Multiplex Assays Market Size, Share, Forecast, & Trends Analysis by Type (Protein [Bead, Planar], Nucleic Acid, Cell) Technology (Flow Cytometry, PCR, Immunoassay) Application (R&D, Diagnosis (Oncology, Infectious) Product, End User - Global Forecast to 2031

Multiplex Assays Market Size & Forecast

The Multiplex Assays Market is expected to reach $6.80 billion by 2031 at a CAGR of 8.9% from 2024 to 2031. Multiplex assays are a form of immunoassay that measures several analytes at once. These assays are derived from the conventional ELISA technology, which generates numerous signal measurements instead of only one, as in ELISA. Multiplex assays use microspheres coated with several antibodies that come in various colors. It uses flow cytometry to separate various colored beads by their diverse degrees of fluorescence, the findings of which are read following incubation.

The growth of this market is attributed to several factors: the advantages of multiplex assays over singleplex assays, the use of multiplexing in companion diagnostics, the increasing prevalence of chronic and infectious diseases, rising use of multiplex assays in drug discovery, and rising awareness about the importance of early disease diagnosis. However, the high costs of multiplex assay equipment restrain the growth of this market.

The growing need for high-throughput and automated laboratory systems and the increasing focus on personalized medicine are expected to generate growth opportunities for the players operating in this market. However, the shortage of skilled professionals and the risk of cross-reactivity are major challenges to market growth.

Multiplex Assays Market Growth Drivers

Advantages of Multiplex Assays over Singleplex Assays

In recent years, scientists and researchers have increasingly adopted multiplex assays due to their advantages over singleplex assays. Multiplex assays generate more reproducible and robust results compared to singleplex assays. These assays are more reliable than singleplex assays, can simultaneously analyze multiple analytes, reduce the chances of human error, and offer more accurate results. Additionally, multiplex assays use similar experimental criteria for all analytes, making experiment results more easily comparable.

The main advantage multiplex assays offer over singleplex assays is their lower sample requirement. The multiplex approach uses lower quantities of samples, reducing associated costs and providing all the required data points from a single reaction. Although singleplex assays are simpler to perform than multiplex assays, the results are more accurate and informative, which drives the preference for multiplex assays among end users.

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Use of Multiplex Assays in Drug Discovery

Pharmaceutical & biotechnology companies allocate significant resources for drug discovery & development. The increasing prevalence of chronic diseases is increasing the need for the development of novel therapies, thus focus on drug discovery is increasing. Multiplex assays have become increasingly important in maintaining precision and accuracy in drug research and development and reducing the time required for research purposes. Multiplex assays are used in biomarker discovery and validation. Identifying and characterizing biomarkers can streamline the drug candidate selection process, thus reducing the number of failures in clinical trials and enabling the discovery of more effective therapeutics hence adopted.

The funding for drug discovery is also increasing, which is driving the demand for multiplex assays. For instance, in March 2023, the Government of Canada provided a fund of USD 59 million to the Canadian Critical Drug Initiative to boost drug research, commercialization, and manufacturing in the Alberta province.

Multiplex Assays Market Trends

Integration of Artificial Intelligence

Disease diagnosis often requires identifying candidate pathogenic variants and determining the correspondence between the diseased individual’s phenotype and pathogenic variant. The integration of AI algorithms into multiplex assays can significantly enhance phenotype-genotype mapping. In molecular diagnostics, automated systems are also used to accurately spot target genes and design oligonucleotide primers, which are important in developing multiplex assays. By compiling data from assay development, diagnostics companies can artificially find the most efficient genetic target for developing a specific multiplexed assay.

Using AI, companies can speed up the development of diagnostic tests by automating the assay designing phase. AI is also incorporated in multiplex assays for drug discovery and design. AI plays a crucial role in drug repurposing, drug target identification & validation, multi-target drug discovery, and biomarker identification. For instance, Seegene, Inc. (South Korea) developed the first multiplex assay with an AI-based system. AI developed the entire assay in just four days. The assay is used to simultaneously detect eight different DNA targets for sexually transmitted infections and meningitis.

