市场调查报告书
商品编码
1509676
IVD品管的全球市场的评估:检体,各产品,各用途,技术,各终端用户,各地区,机会,预测(2017年~2031年)IVD Quality Control Market Assessment, By Source, By Product, By Application, By Technique, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球 IVD 品质控制市场规模预计将从 2023 年的 13.2 亿美元增至 2031 年的 19.1 亿美元,预计在 2024-2031 年期间复合年增长率为 4.77%。各种因素正在塑造市场,包括注重开发创新新产品、增加先进技术的整合、对免疫分析产品的需求不断增加、资料管理解决方案的激增以及优势等。
多种因素正在控制全球 IVD 品质控制市场,包括推动创新和新产品开发。製造商不断寻求开发新的、更好的一次性手术器械,以提高手术效率、病人安全性和可用性。这需要探索尖端的组件、样式和功能,以满足不断变化的医疗保健环境的需求。全球IVD品质控制市场正在整合人工智慧、资料管理系统和自动化等尖端技术。这些技术的发展正在提高诊断测试中品质控制任务的准确性、有效性和可近性。
预计全球 IVD 品质控制市场将由免疫分析/免疫化学领域主导。这是因为免疫测定测试的种类不断增加,现在可以快速、轻鬆、准确地识别和量化目标。资料管理系统在全球 IVD 品质控制行业中越来越受欢迎,因为它们使资料储存、处理和报告更有效率。这些技术可促进资料完整性、提高整体营运效率并简化实验室品质控制任务。
例如,临床诊断产品和生命科学研究领域的全球领导者 Bio-Rad Laboratories, Inc. 致力于将聚合?炼式反应 (PCR) 在基础研究、转化研究、製程开发和品质方面的应用2023年9 月,我们宣布推出PTC Tempo 48/48 和PTC Tempo 384 热循环仪,旨在促进此目标。 Bio-Rad 最新型号的传统 PCR 热循环仪为 PTC Tempo 48/48 和 PTC Tempo 384 热循环仪。 PTC Tempo 热循环仪设计有更新的使用者友善介面和相容的连接选项,包括在 BR.io 云端平台上监控资料和简化协定管理的能力。
市场对PCR检测发展的关注日益增加
在全球IVD品质管制市场中,PCR检测的发展越来越受到重视。在过去的几年里,聚合?炼式反应应用和技术已经被创建、完善并在各个临床领域中被采用。这些新 PCR 方法的品质标准的製定符合良好实验室规范 (GLP) 和国家(和国际)指南,就像任何其结果影响临床决策的 "内部" 检测一样,这是必要的。长期以来,已经为 "经典" 诊断测试(例如 ELISA 和基于培养的测定)以及不断开发和改进的基于 PCR 的新测定建立了品质标准,并且对这两种测试都有既定的建议。
例如,GENE-UP BREWPRO Yeast Slurry (YS) 是体外诊断领域的世界领导者 BioMerieux, Inc. 于 2024 年 5 月宣布的一种新的诊断品质控制 PCR 测试。目的是准确识别原始酵母中的杂质和酵母生长,以确保发酵的最高标准。该解决方案是与 White Labs 合作开发的,具有专为酵母浆料设计的目标和优化的样品製备以实现更高的灵敏度。目前酿造业的品质控制测试套件旨在识别最终产品中可能存在的破坏者,而不是酵母浆本身。
本报告提供全球IVD品管市场相关调查分析,提供市场规模与预测,市场动态,主要企业的形势及预测等资讯。
Global IVD quality control market is projected to witness a CAGR of 4.77% during the forecast period 2024-2031F, growing from USD 1.32 billion in 2023 to USD 1.91 billion in 2031F. Various factors shape the global IVD quality control market, including an increased focus on developing new and innovative products, increased integration of advanced technologies, rise in demand for immunoassay products, increased popularity of data management solutions, and dominance of North America.
Several factors are controlling the global IVD quality control market, including fostering innovations and developing new products. Manufacturers are always trying to create new and better disposable surgical instruments that will increase surgical efficiency, patient safety, and affordability. This requires investigating cutting-edge components, styles, and features to satisfy the changing demands of the medical field. The global IVD quality control market is integrating cutting-edge technology, including artificial intelligence, data management systems, and automation. These technological developments enhance the precision, effectiveness, and accessibility of quality control procedures in diagnostic testing.
