Report Scope:
This report, “DTC Testing Industry: Global Markets,” provides a comprehensive analysis of the DTC testing market in a global context, including market forecasts and sales through 2025. The report analyzes the market by segmenting it into the different test categories: health and wellness tests, ancestry tests, genetic health risk tests, pharmacogenetics tests, carrier screening tests, overall tests, and others.
This study segments the DTC testing market by distribution channel into online, retail, and diagnostic labs. The market is also assessed in all of the geographic regions, including North America, Europe, and emerging markets. The emerging markets include countries and regions like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, and Latin America.
The report features new product developments and patents boosting the growth of this market in the global context.
This report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on the changing market trends, market players, and their leading products. This chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that is expected to shape the industry.
The factors such as strengths, weaknesses, threats, and opportunities that are expected to play a role in the DTC testing market are evaluated in detail.
The report excludes at-home pregnancy and fertility tests. COVID-19 tests are covered, but not their sales. Provider-dependent at-home tests are not included in this report.
The Report Includes:
- 29 data tables and 40 additional tables
- An overview of the global market for Direct-to-consumer (DTC) testing, and discussion on its technology background
- Estimation of the market size and analyses of global market trends, with data from 2018, 2019, estimates for 2020, with projections of compound annual growth rates (CAGRs) through 2025
- Comparative study on traditional vs. DTC testing and identification of new opportunities, challenges, and technological changes within the industry
- Market share analysis of DTC testing based on type, applications, and distribution channel and evaluation of market size, market forecast, and regulatory landscape of DTC testing industry
- Impact analysis of COVID-19 on Direct-to-consumer (DTC) testing industry
- Coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies and details of the investments and new product launches in the market
- Comprehensive company profiles of market-leading participants, including 23andMe, EasyDNA, Ancestry, Color Genomics, Full Genomes, and Genesis HealthCare
Table of Contents
Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources
- Methodology
- Geographic Breakdown
- Analyst's Credentials
- Custom Research
- Related Reports
Chapter 2 Summary and Highlights
- Key Highlights
Chapter 3 Market and Technology Background
- History of DTC Testing
- Difference between Traditional and DTC Testing
- Types of DTC Tests
- Genetic Tests
- Biomarker-based Tests
- Microbiome Tests
- Population Databases or Biobanks
- Applications of DTC Testing
- Health and Wellness
- Ancestry and Genealogy Testing
- Carrier Screening
- Disease Risk Assessment
- Pharmacogenetics
- Whole Genome Sequencing
- Others
- Regulatory Landscape of the DTC Testing Industry
- Role of Federal Agencies in the DTC Testing Industry
- Data Privacy and Security
Chapter 4 Market Breakdown by Technology Type of Test
- COVID-19 and DTC Testing
- At-Home COVID-19 Test Process
- At-Home COVID-19 Tests
- Global Market for DTC Tests by Type
- Market Overview
- Market Revenue
- Market Shares
- DTC Genetic Testing
- DTC Biomarker-Based Testing
- DTC Microbiome Testing
Chapter 5 Market Breakdown by Distribution Channel
- Global Market for DTC Tests by Distribution Channel
- Market Overview
- Market Revenue
- Market Shares
- Online Channel
- Retail Channel
Chapter 6 Market Breakdown by Application
- Global Market for DTC Testing by Application
- Market Overview
- Market Revenue
- Market Shares
- Health and Wellness Testing
- Ancestry and Genealogy Tests
- Disease Risk Assessment
- Carrier Screening
- Pharmacogenetic Testing
- Whole Genome Sequence-based DTC Testing
- Other DTC Tests
Chapter 7 Industry Structure
- Business Models in DTC Testing
- Traditional Business Model of DTC Testing
- Emerging Business Models of DTC Testing
- Grants and Funding in the DTC Testing Industry
- Collaborations and Partnerships
- Mergers and Acquisitions
- Leading Market Players in the DTC Testing Industry
- Leading Market Players in Genetic DTC Tests Market
- Leading Players in the Market for Biomarker-based DTC Tests
- Leading Players in the Market for DTC Microbiome Tests
Chapter 8 Patent Review/ New Developments
- Patent Analysis
- Patents by Year
- Patents by Type
- Patents by Company
- Patents by Country
- Patents by Assignee
Chapter 9 Analysis of Market Opportunities
- Strengths of the Global DTC Testing Market
- Increasing Consumer Awareness
- Decreasing Costs of Genetic Sequencing
- Improvized Business Models and Marketing
- Challenges within the Global DTC Testing Market
- Lack of Regulatory Guidance
- False Positives
- Saturation in Product Offerings
- Ethical and Data Privacy Issues
- Opportunities within the Global DTC Testing Market
- Emerging Markets
- Pharma Tie-ups
- Growing Number of Applications
- Covid-19 Pandemic
- Threats within the Global DTC Testing Market
- Competition
- Regulatory Constraints
Chapter 10 Company Profiles
- 23Andme
- Ancestry.Com Llc
- Chengdu Twenty-Three Rubik Cube Biotechnology Co. Ltd. (23Mofang)
- Circle DNA (Prenetics Ltd.)
