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

Jan 1, 2016
134 Pages - Pub ID: KLI5816129
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The Market for Direct-to-Consumer Genetic Testing and Routine Laboratory Testing 


The growth of the direct-to-consumer lab testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare.  This report provides the reader with an overview of the U.S. DTC (direct-to-consumer) laboratory testing industry for both advanced genetic tests and routine core laboratory testing.  

Direct-to-consumer lab testing is a reality that IVD companies and service providers should be aware of.  Several trends are continuing to shape the direct to consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring and expanded technologies.  This report evaluates those trends and provides useful business information, including the following:

  • U.S. Direct-to-Consumer Laboratory Testing Market Value by Year, 2010-2020
  • U.S. Direct-to-Consumer Laboratory Testing Market : Revenues by Type (Routine vs. Genetic)
  • Routine and Core Laboratory Testing Market
  • DTC Genetic Testing market
  • U.S. DTC Laboratory Testing Market, Uninsured Population Utilization    
  • U.S. Direct-to-Consumer Laboratory Testing, by Target Age, 2020
  • Genetic Testing Services Percentage DTC vs. Physician Ordered

Included in the report are statistics influencing direct-to-consumer lab testing, incidence of diseases in the U.S. and worldwide, demographics; life expectancy, and company strategies. Information is presented as a U.S market report. A market summary includes a total U.S. market analysis and analysis by test segment. Also included are competitive profiles of leading direct to consumer laboratory testing providers.

Since the 1980s, consumers have pushed for access to their laboratory tests but it has been slow to evolve due to concerns that consumers may try to diagnose themselves without understanding how diagnoses information all fits together.  With advances in technology, the completion of the sequencing of the human genome and the pressures of capitalism, direct-to-consumer lab testing is becoming increasingly popular.  With the increased use of the Internet for medical information, consumers have become medical consumers not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions.

The U.S. direct-to-consumer laboratory testing market is highly competitive in terms of prices, locations, and services offered. Larger laboratories such as Quest Diagnostics and LabCorp have advantages in the market due to the wide exposure, large number of locations, and greater financial positions but until recently, had not been directly involved. Smaller, independent laboratories have been the mainstay of the direct to consumer laboratory testing market. Some laboratories, such as 23and Me and have found success in offering specialized genetic testing (ancestral testing) and others have found success operating on a regional basis such as Sonora Quest Laboratories. This report provides an overview of some of the leading market participants in the direct to consumer laboratory testing market. The following companies are among the leaders in the industry:

23andMe
Any Lab Test Now.
Color Genomics
Counsyl
Direct Laboratory Services
Gene by Gene
HealthCheck USA
Home Access Health Corporation
Laboratory Corporation of America
MyMedLab
Mapmygenome India
Positive Bioscience
Quest Diagnostics
Request A Test
Sonora Quest Laboratories
Theranos
Walk-In Lab
WellnessFX
Xcode Life Sciences

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 Information conducted interviews with key 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. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

All market data pertains to the U.S. market at the manufacturers’ level. The base year for data is 2015. Historical data is provided for the years 2010 through 2014, with forecast data provided for 2016 through 2020. Compound annual growth rates (CAGRs) are provided for the 2010-2015 and 2015-2020 periods for each segment covered. The forecasted market analysis through 2020 was largely based on demographic trends, disease trends, new developments, company performance trends, national expansion and recent alliances.

EXECUTIVE SUMMARY
Industry at a Glance
Scope and Methodology
Market Overview
Key Issues and Trends Affecting the Market
Leading Market Participants
INDUSTRY OVERVIEW
The Lab Service Industry
Testing and Services
Routine Testing
Blood Cell Count
Cholesterol Level Testing
HIV Testing
Pregnancy Testing
Substance Abuse Testing
Urinalysis
Specialty Testing
Endocrinology
Esoteric Testing
Genetics
Immunology and Molecular Microbiology
Oncology
Serology
Growth of DTC Lab Testing Market
U.S. Laboratory Industry Structure
CLIA Laboratory Registration, Laboratories by Type
Direct-to-Consumer Impact
Direct-to-Consumer Service Distribution Channels
New Opportunities in Direct-to-Consumer Testing Outlets
Regulation in the Lab Industry
Certificate of Waiver
Certificate of Provider-Performed Microscopy Procedures (PPMP)
Laboratory Developed Tests
State-by-State Evaluations
International Trends and Considerations
INDUSTRY DRIVERS AND BARRIERS
Overview
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
The Aging Population
Incidence and PREVALENCE OF Chronic Diseases and Conditions
Information Technology - Changing the Way Labs Do Business
Growth Barriers To Advancing Direct-to-Consumer Testing
Regulatory Environment
Accuracy
Informed Consent
Payment Structure for Direct-to-Consumer Lab Testing
Patient Direct Pay
Flexible Spending Accounts and Health Savings Accounts
HIPPA Concerns
MARKET PARTICIPANTS
Summary
23andMe, Inc
Company Overview
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Any Lab Test Now
Company Overview
Performance Review
Products and Services
Color Genomics, Inc.
Company Overview
Products and Services
Counsyl, Inc.
Company Overview
Products and Services
Direct Laboratory Services, LLC.
Company Overview
Products and Services
Gene by Gene, Ltd.
Company Overview
Products and Services
HealthCheckUSA
Company Overview
Products and Services
Home Access Health Corporation
Company Overview
Products and Services
Laboratory Corporation of America
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Locations
MyMedLab
Company Overview
Products and Services
Mapmygenome India Limited
Company Overview
Products and Services
Positive Bioscience Ltd.
Company Overview
Key Acquisitions, Alliances, and Partnerships
Products and Services
Quest Diagnostics, Inc.
Company Overview
Performance Review
Key Acquisitions, Alliances, and Partnerships
Products and Services
Growth Strategy
Business Locations
Request A Test, Ltd.
Company Overview
Products and Services
Sonora Quest Laboratories
Company Overview
Products and Services
Theranos, inc.
Company Overview
Products and Services
Walk-In Lab
Company Overview
Products and Services
WellnessFX
Company Overview
Products and Services
Xcode Life Sciences
Company Overview
Products and Services
MARKET TRENDS AND SUMMARY
Direct-to-Consumer Laboratory Testing Market Overview
Direct-to-Consumer Laboratory Testing Markets by Test Segment
Routine and Core Laboratory Testing
Genetic Testing
LIST OF MAJOR COMPANIES

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