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Report Overview

The global molecular quality controls market size was valued at USD 199.40 Million in 2025. The market size is anticipated to grow at a CAGR of 6.80% during the forecast period of 2026-2035 to achieve a value of USD 384.98 Million by 2035. The market growth is driven by the growing adoption of advanced molecular diagnostics and automated laboratory workflows. Increasing demand for precision diagnostics and personalized medicine is expected to propel growth in the forecast period. Additionally, the development of multi-analyte controls and enhanced assay reproducibility will further support market expansion.

Key Market Trends and Insights

  • By DNA-based quality controls, the segment is likely to lead the market during the forecast period.
  • Single analyte control is expected to witness significant market share during the forecast period.
  • By genetic testing, the segment is expected to lead the market during the forecast period.

Market Size and Forecast

  • Market Size (2025): USD 199.40 Million
  • Projected Market Size (2035): USD 384.98 Million
  • CAGR (2026-2035): 6.80%
2025

Base Year

2019-2025

Historical Period

2026-2035

Forecast Period

Compound Annual Growth Rate

6.8%

Value in USD Million

2026-2035


*this image is indicative*

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

The EMR’s report titled “Molecular Quality Controls Market Report and Forecast 2026-2035” 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

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. 

More Insights On

Molecular Diagnostics Market

United States Molecular Diagnostics Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The market attained a value of about USD 199.40 Million in 2025, driven by the rapid technological advancements.

The market is anticipated to grow at a CAGR of 6.80% during the forecast period of 2026-2035 and is likely to reach a market value of USD 384.98 Million by 2035.

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.

Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2025
Historical Period 2019-2025
Forecast Period 2026-2035
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.

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