- Color Genomics Inc.
- Dante Labs
- Easydna
- Everlywell Inc.
- Fitness Genes Ltd.
- Full Genomes Corp.
- Helix Opco Llc
- Identigene Llc (Acquired By DNA Diagnostics Center)
- Karmagenes Sa
- Laboratory Corp. Of America Holdings
- Letsgetchecked (Privapath Diagnostics Ltd.)
- Living DNA Ltd.
- Mapymygenome India Ltd.
- MyHeritage Ltd.
- Microbiome Labs Llc
- Nebula Genomics, Inc.
- Omecare (Formerly Known As Pathway Genomics)
- Psomagen Inc.
- Quest Direct
- Thryve (Quantbiome Inc.)
- Veritas Genetics International Ltd.
- Viome Inc.
Chapter 11 Appendix: Acronyms
List of Tables
Summary Table: Global Market for DTC Tests, by Type, Through 2025
Table 1: Traditional Tests vs DTC Tests
Table 2: Differences between Genotyping and Sequencing
Table 3: List of Biobanks
Table 4: 23andMe Health Predisposition Tests
Table 5: FDA Regulation of DTC Tests
Table 6: FDA EUA Granted at-home DTC COVID-19 Tests (Until December 3, 2020)
Table 7: Comparison of Popular DTC Tests
Table 8: Global Market for DTC Tests, by Type, Through 2025
Table 9: Global Market Shares of DTC Tests, by Type, 2019
Table 10: Global Market for DTC Tests, by Region, Through 2025
Table 11: Global Market Shares of DTC Tests, by Region, 2019
Table 12: Global Market for DTC Genetic Tests, by Region, Through 2025
Table 13: Global Market for DTC Biomarker-Based Tests, by Region, Through 2025
Table 14: Global Market for DTC Microbiome Tests, by Region, Through 2025
Table 15: Global Market for DTC Tests, by Distribution Channel, Through 2025
Table 16: Global Market Shares of DTC Tests, by Distribution Channel, 2019
Table 17: List of Companies Selling on Amazon.com
Table 18: Global Market for DTC Testing Purchased Through the Online Distribution Channel, by Region, Through 2025
Table 19: List of Retail Stores That Sell DTC Tests
Table 20: Global Market for DTC Tests Purchased Through the Retail Distribution Channel, by Region, Through 2025
Table 21: Global Market for DTC Tests, by Application, Through 2025
Table 22: Global Market Shares of DTC Tests, by Application, 2019
Table 23: Global Market for DTC Health and Wellness Tests, by Region, Through 2025
Table 24: Commercialized DTC Ancestry and Genealogy Tests
Table 25: Global Market for DTC Ancestry and Genealogy Tests, by Region, Through 2025
Table 26: Global Market for DTC Disease Risk Assessment Tests, by Region, Through 2025
Table 27: Global Market for DTC Carrier Screening Tests, by Region, Through 2025
Table 28: Global Market for DTC Pharmacogenetic Tests, by Region, Through 2025
Table 29: List of WGS-based DTC Testing Companies
Table 30: Global Market for DTC Whole Genome Sequence-based Tests, by Region, Through 2025
Table 31: Global Market for Other Types of DTC Tests, by Region, Through 2025
Table 32: Grants and Funding in the DTC Testing Industry, 2018-November 15, 2020
Table 33: Collaborations and Partnerships in the DTC Testing Industry, 2018-November 15, 2020
Table 34: Leading Developers of Genetic DTC Tests, 2019
Table 35: Global Market Shares of Leading Manufacturers/Suppliers of DTC Genetic Tests, 2019
Table 36: Leading Developers of DTC Biomarker-Based Tests, 2019
Table 37: Global Market Shares of Leading Manufacturers/Suppliers of DTC Biomarker-Based DTC Tests, 2019
Table 38: Leading Developers of DTC Microbiome Tests, 2019
Table 39: Global Market Shares of Leading Manufacturers/Suppliers of DTC Microbiome Tests, 2019
Table 40: Patents and Patent Families of 23andMe and Ancestry.com
Table 41: Patents Issued on DTC Tests, by Year, 2018-November 10, 2020
Table 42: Patents Issued on DTC Tests, by Type, 2018-November 10, 2020
