Towards Healthcare
Multiplex Detection Immunoassays Market Size, Shares & 9.75% Growth

Multiplex Detection Immunoassays Market to Lead USD 7.81 Billion by 2034

The Multiplex Detection Immunoassays Market to soar from $3.09 billion in 2025 to $5.05 billion in 2030. North America's to continue dominance and rapid expansion in Asia-Pacific. The software segment will see the fastest growth, while the nucleic acid assay segment and multiplex real-time PCR technology will also gain traction. Additionally, clinical diagnostics and hospitals & diagnostics laboratories are expected to contribute notably to this growth.

The global multiplex detection immunoassay market size was estimated at US$ 2.58 billion in 2023 and is projected to grow to US$ 7.81 billion by 2034, rising at a compound annual growth rate (CAGR) of 9.75% from 2024 to 2034. The increasing research in genomics, proteomics, biopharmaceuticals, and clinical diagnostics drives the market.

Multiplex Detection Immunoassays Market Revenue 2023 - 2034

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Major Key Insights of the Multiplex Detection Immunoassays Market

  • North America dominated the market in 2023.
  • Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period.
  • By product, the consumables segment held a dominant presence in the market in 2023.
  • By product, the software segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034.
  • By type, the protein multiplex assay segment accounted for a considerable share of the market in 2023.
  • By type, the nucleic acid assay segment is projected to expand rapidly in the market in the coming years.
  • By technology, the flow cytometry segment led the global market in 2023.
  • By technology, the multiplex real-time PCR segment will gain a significant share of the market over the studied period of 2024 to 2034.
  • By application, in 2023, the research & development segment dominated the market globally.
  • By application, the clinical diagnostics segment is predicted to witness significant growth in the market over the forecast period.
  • By end-user, the pharmaceutical & biotechnology companies segment registered its dominance over the global market in 2023.
  • By end-user, the hospitals & diagnostics laboratories segment is anticipated to grow with the highest CAGR in the market during the studied years.

Multiplex Detection Immunoassays Market: Detecting Growth

Multiplex detection immunoassays are a type of complex immunoassay technique that involves simultaneously detecting multiple biomarkers from the sample. Conventional immunoassay techniques like Western blot and ELISA can detect only a single analyte from the sample solution. Multiplex immunoassays overcome the disadvantages of traditional immunoassays by providing faster and more efficient results. They use multiple primary antibodies to recognize different targets simultaneously. These analytes can be detected using fluorescent, chemiluminescent, or mass cytometry techniques.

These immunoassays offer minimal assay time, cost, and sample volume for the detection of various analytes. They are generally of two types: a) planar microarray (protein chips); and b) suspension array (microparticle or bead microarrays). They are widely used in cell and gene therapy and for the detection of biomarkers involved in several autoimmune disorders and cancer.

What is the Role of AI in Clinical Diagnostics?

AI-based techniques can enable the analysis and detection of biomarkers to support physicians and patients in the early diagnosis and communication of disease risk. Advanced technologies like machine learning and deep neural network facilitates multiplex detection of single particles and molecular biomarkers. The biomarkers can be assessed through automated wearable devices and remote speech recording systems for high-risk individuals. AI can also enable faster detection and monitoring of the results obtained. The optical microscopy imaging can be well integrated with the microfluidic platform, allowing for encoding-decoding through computer vision-based artificial intelligence. Additionally, AI can be incorporated to automate the manufacturing of multiplex immunoassay systems or diagnostic devices providing reproducible results.

  • In June 2024, Quanterix developed a Simoa planar immunoassay technology, SP-X, an innovative digital biomarker solution for accurate multiplex identification for acute and baseline levels in serum and plasma. It is a proprietary, precise digital nanofluidic antibody deposition technology offering numerous advantages of multiplexing for researchers.

Top Companies in the Multiplex Detection Immunoassays Market

  • AstraZeneca
  • BD Biosciences
  • Bio-Rad Laboratories
  • Danaher LifeSciences
  • Luminex Corporation
  • Merck Millipore
  • Meridian Bioscience
  • Meso Scale Diagnostics
  • Microsynth AG
  • Roche Diagnostics
  • Sartorius
  • Sigma-Aldrich
  • Thermo-Fisher Scientific
  • Qiagen

Innovation by Thermo-Fisher Scientific in the Multiplex Detection Immunoassays Market

Company Name Thermo-Fisher Scientific
Headquarters Waltham, Massachusetts, United States
Recent Development In October 2023, Thermo-Fisher Scientific acquired Olink Holding, a platform of proteomics-focused products and services, for $3.1 billion. The acquisition was made to expand Thermo Fisher's presence in proteomics.

