potential
  • Regional Breakdown
  • Abbott
  • Roche
  • Beckman Coulter
  • Siemens/Bayer
  • bioMerieux
• Seimens/Dade Behring

• Immunoassay Test Segments - Mature, Maturing and Emerging
  • Thyroid Function
  • Therapeutic drug tests
  • IMx Sirolimus
  • Tacrolimus
  • Mature Immunoassays
  • Anemia
  • Fertility
  • Tox/DAU
  • Allergy
  • Maturing Immunoassays
  • Proteins
  • Growth Immunoassays
  • Tumor Markers
  • Cardiac Markers
  • Autoimmune
  • Sepsis
  • Diabetes
  • Miscellaneous

• Point-of-care OTC and Professional Use
  • Patient Self-tests (OTC)
  • Pregnancy
  • Fecal Occult Blood
  • Breath Tests
  • Professional POC
  • Cholesterol
  • Cardiac Markers
  • Cancer Markers

• The Commercial Outlook for Immunoassays
• Companies to Watch
• Aesku Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details

• AspenBio Pharma, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Axela Biosensors, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Axis-Shield plc
  • Recent Revenue History
  • Key Comment
  • Details

• BG Medicine Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• The Binding Site
  • Recent Revenue History
  • Key Comment
  • Details

• Biocheck Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• BioCurex, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• BioMarker Group
  • Recent Revenue History
  • Key Comment
  • Details

• BioMedical Diagnostics SA (BMD)
  • Recent Revenue History
  • Key Comment
  • Details

• Biosite Incorporated
  • Key Comment
  • Details

• BioSystems International
  • Recent Revenue History
  • Key Comment
  • Details

• Bio-Rad Laboratories Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Chimera Biotec GmbH
  • Recent Revenue History
  • Key Comment
  • Details

• China Medical Technologies, Inc.
  • Key Comment
  • Details

• Concateno Plc
  • Recent Revenue History
  • Key Comment
  • Details

• Conceivex, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Corgenix Medical Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Crescent Diagnostics Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Critical Therapeutics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Cylex Incorporated
  • Recent Revenue History
  • Key Comment
  • Details

• CytoCore, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Diazyme Laboratories
  • Recent Revenue History
  • Key Comment
  • Details

• Early Detect, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• ESA Biosciences Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Euroimmun AG
  • Recent Revenue History
  • Key Comment
  • Details

• Fujirebio Diagnostics. Inc. (FDI)
  • Recent Revenue History
  • Key Comment
  • Details

• Genosis Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Grifols, S.A.
  • Key Comment
  • Details

• Guava Technologies, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• INOVA Diagnostics Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• LifeAssays AB
  • Recent Revenue History
  • Key Comment
  • Details

• Matritech
  • Recent Revenue History
  • Key Comment
  • Details

• Medical Services International Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Meridian Bioscience, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Miraculins Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Nanobac Pharmaceuticals Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Nanogen
  • Recent Revenue History
  • Key Comment
  • Details

• Onconome, Inc.
• Onconome, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Panacea Pharmaceuticals, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Phadia AB
  • Recent Revenue History
  • Key Comment
  • Details

• Pria Diagnostics LLC
  • Recent Revenue History
  • Key Comment
  • Details

• Pronostics Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Qualigen, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Quidel Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Reagena Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Response Biomedical Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Serion Immundiagnostica GmbH
  • Recent Revenue History
  • Key Comment
  • Details

• Singulex Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Spectral Diagnostics Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Synova Healthcare, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• TOSOH Corporation
  • Recent Revenue History
  • Key Comment
  • Details

Chapter eight: Molecular Assays

• Overview
• Special Topics
  • The Special Case of Regulating Molecular Tests

• The promise of personalized medicine
• PCR Patent Update
• Molecular Testing Innovation: Technology and Players
• Market Analysis
  • Nucleic Acid Tests
  • Prenatal Chromosome Analysis
  • Tissue Typing

• The Commercial Outlook for Molecular Tests
• Companies to Watch
• 23andMe, Inc.
  • Recent Revenue History:
  • Key comment:
  • Details

