Direct-to-Consumer (DTC) Genetic Testing Market Size, Share, Growth, Sales, Trade, Shipment, Export Value And Volume With Sales And Pricing Forecast By 2028

Direct-to-Consumer (DTC) Genetic Testing Market - Introduction

Direct-to-consumer (DTC) genetic testing refers to genetic testing that provides people with their genetic information wherein involvement of healthcare professional or Health Insurance Company is not necessary. While a number of companies are offering the direct-to-consumer (DTC) genetic testing, it is spreading awareness regarding genetic diseases that can be prevented in time. Direct-to-consumer (DTC) genetic testing also offers personalized information about overall health, potential disease risks and other genetic traits.

The direct-to-consumer (DTC) genetic testing market is expected to witness significant growth in the future on the back of rising awareness among patients to go for early diagnosis and obtain in-time treatment. As the prevalence of genetic diseases and rare disorders is increasing across the globe, application of direct-to-consumer (DTC) genetic testing is expected to rise significantly in the coming years.

Direct-to-Consumer (DTC) Genetic Testing Market – Notable Developments

Key players in the direct-to-consumer (DTC) genetic testing market include Ancestry, EasyDNA, 23andMe, Full Genomes, Family Tree DNA, Living DNA, Genesis HealthCare, Helix, Color, Identigene, MyHeritage, Karmagenes, MapMyGenome and Pathway Genomics.

• In March 2018, 23andMe, Inc. received FDA approval for marketing of the company’s genetic test to be used in the screening of BRCA1/BRCA2 breast cancer gene mutations. This is the very first direct-to-consumer (DTC) genetic testing for cancer.
• In November 2018, Berry Genomics partnered with Prenetics, a Hong Kong-based biotechnology company. The partnership is aimed at offering a range of direct-to-consumer (DTC) genetic testing services in the Chinese market.
• In January 2019, Nebula Genomics, a start-up genetics company announced that the company will offer free whole genome sequencing for consumers who are willing to contribute their genomic data for the use of drug development studies. This is expected to bring new avenues in the direct-to-consumer (DTC) genetic testing market with leaders in clinical laboratories as well as anatomic pathologists are planning to offer the same service to advance the field of pharma drug development and treatment.

Direct-to-Consumer (DTC) Genetic Testing Market Dynamics

Opportunities for Manufacturers as FDA Relieves Regulatory Hurdles

In June 2018, the U.S. FDA relieved some of the regulatory hurdles for manufacturers of the direct-to-consumer (DTC) genetic testing for health risk. As per the new regulatory updates, manufacturers, after receiving the first premarket approval for genetic health risk (GHR) test can commercialize the test without the requirement of additional review. GHR tests provide consumers with genetic risk information to consumers, however, it does not determine whether the person is at risk of developing a disease or a condition. While the regulatory process remains equally stringent, the FDA has warned against the use of multiple genetic tests with unapproved claims to predict patient response to a specific set of medications.

Prenatal and Newborn Direct-to-Consumer (DTC) Genetic Testing Demand On the Rise, Reliability Remains a Grey Area

Over the period of the last decade, individuals could easily purchase direct-to-consumer (DTC) genetic testing over online transactions to carry out prenatal and newborn genetic testing without the intervention of health professionals. However, companies that offer such tests lack a comprehensive standard data to which the testing results are compared. While the number of companies offering the direct-to-consumer (DTC) genetic testing for newborn screening is increasing, the reliability of their tests remains a grey area owing to the lack of supervision about test content, interpretation and accuracy.

Integration of Artificial Intelligence to Add Value in DTC Genetic Testing

Direct-to-consumer (DTC) genetic testing holds significant importance in the field of personalized medicine. Health data of an individual derived from direct-to-consumer (DTC) genetic testing in the form of genetic sequencing can be linked with other health indications to gain an overall health outlook. Towards this, many direct-to-consumer (DTC) genetic testing companies are engaged in collaborating with pharma companies. Also, with the integration of artificial intelligence (AI) in the medical diagnostic technologies such as direct-to-consumer (DTC) genetic testing, the derived genetic sequencing data becomes more valuable.

Direct-to-Consumer (DTC) Genetic Testing Market – Segmentation

Direct-to-consumer (DTC) genetic testing market is segmented on the basis of type, application and technology.

Based on type, the Direct-to-consumer (DTC) genetic testing market is segmented into,

• Diagnostic Screening
• Prenatal, newborn screening, pre-implantation diagnosis
• Carrier Testing
• Nutrigenomics Testing
• Relationship Testing

Based on application, the Direct-to-consumer (DTC) genetic testing market is segmented into,

• Direct sales
• Laboratory sales
• Retail sales

Based on technology, the Direct-to-consumer (DTC) genetic testing market is segmented into,

• Single Nucleotide Polymorphism (SNP) Chips
• Targeted Analysis
• Whole Genome Sequencing (WGS)