Direct-to-Consumer Testing Market

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Description

Direct-to-Consumer Testing Market

With advances in technology, the completion of the sequencing of the human genome and the pressures of capitalism, direct to consumer (DTC) laboratory testing is becoming increasingly popular. The growing market for DTC laboratory testing may promote awareness of health issues and genetic diseases, which could allow patients to take a more proactive role in their healthcare. The global DTC testing market is divided into two distinct areas of DTC testing:

  • Routine clinical laboratory testing
  • Medical genetic laboratory testing

Kalorama’s Direct-to-Consumer Testing Market explores the increasing consumer demand for both direct-to-consumer routine clinical laboratory tests and genetic tests, including the following total market information:

  • Global DTC Laboratory Testing Market, 2016-2023 (in millions and % Change at manufacturer level)
  • Global DTC Routine Clinical Testing Market, 2016-2023 (in millions and % Change at manufacturer level)
  • Global DTC Routine Clinical Testing Market, Market Share of Leading Suppliers by %, 2018
  • Global DTC Genetic Testing Market, 2016-2023 (in millions and % change at manufacturer level)
  • Global DTC Genetic Testing Market, Market Share of Leading Suppliers by %, 2018

The DTC Routine Clinical Testing Market

Routine testing is necessary in assisting medical professionals with diagnoses of disease, confirmation of a medical condition, or in preventive care. These tests are done on a regular basis and often have a fast turnaround. Common routine tests include: blood cell count; cholesterol levels; HIV tests; pregnancy tests, (HCG) lab-based; substance abuse tests, lab-based; and urinalysis (and other various) tests, lab-based. The report examines the increasing routine clinical laboratory testing market to the regional level, including the following:

  • Market Size and Growth for United States DTC Routine Clinical Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for European DTC Routine Clinical Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for Asia Pacific DTC Routine Clinical Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for Rest of World DTC Routine Clinical Testing Market, 2018-2023 ($millions)
  • Global Regional Breakdown of DTC Routine Clinical Testing (%), 2018 (US, Europe, Asia Pacific, RoW)
  • Global Regional Breakdown of DTC Genetic Testing (%), 2023 (US, Europe, Asia Pacific, RoW)

The DTC Disease Genetic Testing Market

There are three general categories of genetic testing. The three broad categories are ancestry origin; paternity including maternity, siblings, etc.; and disease. Within these categories there are many subcategories of genetic testing. This report concerns disease genetic testing, excluding paternity testing and ancestry testing. Direct-to-Consumer Testing Market presents the following market data:

  • Market Size and Growth for United States DTC Genetic Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for European DTC Genetic Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for Asia Pacific DTC Genetic Testing Market, 2018-2023 ($millions)
  • Market Size and Growth for Rest of World DTC Genetic Testing Market, 2018-2023 ($millions)
  • Global Regional Breakdown of DTC Genetic Testing (%), 2018 (US, Europe, Asia Pacific, RoW)
  • Global Regional Breakdown of DTC Genetic Testing (%), 2023 (US, Europe, Asia Pacific, RoW)
  • Volume Distribution for DTC Genetic Testing Services, by Order Origination Source (%), 2018 (Pure DTC, Consumer Initiated/Dr ordered)

Issues and Trends Driving the Direct to Consumer Market

The healthcare industry will continue to face growing pressure to increase efficiency and quality while also controlling costs. This presents a challenging atmosphere for many health practitioners, medical payers, and supportive health industry participants to provide optimal health that is being demanded by patients while also restructuring their services to meet the demands for reducing the high cost of services. One of the movements underway to achieve this goal is the development of the direct-to-consumer laboratory testing market. The report looks at the issues and trends driving the direct-to-consumer laboratory testing market, including:

  • DTC Routine Clinical Laboratory Testing: Market Drivers and Barriers
  • DTC Genetic Laboratory Testing, Market Drivers and Barriers
  • Payment Structure for Direct-to-Consumer Laboratory Testing

Competitive Landscape

The current market is highly competitive in terms of prices, locations, and services offered. Direct-to-Consumer Testing Market provides an overview of the leading market participants in the DTC lab testing market, including the following industry leaders:

  • 23andMe, Inc
  • Ambry Genetics Corp.
  • Any Lab Test Now, Inc.
  • Color Genomics, Inc
  • Counsyl, Inc.
  • Direct Laboratory Services, LLC
  • Eastern Biotech & Life Sciences
  • EasyDNA
  • Gene by Gene, Ltd.
  • Genecodebook Oy
  • Genetrainer
  • GHC Genetics UK
  • HealthCheckUSA
  • Home Access Health Corporation
  • International Biosciences
  • Laboratory Corporation of America
  • Mapmygenome India Limited
  • Medichecks.com Ltd.
  • MyMedLab, Inc.
  • Myriad Genetics, Inc.
  • Natera, Inc
  • Pathway Genomics
  • Positive Bioscience
  • Quest Diagnostics, Inc.
  • Request A Test, Ltd.
  • Shuwen Health Sciences/Shuwen Biotech Co. Ltd.
  • Sonora Quest Laboratories
  • Thryve Inc
  • Veritas Genetics
  • Vitagene, Inc.
  • Walk-In-Lab
  • Xcode Life Sciences

