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May 2025
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The global multiplex PCR assay market size is calculated at USD 1.45 in 2024, grew to USD 1.57 billion in 2025, and is projected to reach around USD 3.25 billion by 2034. The market is expanding at a CAGR of 8.54% between 2025 and 2034.
| Metric | Details |
| Market Size in 2025 | USD 1.57 Billion |
| Projected Market Size in 2034 | USD 3.25 Billion |
| CAGR (2025 - 2034) | 8.54% |
| Leading Region | North America |
| Market Segmentation | By Product & Service, By Assay Type, By Application, By End User, By Region |
| Top Key Players | Thermo Fisher Scientific Inc., Bio-Rad Laboratories, QIAGEN, Luminex Corporation, Fluidigm Corporation, BioFire Diagnostics |
The term "multiplex polymerase chain reaction" (also known as "multiplex PCR") describes the use of PCR to amplify multiple DNA sequences at once, utilizing a single amplification protocol for all amplicons and multiple primers in a single tube. When collecting clinical samples is challenging or the amount of the sample is restricted, the ability to identify many targets in a single sample is very crucial. Commonly employed in quality control, research, and diagnostics, it optimizes productivity while preserving priceless samples.
The capacity to enhance the classification accuracy of multiplex PCR experiments utilizing synthetic DNA templates by combining machine learning (ML) algorithms with real-time digital PCR (dPCR) equipment has been shown in recent publications. Recent advances in clinical diagnostics using machine learning techniques have brought attention to the promise of data-driven multiplexing, which overcomes throughput, cost, time, and reliability constraints as compared to traditional techniques.
Highly Advanced Assay Provides Advantages Over Traditional PCR
Compared to conventional and singleplex tests, multiplex assays help cut down on the amount of sample needed and the length of time needed. Their increased productivity, repeatability, and high precision contribute to the market's expansion. It also aids in more thorough diagnosis, quicker processes, and lower costs per data point. These elements support the market expansion for multiplex tests.
Design Challenges
The design issues increase when such a response is multiplexed. Two targets need six primers, three require nine, and so on. If one target needs three, none of which should be able to bind to the template DNA or to one another. Each amplicon needs to be tagged with a fluorescent dye that is spectrally different from the others in the reaction, or it needs to be a different size (for gels).
Rising Demand for Disease Diagnosis
The identification of many pathogen strains, including bacteria and viruses, from a single patient sample is one of the most prominent uses of multiplex PCR. This is especially crucial when handling international health emergencies, such as pandemics, when prompt diagnosis is crucial. Furthermore, as enhanced multiplex PCR techniques enable customized therapies based on genetic profiles, the growth of personalized medicine is anticipated to increase demand for these products.
By product & service, the instruments segment was dominant in the multiplex PCR assay market in 2024. Another sizable portion of the market is made up of equipment utilized in multiplex PCR tests, such as real-time PCR systems and heat cyclers. The necessity for automated and high-throughput solutions in clinical diagnostics and research labs is what is driving the need for this equipment. The introduction of small, easy-to-use, and extremely effective PCR devices as a result of technological breakthroughs has further accelerated market expansion.
By product & service, the software and services segment is expected to be the fastest-growing during the predicted timeframe. Several software programs are used in the creation and analysis of multiplex tests. QIAGEN software offers guidance for developing digital PCR (dPCR) multiplex assays. qPCR is created using IDT software. Compared to single-plex assays, they provide a number of benefits, including as increased efficiency, scalability, the capacity to collect more data from a single experiment, and reduced expenses. These factors facilitate the growth of the software sector and the market for multiplex tests.
By assay type, the planar assay segment led the multiplex PCR assay market in 2024. Planar chromatography reduces costs by providing a straightforward solution to challenging issues. High resolution mass spectrometry (MS) in conjunction with effect-oriented detection can be used to detect bioactive compounds that have detrimental effects that are not detectable by standard target analysis methods like HPLC–MS–MS. Planar chromatography is amazing for providing straightforward answers to difficult problems.
By assay type, the bead-based assay segment is anticipated to witness the fastest growth rate between 2025-2034. Immunoassays have had a significant impact on life sciences research and clinical diagnosis. Bead-based assays have transformed the study of human health and sickness by enabling better tracking of treatment response and the identification of biomarkers linked to disease. Bead-based immunoassays, which build on ELISA technology, offer precise singleplex and multiplex solutions without compromising accuracy, sensitivity, or reproducibility.
By application, the research and development segment dominated the multiplex PCR assay market in 2024. Multiplex assays are becoming more and more necessary in drug development. These assays are used in preclinical and clinical settings to evaluate immunotherapy efficacy, toxicity, and drug response biomarkers. Moreover, biomarker creation and validation are essential for bettering early cancer detection, disease diagnosis, and therapeutic response tracking in the current day. Before a marker candidate may be utilized in clinical settings, it must be verified at each stage of the biomarker route. These R&D applications of multiplex assay are expected to drive market growth.
By application, the disease diagnosis segment is expected to grow at the fastest rate during the forecast period. The diagnostics of infectious diseases have been transformed by PCR. Multiplex PCR, a test variation in which several target sequences are amplified using multiple pairs of primers, was created to overcome the test's fundamental cost disadvantage and increase its diagnostic potential. It has been reported that multiplex PCRs can identify bacterial, viral, and/or other infectious pathogens in a single reaction tube.
