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
CHAPTER TWO: INTRODUCTION
- Hospital Outreach and National Reference Lab Services
CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS
- Market Analysis, revenue estimates 2007 – 2012
- Lab Launches and Acquisitions
- Competition from FDA Cleared Products
- Limited Use of Molecular Testing for Colon Cancer.
- 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
- Can the FDA Regulate New test Modalities?
- 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
- AviaraDx (formerly Arcturus Biosciences)
- Biomedical Diagnostics, LLC/Abviva, Inc.
- Clarient Inc. (formerly ChromaVision
- CombiMatrix Molecular Diagnostics (CMDX)
- Corgenix Medical Corporatio
- EXACT Sciences Corporation
- Laboratory Corporation of America Holdings (LabCorp)
- Mayo Medical Laboratories
- Monogram Biosciences, Inc. (formerly ViroLogic)
- Panacea Pharmaceuticals, Inc.
- Pathway Diagnostics Corporation
- Pathwork Diagnostics (formerly Predicant Biosciences)
- Perceptronix Medical Inc.
- Power3 Medical Products, Inc.
- Precision Therapeutics, Inc.
- Prometheus Laboratories Inc.
- Quest Diagnostics Incorporated
- Signature Genomic Laboratories, LLC
- SpectraCell Laboratories, Inc.
- Targeted Diagnostics & Therapeutics, Inc. (TDT)
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