Table of Contents

Executive Summary

  • Overview
  • Size and Growth of the Market
    • Table Global DTC Laboratory Testing Market 2016-2023 (in millions and % Change at manufacturer level)
    • Table Global DTC Laboratory Testing Market, 2016-2023 (in millions)
  • Scope and Methodology
  • Key Issues and Trends Affecting the Market
  • Leading Market Participants
  • Conclusions

 

Introduction

  • The Laboratory Service Industry
  • U.S. Laboratory Industry Structure
    • Table Growth in Clinical Laboratories, 1997-2017 (half year 2018)
    • CLIA Laboratory Registration, Laboratories by Type
      • Table U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type of Facility, 2018
      • Table CLIA Registered Laboratories by Type of Facility (Exempt/Non-exempt Combined) July 2018
    • Direct-to-Consumer Impact
      • Table Growth in U.S. Pharmacy-Based Laboratories 2011-2018
    • New Opportunities in Direct-to-Consumer Testing Outlets
      • Table U.S. Hospital Types
    • Regulation in the Laboratory Industry
      • Table Selected CLIA Waived Laboratory Tests
      • Table Provider-Performed Microscopy Procedures
    • State-by-State Evaluations
      • Table State Regulation in DTC Laboratory Testing
    • Testing and Services

 

Direct-to-Consumer Routine Clinical Laboratory Testing

  • Routine Testing
    • Blood Cell Count
      • Table Laboratory Reference Parameters for CBC
    • Cholesterol Level Testing
      • Table High Cholesterol Risk Categories
    • HIV Testing
    • Pregnancy Testing
      • Table HCG Levels in Pregnant Women by Days Past Ovulation
    • Substance Abuse Testing
      • Table Substance Detection Periods by Test Method
    • Urinalysis
      • Table Normal Reference Levels in a Medical Urinalysis
    • DTC Routine Clinical Laboratory Market Drivers and Barriers
      • Table DTC Routine Clinical Laboratory Testing: Market Drivers and Barriers
  • Market Size and Growth
    • Table Global DTC Routine Clinical Testing Market 2016-2023 (in millions and % Change at manufacturer level)
    • Table Global Direct-to-Consumer Routine Clinical Testing Market Analysis: 2016-2023 (in millions)
  • Regional Routine Clinical Testing Market
    • United States
      • Table Market Size and Growth for United States DTC Routine Clinical Testing Market, 2018-2023 ($millions)
    • Europe
      • Table Market Size and Growth for European DTC Routine Clinical Testing Market, 2018-2023 ($millions)
    • Asia Pacific
      • Table Market Size and Growth for Asia Pacific DTC Routine Clinical Testing Market, 2018-2023 ($millions)
    • Rest of World
      • Table Market Size and Growth for Rest of World DTC Routine Clinical Testing Market, 2018-2023 ($millions)
      • Table Global Regional Breakdown of DTC Routine Clinical Testing (%), 2018
      • Table Global Regional Breakdown of DTC Genetic Testing (%), 2023
  • Competitive Landscape
    • Table Global Direct to Consumer Routine Clinical Testing Market, Market Share of Leading Suppliers by %, 2018

 

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 DTC Genetic Laboratory Testing, Market Drivers and Barriers
  • International Trends and Considerations
  • Market Size and Growth
    • Table Global DTC Genetic Testing Market 2016-2023 (in millions and % change at manufacturer level)
    • Table Global Direct-to-Consumer Genetic Testing Market Analysis: Genetic Testing Market Trend, 2016-2023 (in millions)
    • Table Volume Distribution for DTC Genetic Testing Services, by Order Origination Source (%), 2018
  • Regional DTC Genetic Testing Market
    • United States
      • Table Market Size and Growth for United States DTC Genetic Testing Market, 2018-2023 ($millions)
    • Europe
      • Table Market Size and Growth for European DTC Genetic Testing Market, 2018-2023 ($millions)
    • Asia Pacific
      • Table Market Size and Growth for Asia Pacific DTC Genetic Testing Market, 2018-2023 ($millions)
    • Rest of World
      • Table Market Size and Growth for Rest of World DTC Genetic Testing Market, 2018-2023 ($millions)
      • Table Global Regional Breakdown of DTC Genetic Testing (%), 2018
      • Table Global Regional Breakdown of DTC Genetic Testing (%), 2023
  • Competitive Landscape
    • Table Global Direct to Consumer Genetic Testing Market, Market Share of Leading Suppliers by %, 2018

