Multiplex Assays Market Set to Reach USD 5.9 Billion by 2031 as Technological Advancements and Rising Autoimmune Disease Prevalence Drive Growth | TMR

The global multiplex assays market, valued at US$3.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6.9% over the forecast period of 2023-2031, reaching an estimated US$5.9 billion by 2031. The market's expansion is primarily driven by the advantages of multiplex assays over singleplex assays and an increasing prevalence of autoimmune diseases, although high system costs remain a notable barrier.

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Multiplex Assays Market Outlook 2031

Rising adoption of multiplex immunoassays, which enable the simultaneous detection of multiple analytes in a single reaction, is transforming research and clinical diagnostics. By offering higher throughput, greater data output per sample, and enhanced efficiency compared to traditional singleplex ELISA assays, these systems are becoming increasingly indispensable in personalized medicine and detailed diagnostics. Moreover, the surge in multiplexed point-of-care testing (xPOCT) is expected to create lucrative opportunities for vendors, particularly in resource-limited settings.

Market Introduction

Multiplex assays, a derivative of the traditional Enzyme-linked Immunosorbent Assay (ELISA), utilize magnetic beads and other technologies-such as multiplex RT-PCR, flow cytometry, fluorescence, and luminescence-to simultaneously quantify a range of analytes. This capability not only saves time and sample volume but also enhances diagnostic accuracy, making these assays highly preferred in both research and clinical settings. As the healthcare landscape shifts toward more efficient and high-throughput diagnostic methods, multiplex assays are increasingly central to advancing life sciences.

Market Drivers

Advantages Over Singleplex Assays

Higher Throughput & Efficiency: Multiplex assays offer a greater output per sample volume and reduce manual sample handling, ultimately lowering the cost per data point.

Time & Resource Savings: By allowing simultaneous detection of multiple analytes, these assays streamline workflows, enabling researchers to generate more comprehensive datasets with fewer resources.

Surge in Prevalence of Autoimmune Diseases

Rising Autoimmune Incidence: With autoimmune conditions such as Crohn's disease, rheumatoid arthritis, type 1 diabetes, and multiple sclerosis on the rise, the demand for diagnostic tools that can efficiently screen for multiple autoantibodies is growing.

Global Health Impact: For instance, the World Health Organization estimates significant global burdens associated with conditions like multiple sclerosis, driving increased adoption of multiplex immunoassays.

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Challenges and Opportunities

High System Costs: The need for specialized equipment and validated antibody pairs makes multiplex assay systems more expensive compared to their singleplex counterparts, potentially limiting their immediate adoption.

Expanding Point-of-Care Testing: The development of multiplexed point-of-care testing systems is providing a significant growth avenue, especially as vendors design solutions that combine high performance with simplified operation suitable for non-expert users.

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Regional Outlook

Leading Region: North America

North America dominated the market in 2022, driven by robust investments in research and development and the presence of leading market players. Regulatory approvals-such as the U.S. FDA clearance for assays like the Alinity m STI Assay, which can simultaneously detect and differentiate multiple sexually transmitted infections-have bolstered market dynamics.

The region's strong focus on innovation and high healthcare expenditure makes it a key hub for multiplex assay development.

Global Expansion Trends

While North America leads, significant opportunities exist in Europe, Asia Pacific, the Middle East & Africa, and South America, where increasing investments in healthcare infrastructure and diagnostics are paving the way for market growth.

Analysis of Key Players

Industry leaders are leveraging their expertise to develop advanced bead-based immunoassays and custom assay development services, which facilitate the multiplexing of new analytes alongside existing ones. Notable companies profiled in the market include:

DiaSorin S.p.A.

Thermo Fisher Scientific, Inc.

Seegene, Inc.

Meso Scale Diagnostics, LLC

Abcam Limited

Bio-Rad Laboratories, Inc.

QIAGEN

Merck KGaA

Quansys Biosciences

Illumina, Inc.

These companies are focusing on innovative product development and strategic collaborations to enhance the precision, automation, and overall efficiency of multiplex assay workflows.

Key Developments

September 2023: GT Molecular, Inc. partnered with F. Hoffmann-La Roche AG to launch a highly multiplexed respiratory panel on the new Roche Digital LightCycler System. This advanced digital PCR assay kit enables the co-quantification of respiratory pathogens-including SARS-CoV-2, influenza A and B, and RSV-within a single reaction well.

February 2023: Thermo Fisher Scientific introduced real-time PCR kits tailored for the detection of multiple infectious diseases in India. These kits, part of the Applied Biosystems TaqPath series, target conditions such as Multi-Drug Resistant Tuberculosis (MTB MDR), hepatitis B and C viruses, and HIV, further underscoring the expanding role of multiplex assays in global diagnostics.

Market Analysis:
The comprehensive report includes both segment and regional analyses, along with qualitative insights into market drivers, restraints, opportunities, and trends. It further incorporates Porter's Five Forces analysis, value chain analysis, and key trend evaluation.

Competition Landscape:
Market share analysis by company and detailed profiles-covering business segments, product portfolios, recent developments, and financial overviews-provide essential insights for stakeholders.

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Market Segmentation:

Product: Instruments, Consumables, Reagents & Kits, Micropipettes & Microplates, Others

Technology: Multiplex RT-PCR, Flow Cytometry, Luminescence, Fluorescence, Others

Application: Research & Development, Drug Discovery, Biomarker Research, Diagnosis (including infectious and autoimmune diseases, cancer, cardiovascular, and neuroendocrine conditions)

End-User: Biotechnology & Biopharmaceutical Companies, Academic & Research Centers, Diagnostic Centers, Hospitals, Others

Regions Covered: North America, Europe, Asia Pacific, Middle East & Africa, South America

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