The global IVD quality control market is anticipated to be dominated by the immunoassay/immunochemistry segment. This is because an increasing variety of immunoassay tests are available, which offer quick, easy, and precise findings for target identification and quantification. Since they make data storage, processing, and reporting more efficient, data management systems are becoming increasingly popular in the global IVD quality control industry. These technologies facilitate data integrity, increase overall operational efficiency, and simplify quality control procedures for laboratories.
For example, a global leader in clinical diagnostic products and life science research, Bio-Rad Laboratories, Inc., announced in September 2023 the introduction of its PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers, intended to facilitate polymerase chain reaction (PCR) applications in basic and translational research, process development, and quality control. The newest models in Bio-Rad's traditional PCR heat cyclers lineup are the PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers. The PTC Tempo Thermal Cyclers are designed with an updated, user-friendly interface and adaptable connectivity options, including the ability to monitor data on the BR.io cloud platform to streamline protocol administration.
Increased Focus on Developing PCR Tests in the Market
The global IVD quality control market is witnessing an increased focus on the development of PCR tests. Applications and methods for polymerase chain reaction have been created, refined, and employed in the last several years for a variety of clinical fields. The creation of quality standards for these new PCR methods has been necessary to comply with both good laboratory practice (GLP) and (inter)national guidelines, as is the case with any "in-house" assay whose results impact clinical decision-making. Quality standards have previously been established for "classical" diagnostic tests like ELISAs and culture-based assays, and there are also established recommendations for both quality assurance and quality control for new PCR-based assays that are constantly being developed and improved.
For example, the GENE-UP BREWPRO Yeast Slurry (YS) is a novel diagnostic quality control PCR test that was introduced in May 2024 by bioMerieux, Inc., a global leader in in vitro diagnostics. Its purpose is to precisely identify impurities in raw yeast materials and yeast propagations to guarantee fermentation of the highest caliber. The solution, which was created in partnership with White Labs, has specialized targets designed specifically for yeast slurries and an optimized sample prep with higher sensitivity. Present-day brewing industry quality control test kits are made to identify possible spoilers in the final product rather than in the yeast slurries themselves.
Increased Integration of Advanced Technologies is Driving the Market
Innovation is essential for improving quality control, and the tremendous transition in the diagnostics industry is bolstering the growth of the global IVD quality control market. The diagnosis procedure is being completely transformed by cutting-edge technology, including automation, machine learning, and artificial intelligence. These developments have the potential to increase the precision, effectiveness, and dependability of quality control procedures, producing test results that are more reliable and consistent. The diagnostics industry's quality control procedures have seen a substantial transformation because of the incorporation of Internet of Things (IoT) technologies. Diagnostic tools with IoT capabilities may continually track several variables, including equipment performance, humidity, and temperature. Proactive quality control procedures are made possible by the quick detection of any deviations from ideal operating conditions made possible by this real-time data collection.
For example, Bio-Rad Laboratories Inc. revealed in August 2023 that they will leverage AWS Systems Manager to build an Internet of Things device that will enhance their Next-Generation Quality Control Informatics Solution. AWS Systems Manager is a comprehensive and secure resource management tool that can be used in hybrid and multi-cloud scenarios. Without requiring any extra IT support, it connects to the instrument, the lab information system, middleware, and other software through an edge device that serves as a bridge between the lab and the cloud.
The Rise in Demand for Immunoassay Products is Boosting Market Growth
Immunoassay products are an important part of the global IVD quality control market. IVD kits and reagent variance are evaluated and tracked using immunoassay-based quality control tools. Any variations in performance can be found and fixed by comparing several IVD products to standardized immunoassay controls. Immunoassay-based quality control products can be used to identify the cause of problems in diagnostic testing. Potential causes of error, such as reagent quality, instrument performance, or operator technique, can be found and fixed by comparing results from control samples to predicted values.
