Northbrook, IL 60062 -- (SBWIRE) -- 08/04/2023 -- Molecular Quality Controls Market in terms of revenue was estimated to be worth $0.2 billion in 2023 and is poised to reach $0.3 billion by 2028, growing at a CAGR of 6.6% from 2023 to 2028 according to a new report by MarketsandMarkets™. The growth of this market is primarily driven by growing adoption of third-party quality controls, the increasing number of accredited clinical laboratories, increasing government funding for genomic projects, and increasing prevalence of infectious diseases, cancer, and genetic diseases. However, the additional costs involved in the quality control process and budget constraints in hospitals and laboratories, are the major factors that are expected to restrain the growth of this market during the forecast period.

The molecular quality controls industry is set to witness significant growth and advancements in the near future. With the increasing demand for accurate and reliable molecular diagnostic tests, the need for robust quality control solutions becomes paramount. Molecular quality controls provide essential tools to ensure the accuracy, precision, and reliability of laboratory testing procedures, including nucleic acid amplification, sequencing, and other molecular assays. As technology continues to advance, the industry is expected to witness the development of more sophisticated and comprehensive quality control materials that mimic complex clinical samples, allowing for better evaluation of assay performance. Furthermore, the integration of artificial intelligence (AI) and machine learning algorithms will enable the generation of data-driven quality control strategies, optimizing test accuracy and efficiency. As the molecular diagnostics field expands and becomes more integrated into routine clinical practice, the molecular quality controls industry will play a pivotal role in ensuring the quality and integrity of test results, ultimately contributing to improved patient care and outcomes.

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Browse in-depth TOC on "Molecular Quality Controls Market"
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The independent controls segment has accounted for the largest share of the market during the forecast period
Based on product, the molecular quality controls market is segmented into independent controls and instrument-specific controls. The independent controls segment accounted for the largest share of the global molecular quality controls market in 2022. The large share of this segment is attributed to the increasing use of third-party independent quality controls due to their benefits, such as applications across different reagent lots, which helps reduce the cost of operation.

The single-analyte controls has accounted for the largest share of the market during the forecast period.
On the basis of analyte type, the molecular quality controls market is segmented into single-analyte controls and multi-analyte controls. Single-analyte controls accounted for the largest share of the molecular quality controls market in 2022. The large share of this segment can be attributed to the significant use of singleplex assays in hospitals and the low risk of cross-reactivity.

The infectious disease diagnostic segment accounted for the largest share of the market in 2022

Based on application, the molecular quality controls market is segmented into infectious disease diagnostics, oncology testing, genetic testing, and other applications (including cardiovascular disease testing, neurology disease testing, DNA fingerprinting, tissue typing, and microbiology). The infectious disease diagnostics segment accounted for the largest share of the global molecular quality controls market in 2022. The large share of this segment is attributed to the development of advanced assays for different infectious diseases and a significant increase in the prevalence of infectious diseases.

The diagnostic laboratories segment accounted for the largest share of the market in 2022

Based on end users, the molecular quality controls market is segmented into diagnostic laboratories, hospitals, IVD manufacturers & CROs, academic & research institutes, and other end users (blood banks, local public health laboratories, home health agencies, and nursing homes). The diagnostic laboratories segment accounted for the largest share of the molecular quality controls market in 2022. This can be attributed to the increasing number of accredited diagnostic laboratories worldwide and the growing number of laboratory tests performed in diagnostic laboratories.

Asia-Pacific is to witness the highest growth during the forecast period.

The Asia-pacific Molecular Quality Controls market is expected to grow at the highest CAGR during the forecast period of 2023-2028. The high growth rate of this market can be attributed to large patient population in the region, rising healthcare needs, increasing focus on improving the quality of laboratory testing, strategic developments by leading players, and the rapid growth in the number of accredited laboratories.

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Molecular Quality Controls Market Dynamics:

Drivers:

1. Rising number of accredited clinical laboratories
2. Growing adoption of third-party quality controls
3. Increasing investments in genomics
4. Growing preference for personalized medicine
5. Increasing prevalence of infectious diseases and cancer
6. Rising demand for external quality assessment support

Restraints:

1. Budgetary constraints in clinical laboratories
2. Unfavorable reimbursements for molecular tests

Opportunities:

1. Rising demand for multi-analyte controls
2. Growth opportunities in emerging markets

Challenges:

1. Stringent regulatory requirements for IVD products

Key Market Players:

The prominent players in this market are Abbott Laboratories (US), Anchor Molecular (US), Thermo Fisher Scientific, Inc. (US), Randox Laboratories Ltd. (UK), LGC Limited (UK), F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation (US), Bio-Rad Laboratories, Inc. (US), Fortress Diagnostics (UK), SERO AS (Norway), Anchor Molecular (US), Vircell S.L. (Spain), Ortho Clinical Diagnostics, Inc. (US), Bio-Techne Corporation (US), Microbiologics, Inc. (US), Steck LLC (US), QuidelOrthoCorporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix, LLC (US), Qnostics (UK), Helena Laboratories Corporation (US), Microbix Biosystems Inc. (Canada), Molbio Diagnostics Pvt. Ltd. (India), SpeeDx Pty. Ltd. (Australia), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).

Recent Developments:

- In 2023, Thermo Fisher Scientific (US) acquired The Binding Site Group to expands the company's existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma.

- In 2022, Microbiologics Inc. (US) acquired the Cryologics (US) to extend the company's capacity to serve quality control microbiologists dedicated to the safety of pharmaceutical and personal care products.

- In 2021, LGC SeraCare expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex SARS-CoV-2 Variant Panel 1.

- In 2020, Roche entered a 15-year non-exclusive partnership with Illumina to broaden the adoption of NGS-based testing in oncology.

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Molecular Quality Controls Market Advantages:

- Test Validation and Calibration: Molecular quality controls provide reference materials with known target concentrations, allowing laboratories to validate and calibrate their testing methods. This ensures that the assay is performing optimally and producing reliable results.

- Quality Assurance: By implementing molecular quality controls, laboratories can monitor the performance of their assays over time. This helps identify and rectify any inconsistencies or deviations, ensuring the ongoing quality assurance of testing procedures.

- Standardization: Molecular quality controls provide a standardized benchmark for comparing and harmonizing results across different laboratories and instruments. This facilitates accurate and consistent interpretation of test outcomes, regardless of the testing location.

- Troubleshooting and Training: When troubleshooting assay failures or training new personnel, molecular quality controls serve as valuable tools. Laboratories can use these controls to identify and address issues related to sample handling, reagent preparation, or instrument performance, thus improving overall laboratory proficiency.
- Regulatory Compliance: The use of molecular quality controls is often mandated by regulatory bodies to ensure the accuracy and reliability of diagnostic testing. Compliance with these regulations not only ensures the quality of laboratory operations but also maintains patient safety and confidence in the testing process.

- Research and Development: Molecular quality controls also play a vital role in research and development efforts, particularly in the development of new diagnostic assays. By using quality controls during the development and optimization phases, researchers can validate and refine their assays before introducing them into clinical practice.

Overall, the molecular quality controls market provides crucial advantages, including test validation and calibration, quality assurance, standardization, troubleshooting and training support, regulatory compliance, and facilitating research and development efforts. These advantages contribute to improved accuracy, reliability, and reproducibility of molecular diagnostic tests, ultimately benefiting patient care and clinical outcomes.