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Published by: Kalorama Information
Published: Aug. 1, 2008 - 200 Pages
Table of Contents
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
AbstractTest services, once the norm in the diagnostics industry, then abandoned for reagent sales, are now making a comeback. IVD companies have established cGMP and CLIA-registered labs by which they offer their proprietary tests to physicians, hospitals and reference labs. These tests are outside the oversight of the traditional FDA and CE Mark test commercialization avenue in the U.S, and Europe and so are thought to come to market by what may seem to be the back door. Kalorama has been watching this trend, and in her unique report, Kalorama Information's diagnostic analyst Shara Rosen covers the increasing trend in diagnostics towards servicing of tests in addition to selling test kit products and where this fits into the IVD industry today.
Information in this report includes
- Current market and forecast for diagnostics test services
- Detailed Analysis of the Esoteric Test Market
(Clinical Chemistry, Immunoassays, Radioimmunoassays, Coagulation, Histology/Cytology, Nucleic Acid Assays, Flow Cytometry)
- Review of Current Products on the Market
- Test Service Revenue Breakdown for Major Companies
- Evaluation of Test Services Products on the Market According to Five Checkpoints
- Strategies for Success In Test Service Commercialization
- Company Profiles
The report covers Clinical test services offered by reference laboratories, hospital laboratory outreach programs, direct to consumer web-based companies, and CLIA-registered company labs. The report describes the lay of the land for test services when they were first launched in the mid 1980s, the status quo in 2008 and a peek into the future.
What are the market factors driving test servicing? What companies are best suited for this strategy now and in the future? What are the best strategies, who has been most successful and where is this trend headed in the future? What are the areas of IVD most likely to be impacted by this trend.? This report answers these questions and more. Rosen's report will not only describe the market as it is today, but provide a clear picture - a roadmap - to how diagnostics will be practiced in this century.
Shara Rosen is Kalorama's lead diagnostic analyst and is the author of the Worldwide Market for In Vitro Diagnostics, 6th Edition., Physician Office Lab Markets,Point of Care Diagnostics and several other important diagnostic studies. This study is the result of her research and analysis and interviews with experts in the field.
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