Molecular Quality Controls Market
Number of pages: 100 | Report Format: PDF | Published date: May 05, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 189.31 million |
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Revenue Forecast in 2031 |
US$ 348.03 million |
|
CAGR |
7.0% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
|
Segments Covered |
Product, Application, End User, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global molecular quality controls market was valued at US$ 189.31 million in 2022 and is expected to register a revenue CAGR of 7.0% to reach US$ 348.03 million by 2031.
Molecular Quality Controls Market Fundamentals
Molecular quality controls are samples or materials used to assess the accuracy, precision, and reliability of molecular diagnostic tests. These controls are typically made up of synthetic or natural materials that mimic the genetic or biological targets detected by the diagnostic test. They are used to monitor the performance of molecular assays and ensure that they produce reliable and accurate results. They are used to assess the performance of the test at various stages, including sample preparation, amplification, detection, and data analysis. The controls are designed to mimic the behavior of clinical samples and can help identify issues such as contamination, instrument failure, or errors in test procedures.
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Molecular Quality Controls Market Dynamics
The molecular quality controls market outlook is looking positive due to the growing demand for accurate and reliable molecular diagnostic tests. As more diagnostic tests become available and are used to diagnose and monitor diseases, the need for reliable and consistent quality controls increases. The rising advancement in molecular biology, including improvements in nucleic acid amplification and detection technologies, are driving the development of new and more complex molecular diagnostic tests. This is increasing the demand for high-quality molecular controls to ensure the accuracy and reliability of these tests. Regulatory bodies globally emphasize the quality of molecular diagnostic tests and require manufacturers to provide evidence of quality control measures and performance specifications. This molecular quality controls industry trend is driving the demand for high-quality molecular controls that meet these regulatory requirements.There is a rise in the adoption of point-of-care testing, which allows for rapid and convenient diagnosis and disease monitoring of diseases, which is driving the demand for high-quality molecular controls that can be used in various settings, boosting the market demand for molecular quality controls. Moreover, the growing popularity of NGS-based diagnostics and research has led to a surge in demand for high-quality controls to ensure the accuracy and precision of these tests, which is also expected to surge the molecular quality controls market size.
However, the cost of producing high-quality molecular control materials is relatively high, restricting the market growth of molecular quality controls. There is currently a lack of standardization in the production and use of molecular quality controls materials, which can make it difficult for laboratories to compare results and may impact the accuracy and reliability of diagnostic tests. Additionally, some molecular diagnostic tests can be complex and require specialized equipment and expertise, cramping the market growth of molecular quality controls.
Molecular Quality Controls Market Ecosystem
The global molecular quality controls market is analyzed from four perspectives: product, application, end user, and region.
Molecular Quality Controls Market by Product
Based on the products, the global molecular quality controls market is segmented into independent controls and instrument-specific controls.
The independent controls segment dominated the molecular quality controls market with the largest revenue share in 2022. Independent controls offer greater flexibility in terms of their use across different diagnostic platforms and tests, as they are not tied to a specific manufacturer or test system. This makes them a more versatile and convenient option for laboratories. Regulatory bodies are focusing more on ensuring the quality of molecular diagnostic tests. They require manufacturers to provide evidence of their quality control measures and performance specifications. This has led to the preference for independent controls not produced by the diagnostic test manufacturer. Independent controls offer an objective and impartial evaluation of the test performance, which aligns with the regulatory requirements for unbiased assessments. Independent controls can provide an additional level of quality assurance and help to identify potential errors or issues in the testing process, improving the accuracy and reliability of diagnostic results. Independent controls can be more cost-effective than manufacturer-provided controls, particularly for laboratories that use multiple diagnostic platforms and tests.
The instrument-specific controls segment accounted for a considerable molecular quality controls market share in 2022. Instrument-specific controls are designed for a specific diagnostic instrument or platform, ensuring compatibility and optimal performance. This provides greater accuracy and reliability of the diagnostic results. Instrument-specific controls are typically easier to use and require less expertise than independent controls. This can be particularly beneficial for laboratories that may not have highly skilled personnel. Instrument-specific controls are often produced and supported by the diagnostic instrument manufacturer, providing more seamless integration into the testing process and greater technical support.
Molecular Quality Controls Market by Application
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Based on the applications, the global molecular quality controls market is segmented into infectious diseases, oncology, genetic testing, and others.