• 454 Life Sciences Corporation
• 454 Life Sciences Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details
  • Affymetrix

• Recent Revenue History:
  • Key Comment:
  • Details

• Almac Diagnostics
  • Recent Revenue History:
  • Key Comment:
  • Details

• Althea Technologies, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Arcxis Biotechnologies
  • Recent Revenue History:
  • Key Comment:
  • Details

• Asuragen, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• AutoGenomics, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• BioNanomatrix
  • Recent Revenue History:
  • Key Comment:
  • Details

• Bruker BioSciences Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Celera
  • Recent Revenue History:
  • Key Comment:
  • Details

• CeMines, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Clinical Data, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• CombiMatrix Molecular Diagnostics (CMDX)
  • Recent Revenue History:
  • Key Comment:
  • Details

• Consumer Genetics
  • Recent Revenue History:
  • Key Comment:
  • Details

• Curidium Medica Plc
  • Recent Revenue History:
  • Key Comment:
  • Details

• Sekisui Medical Co., Ltd
  • Recent Revenue History:
  • Key Comment:
  • Details

• deCode Genetics Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• diaDexus Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• DiagnoCure
  • Recent Revenue History
  • Key Comment:
  • Details

• DxS
  • Recent Revenue history:
  • Key Comment:
  • Details

• eGene Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Eiken Chemical Co., Ltd.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Epigenomics AG
  • Recent Revenue History:
  • Key Comment:
  • Details

• EXACT Sciences Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Exiqon A/S
  • Recent Revenue History:
  • Key Comment:
  • Details

• Fluidigm Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Gen-Probe Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Genomic Health
  • Recent Revenue History:
  • Key Comment:
  • Details

• Genzyme Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Greiner Bio-One International AG
  • Recent Revenue History:
  • Key Comment:
  • Details

• Ipsogen
  • Recent Revenue History:
  • Key Comment:
  • Details

• Laboratory Corporation of America Holdings (LabCorp)
  • Recent Revenue History:
  • Key Comment:
  • Details

• Luminex Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• MacroArray Technologies, LLC
  • Recent Revenue History:
  • Key Comment:
  • Details

• Med BioGene, Inc. (MBI)
  • Recent Revenue History:
  • Key Comment:
  • Details

• Modern Technology Corp.
  • Recent Revenue History:
  • Key comment:
  • Details

• Myriad Genetics, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Nanosphere, Inc.
  • Recent Revenue History:
  • Key Comment:

• Navigenics
  • Recent revenue History:
  • Key Comment:
  • Details

• NeuroMark
  • Recent Revenue History:
  • Key Comment:
  • Details

• NorDiag ASA
  • Recent Revenue History:
  • Key Comment:
  • Details

• Novartis Vaccines and Diagnostics/Chiron
  • Recent Revenue History:
  • Key Comment:
  • Details

• Nuvera Biosciences
  • Recent Revenue History:
  • Key Comment:
  • Details

• Orion Genomics
  • Recent Revenue History:
  • Key Comment:
  • Details

• Osmetech plc
  • Recent Revenue History
  • Key Comment:
  • Details

• ParagonDx LLC
  • Recent Revenue History:
  • Key Comment:
  • Details

• PerkinElmer, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Power3 Medical Products, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Progenika Biopharma
  • Recent Revenue History:
  • Key Comment:
  • Details

• Provista Diagnostics
  • Recent Revenue History:
  • Key Comment:
  • Details

• Psynomics Incorporated
  • Recent Revenue History:
  • Key Comment:
  • Details

• Q Chip Ltd.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Qiagen N.V.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Quest Diagnostics Incorporated
  • Recent Revenue History:
  • Key Comment
  • Details

• Rosetta Genomics Ltd.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Seegene, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• SensiGen LLC
  • Recent Revenue History:
  • Key Comment:
  • Details

• Sequenom, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Source MDx
  • Recent Revenue History:
  • Key Comment:
  • Details

