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Molecular Quality Controls Market

Global Molecular Quality Controls Market Size, Share, Trends: By Product Type: DNA- Based Quality Controls, RNA-Based Quality Control, Protein-Based Quality Controls, Nucleic Acid and Protein Mixtures, Others; By Analyte Type: Single Analyte Control, Others; By Applications; By End User; Regional Analysis; Competitive Landscape; 2024-2032

Global Molecular Quality Controls Market Outlook

The global molecular quality controls market size was valued at USD 186.7 million in 2023, driven by the increasing incidence of HIV and cancer across the globe. The market size is anticipated to grow at a CAGR of 6.8% during the forecast period of 2024-2032 to achieve a value of USD 337.1 million by 2032.

 

Molecular Quality Controls: Introduction

Molecular quality controls are standardized materials or substances used in molecular diagnostic testing to assess the accuracy, precision, and reliability of the testing process. These controls mimic patient samples and contain known quantities of specific nucleic acids, proteins, or other molecular targets of interest. By including molecular quality controls in the testing process, clinical laboratories can monitor the performance of their molecular assays and ensure that the results are accurate and consistent.

 

Global Molecular Quality Controls Market Analysis

The market for molecular quality controls is driven by advancements in molecular diagnostic technologies, coupled with the continuous evolution of RT PCR (Reverse Transcription Polymerase Chain Reaction) and NGS (Next-Generation Sequencing) technologies. These technologies are becoming increasingly sophisticated and efficient, enabling more accurate and comprehensive molecular diagnostics. The emergence of ultrafast PCR technology, utilizing photothermal nanomaterials, represents a groundbreaking trend in the field. This technology has the potential to revolutionize molecular testing by significantly shortening test times, offering results in a fraction of the time compared to conventional PCR testing. Such innovations are enhancing the speed and efficiency of molecular diagnostics, a crucial trend in the healthcare industry.

 

The molecular quality controls market growth is also aided by the rising mergers and investments, along with the rising investment from the government on the development of healthcare sector. Furthermore, the collaborative efforts between pharmaceutical companies like Vertex and CRISPR Therapeutics in developing CRISPR-based therapies for conditions like sickle cell disease are opening new frontiers in molecular medicine. If approved, these therapies would mark a historic milestone as the first CRISPR-based treatments for human use. This signifies the growing potential of CRISPR technology to advance human health, making it a prominent trend to watch.

 

Global Molecular Quality Controls Market Segmentations

Market Breakup by Product Type

  • DNA- Based Quality Controls
  • RNA-Based Quality Control
  • Protein-Based Quality Controls
  • Nucleic Acid and Protein Mixtures
  • Others

 

Market Breakup by Analyte Type

  • Single Analyte Control
  • Multi-Analyte Control

 

Market Breakup by Applications

  • Infectious Diseases
  • Oncology
  • Genetic Testing
  • Other Applications

 

Market Breakup by End User

  • Clinical Laboratories
  • Hospitals
  • IVD Manufacturers
  • Contract Research Organizations
  • Academic and Research Institutes

 

Market Breakup by Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

 

Global Molecular Quality Controls Market Overview

The market for molecular quality controls is driven by the rising prevalence of infectious diseases, which has prompted the need for accurate and reliable molecular diagnostic tests. This increasing demand for diagnostics is fuelling the adoption of molecular quality controls as they play a vital role in ensuring the accuracy and precision of these tests. Rapid advancement in molecular diagnostic technologies is another significant driver which is anticipated to drive the molecular quality controls market demand. As diagnostic methods become more sophisticated and sensitive, the need for equally advanced quality control solutions becomes paramount. Molecular quality controls help diagnostic laboratories validate their tests and maintain high standards of accuracy. The growing emphasis on quality assurance in diagnostic laboratories is promoting the uptake of molecular quality controls. Ensuring the reliability of test results is crucial for patient care, and these controls provide an essential tool for achieving this goal.

 

Moreover, the widespread adoption of internet-based technologies has facilitated the distribution and management of molecular quality controls, making them more accessible and efficient for laboratories worldwide. The growing adoption of third-party quality controls offer laboratories independent and unbiased assessments of their testing processes.

