Genetic testing is oftenly performed as a part of genetic consultation. These tests are performed either on blood, skin, hair, or amniotic fluid. Genetic tests include the analysis of an individual’s genetic material (DNA or RNA), in order to determine the susceptibility to certain abnormalities or specific disorders or to identify the genetic differences (variants) if any. Currently, genetic tests have developed to a larger extent that in turn facilitates the doctors to detect any defective or missing genes. Specific genetic tests are designed for specific disorders to be identified. There are several instances where a doctor may recommend genetic testing or counseling, for example, if a couple’s first child suffers from a severe birth defect, or if a woman has more than two miscarriages, or a woman who is pregnant at or after age 35.
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Genetic consultation is crucial as it helps determination of a genetic or inherited disorder before giving birth to a child and hence avoids the serious birth defects. Diagnostic, pharmacogenetics, prenatal testing, preimplantation testing, presymptomatic and predictive testing and newborn screening constitute several types of genetic tests performed for various reasons. These tests involve the use of reagents of high purity and quality. These are essential in order to ensure accurate results of the tests. Any compromise in the quality and composition of the reagent results in deviation from accurate results and can be misleading.
There is an extensive usage of reagents at each and every step of the process such as from deoxyribonucleic acid (DNA) extraction to isolation and purification. With the rapid pace of technological advances in the field of genomics, more and more genetic tests are being implemented in several laboratories across the globe. This is leading to marketing of the genetic tests without proper regulation. Genetic testing finds application in various areas such as determination of genetic disorders, paternity testing, forensics and others.
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Three federal agencies namely, Center for Medicare and Medicaid services (CMS), Food and Drug Administration (FDA) and Federal Trade Commission (FTC) play a very significant role in regulating genetic tests. CMS regulates the clinical laboratories and confirms the quality of the lab processes implemented. FDA regulates the marketing of various test kits possessing reagents while FTC puts a check on misleading and false advertising. On July 31, 2014, FDA announced that it would release draft guidelines to regulate laboratory developed tests (LDTs) owing to the increased mismatch between the tests performed in commercial laboratories and the physicians ordered tests.
Genetic tests has the capability to revolutionize the clinical practice however, increased adoption of these tests depends on coverage and reimbursement provided by several insurance providers. If these insurance providers are not willing to pay for the tests, it might result in stagnant growth of the market. There is very limited information available on the reimbursement decisions about genetic testing. The genetic test kits include the standard sample, distilled water, buffer solutions and other extraction and isolation reagents. The usage of these reagent kits is prominent in developed regions such as North America and Europe as compared to Asian countries such as India and China.
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The market for genetic testing reagent kits can be analyzed by various geographies such as Europe, North America, Asia Pacific and Rest of the World. Furthermore, this market can be analyzed by various application areas such as new born screening, prenatal testing, forensics and paternity testing. Factors such as regulatory and reimbursement policies govern the commercialization and marketing of genetic testing reagent kits. The major factors favoring the market growth are continuous technological advances, increasing acceptance of genetic consultation and counseling. On other hand factors such as high cost of the procedures and lack of reimbursement and medical coverage restrain the market growth. Danaher Corporation, Sigma-Aldrich Co., LLC. ThermoFisher Scientific, Hologic, Inc., Roche Diagnostics and Abbott Laboratories are some of the key players operating in this market.