Multiplex Assays Market By Product Type (Nucleic Acid Assays, Protein Assays, Cell-Based Assays, Others); By Application (Clinical Diagnostics, Research and Development, Drug Discovery and Development, Others); By End-User (Hospitals and Diagnostic Laboratories, Pharmaceutical and Biotechnology Companies, Research and Academic Institutes); By Geography, Segment revenue estimation, Forecast, 2023-2030

Industry Report and Statistics (Facts & Figures) - Sales Volume & ASP by Product Type & Technology

 

The global multiplex assays market will witness a robust CAGR of 11.2%, valued at $2.5 billion in 2022, and expected to appreciate and reach $5.85 billion by 2030, confirms Strategic Market Research.

 

The multiplex assays market is for technologies and products that enable the simultaneous detection and analysis of several different analytes (such as proteins, nucleic acids, and metabolites) in a single sample. Multiplex assays offer advantages over traditional single-analyte assays, including increased throughput, reduced sample consumption, and improved data quality.

 

Multiplex assays are powerful analytical tools that allow for the simultaneous detection and measurement of multiple analytes in a single sample. These assays have become increasingly important in clinical diagnostics, drug discovery, and basic research. The ability to analyse various parameters in a single experiment can significantly improve efficiency and reduce costs.

                        

 The multiplex assays market is poised for significant growth in the coming years, driven by ongoing technological innovation and increasing demand from various industries. As multiplex assays expand across multiple applications, the market will likely become increasingly competitive. Companies make significant R&D investments to produce new products, improve multiplex assay technologies, and expand their market presence.

 

Key Industry Drivers - 

Rising demand for personalised medicine: The need for personalised medicine has increased steadily in recent years, driven by a growing recognition that one-size-fits-all medical treatments are often ineffective or harmful for specific individuals. Personalised medicine involves tailoring medical treatments to an individual's genetic makeup, lifestyle, and other unique characteristics, allowing for more precise and effective care.

 

The Gates Foundation has committed over $300 million to support research on personalised medicine, including efforts to develop affordable diagnostic tests for infectious diseases.

 

Journal of Clinical Oncology research found that using multiplex assays in cancer treatment improved patient outcomes and reduced healthcare costs, highlighting the potential benefits of personalised medicine.

 

Multiplex assays, which are tests that allow researchers and clinicians to measure and analyse multiple parameters in a single sample, are becoming an essential tool in the development of personalised medicine. These assays enable simultaneous measurement of various biomarkers or molecular targets, providing a more comprehensive and nuanced understanding of biological systems.

 

Growing prevalence of chronic and infectious diseases: The growing prevalence of chronic and contagious diseases is a major global health challenge. The World Health Organisation (WHO) estimates that chronic illnesses, including diabetes, cardiovascular disease, and cancer, account for 71% of all fatalities globally. Particularly in poorer nations, infectious diseases like HIV/AIDS, malaria, and TB continue to represent a danger to public health.

 

Multiplex assays are increasingly used in clinical diagnostics to detect and monitor these diseases. For example, multiplex assays can simultaneously detect multiple disease biomarkers in a single sample, providing clinicians with a more comprehensive picture of a patient's health status. This can lead to earlier and more accurate diagnosis and better disease progression and treatment response monitoring.

 

In addition to clinical diagnostics, multiplex assays are used in drug discovery to identify new therapeutic targets. By measuring the activity of multiple proteins or molecules in a single sample, researchers can better understand disease pathways and identify potential targets for drug development.

Need for more efficient and cost-effective diagnostic and research tools: The need for more efficient and cost-effective diagnostic and analysis tools is an ongoing challenge in the healthcare industry. Multiplex assays have emerged as a promising technology that can address this need by providing a more comprehensive understanding of biological systems more efficiently and cost-effectively.

 

Non-profit organisations such as the Bill and Melinda Gates Foundation have recognised the importance of efficient and cost-effective diagnostic tools in addressing global health challenges. The Gates Foundation has invested in developing multiplex assays for diagnosing infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, which are significant health challenges in developing countries.

 

The Journal of Proteome Research and other journals have also published research on developing and applying multiplex assays. These studies show the adaptability and potential of multiplex assays in various applications, including illness diagnosis and drug development.