 

Furthermore, increasing government funding for genomic projects is driving research and development efforts in the field of molecular diagnostics. This funding helps in the advancement of technology and encourages the development of high-quality molecular quality controls to support these initiatives.

 

Global Molecular Quality Controls Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

 

  • Bio-Rad Laboratories, Inc. 
  • Thermo Fisher Scientific, Inc. 
  • Roche Diagnostics 
  • SeraCare Life Sciences, Inc. 
  • QIAGEN N.V. 
  • Abbott Laboratories 
  • LGC Limited 
  • ZeptoMetrix Corporation 
  • Microbiologics, Inc. 
  • Maine Molecular Quality Controls, Inc. 
  • Seracare Life Sciences, Inc. 
  • Technopath Clinical Diagnostics 
  • Randox Laboratories Ltd. 
  • Helena Laboratories 
  • Streck, Inc. 

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product Type
  • Analyte Type
  • Applications
  • End User
  • Region
Breakup by Product Type
  • DNA- Based Quality Controls
  • RNA-Based Quality Control
  • Protein-Based Quality Controls
  • Nucleic Acid and Protein Mixtures
  • Others
Breakup by Analyte Type
  • Single Analyte Control
  • Multi Analyte Control
Breakup by Applications
  • Infectious Diseases
  • Oncology
  • Genetic Testing
  • Other Applications
Breakup by End User
  • Clinical Laboratories
  • Hospitals
  • IVD Manufacturers 
  • Contract Research Organizations
  • Academic and Research Institutes
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific, Inc.
  • Roche Diagnostics
  • SeraCare Life Sciences, Inc.
  • QIAGEN N.V.
  • Abbott Laboratories
  • LGC Limited
  • ZeptoMetrix Corporation
  • Microbiologics, Inc.
  • Maine Molecular Quality Controls, Inc.
  • Seracare Life Sciences, Inc.
  • Technopath Clinical Diagnostics
  • Randox Laboratories Ltd.
  • Helena Laboratories
  • Streck, Inc.

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1   Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions 
    1.3    Report Coverage – Key Segmentation and Scope  
    1.4    Research Methodology
2    Executive Summary
3    Global Molecular Quality Controls Market Overview 

