Global Multiplex Assay Market Size, Share & Industry Trends Analysis Report By Product, By Type, By End user, By Application (Research & Development, Clinical Diagnostics & Others), By Regional Outlook and Forecast, 2021 - 2027

Analysis of Market Size & Trends

The Global Multiplex Assay Market size is expected to reach $4 billion by 2027, rising at a market growth of 9.8% CAGR during the forecast period.

A multiplex assay is a process that detects and quantifies many analytes such as biomolecules, proteins, cytokines, growth factors, and chemokines at the same time. In comparison to traditional approaches like ELISA, this assay is used to amplify many objectives in a polymerase chain reaction (PCR) and capture more details from minute amounts of proteins or other analytes in less time. Pathogen identification, RNA detection, gene detection analysis, linkage analysis, mutation analysis, and forensic studies all use multiplex assays.

Running numerous tests means there may be little differences within every run, which could affect the results. Running a single experiment prevents this fluctuation from having a large impact, thus any differences in the protein found to be more likely to indicate genuine relative abundance within the sample. One such disease is sepsis, which is defined by a shift in the levels of pro-inflammatory cytokines.

Certain chemicals, some of which have been explored as possible medicinal medications, can also alter cytokine levels. As a result, having a system that can assess the levels of many cytokines at the same time is advantageous. Each bead had captured antibodies for the above cytokines and was differentiated by the ratio of dye added in a bead-based approach.

In addition, high-throughput multiplex detection techniques are used to evaluate a large number of analytes such as nucleic acid assays, immunoassays, enzyme assays, or receptor ligands, in a single biological sample in a fast, sensitive, and specific manner. These methods allow the analysis of a huge number of samples in one go.

COVID-19 Impact Analysis

The COVID-19 pandemic has wreaked havoc on healthcare workflows all around the world. Numerous industries, including plenty of sub-domains of health care, have been compelled to temporarily shut down their production facilities because of the disease. Since multiplex assays are used to diagnose coronaviruses, there has been a substantial demand for multiplex SARS-CoV-2 assays, such as multiplex point-of-care assays, which have helped the multiplex assay market grow during the pandemic. The link of COVID-19 with multiple hazardous disorders increased the utilization of multiplex assays across the market.

In addition, to address the growing demand of the high volume of testing, several businesses got FDA emergency use authorization for their COVID-19 multiplex assays. However, the companies had to deal with several operational issues that hindered their commercial operations throughout the lockdown.

Market Growth Factors:

Increasing popularity of companion diagnostics

Companion diagnostics method is rapidly emerging and being utilized in therapeutics. A companion diagnostic is a diagnostic test that is used in conjunction with a therapeutic drug to determine whether the specific personalized medicine is appropriate for a particular person. Companion diagnostics assays can be conducted on a tissue biopsy or a blood sample utilizing various genomic or protein-based technologies such as next Generation Sequencing, qPCR, and Immunohistochemistry. In the case of cancer, a companion diagnostic test can determine whether a patient's tumor has a specific genetic aberration, such as a mutation, or changed protein expression, that predicts better therapeutic medication efficacy.

Increasing adoption of multiple assays

There is an increased usage of multiplex assays in companion diagnostics, as well as their advantages over singleplex & classical assays is the result of the growing prevalence of chronic diseases. The advantage of multiplex assays over singleplex tests, which includes lower reaction tie, chemicals, and analyte concentration, allows for faster assay results and the handling of unusual samples (low concentration sample). The high frequency of infectious and chronic diseases creates greater market potential through increasing demand for multiplex assays.

Marketing Restraining Factor:

Rising equipment costs and stringent regulations and standards

Multiplex assays comprise the potential to bring a new evolution across the healthcare industry and can play a major role in the developments and enhancements in medications that are being utilized in the treatment of numerous diseases and disorders such as cancer and neurological diseases. However, the equipment that is employed in the utilization of multiplex assays is very costly. Due to the higher cost of the equipment, the researchers or healthcare institutes that comprise lesser financial power would find it difficult to purchase and employ these products.

Product Outlook

Based on the Product, the Multiplex Assay Market is segregated into Reagents & Consumables, Instruments & Accessories, and Software & Services. In 2020, the Instruments & Accessories segment procured the maximum revenue share of the multiplex assays market. The industry standard multiplexing instruments and accessories are capable of performing multiple distinct tests in a single reaction volume. For instance, the flow cytometry-based equipment is capable of producing quick and cost-effective findings. These factors are majorly driving the growth of this segment.

Type Outlook

Based on the Type, the Multiplex Assay Market is segmented into Protein Based Multiplex Assays, Nucleic Acid-Based Multiplex Assay, and Other multiplex Assays. In 2020, the Nucleic Acid-Based Multiplex Assay segment acquired a substantial revenue share of the multiplex assays market. It is owing to the significant features of the nucleic acid-based multiplex assays. Nucleic acid-based approaches are generally precise, and they may be used for a wide range of microorganisms. Because each test is often exclusive to an individual organism, the physician must be aware of the diagnostic options and make appropriate test requests.

