the direct global–for–consumer genetic testing market should grow $5,573.5 million by 2030 from $1,338.6 million in 2021, at a CAGR of 17.6% from 2022 to 2030. Direct-to-consumer genetic testing (DTC-GT) generally refers to tests marketed directly to consumers. DTC-GT tests are sold directly to the consumer without the involvement of a healthcare professional or health insurance company. The data produced by genetic testing can have several uses making each a different revenue model. Genomic information can be used for individual health planning which includes genetic testing to identify disease risks or for nutrigenomics. Consumers can also get comprehensive genomic testing using the third-party as a service platform. Direct-to-consumer genetic testing may also be referred to as DTC genetic testing, direct-access genetic testing, home genetic testing, and home DNA testing, which provides access to genetic information.
The market for direct-to-consumer genetic testing has grown considerably. Awareness among consumers of DTC genetic testing is increasing, driving the bio-boom of genomic services. Another factor that has increased the interest of consumers and pharmaceutical giants is the production of raw genome data and interpretation services. As the cost of genome sequencing has fallen dramatically, companies providing DTC genetic testing are building biobanks of genomic data, which can then be used to develop personalized medicine and for research purposes.
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Through the provision of raw genomic data, consumers are now accessing information that could only have been available through medical institutions or research facilities. Direct-to-consumer genetic testing can primarily be divided into two segments: one-to-one and one-to-many. Many key players in the market offer both services. For example, 23andme, in collaboration with GSK and Pfizer, will share genomic data from their consumers to develop target therapeutics. Gene by Gene also offers raw genomic data to consumers as a separate product offering. Another company that offers similar raw genomic data services is Ancestry.com, which offers its offerings to consumers and pharmaceutical companies.
covid–19 Impact on the Global Direct–for–Consumer Genetic Testing Market
The current global consumer genetic testing market research includes products and services used to analyze the underlying genetic and protein alterations associated with genetic disorders. Since the market is mainly dominated by unregistered clinical use of products, the COVID-19 pandemic has had a medium impact on the revenue generated from the market. The current market valuation has taken into consideration the insights provided by key opinion leaders from the supply and demand side.
Additionally, COVID-19 has also increased revenue generation opportunities for consumer genetic test manufacturers. The increase in the surplus of nucleic acid-based tests has led to the development of self-testing COVID-19 diagnostic tests by several key market players. For example, in 2020, Helix Opco LLC launched the Helix self-collection kit to detect COVID-19. Additionally, the increased attention by major biopharmaceutical companies and government institutions to population genomics due to the current COVID-19 pandemic has also increased the use of these tests.
Global Live–for–Consumer Genetic Testing Market Dynamics
Drivers: Growing number of–for–Consumer Genetic Testing
The number of genetic tests has increased due to the falling cost of DNA sequencing. These tests have recently become the standard of care for pregnant women and oncology patients. According to a study published in 2018 by Concert Genetics and the Department of Clinical Pharmacy at the University of California, San Francisco, there were approximately 75,000 genetic tests on the market, including 10,000 unique test types. Additionally, 14% of these tests were multi-gene panels, including 9,311 multi-analyte tests, 85 non-invasive prenatal tests (NIPT), 122 whole-exome sequencing tests, and 873 whole-genome sequencing tests. Between March 2014 and April 2018, almost 14,000 tests were added, with an average rate of around 10 per day.
The increase in direct-to-consumer genetic testing among consumers is due to sales and marketing activities adopted by major market players. Major players such as 23andme, Inc and Ancestry DNA have the largest database of human genetic information provided through genealogy reports, genetic health risk reports and wellness reports .
