Molecular Quality Controls Market Size, Share, Industry, Forecast and outlook (2024-2031)

Molecular Quality Controls Market is Segmented By Product Type (Independent Control, Instrument Specific-Control), By Application (Oncology, Genetic Testing, Infectious Diseases, Others), By End-user (Clinical Laboratories, IVD Manufacturers & CROs, Others),  and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis,  2024-2031

Molecular Quality Controls Market Overview

Molecular quality controls market size is estimated to reach at a high CAGR 10.9%  during the forecast period 2024-2031.

Molecular quality controls are used to evaluate the performance of molecular tests such as in vitro nucleic acid testing procedures for viral load assays, pathogen detection, leukocyte reduced apheresis platelet (LRAP) units, healthcare-associated infections (HAIs) like pneumonia, urinary tract infections and more. These products majorly focus on the detection of defects, quality control, and validation panels to support in the implementation and monitoring assay-kit lot performance for clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.

Molecular Quality Controls Market Scope

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Molecular Quality Controls Market Dynamics  

The global molecular quality controls market growth is driven by the increased demand for advanced diagnostics for sensitive reports and accurate diagnosis, rising incidence of infectious diseases, cancers and genetic disorders and rise in the volume of accredited clinical laboratories and adoption of third-party quality controls.

Increasing number of accredited clinical laboratories is expected to hold the largest share in this market segment

Globally, the number of laboratory tests being conducted has increased owing to the rising burden of various diseases worldwide. To meet this demand, the number of laboratories in public as well as the private sector is increasing. In most countries, it is mandatory for clinical laboratories to secure accreditation from regulatory bodies such as the International Organization for Standardization (ISO) 15189:2012 and other similar standards to perform diagnostic tests. During the accreditation process, the respective authorities evaluate the quality system and competence of a laboratory based on specific standards.

In 2020, the number of total laboratory entities registered for CLIA accreditation increased to 286,396 as compared to 259,967 in 2017. Also, in 2018, 15,353 laboratories received CLIA accreditation by several accreditation organizations.

Additional costs involved in quality control and budget constraints in hospitals and laboratories is expected hamper the market growth

Setting up a QC process in a clinical laboratory requires significant investments. Laboratories also need to maintain dedicated personnel to manage the QC system. Moreover, QC procedures incur similar costs, regardless of the volume of tests performed. Hence, the cost of adopting QC procedures is very high for clinical laboratories working with low volumes of diagnostic tests. This, coupled with budgetary constraints in many hospitals and laboratories in developed and developing economies, is expected to result in the lower adoption of QC practices.

PEST Analysis:

COVID-19 Impact Analysis on Molecular Quality Controls Market

COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 moved from a regional crisis to a global pandemic in just a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020.

The COVID-19 pandemic negatively affected the sales of companies. Lockdowns resulting from the COVID-19 pandemic caused people to delay undergoing health check-ups, affecting the number of tests being performed and sales of reagents. However, a resurgence in testing numbers is seen as countries gradually ease restrictions on movement. With the COVID-19 pandemic, responding to infectious disease has become a pressing medical issue worldwide. In addition to developing vaccines and therapeutic drugs, there is a growing need for developing more precise and simple testing technologies and the expansion of testing structures. COVID-19 has also impacted the regulatory environment and practices, as governments and healthcare providers face unprecedented challenges. Regulatory authorities utilized methods to speed the approval of diagnostic products. Companies have also taken strategic developments to introduce COVID-19 rapid tests, sustain their revenues, and nullify the impact of COVID-19 on their operational capabilities.

Molecular Quality Controls Market Segment Analysis

The independent controls segment is expected to hold the largest share in this market segment

Independent controls are anticipated to hold the largest market share in the molecular quality controls market due to their highly precise, unbiased, and independent assessment of a testing system or method performance test results in a short time with the highest sensitivity rate as they are manufactured independently of the instrument, reagents, and calibrators. Furthermore, a steep rise in the adoption of these products among the third-party independent quality controls owing to their benefits such as a wide range of applications along with reduced operational costs is also expected to drive the use of independent controls fueling the market.

Molecular Quality Controls Market Geographical Share

North America region holds the largest market share of global molecular quality controls market

North America is expected to dominate the overall molecular quality control market, throughout the forecast period. The high adoption rate of advanced infrastructure, increased number of diagnostic centres and accredited clinical laboratories are factors estimated to fuel the market in the region. In North America, the United States holds the largest market share due to increased patient pool. For instance, as per U.S. Department of Health & Human Services report published in 2020, about 37,832 people in the U.S. were diagnosed with HIV in 2018 and 38,000 new HIV infections still occur in the United States and 6 dependent areas each year which results in rapid spread of various infectious diseases such as meningitis, urinary tract infections fueling the market contributing its outstanding share of the global market revenue during the forecast period.

Molecular Quality Controls Market Companies and Competitive Landscape

The global molecular quality controls market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Bio-Rad Laboratories Inc F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc, bioMerieux Inc, and ZeptoMetrix Corporation, Abbott Laboratories, Thermo Fisher Scientific, Microbiologics Inc, Quidel Corporation and Qnostics Ltd. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Molecular Quality Controls globally. For instance, in April 2019, Bruker expanded its portfolio for microbial identification, infection control, and molecular diagnostics of infectious diseases by introducing new assays, software and library extensions for its MALDI Biotyper, IR Biotyper, and Fluorocycler XT product lines which are expected to have a positive impact on the market.

Bio-Rad Laboratories, Inc

Overview: Bio-Rad Laboratories, Inc. is an American company that continued to produce innovative and useful products in the healthcare industry that assist life science researchers in accelerating the discovery process, and medical diagnostic labs obtain faster better results. Bio-Rad’s life science products essentially include instruments, software, consumables, reagents, and content for the areas of cell biology, gene expression, protein purification, protein quantitation, drug discovery and manufacture, food safety, and science education. These products are based on technologies to separate, purify, identify, analyze, and amplify biological materials such as antibodies, proteins, nucleic acids, cells, and bacteria.

Product Portfolio: It includes products like Amplichek II, Level-1,2,3, Amplichek II, Negative MiniPak etc.