Worldwide Market for In Vitro Diagnostic (IVD) Tests, 6th Edition [with 2009 economy preface]

Worldwide Market for In Vitro Diagnostic (IVD) Tests, 6th Edition [with 2009 economy preface]

This edition of Kalorama’s comprehensive and indispensable report covers the breadth of traditional IVD testing. The report contains complete market statistics and analysis for all areas of IVD, including:

• Point-of-Care


• Core Lab


• Immunoassays


• Molecular Assays


• Hematology


• Coagulation


• Microbiology and Virology


• Blood Banking


• Histology and Cytology

Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Projections are made through 2012.



Six Times Kalorama Has Examined the IVD Market in Full


This 900-page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on:

• The status of POC and decentralization in lab medicine


• Miniaturization and molecularization of devices


• Geo-economic and demographic influences on markets


• Non-invasive sampling


• Greatly expanded market data on PGx and SNP testing


• Revamped segmentation for clinical chemistry to include workstations and immunoanalyzers


• More information about more immunoassays


• Focus on the renewed interest in microbiology/virology based on resistance and the re-emergence of serious hospital- and community-based organisms


• World blood banking developments


• Expanded sections on histology/cytology developments including emerging areas such as tissue microarrays, circulating tumor cells, and genomics-fueled innovation.

In addition, there are now profiles of established and emerging players in IVD, more than 276 companies, from the top tier to emerging and niche competitors to watch.



As part of its coverage, the report breaks down the IVD market for the following regions.

• North America


• Europe (EU)


• Eastern Europe


• South America


• Asia (China and India as subsegments)


• Rest of World

A Report Designed for a Changing Industry


In this sixth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information has reorganized the presentation of the IVD market in a manner that better reflects how the industry has evolved since the first edition was published in 1997.
At that time, molecular testing was a small emerging discipline that related to chlamydia, gonorrhea, TB, and some inherited diseases.

That first edition didn’t even have a chapter for molecular diagnostics; it was a miscellaneous. Now, molecular tests are common in several segments - infectious diseases, bacterial identification, coagulopathologies, blood unit screening, histology and soon as POC devices. Therefore the molecular chapter in this report presents technology and market issues that are common to all segments and concentrates on purely molecular tests for inherited diseases. Molecular tests used in other segments are included in the appropriate chapter.
In 1997, POC testing meant glucose testing.

Similar to molecular testing, rapid and POC tests are becoming an important part of testing on all fronts. Here too the POC chapter presents technology and market issues that are common to all segments and concentrates on blood glucose monitoring.


A Note About The Economy in 2009 and our Forecasts


This report was completed in 2008 before the economic meltdown of 2008/2009 was fully apparent. The report estimates the world market for IVD products. Kalorama Information anticipates that this estimate holds true in spite of the current financial situation. There are many reasons for this rationale. In vitro diagnostics were the first products targeted for cutbacks in the major markets, the IVD industry did not experience the explosive growth seen in some medical devices, purchases are through group purchasing organization, new healthcare initiatives proposed by the new U.S.
administration under the guidance of President Barack Obama further bolster the use of IVDs, and demand for healthcare and thus diagnostic tests in all the major markets. A special appendix to this report is included to address the economy.

THE WORLDWIDE MARKET FOR IN VITRO DIAGNOSTIC TESTS, 6TH ED.

