Market Report Source

Overview

Test 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.

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
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Details

Agendia B.V.
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Details

A RUP Laboratories
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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 Corporation
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
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Details

Exiqon A/S
Key Comment
Details

Focus Diagnostics, Inc.
Key Comment
Details

Genelex Corporation
Key Comment
Details

Genomic Health
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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.
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Details

NeuroMark
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Details

Nuvera Biosciences
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Details

Nymox Pharmaceuticals
Details

Oncolab, Inc.
Key Comment
Details

Panacea Pharmaceuticals, Inc.
Key Comment
Details

Pathway Diagnostics Corporation
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Details

Pathwork Diagnostics (formerly Predicant Biosciences)
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Details

Perceptronix Medical Inc.
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Details

Power3 Medical Products, Inc.
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Details

Precision Therapeutics, Inc.
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Prometheus Laboratories Inc.
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Psynomics Incorporated
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Quest Diagnostics Incorporated
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Rational Therapeutics
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Rosetta Genomics Ltd.
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Signature Genomic Laboratories, LLC
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Details

Smart Genetics
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Details
Specialty Laboratories
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SpectraCell Laboratories, Inc.
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Details

Targeted Diagnostics & Therapeutics, Inc. (TDT)
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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