By end-user, the biopharmaceutical companies segment led the multiplex PCR assay market in 2024. The secret to advancing your biopharma product might be absolute measurement of nucleic acids, from development to quality control and continuous therapeutic assessment. Multiplex PCR is essential to the study, creation, and production of biotherapeutics. Biologic drug development can be accelerated with multiplex PCR technologies while preserving product confidence.
By end-user, the clinical research organizations segment is estimated to grow at the fastest rate during the forecast period. Research on gene expression fold change less than two times, copy number variation, and single-cell or low-abundance gene expression analysis has demonstrated results using multiplex PCR. One use of PCR methods in cancer research is the identification of genes linked to tumors. While multiplex PCR technology offers clinical data to promote better patient outcomes, conventional approaches still play a significant role in the diagnosis of infectious illnesses and other applications.
North America dominated the multiplex PCR assay market in 2024. Another significant factor propelling market expansion is the high burden of infections and tumors on local healthcare systems. Additional factors that are expected to boost the market's expansion in the area include the existence of a well-developed healthcare infrastructure and the increasing use of cutting-edge technology for infectious disease and cancer diagnostics. North America's healthcare expenditures have grown significantly over time. By 2028, national health spending is expected to reach USD 6.2 trillion, growing at an average annual rate of 5.4% from 2019 to 2028. One of the main factors propelling the biotechnology industry is the rising cost of healthcare.
Each level of government—federal, state, and local—has distinct roles in these endeavors, which might differ from one state to the next and even from one town to the next. Public health authorities and duties are derived from the U.S. Constitution. User fees accounted for $3.3 billion (46%) of the FDA's $7.2 billion program-level budget in FY2024. The operational budget for ASPR was $3.65 billion in FY2024. CDC allocated $9.25 billion for its main public health activities in FY2024.
Public health is a necessity for any country, and Canada takes it seriously by continuous investments, launching programs, and other things. Multiplex PCR becomes an essential part of public health. For instance, in 2025, the Canadian government said it will continue to invest over $200 billion over a ten-year period to assist the reform of the healthcare system through the Working Together to Improve Health Care for Canadians Plan. Additionally, the government is investing $5.4 billion in bilateral Aging with Dignity agreements to improve the quality and safety of long-term care and home and community care across the country.
Asia Pacific is estimated to host the fastest-growing multiplex PCR assay market during the forecast period. This is because there are more hospitals in developing nations, the R&D industry is growing, there is a strong need for healthcare infrastructure, and regional rising enterprises are investing. The incidence of cancer linked to cigarette smoking is also anticipated to propel market expansion. For instance, half of the world's tobacco production is consumed in the Asia Pacific. The expansion of the regional market is being driven by the growing demand for mPCR in Asian nations.
The European Centre for Disease Prevention and Control (ECDC) believes that the current epidemiological situation in China is a seasonal increase in respiratory illnesses brought on by common respiratory pathogens, based on the information that is currently available. International attention is being drawn to reports of a human metapneumovirus (HMPV) epidemic in several regions of China. According to reports, the number of HMPV cases among young individuals in northern China has increased recently. There has also been an increase in rhinovirus cases, which are a primary cause of common colds.
The theme, "Healthy Beginnings, Hopeful Futures," kicks off a year-long campaign in 2025 that emphasizes maternity and infant health and calls on nations to prioritize the long-term health of women and put a stop to needless deaths. The Ministry of Health and Family Welfare of the Government of India is steadfast in its dedication to provide high-quality, affordable, and equitable healthcare in line with this objective. India's health sector has advanced significantly over the last ten years, thanks to programs like Ayushman Bharat and the National Health Mission, which have increased access to digital health, improved infrastructure and services, and improved maternal and child health.
Europe is expected to grow significantly in the multiplex PCR assay market during the forecast period, distinguished by active research endeavors and an increasing focus on precision diagnostics. The need for multiplex PCR technologies is growing as a result of nations like France, Germany, and the United Kingdom leading the way in molecular biology research. The use of modern diagnostic equipment is further supported by the region's strict regulatory standards and rising healthcare costs. However, developing economies are also becoming more competitive in the European market, which may affect their rate of expansion. Notwithstanding these obstacles, Europe continues to be a significant market for multiplex PCR tests due to continuous developments in genomics and personalized medicine.
In the post-pandemic age, the German healthcare system, which is well-known for its effectiveness and high standard of care, is at a turning point. In Germany, health insurance is required. About 86% of people are covered by statutory health insurance, which covers prescription drugs, inpatient and outpatient care, and mental health services. Inpatient services and medications include copayments, while sickness funds provide a variety of deductibles.
Another well-known aspect of the United Kingdom is its national health system. It is a model for many nations and distinct from the system in many others. It offers a range of services to both its residents and foreign tourists and residents of the United Kingdom. The NHS is in charge of every facet of the healthcare system in the United Kingdom. The NHS is currently among the biggest public health systems globally. Every 36 hours on average, one million individuals are served. Universality, free distribution, equity, and central finance are among its guiding principles.
In January 2025, making QIAcuity even more the best option for innovative dPCR applications requires the ability to analyze many targets at once from a single biological sample, according to Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. In order to enable researchers to obtain a more thorough biological knowledge of any sample type in an economical manner without the need for laborious optimization or the worry of imprecise quantification, we are investigating methods to further enhance QIAcuity's capabilities.
By Product & Service
By Assay Type
By Application
By End User
By Region
May 2025
December 2024
October 2024
May 2025