| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| CAGR | 3.50 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
In-Vitro Diagnostics Quality Control Market Analysis
The In-Vitro Diagnostics Quality Control Market is expected to register a CAGR of 3.5% during the forecast period.
COVID-19 has significantly impacted the growth of the studied market. Due to the spread of the coronavirus infection among the population, the demand for in-vitro diagnostic kits and devices for rapid and accurate diagnosis of SARS-CoV-2 virus infection increased. Also, the strict regulatory guidelines for reducing the spread of COVID-19 and conducting effective testing increased the need and demand for stringent quality controls of testing kits and devices. This has impacted the market growth during the forecast period.
Certain factors attributing to the market growth are the increasing demand for advanced diagnostics for sensitive reports and accurate diagnosis of chronic and infectious diseases and genetic disorders, the growing volume of accredited clinical laboratories, and the adoption of third-party quality controls.
The increasing incidences of chronic, infectious, and genetic diseases across the globe is the key factor driving the market growth. For instance, as per 2022 statistics published by IDF, it has been observed that 74.1 million people were suffering from diabetes in 2021 in India. This number is estimated to reach 92.9 million and 124.8 million by 2030 and 2045, respectively. Thus, the rising burden of diabetes among the population is expected to increase the demand for conducting in-vitro assays for detecting blood glucose. This is anticipated to propel the demand for effective in-vitro diagnostics, thus propelling the need for strict quality control.
Also, according to the data from American Cancer Society in 2022, an estimated 1,908,030 new cancer cases are expected to be diagnosed in United States in 2022. Moreover, as per the same source, among all cancers, digestive system cancer is expected to account for 343,040 cases, breast cancer is expected to account for 290,560 new cancer cases, followed by respiratory system cancer with 254,850 new cases in 2022. Thus, the rising burden of cancer raises the need to detect cancer early for more effective and timely treatment, which increases the demand for in-vitro diagnostics devices and kits, which is anticipated to boost the need for strict quality control of in-vitro diagnostics devices to reduce the chances of false results, which is expected to augment the market growth over the forecast period.
Furthermore, according to an article published by Frontiers in Medicine in May 2022, it has been observed that automated blood culture systems have improved microbiological diagnostic performance, reduced turnaround times, and enhanced yield as compared to manual blood cultures. Thus, the increasing usage of quality-assured advanced blood culture devices and instruments for detecting bloodstream infections is expected to propel the market growth over the forecast period.
Moreover, the rising company activities in developing technologically advanced diagnostic products and increasing product launches contribute to market growth. For instance, in June 2021, Thermo Fisher Scientific Inc. launched TaqPath, a new CE-IVD-marked fast PCR combo kit 2.0, to detect active SARS-CoV-2 infection.
Therefore, due to the above mentioned factors such as the rising company activities in developing technologically advanced diagnostic products and increasing product launches, increasing usage of quality-assured advanced blood culture devices and instruments for detecting bloodstream infections, the studied market is expected to experience growth during the forecast period of the study. However, unfavorable reimbursement policies for the IVD industry and a lack of stringent regulations for clinical laboratory accreditation in several emerging economies are some of the factors impeding the market growth over the forecast period.
In-Vitro Diagnostics Quality Control Market Trends
Molecular Diagnostics Segment is Expected to Register a Significant CAGR in the In-Vitro Diagnostics Quality Control Market Over the Forecast Period
Molecular diagnostic devices are used to analyze biological markers in the genome and proteome to detect pathogens or mutations. Based on the technology, molecular diagnostic devices can be segmented into chips and microarrays, mass spectroscopy, next-generation sequencing (NGS), polymerase chain reaction (PCR)-based methods, cytogenetics, and molecular imaging. Factors such as large outbreaks of bacterial and viral epidemics, increasing demand for point-of-care diagnostics, and rapidly evolving technology are driving the growth of the molecular diagnostics segment.
The advancement of precision medicine has provided specific strategies for targeted therapies and medicines for patients with cancer and Mendelian diseases, which prove to be better than traditional clinical practices, increasing the demand for next-generation sequencing, which is also expected to propel the segment growth. For instance, according to the data published by the CDC in January 2021, it is projected that more than 60 million people are likely to have their genomes sequenced by 2025 worldwide.
Furthermore, the increasing company focus on developing technologically advanced products in molecular diagnostics and rising new product launches contributes to market growth. For instance, in October 2021, ELITechGroup, an Italy-based company focused on manufacturing and distributing diagnostic solutions to laboratories, launched ELITe BeGenius, a new CE-IVD stand-alone 'Sample-to-Result' real-time (RT) PCR solution. The product makes molecular biology universally accessible with a compact footprint, ease of use, and total automation. The company also offers ELITe InGenius and ELITe BeGenius molecular diagnostics instruments to every lab.
Similarly, in June 2021, Thermo Fisher Scientific Inc. launched TaqPath, a new CE-IVD-marked fast PCR combo kit 2.0, to detect active SARS-CoV-2 infection. Such developments are expected to contribute to segment growth over the forecast period.
Therefore, owing to the abovementioned factors such as increasing company focus on developing technologically advanced products in molecular diagnostics and rising new product launches, the segment is anticipated to witness growth over the forecast period.
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North America Dominates the In-Vito Diagnostics Quality Control Market and Expects to do Same in the Forecast Period.
North America is expected to witness significant growth in the in-vitro diagnostics quality control market over the forecast period. The factors attributing to the market growth are the rising incidences and prevalence of chronic and infectious diseases, genetic disorders, rising technological advancements, and a growing number of regional diagnostic labs.
In addition, the high healthcare expenditures in the region are creating opportunities and rising company focus on developing technologically advanced in-vitro diagnostic devices, which are expected to increase the market growth. For instance, according to the OECD data published in June 2022, United States healthcare spending in 2021 was 17.8% of the country's total GDP.