For instance, Siemens Healthineers AG introduced Atellica CI Analyzer, a small testing equipment designed to address lab problems, in July 2023. With its unique features, the Atellica CI Analyzer is carefully built to maximize downtime and boost lab productivity and profitability. Labs can provide more consistent sample turnaround times thanks to automated maintenance and quality control scheduling, micro-volume aspiration, and random-access sampling. The independence of the immunoassay and chemistry engines ensures that throughput is unaffected if one of them needs to stop.
Data Management Solutions are Popular in the Market
Data management solutions offer a centralized platform for storing, organizing, and managing all data about quality control procedures in the IVD industry. In this way, a single source for quality control data is produced, incorporating information from several diagnostic devices, laboratory information systems (LIS), and other locations. Data management systems offer safe data storage, access controls, and audit trails to guarantee the accuracy and traceability of quality control data. Real-time monitoring of quality control parameters, including test results, reagent stability, and equipment performance, can be facilitated by data management solutions. All these factors make data management solutions an important factor driving the growth of the global IVD quality control market.
For instance, with the introduction of new waters_connect for IVD and QUAN Review Application in May 2024, Waters Corporation simplified the clinical data review process. ExceptionFocused Review (xfR) enables users to quickly identify and address errors that require attention. Its key features include reducing data review time by up to 50% (in comparison to Waters TargetLyn Software) and providing a one-screen dashboard that summarizes key parameters like standards, calibration, and quality control, all grouped for a streamlined view.
North America is Dominating the IVD Quality Control Market
The global IVD quality control market is dominated by North American nations, especially the United States, for several important reasons, including the existence of several accredited clinical laboratories. The United States boasts a well-respected healthcare system and many accredited clinical laboratories that follow tight quality control guidelines. The healthcare systems in North America have embraced cutting-edge diagnostic technologies like immunoassays and molecular diagnostics with great speed. The requirement for quality control procedures to guarantee the precision and dependability of test results has increased because of the growing usage of these technologies.
For example, Next Gen Diagnostics announced on June 11, 2024, that it would open its first laboratory in the United States in Cambridge, Massachusetts. The facility will offer United States' customers and partners fully integrated, affordable bacterial sequencing and bioinformatics services. This ability is enhanced by NGD's best-in-class fully automated bioinformatics, which offers comprehensive analysis of cohort phylogeny, resistance elements, and phenotype, delivered and visualized in a robust user interface, as well as quality control and relatedness determination validated in several publications.
Future Market Scenario (2024-2031F)
The global IVD quality control market is expected to see a rise in demand for multi-analyte controls, which contain numerous analytes of interest.
Point-of-care testing adoption in the global IVD quality control market is motivated by the need for quick, easy-to-use, and trustworthy diagnostic tools that improve patient outcomes and expedite processes.
It is anticipated that the increased focus on developing environmentally friendly and sustainable products will drive the growth of the global IVD quality control market.
In the global IVD quality control market, companion diagnostics, which direct the use of particular treatment products, are becoming increasingly popular.
Key Players Landscape and Outlook
Many major companies in the global IVD quality control market are forming alliances to expand in the industry. Major players can build more sophisticated and comprehensive quality control products by collaborating with other businesses to make use of complementary skills, technology, and resources. Through alliances, prominent players can better serve the different needs of the diagnostics industry by broadening the scope of their quality control solutions and diversifying their product portfolios. Investing heavily in R&D and obtaining regulatory licenses is necessary to develop products with quality control.
For example, top AI software provider Bioz, Inc., dedicated to scientific research, announced in January 2024 that it has partnered with top worldwide diagnostics provider Randox Laboratories Ltd. The organization, which is well-known for its creative research and development, provides a wide range of superior goods and services, such as quality controls, toxicology solutions, modern diagnostic devices, and clinical chemistry reagents. Using this creative partnership, Bioz has integrated Bioz Badges as dynamic, real-time widgets into the product pages of Randox Laboratories' website. These widgets offer real-time scientific application data, including excerpts from peer-reviewed scientific articles that are specifically connected to the use of the product. This collaboration aims to help academics make evidence-based decisions by raising exposure and brand awareness.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.