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

$5,000.00 – $10,000.00

Clear
SKU: 22-712 Category: Diagnostics Market Research Tags: direct to consumer, DTC testing, healthcare, laboratory testing, labs, patient-ordered laboratory testing, Personalized Medicine, Telehealth, Telemedicine Pages: 100
  • Description
  • Table of Contents
  • Latest reports

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

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