
Molecular Quality Controls Market Size Analysis Report - Market Share, Forecast Trends and Outlook (2025-2034)
Description
The global molecular quality controls market size was valued at USD 186.70 Million in 2024 , driven by the increasing incidence of HIV and cancer across the globe. The market size is anticipated to grow at a CAGR of 6.80% during the forecast period of 2025-2034 to achieve a value of USD 360.46 Million by 2034 .
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
“global molecular quality controls market and forecast 2025-2034” offers a detailed analysis of the market based on the following segments:
Market Breakup by Product Type
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:
Molecular Diagnostics Market
United States Molecular Diagnostics Market
*Please Note:* The report will take 5 business days to complete, after order confirmation.
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
“global molecular quality controls market and forecast 2025-2034” offers a detailed analysis of the market based on the following segments:
Market Breakup by Product Type
- DNA- Based Quality Controls
- RNA-Based Quality Control
- Protein-Based Quality Controls
- Nucleic Acid and Protein Mixtures
- Others
- Single Analyte Control
- Multi-Analyte Control
- Infectious Diseases
- Oncology
- Genetic Testing
- Other Applications
- Clinical Laboratories
- Hospitals
- IVD Manufacturers
- Contract Research Organizations
- Academic and Research Institutes
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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.
Molecular Diagnostics Market
United States Molecular Diagnostics Market
*Please Note:* The report will take 5 business days to complete, after order confirmation.
Table of Contents
350 Pages
- 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 (2018-2024)
- 3.2 Global Molecular Quality Controls Market Forecast Value (2025-2034)
- 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
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