Table of Contents 1 Executive Summary

• Introduction
  
  
• Scope and Methodology
  
  
• Size and Growth of the Market
  
  
• Market Trends - a ten year review

2 Introduction

• Background
  
  
• Lab Medicine Disciplines And Applications, new report design
  
  
• Market Analysis of IVD Market Segments
  
  
• Age of the giants and smaller colossuses
  
  
• Licenses and distribution agreements
  
  
• Point of View

3 Overview Of Global In Vitro Diagnostic Markets

• Background
  
  
• The global community strives for regulatory harmonization
  
  
• World Segments of the IVD Market and IVD Market Evolution
  
  
• The United States of America - a free market in disguise - holding its own
  
  
• Europe - economic crisis drives reorganizations
  
  
• China - the WTO powerhouse
  
  
• The lure of emerging markets
  
  
• IVD Market Growth - segments and technologies
  
  
• Traditional IVDs
  
  
• Emerging Tests and Technologies

4 Trends and Innovation

• Background
  
  
• HIV Testing, a 25 year phenomenon
  
  
• 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

5 Point-of-Care Test Platforms

• Overview of POC Tests
  
  
• Leading Innovations
  
  
• Cost Pressures and Perceived Barriers for POC Tests
  
  
• Institutional Users of POC Tests
  
  
• The Commercial Outlook for POC Tests
  
  
• Companies to Watch

6 The Core Lab: ClinicalChemistry/Immunoassays/Hematology/Coagulation/Urinalysis/Microbiology

• Overview
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Lab Automation and Work Station Consolidation
  
  
• Decentralization Imperative
  
  
• The Commercial Outlook for the Core Lab
  
  
• Companies to Watch

7 Immunoassays

• Overview of Immunoassays
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Immunoassay Test Segments - Mature and Emerging
  
  
• Point-of-care OTC and Professional Use
  
  
• The Commercial Outlook for Immunoassays
  
  
• Companies to watch

8 Molecular Assay Platforms

• Overview of Molecular Assays
  
  
• Molecular Testing Innovation -- Technology and Players
  
  
• PCR patents and innovation
  
  
• Expectations for decentralized testing
  
  
• The Commercial Outlook for Molecular Tests
  
  
• Companies to watch

9 Hematology

• Overview of Hematology
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Decentralized Hematology Testing
  
  
• The Commercial Outlook for Hematology Tests
  
  
• Companies to Watch

10 Coagulation

• Overview of Coagulation / Immunohematology Tests
  
  
• Genetic markers of hypercoagulation disorders
  
  
• Decentrealized Coagulation testing - OTC and Professional Use
  
  
• Market Analysis : Leading Suppliers and Growth Potential The Commercial Market for Coagulation Tests Companies to Watch

11 Microbiology and Virology

• Overview of Microbiology / Virology Tests
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Antimicrobial Resistance - a moving target
  
  
• Tradition is Challenged by Molecular Techniques
  
  
• Rapid Microbiology Screening
  
  
• Emerging Organisms and the Globalization of Infectious Diseases
  
  
• The Commercial Outlook for Microbiology / Virology Tests
  
  
• Companies to Watch

12 Blood Banking Services

• Overview of Blood Banking
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Nucleic Acid Testing Continues to Grow
  
  
• The Commercial Outlook for Blood Banking
  
  
• Companies to Watch

13 Histology and Cytology

• Overview of Histology / Cytology
  
  
• Market Analysis : Leading Suppliers and Growth Potential
  
  
• Genomic Medicine Fuels Automated Techniques and FISH
  
  
• Flow Cytometry on the FLOW
  
  
• The Commercial Outlook for Histology and Cytology Tests
  
  
• Companies to Watch

SNP GENOTYPING AND ANALYSIS

TABLE OF CONTENTSCHAPTER ONE: EXECUTIVE SUMMARY

• What is a SNP?
  
  
• Applications
  
  
• The Market
  
  
• Competitive Analysis
  
  
• Challenges
  
  
• Scope and Methodology

CHAPTER TWO: INTRODUCTION

• Background
  
  
• SNP Analysis Methods
  
  
  
  
  
  • Amplification
    
    
  • Allele discrimination / assay reaction mechanism
    
    
  • Single Nucleotide Addition; Pyrosequencing
    
    
  • Assay Format
    
    
  • Detection Method
  
  
  
• Scope and Methodology
  
  
• Definitions
  
  
  
  
  