    3.1    Global Molecular Quality Controls Market Historical Value (2017-2023) 
    3.2    Global Molecular Quality Controls Market Forecast Value (2024-2032)
4    Global Molecular Quality Controls Market Landscape
    4.1    Global Molecular Quality Controls Developers Landscape
        4.1.1    Analysis by Year of Establishment
        4.1.2    Analysis by Company Size
        4.1.3    Analysis by Region
    4.2    Global Molecular Quality Controls Product Landscape
        4.2.1    Analysis by Type
        4.2.2    Analysis by Technology 
        4.2.3    Analysis by Application
5    Global Molecular Quality Controls Market Dynamics
    5.1    Market Drivers and Constraints
    5.2    SWOT Analysis
    5.3    Porter’s Five Forces Model 
    5.4    Key Demand Indicators
    5.5    Key Price Indicators
    5.6    Industry Events, Initiatives, and Trends 
    5.7    Value Chain Analysis
6    Global Molecular Quality Controls Market Segmentation 
    6.1    Global Molecular Quality Controls Market by Product Type
        6.1.1    Market Overview
        6.1.2    DNA- Based Quality Controls
        6.1.3    RNA-Based Quality Control
        6.1.4    Protein-Based Quality Controls
        6.1.5    Nucleic Acid and Protein Mixtures
        6.1.6    Others
    6.2    Global Molecular Quality Controls Market by Analyte Type
        6.2.1    Market Overview
        6.2.2    Single Analyte Control
        6.2.3    Multi Analyte Control
    6.3    Global Molecular Quality Controls Market by Applications
        6.3.1    Market Overview
        6.3.2    Infectious Diseases
        6.3.3    Oncology
        6.3.4    Genetic Testing
        6.3.5    Other Applications
    6.4    Global Molecular Quality Controls Market by End User
        6.4.1    Market Overview
        6.4.2    Clinical Laboratories
        6.4.3    Hospitals
        6.4.4    IVD Manufacturers 
        6.4.5    Contract Research Organizations
        6.4.6    Academic and Research Institutes
    6.5    Global Molecular Quality Controls Market by Region
        6.5.1    Market Overview
        6.5.2    North America 
        6.5.3    Europe
        6.5.4    Asia Pacific
        6.5.5    Latin America
        6.5.6    Middle East and Africa
7    North America Molecular Quality Controls Market
    7.1    Market Share by Country
    7.2    United States of America
    7.3    Canada
8    Europe Molecular Quality Controls Market
    8.1    Market Share by Country
    8.2    United Kingdom
    8.3    Germany
    8.4    France
    8.5    Italy
    8.6    Others
9    Asia Pacific Molecular Quality Controls Market
    9.1    Market Share by Country
    9.2    China
    9.3    Japan
    9.4    India
    9.5    ASEAN
    9.6    Australia
    9.7    Others
10    Latin America Molecular Quality Controls Market
    10.1    Market Share by Country
    10.2    Brazil
    10.3    Argentina
    10.4    Mexico
    10.5    Others
11    Middle East and Africa Molecular Quality Controls Market
    11.1    Market Share by Country
    11.2    Saudi Arabia
    11.3    United Arab Emirates
    11.4    Nigeria
    11.5    South Africa
    11.6    Others
12    Patent Analysis
    12.1    Analysis by Type of Patent
    12.2    Analysis by Publication year
    12.3    Analysis by Issuing Authority
    12.4    Analysis by Patent Age
    12.5    Analysis by CPC Analysis
    12.6    Analysis by Patent Valuation 
    12.7    Analysis by Key Players
13    Grants Analysis
    13.1    Analysis by year
    13.2    Analysis by Amount Awarded
    13.3    Analysis by Issuing Authority
    13.4    Analysis by Grant Application
    13.5    Analysis by Funding Institute
    13.6    Analysis by NIH Departments
    13.7    Analysis by Recipient Organization 
14    Funding Analysis
    14.1    Analysis by Funding Instances
    14.2    Analysis by Type of Funding
    14.3    Analysis by Funding Amount
    14.4    Analysis by Leading Players
    14.5    Analysis by Leading Investors
    14.6    Analysis by Geography
15    Partnership and Collaborations Analysis
    15.1    Analysis by Partnership Instances
    15.2    Analysis by Type of Partnership
    15.3    Analysis by Leading Players
    15.4    Analysis by Geography
16    Regulatory Framework
    16.1    Regulatory Overview
        16.1.1    US FDA
        16.1.2    EU EMA
        16.1.3    INDIA CDSCO
        16.1.4    JAPAN PMDA
        16.1.5    Others
17    Supplier Landscape
    17.1    Bio-Rad Laboratories, Inc.
        17.1.1    Financial Analysis
        17.1.2    Product Portfolio
        17.1.3    Demographic Reach and Achievements
        17.1.4    Mergers and Acquisition
        17.1.5    Certifications
    17.2    Thermo Fisher Scientific, Inc.
        17.2.1    Financial Analysis
        17.2.2    Product Portfolio
        17.2.3    Demographic Reach and Achievements
        17.2.4    Mergers and Acquisition
        17.2.5    Certifications
    17.3    Roche Diagnostics
        17.3.1    Financial Analysis
        17.3.2    Product Portfolio
        17.3.3    Demographic Reach and Achievements
        17.3.4    Mergers and Acquisition
        17.3.5    Certifications
    17.4    SeraCare Life Sciences, Inc.
        17.4.1    Financial Analysis
        17.4.2    Product Portfolio
        17.4.3    Demographic Reach and Achievements
        17.4.4    Mergers and Acquisition
        17.4.5    Certifications
    17.5    QIAGEN N.V.
        17.5.1    Financial Analysis
        17.5.2    Product Portfolio
        17.5.3    Demographic Reach and Achievements
        17.5.4    Mergers and Acquisition
        17.5.5    Certifications
    17.6    Abbott Laboratories
        17.6.1    Financial Analysis
        17.6.2    Product Portfolio
        17.6.3    Demographic Reach and Achievements
        17.6.4    Mergers and Acquisition
        17.6.5    Certifications
    17.7    LGC Limited
        17.7.1    Financial Analysis
        17.7.2    Product Portfolio
        17.7.3    Demographic Reach and Achievements
        17.7.4    Mergers and Acquisition
        17.7.5    Certifications
    17.8    ZeptoMetrix Corporation
        17.8.1    Financial Analysis
        17.8.2    Product Portfolio
        17.8.3    Demographic Reach and Achievements
        17.8.4    Mergers and Acquisition
        17.8.5    Certifications
    17.9    Microbiologics, Inc.
        17.9.1    Financial Analysis
        17.9.2    Product Portfolio
        17.9.3    Demographic Reach and Achievements
        17.9.4    Mergers and Acquisition
        17.9.5    Certifications
    17.10    Maine Molecular Quality Controls, Inc.
        17.10.1    Financial Analysis
        17.10.2    Product Portfolio
        17.10.3    Demographic Reach and Achievements
        17.10.4    Mergers and Acquisition
        17.10.5    Certifications
    17.11    Seracare Life Sciences, Inc.
        17.11.1    Financial Analysis
        17.11.2    Product Portfolio
        17.11.3    Demographic Reach and Achievements
        17.11.4    Mergers and Acquisition
        17.11.5    Certifications
    17.12    Technopath Clinical Diagnostics
        17.12.1    Financial Analysis
        17.12.2    Product Portfolio
        17.12.3    Demographic Reach and Achievements
        17.12.4    Mergers and Acquisition
        17.12.5    Certifications
    17.13    Randox Laboratories Ltd.
        17.13.1    Financial Analysis
        17.13.2    Product Portfolio
        17.13.3    Demographic Reach and Achievements
        17.13.4    Mergers and Acquisition
        17.13.5    Certifications
    17.14    Helena Laboratories
        17.14.1    Financial Analysis
        17.14.2    Product Portfolio
        17.14.3    Demographic Reach and Achievements
        17.14.4    Mergers and Acquisition
        17.14.5    Certifications
    17.15    Streck, Inc.
        17.15.1    Financial Analysis
        17.15.2    Product Portfolio
        17.15.3    Demographic Reach and Achievements
        17.15.4    Mergers and Acquisition
        17.15.5    Certifications
18    Global Molecular Quality Controls Market - Distribution Model (Additional Insight)
    18.1    Overview 
    18.2    Potential Distributors 
    18.3    Key Parameters for Distribution Partner Assessment 
19    Key Opinion Leaders (KOL) Insights (Additional Insight)
20    Company Competitiveness Analysis (Additional Insight)

    20.1    Very Small Companies
    20.2    Small Companies
    20.3    Mid-Sized Companies
    20.4    Large Companies
    20.5    Very Large Companies
21    Payment Methods (Additional Insight)
    21.1    Government Funded
    21.2    Private Insurance
    21.3    Out-of-Pocket


*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The market attained a value of about USD 186.7 million in 2023, driven by the rapid technological advancements.

The market is anticipated to grow at a CAGR of 6.8% during the forecast period of 2024-2032 and is likely to reach a market value of USD 337.1 million by 2032.

The growing healthcare sector and the continuous advancement in molecular diagnostic technologies is a major factor driving the market growth.

The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East and Africa. North America is currently leading the global market.

Various products in the market include DNA-based quality controls, RNA-based quality control, protein-based quality controls, and nucleic acid and protein mixtures, among others.

There are single-analyte control and multi-analyte control in the market.

They find wide applications in infectious diseases, oncology, and genetic testing, among other applications.

End users in the market are clinical laboratories, hospitals, IVD manufacturers, contract research organizations, and academic or research institutes, among others.

Key players involved in the market are Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., Roche Diagnostics, SeraCare Life Sciences, Inc., QIAGEN N.V., Abbott Laboratories, LGC Limited, ZeptoMetrix Corporation, Microbiologics, Inc., Maine Molecular Quality Controls, Inc., Seracare Life Sciences, Inc., Technopath Clinical Diagnostics, Randox Laboratories Ltd., Streck, Inc., and Helena Laboratories.

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