Restraints - Expensive Equipment & Stringent Regulations

High development and validation cost: The development and validation of multiplex assays can be challenging and resource-intensive. According to a study published in Bioanalysis, developing and validating multiplex assays typically involves a series of steps, including selecting appropriate analytes, designing assays, optimising assay conditions, and validating the assay performance. This process can be time-consuming and may require specialised expertise and equipment.

 

In addition to the challenges associated with assay development and validation, the cost of developing and implementing multiplex assays can also be a significant barrier to adoption. Depending on the complexity of the test and the amount of validation required, the cost of designing and verifying multiplex assays can range from tens of thousands to millions of dollars, according to a National Academy of Sciences assessment.

 

A study published in the journal Analytical Chemistry estimated the average cost of developing a single multiplex assay to be around $175,000, based on a survey of assay developers in the United States.

 

To address these challenges, the government has provided funding and resources to support developing and validating multiplex assays. For instance, to accelerate the development and validation of novel assay technologies, the National Institutes of Health (NIH) sponsored many projects. The NIH Common Fund, for instance, has funded several programs focused on developing new and innovative assay technologies for use in biomedical research.

 

Technical Challenges: Multiplex assays, designed to measure multiple analytes simultaneously, can pose significant technical challenges in their development. These challenges are particularly pronounced when the assay is intended to measure a large number of analytes, as this can increase the complexity of the assay and the potential for technical errors.

 

However, advances in technology have led to improvements in multiplex assay development. For example, the Luminex xMAP technology can measure up to 500 analytes in a single assay with high sensitivity and specificity. In addition, a study published in the journal Analytical Chemistry demonstrated using digital droplet PCR to increase the sensitivity and accuracy of multiplex assays.

 

Government funding for research on multiplex assays has increased in recent years. For instance, the National Cancer Institute (NCI) has awarded over $10 million in grants to develop multiplex assays for cancer diagnosis and treatment monitoring. Non-profit organisations like the Bill and Melinda Gates Foundation have also invested in developing multiplex assays for global health applications.

 

Limited Standardisation: Limited standardisation is a significant challenge in developing and using multiplex assays. Because multiplex assays can vary in design, format, and performance, comparing results between different studies or labs can be difficult. This variability can be due to factors such as differences in the type of sample used, the selection of analytes, and the choice of assay platform.

 

Research in the journal Analytical Chemistry claims that inter-laboratory variation in multiplex assays can be as high as 30%, highlighting the need for standardisation in this field. Additionally, a survey conducted by the National Institute of Standards and Technology (NIST) revealed that a lack of reference resources and techniques was cited as one of the significant obstacles in creating and validating multiplex assays.

 

The lack of standardisation in multiplex assays can also make developing universal reference standards for quality control challenging. This is important because reference standards are needed to ensure that assay results are accurate and reproducible. With standardisation, it can be easier to compare assay performance across different labs or to develop quality control materials that are universally applicable.

 

Opportunities - The Increase in the Need for Automated Systems and the Rising Prevalence of the Biomarkers in Protein and Molecular Diagnostics in the Asia-Pacific Region

Expansion into new applications: Multiplex assays are finding applications beyond traditional fields, such as drug discovery and clinical diagnostics. They are increasingly used in environmental monitoring, food safety testing, forensic analysis, and other areas.

 

For example, multiplex assays detect water, soil, and air contaminants in environmental monitoring. Journal of Environmental Monitoring research study demonstrated the use of multiplex assays to detect multiple toxins in water samples. Similarly, in food safety testing, multiplex assays can simultaneously detect numerous foodborne pathogens in a single piece, improving the efficiency and speed of food safety testing. Journal of Food Protection research study demonstrated using a multiplex PCR assay to detect foodborne pathogens in food samples.

 

In forensic analysis, multiplex assays are used to simultaneously detect multiple genetic markers, improving the speed and accuracy of DNA analysis. A study published in the journal Forensic Science International demonstrated using a multiplex PCR assay to detect multiple genetic markers for forensic analysis simultaneously.

 

The NIST reference material for quantifying proteins in human serum using a multiplexed immunoassay has certified values for 23 different proteins, with relative standard uncertainties ranging from 3.5% to 26.3%.

