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Direct to Consumer Testing Industry: Global Markets

January 2021 | 148 pages | ID: D41C63EB219CEN
BCC Research

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Summary:

Traditionally, diagnostic tests are prescribed by the 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 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 for less than $REDACTED.

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 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 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 market growth in the coming years.

Report Scope:

BCC Research’s new 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.

The new BCC 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 are 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.

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
CHAPTER 1 INTRODUCTION

Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research 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

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.
Microbiome Labs Llc
Myheritage Ltd.
Nebula Genomics, Inc.
Omecare (formerly Known As Pathway Genomics)
Psomagen Inc.
Quest Direct
Thryve (quantbiome Inc.)
Veritas Genetics International Ltd.
VIOME INC.


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