The global molecular diagnostics market is expected to reach USD 13.9 billion by 2025, from USD 7.1 billion in 2017 growing at a CAGR of 8.8% during the forecast period of 2018 to 2025. The market report contains data for historic year 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.
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Market Definition: Global Molecular Diagnostics Market
Molecular diagnostics market is increasing with the very high rate. These are the tests that are used to detect specific sequences in DNA or RNA that may or may not be associated with disease, including single nucleotide polymorphism (SNP), insertions, rearrangements, deletions and others. The clinical applications of molecular diagnostics can be found in at least six wide-ranging areas that are oncology, pharmacogenomics, human leukocyte antigen typing, infectious diseases, genetic disease screening and coagulation. Three basic steps are required for each molecular analysis, The first step is extraction and purification of nucleic acid, followed by the second step that is amplification or making copies of the nucleic acid of interest (target) or attaching multiple copies of a dye to a single target copy, and third and the last step is the detection of the amplified target using real time polymerase chain reaction (PCR) or end product detection including microarrays, Luminex i.e. similar to flow cytometry or sequencing. All the three steps can be performed together or separately according to the convenience of the doctors and physicians.
At the association of molecular pathology (AMP), Food and Drug Administration (FDA) has cleared molecular tests that can be modified by a laboratory, through these tests nucleic acid extractor (that differs from the extractors) can be validated. The other example is laboratory validation of a specimen type, which is already approved by the FDA. For instance, ASR (Analyte Specific Reagents) can be used for patient specimens after in-house validation. RUO (Research Use Only) which is usually referred to tests and rarely to devices. LDT (Laboratory Developed Tests) which must be but validated using CLIA standards before they can be used to generate clinically used results. The number of commercially available assays is increasing day by day and it has been observed that the screening for hospital acquired infections (HAIs) such as methicillin-resistant staphylococcus aureus, clostridium difficile or vancomycin-resistant enterococci signifies the additional set of applications of interest to infectious disease investigation and hospital administration.
Major Market Drivers and Restraints:
- High prevalence of infectious diseases and various types of cancers.
- Increasing awareness and acceptance of personalized medicine and companion diagnostics.
- Growth in the biomarker identification market and advancements in molecular techniques.
- Complex regulatory frameworks delaying the approval of new molecular diagnostic tests.
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Market Segmentation: Global Molecular Diagnostics Market
- The global molecular diagnostics market is segmented based on product & services , end user, application, technology and geographical segments.
- Based on product & service, the market is segmented into reagents & kits, instruments and services & software.
- On the basis of application, the market is classified into infectious diseases, oncology, genetic tests and other applications. The infectious diseases market is further sub segmented into hepatitis, HIV, CT/NG, HAIS, HPV, TB, influenza and other infectious diseases. The oncology market is further sub segmented into breast cancer, lung cancer, colorectal cancer, prostate cancer and other cancers.
- Based on technology, the market is segmented into polymerase chain reaction (PCR), isothermal nucleic acid amplification technology (INAAT), DNA sequencing & next-generation sequencing (NGS), in situ hybridization, DNA microarray and other technologies and other technologies.
- On the basis of end users, the market is segmented into hospitals & academic laboratories, reference laboratories and other end users.
- Based on geography , the market report covers data points for 28 countries across multiple geographies namely North America & South America, Europe, Asia-Pacific and, Middle East & Africa. Some of the major countries covered in this report are U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa and Brazil among others.
Key Developments in the Market: Global Molecular Diagnostics Market
- In March 2018, According to the news posted in Globetech Media, Laboratories (Global healthcare diagnostics manufacturer) and Bosch Healthcare Solutions GmbH have partnered to launch molecular diagnostics platform which will be called as Vivalytic, It is an all-in-one fully automated solution that will help in molecular diagnostics.
- In June 2018, MDxHealth has announced worldwide licencing agreement with Koninklijke Philips N.V. for prognostic prostate cancer biomarker and for the rights to manufacture and market Philips. This test is basically based on technology which was jointly developed by Philips Research and The University of Glasgow. With the agreement MDxHealth will be able to prepare the launch of its InformMDx test for prostate cancer i.e. a tissue-based test with the utilization of PDE4D7 that can stratify patients conferring to their risk of disease progression and the development of secondary tumors.
Competitive Analysis: Global Molecular Diagnostics Market
The global molecular diagnostics market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions and others to increase their footprints in this market. The report includes market shares of molecular diagnostics market for global, Europe, North America, Asia Pacific and South America.
Major Market Competitors/Players: Global Molecular Diagnostics Market
Some of the major players operating in the global molecular diagnostics market are Abbott Laboratories, Agilent Technologies, Becton, Dickinson and Company, Biomérieux Sa, Danaher Corporation, Diasorin, Grifols, Hologic Corporation, Qiagen, Myriad Genetics, Cepheid Inc., Genomic Health Inc., Grifols Sa, Bayer Healthcare, Johnson & Johnson, Dalko Diagnostics, Sysmex Corporation, Illumina, Qiagen N.V., Novartis AG, Cepheid, Roche Diagnostics, Siemens AG, Thermo Fisher Scientific among others.
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