 

Development of companion diagnostics: Multiplex assays play an increasingly important role in developing companion diagnostics - tests developed in conjunction with a specific drug or therapy are used to identify patients most likely to benefit from the treatment. Multiplex assays can measure multiple biomarkers simultaneously, making them ideal for developing companion diagnostics that can identify patients who will respond well to a specific therapy.

 

The FDA has approved several companion diagnostic tests that use multiplex assays. For example, the Cobas EGFR Mutation Test v2 is a multiplex PCR assay used to identify non-small cell lung cancer patients with specific mutations in the EGFR gene and are likely to benefit from treatment with EGFR inhibitors, which the FDA approved. This test was found to have a sensitivity of 97.6% and a specificity of 100% for detecting EGFR mutations in clinical samples.

 

Over $1.5 billion has been spent by the Bill and Melinda Gates Foundation in developing diagnostic tools, including multiplex assays, for neglected tropical diseases. One multiplex assay designed with the foundation's funding is the "NDx," a low-cost, portable diagnostic tool that detects multiple pathogens associated with neglected tropical diseases, including leprosy and Buruli ulcer.

 

Adoption of point-of-care testing: Point-of-care testing is becoming increasingly important in healthcare, particularly in low-resource settings where access to laboratory infrastructure may be limited. Multiplex assays have the potential to revolutionise point-of-care testing, as they can simultaneously measure multiple analytes in a single sample, enabling rapid and accurate diagnosis of various conditions.

 

One example of using multiplex assays for point-of-care testing is the "lab-on-a-chip" technology, which researchers at the University of California, Berkeley, have developed. This technology uses a microfluidic chip to conduct multiplex PCR assays to detect sexually transmitted infections, including HIV, chlamydia, and gonorrhoea. The technology was found to have a sensitivity of 100% and a specificity of 97.6% in a clinical validation study.

 

Another example is multiplex assays for detecting respiratory viruses in point-of-care settings. The FilmArray Respiratory Panel, a multiplex PCR assay that can detect multiple respiratory viruses in less than an hour, has been adopted in numerous clinical settings to diagnose respiratory infections, particularly during influenza season rapidly.

 

Journal of Clinical Microbiology research study 

evaluated the performance of a multiplex PCR assay for detecting bacterial and viral pathogens in blood cultures in a point-of-care setting. The assay had a sensitivity of 96.4% and a specificity of 98.5%.

 

Increasing demand for immunoassays: The simultaneous detection of many analytes in a single sample is made possible by multiplex immunoassays, which can speed up research, minimise sample volume, and provide researchers with a complete understanding of the biological system they are studying. This makes them particularly useful in clinical diagnostics, where they can measure multiple biomarkers associated with a disease or condition.

 

A study published in the Journal of Immunological Methods evaluated the performance of a multiplex immunoassay for detecting cytokines in serum and plasma samples. The assay demonstrated good sensitivity, with a limit of detection as low as 0.5 pg/mL for some cytokines and high levels of specificity and reproducibility.

 

A different investigation in the Journal of Clinical Microbiology found that multiplex immunoassays had higher sensitivity and specificity than traditional immunoassays for detecting respiratory viruses in clinical samples, with an overall accuracy of 94.6%.

 

The growing need for accurate and reliable diagnostic tests in clinical and research settings drives the increasing demand for immunoassays. The use of multiplex immunoassays is expected to continue to grow as researchers and clinicians seek to improve the accuracy and efficiency of diagnostic testing. 

 

 

Market Analysis Of Different Segments Covered in the Report

By Product Type: 

• Nucleic acid assays

• Protein assays

• Cell-based assays

• others

 

By Application: 

• Clinical diagnostics

• Research and development

• Drug discovery and development

• Others

 

By End-User: 

• Hospitals and diagnostic laboratories

• Pharmaceutical and biotechnology companies

• Research and academic institutes

• others

 

 

Regional Coverage Analysis

North America

• United States

• Mexico

• Canada

• Rest of North America

 

Europe

• Switzerland

• Russia

• France

• Germany

• U.K

• Finland

• Turkey

• Netherlands 

• Belgium

• Spain

• Italy

• Rest of Europe

 

Asia Pacific

• China

• India

• Indonesia

• South Korea

• Thailand

• Japan

• Singapore

• Malaysia

• Philippines

• Australia

• New Zealand

• Rest of APAC

 

LAMEA

• Brazil

• Saudi Arabia

• Uruguay

• Argentina

• Rest of LAMEA

 

The multiplex assays market is a rapidly growing industry that can be segmented based on product type, application, end-user, and region. The four main product types are nucleic acid, protein, cell-based, and other assays. Nucleic acid assays involve the analysis of DNA and RNA, while protein assays measure the quantity and activity of proteins. Cell-based assays use living cells to evaluate biological processes; other assays include biochemical and immunoassays. The use of multiple assay types is dependent on the specific application and end-user. Cell-based assays are the fastest-growing segment of the numerous assay market. 