  • DNA Microarray
    
    
  • Genome-Wide Association
    
    
  • Linkage Analysis
    
    
  • Mass Spectrometry
    
    
  • Single-Nucleotide Polymorphism (SNP)

CHAPTER THREE: APPLICATIONS

• Life Science Research
  
  
• Pharmacogenetics / Pharmacogenomics
  
  
  
  
  
  • Case Study #1 -- SNPs in Gene for P-glycoprotein Affect Antidepressant Response
    
    
  • Case Study #2 - Celera Studying SNPs Associated With Heart Disease
    
    
  • Case Study #3 - Synonymous SNPs Alter mRNA Splicing with Obesity
    
    
  • Case Study #4 - University of Ottawa Heart Institute (UOHI) Coronary Artery
    
    
  • Disease Research

CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS

• Industry Trends
  
  
  
  
  
  • Consolidation Occurring in Array and Life Science Markets
    
    
  • FDA Involvement Making Drug Industry More Comfortable
    
    
  • Acceptance of SNP Analysis, Pharmacogenetics Reached Tipping Point
    
    
  • Core Labs Becoming Established Paradigm
  
  
  
• Technology Trends
  
  
  
  
  
  • Increased Multiplexing Expands Applications
    
    
  • End-Users Attracted to Larger-Scale SNP Platforms
    
    
  • Complexity of Biological Systems Requires Multiple Techniques
    
    
  • Miniaturization of Equipment and Instruments
  
  
  
• Regulatory Trends
  
  
  
  
  
  • Introduction
    
    
  • Critical Path Initiative
    
    
  • March 2005 - “Guidance for Industry - Pharmacogenomic Data Submissions”
    
    
  • April 2005 - “Drug-Diagnostic Co-Development Concept Paper”
    
    
  • March 2006 - Critical Path Opportunities List
    
    
  • November 2006 - “Recommendations for the Generation and Submission of
    
    
  • Genomic Data”
    
    
  • August 2007 - “Pharmacogenomic Data Submissions — Companion Guidance”
    
    
  • August 2007 - FDA Updates Labeling of Warfarin (Coumadin)
    
    
  • December 2007 - EGAPP Reviews Use of CYP450 Genetic Testing For SSRIs

CHAPTER FIVE: PRODUCTS

• Affymetrix
  
  
  
  
  
  • Overview of Affymetrix Products
    
    
  • Hardware
  
  
  
• Applied Biosystems
  
  
  
  
  
  • Overview of Applied Biosystems Products
    
    
  • Assays and Reagent
    
    
  • Instruments
  
  
  
• Beckman Coulter
  
  
• CombiMatrix
  
  
• Febit
  
  
• GE Healthcare
  
  
• Illumina
  
  
  
  
  
  • Hardware
    
    
  • Microarrays
  
  
  
• LI-COR Biosciences (Lincoln, NE)
  
  
• Roche Applied Science
  
  
• Sequenom
  
  
• Services
  
  
  
  
  
  • Agencourt Biosciences
    
    
  • DNAPrint Genomics
    
    
  • Polymorphic DNA Technologies
  
  
  
• Software
  
  
  
  
  
  • Applied Biosystems
    
    
  • Premier Biosoft
  
  
  
• Public Tools

CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS

• Consortia, Collaborative Projects
  
  
  
  
  
  • The Cancer Genome Atlas (TCGA) Pilot Project
    
    
  • Cancer Sequencing Project
    
    
  • Critical Path Institute
    
    
  • DNA Polymorphism Discovery Resource
    
    
  • Genetic Association Information Network (GAIN)
    
    
  • Genotype-To-Phenotype Database (GEN2PHEN)
  
  
  
• International HapMap Project
  
  
  
  
  
  • Introduction & Background
    
    
  • Rationale for HapMap Approach
    
    
  • Process for Producing HapMap
    
    
  • Populations Included in HapMap
    
    
  • Measures Taken to Protect Donors’ Privacy
  
  
  
