Global Biological Multiplex Assays Market is segmented By Type(Protein-based Multiplex Assays, Nucleic Acid-based Multiplex Assays and Others), By Technology(Multiplex PCR, Multiplex Protein Microarray), By Application(Clinical Diagnostics, Research & Development and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029
Market Overview
The global biological multiplex assays market size was valued at US$ XX million in 2020 and is estimated to reach US$ XX billion by 2029, growing at CAGR of XX % during the forecast period (2022-2029).
In biological science, the biological multiplex assay is a type of immunoassay that uses magnetic beads to measure multiple analytes simultaneously. This assay is a derivative of an ELISA using beads for binding the capture antibody.
Source: DataM Intelligence Analysis (2021)
Market Dynamics
Some of the factors driving the growth of the biological multiplex assays market include increasing research and development activities in the pharmaceutical sector, technological advancements, among others.
Increasing research and development activities in the pharmaceutical sector are expected to drive the growth of the biological multiplex assays market
The pharmaceutical industry has generated many novel therapeutics that are typically protein-based molecules derived from biological sources. However, therapeutic protein products often initiate immune responses against the therapeutic protein that can potentially lead to adverse clinical events in patients. For above 50 years, immunoassays have allowed sensitive and increased specific detection of analytes of interest in biological samples for use in both clinical diagnostics and life science research. Traditional enzyme-linked immunosorbent assays (ELISA assays) measure and detect a single analyte per plate. Latest bead-based immunoassays like the ones based on Luminex xMAP technology, utilize the same principle and apply it to uniquely identifiable beads. These beads allow simultaneous detection of multiple analytes in a single reaction or well. Multiplex immunoassays yield a wealth of information on the roles of multiple proteins and other biomolecules in diverse biological processes, thereby providing clinicians with insight into identifying and assessing disease progression.
The Bio-Plex array system utilizes Multi-Analyte Profiling (MAP) technology developed by the Luminex Corporation (Austin, TX). It comprises a fully integrated system combining hardware and Bio-Plex Manager Software. The Bio-Plex includes enhancements designed by Bio-Rad to increase the dynamic range of the basic Luminex instrument. “Bio-Plex xMAP technology permits the multiplexing of up to 100 different assays within a single sample. The system utilizes a liquid suspension array of 100 sets of 5.5-micron beads, internally each dyed with ratios different of two spectrally distinct fluorophores to assign a unique spectral address.
Technological advancements are expected to drive the biological multiplex assays market in the forecast period
From a single sample, the simultaneous measurement of different substances is an emerging area for achieving high-throughput and efficient detection in several applications. Although immunoanalytical techniques are advantageous and established over alternative screening analytical platforms, one of the challenges for immunoassays is multiplexing. While ELISA is still commonly used to characterize a single analyte, laboratories and organizations use multiplex immunoassays. In a single sample, the validation of novel biomarkers and their mix into multiplex immunoassays confers the prospects of measurement of simultaneous multiple analytes, thereby time, minimising cost and sample. Therefore, in clinical sciences, technological advancement is helpful in the identification of biomarkers or analytes in test samples. The analytical bioanalysers are capable of detecting small analytes type. The simultaneous measurement of different substances from a single sample called multiplexing has become increasingly important for quantifying toxicological or pathological samples.
Drawbacks related to the biological multiplex assays is estimated to hamper the biological multiplex assays market
For basic research and biomarker discovery, multiplex immunoassays confer many advantages over the widely adopted singleplex immunoassays, but successful assays depend on careful, thorough validation and development. Assay development is often limited by the availability of good antibody pairs, matrix interference, cross-talk between assays, and lot-to-lot variability in assay reagents. The quality of a finished multiplex immunoassay critically depends on the pairing of high-quality detection and capture antibodies. Antibodies validated for singleplex immunoassays on one platform don’t always display the same quality in a multiplex setting. In addition, a positive western blot result does not always translate to equal performance in a suspension format. Thus, careful validation of antibody pairs must be carried out on the same platform used for the final assay to ensure optimum performance.
Multiplex immunoassays are used extensively in both diagnostics and research and their continued success relies on careful validation processes. The selection of the appropriate biomarkers and the associated reagents to develop multiplex assays should start with open communications between the end-user and the assay vendor and between the assay vendor and suppliers of the raw materials. This ensures the assays are manufactured according to validation methods that apply to a wide range of academic and clinical research settings.
COVID-19 Impact Analysis
The multiplex assay can detect patient responses to five SARS-CoV-2 proteins simultaneously the full spike protein, three individual spike protein domains (S1, S2, and receptor binding domain), and the nucleocapsid protein. Antibodies to the mentioned proteins are SARS-CoV-2 specific, as antibodies to four common coronaviruses do not cross-react. This new assay provides a novel tool for investigating the spectrum of immune responses to SAR-CoV-2 and is specifically designed for use in the transplant setting. Hence, covid is estimated to have a positive impact on the biological multiplex assays market.