• Tepnel Diagnostics Ltd.
  • Recent Revenue History:
  • Key Comment
  • Details

• Third Wave Technologies Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Whatman plc
  • Recent Revenue History:
  • Key Comment
  • Details

• Xenomics, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

Chapter nine: Hematology

• Overview
• Decentralized Hematology Testing
• Market Analysis: Leading Suppliers
• The Commercial Outlook for Hematology Tests
• Companies to Watch
• Alifax S.p.a.
  • Recent Revenue History
  • Key Comment
  • Details

• CellaVision AB
  • Recent Revenue History
  • Key Comment
  • Details

• Chempaq A/S
  • Recent Revenue History
  • Key Comment
  • Details

• Diesse Diagnostica Senese S.p.A.
  • Recent Revenue History
  • Key Comment
  • Details

• ELITech Group
  • Recent Revenue History
  • Key Comment
  • Details

• Horiba ABX S.A.
  • Recent Revenue History
  • Key Comment
  • Details

• QBC Diagnostics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Sysmex Corporation
  • Recent Revenue History
  • Key Comment
  • Details

Chapter TEN: Coagulation

• Overview of Coagulation and Immunohematology Tests
• Market Analysis
  • Lab-Based Testing
  • D-dimer
  • Aspirin Insensitivity
  • Genetic Markers of Hypercoagulopathies
  • Factor V
  • Warfarin
  • Decentralized Coagulation Testing - Professional Use
  • Decentralized Coagulation Testing - OTC
  • Leading Suppliers

• The Commercial Market for Coagulation Tests
• Companies to Watch
• HemoSense, Inc.
  • Recent Revenue History: 2007 $31.9 million (est)
  • Key Comment
  • Details

• International Technidyne Corp (ITC)
  • Recent Revenue History
  • Key Comment
  • Details

• Diagnostica Stago
  • Recent Revenue History
  • Key Comment
  • Details

• Trinity Biotech plc
  • Revenues

• Revenues
  • Key Comment
  • Details

• ZyCare, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

Chapter eleven: Microbiology and Virology

• Overview
• Special Topics
  • Hospital Acquired Infections (HAIs)
  • MRSA
  • HIV, a 25-year Phenomenon
  • Rapid Tests for HIV
  • Tuberculosis
  • Cellestis
  • MDR-TB
  • Emerging Organisms and the Globalization of Infectious Diseases
  • SARS
  • Viral Hemorrhagic Fever
  • Dengue
  • MPV
  • Globalization Brings New Threats
  • Yaws
  • Andenovirus type 14
  • Non-Traditional Systems
  • FISH
  • Cell Counting by Flow Cytometry
  • Laser Based Microbial Detection

• Market Analysis
  • Supplies
  • Microbial Identification and Antimicrobial Sensitivity Tests
  • Blood Culture
  • Rapid Tests
  • Immunoassays - Lab based
  • STDs
  • Flu
  • Immunoassays - Rapid
  • Molecular Tests

• The Commercial Outlook for Microbiology / Virology Tests
• Companies to Watch
• 3M Medical Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details

• Accelr8 Technology Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• AdvanDx, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Becton, Dickinson and Company (BD)
  • Recent Revenue History
  • Key Comment
  • Details

• bioMerieux Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• bioLytical Laboratories
  • Recent Revenue History
  • Key Comment
  • Details
  • Recent Revenue History
  • Key Comment
  • Details

• The BioPen Company
  • Recent Revenue History
  • Key Comment
  • Details

• Calypte Biomedical Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Cellestis Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Cepheid
  • Recent Revenue History
  • Key Comment
  • Details

• Chembio Diagnostics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Common Sense Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Diagnostic HYBRIDS, Inc. (DHI)
  • Recent Revenue History
  • Key Comment
  • Details

• Dynacon Inc.
  • Recent Revenue History
  • Ket Comment:
  • Details

• Enigma Diagnostics Limited
  • Recent Revenue History
  • Key Comment
  • Details

• GenPrime, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Hain Lifescience GmbH
  • Recent Revenue History
  • Key Comment
  • Details

