Regulatory Landscape: Compliance and Impact on Multiplex Assays Industry

Multiplex Assays Market in terms of revenue was estimated to be worth $3.5 billion in 2022 and is poised to reach $5.3 billion by 2027, growing at a CAGR of 8.8% from 2022 to 2027 according to a new report by MarketsandMarkets™.

Growth in this market is mainly driven by factors such as the emerging applications of multiplex assay in companion diagnostics and the growing need for automated and efficient systems in laboratories.

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Report Coverage	Details
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	Product & service, type, technology, application, end user, and region
Geographies Covered	North America, Europe, Asia Pacific, and the Rest of the World
Report Highlights	Updated financial information / product portfolio of players

 

The multiplex assays market is segmented into protein, nucleic acid, and cell-based multiplex assays according to type. The protein multiplex assays segment accounted for the largest share in the global multiplex assays market in 2022. As compared to traditional assays, protein multiplex assays prove to be faster and more efficient for protein profiling. Protein assays are highly efficient, require minimal sample volumes, and help reduce turnaround times; however, the equipment is expensive and requires skilled labor. This is expected to hamper the growth of the protein assays market.

 

Based on applications, the multiplex assays market is segmented into research & development and clinical diagnostics. The clinical diagnostics segment is further segmented into infectious diseases, cancer, cardiovascular diseases, autoimmune diseases, nervous system disorders, metabolism & endocrinology disorders, and other diseases. In 2022, the infectious diseases segment accounted for the largest share of the multiplex assays market for clinical diagnostics. Conventional analytical techniques that are used for the detection and identification of pathogens, such as ELISA and cell culture assays, take 2–3 days to produce results. Some multiplex assays, on the other hand, can provide results in a day or less; their rapidity is the key factor supporting their adoption in infectious disease diagnostics.

 

The global multiplex assays market has been segmented into five major regions—North America, Europe, the Asia Pacific, and the Rest of the World. In 2022, North America accounted for the largest share of the multiplex assays market. The large share of this region can be attributed to the highly advanced healthcare system in the US and Canada. Over the years, healthcare spending in North America has increased at a significant rate. National health spending is projected to grow at an average annual rate of 5.4% during 2019–2028 and reach USD 6.2 trillion by 2028 (Source: Centers for Medicare & Medicaid Services). The growing healthcare expenditure is also one of the major drivers for the biotechnology sector.

 

Multiplex Assays Market Dynamics:

 

Drivers:

1.       Increasing prevalence of chronic respiratory diseases

2.       Growing demand for emergency and intensive care

3.       Growing incidence of pre-term births globally

4.       Government support for improving emergency care infrastructure

Restraints:

1.       Lack of reimbursement policies across developing countries

Opportunities:

1.       Growing demand for single-use Multiplex Assays

2.       Increased growth potential in emerging countries

Challenges:

1.       Harmful effects of Multiplex Assays on neonatal patients

2.       Dearth of skilled professionals for airway management procedures

3.       Increasing pricing pressure on key market players

 

Key Market Players:

 

The major players operating in this market are Illumina, Inc. (US), Thermo Fisher Scientific, Inc. (US), Bio-Rad Laboratories, Inc. (US), Becton, Dickinson and Company (US), DiaSorin S.p.A. (Italy), QIAGEN N.V. (Netherlands), Abcam plc (UK), Merck KGaA (Germany), Agilent Technologies, Inc. (US), Quanterix (US), Bio-Techne (US), MESO SCALE DIAGNOSTICS, LLC (US), Randox Laboratories Ltd. (UK), Olink (Sweden), Seegene Inc. (South Korea), Siemens Healthcare AG (Germany), PerkinElmer Inc. (US), Shimadzu Corporation (Japan), Promega Corporation (US), Enzo Biochem Inc. (US), Cayman Chemical (US), Boster Biological Technology (US), Antigenix America, Inc. (US), Quansys Biosciences Inc. (US), and RayBiotech Life, Inc. (US).

 

Recent Developments:

·         In September 2021, Bio-Rad Laboratories launched its Bio-Plex Pro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens. The panels are for research use only (RUO).

·         In September, DiaSorin S.p.A. received the CE mark approval for its Simplexa COVID-19 & Flu A/B Direct kit, a multiplex test for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, and influenza B virus from the same patient sample in one reaction well. The assay is designed for use on the LIAISON MDX and is run directly from nasopharyngeal swabs (NPS) without the need for offboard extraction.

·         In August 2021, Becton, Dickinson and Company launched its new and fully automated high-throughput diagnostic system, BD COR System. The system uses robotics and sample management software algorithms to set a new standard in automation for infectious disease molecular testing in core laboratories and other centralized laboratories in the US.

·         In July 2021, DiaSorin S.p.A. acquired the leading company of multiplex assays, Luminex Corporation, for a price of USD 37.00 per share, that corresponds to a total equity value of approximately USD 1.8 billion.

·         In February 2021, Thermo Fisher Scientific acquired Mesa Biotech, a privately-held point-of-care molecular diagnostic company. This acquisition strengthened Thermo Fisher's operational excellence, access to raw materials, and existing distribution & sales channels with Mesa's innovative platform with a diverse array of diagnostic products, such as Accula System by Mesa Biotech that is dedicated to COVID-19 testing.

 

Multiplex Assays Market - Report Highlights:

 

·         More Refined Presentation of the Competitive Landscape and Recent Market Developments:

·         We have added market shares for top players. Recent developments are helpful to know the market trends and growth strategies adopted by players in the market. The report provides updated developments in product launches, collaboration, acquisitions, and partnerships.

·         Additional Information: The current edition of the report covers recession impact analysis.

·         More Refined Presentation of the Company Profiles Segment: Company profiles give a glimpse of the key players in the market with respect to business overviews, financials, product offerings, and recent developments. The new edition of the report provides an updated product portfolio of the companies profiled in the report. A total of 25 companies have been profiled. These companies have emerged as key market players in recent years due to the products they offer, and various strategic investments undertaken in the multiplex assays market space.

·         Newer and Improved Representation of Financial Information: The new edition of the report provides updated financial information in the context of the multiplex assays market until 2021/2022 (depending on availability) for each listed company. This will help analyze the present status of the profiled companies in terms of their financial strength, profitability, key revenue-generating country/region, business segment focus in terms of the highest revenue-generating segments, and investments in research and development activities.

·         Recent Market Developments: Recent developments are important to understand the market trends and growth strategies adopted by players operating in the global multiplex assays market. The current edition of this report provides updated developments of profiled players from January 2020 to April 2023, indicating a continuation of the previous version. Product launches and acquisitions are the principal growth strategies adopted by market players in this period.

 

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