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Clinical Trials

Clinical Laboratory Testing Volume 2: Business Strategies


Publication Date   March 2007
Publisher   TriMark Publications
Product Type   Report
Pages   96
ISBN Number   TMRCLTV207-0301
Product Code   TRI069
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Summary


Clinical laboratory testing is generally categorized as either of two general areas-clinical testing and anatomical pathology testing. Clinical and anatomical pathology procedures are frequently ordered as part of regular physician office visits and hospital admissions in connection with the diagnosis and treatment of illnesses. As such, clinical laboratory analysis is one of the most important sections of medical care. The purpose of this report is to describe the specific segments of the clinical laboratory analysis business. The emphasis in this review is on those companies that are actively developing and marketing laboratory data for the clinical setting, including hospitals, independent labs, physician's offices and miscellaneous clinics. This study concentrates on the clinical laboratory industry in the U.S. It defines the dollar volume of sales in each major market and analyzes the factors that influence the size and the growth of the individual market segments. The study surveys some of the primary companies known to be marketing clinical laboratory data into the market. Each company is discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market.

Content


  • 1. Overview
    • 1.1 Objectives of the Report
    • 1.2 Methodology
    • 1.3 Scope of the Report
    • 1.4 Executive Summary
  • 2. IVD Clinical Laboratory Market
    • 2.1 Introduction
    • 2.2 Key Players for Independent Clinical Labs
    • 2.3 Reimbursement Pressure
    • 2.4 Medicare Part B Spending Trends
    • 2.5 Cost of Billing and Average Receipts for Commercial Labs
    • 2.6 Hospital Outreach Programs
    • 2.7 Criteria for Selection of Lab Services
  • 3. The Clinical Laboratory Testing Market
    • 3.1 U.S. Market
      • 3.1.1 Hospital-based Clinical Laboratories
      • 3.1.2 Commercial Clinical Laboratory Testing
      • 3.1.3 Physician Office Laboratories (POLs)
    • 3.2 Clinical Lab Testing Key Players
      • 3.2.1 Commercial Clinical Labs
      • 3.2.2 Hospital Lab Collaborative Ventures
      • 3.2.3 Specialty Labs
    • 3.3 Revenue and Reimbursement
    • 3.4 Outlook for Clinical Laboratory Testing
      • 3.4.1 Long-Term Changes
      • 3.4.2 Market Drivers
      • 3.4.3 The Limits to Growth
      • 3.4.4 Key Technologies
      • 3.4.5 Conclusion
  • 4. Hot Sectors in the Clinical Lab Testing Market
    • 4.1 Workplace Drugs-of-Abuse Testing
    • 4.2 Clinical Toxicology
    • 4.3 Clinical Testing for the Pharmaceutical Industry
    • 4.4 Heavy Metal, Trace Element, and Solvent Analyses
    • 4.5 Diabetes (Glucose) Testing
    • 4.6 Molecular Diagnostic Testing
    • 4.7 Cardiac Markers
    • 4.8 Blood Bank Screening
    • 4.9 Genetic Testing
    • 4.10 Predictive Medicine Testing
    • 4.11 Personalized Medicine
    • 4.12 Cancer Testing
    • 4.13 Cell Based Cancer Testing
    • 4.14 Monitoring Technologies
    • 4.15 Anatomic Pathology
  • 5. Important Technology Trends
    • 5.1 Technology Platform Innovations in Point-of-Care Testing
    • 5.2 The New Paradigm
    • 5.3 Consolidated Workstations
    • 5.4 Automation in the Laboratory
    • 5.5 Laboratory Information Systems
    • 5.6 New User-friendly Interface
    • 5.7 Data-Management Issues
      • 5.7.1 Wireless LANs