• Laboratories and Technologies Involved in HapMap
  
  
• Practical Use of the HapMap Data
  
  
  
  
  
  • MicroArray Quality Control (MAQC) Project
  
  
  
• NIH Roadmap
  
  
  
  
  
  • NIH Roadmap for Medical Research
    
    
  • Pharmacogenetics Research Network (PGRN)
  
  
  
• NIH Involvement, Funding for SNPs and Sequencing
  
  
• Funding for Sequencing Projects Affecting SNP Market
  
  
  
  
  
  • Continued Rapid Growth in Sequence Production
    
    
  • Funding and Consortia for Sequencing
  
  
  
• NHGRI Funds Large-Scale Sequencing Centers, 2006
  
  
• Competitive Activity

CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS

• Historical
  
  
  
  
  
  • Illumina as Bellwether for SNP Analysis Market
    
    
  • Applied Biosystems as Bellwether for RT-PCR Products
  
  
  
• Forecast
  
  
  
  
  
  • Assumptions
    
    
  • SNP Revenues by Region
    
    
  • SNP Revenues by Product
  
  
  
• Competitive Analysis

CHAPTER EIGHT: CORPORATE PROFILES

• Affymetrix
  
  
• Applied Biosystems
  
  
• Illumina

CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS

• Challenges
  
  
  
  
  
  • Cheaper Sequencing Creates Competition for SNP Analysis Platforms
    
    
  • Market Is Dominated by a Small Number of Suppliers
    
    
  • Issues Arise With Use of Public Databases
    
    
  • Data Management Requirements Limit Large-Scale Technologies
    
    
  • Diagnostic Market Holds Obstacles For New Innovations
    
    
  • Backlash Against Rush Into Genetic Testing, DTC Marketing
    
    
  • Standard Processes for SNP Experiments Still Not Established
    
    
  • Shortcomings in Sample Preparation and Handling Hinder Success
    
    
  • Privacy Concerns Pose Threat to Broad Technology Adoption
  
  
  
• Strategic Recommendations

TABLE OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY

• Figure-1-1: SNP Analysis Market 2007-2013
  
  
• Figure 1-2: Growth Rate in SNP Analysis Revenues 2008-2013

CHAPTER TWO: INTRODUCTION

• Table 2-1 Adelle-Specific Invasive Cleavage
  
  
• Table 2-2 Adelle-Specific Ligation
  
  
• Table 2-1 Allele-Specific Primer Extension
  
  
• Table 2-4 Single Base Primer Extension

CHAPTER FOUR: INDUSTRY AND REGULATORY TRENDS

• Table 4-1: Critical Path Opportunities List

CHAPTER FIVE: PRODUCTS

• Figure 5-1: Taq Man Assay
  
  
• Figure 5-2: SOLID System Average Throughput Progress
  
  
• Figure 5-3: SNPstream Method
  
  
• Figure 5-4: Roche SimpleProbe System
  
  
• Figure 5-5: Roche HybProbe System
  
  
• Table 5-1 Products in the SNP Analysis Market
  
  
• Table 5-2 Public SNP Tools and Resources (Tool, Website)

CHAPTER SIX: CONSORTIA, GOVERNMENT INVOLVEMENT, DEALS

• Table 6-1: Number of Individuals in Each Subset (Population Group, Full Set, Subsets)
  
  
• Figure 6-1: Domains of Genomes Sequenced by Year (Archaea, Bacteria, Eukaryota)
  
  
• Table 6-2: Composition of the DNA Polymorphism Discovery Resource (Population Group, Proportion of Admixture, Number of Individuals, Number of Genomes by Continent)
  
  
• Table 6-3: Companies’ Technologies Used in First Phase of HapMap (Company, Percent of Genome)
  
  
• Table 6-4: Companies’ Technologies Used in First Phase of HapMap (Group, Technology, % of Genome)
  
