Molecular diagnostics is referred as the laboratory tests used to detect and identify the presence of genetic material associated with health condition or disease by examining their proteins levels, DNA (deoxyribonucleic acid), RNA (ribonucleic acid). These tests are commonly performed on samples of blood and tumour tissue. Such diagnostics test provides important insights at every stage of the disease such as prevention of disease, detection, and successful treatment plan. Molecular diagnostic is a subset of in-vitro diagnostics. Molecular diagnostic refers to a tool to increase the efficiency of clinical outcomes and treatment decisions. Nowadays, such diagnostics tests are performed for the early detection of infectious diseases, genetic disorder and cancer with the use of genetic and molecular technologies. Molecular diagnostics is widely used in the area of cancer treatment plan. Such tests have the provision of differentiating cancer from benign tumors (i.e., growths of cells that are on initial stages and not harmful) and can further provide insights to detect the type of tissue in which cancer originated including breast, skin, and lung. Molecular diagnostics helps to provide critical insight to classify different cancer subtypes that affect the same tissue. For example, blood cancer is also called as acute myelogenous leukemia (AML) and can be bifurcated into poor and intermediate types, based on critical examining of chromosomes.
According to the American Cancer Society report, there will be around 1.7 million new cases of cancer diagnosed in the United States and approximately 609,640 Americans will die from the cancer in 2018. Moreover, according to the American Cancer Society epidemiologists, in 2018, there are approximately 42% new registered cancer cases, which imply around 729,000 cases of the newly diagnosed cancers in the U.S. Out of which, 19% cases are triggered by smoking and 18% cases are caused by several factors which includes physical inactivity, excess alcohol consumption, combination of excess body weight, and poor nutrition. Certain cancers are caused due to the spread of infectious agents which includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV) and Helicobacter pylori (H. pylori).
Rising prevalence of cancer owing to the exposure to harmful radiation and unhealthy dietary habits, physical inactivity and increasing geriatric population have added to the growth of molecular diagnostics market. Moreover, successful prognosis of a wide range of contagious diseases including HIV and hepatitis and growing demand for biomarkers for conducting diagnosis test have been the significant factors in charge of fuelling the demand in the market. In addition, increasing demand for point of care diagnostic technologies (POCT) and next generation sequencing (NGS) have propeled the market growth. However, stringent regulation of U.S. FDA approval for molecular diagnostic technology, lack of well-defined guidelines associated with molecular diagnostic test in emerging countries, and high cost of diagnostics test may hamper the growth of the market. On the other hand, advancement of technology in the area of Genomics and Proteomics will provide the opportunity for the expansion of the market.
Geographically, the molecular diagnostics market can be analysed into North America, Europe, Asia Pacific, and LAMEA. North-America is expected to be dominant in the market by following factors, which include advancements in the field of molecular diagnostics, increasing application of blood-screening, growing awareness associated with cancer disease, and well-established diagnostic infrastructure. The Asia-Pacific market is expected to be driven by factors including the development of health-care infrastructure, high adoption of new technology and medical devices, presence of a large target population, and unmet clinical needs.
Major key players in the market are Novartis AG, Roche Diagnostics, Siemens Healthcare, Abbott Laboratories Inc., QIAGEN, Cepheid Inc., Beckman Coulter Inc., Myriad Genetics Inc., bioMerieux, Gen-Probe Inc. (Hologic Inc.), Becton, and Dickinson and Company among others.
FoundationOne CDx™ was approved by US Food and Drug Administration (FDA). FoundationOne is the pan-tumour comprehensive companion diagnostic assay for personalised oncology care. This diagnostic assay identifies patients with advanced cancer and assesses all four classes of genomic changes in 324 genes which helps physician to decide therapies accordingly.
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