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Global Multiplex assays Market Size, Share & Trends Analysis Report by Type (Protein Multiplex Assays, Nucleic Acid-Based Multiplex Assays, and Cell-based Multiplex Assays), by Technology (Multiplex Real-Time PCR, Luminex Bead Technology, Flow Cytometry, and Others), and by End-User (Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations (CROs), Research and Academic Institutions, Others), Forecast Period (2023-2030)
The global multiplex assays market is anticipated to grow at a CAGR of 14.8% during the forecast period (2023-2030). The market's growth is attributed to the increasing advancements in immunotherapy. The increased use of immunotherapy, particularly chimeric antigen receptor (CAR) T cell therapy, for cancer treatment increases the need for accurate measurement and monitoring of CAR-T cells. Multiplex digital PCR assays satisfy the demand by delivering accurate, comprehensive analysis necessary for determining therapy success. For instance, in June 2023, BioPharma Services, Inc., launched new multiplex digital PCR assays for comprehensive quantification of multiple CAR-T cells, a type of cancer immunotherapy that involves genetically modifying T-cells to recognize and destroy certain cancers. The analysis is based on the Qiagen QIAcuity digital PCR methodology, that offers a powerful yet simple digital PCR experience with its unique nanoplate methodology.
The global multiplex assays market is segmented on the type, technology, and end-user. Based on the type, the market is sub-segmented into protein multiplex assays, nucleic acid-based multiplex assays, and cell-based multiplex assays. Based on the technology, the market is sub-segmented into multiplex real-time PCR, Luminex bead technology, flow cytometry, and others. Further, based on the end-user, the market is sub-segmented into pharmaceutical and biopharmaceutical companies, CROs, research and academic institutions, and others. Among the type, the nucleic acid-based multiplex assays subcategory is expected to capture a significant portion of the market share. This is attributed to the increase in the usage of nucleic acid-based multiplex assays and research on nucleic acid-based multiplex assays.
Among the technology, the multiplex real-time PCR sub-segment is expected to hold a considerable share of the global multiplex assays market. The segmental growth is attributed to the enhanced testing efficiency. Multiplex assays simplify testing by detecting several targets in a single response. The capacity to recognize two N-gene target sequences in a single reaction decreases testing time, boosts throughput, and enhances diagnostic laboratory efficiency. For instance, in May 2020, Gold Standard Diagnostics Launched Multiplex Real-Time PCR Assay for SARS-CoV-2. GSD NovaPrime SARS-CoV-2 (COVID-19) is a real-time PCR test designed to detect SARS-CoV-2. It is a multiplex test which detects two target sequences of the N-gene in one reaction, providing results in 2 hours. The reagents include an extraction/ inhibition control and a positive control.
The global multiplex assays market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, North America is anticipated to hold a prominent share of the market around the globe, owing to the increasing number of individuals suffering from chronic and infectious diseases, in addition to increased awareness of the usage of multiplex assay products and services.
Among all regions, the North America region is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the pandemic preparedness and surveillance. A primary driving element is the urgent need for precise and efficient serological assays to detect prior infections and track population exposure rates during the COVID-19 pandemic. Multiplex assays with high specificity and sensitivity, such as this serological assay, are essential in population-level surveillance. According to the National Institute of Health (NIH.gov), in January 2022, a serological COVID-19 multiplex assay was developed and validated using serum samples from 2 groups of recovered people; and those who had not yet been infected. After testing multiple potential antigens, the SARS-CoV-2 nucleocapsid protein (NP) and receptor-binding domain (RBD) of the spike protein were selected for the human COVID-19 multiplex assay. A comparison of synthesized and mammalian expressed RBD proteins showed the advantages of mammalian expression. Detection of NP and RBD specific IgG and IgA had excellent performance (AUC > 0.90) for distinguishing patients from controls, with the IgG assay having a wider dynamic range. This assay was used to evaluate seroprevalence to SARS-CoV-2 in people living in a low-incidence community in Ithaca, NY. Of the 332 healthy volunteers sampled 2020, 1.2-5.7% tested positive for either NP or RBD, which was higher than the county's reported incidence rate of 0.16%. This assay can be used to monitor community exposure rates and the duration of immune response following infection or vaccination.
The major companies serving the global multiplex assays market include Bio-Rad Laboratories, Inc., Merck Group, PerkinElmer U.S. LLC, Quansys Biosciences Inc., Thermo Fisher Scientific Inc., and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in July 2023, EDP Biotech merged with New Day Diagnostics to form a vertically integrated diagnostic company to advance the development and commercialization of diagnostic tests. EDP offers the ColoPlex in vitro diagnostic assay, that assists in the early detection of pre-cancerous cancer polyps and colorectal cancer.