U.S. Multiplex Assays Market Revenue to Attain USD 1,640 Mn by 2033

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U.S. Multiplex Assays Market Revenue and Trends 2023 to 2033

The U.S. multiplex assays market revenue surpassed USD 460 million in 2024 and is predicted to attain around USD 1,640 million by 2033, growing at a CAGR of 15.15%. The increasing research in genomics, proteomics, clinical diagnostics, and biopharmaceuticals along with developments in screening techniques for detection of antibiotic residues is driving the market for the U.S. multiplex assays.

Market Overview

Multiplex assays involve the detection of multiple biomarkers from the samples. Conventional immunoassay techniques such as ELISA and Western Blot identify only a single analyte, whereas multiplex immunoassays provide more efficient and fast results. They detect several types of targets using fluorescent, chemiluminescent, and mass cytometry techniques. These immunoassays reduce cost and time and help identify several analytes. There are two main types of multiplex assays: planar microarray and suspension array. Both are used in gene and cell therapy to detect biomarkers.  

Multiplex assays are used in various studies, such as immunology, oncology, and infectious diseases, to monitor the immune response and detect biomarkers. They utilize antibodies that bind to specific targets and enable the detection and quantification of multiple analytes. 

The market is experiencing rapid growth due to the rising prevalence of diseases like cancer and Alzheimer’s, boosting the demand for cost-effective treatments. Moreover, multiplex immunoassays are used across several applications like infectious disease testing, food contamination testing, veterinary testing, and R&D. The rise in prosthetic joint replacement that improves the quality of life and restores joint function may also lead to prosthetic joint infection if not taken proper care, leading to arthroplasties, thus driving the market growth. Many scientists are developing multiplex serologic assays, which contribute to market expansion. 

Report Highlights of the U.S. Multiplex Assays Market 

• By product, the consumables segment dominated the market in 2023 due to the rise in the use of multiplex detection immunoassay kits to identify specific disease indicators and analyze the amount and interactions of signaling proteins. These kits are utilized by laboratory technicians for diagnosis and contain several analytes, reagents, beads, and buffers that analyze various markers in serum, plasma, tissues, cultured cells, and other samples.
• By type, the protein multiplex assay segment accounted for the largest share of the market in 2023. Protein multiplex assays are used to identify and quantify the amounts of proteins in samples and protein targets.
• By technology, the flow cytometry segment led the market with the largest share in 2023, as it analyzes the characteristics of cells or particles within samples. They are treated with fluorescent antibody dye to label the proteins inside the cells inserted into a flow cytometer. This flow cytometer identifies multiple sizes of beads with multiple levels of fluorescence intensity.
• By application, the research and development segment dominated the market in 2023. The rising prevalence of cancer, cardiovascular diseases, infectious diseases, and autoimmune diseases increased research and development activities in protein target identification, contributing to segmental growth.
• By end-user, the pharmaceutical and biotechnology companies segment dominated the market for multiplex assays in 2023. The segmental dominance is attributed to the rise in the use of multiplex immunoassays in detecting protein targets involved in disease, biomarker research, drug development, antibody detection, and precision medicine.

U.S. Multiplex Assays Market Trends

• Rising Incidence of Infectious Diseases: Several pathogens such as viruses, bacteria, and fungi that lead to infectious diseases need to be diagnosed through proper screening methods to identify the infection source. These techniques help to understand the etiology, and patient prognosis, and track the severity of the disease. The multiplex assays further reduce the chances of misdiagnosis.
• Rising Demand for Point-of-Care Testing: The increasing demand for point-of-care testing for quick screening across several laboratory settings is a major factor driving the market. Also, it helps in detecting several diseases, managing large datasets, and improving diagnosis accuracy. For instance, in November 2023, Binx Health, a US-based healthcare company, partnered with Fisher Healthcare to distribute a molecular point-of-care platform nationwide to increase the timely diagnosis of chlamydia and gonorrhea. 
• Technological Advancements: Increasing advancements in technology contribute to market expansion. Implementing technologies like artificial intelligence helps in analyzing and detecting biomarkers, allowing healthcare professionals to diagnose diseases early. Advanced technologies such as machine learning and deep neural networks identify single particle and molecular biomarkers. Moreover, the use of microscopy imaging with a microfluidic platform allows encoding decoding through vision-based artificial intelligence. 
• Increasing Aging Population: The rising geriatric population and the demand for preventive treatment and drug monitoring fuel the growth of the U.S. multiplex assays market. Many laboratories are focusing on laboratory automation, which helps with large sample processing capacity and testing in a short time with minimum labor requirement, integrated quality control, and data storage. 

Market Opportunity

Rising demand for cell and gene therapies creates immense opportunities in the market. Cell and gene therapies, such as CAR-T cells, stem cells, and CRISPR/Cas9, are used to treat autoimmune and genetic disorders. However, multiplex assays are used in viral vector genome titer measurement, vector copy determination, and gene therapy development. These assays are convenient and measure cytokines to test the potency of CAR-T cells.

Market Coverage

Market News

• In April 2024, Thermo Fisher Scientific, a US-based life science and clinical research company, launched the EXENT solution, after receiving IVDR certification. The solution is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies.
• In April 2024, Labcorp, a US-based company, announced the availability of blood-based biomarkers in the U.S. market for the early detection of neurodegenerative diseases and brain injuries. 
• In April 2023, NIBIB issued the OTC multiplex test solicitation with the goal of increasing the availability of multiplex rapid tests for the U.S. market. 

Market Segmentation

By Product

• Consumables
• Instruments
• Software

By Type

• Protein Multiplex Assays
  • Planer Protein Assays
  • Bead-based Protein Assays
• Nucleic Acid Multiplex Assays
  • Planer Protein Assays
  • Bead-based Protein Assays
• Cell-based Multiplex Assays 

By Technology

• Flow Cytometry
• Fluorescence Detection
• Luminescence
• Multiplex Real-Time PCR
• Other Technologies

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
  • Other Diseases

By End-use

• Pharmaceutical & Biotechnology Companies
• Hospitals & Diagnostic Laboratories
• Research & Academic Institutes
• Other End-users

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