Development of Smartphone-based Diagnostic Testing Platforms

The demand for high-quality medical services is rising continuously. Smartphone-based platforms find applications in tele-imaging, food technology, and education. Smartphone-based detection is versatile and has a wide range of medical applications. Diagnostic multiplex assays play an important role in simultaneously detecting multiple pathogens. With high diagnosis costs and the limited availability of benchtop readers in remote/resourceless areas, the demand for smartphone-based multiplex diagnostics is rising continuously. These smartphone-based end-to-end platforms are complemented with deep learning methods to further increase device efficiency. These smartphone-based detection methods provide automated detection and analysis of the results and support human expertise. The transactions involved in patient data handling are secured via blockchain technology. For instance, Luminostics, Inc. (U.S.) received the FDA’s Emergency Use Authorization (EUA) for its Clip COVID Rapid Antigen Test, a rapid (results generated in 15 minutes), smartphone-connected antigen immunoassay that uses glow-in-the-dark nanomaterials to detect and differentiate SARS-CoV-2 and influenza A/B.

Multiplex Assays Market Opportunities

Increasing Focus on Personalized Medicine

Personalized/precision medicine uses an individual’s genomic information to offer targeted treatment. Multiplex assays can simultaneously detect multiple biomarkers, driving their utilization in precision medicine. Multiplex assay approaches are used to identify changes in gene expression, genetic variations, or epigenetic modifications associated with a particular disease or condition; thus, these assays are useful in developing personalized medicines.

Additionally, cell-based multiplexing is an important aspect of personalized medicine as it creates a cell or tissue-specific spatial context for extending, interpreting, and understanding the information captured from multiple biomarkers, which can be important in guiding treatment decisions in personalized medicine.

According to an article published in the MDPI journal in 2020, multiplex immunoassays provide an overall understanding of the disease and pathways involved in Rheumatoid Arthritis (RA) and simultaneously analyze multiple proteins that can yield biomarker signatures of RA subtypes to enable patients to benefit from personalized medicine.

Multiplex Assays Market Analysis: Key Findings

By Type: In 2024, the Protein Multiplex Assays Segment to Dominate the Multiplex Assays Market

Based on type, the multiplex assays market is segmented into protein multiplex assays, nucleic acid multiplex assays, and cell-based multiplex assays. In 2024, the protein multiplex assays segment is expected to account for the largest share of 53.3% of the multiplex assays market. Protein multiplex assays are segmented into bead-based assays and planar assays. In 2024, the bead-based assays segment is expected to account for the largest share of the protein multiplex assays market. Multiplex bead-based assays have become essential tools for diagnosing various diseases. These assays are used for testing allergies, cancer markers, cytokines, cardiac markers, autoimmune diseases, and endocrine diseases. Their increasing application areas in clinical diagnostics and R&D are driving the market's growth. Also, bead-based assays require a limited sample volume and less time, thus making it a preferable technique for studies or experiments of many factors, such as pituitary hormones and cytokines, thereby contributing to the largest share of the segment.  

By Product: In 2024, the Consumables Segment to Dominate the Multiplex Assays Market

Based on product, the multiplex assays market is segmented into consumables, instruments, and software & services. In 2024, the consumables segment is expected to account for the largest share of the multiplex assays market. Diagnostic kits are designed to provide highly accurate results with minimal risk of user error. They are pre-packaged with all the necessary materials and reagents, ensuring that the correct amounts are used while reducing the risk of contamination. Assay kits are used in various applications, including COVID-19 diagnosis, infectious disease testing, oncology, cardiovascular, and other applications, contributing to the largest share of the segment.

By Technology: In 2024, the Flow Cytometry Segment to Dominate the Multiplex Assays Market

Based on technology, the multiplex assays market is segmented into flow cytometry, multiplex real-time PCR, multiplex immunoassay, sequencing, and other technologies. In 2024, the flow cytometry segment is expected to account for the largest share of 40.0% of the multiplex assays market.  Flow cytometry technology is preferred over other technologies due to its rapid, high-throughput, and sensitive results. Its reproducible detection capabilities make it ideal for various biomedical applications requiring multiplex protein or nucleic acid analyte detection. Additionally, the high penetration of flow cytometry in both research & development and clinical diagnosis contributes to the largest share of the segment.

