Major players in the microbiology diagnostics devices and equipment market are Becton, Dickinnson and Company, Biomerieux , Danaher, Thermo Fisher Scientific and Abbott Laboratories. The global microbiology diagnostic devices and equipment market is expected to grow from $3.
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5 billion in 2019 to $3.7 billion in 2020 at a compound annual growth rate (CAGR) of 4.6%. The growth of this market is mainly due to the increased diagnostic testing in laboratories, hospitals, and other testing sites across various country to detect the pandemic COVID-19 virus. The need for rapid diagnostic testing such as molecular and RT PCR based testing to identify people infected by coronavirus is driving the in-vitro diagnostics market. The market is then expected to grow at a CAGR of 8% from 2021 and reach $4.6 billion in 2023.
The microbiology diagnostics devices and equipment market consists of sales of microbiology diagnostics devices and equipment and related services. Microbiology diagnostics devices and equipment are used to diagnose infectious diseases by examining pathogens. These instruments include incubators, autoclave sterilizers, anaerobic culture systems, blood culture systems, gram strainers, microscopes, mass spectrometers, molecular diagnostic instruments, reagents pathogen specific kits and general reagents.
In February 2019, Biomerieux, biotechnology company specialized in in vitro diagnostics, acquired Invisible Sentinel, a US-based company, for $75 million. This acquisition enables bioMérieux’s to expand its customer segments, innovative alternatives to deliver accurate results by rare pathogen testing and challenging food matrices. Invisible Sentinel provides microbial detection tools and devices for food and beverage molecular testing in order to improve safety, quality and productivity. These provide bioMérieux’s molecular food testing solution, ’GENE-UP®’, an opportunity to adapt Invisible Sentinel assays to process high volumes of samples.
The microbiology diagnostic devices and equipment market has been geographically segmented into North America, Western Europe, Asia-Pacific, Eastern Europe, South America and Middle East & Africa. The North American market is the largest market for microbiology diagnostic devices and equipment and is expected to continue to be the largest market during the forecast period.
Unfavorable regulatory scenarios is one of the major restraints in the microbiology diagnosis devices market. In the US, section 510(k) of the Food, Drug and Cosmetic Act states that every device manufacturer must register with FDA and notify their intent to market a medical device at least 90 days in advance. These pre-market notifications are considered to be lengthy, rigorous and time-consuming processes for the approval of medical devices. If in case the submission fails due to some uncertainty, the company has to reperform all the tests and resubmit the premarket approval application. For instance, a ’Verticle Autoclave’, a microbiology diagnostic device, complies with the strict international directives and standards such as capacity of 80-120 litre autoclave chamber volume, low sensitivity loads, restrictions on temperature calibration and a certificate from ISO17025 accreditation lab for temperature, pressure gauges & timer.
Next Generation Sequencing (NGS) technologies are increasing their prevalence in the microbiology diagnostic devices market due to its cost effectiveness, sensitivity to detect low-frequency variants and comprehensive genomic coverage. Next Generation Sequencing (NGS) or high throughput sequencing or Massively Parallel Sequencing (MPS) is a method of sequencing genomes with an ability to sequence hundreds to thousands of genes or gene regions and capability to detect novel resistance genes (ARG) in bacteria. In 2015, bioMérieux partnered with Illumina to develop bioMérieux EpiSeq™, a NGS service which will facilitate epidemiological monitoring of bacterial infections and monitor outbreaks in hospitals. Some of the modern next generation sequencing technologies that help to sequence DNA and RNA include Illumina (Solexa) sequencing, Roche 454 sequencing, Ion torrent Proton / PGM sequencing, and SOLiD sequencing.
In April 2017, the European parliament approved the 2012 proposal of European Commission for regulations on in-vitro diagnostic Medical Devices (IVD) and other medical devices. The two new regulations replace the three existing directives on medical devices in order to enhance patient safety. These changes by the EU legislation aids in the development of microbiology diagnostic devices, as they focus on providing transparency of information through EUDAMED (the new European database of medical devices), allowing manufacturers to monitor products, stronger clinical evidence, post-market surveillance, and enhance safety improvements.
Increasing funding of public and private investments in the medical devices is driving the growth of microbiology diagnostic devices market. Increasing Investments indicates rising confidence of various private and public players on microbiology diagnostic devices thereby indicating a progressive increase and stimulating growth. For instance, the global medical device funding accounted for $4,804 million in 2014 and has raised to $6,133 million in 2017. The increasing investments on digital health technologies, artificial intelligence and non-invasive monitoring capability, delivery of gene therapy and regenerative medicines technologies, customized 3D printing of medical devices are expected to drive the microbiology diagnostic devices market.
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