Report Overview

United States Direct-to-Consumer Genetic Testing Market - Industry Trends & Forecast Report, 2029

United States direct-to-consumer genetic testing market size was estimated at USD 1.1 billion in 2022. During the forecast period between 2023 and 2029, the size of United States direct-to-consumer genetic testing market is projected to grow at a CAGR of 11.34% reaching a value of USD 2.33 billion by 2029. Major growth drivers for the United States direct-to-consumer genetic testing market include increasing awareness among the general public regarding the accessibility of direct-to-consumer genetic tests, spanning both developed and developing nations. Prominent participants in the market have strategically focused on developing high-quality solutions for direct-to-consumer genetic testing, ensuring the delivery of precise and dependable genetic test outcomes. This trend significantly drives the global Direct-To-Consumer (DTC) Genetic Testing Market. Also, enterprises like 23andMe have undertaken deliberate marketing initiatives to promote their direct-to-consumer genetic tests through both brick-and-mortar and online pharmaceutical outlets. Additionally, businesses are enticing customers with attractive discounts and promotional incentives for their offerings. Genetic testing encompasses medical procedures aimed at examining variations in genes, chromosomes, or proteins, with the objective of confirming or negating the presence of a genetic disorder, or estimating an individual's predisposition towards one. Through direct-to-consumer genetic testing, individuals can access genetic tests with minimal or no involvement of a third-party healthcare professional.

United States Direct-to-Consumer Genetic Testing Market – Overview

Genetic testing encompasses the analysis of genetic material to identify genetic alterations, aiding in diagnosing disorders and predicting susceptibility. In the early 2000s, direct-to-consumer (DTC) genetic testing emerged, empowering individuals to access genetic insights independently. This approach bypasses the need for healthcare intermediaries. DTC genetic testing kits are marketed through online platforms and printed materials, making genetic information accessible to a wider audience. Leading players like 23andMe and Ancestry dominate this landscape, offering insights into both medical and non-medical traits. However, growth is challenged by privacy concerns as companies handle sensitive data. Despite this, positive public perception and continuous investments foreshadow substantial market expansion.

United States Direct-to-Consumer Genetic Testing Market

Growth Drivers

Consumer Interest in Personalized Health

The direct-to-consumer genetic testing market is expected to experience advantageous growth due to the increasing popularity of pharmacogenetics. One notable application of genetics-based personalization lies in the realm of pharmacogenetics, where genetic variations influence the selection of drug therapies, fostering business expansion. Notably, the evaluation and regulation of individualized tests are facilitated through consumer comprehension. Service providers furnish comprehensive information about the analytical and clinical validity of tests, consequently elevating demand within the industry. Moreover, the cost-effectiveness of these personalized tests compared to traditional genetic screenings contributes to their appeal. Also, the results yielded by personalized direct-to-consumer genetic tests can be swiftly obtained using user-friendly and non-invasive methodologies. These factors collectively projects a significant enhancement in the overall market share of direct-to-consumer genetic testing. As this trend gains momentum, the market landscape is likely to witness further evolution and innovation.

Restraints

Regulatory and Ethical Concerns

Regulatory challenges and ethical concerns could affect the expansion of the United States direct-to-consumer genetic testing market. These issues, rooted in concerns about data privacy, accuracy, and appropriate use of genetic information, are causing a restraint in the market's growth trajectory. While DTC genetic testing offers personalized insights to consumers, navigating the complex landscape of regulations and ensuring ethical practices are crucial factors that need to be addressed for sustainable market development. As stakeholders work towards establishing a balance between innovation and responsible practices, the market's future dynamics will be influenced by the resolution of these challenges.

Impact of COVID-19 on United States Direct-to-Consumer Genetic Testing Market

COVID-19 pandemic had a mixed impact on the United States direct-to-consumer genetic testing market. Widespread diagnostic and serological testing have played a pivotal role in containing the disease, facilitating the easing of lockdown measures, and shaping policies for economic recovery. While healthcare providers traditionally administer most diagnostic and serological tests, an emerging trend involves certain companies offering COVID-19 testing directly to consumers (DTC). In this approach, consumers initiate tests through the company's website, diverging from the conventional involvement of healthcare professionals. While limited interactions with healthcare experts are possible, they might primarily involve brief reviews of questionnaires completed during the purchasing process. Consequently, consumers might require increased engagement with healthcare professionals, although select companies do allow post-test consultations for positive results. Also, as these DTC testing entities function independently from established healthcare systems, the integration of test results into patients' medical records remains sporadic.

