Syndromic Multiplex Diagnostic Market Size, Share, Industry, Forecast and outlook (2024-2031)

Syndromic Multiplex Diagnostic Market is Segmented By Type (Multiplex PCR Test, Multiplex Panel Test, Other), By Application(Respiratory Syndrome, Gastrointestinal, Central Nervous System, Other), By End-User(Hospitals, Diagnostics Laboratories, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030.

Syndromic Multiplex Diagnostic Market Overview

Syndromic Multiplex Diagnostic Market is expected to reach at a CAGR of 7.3% during the forecast period (2023-2030). A single test for all microorganisms commonly responsible for infectious disease, the syndromic approach represents a new line of attack against infectious diseases. 168 pages report analyses the Syndromic Multiplex Diagnostic market shares, recent trends, competitive intelligence and future market outlook. Syndromic Multiplex Diagnostic usage in diagnostic procedures for infectious diseases is on the rise. Demand from pharmaceuticals & commercial infrastructure in ‘Asia Pacific’ is booming. Competitive rivalry intensifies with Biomerieux SA, Luminex Corporation, QIAGEN, Applied BioCode, Akonni Biosystems, Abbott Diagnostics and others operating in the market.

Syndromic Multiplex Diagnostic Market Scope

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Syndromic Multiplex Diagnostic Market Dynamics

The factor driving the syndromic multiplex diagnostic market is the rising demand for diagnostic procedures for infectious diseases.

The rising demand for the diagnostic procedure for infectious diseases is expected to drive the market growth

The first symptoms of an infectious disease in most patients are not specific to the cause of infection: fever, diarrhea, coughing, headache, and so on. Traditionally, the strategy for identifying the responsible disease agents has been based on testing for the most likely cause of a disease, waiting for test results, and then repeating the process if the results are negative.

As a result, the syndromic approach, which employs a single test for all microorganisms suspected of causing infectious disease, provides an innovative solution to the problem of infectious disease diagnosis. When the disease is diagnosed, it saves time and allows the patient to begin treatment sooner. In critical care, the syndromic multiplex diagnostic test provides more accurate, realistic, and comprehensive results.

For example, The BIOFIRE FILMARRAY technology employs a single test to detect bacteria, viruses, fungi, or parasites that can cause infectious disease, with results delivered in 45 to 65 minutes.

The high cost of diagnostic tests and equipment’s is expected to hamper the global syndromic multiplex diagnostic market

Syndromic panels for BSIs are an adjunct test, not a replacement for culture or comprehensive antimicrobial susceptibility testing. The Accelerate PhenoTest BC (Accelerate Diagnostics, Tucson, AZ) is an exception, as it provides identification and complete phenotypic susceptibility results in 9 hours. The limitations of these assays include the inability to detect off-target pathogens, a lack of complete susceptibility information, high costs, and false-positive results. On syndromic panels, not every bloodstream pathogen is represented as a target organism, and no identification is provided for these off-target organisms.

As a result, laboratories must take strict measures to ensure that syndromic panels are used responsibly, such as optimizing clinician ordering practices, prohibiting repeat testing, and educating clinicians on the usefulness and limitations of assays. To aid provider interpretation, thoughtful reporting of results with interpretative comments and/or consultation with the clinical microbiology laboratory director is required.

COVID-19 Impact Analysis On Syndromic Multiplex Diagnostic Market

Molecular diagnostic approaches are preferable to other syndromic testing approaches because molecular diagnosis targets the pathogen's genome or proteome, making it a specific and reliable method of diagnosis. For a novel pathogen, sequencing and diagnosis are required to determine the pathogen's nature and genomic composition. Random amplification and deep sequencing strategies were critical in identifying SARS-CoV-2, which was later confirmed to be a member of the coronavirus family using various bioinformatics approaches. The first genomic sequencing for SARS-CoV-2 was performed using metagenomic sequencing. The one-step assay combines reverse transcription and PCR amplification in a single tube, making detection fast and reproducible. Hence, the global syndromic multiplex diagnostic market was positively impacted.