Segment Analysis
The protein-based assay segment is estimated to dominate the biological multiplex assays market
For detecting protein-specific functional groups protein assays differ in their chemical basis. Some assay methods detect peptide bonds. Each protein assay instead detects one or several amino acids with greater sensitivity than others. Proteins with different amino acid compositions consequently produce color at different rates or intensities in any protein assay. The Bradford protein assay uses a blue dye that binds to specific amino acids. The resulting intensity of the blue color can be measured with a spectrophotometer. The resulting absorbance is compared to a standard to determine the concentration of protein in the sample. This method is called the Coomassie dye protein assay because the dye used is called a Coomassie dye.
The protein assay aims to determine the concentration or amount of a specific protein or an array of proteins in a different sample. Detecting and isolating protein is used for many clinical and research processes. This can be a primary step before further manipulation in a research and development process, an initial protein capture before structural analysis or a final detection step in a clinical laboratory as part of a disease diagnosis.
Multiplex PCR segment is expected to dominate the biological multiplex assays market
Multiplex PCR is a two-amplicon system that amplifies 13 or more separate regions of DNA. It can be the endpoint of the analysis, or it may be preliminary to further analysis such as sequencing and hybridisation. Producing multiplex PCR systems can be simple as combining two sets of primers for which reactions have been separately determined. However, for the regions to be amplified multiplex PCRs should be developed with careful consideration, the sizes of relative fragments, the dynamics of the primers and the optimisation of PCR technique to accommodate multiple fragments. The expense of reagents and time of preparation is less in multiplex PCR than in other systems. Multiplex PCR assays can be time-consuming, tedious and lengthy procedures for optimisation such as adjusting primers concentration, the concentration of Mg2 + and amount of enzyme are often necessary. Novel developments in reaction chemistry have made multiplex PCR more straightforward. Multiplex PCR methods exhibit great flexibility in overcoming limiting primer kinetics and in experimental design and fragment competition.
A molecular technique multiplex PCR is used for the diagnosis of important foodborne microorganisms. In the same reaction, this technique uses more than one primer pair, thus permitting the simultaneous amplification of different DNA sequences. It can be used to simultaneously amplify target sequences of different pathogenic microorganisms in a single reaction, with potential application in routine laboratories.
The clinical diagnostics segment is expected to dominate the market
Multiplex assay techniques are highly sensitive yet versatile, they are well suited to clinical applications such as immunology, cancer diagnosis and immuno-oncology. They are particularly useful for biomarker discovery. A panel of analytes is measured together as an indicator for a specific disease, a response to medical treatment, or stratifying treatments at the patient level.
Then single assay testing requires samples in far smaller quantities, and are particularly valuable where sample volumes are limited. This includes research that uses mice models, research and clinical treatment of neonates and analysis of tumor biopsy samples. The applications for immunoassays were limited to basic research once but have expanded into diagnostic- and clinical-research spaces. With the invention of multiplex immunoassays, researchers have gained the opportunity for more information about a protein or series of proteins within a single reaction of an experiment. These enable users to gather more information in less time and help researchers conserve very small volumes of samples. The increasing number of tools are being used by researchers available for multiplex immunoassays to investigate cellular regulatory events involved in cancer. For instance, pharmaceutical companies are using multiplex immunoassays to increase their testing power.
Geographical Analysis
North America region dominated the biological multiplex assays market
Increasing funding from government agencies and a rise in focus to develop novel drugs and biomarkers in this region is expected to account for the largest market share in the global biological multiplex assays market.
The ideal government upholds adding to the market development. North America held a generous offer attributable to the most elevated number of preliminaries embraced and reevaluated in the locale. Moreover, developing government uphold for R&D exercises through awards and assets to explore establishments and organizations has driven this local market. Canada and USA play a leading role in the increasing globalisation of science and research. In the world, North America and especially the USA continues to be the most competitive research region. More than a quarter of the global funds spent on research and development are invested her
Source: DataM Intelligence Analysis (2021)
Competitive Landscape
The biological multiplex assays market is highly competitive with the increasing demand for assays in pharmaceutical research and development and new drug launches.
Some of the major key players in the global biological multiplex assays market are Luminex Corporation, Thermo Fisher Scientific Inc., Illumina Inc., Bio-Rad Laboratories Inc., QIAGEN N.V., Becton, Dickinson and Company, Abcam PLC, Seegene Inc., Meso Scale Diagnostics LLC, and Randox Laboratories Ltd.
Thermo Fisher Scientific Inc.
Overview: Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. It is a company based in the United States that sells scientific instruments, reagents and consumables, and software services. Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon are just a few of their industry-leading brands.
Product Portfolio: The company comprises analytical instruments, laboratory supply chain programs and eCommerce, laboratory equipment, lab services, speciality diagnostics, life sciences, pharma services, and CDMO.
Key Development: On 16th April 2021, Thermo Fisher Scientific acquired PPD, Inc., a leading clinical research organization to further expand the service offering to pharma and biotech customers.
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