Genetic testing is one of the most rapidly growing segments in molecular diagnostics industry that helps in delivering customized health services and is also called as personalized medicine. The genetic testing services include genetic testing, results interpretation, information analysis, education and counseling. Growing know-how about genetic testing, technological advances in genetic sequencing, rising incidences of genetic diseases especially cancer is the major factors propelling the genetic testing services market. Currently genetic testing services are directed towards prediction of possible diseases, detection of existing diseases, and designing personalized care regime. Genetic testing services have been beneficial not only in the field of oncology, but have also been used in diagnosis of diseases such as hemophilia, sickle cell anemia, cystic fibrosis and many others. In the future, the market will particularly benefit from genetic testing of newborns for possible genetic disorders. Early diagnosis or prediction of possible disorders in the future may help in avoiding complications and also reduce mortalities to a great extent. Genetic testing services help in accurate diagnosis of diseases which have common symptoms and also those difficult to diagnose with routine tests. Genetic testing is applied in prescribing accurate drug therapies in light of patient’s genotype for genetic linkage for drug efficacy and toxicity. Genetic testing services will also help in reducing the overall cost of treatment and also avoid possible side effects. Thus development of genetic testing services will bring a change in various areas in healthcare sector.
Direct-to-customer genetic testing still continues to restrict the market growth due to mixed reviews on permissibility. In November 2013, FDA implemented a ban on marketing of direct-to-customer genetic testing services provided by 23andMe for its saliva based test. FDA argues that the company must seek an approval for the medical device. Various articles also criticize that the direct-to-customer genetic testing service is not fruitful, and is clearly a waste of money. Direct-to-customer companies provide testing services to consumers, without involvement of physician in primary checkup. Genetic makeup alone is a poor predictors of common diseases hence the approach is likely to lead people receiving potentially harmful treatment. Lack of proper counseling also misleads people about healthcare services and also builds incorrect perceptions about the genetic testing services. This may prove to be potential threat to the future market growth. Although currently direct-to-customer testing is a small segment of the genetic testing services market, the service providers are constantly trying to become an integral part of clinical care.
Majority of the genetic testing market is dominated by the U.S. market owing to higher disposable income, and increased awareness about the service. Major companies operating in the U.S. who provide genetic testing services include 23andMe, DNA Direct, Genova Diagnostics, GeneLink, and Interleukin Genetics. Reimbursement remains a barrier for the adoption of the service. The service on the other hand is expected to spur the concept of “evidence based coverage”. This will not only benefit the insurance provider but also provide necessary leverage for market growth. High cost of the service is a major hurdle for the market to enter Asia-Pacific and other countries. But with increasing per capita income and gradual development of healthcare sector in countries such as India and China, the market is expected to grow rapidly in the near future in these regions. Fully developed medical sector of Japan will serve as a gateway in the Asia-Pacific market.
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