Global Molecular Diagnostics Devices And Equipment Market Report 2022

The global molecular diagnostics devices and equipment market is expected to grow from $24.19 billion in 2021 to $27.91 billion in 2022 at a compound annual growth rate (CAGR) of 15.3%. The market is expected to grow to $46.87 billion in 2026 at a compound annual growth rate (CAGR) of 13.8%.

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 the molecular level. It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease.

The main products of molecular diagnostics devices (or) equipment are instruments, reagents, and consumables. A reagent is a substance that is used for causing a chemical reaction. Reagents are used to indicate the presence of another substance. The technologies involved are DNA (deoxyribonucleic acid) sequencing, polymerase chain reaction, isothermal nucleic acid amplification technology, transcription-mediated amplification (TMA), in situ hybridization, microarrays, mass spectrometry, and others (southern blotting, northern blotting, and electrophoresis). The various applications are cancer, pharmacogenomics, genetic testing, infectious disease, prenatal, neurological disease, and cardiovascular disease that are used by various end-users such as diagnostic laboratories, hospitals, and others (nursing homes, blood banks, point of care).

Asia Pacific was the largest region in the molecular diagnostics devices (or) equipment market in 2021. Western Europe was the second largest market in molecular diagnostics devices (or) equipment market. The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The growth in the molecular diagnostic devices and equipment market is attributed to factors such as the rapid rise in various bacterial and viral epidemics. The increase in the spread of diseases increases the demand for early and improved diagnostic methods. To improve the technology to enable the early diagnosis of such diseases, the Government and different organizations extend their financial support towards the major key players of the industry. For example, according to the reports from Centres for Disease Control and Prevention (CDC) US, as of 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. Following the increase in demand for 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 the 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 developing nations such as India and China lack of a 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 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 on 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 used for molecular diagnostic processes. Automation of the process will help to enhance the productivity and consistency of the whole diagnostic process. Computerization 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 Nano Sensor Test (OFNASET). The test uses a microfluidic-based nanosensor for the detection of oral cancer biomarkers in saliva. 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 workflow.

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, to evaluate their safety and effectiveness or substantial equivalence regarding 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 devices i.e. classes A-D. Class A refers to the lowest risk tests and class D refers to the 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.

The countries covered in the molecular diagnostics devices (or) equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia.

Major players in the molecular diagnostics devices (or) equipment market are Roche Ltd, Hologic, QIAGEN, Abbott, Danaher Corporation, Bio-Rad Laboratories, Siemens Healthcare, Becton Dickinson and Company, Cepheid Inc, and bioMerieux S.A.

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