Multiplex Assay Market Size, Share & Trends Analysis Report By Product (Consumables, Software), By Application (R&D, Clinical Diagnostics), By Type, By Technology, By End-user, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global multiplex assay market size was valued at USD 2.05 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 14.77% from 2023 to 2030. Multiplex assay is a technique in which various analytes (such as growth factors, chemokines, biomolecules, cytokines, and proteins, among others) are profiled by detecting and quantifying them simultaneously. Multiplex assays are broadly used for mutation analysis, linkage analysis, pathogen identification, forensic studies, and gene detection analysis among others. The key factors driving the industry include the growing prevalence of chronic and infectious diseases, significant advantages of multiplex assays over singleplex & traditional assays, increasing applications of multiplex assays in companion diagnostics, and rising awareness about early diagnosis.

The rapidly evolving epidemiology of the COVID-19 pandemic has accelerated the need for novel diagnostic tools, thereby driving the need for multiplex assays. For instance, the CDC Influenza SARS-CoV-2 multiplex assay was majorly deployed to differentiate and detect the RNA from influenza B virus, SARS-CoV-2, and influenza A virus, and in the lower or upper respiratory specimens. Moreover, in July 2020, The USFDA granted Emergency Use Authorization for the same assay. The several growth initiatives undertaken by key players also significantly impacted the industry's growth through these assays.

For instance, in response to the COVID-19 outbreak, Thermo Fisher Scientific developed a multiplex real-time PCR diagnostic kit (TaqPath COVID-19 Multiplex Diagnostic Solution) to facilitate public and clinical health laboratories to rapidly diagnose SARS-CoV-2 infection. The growing prevalence of cancer and infectious diseases is leading to development of new therapeutics. The drug development process and clinical trials are witnessing increased adoption of multiplex assays. These assays can simultaneously determine the presence of infection with multiple pathogens. It also aids to study and analyze the efficacy of a particular disease and in the detection of antibodies against various diseases.

For instance, according to a report published by the WHO, in April 2021, every year, about 41 million people die globally, equivalent to 71% of overall deaths, due to chronic diseases or non-communicable diseases. Thus, the increasing prevalence of diseases is expected to fuel industry growth. Furthermore, significant advantages of multiplex assay over singleplex and traditional assay can boost the industry growth in the coming years. Numerous benefits offered by these automated tests include miniaturization, which reduces sample consumption, high operational efficiency, easy operations, and reduced labor costs. Moreover, various arrays are measured in a single trial, which leads to quicker results in these assays.

For instance, in September 2020 Abacus Diagnostica launched a multiplex assay that provides reliable diagnosis for respiratory infections in 75 minutes. Such advantages can increase the applications of multiplex assay in the healthcare domain and can significantly contribute to industry growth. Moreover, the increasing use of multiplex assay in companion diagnostics can accelerate industry growth. Personalized medicines aim at offering customized therapies to individual patients based on the molecular basis of the disease. Companion diagnostics are marching to be a crucial part of personalized medicine and are expanding rapidly, both in terms of number and application in disease areas.

Based on the current drug approval scenarios, the rapid growth of companion diagnostics can be seen in the near future. For instance, in August 2021, Roche received FDA approval for companion diagnostics to detect dMMR solid tumors for patients suitable for anti-PD-1 immunotherapy. Thus, the growth of companion diagnostics can significantly aid in the development of the global market. Early diagnosis of various chronic diseases, such as cancer, can increase the quality of a patient’s life with more than three times higher survival rate when diagnosed at early stages. In addition, early diagnosis can increase the number of treatment options and reduce the costs required for prolonged diseases.

For instance, according to an article published in Avalere in July 2021, patients with non-small cell lung cancer, stomach, and pancreatic cancers, between 36% and 53% of patients are diagnosed with stage four cancer, by the time cancer spreads to other parts of the body and decreases the survival chances. If detected at the early stages 5-year survival rate for non-small-cell lung cancer, stomach, and pancreatic cancer survival rate can be doubled. These differences are creating awareness for early diagnosis of various diseases and can considerably drive market growth during the forecast period. Increasing validation of biomarkers in molecular & protein diagnostics and the rising need for high-throughput assay & automated systems will also create growth opportunities for the market.

Multiple biomarker analysis has a wide range of applications in the area of neurodegenerative diseases, autoimmune diseases, and cancer. Numerous biomarkers are being discovered and validated, and there is a high possibility of the development of novel diagnostics. Multiplex assay can be used in the quantitative measurement of proteins in the discovery of biomarkers. These assays allow the measurement of numerous potential protein biomarkers in a statistically significant number of samples and controls. Therefore, multiplex assay in biomarker validation improves the efficiency and speed of delivering accurate results and can fuel market growth in the near future.

