Molecular diagnostic is the technique for identifying alterations in DNA or RNA sequence, associated with any medical condition. Molecular diagnostic is techniques used to analyze biological markers in an individual's genetic code and to analyze how their cells express their genes as proteins.
Among the technology, the polymerase chain reaction (PCR) is the most widely used method for DNA amplification for detection and identification of infectious diseases, genetic disorders and other research purposes. The large share of this segment is attributed to the growing use of PCR in proteomics and genomics, automation of PCR instruments, and the emergence of advanced technologies like qRT-PCR. PCR can be used for the diagnosis of various diseases such as sickle cell anaemia, malaria, cancer, inherited diseases and other bacterial & infectious diseases and sheds light on variants of PCR.
Among all the molecular diagnostics technologies, PCR is one of the most developed molecular techniques which has a wide range of applications in the field of medicine, broad-spectrum pathogen detection and evaluation of emerging novel infections, surveillance. Also, PCR-based methods are cost-effective relative to other molecular diagnostic technologies.
The molecular diagnostics market is estimated to be valued at US$8,816.2 Mn in 2017 and is expected to witness a robust CAGR of 10.5% during the forecast period (2019-2026).
Rising Incidences of Infectious Disease and Cancer:
Increasing prevalence of infectious diseases and rising incidences of cancer is expected to be among the major factors boosting the molecular diagnostic market growth over forecast period. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2015, around 5,251 deaths were reported due to influenza infection in the U.S. Furthermore, according to a National Cancer Institute, 2016, an estimated 16.8 million new cases of cancer were diagnosed in the U.S. with an estimated 595,690 deaths from the disease. The number of people with cancer is expected to rise to 19 million by 2024. Additionally, cancer is also a major cause molecular diagnostic market. For instance, according to cancer.gov, in 2018, an estimated 1,735,350 new cases of cancer were diagnosed in the U.S. and 609,640 people died from cancer. The major cancer in descending order are breast cancer, lung and bronchus cancer, prostate cancer, colon and rectum cancer, melanoma of the skin, bladder cancer, non-Hodgkin lymphoma, kidney and renal pelvis cancer, endometrial cancer, leukemia, pancreatic cancer, thyroid cancer, and liver cancer. Breast cancer is the most common type of cancer and can occur both in men and women. However, it is mostly found among females and the male occurrence of breast cancer is very rare.
The other factors influencing the growth of molecular diagnostic marker are research and development for identification of biomarkers have led to development of new molecular diagnostic tests. For instance, in February 2018, FDA granted marketing approval to Banyan Biomarkes, Inc. for the first diagnostic blood test.
However, stringent regulation by FDA to regulate molecular diagnostic tests is expected to be major factor restraining growth of the market. Framework regarding regulatory approval process is been one of the major setbacks for molecular diagnostic market. Emerging countries, such as India and China, lack standard structured regulatory framework and guidelines on diagnostics, which certainly had a negative impact on the growth regional molecular diagnostic market irrespective of the presence of a large population. Regulatory uncertainties in approval process of molecular diagnostics leads a low profiled profit scenario among the manufacturers.
Competitive Landscape: Product Launch and Mergers and Acquisition to play a major role in molecular diagnostic market reach
Product Launch, Merger and acquisition and technological advancement paving way for robust increase in the global molecular diagnostic market. For instance, Abbott Laboratories in August 2016 launched Alinity, a next generation system, which is advanced in the segments such as immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics. HTG Molecular Diagnostics, Inc. in 2017, is expected to launch HTG EdgeSeq PATH Assay, which is used for retrospective gene expression profiling to complement traditional immunohistochemistry (IHC) testing in the second quarter. Alton Diagnostic, 2018, launched its new CE-IVD marked AltoStar Molecular Diagnostic Workflow, which automates the entire workflow from sample preparation to analysis. In 2016, Debiopharm Group, acquired a majority holding in GenePOC, Inc., the Canadian developer of affordable, rapid molecular tests that identify infectious agents at the point-of-care.
Key companies operating in the global molecular diagnostic market are Hologic,Inc., Grifols, S.A., Abbott Laboratories, Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton, Dickinson and Company, and Beckman Coulter, Inc., among others.
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