Innovation by Qiagen in the Multiplex Detection Immunoassays Market

Company Name Qiagen
Headquarters Hilden, Germany
Recent Development In June 2024, Qiagen announced the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its dPCR platform QIAcuity. The recent development enables customers from a wide range of assay customization options, from simple to complex multiplex assays, while further improving the user experience.

Increasing Incidence of Infectious Diseases Drive the Market

Infectious diseases are one of the leading causes of morbidity and mortality in humans accounting for more than 52 million (33%) annual deaths globally. Various pathogens like bacteria, viruses, fungi, etc. are responsible for the cause of infectious diseases in humans. These infectious diseases need to be diagnosed by sensitive and accurate screening methods for identifying sources of infection and controlling infectivity. Multiplex immunoassay facilitates understanding the etiology of the disease, recognizing different stages of the disease, forecasting patient prognosis, and tracking the severity of the disease, and the effectiveness of the treatment.

The emergence of multiplex immunoassay methods enables the reduction of the possibility of misdiagnosis and incomplete diagnosis with similar symptoms. Furthermore, with multiplex detection, the sensitivity and specificity of every test can be guaranteed due to the relatively independent reaction space available on the platforms. The COVID-19 pandemic has increased the demand for point-of-care diagnostics globally allowing for rapid and accurate tests for infectious diseases.

Infectious Diseases Incidence (2022) Deaths (2022)
Tuberculosis 10.6 Million 1.3 Million
HIV/AIDs 1.3 Million 630,000
Diarrheal Disease 1.7 Billion 494,683
Malaria 249 Million 608,000
Measles 9 Million 136,000
Syphilis 8 Million 390,000

Restraint

High Initial Investments

The multiplex immunoassay technique requires high initial investment for setting up the equipment. Also, the multiplex immunoassay kits available are expensive which limits the affordability of many researchers and research institutions, especially in the developing countries. Another challenge is the lack of trained personnel which may lead to inaccurate results. The complexity of the technique necessitates professionals to advance their skills. Furthermore, the analysis of multiple antibodies from the same sample increases the chances of cross-reactivity. The cross-reactivity leads to the binding of one antibody to another antigen, thereby increasing contamination and loss of specificity.

Cell and Gene Therapy as an Opportunity for the Market

Cell and gene therapy is a rapidly evolving field of pharmaceutical & biotechnology research. Cell therapy like stem cells and CAR-T cells and gene therapy like CRISPR/Cas9 are used for the development of novel treatment for several autoimmune and genetic disorders. Multiplex immunoassay technique is used in viral vector genome titer measurement, vector copy number determination, gene therapy development and manufacturing, and CAR-T cell therapy development and manufacturing. Additionally, multiplex immunoassays are a convenient and comprehensive techniques to measure cytokines to indirectly test for potency of CAR-T cells. Till date, the USFDA has approved 38 cellular and gene therapy products for treatment of various diseases.

  • In June 2024, InDevR, Inc, and Sino Biological, Inc. collaborated to speed development of multiplexed assays for a broad range of vaccine, mRNA therapies and cell and gene therapy applications. The collaboration was made to accelerate the development and deployment of multiparametric analytical tools.

The Consumables Segment Dominated the Market in 2023

By product, the consumables segment held a dominant presence in the multiplex detection immunoassays market in 2023. The researchers commonly use multiplex immunoassay kits depending on their research requirements. Novel therapeutic targets and specific disease indicators are frequently identified by analyzing the amounts and interactions of essential signaling proteins. Hence, the immunoassay kits are also utilized by laboratory technicians or patients for rapid diagnosis of a disease. The immunoassay kits contain several analytes, reagents, buffers, beads, etc. for analyzing various markers in plasma, serum, tissues, cultured cells, or other biological samples.

  • In April 2022, biomedical technology researchers from the University of Reading developed a new rapid multiplex immunoassay kit, Cygnus, to detect Dengue fever. The new kit was based on “lab-on-a-strip” technology which performs 10 or more tests using a very small amount of liquid sample.

By product, the software segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. The software helps in operating instruments and analyzing complex sample data. It provides system control, validation, calibration, data acquisition, and data analysis for multiplex assays. The software can also enable washing of the microplate according to the wash routines and maximize wash efficiency. A user-friendly tool enables data evaluation to enhance experimental integrity and reproducibility.

The Protein Multiplex Assays to Remain Prominent Choice

By type, the protein multiplex assay segment accounted for a considerable share of the multiplex detection immunoassays market in 2023. The protein multiplex assay involves detecting and quantifying the presence and amount of proteins in a given sample. It can be used for analyzing several protein targets involved in a disease. The rising demand for proteomics research and clinical diagnostics boosts the market.