 

The applications of multiplex assays are diverse and include clinical diagnostics, drug discovery and development, and research and development. Clinical diagnostics involves using assays to detect and diagnose diseases in patients, while drug discovery and development use assays to identify and optimise drug candidates. Research and development encompass various applications, including basic research, disease modelling, and biomarker discovery. Other applications of multiplex assays include environmental monitoring, food safety testing, and forensic analysis. Clinical diagnostics is the largest application segment of the numerous assay market, accounting for over 50% of the market share. 

 

The end-users of multiplex assays include hospitals and diagnostic laboratories, pharmaceutical and biotechnology companies, research and academic institutes, and others. Hospitals and diagnostic laboratories require highly accurate and reliable disease diagnosis and monitoring assays, while pharmaceutical and biotechnology companies use high-throughput assays for drug discovery and development. Research and academic institutes use multiplex assays for basic research and translational studies. Other end-users include government agencies, contract research organisations, and forensic laboratories. During the projection period, the pharmaceutical and biotechnology companies are anticipated to experience the most significant CAGR growth, driven by the increasing demand for high-throughput assays for drug discovery and development.

 

The multiplex assays market is also segmented by region, with North America, Europe, and the central regions being Asia-Pacific, Latin America, the Middle East, and Africa. North America and Europe have well-established healthcare systems and regulatory frameworks that promote developing and adopting new assays. Asia-Pacific has a large and growing population with a high burden of infectious diseases and cancer, making it an essential market for nucleic acid and cell-based assays. The Africa, Middle East and Latin America are emerging markets with increasing demand for high-quality healthcare and advanced diagnostic technologies.

 

Global Multiplex Assays Market Competitive Landscape Analysis

The competitive landscape analysis provides information about the crucial competitors prevailing in the worldwide market environment. The comparison is performed based on overall revenue generation, market initiatives, company overview, investment in R&D, company financials, company strengths and weaknesses, global presence, production capacity, production sites and facilities, market potential, etc.

• Thermo Fisher Scientific Inc. (US)

• Shimadzu Biotech (Japan)

• AYOXXA Biosystems GmbH (Germany)

• Bio-Rad Laboratories, Inc. (US)

• Boster Biological Technology (US)

• Seegene (South Korea)

• Illumina, Inc (US)

• Enzo Life Sciences, Inc. (US)

• Merck KGaA (Germany)

• Randox Laboratories (UK)

• Antigenix America, Inc. (US)

• Bio-Techne Corporation (US)

• Cayman Chemical Company (US)

• DiaSorin S.p.A. (Italy)

• Luminex Corporation (US)

• Meso Scale Diagnostics (US)

• Olink (Sweden)

• PerkinElmer, Inc. (US)

• Promega Corporation (US)

• Quanterix (US)

• Siemens Healthineers (Germany)

• Abcam plc (UK)

 

Multiplex Assays Market Report Coverage

Report Attribute	Details
Forecast Period	2023-2030
Market size value in 2022	$2.5 billion
Revenue forecast in 2030	$5.85 billion
Growth rate	11.2%
Base year for estimation	2022
Historical data	2017-2021
Unit	USD Billion, CAGR (2023 - 2030)
Segmentation	By Product Type, By Application, By End-User, By Region
By Product Type	nucleic acid assays, protein assays, cell-based assays, others
By Application	clinical diagnostics, research and development, drug discovery and development, others.
By End-User	Hospitals and diagnostic laboratories, pharmaceutical and biotechnology companies, research and academic institutes, others.
By Region	North America, Europe, Asia-Pacific, Latin America, The Middle East and Africa.
Key Industry Players	Thermo Fisher Scientific Inc. (US), Shimadzu Biotech (Japan), AYOXXA Biosystems GmbH (Germany), Bio-Rad Laboratories, Inc. (US), Boster Biological Technology (US), Seegene (South Korea), Illumina, Inc (US), Enzo Life Sciences, Inc. (US), Merck KGaA (Germany), Randox Laboratories (UK), Antigenix America, Inc. (US), Bio-Techne Corporation (US), Cayman Chemical Company (US), DiaSorin S.p.A. (Italy), Luminex Corporation (US), Meso Scale Diagnostics (US), Olink (Sweden), PerkinElmer, Inc. (US), Promega Corporation (US), Quanterix (US), Siemens Healthineers (Germany), Abcam plc (UK).

