Molecular Diagnostics Market, by Product Type (Reagents & Kits and Instruments), by Application (Oncology, Genetic Testing, Microbiology, STDs, Blood Screening, Virology, Tissue Typing, Prenatal Diagnosis, and Others), by End User (Hospitals, Diagnostic Laboratories, Academic and Research Labs, and Other), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)- Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030
Molecular diagnostics is used for detection in various applications such as oncology, genetic testing, microbiology, STDs, blood screening, virology, tissue typing, and prenatal diagnostics. Molecular diagnostics are laboratory tests, conducted to identify a disease by analyzing DNA, RNA or proteins in humans. Furthermore, the reagent and kits for molecular diagnostics kits vary according to the application, as the kits consists of probes that are directed against specific sequence of viruses, bacteria, and parasites. Increasing use of biomarker specific testing kits is expected to foster growth of the molecular diagnostics market, as these tests are useful prior to initiation of any therapy or treatment.
Market Dynamics
The global molecular diagnostics market is projected to witness significant growth over the forecast period, owing to rapid advancements in technology for development of novel biomarkers. For instance, in June 2017, Qiagen N.V. expanded its biomarker content portfolio by adding new biomarkers for microsatellite instability (MSI) and Mismatch repair (MMR) in its NGS panels. This extension in the product portfolio was done to cater to growing demand for molecular diagnostics for immuno-oncology therapies.
Furthermore, precision medicine aids in treatment of diseases and prevention based on individual’s genes, lifestyle, and environment. This helps to offer proper treatment, which has led to high demand for precision medicine, in turn, favoring growth of the market.
However, stringent regulation by FDA to regulate molecular diagnostic tests is expected to be major factor restraining growth of the market. The FDA regulates molecular diagnostic tests in various ways, including in some instances, wherein, certain tests require regulatory pathways as complex as Class III medical devices.
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