Table 43: Patents Issued on DTC Tests, by Company, 2018-November 10, 2020
Table 44: Patents Issued on DTC Tests, by Country, 2018-November 10, 2020
Table 45: Patents Issued on DTC Tests, by Assignee Type, 2018-November 10, 2020
Table 46: Emerging Applications of DTC Tests
Table 47: 23andMe’s Product List
Table 48: Ancestry.com’s Product List
Table 49: 23Mofang's Product List
Table 50: CircleDNA's Product List
Table 51: Color's Product List
Table 52: Dante Labs’ Product List
Table 53: EasyDNA's Product List
Table 54: Everlywell's Product List
Table 55: Fitness Genes' Product List
Table 56: Full Genomes' Product List
Table 57: Helix's Product List
Table 58: Karmagenes' Product List
Table 59: LabCorp's Product List
Table 60: LetsGetChecked's Product List
Table 61: LivingDNA's Product List
Table 62: MapMyGenome's Product List
Table 63: Nebula Genomics' Product List
Table 64: OmeCare's Product List
Table 65: Psomagen's Product List
Table 66: QuestDirect's Product List
Table 67: Viome's Product List
Table 68: Acronyms Used in the DTC Testing Industry
List of Figures
Summary Figure: Global Market for DTC Tests, by Type, 2018-2025
Figure 1: History of DTC Testing, 2006-Present
Figure 2: Polymerase Chain Reaction
Figure 3: Traditional Testing Process vs DTC Testing Process
Figure 4: Global Market for DTC Tests, by Type, 2018-2025
Figure 5: Global Market Shares of DTC Tests, by Type, 2019
Figure 6: Global Market for DTC Tests, by Region, 2018-2025
Figure 7: Global Market Shares of DTC Tests, by Region, 2019
Figure 8: Global Market for DTC Genetic Tests, by Region, 2019-2025
Figure 9: Global Market for DTC Biomarker-Based Tests, by Region, 2018-2025
Figure 10: Global Market for DTC Microbiome Tests, by Region, 2018-2025
Figure 11: Global Market for DTC Tests, by Distribution Channel, 2018-2025
Figure 12: Global Market Shares of DTC Tests, by Distribution Channel, 2019
Figure 13: Global Market for DTC Testing Purchased Through the Online Distribution Channel, by Region, 2018-2025
Figure 14: Global Market for DTC Tests Purchased Through the Retail Distribution Channel, by Region, 2018-2025
Figure 15: Global Market for DTC Tests, by Application, 2018-2025
Figure 16: Global Market Shares of DTC Tests, by Application, 2019
Figure 17: Global Market for DTC Health and Wellness Tests, by Region, 2018-2025
Figure 18: Global Market for DTC Ancestry and Genealogy Tests, by Region, 2019-2025
Figure 19: Global Market for DTC Disease Risk Assessment Tests, by Region, 2018-2025
Figure 20: Global Market for DTC Carrier Screening Tests, by Region, 2018-2025
Figure 21: Global Market for DTC Pharmacogenetic Tests, by Region, 2018-2025
Figure 22: Global Market for DTC Whole Genome Sequence-based DTC Tests, by Region, 2018-2025
Figure 23: Global Market for Other Types of DTC Tests, by Region, 2018-2025
Figure 24: Process of DTC Testing
Figure 25: Global Market Shares of Leading Manufacturers/Suppliers of DTC Genetic Tests, 2019
Figure 26: Global Market Shares of Leading Manufacturers/Suppliers of DTC Biomarker-Based Tests, 2019
Figure 27: Global Market Shares of Leading Manufacturers/Suppliers of DTC Microbiome Tests, 2019
Figure 28: `Patents Issued for DTC Tests, by Year, 2018-November 10, 2020
Figure 29: Patents Issued on DTC Tests, by Type, 2018-November 10, 2020
Figure 30: Patents Issued on DTC Tests, by Company, 2018-November 10, 2020
Figure 31: Patents Issued for DTC Tests, by Country, 2018-November 10, 2020
Figure 32: Patents Issued on DTC Testing, by Assignee Type, 2018-November 10, 2020
Figure 33: SWOT Analysis of the DTC Testing Market