• HIVmirror LLC
  • Recent Revenue History
  • Key Comment
  • Details
  • Recent Revenue History
  • Key Comment
  • Details

• MedMira, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Microbionetics/IME, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Micro Imaging Technology, Inc. (MIT)
  • Recent Revenue History
  • Key Comment
  • Details

• Microgen Bioproducts Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• Mobidiag Oy
  • Recent Revenue History
  • Key Comment
  • Details

• Molzym GmbH & Co. KG
  • Recent Revenue History
  • Key Comment
  • Details

• Monogram Biosciences, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Myconostica, Ltd.
  • Recent Revenue History
  • Key Comment
  • Details

• OraSure Technologies, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Oxoid
  • Recent Revenue History
  • Key Comment
  • Details

• Pathway Diagnostics Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Pocared Diagnostics Ltd
  • Recent Revenue History
  • Key Comment
  • Details

• SIRS-Lab
  • Recent Revenue History
  • Key Comment
  • Details

• StatSure Diagnostic Systems, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• TREK Diagnostic Systems
  • Recent Revenue History
  • Key Comment
  • Details

Chapter twelve: Blood Banking Services

• Overview
  • Donor Pools, Costs, Safety, Blood Supply

• The Safety Imperative
  • Chagas
  • West Nile
  • Hepatitis and HIV
  • Platelets

• Market Analysis
  • Blood Grouping
  • Immunoassays
  • Nucleic Acid Testing (NAT) Continues to Grow

• The Commercial Outlook for Blood Banking
• Companies to Watch
• Cerus Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Navigant Biotechnologies, LLC
  • Recent Revenue History:
  • Key Comment:
  • Details

• Haemonetics Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Immucor, Inc.
  • Recent Revenue History:
  • Key Comment:
  • Details

• Medion Diagnostics AG
  • Recent Revenue History: Private
  • Key Comment:
  • Details

• Pall Corporation
  • Recent Revenue History:
  • Key Comment:
  • Details

• Sanquin Reagents
  • Key Comment
  • Verax Biomedica Inc.
    • Recent Revenue History
    • Private
    • Key Comment
    • Details

Chapter thirteen: Histology and Cytology

• Overview
• Special Topics
  • Cancer Drives Histology/Cytology Development
  • The Future of the Pap Smear & HPV testing

• Market Analysis
  • Histology/Cytology
  • Traditional Stains
  • In situ Hybridization Products: ISH, CISH and FISH
  • Immunohistochemistry and in situ Hybridization
  • Flow Cytometry

• The Commercial Outlook for Histology and Cytology Tests
• Companies to Watch
• Agendia B.V.
  • Recent Revenue History:
  • Key Comment
  • Details

• Aperio Technologies, Inc.
  • Recent Revenue History
  • Private
  • Key Comment
  • Details

• Applied Imaging Corp./Genetix
  • Recent Revenue History
  • Key Comment
  • Details

• AviaraDx (formerly Arcturus Biosciences)
  • Recent Revenue History
  • Key Comment
  • Details

• BioImagene, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• BIOVIEW, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Celerus Diagnostics
  • Recent Revenue History
  • Key Comment
  • Details

• Clarient Inc. (formerly ChromaVision)
  • Recent Revenue History
  • Key Comment
  • Details

• Compucyte Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Cytyc Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• Dako A/S
  • Recent Revenue History
  • Key Comment
  • Details

• Diamics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Digene Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• eXagen Diagnostics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• HistoRx, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Ikonisys Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Immunicon Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• InterGenetics, Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• MDS/Molecular Devices Corporation
  • Recent Revenue History
  • Key Comment
  • Details

• MonoGen
  • Recent Revenue History
  • Key Comment
  • Details

• mtm laboratories AG
  • Recent Revenue History
  • Key Comment
  • Details

• Pathwork Diagnostics (formerly Predicant Biosciences)
  • Recent Revenue History
  • Key Comment
  • Details

