Number of pages: 100 | Report Format: PDF | Published date: March 16, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market size value in 2022 |
US$ 3.5 billion |
Revenue Forecast in 2031 |
US$ 7.03 billion |
CAGR |
7.8% |
Base Year for Estimation |
2022 |
Forecast Period |
2023-2031 |
Historical Year |
2021 |
Segments Covered |
Type, Technology, Applications, End-user, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global multiplex assay market was valued at US$ 3.5 billion in 2022 and is expected to register a revenue CAGR of 7.8% to reach US$ 7.03 billion by 2031.
Multiplex Assay Market Fundamentals
A multiplex assay is an immunoassay that uses magnetic beads to test numerous analytes at a given time in a single experiment. A multiplex test is an ELISA variant that uses beads to bind the capture antibody. Multiplex assays are still used in research settings rather than therapeutic ones. Microspheres of different colors are coated with antibodies with different binding specificities in multiplex experiments. Flow cytometry can read the results because the beads have a distinct fluorescence signature. The amount of various bead colors determines the number of analytes analyzed. Multiplex test is a technique for profiling analytes (such as growth factors, chemokines, biomolecules, cytokines, and proteins) by detecting and measuring them simultaneously. Multiplex assays are widely utilized in various applications, including mutation analysis, linkage analysis, pathogen identification, forensic research, and gene detection analysis.
Multiplex immunoassays are similar to ELISA as they rely on antigen-antibody specificity. They will also require a detecting system. Traditional ELISAs use an enzymatic reaction. However, most current multiplex assays use fluorescence probes. Multiplex immunoassays are classified into two broad types based on the type of surface to which the antibodies or antigens are attached. A solid planar surface with antigen- or antibody-bound beads bearing an identifying dye and spatially separated targets for each analyte. The bead-based multiplex immunoassay uses polystyrene beads treated with red and near-infrared dyes. The fluorescent bead-based multiplex technique is excellent for nucleic acid detection. In this scenario, a single-strand sequence is covalently bonded to the bead surface.
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Multiplex Assay Market Dynamics
The COVID-19 pandemic’s rapidly shifting epidemiology has expedited the need for improved diagnostic methods, pushing the demand for multiplex assays. For instance, the CDC Influenza SARS-CoV-2 multiplex test was widely used to distinguish and identify RNA from influenza B virus, SARS-CoV-2, and influenza A virus in lower or upper respiratory tissues. Furthermore, the USFDA, or US Food and Drug Administration, approved Emergency Use Permission for the same test in July 2020. Many growth initiatives performed by important firms also substantially impacted the market revenue growth as measured by these assays.
The market for multiplex assay is expected to register revenue growth at a rapid pace due to the increasing cases of chronic diseases, the growing adoption of customized treatment, and the numerous advantages of multiplex assays over standard tests. Furthermore, the growing elderly population, increased product launches, and rising R&D studies will contribute to considerable market expansion. Personalized medicine, which has gained popularity in recent years, strives to give tailor-made therapies to individual patients based on the biological foundation of the disease. Companion diagnostics are quickly becoming an integral aspect of personalized medicine in terms of volume and applicability in disease areas. According to the current product pipeline, companion diagnostics are expected to increase rapidly in the near future. This growth in companion diagnostics is also predicted to impact the worldwide multiplex assay market substantially.
Based on current drug approval scenarios, companion diagnostics are expected to grow rapidly in the near future. For instance, Roche received FDA approval for companion diagnostics in August 2021 to detect deficient mismatch repair solid tumors in patients who are candidates for anti-PD-1 immunotherapy. As a result, the expansion of companion diagnostics has the potential to greatly aid in the development of the global market. Early detection of numerous chronic diseases, such as cancer, can improve a patient’s quality of life, with a threefold improvement in survival rate when detected early. Furthermore, early detection can expand the number of treatment options available and lower the expenses associated with chronic conditions.
Multiplex Assay Market Ecosystem
The global multiplex assay market has been analyzed from five perspectives: type, technology, application, end-user, and region.
Multiplex Assay Market by Type
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Based on type, the global multiplex assay market has been segmented into protein, nucleic acid, and cell-based multiplex assay. The protein segment is sub-segmented into bead-based and planar protein assays. Moreover, the nucleic acid segment is sub-segmented into planar protein assays and bead-based protein assays.
The protein segment is likely to dominate the market during the forecast period due to a greater emphasis on proteomics investigations for biomarker research and clinical diagnostics. The search for acceptable biomarkers has expanded dramatically in clinical practice, and quantitative protein assessment is an important stage in biomarker identification. Assessing many putative protein biomarkers in a statistically significant number of samples and controls is a significant technical challenge.
Protein multiplex assays have various advantages regarding the amount of data that may be obtained, sample demand, reagent cost, time, and data generation. For instance, a July 2022 paper published in eCinical Medicine used a multiplex protein panel assay to determine disease severity and prognosis in COVID-19 patients. As a result, rising applications of protein multiplex assay in proteomics research are expected to drive segment growth. Over the forecast years, the nucleic acid assay is expected to be the fastest-growing segment.
Multiplex Assay Market by Technology
Based on technology, the global multiplex assay market has been segmented into flow cytometry, fluorescence detection, luminescence, multiplex real-time PCR, and other technologies.