 

 

 

Recent Developments

April 2023: Siemens Healthineers, a German multinational medical technology company, has recently announced its plans to expand its manufacturing base in India. The company aims to establish a new factory in Bengaluru, India, with an investment of around INR 1,300 crore (approximately $ 177 million). By 2025, the new facility is anticipated to be operating and producing a range of laboratory tests and diagnostic imaging products.

 

April 2023: To enhance high-parameter panels on Cytek Cell Analysis Systems using Bio-Rad's StarBright Dyes, Cytek Biosciences has teamed with Bio-Rad Laboratories. Cytek will produce and sell reagent products to support high-parameter applications on Aurora and Northern LightsTM flow cytometry equipment. To increase the resolution of particular cell populations, researchers can construct larger, better panels with higher brightness and restricted excitation and emission characteristics thanks to the partnership. A wider variety of colour possibilities will be available using Cytek's patented cFluor® family of dyes in addition to Bio-Rad's StarBright Dyes.

 

April 2023: Thermo Fisher Scientific, a leading provider of life sciences research and diagnostic solutions, announced a new partnership with GeneProof, a leading manufacturer of molecular diagnostic solutions, to expand its PCR test menu. Thermo Fisher will offer GeneProof's broad range of PCR-based assays, which include tests for infectious diseases, genetic disorders, and oncology. This collaboration will allow Thermo Fisher to expand its offering to healthcare providers, research institutions, and pharmaceutical companies, providing them access to a broad range of PCR-based diagnostic tests.

 

February 2023: Roquefort Therapeutics has signed a new agreement with Randox Laboratories to collaborate on developing diagnostic tests. Under the terms of the deal, Roquefort will work with Randox to develop and commercialise diagnostic tests that can identify biomarkers associated with various diseases and conditions. The partnership will focus on developing tests for use in clinical trials and, eventually, in routine clinical practice.

 

Products developed by major companies:

Thermo Fisher Scientific Inc. is a leading company in developing and manufacturing various scientific instruments, reagents, and software. They offer a broad range of products for life science research, clinical diagnostics, and pharmaceutical development. Some of their notable products include the Applied Biosystems qPCR instruments, Ion Torrent sequencing systems, and Invitrogen antibodies.

 

Bio-Rad Laboratories, Inc. is another major player in the life sciences industry, offering products and solutions for research, clinical diagnostics, and food safety testing. Their products include:

PCR instruments.

Genomic and proteomic research tools.

Quality control solutions for clinical laboratories

Randox Laboratories Ltd. is a global leader in clinical diagnostics, offering high-quality products and solutions for laboratory testing. Their products include reagents, analysers, and quality control solutions for clinical chemistry, immunoassay, and molecular diagnostics. Randox also offers a range of innovative diagnostic tests for cardiovascular disease, cancer, and infectious diseases.

One of their notable products is the Droplet Digital PCR system, which provides highly sensitive and accurate quantification of nucleic acids.

 

Illumina, Inc. is a leading genomics company that develops and manufactures innovative sequencing and array technologies for genomics research and clinical applications. Their products include the NovaSeq, HiSeq, and MiSeq sequencing systems, which enable researchers to sequence DNA and RNA at high throughput and low cost. Illumina also offers a range of genotyping and gene expression arrays for research and clinical applications.

 

Luminex Corporation is a biotechnology company that develops and manufactures innovative solutions for multiplexed assay analysis. Their products include the xMAP technology platform, which enables simultaneous analysis of up to 500 analytes in a single sample. Luminex also offers a range of assay kits for clinical diagnostics and research applications.