      • 5.7.2 Data and Workflow Management Systems
      • 5.7.3 Beckman Central Command
      • 5.7.4 Clinical IT More Widely Available in Physician Practices
      • 5.7.5 Physician Electronic Health Records (EHRs)
  • 6. Business Trends in the Clinical Laboratory Analyzer Sector
    • 6.1 Key Developments
    • 6.2 Sector Consolidation
    • 6.3 Acquisition Pricing
    • 6.4 A Closer Look at Six Big Lab Deals
    • 6.5 Acquisition, License Agreements, Internal Development and Partnerships
    • 6.6 Comparison of Quest and LabCorp
      • 6.6.1 Quest
      • 6.6.2 Acquisitions
      • 6.6.3 Quest's Growth, 2000-2006
      • 6.6.4 Laboratory Corporation of America
      • 6.6.5 LabCorp's Growth, 2000-2006
      • 6.6.6 Competitive Advantages at Quest and LabCorp
      • 6.6.7 National Managed Care Contracts
      • 6.6.8 Billing and Collection Management
      • 6.6.9 Lower Reagent and Supply Costs
      • 6.6.10 Esoteric Testing Capabilities
      • 6.6.11 Ability to Invest in Web-Based Connectivity Solutions
      • 6.6.12 Competitive Disadvantages of Quest and LabCorp
      • 6.6.13 Difficulties with Turnaround Times and Stat Services
      • 6.6.14 Physician-Laboratory Communication
      • 6.6.15 Specimen Pickup Scheduling Inflexibility
    • 6.7 Regulation of Clinical Laboratory Operations
      • 6.7.1 CLIA and State Regulations
      • 6.7.2 Drug Testing
      • 6.7.3 Controlled Substances
      • 6.7.4 Medical Waste, Hazardous Waste and Radioactive Materials
      • 6.7.5 FDA
      • 6.7.6 Occupational Safety
      • 6.7.7 Specimen Transportation
      • 6.7.8 Corporate Practice of Medicine
    • 6.8 Hospital Outreach Programs
    • 6.9 Supply Chain and GPO Contracting
    • 6.10 Specialty Labs
    • 6.11 Expansion of Hospital-Based Labs and Hospital Outreach Programs
    • 6.12 Managed Care
  • 7. Company Profiles
    • 7.1 ACM Medical Laboratory
    • 7.2 American Esoteric Laboratories
    • 7.3 American Medical Laboratories
    • 7.4 AmeriPath
    • 7.5 ARUP Laboratories
    • 7.6 Athena Diagnostics
    • 7.7 Bio-Reference Laboratories, Inc.
    • 7.8 BioTech Labs
    • 7.9 BioLabs, Inc.
    • 7.10 CBLPath
    • 7.11 Centrex Clinical Laboratories
    • 7.12 Clarient, Inc.
    • 7.13 Clinical Laboratories of Hawaii
    • 7.14 Clinical Reference Laboratory
    • 7.15 Clongen Laboratories
    • 7.16 CompuNet Clinical Laboratories
    • 7.17 Diagnostic Systems Laboratories
    • 7.18 Enzo Biochem, Inc.
    • 7.19 Esoterix
    • 7.20 Focus Diagnostics
    • 7.21 Fresenius Medical Care AG & Co. KGaA
    • 7.22 Geneva Laboratories
    • 7.23 Genomic Health, Inc.
    • 7.24 Genzyme
    • 7.25 IBT Laboratories
    • 7.26 Integrated Regional Laboratories
    • 7.27 LabCorp
    • 7.28 MDS Diagnostic Services
    • 7.29 MEDTOX Scientific, Inc.
    • 7.30 Meriter Health Services
    • 7.31 Mid America Clinical Laboratories
    • 7.32 Monogram Biosciences, Inc.
    • 7.33 Myriad Genetics, Inc.
    • 7.34 National Jewish Medical and Research Center
    • 7.35 Parkway Clinical Laboratories
    • 7.36 Pathology Associates Medical Laboratories
    • 7.37 Psychemedics Corporation
    • 7.38 Quest Diagnostics Incorporated
    • 7.39 RDL Reference Laboratory
    • 7.40 Satellite Laboratory Services
    • 7.41 Spectrum Laboratory Network
  • 8. Clinical Laboratory Testing Sector Trends and Forecasts
    • 8.1 Home Care Analysis
    • 8.2 Non-Traditional Collection for Laboratory Testing
    • 8.3 New Systems for Critical-Care and Near-Patient Testing
    • 8.4 Shift to Preventative Medicine
    • 8.5 Mergers of Diagnostic Companies