Constraints: Uncertain regulatory standards for live–for–Consumer Genetic Testing
The global healthcare industry is suffering from rising treatment costs due to the high disease burden. The fragmented healthcare system within countries has led to difference in treatment protocols for chronic diseases, including cancer, neurological disorders and infectious diseases, which require combinations of treatment regimens. Due to the difference or absence of standard treatment protocols, the treatment actually administered or the effectiveness of the treatment is not estimated, which affects the effectiveness of diagnostics or medications. Additionally, the non-reproducibility of consumer genetic testing coupled with the lack of involvement of healthcare professionals affects product reimbursement recommendations as payers move away from fee-for-service towards reimbursement strategies based on performance or value. .
Opportunities: Massive Reach for Genomics Adoption–Medicine based in emerging countries
The availability of high quality diagnostic tests, particularly molecular tests for genetic diseases, is a global priority. Although there have been significant advances in the advancement of biomarker-based testing and its consequent adoption into routine healthcare procedures, people living in low-income countries do not have access to it. This restriction can deprive them of life-saving treatments and reduce opportunities for effective prevention of onward transmission of infectious diseases. Diagnostic laboratories face insufficient resources in developing countries and are poorly distributed. There is huge scope for improving access by using tests that can be used without the help of a laboratory.
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Range of the Direct–for–Consumer Genetic Testing
The study categorizes the direct-to-consumer genetic testing market on the basis of technology, distribution channel, and product type regionally and globally.
By Technology Insights (IncomeUSD million, 2017–2030)
- Single nucleotide polymorphism
- Targeted analysis
- Whole genome sequencing
By distribution channel Perspectives (IncomeUSD million, 2017–2030)
- online channel
- OTC Channel
By product type Outlook (IncomeUSD million, 2017–2030)
- health and wellbeing
Outlook by region (IncomeUSD million, 2017–2030)
- North America (United States, Canada, Mexico)
- South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
- Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, Netherlands, Norway, Sweden, Denmark, Rest of Europe)
- Asia-Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Philippines, Singapore, Australia and New Zealand, Rest of Asia-Pacific)
- The Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa, North Africa, Rest of MEA)
By technology, the single nucleotide polymorphism segment is expected to account for the largest market share
Based on technology, the global direct-to-consumer genetic testing market is divided into single nucleotide polymorphism, targeted analysis and whole genome sequencing. In 2021, the single nucleotide polymorphisms segment accounted for the largest market share of 52.4% in the global direct-to-consumer genetic testing market. The growth of the segment is mainly attributed to the increased use of technology for the development of consumer genetic panels for ancestry testing, paternity testing and ancestry predictions. In addition, SNPs also offer information about carrier genes and the identification of specific variants susceptible to disease development. Additionally, SNPs are also used for predictive models among the Genome-Wide Association Study (GWAS) results of relevant literature, which simultaneously supported the growth of the market.
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Asia Pacific represents the highest CAGR over the forecast period
Based on region, the global direct-to-consumer genetic testing market has been segmented into North America, Asia-Pacific, Europe, South America, and Middle East & Africa. Globally, Asia-Pacific is expected to be the fastest growing region with a CAGR of 18.1% during the forecast period. Several new and advanced high-quality human genome libraries are observed to produce ethnic-specific sequences and help scientists use genetic information to improvise precision medicine research in the Asia-Pacific region.
As millions of people move from the countryside to cities across Asia, so-called “lifestyle” conditions such as heart disease and diabetes have become more common as the population is prone to processed foods and a sedentary lifestyle. Therefore, scrutinizing one’s DNA can give the necessary information about the health status of the individual. Additionally, the rise in obesity cases in Asia-Pacific countries like Japan and China has encouraged individuals to take a keen interest in understanding how nutrition and genes are intertwined with health.
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Main market players
Each company follows its business strategy to achieve the maximum market share. Currently Myriad Genetics, Konica Minolta, Inc., 23andme, Color Health, Inc., My heritage, Atlas Biomed, Ancestry.com LL, Mapmygenome, 23mofang, EasyDNA, DNA fit, Gene by Gene and XCode Life. are some of the major players operating in the global direct-to-consumer genetic testing market.