The infectious diseases segment accounted for the highest revenue share of the molecular quality controls market. Infectious diseases are a significant global health concern, with high prevalence rates in many regions. This has led to increased demand for molecular diagnostic tests to detect and manage these diseases accurately, driving the growth of the molecular quality controls market for infectious diseases. A wide range of molecular diagnostic tests are available for infectious diseases, including viruses, bacteria, and fungi. This has resulted in a significant demand for molecular quality controls that can ensure the accuracy and reliability of these tests. The growing focus on precision medicine and personalized treatment for infectious diseases requires accurate and reliable diagnostic tests. Molecular quality controls play a critical role in ensuring the accuracy and reliability of these tests, driving demand for these products.
The oncology segment accounted for a significant molecular quality controls market revenue share. Molecular diagnostic tests are increasingly being used in diagnosing and treating cancer, as they offer greater accuracy and specificity than traditional diagnostic methods. This has resulted in a significant demand for molecular quality controls that can ensure the accuracy and reliability of these tests. The global burden of cancer is increasing, with many people being diagnosed yearly. This has increased demand for molecular diagnostic tests and quality controls that can accurately detect and monitor cancer. Cancer care increasingly uses precision medicine, which tries to customize treatment to the particular patient. Ensuring the treatment is effective necessitates precise and dependable molecular diagnostic tests and quality controls.
Molecular Quality Controls Market by End User
Based on the end users, the global molecular quality controls market is segmented into clinical laboratories, hospitals, IVD manufacturers & contract research organizations, academic & research institutes, and others.
The clinical laboratories segment accounted for the prominent molecular quality controls market share in 2022. The demand for molecular diagnostic tests is increasing, driven by factors such as the growing prevalence of infectious and chronic diseases and the shift toward precision medicine. This has led to significant demand for molecular quality controls in clinical laboratories to ensure the accuracy and reliability of these tests. The number of clinical laboratories is increasing, driven by factors such as the aging population and the increasing prevalence of chronic diseases. This has increased the demand for molecular quality controls in these laboratories. Advances in technology have led to the development of new molecular diagnostic tests and platforms, which require specialized molecular quality controls. This has led to a greater demand for molecular quality controls in clinical laboratories that use these advanced technologies.
The academic & research institutes segment accounted for a considerable revenue share of the molecular quality controls market. Academic and research institutions are crucial in developing new molecular diagnostic tests and technologies. These institutions require high-quality molecular quality controls to ensure the accuracy and reliability of their research findings. Funding for academic and research institutions has been increasing globally, which has led to a rise in research activities related to molecular diagnostics. As a result, the demand for molecular quality controls in academia and research institutions has also increased significantly. The global burden of diseases is increasing, which has led to a greater need for molecular diagnostic tests to detect and manage these diseases. This has contributed to the demand for molecular quality controls in academia and research institutions.
Molecular Quality Controls Market by Region
Geographically, the global molecular quality controls market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest molecular quality controls market size in terms of revenue generation. The incidence of chronic diseases such as cancer, cardiovascular diseases, and diabetes is increasing in North America. This has led to a greater demand for molecular diagnostic tests requiring high-quality molecular quality controls to ensure accurate and reliable results. North America is a hub for technological advancements in the field of molecular diagnostics. Advances in technologies such as next-generation sequencing, polymerase chain reaction (PCR), and microarray technologies have led to the development of new molecular diagnostic tests and platforms that require specialized molecular quality controls. Regulatory bodies such as the US FDA and Health Canada have stringent requirements for validating and quality control molecular diagnostic tests. This has increased the demand for high-quality molecular quality controls in North America. Key players in the molecular quality controls market are entering into collaborations and partnerships with academic and research institutions and other companies to develop new products and expand their market presence. This is expected to drive further the growth of North America's molecular quality controls market.
Molecular Quality Controls Market Competitive Landscape
The prominent players operating in the global molecular quality controlsmarket are:
Molecular Quality Controls Market Strategic Developments
Molecular quality controls are samples or materials used to assess the accuracy, precision, and reliability of molecular diagnostic tests. These controls are typically made up of synthetic or natural materials that mimic the genetic or biological targets detected by the diagnostic test.
Asia Pacific can be considered as the key growth region due to the surge in molecular quality controls industry trends in China, Japan, and the Indian subcontinent.
The prominent players operating in the global molecular quality controls market are Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., F. Hoffmann La-Roche Ltd., Maine Molecular Quality Controls, Inc., and Abbott Laboratories Inc.
The global molecular quality controls market growth is estimated to be at a revenue CAGR of 7.0%.
The estimated size of the global molecular quality controls market in 2031 is US$ 348.03 million.
*Insights on financial performance are subject to the availability of information in the public domain