Molecular Quality Controls Market Size, Share, Growth, And Industry Analysis, By Type (Independent, Instrument Specific and Molecular Quality Controls), By Application (IVD Manufacturers and Research Institute), Regional Insights and Forecast From 2025 To 2033

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Molecular Quality Controls Market Report Overview

The global molecular quality controls market size was USD 0.22 billion in 2024 and is projected to grow to USD 0.42 billion by 2033, at a CAGR of 7.7% during the forecast period.

In vitro nucleic acid testing processes for viral load tests, healthcare-associated infections (HAIs), including bloodstream infections, urinary tract infections, pneumonia, and other illnesses connected to sexually transmitted diseases, are primarily monitored by molecular quality controls. Testing molecular diagnostic goods, finding flaws, and reporting them to management authorities are the main goals of molecular quality control.

COVID-19 Impact: Pandemic Hamper the Demand of Molecular Quality Control to Market Growth

The global COVID-19 pandemic has been unprecedented and staggering, with the molecular quality controls market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden spike in CAGR is attributable to the market's growth and demand returning to pre-pandemic levels once the pandemic is over.

Global disruptions brought about by the coronavirus pandemic are unprecedented. The molecular quality controls market could grow significantly during the pandemic, even though this disruptive force has caused disruptions in many industrial sectors. This is because clinical laboratories and diagnostic manufacturers are working to meet the rising demand for testing solutions, which are important components of COVID-19 disease management. To that aim, ZeptoMetrix revealed the expansion of its extensive Infectious Disease NATtrolTM Quality Controls range with the inclusion of yet another significant molecular quality control. The solution, known as the SARS-CoV-2 Variant Panel, consists of four distinct vials, one for each of the variants: Alpha, Beta, Gamma, and Delta. Soon, developments like this might help to meet the rising demand for molecular quality control solutions.

Latest Trends

"A Growing Number of Clinical Laboratories are Accredited to Boost Market Growth"

The growing prevalence of various diseases around the world has led to an increase in the number of laboratory tests being performed globally. Both public and commercial sector laboratories are opening in order to address this need. To perform diagnostic tests, clinical laboratories must get accreditation from regulatory organisations such as the International Organization for Standardization (ISO) and other standards of a like kind in most nations. The relevant authorities analyse a laboratory's competency and quality system during the accreditation procedure using predetermined standards.

Molecular Quality Controls Market Segmentation

• By Type Analysis

According to type, the molecular quality controls market can be segmented into Independent, Instrument Specific and Molecular Quality Controls.

In terms of type, the Instrument Specific is anticipated to be the largest segment during the forecast period.

• By Application Analysis

Based on application, the molecular quality controls market can be divided into IVD Manufacturers and Research Institute.

In terms of application, IVD manufacturers market is projected to hold the largest market share through 2028.

Driving Factors

"High-Cost Restrictions in Hospitals and Additional Costs Related to quality controlto Increase Market Growth "

It costs a lot of money to put up a quality control process in a clinical lab. Additionally, laboratories must keep a specialised staff on hand to oversee the QC system. In addition, the costs associated with QC procedures are constant regardless of the number of tests run. Due to the low volume of diagnostic tests performed in clinical laboratories, QC procedures have a relatively high implementation cost. This is predicted to lead to a lesser adoption of QC procedures, along with budgetary restrictions in many hospitals and laboratories in developed and emerging nations. These are a few of the elements that are preventing the market from expanding as quickly as predicted.

"Increasing Need for Multi-Analyte Control Which Led to Expand Market Growth "

The development of a new variety of multi-analyte and multi-instrument controls is the result of technological breakthroughs. These cutting-edge controls combine several instrument-specific controls into one control, allowing clinical laboratories to save money. Additionally, these controls eliminate the need for separate QC processes for each individual analyte, which saves time. In the upcoming years, market expansion is anticipated to be supported by the expanding availability of such molecular quality controls for infectious disease diagnostics and other applications.

Restraining Factors

"Budgetary Limitations in Hospitals as well as additional costs related to quality control is Decline Market Growth"

It costs a lot of money to set up a QC process in a clinical laboratory. Additionally, laboratories must keep specialized staff on hand to oversee the QC system. Moreover, regardless of the number of tests conducted, QC procedures are expensive. As a result, QC methods are particularly expensive to adopt for clinical laboratories that perform few diagnostic tests. This is predicted to lead to a lesser adoption of QC procedures, along with budgetary restrictions in many hospitals and laboratories in developed and emerging nations.

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Molecular Quality Controls Market Regional Insights

"The North American Region will Dominate Market Due to Large Patient Population"

Over the predicted period, the North American area grew to be the dominating regional market share accounting. A developed healthcare system, the existence of numerous top producers of molecular quality control products, and easy access to technologically cutting-edge goods made North America the largest regional market for molecular quality controls.The main drivers of the growth of the molecular quality controls market are the large patient population in this region and the significant demand for high-quality and accurate diagnostic tests.

Key Industry Players

"Adoption Experiential Marketing Services by Key Players Influencing Market Development"

The top key players in the market areSeraCare Life Sciences, ZeptoMetrix Corporation, Bio-Rad Laboratories, Microbiologics Inc, Thermo Fisher Scientific, Maine Molecular Quality Controls. Most of the top players hold themolecular quality controls market share in some regions. In addition, the strategies to develop new technologies, capital investment in R&D, improve product quality, acquisitions, mergers, and compete for the molecular quality controls market growth in the competition help them to perpetuate their position and value in the market. Besides, collaboration with other companies & extensive possession of market shares by the key players stimulates the molecular quality controls market.

LIST OF TOP MOLECULAR QUALITY CONTROLS COMPANIES

• SeraCare Life Sciences (U.S.)
• ZeptoMetrix Corporation(U.S.)
• Bio-Rad Laboratories (U.S.)
• Microbiologics Inc(U.S.)
• Thermo Fisher Scientific(U.S.)
• Maine Molecular Quality Controls(U.S.)
• Abbott Laboratories(U.S.)
• Roche Diagnostics (Switzerland)
• Quidel Corporation (U.S.)
• Qnostics (UK.)

Report Coverage

This report examines an understanding of the molecular quality controls market’s size, share, growth rate, segmentation by type, application, key players, and previous and current market scenarios. The report also collects the market’s precise data and forecasts by market experts. Also, it describes the study of this industry’s financial performance, investments, growth, innovation marks, and new product launches by the top companies and offers deep insights into the current market structure, competitive analysis based on key players, key driving forces, and restraints that affect the demand for growth, opportunities, and risks.

Furthermore, the post-COVID-19 pandemic’s effects on international market restrictions and a deep understanding of how the industry will recover, and strategies are also stated in the report. The competitive landscape has also been examined in detail to provide clarification of the competitive landscape.

This report also discloses the research based on methodologies that define price trend analysis of target companies, collection of data, statistics, target competitors, import-export, information, and previous years’ records based on market sales. Moreover, all the significant factors which influence the market such as small or medium business industry, macro-economic indicators, value chain analysis, and demand-side dynamics, with all the major business players have been explained in detail. This analysis is subject to modification if the key players and feasible analysis of market dynamics change.