End User Outlook

Based on the End-user, the Multiplex Assay Market is categorized into Hospitals, Clinical Laboratories, Research Institutes, and Pharmaceutical & Biotechnology Companies. In 2020, the research institutes garnered a significant revenue share in the multiplex assays market. Multiplex assay methods are widely utilized in research and development operations. The rising utilization of the multiplex assays across research institutes is owing to the fact that multiplex assays provide convenience and faster results when running experiments.

Application Outlook

Based on the Application, the Multiplex Assay Market is divided into Clinical Diagnostics, Research & Development, and Companion Diagnostics. In 2020, the companion diagnostics segment procured the second-largest revenue share of the multiplex assays market. The growth of this segment is attributed to the fact that the test facilitates a practitioner to determine if the benefits of a drug combination can cause any potentially critical side effects to patients or not. Moreover, companion diagnostics tests allow healthcare practitioners to determine the efficiency of the personalized combination.

Multiplex Assay Market Report Coverage

Report Attribute	Details
Market size value in 2020	USD 2 Billion
Market size forecast in 2027	USD 4 Billion
Base Year	2020
Historical Period	2017 to 2019
Forecast Period	2021 to 2027
Revenue Growth Rate	CAGR of 9.8% from 2021 to 2027
Number of Pages	269
Number of Tables	454
Report coverage	Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Competitive Landscape, Companies Strategic Developments, Company Profiling
Segments covered	Product, Type, Application, End User, Region
Country scope	US, Canada, Mexico, Germany, UK, France, Russia, Spain, Italy, China, Japan, India, South Korea, Singapore, Malaysia, Brazil, Argentina, UAE, Saudi Arabia, South Africa, Nigeria
Growth Drivers	Increasing popularity of companion diagnostics Increasing adoption of multiple assays
Restraints	Rising equipment costs and stringent regulations and standards

Regional Outlook

Based on the Region, the Multiplex Assay Market is analyzed across North America, Europe, APAC, and LAMEA. In 2020, North America emerged as the leading region in the multiplex assays market with the largest revenue share. The increased growth of the segment is attributed to the rise in the number of research institutes. Due to the increasing interest of North American researchers toward discovering more potentials of these immunoassays for making treatment of various diseases and disorders more efficient.

Free Valuable Insights: Global Multiplex Assay Market size to reach USD 4 Billion by 2027

KBV Cardinal Matrix - Multiplex Assay Market Competition Analysis

The major strategies followed by the market participants are Product Launches. Based on the Analysis presented in the Cardinal matrix; Thermo Fisher Scientific, Inc. and Bio-Rad Laboratories, Inc. are the forerunners in the Multiplex Assay Market. Companies such as Becton, Dickinson and Company, Seegene, Inc. and DiaSorin S.p.A. (Luminex Corporation) are some of the key innovators in the Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Becton, Dickinson and Company, Seegene, Inc., Randox Laboratories Limited, Illumina, Inc., Qiagen N.V., DiaSorin S.p.A. (Luminex Corporation), Abcam plc, and Meso Scale Diagnostics LLC.

Recent Strategy Deployed in Multiplex Assay Market

» Partnerships, Collaborations and Agreements:

• Oct-2021: Becton, Dickinson, and Company partnered with the Biomedical Advanced Research and Development Authority, a member of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response. This partnership aimed to encourage the development of a range of COVID-19 combination diagnostic tests for core laboratories, at the point of care, and hospitals.
• Jun-2021: Bio-Rad Laboratories entered into a partnership with Seegene, a leading vendor in multiplex molecular diagnostics. Through this partnership, the companies would emphasize bringing developments across clinics as well as commercializing infectious disease molecular diagnostic products. Under this partnership, Seegene assays provide multiplex concurrent PCR detection and differentiation with enhanced sensitivity and specificity of up to seven targets in one reaction. Moreover, the assays provide outcomes in an estimate of four hours.
• May-2021: Qiagen joined hands with Mirati Therapeutics, a clinical-stage biotechnology company. The collaboration aimed to continue the development of KRAS companion diagnostic based on tissue in order to detect cancer with KRASG12C mutation in patients to provide a more efficient diagnosis with adagrasib.
• Apr-2021: DiaSorin partnered with QIAGEN, a German provider of sample and assay technologies for molecular diagnostics. Following this partnership, the companies launched LIAISON LymeDetect assay for commercial usage under the CE mark. In addition, the new assay would facilitate the detection of early Lyme Borreliosis infection on LIAISON analyzer systems.
• Aug-2020: Thermo Fisher's transplant diagnostic business came into collaboration with histocompatibility, infectious disease, and nephrology laboratories at Emory University, Stanford University, University of Cincinnati, and the University Health Network in Toronto. With this collaboration, the companies aimed to unveil the LABScreen COVID Plus Assay. The assay utilizes the Luminex xMAP technology in order to identify various different antibodies and fragments intending to make it more specific and reduce the opportunities of incorrect results.
• Dec-2019: Illumina came into a partnership with ArcherDX, a growth-stage molecular diagnostics company. The companies aimed to develop in-vitro diagnostic tests for Archer's offerings of companion diagnostics-based next-generation sequencing. In addition, ArcherDX's IVD tests would run on NextSeq 550Dx System of Illumina. Moreover, ArcherDX would get mandatory regulator approvals for every IVD kit and their subsequent commercialization.
• May-2017: Thermo Fisher Scientific partnered with Seegene, a leading vendor in multiplex molecular diagnostics technologies and assays. Under this partnership, the companies would focus on obtaining the approval of the US FDA for the AllplexTM range of Seegene while Thermo Fisher would work on gaining the approval for running AllplexTM on its QuantStudio, 5 Real-Time PCR System. In addition, the integration of these products would unlock a new standard of innovation across the industry in order to enable a comprehensive MDx solution.

