Molecular Diagnostic Equipment & Equipments Global Market Report 2022



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

NEW YORK, May 13, 2022 (GLOBE NEWSWIRE) – announces the release of “The 2022 Global Molecular Diagnostic Devices and Equipment Market Report” –

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 with a compound annual growth rate (CAGR) of 13.8%.

The Molecular Diagnostic Equipment market consists of sales of Molecular Diagnostic Equipment and related services. Molecular diagnostic devices are used to diagnose infectious diseases and perform screening by detecting specific DNA or RNA sequences at the molecular level.

It helps doctors prescribe more accurate treatment interventions in the early stages of the disease.

The main products of molecular diagnostics (or) equipment are instruments, reagents and consumables, and a reagent is a substance that is used to cause a chemical reaction.

Reagents are used to indicate the presence of another substance, the techniques involved are DNA sequencing (deoxyribonucleic acid), polymerase chain reaction, isothermal DNA 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, pharmaceutical genomics, genetic testing, infectious diseases, prenatal diseases, neurological diseases, cardiovascular diseases which are used by many end users such as diagnostic laboratories, hospitals, etc. (nursing homes, blood banks, points of care).

The Asia Pacific region was the largest region in the molecular diagnostic devices (OR) market in 2021, and Western Europe was the second largest market for the molecular diagnostic devices (OR) equipment market.

The regions covered in this report are Asia Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East and Africa.

The growth in the molecular diagnostic devices and equipment market has been attributed to factors such as the rapid rise in various bacterial and viral epidemics and the increase in the prevalence of diseases increasing the demand for early and improved diagnostic methods.

To improve technology to enable early diagnosis of such diseases, the government and various organizations are offering their financial support towards the major players in the industry. For example, according to the United States Centers for Disease Control and Prevention (CDC), as of March 2019, 72 cases of Zika virus disease were reported in a US state and 148 cases of Zika virus disease were reported in US territories. Thus, the emergence of such chronic diseases acts as a major driver for industry players to develop more accurate and advanced diagnostic devices and equipment. After the increased demand for early diagnosis of Zika virus, Co-Diagnostics, Inc. In February 2019 the first multi-disease molecular diagnostic test for dengue, chikungunya, and Zika.

The regulatory process that involves approval of molecular diagnostic tests is often slow, and the lack of a clear definition coupled with constant changes in regulations poses a challenge to the companies developing these kits.

In developing countries like India and China, the lack of a well-defined regulatory framework adversely affects the market, apart from having a large population.

In the US market, due to changes in rules and regulations, products already on the market may also be required to undergo the pre-approval process of the Food and Drug Administration (FDA), eg, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certify their health Laboratory tests but does not regulate the clinical validity of molecular diagnostic tests.

This means that it does not control the clinical validity of these findings. This argument places limitations on the industry and opens an argument that the Food and Drug Administration should play a greater role in oversight of laboratories.

The major players in the molecular diagnostics industry focus on developing automated solutions for devices and equipment used in molecular diagnostics, and process automation will help enhance the productivity and consistency of the entire diagnostic process.

Computerization of the diagnostic process gives reliable and effective test results that are not provided by manual testing by different experts.

The test uses a microfluidic-based nanosensor to detect oral cancer biomarkers in saliva. To keep pace with the trend of automation and accuracy, Roche has created Cobas Communication Modules (CCM) to improve scalability and sample flow efficiency by allowing samples to move automatically between different systems and tools.

Thus, creating a fully automated workflow.

Molecular diagnostic devices are approved in the United States by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). These diagnostic devices have generally been approved with an accompanying test, to assess their safety, efficacy or significant equivalence with respect to the assays being run and the specific performance parameters of the assay.

However, the same tools do not require FDA approval or authorization when used for basic scientific research purposes. The European regulatory landscape is becoming more technically rigorous and challenging for medical device companies.

Introducing four different risk classes for diagnostic devices i.e. AD classes. Class A refers to the least risky tests, and Class D refers to the most severe testing such as HIV testing, blood pooling, and prenatal testing. Most genetic tests are classified as Category C. Products marked with CE mark, approved European tests, are safe to use, and fully compliant.

In March 2019, Abbott obtained CE Mark for Alinity m molecular diagnostic testing machine. This will allow her to sell the product throughout Europe.

Countries covered in the Molecular Diagnostic Devices (or) Equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA and Australia.
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