DUBLIN--(BUSINESS WIRE)--The "Molecular Diagnostics Devices And Equipment Global Market Report 2020" report has been added to ResearchAndMarkets.com's offering.
The global molecular diagnostics devices and equipment market was valued at about $7.5 billion in 2018 and is expected to grow to $7.71 billion at a CAGR of 0.7% through 2022.
The molecular diagnostics devices (or) equipment market consists of sales of molecular diagnostics devices and related services. Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA at molecular level. It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease. This market is segmented into instruments, reagents and consumables.
The North American Market is the largest market for Molecular Diagnostic Devices And Equipment and is expected to continue to do so during the forecast period
The growth in molecular diagnostic devices and equipment market is attributed to factors such as rapid rise in various bacterial and viral epidemics. The increase in the spread of diseases increases the demand for early and improved diagnostic methods. In order to improve the technology to enable early diagnosis of such diseases, Government and different organization's extend their financial support towards the major key players of the industry.
For example, according to the reports from Centers for Disease Control and Prevention (CDC) US, as on March 2019, 72 Zika virus disease cases were reported in U.S state and 148 Zika virus disease cases reported in US Territories. Thus, the rise of such chronic diseases serves as a prime driver for the players in the industry to develop more accurate and sophisticated diagnostic devices and equipment's. Following the increase in demand of early diagnosis of Zika virus, Co-Diagnostics, Inc. in February 2019 launched its first multi-disease molecular diagnostic test for dengue, chikungunya and Zika .
The regulatory process involving approval of molecular diagnostic tests is often slow. The lack of clear definition coupled with constant changes in the regulations is a challenge for companies developing these kits. In the developing nations such as India and China lack of well-defined regulatory framework negatively impacts the market, irrespective of the presence of a large population.
In the US market, because of the changes in the rules and regulations, the products already in the market may also be required to go through Food and Drug Administration (FDA)'s pre-marketing approval process.
For example, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certifies the validity of a laboratory based tests but it does not regulate the clinical validity of molecular diagnostic tests. This means that it does not control whether these results are clinically correct. This argument puts a restraint to the industry and opens an argument that FDA should play a greater role in overseeing laboratories.
The major players in the molecular diagnostic industry are focusing on developing automated solutions for devices and equipment's used for molecular diagnostic processes. Automation of the process will help to enhance productivity and consistency of the whole diagnostic process. Computerisation of the diagnostic process gives reliable and efficient test results that manual testing by various experts does not.
The major players of the industry are using nanotechnology based Oral Fluid NanoSensor Test (OFNASET).The test uses a microfluidic-based nano sensor for the detection of oral cancer biomarkers in saliva. In order to keep up with the trend of automation and accuracy, Roche, created cobas connection modules (CCM) to improve scalability and sample-flow efficiency by allowing samples to automatically move between different systems and instruments. Thus, creating a fully automated work flow.
The molecular diagnostic devices in the US are approved by Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). These diagnostics devices are generally approved with an accompanying assay, in order to evaluate their safety and effectiveness or substantial equivalence with reference to the assays they run and the assay's defined performance parameters. However, the same instruments do not require FDA approval or clearance when used for basic scientific research-purposes.
The European regulatory landscape has become more stringent and technically challenging for medical device companies. The introduction of four different risk classes of diagnostic device, i.e. classes A-D. Class A refers to lowest risk tests and class D refers to highest risk test such as HIV testing, blood grouping, and prenatal testing. Most of the genetic testing is classed into class C. The products bearing a CE mark, European approved tests, are safe to use and are in full compliance.
In March 2019, Abbott received a CE mark for its Alinity m molecular diagnostic testing machine. This would allow it to sell the product across Europe.
Major players in the market are Roche Ltd, Hologic, QIAGEN, Abbott, Danaher Corporation
Other Companies Mentioned
- Bio-Rad Laboratories
- Siemens Healthcare
- Becton Dickinson and Company
- Cepheid Inc.
- bioMerieux S.A.
- Agilent Technology
- Johnson and Johnson
- Tecan Group
- Bayer AG
- Danaher Corporation
- Thermo Fisher Scientific
- Sysmex Corporation
- Myriad Genetics
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