By Application: In 2024, the Research & Development Segment to Dominate the Multiplex Assays Market

Based on application, the multiplex assays market is segmented into research & development and clinical diagnosis applications. In 2024, the research & development segment is expected to account for the largest share of the multiplex assays market. Multiplex assays are increasingly used in the research & development of personalized medicines and research programs for understanding disease mechanisms. Furthermore, increasing pharmaceutical research & development spending, rising new molecular entity approvals, and the launch of multiplex assay panels for research applications by the key players contribute to the largest share of the segment.

By End User: In 2024, the Pharmaceutical & Biotechnology Companies Segment to Dominate the Multiplex Assays Market

Based on end user, the multiplex assays market is segmented into pharmaceutical & biotechnology companies, diagnostic laboratories, hospitals, and other end users. In 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the market. The rising number of research laboratories, increasing investment in R&D, and rising funding for research laboratories support the largest share of the market.  The funding for research laboratories is increasing due to the increasing demand for new drugs and therapies and advancements in laboratory equipment. For instance, in 2021, the U.S. Federal Government invested USD 179.5 billion in R&D. (Source: U.S. Government Accountability Office). Additionally, pharmaceutical companies are increasingly partnering with CROs for product development. The expansion of CROs to meet the growing demand for new product development also supports the market's largest share.

Geographical Analysis

In 2024, North America to Dominate the Market

In 2024, North America is expected to account for the largest share of 39.2% of the multiplex assays market. The large market share of this region is attributed to the high prevalence of chronic and infectious diseases, awareness regarding early disease diagnosis, high adoption of advanced diagnostic products, and increasing funding activities. According to the U.S. Department of Health & Human Services, in 2022, the National Institute of Health (NIH) allocated USD 45 billion for biomedical research. Moreover, the government partnership with key players for the development of multiplex assay, rising prevalence of cancer, strong academic research, and the presence of key players are contributing to the largest share of the market.

Asia-Pacific is expected to grow at the highest CAGR of 10.8% during the forecast period. The growth of the multiplex assays market in Asia-Pacific is attributed to the rising research funding in the healthcare and pharmaceutical industry, the rising number of research laboratories, the advancing research framework, and the growing number of diagnostic laboratories in countries such as China, India, Japan, South Korea, and others. For instance, in 2022, the R&D spending of BeiGene Ltd. (China), one of the major pharmaceutical companies, increased by 12.4% from 2021. The increasing use of multiplex immunoassay in precision medicine and government initiatives for precision medicine is also driving the market growth.

Multiplex Assays Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over the years . The key players operating in the multiplex assays market are Thermo Fisher Scientific, Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Seegene, Inc. (South Korea), QIAGEN N.V. (Netherlands), PerkinElmer, Inc. (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (U.S.), Abbott Laboratories (U.S.), Siemens Healthineers AG (Germany), Illumina, Inc. (U.S.), Becton, Dickinson and Company (U.S.), Quanterix Corporation (U.S.), DiaSorin S.p.A. (Italy), and Merck KGaA (Germany).

Multiplex Assay Market Overview: Latest Developments from Key Industry Players

• In April 2023, Seegene, Inc. (South Korea) partnered with the International Vaccine Institute (IVI) (South Korea) to utilize Seegene's HPV diagnostic reagent for conducting HPV tests in approximately 50,000 people across eight Asian and African countries for up to five years from August.

• In April 2023, QIAGEN N.V. (Netherlands) launched the QIAstat-Dx syndromic testing solution and SARS-CoV-2 Respiratory Panel in Japan. The SARS-CoV-2 Respiratory Panel detects more than 20 pathogens from a single patient sample.

• In February 2023, F. Hoffmann-La Roche Ltd. (Switzerland) collaborated with Janssen Biotech Inc. (U.S.) to create multiple companion diagnostic technologies, including immunoassays, digital pathology, PCR, next-generation sequencing, and immunohistochemistry.
• In February 2023, Thermo Fisher Scientific, Inc. (U.S.) launched ‘Applied Biosystems TaqPath’ PCR kits for infectious diseases such as genetic analysis (HLA B27), Multi-Drug Resistant Tuberculosis (MTB MDR), Human Immunodeficiency Virus (HIV), M. Tuberculosis complex (MTB), Hepatitis C Virus (HCV), and Hepatitis B Virus (HBV). The kits also have received licensing rights from the Central Drugs Standard Control Organization (CDSCO) and are manufactured in India in association with Mylab Discovery Solutions (India).

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