Molecular quality control focuses on testing of molecular diagnostic products for identification of defects and reporting these to the management, influencing the decision on whether to release the product or not. Quality control procedures for molecular testing have been widely adopted in the past few years, particularly for infectious disease tests, where quality control materials are available, tests are cleared by the FDA, published quality control protocols are available, and the tests are quantitative with limited number of analytes. Additionally, quality controls are available for some of the multiplex tests such as cystic fibrosis test.
The global molecular quality controls market is driven by rise in focus of market players on developing molecular diagnostic tests for identification of infectious diseases and detection of cancer; rise in adoption of third-party quality controls by end-users, increase in the number of accredited clinical laboratories, and surge in demand for external quality assessment support. Additionally, focus of market players on product launches and partnerships to expand product portfolio and geographic presence boosts market growth. For instance, in 2018, Microbiologics launched a range of quality control products including vaginal verification panel, enteric viral control panel, blood culture control panel, and vaginal control panel. In the same year, Seracare entered into a partnership with AccuRef Diagnostics to market the latter’s portfolio of CRISPR-engineered cell line reference materials. However, unfavorable reimbursement scenario for molecular diagnostic tests, high costs associated with quality control process, and budget constraints of end-users such as hospitals and clinical laboratories are likely to hamper the growth of the molecular quality controls market.
The global molecular quality controls market can be segmented based on product, analyte type, application, end-user, and region. In terms of product, the molecular quality controls market can be bifurcated into independent control and instrument control. The instrument control segment can be classified into polymerase chain reaction instruments (PCR), next-generation sequencing (NGS), and others. Based on analyte type, the global molecular quality controls market can be categorized into single-analyte controls and multiple-analyte controls. In terms of application, the molecular quality controls market can be divided into infectious diseases, oncology, genetic testing, and others. Based on end-user, the global molecular quality controls market can be classified into clinical laboratories, hospitals, in vitro diagnostics manufacturers, contract research organizations, academic & research centers, and others.
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Geographically, the global molecular quality controls market can be segmented into five major regions: North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America was the major market for molecular quality controls in terms of revenue in 2017. The region is anticipated to continue to dominate the global molecular quality controls market during the forecast period. The U.S. was the major market in North America in terms of revenue in 2017. The market in the country is projected to grow at a rapid pace owing to rise in CLIA accreditation of clinical laboratories. Additionally, well-established health care infrastructure, increase in investments by key players in the development of advanced diagnostic procedures for cancer diagnosis and detection of infectious diseases, presence of leading players, and ease of availability of technologically advanced products boost market growth. Europe was the next leading market in terms of revenue in 2017 and is expected to sustain its position during the forecast period. Growth of the molecular quality controls market in the region is attributed to rise in the number of contract research organizations and increase in demand for third-party quality control support. The market in Asia Pacific is expected to expand at a high CAGR from 2018 to 2026, owing to increase in incidence of infectious diseases, government focus on enhancing the health care infrastructure, and focus of key players on exploiting opportunities in the emerging markets.
Leading players operating in the global molecular quality controls market are Seracare Life Sciences, Inc., Zeptometrix, Thermo Fisher Scientific, Abbott Laboratories, Bio-Rad Laboratories, Roche Diagnostics, Microbiologics, Inc., Maine Molecular Quality Controls, Inc., Quidel, Qnostics, and Theranostica, among others.
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