The flow cytometry segment is projected to dominate the market during the forecast period. Flow cytometry has become a critical tool for basic research and clinical diagnostics. It does multiparametric analysis on thousands of single cells per second. Furthermore, various companies’ technological improvements and the introduction of novel flow cytometers are boosting the industry’s growth. For instance, Thermo Fisher Scientific Inc. launched a novel flow cytometer with imaging capability in June 2021, allowing users to collect data and better comprehend the quality and morphology of the cells in these experiments.
Multiplex Assay Market by Application
Based on application, the global multiplex assay market has been segmented into research & development and clinical diagnostics. The research & development segment is further sub-segmented into drug discovery & development, biomarker discovery & validation. Furthermore, the clinical diagnostics segment is sub-segmented into infectious diseases, cancer, cardiovascular disease, autoimmune diseases, nervous system disorders, metabolism & endocrinology disorders, and other diseases.
The research & development segment is expected to dominate the market during the projection period. The demand for multiplex assay is steadily increasing in drug discovery. These assays are used in clinical and preclinical stages to evaluate toxicity, immunotherapy success, and drug response biomarkers. In addition, biomarker discovery and validation are essential in the current era for healthcare professionals to improve disease diagnosis and cancer detection at initial stages and monitor therapeutic responses. The validation of the marker candidate is required in each stage of the biomarker pipeline to reach its clinical utility.
Multiplex Assay Market by End-user
Based on end-user, the global multiplex assay market has been segmented into pharmaceutical & biotechnology companies, hospitals & diagnostic laboratories, research & academic institutes, and others.
The pharmaceutical & biotechnology companies segment is projected to dominate the market during the forecast period. This is due to increased pharmaceutical and biotech alliances and collaborations to improve multiplexing capabilities. For instance, Becton, Dickinson and Company, and Labcorp cooperated in August 2022 to create flow cytometry-based companion diagnostics to provide patients with efficient treatment alternatives. In the CDx landscape, flow cytometry technology supports multiplexing and has great sensitivity. Consequently, collaborations improve the growth possibilities of multiplex tests and potentially increase industry growth.
The hospitals and diagnostic laboratories segment is expected to develop at the fastest revenue CAGR during the forecast period due to the increased demand for timely and reliable diagnoses of various chronic conditions. Multiplex assays provide speedy answers for many biomolecule targets in a single run, making them an excellent choice for patient illness detection.
Multiplex Assay Market by Region
Based on region, the global multiplex assay market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region is projected to dominate the market during the forecast period. The growing burden of chronic diseases, such as HIV, CNS disorders, and gastrointestinal disorders, rising adoption of multiplex assays over single assays, increasing product approvals, growing investments, and key initiatives taken by key players are the primary driving factors for the revenue growth of the North America multiplex assay market. The United States is predicted to grow significantly within North America during the forecast period. The increased prevalence of chronic diseases is projected to drive progress in the multiplex tests industry. According to the HIV Government factsheet, in May 2021, around 1.2 million persons in the United States were infected with HIV. A third of them are ignorant of it and must be tested. In 2019, about 34,800 new HIV infections were registered in the United States, with 36,801 people receiving an HIV diagnosis. As a result of the country’s increased prevalence of infectious diseases, demand for multiplex assays is predicted to rise over the forecast period.
Introducing new products and services in North America is anticipated to greatly impact the market. For instance, Applied BioCode received Emergency Use Permission from the USFDA for its BioCode CoV-2 Flu Plus Test in December 2021. In nasopharyngeal swab specimens, this PCR-based multiplex molecular diagnostic assay may identify and discriminate SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3, Influenza B), and Respiratory Syncytial Virus (RSV).
Asia Pacific is expected to register growth at the fastest revenue CAGR during the projection period. This is attributable to the growing number of hospitals in developing nations, the rapidly growing R&D industry, the strong demand for healthcare infrastructure, and investments by emerging regional businesses. For instance, in November 2021, QuantuMDx received a US$ 10.9 million investment from Vita Spring and signed a corporation agreement with Sansure Biotech to enhance multiplexing capabilities in China.
Multiplex Assay Market Competitive Landscape
Key companies are using a variety of initiatives, such as collaborations, the launch of breakthrough technology and products, and partnerships, to expand their industry presence. For instance, in June 2021, Bio-Rad partnered with Seegene to provide molecular diagnostic testing solutions in the United States. Furthermore, in November 2020, Qiagen announced the NeuMoDx multiplex assay to provide a comprehensive spectrum of SARS-CoV-2 testing solutions in Europe and other markets.
The prominent players in the global multiplex assay market include:
Multiplex Assay Market Strategic Developments
A multiplex assay is an immunoassay that uses magnetic beads to test numerous analytes at a given time in a single experiment. A multiplex test is an ELISA variant that uses beads to bind the capture antibody. Multiplex assays are still used in research settings rather than therapeutic ones.
Asia Pacific the key growth region in the global multiplex assay market.
The global multiplex assay market is expected to reach US$ 7.03 billion by 2031.
The global multiplex assay market is expected to register a revenue CAGR of 7.8% during the forecast period.
Some prominent players in the global multiplex assay market include Luminex Corp., Bio-Rad Laboratories Inc., and Thermo Fisher Scientific Inc.
*Insights on financial performance are subject to the availability of information in the public domain