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