  
• Figure 6-4: Major Sequencing Centers and Percent of Sequencing Projects (WORLD, GENOSCOPE, BMC, Sanger, WashU, BROAD, JCVI, JGI), Jan 2008
  
  
• Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008($M)
  
  
• Figure 6-4: Major Sequencing Centers and Percent of Sequencing Projects (WORLD, GENOSCOPE, BMC, Sanger, WashU, BROAD, JCVI, JGI), Jan 2008
  
  
• Figure 6-5: Top Funding Agencies, DNA Sequencing, 2008 ($M)
  
  
• Figure 6-6: Human Genome Project Funding, DOE& NIH ’90-‘03
  
  
• Figure 6-7: Areas Funding Genome Sequencing, Jan 2008 (Medical, Evolutionary, Agricultural, Environmental, Biotechnology)
  
  
• Table 6-5: Large-Scale Sequencing Centers, NHGRI Funding, 2004-2006
  
  
• Figure 6-8: Top Genome Sequencing Countries, Jan. 2008 (# projects)
  
  
• Figure 6-9: SNP Analysis Related Deals (Companies, Date, Details of Deal)
  
  
• Figure 6-10: SNP: NHGRI Funded Large-Scale Sequencing Ctrs, ‘07
  
  
• Table 6-6: SNP Analysis-Related Deals (Companies, Date, Details of Deal)

CHAPTER SEVEN: MARKET DATA AND COMPETITIVE ANALYSIS

• Figure 7-1: Illumina Quarterly Revenues, 2001-2007 ($M)
  
  
• Figure 7-2: Applied Biosystems Revenues in Real Time PCR/Applied Genomics
  
  
• Table-7-1: Forecasted Revenues in the SNP Analysis Market
  
  
• Figure-7-3: Forecasted Revenues in the SNP Analysis Market
  
  
• Table 7-2: Growth Rate in SNP Analysis Tools Market, 2008-2013
  
  
• Figure 7-4: Growth Rate in SNP Analysis Tools Market, 2008-2013
  
  
• Figure 7-5: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
  
  
• Table 7-3: SNP Analysis Revenues by Region (North America, Europe, Rest of World)
  
  
• Figure 7-6 SNP Market by Product Segment (Instruments, Consumables, Software & Services)
  
  
• Table 7-4: SNP Market by Segment (Instruments, Consumables, Software & Services)
  
  
• Table 7-5: Revenues Among the Top Companies in SNP Analysis (Illumina, Affymetrix, Applied Biosystems, Other)
  
  
• Figure 7-7: SNP Analysis Market Share, 2007

CHAPTER EIGHT: CORPORATE PROFILES

• Figure 8-1: Affymetrix’ Revenues by Product Type, 2004 - 2007
  
  
• Figure 8-2: Illumina BeadStation Installed Base, 2004-2006

CHAPTER NINE: CHALLENGES AND STRATEGIC RECOMMENDATIONS

• Figure 9-1: Estimated Decrease in Screening Price

COMPANION DIAGNOSTICS MARKETS

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

• Background
  
  
  
  
  
  • Potential Benefits of Companion Diagnostics
    
    
  • Pitfalls of Personalized Medicine
    
    
  • Scope and Methodology
    
    
  • Market Factors and Estimates
    
    
  • Drivers For Companion Diagnostics
    
    
  • Assumptions
    
    
  • Important Trends
    
    
  • Possible Tactic: Royalty Model

CHAPTER TWO: OVERVIEW OF COMPANION DIAGNOSTICS

• Personalized Medicine
  
  
  
  
  
  • Potential Benefits
    
    
  • Privacy and Public Perception
    
    
  • Biomarkers and Companion Diagnostics
    
    
    
    
    
    • Types of Biomarkers

CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS

• Pharmacogenetics and Pharmacogenomics
  
  
  
  
  
