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The Market for Direct-to-Consumer Genetic Testing and Routine Laboratory Testing


Attention: There is an updated edition available for this report.

The Market for Direct-to-Consumer (DTC) Laboratory Testing

This Kalorama Information report provides reliable business intelligence on the growing Direct-to-Consumer (DTC) Testing market. The report details the companies that are providing this service and innovations that have recently occurred in the market. The report provides the trends driving growth, and stats influencing companies in the industry, the incidence of diseases in the U.S. and worldwide, demographics; life expectancy, and company strategies. Information is presented as a U.S market report.

Specific information in the report includes:

Personalized Medicine, Consumer Medical Information and Other Trends Shaping DTC Testing

The Current Clinical Laboratory Market and How DTC May Shake Up the Industry

US DTC Market to 2020.
US DTC Market for Routine Tests, to 2020
US DTC Market for Genetic Tests, to 2020
Age- Based Market Trends
DTC vs. Physician Ordered.

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama interviewed industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report.

18 Companies actively participating in this report are profiled in it.


  • Executive Summary
    • INDUSTRY AT A GLANCE
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEW
      • Table U.S. Direct-to-Consumer Laboratory Testing Market Value by Year, 2010-2020 (in millions of dollars)
    • KEY ISSUES AND TRENDS AFFECTING THE MARKET
    • LEADING MARKET PARTICIPANTS
  • Industry Overview
    • THE LAB SERVICE INDUSTRY
    • TESTING AND SERVICES
      • Routine Testing
        • Table Laboratory Reference Parameters for CBC
        • Table High Cholesterol Risk Categories
        • Table HCG Levels in Pregnant Women by Days Past Ovulation
        • Table Substance Detection Periods by Test Method
        • Table Normal Reference Levels in a Medical Urinalysis
      • Specialty Testing
    • GROWTH OF DTC LAB TESTING MARKET
    • U.S. LABORATORY INDUSTRY STRUCTURE
      • CLIA Laboratory Registration, Laboratories by Type
        • Table CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) July 2015
      • Direct-to-Consumer Impact
        • Table U.S. Hospital Types
    • REGULATION IN THE LAB INDUSTRY
      • Certificate of Waiver
        • Table Selected CLIA Waived Laboratory Tests
      • Certificate of Provider-Performed Microscopy Procedures (PPMP)
        • Table Provider-Performed Microscopy Procedures
      • Laboratory Developed Tests
      • State-by-State Evaluations
        • Table State Regulation in Direct-to-Consumer Laboratory Testing
    • INTERNATIONAL TRENDS AND CONSIDERATIONS
  • Industry Drivers and Barriers
    • OVERVIEW
      • Table Direct to Consumer Lab Testing, Market Drivers and Barriers
    • ISSUES/TRENDS DRIVING THE DIRECT-TO-CONSUMER
    • THE SELF-TREATING CONSUMER - CONSUMER DRIVEN HEALTHCARE
      • Affordability and Accessibility
      • Privacy
    • EMPHASIZING PREVENTIVE HEALTHCARE
    • MOBILE DEVICES OFFER ADDITIONAL CONVENIENCE IN HEALTHCARE DELIVERY
    • DEMOGRAPHICS
      • Table Total U.S. Population, 1980-2050
      • The Aging Population
        • Table Percent U.S. Population Over Age 65 by Year, 2000-2050
    • INCIDENCE AND PREVALENCE OF CHRONIC DISEASES AND CONDITIONS
    • INFORMATION TECHNOLOGY - CHANGING THE WAY LABS DO BUSINESS
      • Table Leading Laboratory Information Management System Providers
    • GROWTH BARRIERS TO ADVANCING DIRECT-TOCONSUMER TESTING
      • Regulatory Environment
      • Accuracy
      • Informed Consent
      • Payment Structure for Direct-to-Consumer Lab Testing
        • Table Select Tests and Prices by Direct-to-Consumer Laboratory Service Provider (as of December 1, 2015)
      • HIPPA Concerns
  • Market Participants
    • SUMMARY
    • 23ANDME, INC
      • Company Overview
        • Table Corporate Details of 23andMe
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
      • Growth Strategy
    • ANY LAB TEST NOW
      • Company Overview
        • Table Company Details for Any Lab Test Now
      • Performance Review
      • Products and Services
    • COLOR GENOMICS, INC.
      • Company Overview
        • Table Corporate Details of Color Genomics, Inc
      • Products and Services
    • COUNSYL, INC.
      • Company Overview
        • Table Corporate Details of Counsyl, Inc
      • Products and Services
    • DIRECT LABORATORY SERVICES, LLC.
      • Company Overview
        • Table Corporate Details of Direct Laboratory Services
      • Products and Services
    • GENE BY GENE, LTD.
      • Company Overview
        • Table Corporate Details of Gene by Gene
      • Products and Services
    • HEALTHCHECKUSA
      • Company Overview
        • Table Company Details for HealthCheckUSA
      • Products and Services
    • HOME ACCESS HEALTH CORPORATION
      • Company Overview
        • Table Company Details for Home Access Health Corporation
      • Products and Services
    • LABORATORY CORPORATION OF AMERICA
      • Company Overview
        • Table Corporate Details of Laboratory Corporation of America
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
      • Growth Strategy
      • Locations
    • MYMEDLAB
      • Company Overview
        • Table Corporate Details of Mapmygenome India Limited
      • Products and Services
    • MAPMYGENOME INDIA LIMITED
      • Company Overview
        • Table Corporate Details of Mapmygenome India Limited
      • Products and Services
    • POSITIVE BIOSCIENCE LTD.
      • Company Overview
        • Table Corporate Details for Positive Bioscience
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • QUEST DIAGNOSTICS, INC.
      • Company Overview
        • Table Corporate Details of Quest Diagnostics
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
      • Growth Strategy
      • Business Locations
    • REQUEST A TEST, LTD.
      • Company Overview
        • Table Company Details for Request A Test
      • Products and Services
    • SONORA QUEST LABORATORIES
      • Company Overview
        • Table Company Details for Sonora Quest Laboratories
      • Products and Services
    • THERANOS, INC.
      • Company Overview
        • Table Company Details for Theranos
      • Products and Services
    • WALK-IN LAB
      • Company Overview
        • Table Corporate Details of Walk-In Lab
      • Products and Services
    • WELLNESSFX
      • Company Overview
        • Table Corporate Details of WellnessFX
      • Products and Services
    • XCODE LIFE SCIENCES
      • Company Overview
        • Table Corporate Details of Xcode Life Sciences
      • Products and Services
  • Market Trends and Summary
    • DIRECT-TO-CONSUMER LABORATORY TESTING MARKET OVERVIEW
      • Table U.S. Direct-to-Consumer Laboratory Testing Market Value by Year, 2010-2020 (in millions of dollars)
      • Direct-to-Consumer Laboratory Testing Markets by Test Segment
        • Table U.S. Direct-to-Consumer Laboratory Testing Market Analysis by Test Type, 2010-2020 (in millions of dollars)
      • Routine and Core Laboratory Testing
      • Genetic Testing
  • List of Major Companies

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