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August 2024
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.
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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.
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.
| 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. |
| 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. |
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 |
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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August 2024
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