Molecular Quality Controls

Global Molecular Quality Controls Market to Reach US$319.9 Million by 2030

The global market for Molecular Quality Controls estimated at US$238.2 Million in the year 2024, is expected to reach US$319.9 Million by 2030, growing at a CAGR of 5.0% over the analysis period 2024-2030. Independent Controls, one of the segments analyzed in the report, is expected to record a 5.4% CAGR and reach US$211.3 Million by the end of the analysis period. Growth in the Instrument-Specific Controls segment is estimated at 4.4% CAGR over the analysis period.

The U.S. Market is Estimated at US$65.5 Million While China is Forecast to Grow at 4.7% CAGR

The Molecular Quality Controls market in the U.S. is estimated at US$65.5 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$50.0 Million by the year 2030 trailing a CAGR of 4.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 4.7% and 3.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 3.9% CAGR.

Global Molecular Quality Controls Market - Key Trends and Drivers Summarized

How Are Molecular Quality Controls Shaping Diagnostic Accuracy?

Molecular quality controls play a crucial role in clinical laboratories and diagnostic centers by ensuring the accuracy, reliability, and consistency of molecular diagnostic tests. These controls are used to monitor the performance of nucleic acid testing procedures, including PCR, NGS, and other molecular assays, ensuring the validity of test results. They help laboratories comply with regulatory requirements, maintain high-quality standards, and detect any potential issues in diagnostic workflows. As molecular diagnostics become increasingly essential in healthcare, the need for stringent quality controls has intensified. The application of molecular quality controls spans across various domains such as infectious disease testing, oncology, genetic testing, and personalized medicine. With the rising prevalence of diseases such as cancer and infectious conditions, molecular diagnostic tests are becoming more sophisticated, demanding enhanced quality control measures. Molecular quality controls ensure that the diagnostic assays produce accurate results, leading to better patient outcomes and improved healthcare services.

What Trends Are Shaping the Molecular Quality Controls Market?

Key trends influencing the molecular quality controls market include the rapid advancements in molecular diagnostics, the increasing adoption of personalized medicine, and the growing emphasis on regulatory compliance in laboratory practices. Technological innovations in molecular diagnostics, such as real-time PCR and next-generation sequencing (NGS), have led to more complex testing processes, which require stringent quality controls to ensure reliable performance. The market is also witnessing an increased focus on personalized medicine, where accurate molecular testing is crucial for tailoring treatments to individual patients. Regulatory agencies such as the FDA and CLIA mandate the use of quality controls in molecular diagnostics to ensure the accuracy and reproducibility of test results. This regulatory landscape is driving the adoption of molecular quality controls across laboratories and diagnostic centers. Additionally, the increasing prevalence of infectious diseases and cancer is propelling demand for molecular diagnostics, further boosting the need for quality controls to maintain high testing standards.

How Do Market Segments Impact the Molecular Quality Controls Landscape?

Product types include independent controls, instrument-specific controls, and analyte-specific controls, with independent controls gaining popularity due to their ability to validate the entire testing process. Applications encompass infectious disease testing, oncology testing, and genetic testing, with infectious disease diagnostics accounting for a significant share due to the high volume of tests conducted for conditions like COVID-19 and influenza. End-users of molecular quality controls include diagnostic laboratories, hospitals, research institutions, and academic centers. Diagnostic laboratories represent the largest end-user segment due to the high demand for molecular testing in clinical settings. Geographically, North America dominates the market due to advanced healthcare infrastructure, regulatory compliance requirements, and a high prevalence of chronic diseases. The Asia-Pacific region is witnessing rapid growth due to increased healthcare investments and the rising adoption of molecular diagnostics.

What Factors Are Driving the Growth in the Molecular Quality Controls Market?

The growth in the molecular quality controls market is driven by several factors, including the increasing adoption of molecular diagnostics, advancements in testing technologies, and stringent regulatory requirements for quality assurance. The demand for accurate and reliable diagnostic tests is fueling the need for molecular quality controls. Technological innovations such as NGS and digital PCR are creating opportunities for the development of more sophisticated quality control solutions. Additionally, the growing focus on personalized medicine and the rising prevalence of infectious diseases and cancer are further accelerating market growth.

SCOPE OF STUDY:

The report analyzes the Molecular Quality Controls market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (Independent Controls, Instrument-Specific Controls); Analyte Type (Single-Analyte Controls, Multi-Analyte Controls); Application (Infectious Diseases, Oncology, Genetic Testing, Other Applications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 33 Featured) -

• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Danaher
• F. Hoffmann-La Roche Ltd
• Helena Biosciences Europe
• Maine Molecular Quality Controls, Inc.
• Microbiologics, Inc.
• Qnostics
• Quidel Corporation
• Randox Laboratories Ltd.
• SeraCare Life Sciences, Inc.
• SERO AS
• Technopath Clinical Diagnostics
• Thermo Fisher Scientific Inc.
• ZeptoMetrix Corporation

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks. The Publisher uses digital controls protecting against copying and printing is restricted to one full copy to be used at the same location.

The latest version of Adobe Acrobat Reader is required to view the report. Upon ordering an electronic version, the Publisher will provide a link to download the purchased report.

Prior to fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.