Product Insights

Based on products, the global industry has been further categorized into consumables, instruments, and software. The consumables segment captured 74.38% of the market share in 2022, and is also predicted to be the fastest growing segment during the forecast period. The segment is estimated to expand further at the fastest CAGR retaining its dominant market position throughout the forecast period. The high share and rapid growth of this segment can be attributed to the recurring purchases of consumables along with a rise in the number of diagnostic tests.

The software segment is also projected to register considerable CAGR during the forecast period. Certain factors such as superior efficiency of software and increasing number of product launches are estimated to leverage the segment growth during the forecast period. For instance, in August 2022, Bio-Techne Corporation announced launch of Quantist Luminex data analysis software which can help the researchers to extract meaningful insights from complex data.

In addition, several key players are offering a wide range of consumables with several advantages, such as cost-effectiveness, customization of analytes, and faster delivery time with robust and reliable data. For instance, Bio-Techne Corp., a life science regent manufacturer, offers the most customizable Luminex analyte menu to choose from over 450 analytes along with flexible formats. Such advantages are expected to increase the specificity, precision, and stability to ensure consistent and accurate results, and are expected to broaden the applications of consumables in the market.

Type Insights

The protein multiplex assay segment dominated the global industry in 2022 and accounted for the highest share of more than 52.71% of the overall revenue. This is owing to the increasing focus on proteomics studies for biomarker research and clinical diagnostics. The quest for suitable biomarkers has significantly increased in clinical practice and quantitative measurement of protein is a crucial step in biomarker discovery. Analyzing a huge number of potential protein biomarkers in a statistical number of samples and controls constitutes a major technical obstacle.

Protein multiplex assays offer several advantages regarding the amount of data that can be generated, sample requirement, reagent cost, time, and the amount of data that can be generated. For instance, according to an article published in eCinical Medicine in July 2022, a multiplex protein panel assay was utilized for determining disease severity and prognosis in COVID-19 patients. Thus, increasing applications of protein multiplex assay in proteomics study is anticipated to boost segment growth. The nucleic acid assay is projected to be the fastest-growing segment over the forecast years.

Nucleic acid assay aids in the molecular tests to diagnose human diseases, such as human genetic marker indicative of disease (autoimmune disease and cancer), genetic markers for predisposition to disease, and tests to identify disease-causing pathogens. For instance, according to an article published by the American Chemical Society in September 2021, a nucleic acid assay based on lanthanide nanoparticles was used in the diagnosis of SARS-CoV-2to achieve fast screening with high accuracy. Hence, the increasing prevalence of chronic and infectious diseases is expected to widen the nucleic acid multiplex assay application in disease diagnosis and drive segment growth during the forecast period.

Technology Insights

The flow cytometry technology segment dominated the global industry in 2022 and accounted for the maximum share of more than 34.84% of the overall revenue. Flow cytometry has become an indispensable tool for basic research and clinical diagnostics.  It provides information-rich multiparametric analysis for thousands of single cells per second. In addition, technological advancements and the launch of novel flow cytometers by various companies are contributing to the industry's growth. For instance, in June 2021, Thermo Fisher Scientific Inc. launched an innovative flow cytometer with imaging ability that enables users to collect data and better understand the quality and morphology of the cells in these assays.

The multiplex real-time PCR segment is expected to witness the fastest growth rate during the forecast years. Multiplex real-time PCR is a modified version of conventional PCR, it amplifies several target sequences using various sets of primers in a single PCR mixture. It controls internal amplification to enhance the accuracy of the negative PCR results. In addition, this technology enables the detection of various pathogens in a single reaction, even if they are from taxonomically different groups. These advantages are anticipated to increase its application in clinical diagnostics and can boost industry growth during the forecast period.

End-user Insights

The pharmaceutical and biotechnology companies segment dominated the global industry in 2022 and accounted for the highest share of more than 40.90% of the overall revenue. This is due to the rising pharma & biotech partnerships and collaborations to increase multiplexing capabilities. For instance, in August 2022, Becton, Dickinson and Company, and Labcorp collaborated to develop flow cytometry-based companion diagnostics for providing patients with efficient treatment options. Flow cytometry technology supports multiplexing and offers high-sensitivity capabilities in the CDx landscape. Thus, partnerships are enhancing the growth prospects of multiplex assays and can boost industry growth.

