United States Molecular Quality Controls (MQC) Market: IVD Manufacturers & CROs Growth Strategy | Top Most Keyplayers - Bio-Rad Laboratories Inc, F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, BioMerieux Inc.

Market Size and Forecast:

Molecular Quality Controls Market size is estimated to reach at a high CAGR 10.9% during the forecast period 2024-2031.

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Key Development:

USA

August 27, 2025: Abbott Molecular received FDA clearance for its Alinity m HIV-1/HIV-2 NAT (Nucleic Acid Test) kits and controls, demonstrating continuous regulatory advancement and commercialization of automated molecular QC solutions for infectious disease screening.

July 2025: Roche Molecular Systems received FDA clearance for its cobas® HIV-1 Quantitative and Qualitative NAT kits and controls for use on its high-throughput systems, reflecting the trend toward instrument-specific quality controls tailored for automated molecular diagnostic platforms.

Japan

September 30, 2025: Sysmex Corporation and QIAGEN entered an exclusive distribution agreement in Japan for QIAGEN's molecular diagnostic instruments, reagents, and other products (including oncology and infectious disease controls), strengthening the distribution network for global QC products.

September 25, 2025: Hitachi High-Tech Corporation partnered with ELITechGroup for molecular testing in infectious disease, focusing on joint development and supply of fully automated PCR testing systems and their related quality control components.

Molecular Quality Controls ensure the accuracy, reliability, and consistency of molecular diagnostic tests such as PCR and next-generation sequencing. They help laboratories validate assay performance, detect errors, and maintain regulatory compliance. With the growing demand for precision diagnostics, robust molecular quality controls are essential for improving patient outcomes and diagnostic confidence.

Key Players:

Bio-Rad Laboratories Inc
F. Hoffmann-La Roche AG
SeraCare Life Sciences Inc
BioMerieux Inc
ZeptoMetrix Corporation
Abbott Laboratories
Thermo Fisher Scientific
Microbiologics Inc
Quidel Corporation
Qnostics Ltd

Growth Forecast Projected:

The Global Molecular Quality Controls Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Molecular Quality Controls Market Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Product Type: Independent Control, Instrument Specific-Control
➥ By Application: Oncology, Genetic Testing, Infectious Diseases, Others
➥ By End User: Hospitals, Clinical Laboratories, IVD Manufacturers & CROs, Others

Regional Analysis for Molecular Quality Controls Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Molecular Quality Controls Market producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Molecular Quality Controls Market revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

Q: What is the growth rate of the Molecular Quality Controls Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 10.9% during the forecast period from 2024 to 2031.

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