  • Historical Basis
    
    
  • Current Techniques
    
    
  • Requirements
    
    
  • Cost-effectiveness
    
    
  • Applications
    
    
    
    
    
    • The Cytochrome System
      
      
    • Cancer
      
      
    • Amgen
      
      
    • UAMS Multiple Myeloma Project
      
      
    • DakoAssay for TOP2A
      
      
    • GE and Eli Lilly
      
      
    • Epigenomics and Abbott
      
      
    • Celera and Merk
      
      
    • bioMerieiux and Ipsen
      
      
    • Acute Lymphoblastic Leukemia
    
    
    
  • Regulatory Agencies
    
    
  • Applications of Genome More Challenging Than Expected
    
    
    
    
    
    • Cardiovascular Disease
    
    
    
  • RAS polymorphisms With Drug Effectiveness
    
    
    
    
    
    • Pgp
      
      
    • Thiazide diuretics
      
      
    • 825T allele
      
      
    • HIT
      
      
    • Statins
    
    
    
  • Psychiatry and Pharmacogenetics/Pharmacogenomics
    
    
  • Drug Development Rescue
    
    
  • Is Herceptin a Paradigm?
    
    
  • A Balancing Act Between the Players
  
  
  

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS

• Estimating Market Potential
  
  
  
  
  
  • Associated Testing
    
    
  • The Needs of Pharma and of Diagnostic Companies
    
    
  • Questions Determining Companion Diagnostics Growth
    
    
  • A Partial Change in Attitude
    
    
  • Intellectual Property
    
    
  • Cancer Market Potential Estimate
    
    
  • Ideal Market Potential - Cancer, Heart Disease, Psychiatric
    
    
  • Challenges Unique to Companion Diagnostics
    
    
    
    
    
    • Privacy Concerns
      
      
    • Fear of Learning About Diseases
      
      
    • Use of Remnant Samples
    
    
    
  • Avoiding Pitfalls of Market Calculation
    
    
    
    
    
    • Companion Diagnostics Not Linked to Molecular Diagnostics
      
      
    • Demonic and SNP Analysis
      
      
    • Considering Time of Cooperative Development
    
    
    
  • Market Realities to Consider
    
    
  • Possible Tactic: Royalty Model

CHAPTER FIVE: COMPANY SUMMARIES

• Overview
  
  
• Abbott (Molecular) Diagnostics Subsidiary of Abbott Laboratories
  
  
• Affymetrix, Inc.
  
  
• Agilent Technologies, Inc
  
  
• Althea Technologies, Inc.
  
  
• Curidium Medica plc
  
  
• Dako
  
  
• Gen Probe
  
  
• Genzyme Corporation
  
  
• Ipsogen SAS
  
  
• Lipomics Technologies, Inc.
  
  
• Osmetech plc
  
  
• Perlegen Sciences
  
  
• Provista Life Sciences
  
  
• Qiagen NV
  
  
• Singulex, Inc.
  
  
• Theranostics Health
  
  
• Ventana Medical Systems

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

• First Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Second Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Third Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Fourth Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Fifth Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Sixth Conclusion
  
  
  
  
  
  • Implications:
  Seventh Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Eighth Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Ninth Conclusion
  
  
  
  
  
  • Implications:
  
  
  
• Tenth Conclusion
  
  
  
  
  
  • Implications:

APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• 
  
  

  Table 1-1: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018

  
  
  
• 
  
  

  Figure 1-1: Market Projection Trends for Companion Diagnostics in the United States: 2008 - 2018

CHAPTER THREE: APPLICATIONS OF COMPANION DIAGNOSTICS

• Table 3-1 Companion Diagnostics Groups
  
  
• Table 3-3: Frequency of Recessive Traits
  
  
• Table 3-4: Existing Cancer Drugs Complimentary to Companion Diagnostics
  
  
• 
  
  