    • 8.6 Information Management Advances
    • 8.7 Test Ordering Patterns
    • 8.8 Patient Satisfaction
    • 8.9 Move Away from Central Laboratory
    • 8.10 Healthcare Cost Controls
    • 8.11 Competition for Services
    • 8.12 Drivers and Barriers of Clinical Laboratory Testing
    • 8.13 Confluence of New Technology
    • 8.14 New Trends in Clinical Laboratory Testing
      • 8.14.1 Trends in Reimbursement Practices
      • 8.14.2 Managed Care
      • 8.14.3 Point of Care Testing
      • 8.14.4 Satellite Facilities
  • List Of Figures
    • Figure 2.1: Total Medicare Expenditures, 1995-2005
    • Figure 2.2: Effect of Medicare Laboratory Fee Schedule Changes on a $10 Test, 1984-2006
    • Figure 2.3: Part B Spending on Clinical Laboratory Services, 1991-2005
    • Figure 2.4: Cost Per Billable Test
    • Figure 2.5: Annual Billable Tests Processed Per FTE
    • Figure 2.6: Outreach Business Operated at a Freestanding Lab Facility
    • Figure 2.7: Volume of Dedicated Sales and Marketing Staff for Outreach Business
    • Figure 2.8: Separately Managed Outreach Billing and Collection
    • Figure 3.1: Lab Revenue by Lab Type
    • Figure 3.2: Lab Revenue by Test Type
    • Figure 3.3: Physician Office Laboratory Revenue, 2000-2006
    • Figure 3.4: Unweighted Average Medicare Reimbursement for the 10 Most Common POL Tests
    • Figure 3.5: Total Number of Non-Waived POLs, 2000-2006
    • Figure 3.6: Number of New Tests Granted CLIA-Waived Status, 2000-2006
    • Figure 3.7: High-Volume Waived Tests
    • Figure 4.1: Laboratory Service Revenue from Pap Testing, 1998-2005
    • Figure 4.2: Percentage of Pap Tests Performed Using Mono-Layer Methods, 1998-2006
    • Figure 4.3: Market Share for Pap Test Vendors, 2006
    • Figure 5.1: Percentage of Physicians in Practices with IT for Specific Clinical Activities
    • Figure 5.2: Office-Based Physicians That Use EHRs, 2001-2005
    • Figure 6.1: Average Revenue Multiple Paid to Acquire Labs, 2000-2006
    • Figure 6.2: Hospital Market Share for Outreach Programs
  • List Of Tables
    • Table 2.1: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005
    • Table 2.2: Medicare Spending on Clinical Lab Services, 1991-2005
    • Table 2.3: Medicare Part B Spending Per Medicare Enrollee, 1998-2005
    • Table 2.4: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005
    • Table 2.5: Washington G-2 Hospital Lab Outreach Survey
    • Table 3.1: U.S. Clinical Laboratory Testing Market Revenue, 2005-2012
    • Table 3.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006
    • Table 3.3: Growth Rates of Test Types
    • Table 3.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012
    • Table 3.5: Twenty Most Common Laboratory Tests Offered at Family Physician Offices
    • Table 3.6: Important New Waived Tests
    • Table 3.7: Revenue Growth At 14 Publicly-Traded Lab Companies, 2005
    • Table 3.8: Payer Group wise Percentage of Total Volume of Requisitions and Net Revenues
    • Table 4.1: Pap Testing at the Largest U.S. Laboratory Companies, 2006
    • Table 5.1: Applications for Wireless LAN Technology
    • Table 6.1: Laboratory/Pathology Acquisitions
    • Table 6.2: Revenue Growth at Quest Diagnostics, 2000-2006
    • Table 6.3: Revenue Growth at LabCorp, 2000-2006
    • Table 6.4: LabCorp Revenue from Managed Care Contracts, 2004-2006
    • Table 6.5: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006
    • Table 8.1: Medicare Billing Guidelines for Multi-channel Laboratory Tests
    • Table 8.2: Targeted Lab Tests and Brief Educational Reminder Messages