 

Industry Drivers and Barriers

  • Overview
    • Table 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
    • Table Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050 (population in millions)
    • Increase in Chronic Disease
      • Table Global Prevalence of Disease, 2000, 2015 and Projected 2030 (prevalence in millions of population)
      • Table Mortality – Chronic vs. Acute (%), 2018
  • Emphasis on Preventative Healthcare
  • Information Technology
    • Table Selected Laboratory Information Management System Providers
  • Regulatory Environment
    • Accuracy
    • Informed Consent
  • Payment Structure for Direct-to-Consumer Laboratory Testing
    • Patient Direct Pay
      • Table Select Tests and Prices by Select Laboratory Service Providers, 2018 (in US $)
    • Flexible Spending Accounts and Health Savings Accounts
    • HIPPA Concerns and Privacy
  • Sales by Distribution Channel
    • Table Global DTC Laboratory Testing by Channel Type, 2018 (US$ millions)
  • Mobile Devices
  • Theranos
  • DTC 2.0 Model

Company Profiles

  • 23andMe, Inc
    • Table 23andMe Corporate Summary
    • Company Overview
    • Products
  • Ambry Genetics Corp.
    • Table Ambry Genetics Corporate Summary
    • Company Overview
    • Products
  • Any Lab Test Now, Inc.
    • Table Any Lab Test Now Corporate Summary
    • Company Overview
    • Products
  • Color Genomics, Inc
    • Table Color Genomics Corporate Summary
    • Company Overview
    • Products
  • Counsyl, Inc.
    • Table Counsyl Corporate Summary
    • Company Overview
    • Products
  • Direct Laboratory Services, LLC
    • Table Direct Laboratory Services Corporate Summary
    • Company Overview
    • Products
  • Eastern Biotech & Life Sciences
    • Table Eastern Biotech and Life Sciences Corporate Summary
    • Company Overview
    • Products
  • EasyDNA
    • Table EasyDNA Corporate Summary
    • Company Overview
    • Products
  • Gene by Gene, Ltd.
    • Table Gene by Gene Corporate Summary
    • Company Overview
    • Products
  • Genecodebook Oy
    • Table Genecodebook Oy Corporate Summary
    • Company Overview
    • Products
  • Genetrainer
    • Table Genetrainer Corporate Summary
    • Company Overview
    • Products
  • GHC Genetics UK
    • Table GHC Genetics UK Corporate Summary
    • Company Overview
    • Products
  • HealthCheckUSA
    • Table HealthCheckUSA Corporate Summary
    • Company Overview
    • Products
  • Home Access Health Corporation
    • Table Home Access Health Corporate Summary
    • Company Overview
    • Products
  • International Biosciences
    • Table International Biosciences Corporate Summary
    • Company Overview
    • Products
  • Laboratory Corporation of America
    • Table Laboratory Corporation of America Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table LabCorp Revenue (2015-2018) ($ millions)
  • Mapmygenome India Limited
    • Table Mapmygenome Corporate Summary
    • Company Overview
    • Products
  • Medichecks.com Ltd.
    • Table Medichecks Corporate Summary
    • Company Overview
    • Products
  • MyMedLab, Inc.
    • Table MyMedLab Corporate Summary
    • Company Overview
    • Products
  • Myriad Genetics, Inc.
    • Table Myriad Genetics Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table Myriad Diagnostics Revenue (2015-2018) ($ millions)
  • Natera, Inc
    • Table Natera Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table Natera Revenue (2015-2018) ($ millions)
  • Pathway Genomics
    • Table Pathway Genomics Corporate Summary
    • Company Overview
    • Products
  • Positive Bioscience
    • Table Positive Bioscience Corporate Summary
    • Company Overview
    • Products
  • Quest Diagnostics, Inc.
    • Table Quest Diagnostics Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table Quest Revenue (2015-2018) ($ millions)
  • Request A Test, Ltd.
    • Table Request A Test Corporate Summary
    • Company Overview
    • Products
  • Shuwen Health Sciences/Shuwen Biotech Co. Ltd.
    • Table Shuwen Health Sciences Corporate Summary
    • Company Overview
    • Products
  • Sonora Quest Laboratories
    • Table Sonora Quest Labs Corporate Summary
    • Company Overview
    • Products
  • Thryve Inc
    • Table Thryve Corporate Summary
    • Company Overview
    • Products
  • Veritas Genetics
    • Table Veritas Genetics Corporate Summary
    • Company Overview
    • Products
  • Vitagene, Inc.
    • Table Vitagene Corporate Summary
    • Company Overview
    • Products
  • Walk-In-Lab
    • Table Walk-In Lab Corporate Summary
    • Company Overview
    • Products
  • Xcode Life Sciences
    • Table Xcode Life Sciences Corporate Summary
    • Company Overview
    • Products

 

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