Syndromic Multiplex Diagnostic Market Segmentation Analysis

Respiratory Syndrome held the largest share in the global syndromic multiplex diagnostic market

Over the last decade, the number of FDA-approved molecular diagnostics for acute respiratory tract infection (RTI) has increased significantly. Furthermore, the FDA has granted Emergency Use Authorization for several nucleic acid amplification tests (NAATs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NAATs that are highly sensitive and specific enough to detect one or more viruses have become the diagnostic "gold standard" in clinical virology. Furthermore, several of the most recent assays detect and identify the most common causes of bacterial pneumonia, as well as selected drug-resistance determinants.

In pediatric patients, where it can reduce unnecessary antibiotics and chest radiographs, upfront multiplex testing for multiple viruses may be the most cost-effective. In contrast, a Veterans Affairs study evaluating a multiplex NAAT assay in adult outpatients during influenza season suggested that testing for influenza alone may be more cost-effective in this patient population than a syndromic approach. Multiplex viral NAAT (possibly in combination with bacterial NAAT) makes clinical sense for immunocompromised and critically ill patients with pneumonia, as well as those with airway disease exacerbations.

On 18th March 2021, BioFire Diagnostics specializing in molecular syndromic infectious disease testing received FDA De Novo approval for the BIOFIRE® RP2.1 Panel. This panel detects 22 viral and bacterial pathogens that cause respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel is the first SARS-CoV-2 diagnostic test of any kind to be granted De Novo status by the US Food and Drug Administration (FDA), having gone through the normal FDA review pathway outside of the Emergency Use Authorization (EUA) track.

Syndromic Multiplex Diagnostic Market Geographical Analysis

North America region accounted for the largest market share in the global syndromic multiplex diagnostic market

Owing to the adoption of technological advancements and the rise in R&D research this region is expected to dominate the market.

On March 31st, 2020, The U.S. Food and Drug Administration (FDA) granted QIAGEN emergency use authorization (EUA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to diagnose patients infected with the novel COVID-19 coronavirus.

In a single testing run of about an hour, the QIAstat-Dx test kit can distinguish the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients with similar symptoms. It is a multiplexed nucleic acid test that evaluates samples like nasopharyngeal swabs obtained from people suspected of having respiratory tract infections.

On July 21, 2021, an amendment was granted by the FDA to the EUA for the CDC Flu SC2 Multiplex Assay to update the in-silico analysis of assay primer/probe sequences against available genomic sequences of SARS-CoV-2 viruses/variants circulating in the US.

Syndromic Multiplex Diagnostic Market Competitive Landscape

The global syndromic multiplex diagnostic market is moderately competitive with major players launching products, mergers and acquisitions. Some of the major key players in the global syndromic multiplex diagnostic market are Biomerieux SA, Luminex Corporation, QIAGEN, Applied BioCode, Akonni Biosystems, Abbott Diagnostics, Accelerate Diagnostics, BD Diagnostics, BioFire Diagnostics and GenMark Dx.

Biomerieux SA

Overview: BioMérieux SA is a French multinational biotechnology company headquartered in France. BioMérieux is present in 44 countries and serves over 160 countries via a large network of distributors.

Product Portfolio: The company’s BIOFIRE FILMARRAY Pneumonia plus Panel enables rapid and accurate automated testing for 27 bacteria and viruses that cause pneumonia and other lower respiratory tract infections (LRTI), as well as 7 antibiotic resistance genetic markers.

Key Development: On March 18th, 2021, BioFire Diagnostics specialising in molecular syndromic infectious disease testing, received FDA De Novo approval for the BIOFIRE® RP2.1 Panel. Using a single simple test, the BIOFIRE® RP2.1 Panel enables healthcare providers to quickly identify common respiratory pathogens found in patients with acute respiratory tract infections.