Furthermore, the growing burden of chronic, infectious diseases and genetic disorders is the key factor driving the demand for in-vitro diagnostic tests, propelling the need for effective diagnostic instruments and devices, thereby propelling the market growth. For instance, according to 2022 statistics published by IDF, about 2.9 million people were living with diabetes in Canada in 2021. In addition, as per the same source, this number is projected to reach 3.2 million and 3.4 million by 2030 and 2045, respectively.
Also, as per the 2022 statistics published by the Canadian Cancer Society, about 28,600 Canadian women are expected to be diagnosed with breast cancer in 2022, representing 25% of all new cancer cases in women in 2022. The high number of breast cancer cases among the population is expected to increase the demand for effective diagnostic tests, which is anticipated to propel the demand for in-vitro diagnostic devices and kits. Thus, with the rising demand for diagnostic kits and devices, the need for quality control also increases, which is expected to augment the market growth over the forecast period.
Moreover, the increasing product launches in the region are also expected to increase the need for strict and comprehensive quality control of diagnostic devices to provide accurate test results, which are anticipated to fuel the market growth in the region. For instance, in April 2022, Bruker Corporation announced further to advance its market-leading MALDI Biotyper (MBT) platform and launch new multiplex PCR infectious disease assays based on its proprietary LiquidArray technology. In a single test, the FluoroType Mycobacteria PCT test uses sophisticated Liquid Array technology to distinguish 31 clinically important non-tuberculous mycobacteria and the Mycobacterium tuberculosis complex from cultures. Also, in October 2021, ThermoFisher Scientific launched Applied Biosystem QuantSudio Absolute Q-Digital PCR System, designed to provide highly accurate results in genetic analysis. Digital PCR is already in use for monitoring cancer-driven mutations in liquid biopsy. This has helped the company to increase its product portfolio. Therefore, owing to the abovementioned factors, the segment is anticipated to witness growth over the forecast period.
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In-Vitro Diagnostics Quality Control Industry Overview
The in-vitro diagnostics quality controls market is moderately competitive and consists of several major players. Some companies are expanding their market position by adopting various strategies such as acquisitions and mergers, while others are developing new methods for the quality check to maintain their market share. Bio-Rad Laboratories Inc., F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc., bioMerieux Inc., and ZeptoMetrix Corporation are some of the companies currently dominating the market.
In-Vitro Diagnostics Quality Control Market Leaders
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Bio-Rad Laboratories Inc
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bioMerieux Inc
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F. Hoffmann-La Roche AG
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SeraCare Life Sciences Inc
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ZeptoMetrix Corporation
- *Disclaimer: Major Players sorted in no particular order
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In-Vitro Diagnostics Quality Control Market News
- In July 2022, BrightSight Inc. launched a digital Connected Diagnostics Platform at the 2022 AACC Annual Scientific Meeting and Clinical Lab Expo. This diagnostic platform is developed for in vitro diagnostics manufacturers that streamline workflows. It includes a Proxy Agent, Analytics Dashboards, Integration Middleware, and Workflow Portals.
- In June 2022, EKF Diagnostics launched its new EKF Link digital connectivity solution for the secure management of point-of-care (POC) analyzers and associated data on one centralized platform.
In-Vitro Diagnostics Quality Control Industry Segmentation
As per the scope of the report, in-vitro diagnostic quality controls are used to evaluate the performance of in-vitro diagnostic tests, such as in vitro nucleic acid testing procedures for pathogen detection, healthcare-associated infections (HAIs) like pneumonia, and urinary tract infections. These products majorly focus on the detection of defects, quality control, and validation panels, such as the Human Papillomavirus (HPV) Control Panel and Blood Culture (BCID) Control Panel, to support the implementation and monitoring of the performance of clinical and research laboratories, blood diagnostic centers, and IVD manufacturers. The In-Vitro Diagnostics Quality Control Market is segmented by Products and Services (Quality Control Products, Data Management Solutions, and Quality Assurance Services), Applications (Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, and Other Applications), End Users (Hospitals, Clinical Laboratories, IVD Manufacturers & CROs and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (USD million) for the above segments.
| Products and Services | Quality Control Products | |
| Data Management Solutions | ||
| Quality Assurance Services | ||
| Application | Immunochemistry | |
| Hematology | ||
| Molecular Diagnostics | ||
| Coagulation/Hemostasis | ||
| Other Applications | ||
| End Users | Hospitals | |
| Clinical Laboratories | ||
| IVD Manufacturers & CROs | ||
| Other End Users | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
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In-Vitro Diagnostics Quality Control Market Research FAQs
What is the current In-Vitro Diagnostics Quality Control Market size?
The In-Vitro Diagnostics Quality Control Market is projected to register a CAGR of 3.5% during the forecast period (2025-2030)
Who are the key players in In-Vitro Diagnostics Quality Control Market?
Bio-Rad Laboratories Inc, bioMerieux Inc, F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc and ZeptoMetrix Corporation are the major companies operating in the In-Vitro Diagnostics Quality Control Market.
Which is the fastest growing region in In-Vitro Diagnostics Quality Control Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in In-Vitro Diagnostics Quality Control Market?
In 2025, the North America accounts for the largest market share in In-Vitro Diagnostics Quality Control Market.
What years does this In-Vitro Diagnostics Quality Control Market cover?
The report covers the In-Vitro Diagnostics Quality Control Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the In-Vitro Diagnostics Quality Control Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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In Vitro Diagnostics Quality Control Industry Report
Statistics for the 2025 In-Vitro Diagnostics Quality Control market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. In-Vitro Diagnostics Quality Control analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
