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

  • Report
  • 115 Pages
  • May 2022
  • Region: United States
  • Kalorama Information
  • ID: 5599769

Growing Demand for Early Disease Detection & Diagnosis and Personalized Medicine

Direct to consumer laboratory testing is also known as patient-ordered laboratory testing. A variety of tests are now available for direct to consumer testing.

The growing market for direct-to-consumer laboratory testing may promote awareness of health issues and genetic diseases, which will allow patients to take a more proactive role in their healthcare. With advances in technology, the completion of the sequencing of the human genome and the pressures of the pandemic, direct to consumer lab testing is becoming increasingly popular. Still, clinical laboratories are an essential part of the health industry. It is estimated that the vast majority of physician’s diagnoses are a result of laboratory tests. In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

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, consumer acceptance and expanded technologies. This report, Global Market for Direct-to-Consumer (DTC) Laboratory Testing, examines these and other essential market trends. 


Additionally, issues and trends explored in this report include:

  • Demographics and Aging Population
  • Growing Incidence of Disease
  • Regulatory Environment
  • Consumer Driven Health Care
  • Emphasis on Preventative Healthcare
  • Developments in Personalized Medicine
  • Mobile Devices 
  • Informed Consent
  • Payment Structure
  • Sales by Distribution Channel
  • Large Diagnostic Companies and DTC
  • Telehealth and DTC Testing

Leading companies profiled in the report include: 

  • 23andMe
  • Any Lab Test Now
  • Color Genomics
  • Direct Laboratory Services 
  • EasyDNA
  • Everlywell
  • Laboratory Corporation of America
  • MyMedLab
  • Medichecks.com
  • Ombre Gut Health (formerly Thryve)
  • Quest Diagnostics
  • Request A Test

Scope and Methodology


The scope of the report is direct to consumer (DTC) laboratory testing. This does not include point of care testing or over the counter testing (i.e., pregnancy testing) because the laboratory is not needed to run the test or interpret the results. This report was assembled using both secondary and primary data. Data from the analyst's previous DTC Laboratory Testing report, in addition to company annual reports, trade publications, government and medical literature were used as a foundation for estimates and forecasts. Interviews with executives at 8 DTC laboratory testing companies were conducted and are a key source of estimates for the market. The analyst focuses on estimates of manufacturer revenues for business planning. The geographical scope is the United States.

The base year for data was 2021. The forecast years are 2022-2026 with compound annual growth rates (CAGRs) provided for 2021-2026 periods for each segment covered. The forecasted market analysis for 2021-2026 was largely based on demographic trends, new developments, and innovative technology.

It is important to note that the market areas covered by this report are evolving very quickly, and that some of the company and technology information may be outdated even as the report goes to press. The analyst is fully aware of these developments. Even though some of the details may have changed by the time this report is published, the major themes, players and issues remain unchanged.

