Molecular Quality Control Market

Market Overview

The global molecular quality controls market was valued at USD 214.32 million in 2023. It is estimated to reach USD 473.21 million by 2032, growing at a CAGR of 9.21% during the forecast period (2024–2032). Technological advancements in molecular testing, such as PCR (polymerase chain reaction), NGS (next-generation sequencing), and others, have led to the development of more sensitive and specific assays. Molecular quality controls play a crucial role in validating and verifying the performance of these advanced testing platforms.

Highlights

• Independent controls dominate the product segment
• Single-analyte controls dominate the analyte segment
• Infectious disease diagnostics dominates the application segment
• Diagnostic laboratories dominate the end-user segment
• North America is the highest shareholder in the global market

Molecular quality controls refer to the fundamental benchmarks and procedures used to guarantee the accuracy and consistency of molecular biology methods such as DNA sequencing and polymerase chain reaction (PCR). These controls encompass known, meticulously selected samples possessing specific genetic characteristics, which serve as benchmarks for validating the performance of laboratory equipment, reagents, and assay conditions. The overarching objective is to uncover any anomalies or deficiencies in the molecular testing process, thereby providing the accuracy and reproducibility of the results obtained.

In medical diagnostics, they are indispensable for delivering precise patient diagnoses, ensuring that healthcare professionals can rely on the integrity of the results to make informed decisions about treatment and care. In forensics, molecular quality controls are crucial for upholding the integrity of DNA profiling, thereby bolstering the credibility of evidence presented in the criminal justice system. In research laboratories, these controls validate studies, contributing to scientific discoveries across a spectrum of disciplines. By verifying the accuracy and consistency of experimental findings, molecular quality controls enhance the reliability of research outcomes, thereby advancing knowledge and innovation in fields ranging from genetics to infectious diseases.

Market Dynamics

Global Molecular Quality Controls Market Drivers:

Growing Preference for Personalized Medicines

Genomics has emerged as a fundamental driver propelling the molecular quality controls market growth. As personalized medicine gains prominence, the demand for accurate and reliable molecular diagnostics escalates. Molecular quality controls serve as linchpins in this landscape, ensuring the precision and validity of genetic testing processes. The need for robust quality controls becomes paramount with personalized medicine's emphasis on tailoring treatments to individuals based on their genetic makeup. Molecular quality controls provide benchmarks for validating laboratory equipment, reagents, and assay conditions, guaranteeing genetic tests' accuracy and reproducibility. This assurance is crucial in optimizing patient outcomes and minimizing adverse effects, aligning with the core tenets of personalized medicine.

Regulatory bodies like the FDA play a pivotal role in shaping the molecular diagnostics landscape. The FDA's approval of new molecular entities (NMEs) underscores the growing significance of personalized medicine. In 2022, a notable portion of the FDA-approved therapeutic products were attributed to personalized medicine, highlighting the increasing adoption of precision-based approaches in drug development and approval. Moreover, the approval of cell-based therapies signifies the expanding frontier of personalized medicine, wherein innovative modalities leveraging cellular and genetic technologies address unmet medical needs. Genomics-driven personalized medicine acts as a catalyst, driving the demand for molecular quality controls.

Global Molecular Quality Controls Market Restraint:

Budgetary Constraints in Clinical Laboratories

Establishing a quality control process in a clinical laboratory necessitates substantial investment. Laboratories must allocate resources to procure quality control materials, implement specialized equipment, and retain dedicated personnel to oversee the quality control system. The costs associated with quality control procedures remain consistent regardless of the volume of tests performed, posing financial challenges for laboratories with lower diagnostic test volumes. As a result, the upfront costs of implementing quality control procedures can be prohibitively expensive, particularly for clinical laboratories operating with limited resources.

This financial burden is compounded by budgetary constraints prevalent in hospitals and laboratories across both developed and developing countries. These factors collectively contribute to a potential decrease in the adoption of quality control practices, as laboratories may struggle to justify the initial investment and ongoing operational expenses. Without adequate resources and support, laboratories may opt to prioritize other areas of expenditure, potentially compromising the reliability and accuracy of diagnostic testing processes.

Global Molecular Quality Controls Market Opportunities:

Increasing Demand for Multi-Analyte Controls

A new generation of multi-analyte and multi-instrument controls has emerged, revolutionizing quality assurance procedures. These innovative controls combine multiple instrument-specific controls into a singular entity, enabling clinical laboratories to streamline operations and reduce costs. By consolidating various controls into a single product, these advancements eliminate the need for separate quality control procedures for each analyte, saving valuable time and resources. This consolidation simplifies the quality control process and enhances laboratory workflow efficiency.

Moreover, numerous multi-analyte controls have entered the market, offering diverse options to meet laboratories' needs. Among these are the Amplicheck Series by BD Company, the AcroMetrix Series by Thermo Fisher Scientific, the Seraseq Controls by SeraCare, and the Introl Series by Maine Molecular Quality Controls. These controls empower laboratories to conduct quality control assessments for many parameters, spanning cardiac and tumor markers to DNA/RNA from various infectious disease-causing agents, all within a single run.

By leveraging these innovative multi-analyte controls, clinical laboratories can achieve comprehensive quality control coverage while optimizing resources and maximizing efficiency. This not only enhances the reliability and accuracy of diagnostic testing but also contributes to cost containment and operational sustainability in laboratory settings. As technology continues to evolve, the continued development and adoption of multi-analyte controls promise to further revolutionize quality assurance practices in clinical laboratories worldwide.

Regional Analysis

Based on region, the global molecular quality controls market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global molecular quality control market shareholder and is expected to expand substantially during the forecast period. This growth trajectory is propelled by several factors unique to the region. Firstly, North America boasts a high adoption rate of advanced infrastructure, including cutting-edge laboratory facilities and diagnostic centers. These facilities are pivotal in driving demand for molecular quality control solutions, as they uphold rigorous standards of accuracy and reliability in diagnostic testing. Secondly, the region is home to a proliferation of accredited clinical laboratories, further bolstering the demand for quality control solutions. These laboratories adhere to stringent quality assurance protocols, driving the adoption of molecular quality control measures to ensure the accuracy and dependability of diagnostic results. The United States, in particular, commands the largest market share within North America, owing to its substantial patient population.

For instance, according to a 2020 report by the United States Department of Health and Human Services, the country witnesses a significant burden of infectious diseases such as HIV, fueling the demand for molecular diagnostics and quality control solutions. North America's regulatory landscape, exemplified by the stringent oversight of the FDA, underscores the region's commitment to quality and standardization in molecular diagnostics. These regulatory frameworks mandate the use of quality control solutions, fostering a culture of standardized and high-quality diagnostic practices. However, renowned market players like Abbott Laboratories and Roche Diagnostics in North America significantly influence market dynamics. These industry leaders drive technological advancements and innovation, contributing to the region's global molecular quality control market dominance.

Segmental Analysis

The global molecular quality controls market is bifurcated into products, analytes, applications, and end-users.

Based on product, the global molecular quality controls market is segmented into independent controls and instrument-specific controls.

Independent controls stand out as the predominant product segment within the market, owing to their versatility and broad applicability across molecular biology procedures. These controls offer laboratories the flexibility to test and validate various techniques, including PCR, DNA sequencing, and nucleic acid amplification. Distinguished by their well-characterized samples with known genetic traits, independent controls are indispensable tools for laboratories to monitor and troubleshoot their testing processes. By incorporating these controls into their quality assurance protocols, laboratories can uphold the integrity of their molecular diagnostic and research findings. By providing laboratories with standardized reference materials, independent controls empower researchers and diagnosticians to calibrate their instruments, verify assay performance, and detect any aberrations or anomalies in testing procedures.

Based on analyte type, the global molecular quality controls market is segmented into single-analyte controls and multi-analyte controls.

Single-analyte controls dominate the analyte type segment. This is owing to their focused nature and specialized utility. Designed to assess the effectiveness of molecular assays targeting specific analytes, such as genes or biomarkers, single analyte controls offer precision and tailored validation. This targeted approach proves invaluable in ensuring the accuracy and reliability of diagnostic procedures and research endeavors aimed at specific genetic markers.

By effectively evaluating the performance of assays that focus on individual analytes, single-analyte controls provide researchers and diagnosticians with crucial insights into assay efficacy and performance. Moreover, the prevalence of single analyte controls underscores their pivotal role in upholding the quality and dependability of molecular testing methods. Their ability to serve as dedicated benchmarks for specific genetic targets ensures that diagnostic results and research findings are precise, reproducible, and trustworthy.

Based on application, the global molecular quality controls market is bifurcated into infectious disease diagnostics, oncology testing, genetic testing, and others.

Infectious disease diagnostics dominates the application segment. Molecular quality controls play a pivotal role in ensuring the precision of diagnostic assays utilized for detecting a wide array of infectious agents, including bacteria, viruses, and fungi. The significance of robust quality controls in infectious disease diagnostics cannot be overstated, as erroneous results, whether false-positive or false-negative, can have profound implications for patient care, public health interventions, and the overall efficacy of disease management strategies. Inaccurate test outcomes can lead to misdiagnoses, inappropriate treatments, and potentially adverse health outcomes for individuals, as well as hinder effective disease surveillance and control efforts. Given these stakes, the infectious disease diagnostics segment emerges as a focal point for the implementation of stringent molecular quality standards.

Based on end-users, the global molecular quality control market is bifurcated into diagnostic laboratories, hospitals, IVD manufacturers and contract research organizations, academic and research institutes, and other end-users.

Diagnostic laboratories dominate the end-user segment. This underscores their pivotal role as frontline providers of accurate and reliable diagnostic results. These laboratories serve as the cornerstone of medical testing, leveraging advanced molecular tools such as PCR and DNA sequencing to diagnose diseases and profile patients with unprecedented precision. Moreover, the dominance of the diagnostic laboratories' end-user segment highlights their unparalleled contribution to healthcare delivery and disease management. Diagnostic laboratories set the gold standard for diagnostic testing and play a pivotal role in guiding clinical decision-making and patient care pathways.

Impact of covid-19

The increasing volume of testing for COVID-19 is expected to spur the molecular quality control demand, especially if clinical testing goes beyond symptomatic patients. As the disease continues for a longer duration, the U.S. FDA has made molecular diagnostic tests available under an emergency use authorization (EUA), owing to accuracy and faster development time of molecular testing than serological tests. Roche and Thermo Fisher Scientific are among the molecular diagnostic vendors that have received EUAs for testing COVID-19 as these players have their quality control systems available.

Recent Developments

• January 2024- Abbott announced a collaboration agreement with Personalis, Inc. to develop and market liquid biopsy controls for next-generation sequencing (NGS) experiments. This collaboration aims to improve the accuracy and reliability of liquid biopsy tests for cancer identification and monitoring.
• January 2024- Roche Diagnostics introduced its new AmpliRun Control Set, which provides a comprehensive solution for quality control in qPCR experiments. This collection comprises controls for various target genes, allowing laboratories to validate analytical performance and assure consistent results.