» Product Launches and Product Expansions:

• Dec-2021: Becton, Dickinson, and Company introduced some enhancements in BD COR System with the addition of a new MX instrument. This product would offer high-throughput molecular testing of contagious diseases. Additionally, the new enhancement is CE marked to the IVD directive 98/79/EC. Moreover, the new instrument completed BD COR System, which comprises a PX instrument with the ability to deliver diagnostic samples by automating relevant pre-analytical processing steps, and a GX instrument which utilizes the BD Onclarity HPV Assay along with tended genotyping to screen for HPV infections.
• Apr-2020: Bio-Rad Laboratories launched a blood-based immunoassay kit. The new product would facilitate the identification of antibodies to the coronavirus SARS-CoV-2 virus that causes COVID-19. In addition, leveraging serology tests in order to enhance the diagnosis of the COVID-19 along with screening populations can offer a well-detailed understanding of infection rates and immunity.

» Approvals and Trials:

• Nov-2021: DiaSorin along with QIAGEN received the approval for the LIAISON QuantiFERON, TB Gold Plus assay, from the US, FDA. The new product would be used on LIAISON XS, an automated platform of DiaSorin. In addition, the approval expands the accessibility of the customers across the US to automation solutions in order to process QIAGEN’s best-in-class blood-based test for latent tuberculosis detection and facilitate the transformation from the conventional tuberculin skin tests.
• Sep-2021: DiaSorin received approval for its Simplexa, a COVID-19 & Flu A/B Direct kit. This kit would enable the user an in vitro qualitative detection and differentiation of nucleic acids from critical acute respiratory syndrome coronavirus 2 along with influenza A virus as well as influenza B virus from the same sample of the patient. Moreover, this assay would be utilized on LIAISON MDX and can be directly conducted through nasopharyngeal swabs, eliminating the requirement for off-board extraction.
• Jul-2021: Seegene received a CE-IVD mark for its Allplex SARS-CoV-2 Variants II Assay. This product range would detect major genetic mutations of SARS-CoV-2 variants including W152C, K417N, L452R, and K417T. Moreover, the variants diagnostic kit comprises the ability to detect a total of six COVID-19 variants that are apparently originated from India through a single sample viz. Delta Plus, Kappa, Gamma, Delta, Epsilon, and Beta
• Feb-2020: Seegene received Korea Ministry of Food and Drug Safety approval for its Allplex 2019-nCoV Assay, a Real-time PCR assay for Emergency Use. Following this approval, the company would provide assays in Korea as well as all over the world.
• Jun-2017: Bio-Rad Laboratories received the US FDA approval for its BioPlex 2200 Syphilis Total and RPR assay. The new product aimed to treat syphilis infection and comprise a fully automated Treponemal/non-Treponemal dual assay that identifies Treponema pallidum (T. Pallidum) and reagin antibodies at the same time to allow more efficient diagnosis and monitoring.

» Geographical Expansions:

• Jan-2021: Seegene expanded its geographical footprint in Latin America. Through this expansion, the company would enter the region with an increased focus on its multiplex assay product.

Scope of the Study

Market Segments Covered in the Report:

By Product

• Reagents & Consumables
• Instruments & Accessories
• Software & Services

By Type

• Protein Based Multiplex Assays
• Nucleic Acid-Based Multiplex Assay
• Others

By End User

• Pharmaceutical & Biotechnology Companies
• Research Institutes
• Clinical Laboratories
• Hospitals

By Application

• Research & Development
• Clinical Diagnostics
• Companion Diagnostics

By Geography

• North America
  • US
  • Canada
  • Mexico
  • Rest of North America
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
• LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA

Key Market Players

List of Companies Profiled in the Report:

• Thermo Fisher Scientific, Inc.
• Bio-Rad Laboratories, Inc.
• Becton, Dickinson and Company
• Seegene, Inc.
• Randox Laboratories Limited
• Illumina, Inc.
• Qiagen N.V.
• DiaSorin S.p.A. (Luminex Corporation)
• Abcam plc
• Meso Scale Diagnostics LLC