Table of Contents

Chapter 1: Executive Summary
  • Overview
  • Size and Growth of the Market
  • Scope and Methodology
  • Key Issues and Trends Affecting the Market
  • Leading Market Participants
  • Conclusions
Chapter 2: Introduction
  • The U.S. Laboratory Service Industry
  • Growth of the DTC Testing Market
  • U.S. Laboratory Industry Structure
  • CLIA Laboratory Registration, Laboratories by Type
  • Direct-To-Consumer Testing
  • DTC in Genetic Testing
  • New Opportunities in Direct-To-Consumer Testing Outlets
  • Dialysis Clinics
  • Hospitals
  • Regulation in the Laboratory Industry
  • Certificate of Waiver
  • Laboratory Developed Tests
  • State-By-State Evaluations
  • Testing and Services
Chapter 3: Direct-To-Consumer Routine Clinical Laboratory Testing
  • Routine Testing
  • Blood Cell Count
  • Cholesterol Level Testing
  • Diabetes Testing
  • HIV Testing
  • Pregnancy Testing
  • Substance Abuse Testing
  • Urinalysis
  • COVID-19
  • Saliva Testing
  • DTC Routine Clinical Laboratory Market Drivers and Barriers
  • Market Size and Growth
  • Competitive Landscape
Chapter 4: Direct-To Consumer Genetic Laboratory Testing Market
  • Genetic Research
  • Growth of DTC Genetic Testing Market
  • Types of DTC Genetic Testing
  • Evolution of DTC Genetic Testing
  • DTC Genetic Testing Business Model
  • Market Constraints
  • DTC Genetic Laboratory Testing Market Drivers and Barriers
  • Market Size and Growth
  • Competitive Landscape
Chapter 5: Industry Drivers and Barriers
  • Overview
  • Issues and Trends Driving the Direct-To-Consumer Market
  • Consumer Driven Healthcare
  • Affordability and Accessibility
  • Privacy
  • Aging Population
  • Increase in Chronic Disease
  • Emphasis on Preventative Healthcare
  • Regulatory Environment
  • Regulatory Pathway
  • Accuracy
  • Informed Consent
  • Payment Structure for Direct-To-Consumer Laboratory Testing
  • Patient Direct Pay
  • Flexible Spending Accounts and Health Savings Accounts
  • Sales by Distribution Channel
  • Mobile Devices
  • Large Diagnostic Companies and DTC
  • Telehealth and DTC Testing
Chapter 6: Company Profiles
  • 23andMe, Inc. (Company Overview, Products, Company Financials)
  • Any Lab Test Now, Inc. (Company Overview, Products)
  • Color Genomics, Inc. (Company Overview, Products)
  • Direct Laboratory Services, LLC (Company Overview, Products)
  • EasyDNA (Company Overview, Products)
  • Everlywell (Company Overview, Products)
  • Laboratory Corporation of America (Company Overview, Products, Company Financials)
  • MyMedLab, Inc. (Company Overview, Products)
  • Medichecks.Com Ltd. (Company Overview, Products)
  • Myriad Genetics, Inc. (Company Overview, Products, Company Financials)
  • Ombre Gut Health (Formerly Thryve) (Company Overview, Products)
  • Quest Diagnostics, Inc. (Company Overview, Products, Company Financials)
  • Request a Test, Ltd. (Company Overview, Products)
List of Tables
Table 1-1: U.S. DTC Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
Table 2-1: CLIA Registered Laboratories by Type of Facility (Exempt/Non-exempt Combined) May 2022
Table 2-2: Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and LabCorp On Demand) 2022* (in US $)
Table 2-3: U.S. Hospital Types
Table 2-4: Selected CLIA Waived Laboratory Tests
Table 2-5: State Regulation in DTC Laboratory Testing
Table 2-6: DTC Tests with FDA Marketing Authorization
Table 3-1: Laboratory Reference Parameters for CBC
Table 3-2: High Cholesterol Risk Categories
Table 3-3: HCG Levels in Pregnant Women by Days Past Ovulation
Table 3-4: Substance Detection Periods by Test Method
Table 3-5: Normal Reference Levels in a Medical Urinalysis
Table 3-6: DTC Routine Clinical Laboratory Testing : Market Drivers and Barriers
Table 3-7: US DTC Routine Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
Table 4-1: DTC Genetic Laboratory Testing, Market Drivers and Barriers
Table 4-2: U.S. DTC Genetic Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
Table 5-1: DTC Laboratory Testing Market Drivers and Barriers
Table 5-2: Select Tests and Prices by Laboratory Service Providers 2022 (in US $)
Table 6-1: 23andMe Corporate Summary
Table 6-1: 23andMe Revenue (2019-2021) ($ millions)
Table 6-2: Any Lab Test Now Corporate Summary
Table 6-3: Color Genomics Corporate Summary
Table 6-4: Direct Laboratory Services Corporate Summary
Table 6-5: EasyDNA Corporate Summary
Table 6-6: Everlywell Corporate Summary
Table 6-7: Laboratory Corporation of America Corporate Summary
Table 6-8: LabCorp Revenue (2019-2021) ($ millions)
Table 6-9: MyMedLab Corporate Summary
Table 6-10: Medichecks Corporate Summary
Table 6-11: Myriad Genetics Corporate Summary
Table 6-12: Myriad Diagnostics Revenue (2019-2021) ($ millions)
Table 6-13: Ombre Corporate Summary
Table 6-14: Quest Diagnostics Corporate Summary
Table 6-15: Quest Revenue (2019-2021) ($ millions)
Table 6-16: Request A Test Corporate Summary
List of Figures
Figure 1-1: U.S. DTC Laboratory Testing Market, 2021-2026
Figure 2-1: Growth in Clinical Laboratories, 1997-2021
Figure 2-2: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type of Facility, 2022
Figure 3-1: U.S. Direct-to-Consumer Routine Clinical Testing Market Analysis: 2021-2026
Figure 3-2: U.S. Direct-to-Consumer Routine Clinical Testing Compared to COVID-19 Testing, 2021
Figure 3-3: Global Direct to Consumer Routine Clinical Testing Market, Market Share of Leading Suppliers by % 2021
Figure 4-1: U.S. Direct-to-Consumer Genetic Laboratory Testing Market Analysis 2021-2026
Figure 4-2: U.S. Direct to Consumer Genetic Testing Market, Market Share of Leading Suppliers by % 2021
Figure 5-1: US Population Trends, 65 Years and Older Percent of Total Population 2000-2050
Figure 5-2: Prevalence of Disease, 2000, 2015 and Projected 2030
Figure 5-3: Global DTC Laboratory Testing by Channel Type 2021 by Percent

Companies Mentioned

  • 23andMe
  • Any Lab Test Now
  • Color Genomics
  • Direct Laboratory Services 
  • EasyDNA
  • Everlywell
  • Laboratory Corporation of America
  • MyMedLab
  • Medichecks.com
  • Ombre Gut Health (formerly Thryve)
  • Quest Diagnostics
  • Request A Test