By type, the nucleic acid assay segment is projected to expand rapidly in the market in the coming years. Nucleic acid multiplex assay involves the simultaneous detection of more than one nucleic acid target from a biological sample. Nucleic acid tests are important in various applications like pathogen detection, genetic analysis, and environmental monitoring.

  • In January 2024, researchers from Shenzhen University developed StratoLAMP, a label-free, multiplex digital loop-mediated isothermal amplification based on visual stratification of the precipitate byproduct. The study demonstrated the capability of StratoLAMP in simultaneously quantifying two nucleic acid targets within the samples without the need for fluorescence for the detection.

The Flow Cytometry Segment Led the Market in 2023

By technology, the flow cytometry segment led the global market in 2023. Flow cytometry is a technique to analyze the characteristics of cells or particles in a sample. The sample cells are initially treated with florescent antibody dye to label the proteins inside the cells and subsequently inserted into a flow cytometer. The computer then analyzes approximately 10,000 cells within a minute. In the case of the multiplex immunoassay technique, a flow cytometer is used to determine multiple sizes of beads with multiple levels of fluorescence intensity. Each bead population is conjugated with a specific antibody to trap the protein of interest in the sample. Hence flow cytometry detects the amount and nature of proteins in the sample.

  • In May 2022, Sartorius, a leading international pharmaceutical & laboratory equipment supplier, developed iQue SARS-CoV-2 (IgG, IgM and IgA) kit, a bead-based immunoassay kit for the simultaneous detection of human antibodies specific to SARS-CoV-2 spike protein RBD produced by the immune system as the body’s response to vaccination or viral infection. iQue is a high-throughput screening (HTS) by cytometry platform designed to focus on speed from installation to acquisition and analysis.

By technology, the multiplex real-time PCR segment will gain a significant share of the market over the studied period of 2024 to 2034. The multiplex real-time PCR (qPCR) allows to amplify and detect more than two genes in a single reaction, using the same reagent mix. Since it can amplify multiple DNA or RNA targets simultaneously, it can be used to diagnose several genetic disorders. According to the WHO, approximately 10 in every 1000 people are affected, i.e., around 70-80 million people globally are living with genetic disorders. Hence, multiplex real-time PCR has a huge demand in clinical diagnostics.

  • In July 2024, the Post Graduate Institute of Child Health, Noida, introduced a new testing method called Molecular Real-Time Multiplex PCR for patients with tropical fevers. The technique allows the detection of multiple pathogens in a single sample. The test can identify infections caused due to Dengue, Chikungunya, West Nile, Zika virus, Malaria, Salmonella, etc.

The Research & Development Segment Dominated

By application, in 2023, the research & development segment dominated the market globally. The growing research and development in protein target identification and drug development globally augments the market. The rising incidences of cancer, cardiovascular disorders, infectious diseases, and autoimmune disorders led to an increase in biopharmaceutical research. Additionally, the growing demand for cell and gene therapy for treating chronic disorders increases the demand for multiplex immunoassay. It is estimated that around 14% to 50% of top pharmaceuticals revenue was invested in R&D in 2023. Merck and Roche made the highest R&D investments of $30.5 billion and $15.56 billion in 2023, followed by Johnson & Johnson, Novartis and AstraZeneca. All these collectively augment the multiplex immunoassay detection market.

By application, the clinical diagnostics segment is predicted to witness significant growth in the market over the forecast period. The increasing cases of chronic disorders globally necessitate the use of immunoassay techniques for their early detection. Multiplex detection immunoassay technique is a simple, sensitive, and fast technique that can detect minute quantities of autoantibody and antigen from a small amount of blood or other body fluids. Additionally, the rising need for novel biomarkers or drug targets, and their diagnostic, prognostic, and therapeutic applications require multiplex immunoassay techniques.

  • In April 2024, Bio-Rad Laboratories launched its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The kit can simultaneously detect, discriminate, and quantitate seven known ESR1 mutations in a single well.

The Pharmaceutical & Biotechnology Companies Segment Dominated

By end-user, the pharmaceutical & biotechnology companies segment registered its dominance over the global market in 2023. The growing research in the pharmaceutical & biotechnology companies boosts the market growth. Multiplex immunoassay techniques are commonly used in pharmaceutical & biotechnology companies for detecting protein targets involved in a disease, biomarker research, drug development, antibody detection, precision medicine, etc.

