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Global Multiplexed Diagnostics Market $57.1 Billion by 2031

The global market for multiplexed diagnostics projected to reach $57.1 billion by 2031, expanding at a double-digit CAGR of 16.2% over the forecast period, primarily driven by unique advantages in cost and time savings, coupled with high precision and high throughput facilitates.

  • Multiplexed assays are used by healthcare professionals especially by research scientists and clinical laboratory technicians for diseases diagnosis.
    • The global multiplexed assay market has experienced impressive growth in the past decade, due to factors such as completion of the human genome project and increase in the prevalence of cancer and infectious diseases.
  • Major factors influencing this industry is increasing demand for a technology capable of giving out the information of variety of bio molecules with wide density range.
    • Major factor restraining growth of multiplexed assay market is lack of clear reimbursement structure.
      • Considering all the growth drivers and restraining factors the major opportunities for multiplexed assay market lay in technical development in terms of automation of multiplexed techniques and development of generic platforms that can be used for a wide range of samples.
Global Multiplexed Diagnostics Market

Multiplex assays within a given application area or class of technology can be further stratified based on how many analytes can be measured per assay, where “multiplex” refers to those with the highest number of analyte measurements per assay (up to millions) and “low-plex” or “mid-plex” refers to procedures that process fewer (10s to 1000s).

Multiplex diagnostic assays are widely used in functional genomics experiments that endeavor to detect or to assay the state of all biomolecules within a biological sample, to determine the effect of an experimental treatment or the effect of the biomolecules or pathways in the sample.

  • Multiplex tests can be used to inform patient care. Given the limited clinical expertise and treatment options available at the community and primary care levels, multiplex tests are likely to be more relevant at the hospital level to identify pathogens in admitted patients.
  • Other multiplex efforts focus on developing device-based platforms that are more expensive and slightly more complex to implement.
    • However, device based tests often combine both antigen/antibody detection with molecular testing modalities.
      • These devices are likely to be used primarily at hospital level, given high costs and limitations on how actionable the results are (e.g. treatments available).

The global multiplexed diagnostics market report provides market size ($million 2021 to 2031), market share, growth trends and forecast (CAGR%, 2024 to 2031). 

The global market for multiplex diagnostics segmented by technology (low density multiplexed assays, medium density multiplexed assays, high density multiplexed assays), very high-density multiplexed assays, next generation sequencing assays), application (allergies, autoimmune diseases, cardiac disorders, infectious disease diagnosis, oncology), and geography.

  • Based on the technology, the medium density multiplexed assays segment accounted for the largest share of the total multiplexed diagnostics market, mainly driven by increasing use in genetic research. However it is predicted to decline in market size over the coming years and replaced by the next-generation sequencing and high density multiplexed assays segments.
    • Similarly, increasing emerging diseases that need new diagnosis tests and new drug development create demand for high density multiplexed assays.
  • On the other hand, the next-generation sequencing (NGS) segment expected to witness the largest revenue share by the end of forecast period, attributed to its wider use in the detection of infectious microorganisms such as viruses and bacteria.
    • Next generation sequencing technique is rapidly replacing all the other multiplexing techniques available in the market, due to the advantage of broader coverage of the diagnostic area, enhanced sensitivity, accurate results and reduced cost.
  • Multiplexing in diagnostics enables detection and analysis of several assays in parallel providing advantages such as saving cost for reagents, consumables and labor, saving time to read dozens, even hundreds of data points simultaneously, saving precious sample, as well as the ability to test a host of markers simultaneously.
    • The multiplex diagnostic protocols ensure the accuracy of test results through the inclusion of internal quality controls, standards and calibration curves, and increased sample throughput.
  • Validation of a large number of disease markers in both molecular and protein diagnostics has paved the way for the emergence of the multiplex assay.
    • Microspot microarray technology, in combination with protein biomarkers and nucleic acid diagnostics, appears to be the future high-performance analytical platform of choice.
  • The application of ELISA in a microarray format has the potential to simultaneously measure the presence and/or concentrations of numerous proteins.
    • Lateral flow assays (LFAs) are the mainstay of rapid point-of-care diagnostics, with the potential to enable early case management and transform the epidemiology of infectious disease.

The global multiplex diagnostics market research report is further divided by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA) and Rest of the World.

  • In terms of geography, the North America, followed by Europe regions led the global multiplexed diagnostics market, accounting for largest share.
    • Rising consumer awareness, technological advancements, growing prevalence of diseases, rapid adoption of advanced diagnostic methods, well-defined regulatory framework and observation guidelines, and sophisticated healthcare infrastructure, as they address high unmet needs are the major factors driving the market growth in developed regions.
  • However, the Asia Pacific region anticipated to witness fastest growth rate, owing to high unmet needs, growing public awareness, improving healthcare spending, presence of a large population base susceptible to infections and chronic diseases, lower cost of products and tests, and increase in the investment by the major companies in the developing countries.

The global multiplexed diagnostic assays market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market and provides analysis of the company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market.

In the multiplex diagnostics industry, there are limited, but some efforts to develop disposable, lateral flow based multiplex tests by the diagnostic companies.

  • Qiagen NV acquired start-up STAT-Dx with the goal of developing the next-generation of multiplex diagnostics for one-step, fully integrated molecular analysis of common syndromes, such as serious respiratory or gastrointestinal infections, as well as in oncology.
    • STAT-Dx’s DiagCORE point-of-care platform is designed to test for the presence or absence of multiple pathogens that may cause clinical syndromes.
      • STAT-Dx developed two DiagCORE tests, extensive respiratory and gastrointestinal panels, which was launched in Europe in 2018, and planned for the US in 2019, following regulatory clearances, and then in other markets worldwide.
      • More tests in development will target infectious disease, immune response monitoring, oncology and companion diagnostics.
    • The next-generation system, QIAstat-Dx can process up to 48 molecular targets simultaneously, and provide qualitative and quantitative insights in less than an hour, helping physicians make decisions about proper treatment, according to the firms.
      • It is designed for significantly more cost-efficient test processing as required by the current reimbursement environment.
    • Additional application areas for this system include companion diagnostics, quantitative analysis and immunoassay tests, offering customers a new level of flexibility and accurate diagnosis designed to support better outcomes for patients and health-care systems.
  • Chembio Diagnostic Systems Inc., a US-based company is developing several multiplex diagnostic technologies for fever management. The tests are based on company’s patented Dual Path Platform (DPP), which offers improved performance over traditional lateral flow technology, as well as simultaneous detection capabilities of both antigen and antibody in a disposable rapid test format.
    • The company’s DPP Zika, Chikungunya, Dengue IgM/IgG Assay System is in development through a partnership with the Paul G Allen Family Foundation, the United States Centers for Disease Control (CDC) and the United States Biomedical Advanced Research and Development Authority (BARDA). It is a disposable multiplex POC test for three febrile diseases with current expansion in multiple countries.

Major competitros operating in the global multiplexed diagnostic assays market and included in this report are Agilent Technologies, Inc., bioMerieux, Inc., Bio-Rad Laboratories, Inc., Hologic plc (Gen-Probe, Inc.), Illumina, Inc., DiaSorin (Luminex Corporation), Roche Holding AG, Seegene, Inc., and Thermo Fisher Scientific, Inc. (Affymetrix, Inc., Life Technologies Corp.).

  • Technology
    • Low Density Multiplexed Assays (plex ≤ 5)
    • Medium Density Multiplexed Assays (plex < 500)
    • High Density Multiplexed Assays (500 ≤ plex ≤ 10,000)
    • Very High-Density Multiplexed Assays (> 10,000-plex)
    • Next Generation Sequencing Assays
  • Application
    • Allergies
    • Autoimmune diseases
    • Cardiac Disorders
    • Infectious Disease Diagnosis
    • Oncology
    • Others
  • Geography
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC)
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • Agilent Technologies, Inc.bioMerieux, Inc.Bio-Rad Laboratories, Inc.Gen-Probe, Inc. (Hologic plc)Illumina, Inc.Luminex Corporation (DiaSorin)Roche Holding AG
    • Seegene, Inc.
    • Thermo Fisher Scientific. Inc. (Affymetrix, Inc., Life Technologies Corp.)

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