• Perceptronix Medical Inc.
  • Recent Revenue History:
  • Key Comments
  • Details

• Rational Therapeutics
  • Recent Revenue History
  • Key Comments
  • Details

• Tripath Imaging, Inc.
  • Recent Revenue History:
  • Key Comments
  • Details

• Ventana Medical Systems. Inc.
  • Recent Revenue History
  • Key Comment
  • Details

• Veridex, LLC
  • Recent Revenue History
  • Key Comment
  • Details

• Vision BioSystems Ltd/Danaher Corp.
  • Recent Revenue History:
  • Key Comment
  • Details

Table of Exhibits

CHAPTER ONE: Executive Summary

• Figure 1-1: World In Vitro Diagnostics Market 2007-2012 ($millions)
• Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Country/Region 2007-2012
• Figure 1-2: Regional Market Share of In Vitro Diagnostics Market, 2007 (North America, EU, Japan, Latin America, Eastern Europe, India, China, ROW)
• Table 1-3: Top Tier IVD Companies, 2007 (Company, Country)
• Figure 1-3 Share of Top Tier Companies, 2007 vs. 2005
• Table 1-1: Exchange Rate Fluctuations, 2003-2007

CHAPTER TWO: Introduction

• Figure 2-1: Worldwide IVD Market Share by Segment
• Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market 2007-2012, $ million
• Table 2-2: Selected Diagnostics Industry Acquisitions, 2006-2007
• Table 2-3: Selected Diagnostics Industry Distribution Agreements 2006-2007
• Table 2-4: Selected Diagnostics Industry Collaborations and Licensing Agreements, 2006-2007
• Table 2-5: Revenues of Selected IVD Companies, 2005-2007

CHAPTER THREE: OVERVIEW OF WORLD IVD MARKETS

• Table 3-1: Number of People Who Get Chronic Diseases Every Year Worldwide by Disease
• Table 3-2: WHO Health Spending Statistics
• Figure 3-1: Health Expenditure as a Share of GDP, Developing Countries
• Figure 3-2 Health Expenditure per Capita: Private and Public
• Table 3-3: Worldwide In Vitro Diagnostics Sales by Country/Region 2007-2012
• Table 3-4: European Union IVD Sales by Country 2006
• Figure 3-3: Chinese Market for IVD Reagents 2007-2012
• Figure 3-4: Indian Market for IVD Reagents 2007-2012

CHAPTER FIVE: Point-of-Care Tests

• Table 5-1: POC Sales by Test Category, worldwide 2007-2012
• Table 5-2: World Glucose Monitoring Sales, by Company, 2005 - 2007
• Table 5-3: Selected Blood Glucose Test Devices Innovations, 2006-2007
• Table 5-4: Selected Blood Glucose Test Devices Innovations, 2006-2007

CHAPTER SIX: THE CORE LAB

• Table 6-1: Clinical Chemistry/Immunoassay Sales, 2007-2012
• Table 6-2: Chemistry/Immunochemistry Sales of Top Five Manufacturers, 2003-2005
• Table 6-3: Selected Workstation Innovations, 2006-2007
• Table 6-4: Worldwide Clinical Chemistry Sales by Test Category 2007-2012 (General Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Figure 6-1: Worldwide Clinical Chemistry Sales by Test Category (General Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Table 6-5: Selected Small Lab Workstations, 2006-2007 (Company, Location, Details, Status)