By end-user, the hospitals & diagnostics laboratories segment is anticipated to grow with the highest CAGR in the market during the studied years. The multiplex immunoassay technique is widely used in hospitals & diagnostics laboratories to screen for specific antibodies, disease diagnosis, quantify the number of multiple proteins, and identify cytokines. The increasing incidence of chronic disorders like cancer, Alzheimer’s disease, cardiovascular disorders, etc.

R&D and Technologies to Project the Dominance of North America

By region, North America dominated the multiplex detection immunoassay market in 2023. The state-of-the-art R&D facilities, advanced healthcare facilities, increasing investments & collaborations, presence of key players drive the market growth. Countries like the US and Canada are at the forefront of pharmaceutical & biotechnology research, thereby boosting the market. Every year billion dollars are invested in pharmaceutical R&D in the US.

According to a report published by the researchers of Bentley University, the USFDA approved 356 drugs from 2010 to 2019. During this period, the NIH spent $1.44 billion per approval on basic or applied research for novel targets or $599 million per approval on basic research to multiple products.

  • In August 2024, SGS announced the release of its new specialized bioanalytical testing services in North America to be used for both pharmaceutical and biopharmaceutical applications. The new services will be delivered from a laboratory in Hudson, New Hampshire, and will support discovery, preclinical trials, clinical trials, development validation, immunogenicity testing, ELISA, multiplex assays, bioassays, etc.

Precision Medicine: Asia’s Significant Growth Rate in Upcoming Years

By region, Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period. The rising incidences of chronic disorders, ageing, increased investments & collaborations, affordable labor, increasing demand for precision medicine, advanced R&D facilities, and presence of key players drive the market growth. Countries like India and China have the largest population in the world. Hence, there is a need for personalized treatment to cater to diverse population in these countries. The government initiatives and policies further promote the need for precision medicines. Furthermore, increasing investments in genomics and proteomics also promote the market growth.

  • In March 2024, CoSara Diagnostics received clearance by CDSCO to manufacture and sell its SARAPLEX Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic for detecting and differentiating influenza A and B.

New Advancements in the Multiplex Detection Immunoassays Market

  • In January 2023, Agilent Technologies and Akoya Biosciences collaborated to develop multiplex-immunohistochemistry diagnostic products for tissue analysis. The collaboration was made to develop chromogenic and immunofluorescent multiplex assays, which will include spatial analysis for companies that develop precision therapeutics for cancer.
  • In April 2024, Thermo Fisher Scientific developed Applied Biosystems TaqMan QSY2 probes for better assay performance retention when transitioning from single-plex to six-plex. This enables researchers to develop multiplexed in-house assays faster and unlock the full potential of qPCR.
  • In August 2024, Qiagen expanded its agreement with AstraZeneca to develop real-time PCR-based test panels for clinical molecular diagnostic testing in chronic disease investigational drug selection. The QIAstat-Dx system is an automated platform that detects and differentiates between multiple biomarkers and provides results within an hour.

Segments Covered in the Report

By Product

  • Consumables
  • Software
  • Instruments

By Type

  • Protein Multiplex Assays
    • Planar Protein Assays
    • Bead-Based Protein Assays
  • Nucleic Acid Multiplex Assays
    • Planar Nucleic Acid Assays
    • Bead-Based Nucleic Acid Assays
  • Cell-Based Multiplex Assays

By Technology

  • Flow Cytometry
  • Multiplex Real-Time PCR
  • Fluorescence Detection
  • Luminescence
  • Others

By Application

  • Research & Development
    • Drug Discovery & Development
    • Biomarker Discovery & Validation
  • Clinical Diagnostics
    • Infectious Diseases
    • Cancer
    • Cardiovascular Diseases
    • Autoimmune Diseases
    • Nervous System Disorders
    • Metabolism & Endocrinology Disorders
    • Others

By End-User

  • Pharmaceutical & Biotechnology Companies
  • Hospitals & Diagnostic Laboratories
  • Research & Academic Institutes
  • Others

By Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Insight Code: 5217
  • No. of Pages: 150+
  • Format: PDF/PPT/Excel
  • Published: September 2024
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2022
  • Base Year: 2023
  • Estimated Years: 2024-2033

About The Author

Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.

FAQ's

Multiplex immunoassay is a technique in which several analytes can be detected and measured from the same sample fluid in a single experiment.

Multiplex immunoassay offers several advantages over conventional immunoassay. It facilitates detecting and quantifying more than analyte from a sample solution simultaneously. It requires very less amount of sample. The monitoring of numerous analytes saves time of individual analysis and improves workflows.

Multiplex immunoassays are widely used in biomarker research, new drug development, identification of protein target in a disease, clinical diagnostics, precision medicine, etc.

World Health Organization, Centers for Disease Control and Prevention, USFDA, World Stroke Organization, National Institute of Health