Molecular Quality Controls Market Size to Reach USD 289.7 Million in 2030 | Emergen Research

Increasing prevalence of infectious diseases, cancer, & genetic diseases is a key factor driving market revenue growth 


Vancouver, Sept. 07, 2023 (GLOBE NEWSWIRE) -- The global molecular quality controls market size was USD 160.2 Million in 2021 and is expected to register a revenue CAGR of 6.7% during the forecast period, according to latest analysis by Emergen Research. Molecular quality control market revenue growth is driven by factors such as increasing number of accredited clinical laboratories, growing adoption of third-party quality controls, and rise in government funding to support genomics projects. 

Molecular quality controls are helpful for evaluating the efficacy of in vitro nucleic testing processes for viral load tests, healthcare infections, and sexually transmitted infectious diseases. The major purpose of such quality controls is to examine molecular detection products to discover faults and alert management authorities. Increasing number of molecular quality control solutions makes it simple to achieve risk reduction targets by enabling laboratories to apply the best Quality Control (QC) procedures and cutting-edge data management systems.

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Infectious illness testing is one of the areas in which quality control processes have been widely adopted since recent years; these tests are frequently quantitative, FDA-cleared, have stated quality control protocols, and utilize a small number of analyses, which are all ideal conditions for the successful implementation of quality control procedures. The test for cystic fibrosis is one example of a multiplex diagnostic with quality controls. When it comes to monitoring testing methods, molecular quality controls can be extremely helpful. By performing these tests, essential and precise diagnostic information can be obtained.

A new section of multi-instrument and multi-analyte controllers has been created as a result of technological improvements. Using these modern controls, clinical laboratories can reduce expenses by eliminating the need for various controls for different instruments. Furthermore, these controls eliminate the need for time-consuming and independent quality control procedures for each analyte. The number of services offered by various companies has grown as new diagnostic options have been integrated. To help laboratories save time and space, Bio-Rad Laboratories (US) introduced EDX RP Positive Run Control in February 2020. This is the first multi-analyte control to target 22 analytes in a single vial.

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Scope of Research

Report DetailsOutcome
Market Size in 2021USD 160.2 Million
CAGR (2022–2030)6.2%
Revenue Forecast to 2030USD 289.7 Million
Base Year for Estimation2021
Historical Data2019–2020
Forecast Period2022–2030
Quantitative UnitsRevenue in USD Million and CAGR in % from 2022 to 2030
Report CoverageRevenue forecast, company ranking, competitive landscape, growth factors, and trends
Segments CoveredProduct, analyte type, application, end-use, and region
Regional ScopeNorth America, Europe, Asia Pacific, Latin America, and Middle East & Africa
Country ScopeU.S., Canada, Mexico, Germany, France, UK, Italy, Spain, Benelux, Rest of Europe, China, India, Japan, South Korea, Rest of APAC, Brazil, Rest of LATAM, Saudi Arabia, UAE, South Africa, Turkey, and Rest of Middle East & Africa
Key Companies ProfiledAbbott, LGC Limited, Thermo Fisher Scientific, Bio-Rad Laboratories, Inc., Microbiologics, Inc., F. Hoffmann-La Roche Ltd, ZeptoMetrix®, LLC, Quidel, Maine Molecular Quality Controls, INC., Bio-Techne.
Customization Scope10 hours of free customization and expert consultation

 Major Companies and Competitive Landscape

The global molecular quality control market is fairly fragmented, with a number of large and medium-sized players accounting for majority market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective solutions. Some major companies included in the global molecular quality control market report are:

  • Abbott
  • LGC Limited 
  • Thermo Fisher Scientific
  • Bio-Rad Laboratories, Inc.
  • Microbiologics, Inc.
  • F. Hoffmann-La Roche Ltd
  • ZeptoMetrix®, LLC 
  • Quidel
  • Maine Molecular Quality Controls, INC.
  • Bio-Techne

Strategic Development

  • On 05 March 2021, Bio-Rad and Roche have agreed into a global agreement to give Roche's customers access to Bio-complete Rad's portfolio of InteliQ devices and Unity QC data management solutions, as well as training and support services. The InteliQ products are intended to facilitate the streamlining of a lab's QC workflow with load-and-go efficiency and Unity QC data management solutions that reduce turnaround time and improve a lab's overall performance.
  • On 15 March 2021, Roche and GenMark Diagnostics recently announced that they had entered into a formal merger agreement for Roche to acquire GenMark in a cash-only deal for USD 24.05 per share. On a fully diluted basis, this equates to a total transaction value of about USD 1.8 billion.