  Table 3-5: Recent Activities in Companion Diagnostics

CHAPTER FOUR: MAJOR WORLD MARKET FACTORS AND DATA FOR COMPANION DIAGNOSTICS

• Table 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008
  
  
• Figure 4-1: The Ideal Potential Companion Diagnostics Markets for Cancer Therapeutics: 2008
  
  
• Table 4-2: The Ideal Potential Companion Diagnostics Markets for Therapeutics Addressing the Top Four, High-Profile Cancers: 2008
  
  
• Figure 4-2: The Ideal Potential Companion Diagnostics Markets for Therapeutics Addressing the Top Four, High-Profile Cancers: 2008
  
  
  
  
  
• Figure 4-3: The Ideal Companion Diagnostics Market (Ideal vs. Likely to Benefit)
  
  
• Figure 4-4 Subset of Ideal Market Likely to Benefit From Pharmaceutical Intervention (Likely to Benfit vs. Realistic Market)
  
  
• Table 4-3: Market Projections for Companion Diagnostics* in the United States: 2008 - 2018
  
  
• Figure 4-1: Market Projection Trends for Companion Diagnostics* in the United States: 2008 - 2018

CHAPTER SIX: CONCLUSIONS AND STATEGIC IMPLICATIONS

• Table 6-1: Hypothetical Cancer Therapy Outcome Based on Associated Genes

TEST SERVICES COMMERCIALIZATION

CHAPTER ONE: EXECUTIVE SUMMARY

• Scope and Methodology
  
  
• Market Trends
  
  
• Clinical Chemistry
  
  
• Coagulation tests
  
  
• Flow Cytometry
  
  
• Histology/Cytology
  
  
• Infectious Diseases
  
  
• Keys to Success

CHAPTER TWO: INTRODUCTION

• Background
  
  
• The U.S. Versus Europe
  
  
• ASRs
  
  
• Hospital Outreach and National Reference Lab Services
  
  
• Lab Outreach Testing
  
  
• Independent Laboratories
  
  
• Status quo and Future
  
  
• Tests in Development
  
  
• Serendepity or Strategy?

CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS

• Background
  
  
• Market Analysis, revenue estimates 2007 - 2012
  
  
• Testing Markets
  
  
• ISC and ISH
  
  
• Market and Growth
  
  
• Market Share
  
  
• Lab Launches and Acquisitions
  
  
• Market Leaders
  
  
• Evaluation of Lab Tests
  
  
  
  
  
  • Uniqueness
    
    
  • Need
    
    
  • Reimbursed
    
    
  • Incumbent
    
    
  • Recognized
    
    
  • Peer Reviewed
  
  
  
• Competition from FDA Cleared Products
  
  
• Cost
  
  
• Competitive Technologies
  
  
• Pathwork
  
  
• BRCA analysis
  
  
• Mammastatin
  
  
• Limited Use of Molecular Testing for Colon Cancer.
  
  
• TDT
  
  
• Ovarian Cancer Testing
  
  
• Future Leaders?
  
  
• HIV Testing
  
  
• Mental Illness
  
  
• Test Services on the Horizon

CHAPTER FOUR: MARKET TRENDS/ DEMAND ANALYSIS

• The Commercialization of Multiplexed and Complex Analyses
  
  
• Opportunity Pricing and margins are attractive Demand for Esoteric Tests

CHAPTER FIVE: MARKET BARRIERS FOR TEST SERVICES

• Regulatory affairs
  
  
• Can the FDA Regulate New test Modalities?
  
  
• IVDMIAs
  
  
• Pending LDT Legislation
  
  
• Reimbursement Imperative
  
  
• Physician Uptake
  
  
• Connectivity, a Force to Consider
  
  
• The In Vivo - In Vitro Diagnostic Paradigm
  
  
• Social media and Internet-Based Services

CHAPTER SIX: TESTS AND COMPANIES TO WATCH

• 23andMe, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Affymetrix
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Agendia B.V.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• A RUP Laboratories
  
  
• Key Comment
  
  
  
  
  
• Athena Diagnostics, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Atherotech
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• AviaraDx (formerly Arcturus Biosciences)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Biomedical Diagnostics, LLC/Abviva, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Biophysical Corporation
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Caris MPI
  
  
• Key Comment
  
  
  
  
  
• Clarient Inc. (formerly ChromaVision
  
  
• Key Comment
  
  
• Detail
  
  
  
  
  
• Clinical Data, Inc
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• CombiMatrix Molecular Diagnostics (CMDX)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Consumer Genetic
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Corgenix Medical Corporatio
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Correlogic Systems, Inc
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• deCode Genetics Inc.
  
  
• Details
  
  
  
  
  
• DiagnoCure
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• DNA Direct, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• EXACT Sciences Corporation
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Exiqon A/S
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Focus Diagnostics, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Genelex Corporation
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Genomic Health
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Genoptix, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Genzyme Corporation
  
  
• Details
  
  
  
  
  
• InterGenetics, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Knome, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Lab21 Healthcare
  
  
• Key Comment
  
  
  
  
  
• Laboratory Corporation of America Holdings (LabCorp)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• LipoScience, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Mayo Medical Laboratories
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Monogram Biosciences, Inc. (formerly ViroLogic)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Myriad Genetics, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• NeuroMark
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Nuvera Biosciences
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Nymox Pharmaceuticals
  
  
• Details
  
  
  
  
  
• Oncolab, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Panacea Pharmaceuticals, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Pathway Diagnostics Corporation
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Pathwork Diagnostics (formerly Predicant Biosciences)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Perceptronix Medical Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Power3 Medical Products, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Precision Therapeutics, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Prometheus Laboratories Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Psynomics Incorporated
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Quest Diagnostics Incorporated
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Rational Therapeutics
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Rosetta Genomics Ltd.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Signature Genomic Laboratories, LLC
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Smart Genetics
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Specialty Laboratories
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• SpectraCell Laboratories, Inc.
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• Targeted Diagnostics & Therapeutics, Inc. (TDT)
  
  
• Key Comment
  
  
• Details
  
  
  
  
  
• XDx Inc.
  
  
• Key Comment
  
  
• Details

CHAPTER SEVEN: CONCLUSION

• Is There a Market for Test Services?
  
  
• Strategies for Successful Market Entry

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Figure 1-1: Sales of 7 Key IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components, 2007
  
  
  
  
  
• Figure 1-2: Growth Rate 7 IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components , 2007
  
  
  
  
  
• Figure 1-3: Esoteric Test Service Revenues, Reference Labs and CLIA-registered Company Test Service Offerings, 2007 and 2012

CHAPTER TWO INTRODUCTION

• Figure 2-1: Explosion of Test Capabilities 20th and 21st Century

CHAPTER THREE: MARKET OVERVIEW AND SUPPLY ANALYSIS

• Table 3-1: Worldwide Esoteric Test Reagent Sales by Product Market, 2007
  
  
  
  
  
• Figure 3-1: Esoteric Sales Across IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry), 2007
  
  
  
  
  
• Table 3-2: Worldwide Test Servcies Market
  
  
  
  
  
• Table 3-3: Esoteric and Genomic Service Test Sales, Selected Companies (Company, Location, Area, 2005-2008 sales, % of Change)
  
  
  
  
  
• Table 3-4: Selected CLIA- Registered Company Lab Tests Evaluated Selected CLIA- mRegistered Company Lab Tests Evaluated by Five Evaluation Points(Uniqueness, Need, Reimbursement, Incumbent Presence, Recognizable Technology)
  
  
  
  
  
• Table 3-5: Selected CLIA-Registered Lab Test Services, 2007

CHAPTER FOUR: MARKET TRENDS AND DEMAND ANALYSIS

• Table 4-1: Number of People Who Get Chronic Diseases Every Year