CHAPTER SEVEN: IMMUNOASSAYS

• Table 7-1: Selected New Immunoassay Platforms, 2007
• Table 7-2: Selected Small Footprint Immunoassay Systems
• Table 7-3: Worldwide Lab-Based Immunoassay Sales by Analyte Type 2007-2012 (ID, Tumor Markers, Cardiac Markers, Diabetes/HbA1c, Thyroid, Proteins, Autoimmune, Anemia, Therapeutic Drugs, Fertility, Allergy, Drugs of Abuse)
• Table 7-4: Revenue History of Leading Immunoassay Vendors, $ million 2005-2007
• Table 7-5: Selected Tumor Marker Innovations, 2006-2007
• Table 7-6: Selected Cardiac Marker Innovations, 2006-2007
• Table 7-7: Selected Autoimmune Immunoassay Innovations, 2006-2007
• Table 7-8: Selected Sepsis Marker Innovations, 2006-2007
• Table 7-9: Selected Immunoassay Innovations, 2006-2007
• Table 7-10: Regional Breakdown of POC Immunoassay Market
• Figure 7-1 Regional Breakdown of POC Immunoassay Market
• Figure 7-2: Growth Rate of Immunoassays (All Immunoassays, POC OTC Immunoassays and Professional POC)
• Table 7-10: POC OTC Immunoassay Test Sales by Test Category 2007-2012 (Pregnancy/Ovulation, Fecal Occult Blood, Drugs of Abuse, Cholesterol)
• Table 7-11: Selected OTC Test Devices, 2007
• Table 7-12: Professional POC Testing 2005-2010 (Pregnancy, Cardiac Markers, Cholesterol/Lipids, HbA1, Fecal occult blood, Cancer Markers, Drugs of Abuse, Other)
• Table 7-13: Selected Professional POC Tests on the Market and in Development, 2006-2007

CHAPTER EIGHT: Molecular Assays

• Table 8-1: Selected Molecular Test Innovations, 2006/07
• Table 8-2: Selected Nucleic Acid Testing Platforms, 2006-2007
• Table 8-3: Selected Molecular Test Services, 2007
• Table 8-4: Worldwide Molecular Test Sales by Type, $million 2007-2012
• Table 8-5: Molecular Test Revenues of Selected IVD Vendors, 2005-2007
• Table 8-6: Selected Molecular Sample Preparation Products
• Table 8-7: Worldwide Molecular Test Sales, 2005-2010 (Sales in millions)
• Table 8-8: Most Frequently Requested Genetic Tests

CHAPTER NINE: Hematology

• Table 9-1: Selected New Hematology Analyzer Tests 1990s - 2007
• Table 9-2: Selected New Hematology Research Projects
• Figure 9-1: Estimated Market for Manual and Automated Sed Rates 2007-2012
• Table 9-3: Selected Automated ESR Systems, 2007
• Figure 9-2: Estimated Share of Hematology Market by Setting (Central vs Decentralized) 2007
• Table 9-4: Selected POC Hematology Systems, 2007
• Figure 9-3: Estimated Distribution of Hemoglobin Testing Volume by Region (U.S., Europe, ROW)
• Table 9-5: Revenue History of the Major Hematology Vendors by Company 2001-2007
• Figure 9-4: Market Share of Hematology Vendors 2007
• Figure 9-5: World Market for Hematology 2007-2012
• Figure 9-6: Estimated Distribution of Hematology Revenues by Region (U.S., Europe, Japan, ROW) 2007
• Table 9-6: Selected Hematology Innovations (Company, Location, Segment, Details, Market Status) 2006-2007

CHAPTER TEN: Coagulation

• Table 10-1: Worldwide Coagulation Sales by Segment 2007-2012
• Figure 10-1: Regional Share of Coagulation Market, 2007
• Figure 10-2: Lab-Based Coagulation Testing 2007-2012
• Table 10-2: Selected Coagulation Automation Innovations
• Figure 10-3: Growth Rate in Coagulation Testing Segments (Genetic Markers compared to Lab-Based, POC Self Test, and POC Professional)
• Table 10-3: Selected New Warfarin Sensitivity Tests, 2006-2007 (Company, Location, Test, Status)
• Figure 10-4 Decentralized (POC) Coagulation Testing, Professional: 2007 and 2012 ($millions)
• Figure 10-5: Coagulation POC Testing by Region (US, Europe, ROW)
• Table 10-4: CLIA Waived PT Devices
• Figure 10-6: Decentralized (POC) Coagulation Testing, Over the Counter: 2007 and 2012
• Table 10-5: Top Coagulation Company Revenues 2005 - 2007
• Table 10-6: Selected Coagulation Test Innovations 2006-2007

Chapter eleven: Microbiology and Virology

• Table 11-1: Percent of Staph infections Among U.S. Intensive Care Patients That Are Infected with MRSA
• Table 11-2: CLIA waved Tests for HIV Market
• Table 11-3: Selected HIV Test Innovation, 2007
• Table 11-4: PCR, FISH, Flow and Cell Imaging Systems for Bacteria / Virus Detection, 2007 and 2012 ($million)
• Table 11-5: Worldwide Microbiology/Virology Sales by Type 2007-2012
• Table 11-4: Selected Chromogenic Growth Media
• Table 11-6: Revenue of Selected ID/AST Product Companies, 2007
• Table 11-7: Selected Microbiology/Virology Innovations, 2006-2007 (Company, Location, Details, Status)
• Table 11-8: Selected Immunoassays for Sepsis (Company, Location, Details, Status)
• Table 11-9: Selected Syphilis Immunoassays, 2007
• Table 11-10: Selected Infectious Disease Immunoassay Innovations, 2006-2007
• Table 11-11: Selected POC Tests for Infectious Diseases, 2006-2007
• Figure 11-1: Molecular Tests vs. Traditional Lab-Based Immunoassays 2005-2012 ($millions)
• Table 11-12: Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits, GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory, Others), 2007-2012 ($ Millions)
• Figure 11-2: Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits, GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory, Others), 2007-2012
• Figure 11-3 Molecular Testing Emerging Infectious Disease vs. First Wave
• Table 11-13: Selected Infectious Disease Molecular Test Innovations, 2006-2007

CHAPTER TWELVE: Blood Banking Services

• Table 12-1: Selected Blood Treatment Systems, 2007
• Table 12-2: Worldwide Blood Bank Sales, 2007-2012 (ABO Grouping, Immunoassay Screen, NAT Screen)
• Table 12-2: Worldwide Blood Bank Sales, 2007 and 2012 ($ millions)
• Figure 12-1: ABO Grouping Revenues by Region (North America, EU, Japan, ROW)
• Table 12-3: Selected Blood Grouping Innovations, 2006-2007
• Table 12-4: Selected Blood Screen Immunoassay Innovations, 2006-2007
• Table 12-5: Selected Blood Bank Innovations, 2006-2007

Chapter thirteen: Histology and Cytology

• Table 13-1: Selected IVD Cancer Markers
• Table 13-2: Selected Microscopy and Image Analysis Product Companies
• Figure 13-1: The Future of Pap Smear Testing, 2005 and 2012
• Table 13-3: Selected Advanced HPV Tests, 2006-2007
• Table 13-4: Worldwide Histology/Cytology Sales by Type 2007-2012 ($million)
• Figure 13-2: Worldwide Histology/Cytology Sales by Type 2007-2012 ($million)
• Table 13-5: Worldwide Flow Cytometry Sales 2007-2012 ($million)
• Table 13-6:Worldwide CTCs and Tissue Microarray Sales 2007-2012
• Table 13-7: Selected Vendors of Traditional Histology Stains
• Table 13-8: Revenues of the Major Automated Histology Companies $ million, 2003-2007
• Figure 13-3: Revenues of the Major Automated Histology Companies, 2003-2007 ($millions)

WHAT IS WORKING IN IVD

EXECUTIVE SUMMARY

• Scope and Methodology
• Keys to Success

INTRODUCTION

• Background
• Crucial Keys to Successful New Product Commercialization - Six Strengths Model
• Point of View

Strength Point One - STRATEGIC PLANNING

• Clinical Trial and Information Management
  • Qiagen/Digene
  • Aspen Bio AppyScore
  • AdvanDx PNA FISH test
  • Epigenomics PRESEPT
  • Genomic Health Oncotype DX
  • Hologic
• Product Development
  • PGxHealth
  • Evidenced Based Medicine
• Pricing Challenges
  • Down Economy Pricing Advice
  • Five Steps to Value Pricing
  • Pricing as an Impression
• Distribution Strategies
  • Examples of IVD Distribution Arrangements
  • Test Commercialization
• A New look at Customer Segmentation
  • Finding "Buckets Within Buckets" of Customers
• Conclusion