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Some Key Highlights From the Report

  • Instrument-specific controls segment accounted for significantly large revenue share in 2021. Quality control in a Polymerase Chain Reaction (PCR) laboratory is primarily concerned with preventing errors during the execution of tests and validating the results of such tests. Quality control of both, the interior and exterior, is incorporated. Monitoring laboratory performance through the use of control material and/or repeated measurements is a component of internal quality control. This method has become a significant tool for detection of pathogenic microorganisms that do not grow in traditional culture media. Methods based on PCR are highly effective, allowing for the detection of even a single DNA molecule, which allows for the detection of diseases at extremely low concentrations.
  • Single analyte control segment accounted for a significantly large revenue share in 2021. Use of single-analyte standards has become incredibly common in clinical settings due to the ease of data processing and interpretation they provide and reduced risk of cross-reactivity. Single-Analyte kits are designed to quantify a single cytokine or chemokine in numerous samples using Enzyme-Linked Immunosorbent Assay (ELISA).
  • Infectious disease diagnostic segment accounted for a significantly large revenue share in 2021. Infectious diseases have been a leading source of mortality and disability for humans for a very long time. There are several ways in which human progress in civilization influenced the spread of infectious illnesses. For instance, domestication of animals is leading to an increase in prevalence of parasitic and zoonotic diseases, whereas the spread of airborne bacterial and viral infections has followed the rise of major settlements and urbanization. Large pandemics such as the plague, cholera, smallpox, influenza and COVID-19 have affected humanity throughout history, but chronic infectious diseases such as tuberculosis and syphilis have been silent killers. Molecular diagnostic tests can pick up on traces of RNA and DNA that may or may not be related to illness. Human leukocyte antigen typing, genetic disease screening, coagulation, and the study of infectious illnesses and cancer all rely heavily on these diagnostic tools 
  • Market in Asia Pacific accounted for a moderately large revenue share in 2021. Rising preference for early diagnosis, a large patient population, improved infrastructure and services, and persistent scientific investigation into diagnostic methods all contribute to a rapid expansion strategy. Revenue growth of the molecular diagnostics market in this region is being driven by a number of factors, including the government's efforts to raise awareness of the importance of early detection of diseases and routine health checkups, growing proportion of hospitals and medical laboratories in India and China, continuously rising cost of healthcare, and the strengthening of the research base for diagnostic procedures in countries such as India, China, and Japan.

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Emergen Research has segmented the global molecular quality control market on the basis of product, analyte type, application, end-use, and region:

  • Product Outlook (Revenue, USD Million; 2019-2030)
    • Independent Controls
    • Instrument-Specific Controls
      1. Polymerase Chain Reaction (PCR)
      2. DNA Sequencing & NGS
  • Analyte Type Outlook (Revenue, USD Million; 2019-2030)
    • Single-Analyte Controls
    • Multi-Analyte Controls
  • Application Outlook (Revenue, USD Million; 2019-2030)
    • Infectious Disease Diagnostics
    • Oncology Testing
    • Genetics Testing
    • Other Applications
  • End-use Outlook (Revenue, USD Million; 2019-2030)
    • Hospitals
    • Diagnostic Laboratories
    • IVD Manufacturers
    • Academic & Research Institute
    • Other End-users
  • Regional Outlook (Revenue, USD Million; 2019-2030)
    • North America
      1. U.S.
      2. Canada
      3. Mexico
    • Europe
      1. Germany
      2. France
      3. U.K.
      4. Italy
      5. Spain
      6. Benelux
      7. Rest of Europe
    • Asia Pacific
      1. China
      2. India
      3. Japan
      4. South Korea
      5. Rest of APAC
    • Latin America
      1. Brazil
      2. Rest of LATAM
    • Middle East & Africa
      1. Saudi Arabia
      2. UAE
      3. South Africa
      4. Turkey
      5. Rest of MEA

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