The hospitals and diagnostic laboratories segment is likely to register the fastest CAGR during the forecast period owing to the growing demand for rapid and accurate diagnosis for numerous chronic diseases. Multiplex assay offers quick results for multiple biomolecule targets in a single run and makes it a superior choice for disease identification in patients. For instance, according to the CDC, 9.3 to 45 million are infected by influenza annually, with 140,000 – 810,000 hospitalizations, and 12,000 – 61,000 deaths. For patients with multiple symptoms associated with respiratory viral infections, multiplex assay not only detects the influenza virus but also identifies other pathogens at once to provide a more comprehensive clinical diagnosis.

Application Insights

The research and development application segment dominated the global industry in 2022 and accounted for the maximum share of more than 52.46% of the overall revenue. 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.

Such applications of multiplex assay in R&D are expected to fuel segment growth. The clinical diagnostics segment is estimated to witness the fastest growth rate from 2022 to 2030 owing to the increasing prevalence of chronic diseases, such as infectious diseases, cancer, autoimmune diseases, and Cardiovascular Diseases (CVDs) For instance, according to the CDC, 3.4 million patients require a diagnosis for infectious and parasitic diseases in the emergency department. According to a 2022 report by the CDC, in the U.S., one person dies every 34 seconds due to CVD. Multiplex assay helps in the identification of various biomarkers for CVD in a single sample and provides accurate, reproducible, simultaneous measurement of 39 CVD biomarkers in tissue culture samples plasma and serum.

Regional Insights

North America dominated the global industry in 2022 and accounted for the highest share of more than 36.88% of the overall revenue due to the growing R&D activities for the development of novel drugs and diagnosis & treatment options. The increasing incidence of chronic conditions, such as stroke & cancer, and the rising government funding for the detection of new biomarkers are anticipated to drive the region’s growth. In addition, the presence of key players in the region is likely to fuel the growth. Asia Pacific, on the other hand, is anticipated to register the fastest growth rate during the forecast years.

This is due to the rising number of hospitals in emerging countries, the developing R&D sector, the high demand for healthcare infrastructure, and investments by emerging players in the region. For instance, in November 2021, QuantuMDx received an investment of USD 10.9 million from Vita Spring and entered into a corporation agreement with Sansure Biotech to develop multiplexing capabilities in China. The rising prevalence of cancer is due to tobacco consumption. For instance, currently, half the world’s tobacco grown is consumed by people in the Asia Pacific region. As a result, there is a gradual rise in the number of people undergoing screenings in the region, which is anticipated to boost market growth in the near future.

Key Companies & Market Share Insights

Key companies are implementing numerous strategies, such as collaborations, the launch of novel technologies & products, and partnerships, to enhance their industry presence. For instance, in June 2021, Bio-Rad announced its partnership with Seegene to provide molecular diagnostic testing products in the U.S. market. In addition, in November 2020, Qiagen launched the NeuMoDx multiplex assay to provide a complete range of testing solutions for SARS-CoV-2 in Europe and other markets. Some of the key players in the global multiplex assay market include:

• Luminex Corp.

• Bio-Rad Laboratories, Inc.

• Abcam plc.

• Seegene Inc.

• Merck KGaA

• Assay Genie

• Promega Connections

• QIAGEN N.V.

• Thermo Fisher Scientific

• Perkin Elmer Inc.

• Advanced Cell Diagnostics, Inc.

• R&D Systems, Inc.

Recent Development

• In August 2022, Bio-Rad Laboratories, Inc.expanded the range of StarBright Violet and UltraViolet dyes for multiplexed flow cytometry. This provides researchers with highly stable, specific to key immunophenotyping targets, supporting multiplex flow cytometry panels in immunology research.

• In April 2021, xMAP launched the next-generation xMAP platform. The xMAP INTELLIFLEX system is equipped with a third laser (violet) and can measure two parameters per analyte for up to 500 analytes per well.

Multiplex Assay Market Report Scope

Global Multiplex Assay Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global multiplex assay market report based on product, type, technology, application, end-user, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Consumables

  • Instruments

  • Software

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Protein Multiplex Assays

    • Planar Protein Assays

    • Bead-based Protein Assays

  • Nucleic Acid Multiplex Assays

    • Planar Protein Assays

    • Bead-based Protein Assays

  • Cell-based Multiplex Assays

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Flow Cytometry

  • Fluorescence Detection

  • Luminescence

  • Multiplex Real-time PCR

  • Other Technologies

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Research & Development

    • Drug Discovery & Development

    • Biomarker Discovery & Validation

  • Clinical Diagnostics

    • Infectious Diseases

    • Cancer

    • Cardiovascular Diseases

    • Autoimmune Diseases

    • Nervous System Disorders

    • Metabolism & Endocrinology Disorders

    • Other Diseases

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical & Biotechnology Companies

  • Hospitals & Diagnostic laboratories

  • Research & Academic Institutes

  • Other End-users

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait