Immunoassay is a technique utilized for sensitive and highly specific detection of analytes present in biological samples utilized for both life sciences research and clinical diagnostics. Multiple immunoassays provide wealth of information based on multiple proteins and other bio molecules in diverse biological processes thus offering clinicians with insight for identification and assessment of disease progression.

In addition, immunoassay are gaining high popularity and acts as a promising evaluation technique for environmental and food protection. This accelerates the utility that enhances innovations across the global Multiplex Detection Immunoassay market.

Validation for Clinical Diagnostics Should be on a Frontline in the Forthcoming Years

The ability to measure several analytes simultaneously, Multiplex Detection Immunoassay undergoes several quality control barrier compared to singleplex arrays. Despite extensive and transparent quality standards in Point-of-Care (POC) settings, implementation of Multiplex Detection Immunoassay is still underdevelopment that represents an uncompromising obstacle in widespread application in clinical settings. Lack of robust multivariate quality control algorithms and data rejection criteria for Multiplex Detection Immunoassay is also problematic. Moreover, standardization of data reporting, common analysis apparatus and meaningful controls is under developmental stage to enhance statistical confidence with consistent and reliable results.

For records, the Clinical Laboratory Improvements Amendments (CLIA), Food and Drug Administration (FDA),  Medicines and Healthcare Products Regulatory Agency (MHRA), and United Kingdom Accreditation Service (UKAS) acts as strong regulatory bodies involved in validation of novel or modified Multiplex Detection Immunoassay prior to their enrolling in routine clinical diagnostics for the generation of legitimate patient results. The clinical practice validation involves proficiency testing, instrument calibration and correlation clinical findings, and assessment of employee competency. Further, development of standardized evaluation paradigm will ensure highest level of performance within and across laboratories so that tests provide patients with accurate results.

Impact of COVID-19 on Multiplex Detection Immunoassay Market

The pandemic Corona virus represents the need for rapid and effective test method in order to detect and identify the target virus. High spread of the disease has set an alarm for the healthcare providers to supply the necessary immunoassay test kits. Immunoassay test strips acts as a promising tool for the first line diagnosis COVID-19 during the ascendant phase of the virus and will maintain positive growth rate. This is attributed due to no requirement for expensive equipment and chemicals which make them affordable and easily available as Point-of-care (POC) tests. Faster results and high scalability are the other factors that drive the demand for such test kits. Multiplex detection kits for centralized or laboratory testing has grab a revenue share of around 67.9% in 2020. By integration of automated high throughput laboratory platforms enables laboratories to efficiently process multiple numbers of samples with the maintenance of high quality and integrity in results. Such factors contribute to Multiplex Detection Immunoassay as a centralized procedure and critical element in COVID-19 response strategy.

 Market Dynamics

Prevalence of Chronic and Infectious Diseases fuel the demand for Multiplex Detection Immunoassay Test Kits

As per World Health Organization (WHO), in 2019 the top 10 causes of death accounted for 55% of the 55.4 million deaths worldwide. These causes of deaths can be categorized as communicable infectious and parasitic diseases and maternal, prenatal, and nutritional conditions non-communicable (chronic) and injuries. Globally, 7 out of 10 leading causes of in 2019 were non-communicable diseases that accounted for 74% of all deaths recorded worldwide in 2019.

Centers for Disease Control and Prevention (CDC), highlight that 6 in 10 adults in the US suffer from chronic diseases. It is anticipated that nearly half around 49% of the population of the country is likely to get affected by chronic disease by 2025. Such factors bolster the demand for immunoassay test kits. By introducing new testing technology in the market for mitigating adverse impact of current pandemic act as a revenue growth factor for the competitive players supply these detection test kits. 

One such technology is Next-Generation Sequencing Technology (NGS). The technology possess strong potential to run 1,00,000 pooled sampling a single instrument within 8 to 12 hours that escalates the testing capacity. Such technologies also act as a market opportunity in the coming years.

Demand for Laboratory Integration and Automation acts as a Key Driver for Multiplex Detection Immunoassay Market

Utility of automated immunoassay analyzers in hospitals accounted largest revenue of around USD 2,925.8 million in 2017. The demand for such analyzers was at a peak due to high consolidation trend among hospitals that led to high test volumes and favorable health reforms to offer better hospital care. Moreover, rising number of corporate hospital chains boosts automated immunoassay analyzers market.

One such automated immunoassay is Chemiluminescence immunoassay analyzer. In 2017, it contributed around USD 2,890.5 million revenue share and acts a largest revenue contributor in the global market. Factors involve high sensitivity and accuracy of analyte detection that results in accurate diagnosis, higher receptiveness, and veracity.

Rising demand for Multiplex Detection Immunoassay for Clinical Diagnosis Application

The rising demand for Multiplex Detection Immunoassay in clinical diagnosis will gain a significant upward peak owing to wide application for infectious disease testing, veterinary disease testing, and R&D activities.

Prosthetic joint replacements are primarily used to enhance quality of life, improve mobility, and restore joint functions. As prosthetic joint replacement is a globally accepted treatment, prosthetic joint infection is one of the leading causes of knee arthroplasties that makes early diagnosis critical. This drives the demand for Multiplex Detection Immunoassays.

For instance, to prevent prosthetic joint infection, several immunoassays are available to assist in early detection of infections among which lateral flow Multiplex Detection Immunoassay takes a forefront lead in the market due to high adoption rate as available at low simplicity, and speed of activity.

Market Segmentation

Multiplex Detection Immunoassay market is segmented by Assay Type, Technique, Application, and End-User. By Assay Type, the market is bifurcated as Bed based Assay and Planar Assay. By Technique the market is segmented as Protein Based Technique, Bio-sensor Based Technique, and Nucleic Acid-Based Technique. Further, Application is segregated as Food Contamination Testing, R&D, Disease Testing, and Veterinary Disease Testing. End-User is segmented into Clinical Research Organizations, Pharmaceutical & Biopharmaceutical Companies, Academic & Research Institutes, Diagnostic Centers, and Others.

By Assay Type, Planar Assay will gain a significant growth in the forthcoming years globally. Factors that attribute for growth of this segment involves in-built high resolution imaging that support quality control information. By providing appropriate software that comprises of “Molecular Devices Genepix Pro software” have gain a significant pace in the worldwide market. Apart from that, alignment of data grid that integrates the actual tracing of the detection spots with the help software to locate the outline of each spots.

By Technique, Protein based Technique will take a strong lead in the market. Protein based assay are used to determine the concentration of solubilized protein. Several biochemical method are available that includes isolation, quantification, and analysis of proteins. As protein based assays have therapeutic applications such as electrophoresis, molecular biology, cell biology, protein purification, it has gained significant attention in the worldwide market. Other factors that contribute for the significant growth of protein based assay includes substantial public private investments in proteomic research and  high spending on pharmaceutical and biotechnology R&D for diagnosis of chronic diseases such as HIV and cancer.

For records, in 2018, UK government announced an initial investment of US$ 279.9 million for development of initial medicine that identify individual suffering from rare disease and geriatric population that boosts research activities development of antibodies.

As per the Information Technology & Innovation Foundation (ITIF), biopharmaceutical companies heavily invest research, discovery, testing, and manufacturing of medicines and therapeutics. Large biopharmaceutical companies invest considerable resources in R&D that is responsible of 77% global pharmaceutical companies R&D funding.  In the US life-science sector is extremely research centric that invests over 21% of its sales in R&D   that accounts for 23% of domestic R&D funded by US businesses more than one sector. Moreover, in 2015, the US attracted 74% of all global venture-capital investment in the pharmaceutical & biopharmaceutical industry. 

Regional Landscape

Based on regions, the market for Multiplex Detection Immunoassay covers North America, Asia Pacific, the Middle East & Africa, Latin America, and Europe.

Based on regions, North America will gain a significant momentum and act as revenue generator in the Multiplex Detection Immunoassay market owing to emerging several market players in this region and well developed healthcare infrastructure. In addition, high government spending and demand for new development of novel drug and biomarkers further spur the regional growth.

With the outbreak of novel corona virus the demand for funds for aligning the tests kits and actual experimentation at laboratory sites have expanded globally. On March 13, 2020-HHS announced funding for developmeCOVID-19 diagnostic test kits. The Biomedical Advanced Research Development Authority (BARDA) offered a package of approx. US$ 5,98,000 to QIAGEN LLC of Germantown, Maryland that focus on accelerating development of  QIAstat-Dx RPS2 test for COVID-19. 

Asia Pacific is anticipated to register highest growth rate in the forthcoming years. The factor that contributes for the significant growth involves high government initiatives that encourage drug discovery and development. Japanese government promotes strategic alliances between the market players development of market assay tests. Further, Chinese pharmaceuticals are focussing upon production of precision medicines, biomarkers, multiplex assays and novel therapies whereas Indian market is decided by a high number of clinical trials for cancer coupled with government investments in promoting drug discovery activities. The clinical trails for cancer would raise the demand for multiplex assays test and assays required to develop personalized medicines that detect biomarkers directing specific therapies benefiting the patients.

Competitive Landscape

Key companies profiled in this report involve Hoffmann-La Roche Ltd, QIAGEN, Merck KGaA, Microsynth AG, Bio-Rad Laboratories, Thermo Fisher Scientific, Luminex Corporation, Becton, and Dickinson and Company.

Market Segmentation

Market By Assay Type

Planar Assay

Bead-based Assay

Market By Technique

Nucleic Acid-based Techniques

Protein-based Techniques

Biosensor-based Techniques

Market By Application

Disease Testing

Food Contamination Testing

Research & Development

Veterinary Disease Testing

Market By End User

Pharmaceutical & Biopharmaceutical Companies

Clinical Research Organizations

Food & Beverages Industry

Academic & Research Institutes

Diagnostic Centers

Others

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa