+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Molecular Quality Controls Market Report and Forecast 2024-2032

  • PDF Icon

    Report

  • 140 Pages
  • October 2023
  • Region: Global
  • Expert Market Research
  • ID: 5910829
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 essential tools used in molecular diagnostics and clinical laboratories to ensure the accuracy and reliability of test results. These controls serve as external verification samples containing target nucleic acids (like DNA or RNA) that mimic patient samples. By testing these controls alongside patient samples, laboratories can confirm that their diagnostic processes are functioning correctly and producing consistent and accurate results.

Key Trends in the Global Molecular Quality Controls Market

The global molecular quality controls market is undergoing dynamic shifts, largely driven by the rising emphasis on accurate and reliable diagnostic testing. A prominent trend is the increasing adoption of third-party independent controls, which provide an unbiased assessment of assay performance, gaining preference over manufacturer-provided controls. There's also a heightened demand for multi-analyte controls, allowing labs to verify multiple targets in a single control, thereby optimizing workflow and cost-efficiency.

With the rapid proliferation of molecular diagnostic tests, especially amid the COVID-19 pandemic, there's a marked surge in the demand for controls specific to emerging infectious diseases. Technological advancements have also ushered in the era of digital molecular controls, leveraging synthetic DNA sequences and bioinformatics for enhanced precision and reproducibility. Regulatory bodies worldwide are now emphasizing stricter guidelines, pushing laboratories to adopt frequent quality control measures. Moreover, the growth of personalized medicine and next-generation sequencing (NGS) techniques necessitates advanced controls to ensure the accuracy of complex diagnostic outputs. In essence, the global molecular quality controls market is evolving rapidly, shaped by technological innovations, regulatory mandates, and the ever-growing need for precise diagnostic assays.

Global Molecular Quality Controls Market Segmentation

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 global molecular quality controls market is witnessing significant growth, underscored by the burgeoning demand for high-precision molecular diagnostic testing. This growth is reinforced by the increasing prevalence of infectious diseases, genetic disorders, and the broad acceptance of personalized medicine, all of which necessitate accurate diagnostic results. The market's landscape is further enriched by the emergence of third-party independent controls, offering an impartial evaluation of assay performance. These controls have become particularly relevant as they counteract potential biases associated with manufacturer-provided controls. The rapid response to emerging infectious diseases, as evidenced during the COVID-19 pandemic, has catapulted the demand for specialized quality controls, ensuring the reliability of newly developed tests.

Technological forays, including digital molecular controls and multi-analyte controls, are paving the way for enhanced efficiency and reproducibility. Concurrently, tightening regulatory frameworks globally are propelling laboratories towards more rigorous and consistent quality control measures. While North America dominates the market share due to its advanced diagnostic infrastructure and stringent regulatory norms, Asia Pacific regions are showcasing robust growth, fueled by rising healthcare investments and growing awareness about diagnostic accuracy. All in all, the global molecular quality controls market stands at the nexus of technological innovation, regulatory emphasis, and an ever-present need for diagnostic precision, making its growth trajectory promising and resilient.

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.
The publisher always strives to provide you with the latest information. The numbers in the article are only indicative and may be different from the actual report.


This product will be delivered within 5-7 business days.

Table of Contents

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

Companies Mentioned

  • 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.

Methodology

Loading
LOADING...