United States Direct-to-Consumer Genetic Testing Market

Segmental Coverage

United States Direct-to-Consumer Genetic Testing Market – By Test Type

By test type, the United States direct-to-consumer (DTC) genetic testing market is divided into Nutrigenomics Testing, Predictive Testing, and Carrier Testing segments. The carrier testing segment holds the highest share in the United States DTC genetics testing market by test type in 2022. It can be attributed to increasing prevalence of genetic disorders stemming from chromosomal and gene mutations. Many instances of genetic mutations arise from preexisting conditions, familial history complications, or congenital disabilities. Consequently, carrier screening is routinely conducted among pregnant women to assess the risk of transmitting particular genetic disorders to their offspring. These factors collectively contribute to market expansion, propelling the global growth of the direct-to-consumer genetic testing sector. Furthermore, the mounting acknowledgment of the significance of early identification and diagnosis of genetic disorders empowers market stakeholders to formulate strategies across diverse geographical regions.

United States Direct-to-Consumer Genetic Testing Market – By Technology

Based on technology, the United States direct-to-consumer genetic testing market is divided into Whole Genome Sequencing, Single Nucleotide Polymorphism Chips, and Targeted Analysis segments. The whole genome sequencing segment held the highest market share by technology. Whole genome sequencing stands out as an optimal approach for comprehending specific malignancies, affording comprehensive insights spanning from single-base alterations to extensive chromosomal rearrangements. The escalating demand for malignant tumor identification is concurrent with the market's expansion. Whole-genome sequencing (WGS) presents an unparalleled understanding of pathogenesis and cancer biology, carrying implications for diagnostics, prognostics, and the selection of therapeutic interventions. WGS has the capacity to detect sequence and structural variants, effectively merging the core facets of cytogenetics and molecular genetics. Meanwhile, the single nucleotide polymorphism chips segment is expected to witness the fastest growth rate during the forecast period due to its precision in identifying genetic variations at the single nucleotide level. This technology offers comprehensive insights into health predispositions and ancestry, making it a preferred choice among consumers seeking accurate and personalized genetic information. Additionally, SNP chips are cost-effective and offer a wide array of applications, further contributing to their prominent market share.

United States Direct-to-Consumer Genetic Testing Market – By Distribution Channel

Based on distribution channel, the United States direct-to-consumer genetic testing market is bifurcated into Online Platform and OTC segments. The online platform segment held a higher market share by distribution channel due to its convenience and accessibility. Consumers are increasingly drawn to the ease of ordering and receiving genetic testing kits from the comfort of their homes. This segment also benefits from effective marketing strategies, user-friendly interfaces, and the ability to reach a wide audience. These factors collectively contribute to the online platform's prominent position in the market.

Competitive Landscape

Major players operating in the United States direct-to-consumer genetic testing market include 23andMe, AncestryDNA, MyHeritage DNA, Helix, Color, Veritas Genetics, Living DNA, Gene by Gene, TellmeGen, and Pathway Genomics. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

Recent Developments

• In January 2022 - 23andMe declared that its Direct-to-Consumer (DTC) Genetic Test had received approval from the FDA for a hereditary prostate cancer marker. This marked the third instance of the company obtaining clearance for its cancer risk reports.