Figure 34: Consumers Comfortable with DTC Testing Options
Executive Summary
Traditionally, diagnostic tests are prescribed by medical practitioners, approved by healthcare providers, and the results are discussed with the patients. The direct-to-consumer (DTC) or at-home tests have transformed conventional testing and have enabled consumers to order their tests from the convenience of their homes, at any time. With no physician approval required, the DTC tests provide the consumers with the freedom to order any test at an affordable cost. Moreover, they have access to the test results, which they can then share with their physicians if they wish to.
There are several DTC companies across the globe that offer various types of personalized testing. While the majority of these tests are genetic tests, routine biomarker tests and novel microbiome tests have also entered this booming market. The applications of DTC tests range from ancestry and genealogy testing to screening for diseases in couples, to identification of genes associated with certain heritable diseases and cancers. Advances in genotyping custom arrays have enabled the identification of traits that are linked to fitness, allergies, sleep disorders, neurological diseases, and many other health and wellness aspects.
Next-generation sequencing (NGS) techniques and reducing costs of genetic sequencing have led to significant adoption of whole-genome sequencing (WGS) for routine testing. Companies such as Veritas and Nebula Genomics now offer DTC WGS products.
Leading players, such as 23andMe, are strategizing new business models to foster growth in this market. Partnerships with healthcare and pharmaceutical companies to drive research in disease pathogenesis and drug discovery are accelerating. Also, many companies have partnered with large healthcare networks such as PWN Health to provide in-house licensed physicians, and thereby, add reliability to their products. The DTC testing market is driven by increasing consumer demand for at-home testing kits, expanding access to these products through online and retail options, decreasing test costs, and expanding applications of these tests.
The market is, however, restrained by a lack of proper regulation for DTC tests. Data privacy and security are ongoing challenges. Lack of population-specific databases has also delayed the adoption of tests by many populations.
As new players enter the emerging markets and population-based projects also expand, the DTC testing market is expected to have new opportunities in these regions. Growing consumer awareness and improving lifestyles are also expected to contribute to the further growth of this market. Many players, including Quest Diagnostics, EverlyWell, and many others, launched COVID-19 at-home testing kits. Sales from these kits are expected to boost the market growth in the coming years.
Companies Mentioned
- 23Andme
- Ancestry.Com Llc
- Chengdu Twenty-Three Rubik Cube Biotechnology Co. Ltd. (23Mofang)
- Circle DNA (Prenetics Ltd.)
- Color Genomics Inc.
- Dante Labs
- Easydna
- Everlywell Inc.
- Fitness Genes Ltd.
- Full Genomes Corp.
- Helix Opco Llc
- Identigene Llc (Acquired By DNA Diagnostics Center)
- Karmagenes Sa
- Laboratory Corp. Of America Holdings
- Letsgetchecked (Privapath Diagnostics Ltd.)
- Living DNA Ltd.
- Mapymygenome India Ltd.
- MyHeritage Ltd.
- Microbiome Labs Llc
- Nebula Genomics, Inc.
- Omecare (Formerly Known As Pathway Genomics)
- Psomagen Inc.
- Quest Direct
- Thryve (Quantbiome Inc.)
- Veritas Genetics International Ltd.
- Viome Inc.