Strength Point Two - MANAGING INTELLECTUAL PROPERTY

• Some IP and Patent Basics
• Barriers to Patent Protection
• Gene Patents
• To Partner Or Not
• Conclusion

Strength Point Three - MANAGING THE REGULATORY PROCESS

• Overview Of Regulatory Trends
• Multiplexed and Molecular Tests
• Regulatory Process by Region/Country
  • United States
  • European Economic Union
  • Japan
  • China
  • India

Strength Point Four - ASSURING PRODUCT REIMBURSEMENT

• Reimbursement Issues and Strategies
• Governments React
• IVDs in Obama' s Healthcare World
• Wins and Disappointments
  • Genomic Health
  • Biosite/Inverness Medical Innovations
  • Digene/Qiagen
• Conclusion

Strength Point Five - MANAGING THE PRODUCT LIFE CYCLE

• PR - Tell Your Story
• Scale-UP Issues
• Building a Supportive Organizational Structure

Strength Point Six - MANAGING MARKET FORCES

• Investors
  • Venture Capital Activities in IVD
• Consumer Power
  • Steps between Evaluation of Needs and a Purchase Decision
• Scientific/Medical Community
• Payer Groups
• Conclusion

SWINE FLU MARKET ALERT

CHAPTER ONE: EXECUTIVE SUMMARY

• Background
  • Exhibit 1: Flu Epidemics Compared to Present 1918-Today
• Scope And Methodology
• Point of View
• Information Sources

CHAPTER TWO: 2009 SWINE INFLUENZA AND OTHER FLU EPIDEMICS

• Influenza Overview
• Overview of Virus Types
• What' s So Special About This Latest Flu?
• Flu Therapeutics
• WHO Global Influenza Preparedness Plan

CHAPTER THREE: FLU DIAGNOSTICS

• Background
• Exhbit 2: Influenza Test Innovations, 2009 (Company, Technology, Test Details, Status)
• Immunoassays
  • Rapid Testing
  • Market Performance of Rapid Test
  • New Entrant Possiblity
  • Conclusion: Impact of Swine Flu on Rapid Testing
• Molecular Assays
  • Molecular Influenza Detection Techniques
  • PCR, Sequencing or Both
  • Lessons and Market Impact of the H5N1 Epidemic

CHAPTER FOUR: PROGNOSIS FOR A/H1N1

• Background
• Pandemic - Where? When?
  • 1976 Hsw1N1 Swine Flu Case
  • Comparing Past Flu Epidemics to 2009
  • International Reaction
• Swine Flu and the IVD Industry
  • Origin of Flu Virus Mixes
  • PCR Test Development
  • Late-Breaking Research Developments
  • Use of Rapid Tests in Current Epidemic

CHAPTER FIVE: COMPANIES AND PRODCUTS IMPACTED BY SWINE FLU EPIDEMIC

• Immunoassays
  • 3M Medical Diagnostics
  • Becton, Dickinson and Company (BD)
  • Genzyme Corporation
  • Inverness Medical Innovations
  • Meridian Bioscience, Inc.
  • Quidel Corporation
  • Remel, Inc.
  • Response Biomedical Corporation
• Molecular Tests
  • Arbor Vita Corporation
  • CombiMatrix Molecular Diagnostics (CMDX)
  • Diagnostic HYBRIDS, Inc. (DHI)
  • eGene Inc.
  • Eiken Chemical Co., Ltd
  • Life Technologies/Applied Biosystems/ Invitrogen Corporation (ABI)
  • Lab21
  • Laboratory Corporation of America Holdings (LabCorp)
  • Luminex Corporation
  • Nanogen
  • Prodesse Inc.
  • Qiagen N.V.
  • Seegene Inc.
  • Veredus Laboratories Pte