Scope of the Report

By Test Type

• Nutrigenomics Testing

• Predictive Testing

• Carrier Testing

By Technology

• Whole Genome Sequencing

• Single Nucleotide Polymorphism Chips

• Targeted Analysis

By Distribution Channel

• Online Platform

• OTC

1. Research Framework
   1. Research Objective
   2. Product Overview
   3. Market Segmentation
2. Executive Summary
3. United States Direct-to-Consumer (DTC) Genetic Testing Market Insights
   1. Industry Value Chain Analysis
   2. DROC Analysis
      1. Growth Drivers
         1. Consumer Interest in Personalized Health
         2. Convenience and Accessibility
      2. Restraints
         1. Privacy Concerns
         2. Regulatory and Ethical Issues
      3. Opportunities
         1. Healthcare Integration
         2. Continuous Innovation
      4. Challenges
         1. Data Security
         2. Interpretation Complexity
   3. Technological Advancements/Recent Developments
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of New Entrants
      4. Threat of Substitutes
      5. Intensity of Rivalry
4. United States Direct-to-Consumer (DTC) Genetic Testing Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share and Forecast
      1. By Test Type
         1. Nutrigenomics Testing
         2. Predictive Testing
         3. Carrier Testing
         4. Others
      2. By Technology
         1. Whole Genome Sequencing
         2. Single Nucleotide Polymorphism Chips
         3. Targeted Analysis
         4. Others
      3. By Distribution Channel
         1. Online Platform
         2. OTC
5. Competitive Landscape
   1. List of Key Players and Their Offerings
   2. United States Direct-to-Consumer (DTC) Genetic Testing Market Share Analysis, 2022
   3. Competitive Benchmarking, By Operating Parameters
   4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)
6. Impact of Covid-19 on United States Direct-to-Consumer (DTC) Genetic Testing Market
7. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)
   1. 23andMe
   2. AncestryDNA
   3. MyHeritage DNA
   4. Helix
   5. Color
   6. Veritas Genetics
   7. Living DNA
   8. Gene by Gene
   9. TellmeGen
   10. Pathway Genomics
   11. Other Prominent Players
8. Key Strategic Recommendations
9. Research Methodology
   1. Qualitative Research
      1. Primary & Secondary Research
   2. Quantitative Research
   3. Market Breakdown & Data Triangulation
      1. Secondary Research
      2. Primary Research
   4. Breakdown of Primary Research Respondents, By Region
   5. Assumptions & Limitations

*Financial information of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable

List of Figures

Figure 1 United States Direct-to-Consumer (DTC) Genetic Testing Segmentation

Figure 2 United States Direct-to-Consumer (DTC) Genetic Testing Market Value Chain Analysis

Figure 3 Company Market Share Analysis, 2022

Figure 4 United States Direct-to-Consumer (DTC) Genetic Testing Market Size, By Value (USD Million), 2019–2029

Figure 5 United States Direct-to-Consumer (DTC) Genetic Testing Market Share, By Test Type, By Value, 2019–2029

Figure 6 United States Direct-to-Consumer (DTC) Genetic Testing Market Share, By Technology, By Value, 2019–2029

Figure 7 United States Direct-to-Consumer (DTC) Genetic Testing Market Share, By Distribution Channel, By Value, 2019–2029

List of Tables

Table 1 United States Direct-to-Consumer (DTC) Genetic Testing Market Size, By Value (USD Million), 2019–2029

Table 2 United States Direct-to-Consumer (DTC) Genetic Testing Market Size, By Test Type, By Value, 2019–2029

Table 3 United States Direct-to-Consumer (DTC) Genetic Testing Market Size, By Technology, By Value, 2019–2029

Table 4 United States Direct-to-Consumer (DTC) Genetic Testing Market Size, By Distribution Channel, By Value, 2019–2029

Table 5        23andMe Company Overview

Table 6        23andMe Financial Overview

Table 7        AncestryDNA Company Overview

Table 8        AncestryDNA Financial Overview

Table 9        MyHeritage DNA Company Overview

Table 10      MyHeritage DNA Financial Overview

Table 11      Helix Company Overview

Table 12      Helix Financial Overview

Table 13      Color Company Overview

Table 14      Color Financial Overview

Table 15      Veritas Genetics Company Overview

Table 16      Veritas Genetics Financial Overview

Table 17      Living DNA Company Overview

Table 18      Living DNA Financial Overview

Table 19      Gene by Gene Company Overview

Table 20      Gene by Gene Financial Overview

Table 21      TellmeGen Company Overview

Table 22      TellmeGen Financial Overview

Table 23      Pathway Genomics Company Overview

Table 24      Pathway Genomics Financial Overview

Table 25      Other Prominent Players Company Overview

Table 26      Other Prominent Players Financial Overview