分子品质控制市场规模：依产品类型、分析物类型、应用、最终用户、地区、范围和预测

分子品质控制市场规模及预测

2023 年分子品质控制市场规模为 2.0418 亿美元，预计 2024 年至 2031 年复合年增长率为 6.55%，到 2031 年将达到 3.3919 亿美元。分子品质控制包括用于验证聚合□炼式反应 (PCR) 和 DNA 定序等分子生物学技术的可靠性和准确性的标准和流程。这些控制涉及使用具有特定遗传特征的已知预设样本，并作为验证实验室设备、试剂和整体测定条件的性能的基准。主要目标是检测分子检测过程中的诈欺和缺陷，并确保结果的准确性和可重复性。

此外，在医疗诊断中提供准确的患者诊断，在法医学中保持刑事司法系统DNA 分析的完整性，在研究机构中验证研究并跨越多个学科，它在为科学做出贡献方面发挥着重要作用。

分子品质控制市场动态

塑造分子品质控制市场的关键市场动态

主要市场驱动因子

对准确诊断的需求不断增加：

人们对准确诊断和定製药物以实现早期诊断和及时治疗的需求日益增长。因此，分子检测在这些领域发挥重要作用，品质控制提高了检测结果的可靠性，并增加了对诊断和治疗决策准确性的信心。

慢性病盛行率增加：

癌症、糖尿病和传染病等慢性病的盛行率不断上升也是一个原因。随着这些疾病负担的增加，对分子诊断的需求也随之增加，需要全面的品质控制实践以确保诊断测试的准确性和可靠性。

分子技术的进步：

分子技术的进步，特别是新一代定序 (NGS) 和数位 PCR，正在推动产业扩张。随着这些技术的发展，有必要根据每个人的需求建立客製化的品质控制，以确保使用这些先进技术进行的测试的准确性。

主要挑战

认识与采用有限：

知识有限且实施严格的品质控制是一项重大挑战。儘管人们对先进诊断方法的兴趣日益浓厚，但对严格品质控制的必要性和好处的瞭解可能并不普遍，特别是在资源匮乏的环境中。这种意识的缺乏可能会导致控制系统的利用不足，并损害测试结果的准确性和可靠性。

严格的规定和复杂的实施：

FDA 和 EMA 等监管机构执行严格的规则是一把双面刃。虽然这些法规对于确保分子诊断的准确性和可靠性是必要的，但它们也增加了製造商和最终用户的成本和复杂性。对于资源有限的小型实验室来说，合规可能会更加困难，这可能会限制他们正确遵守这些法规的能力。

细分市场：

许多製造商提供的控制器种类繁多，使消费者很难比较和选择最适合其要求的控制器。跨平台和检测缺乏通用的控制物质和参考值阻碍了品质控製程序，并阻碍了多个诊断过程的顺利整合。

主要趋势：

扩大护理点采用范围：

另一个重要的发展是床边诊断 (POC) 诊断的扩大使用。随着分子检测变得越来越容易为患者所接受，需要针对分散环境设计的便携式、易于使用的品质控制系统。这与个人化和客製化管理的整体趋势是一致的，并且代表了向使管理解决方案适应特定实验室需求和测试的转变。因此，越来越多地使用即时诊断 (POC) 已成为分子品质市场的重要发展。

专注于自动化和效率：

对自动化和效率的关注是一种持续的趋势，实验室扩大采用自动化技术来简化程序并提高整体效率。这种自动化趋势延伸到了品质控制，製造商部署自动化控制系统来消除人为错误并提高数据一致性，最终使分子测试更加可靠。

分子品质控制市场的区域分析

分子品质控制市场的详细区域分析如下：

北美：

预计北美将在预测期内主导分子品质控制市场。北美在分子品质控制市场的主导地位是由于其拥有完善的医疗保健基础设施以及专注于遵守严格监管框架的产品开发和研发活动的市场参与者。

该地区拥有强大且先进的医疗保健系统，拥有现代化的实验室和诊断技术。该基金会为分子品质标准的传播创造了有利的环境，确保诊断测试的可靠性和准确性。

北美地区遵循食品药物管理局 (FDA) 规定的严格规定。这些法规促进了品质控制解决方案的实施，并鼓励标准化、高品质的分子诊断文化。我们对监管合规性的承诺提高了我们诊断结果的有效性和可靠性，并有助于我们在该地区的市场领导地位。

此外，北美是雅培实验室和罗氏诊断等有影响力的市场参与者的所在地，它们对市场动态产生了重大影响。这些行业参与者正在为该地区的技术发展和创新做出贡献，为全球分子品质控制市场铺平道路。

欧洲：

人们越来越认识到自动化整合的好处和品质控制的重要性，这促使该地区强大的医疗保健系统采用分子品质控制来遵守当今严格的法规。

具有现代诊断能力的强大医疗保健系统的存在有望为采用分子品质控制创造理想的环境。

严格的监管框架确保实验室测试方法的高水准品质保证。由于欧洲政府优先考虑患者安全和准确诊断，因此对可靠的分子品质标准的需求仍然很高。

此外，自动化和品质控制技术的改进在欧洲变得越来越普遍。自动化不仅提高了效率，还减少了人为错误的可能性，并符合该地区维护高分子诊断标准的承诺。所有这些因素结合起来，使欧洲在分子品质控制市场上占据了第二主导地位。

亚太地区：

由于医疗基础设施的快速增长以及所有年龄层的慢性病的增加，特别是老龄化人口的增加，预计亚太地区在市场估计和预测期内将快速增长。除此之外，政府以及跨国和地区品质控制製造商提供的支援和资金在推动当前市场扩张方面发挥重要作用。

随着对先进医疗设施和诊断能力的投资增加，该地区的医疗保健基础设施显着增长。这种扩展对于新分子诊断技术的引入和应用至关重要，并产生了品质控制的需求。

人们对慢性病的认识不断提高，对可靠诊断的重视程度不断提高，推动了该地区对分子品质控制的需求。随着人们健康意识的增强，对可靠、准确的诊断设备的需求将会增加，对品质控制的需求也会增加。

此外，亚太地区国际和区域品质控制製造商的存在增加了可及性和可用性，从而促进了分子品质控制市场的成长。

目录

第1章全球分子品质控制市场简介

• 市场概览
• 调查范围
• 先决条件

第 2 章执行摘要

第3章验证市场情报研究方法

• 资料探勘
• 验证
• 主要来源
• 资料来源列表

第4章全球分子品质管制市场展望

• 摘要
• 市场动态
  • 促进因素
  • 抑制因素
  • 机会
• 波特的五力模型
• 价值链分析

第5章分子品质控制的全球市场（按产品）

• 摘要
• 特定于设备的控制
• 独立控制

第 6 章全球分子品质管制市场：依分析物类型划分

• 摘要
• 单一分析物对照
• 多种分析物对照

第 7 章分子品质控制的全球市场：按应用划分

• 摘要
• 传染病诊断
• 肿瘤检查
• 基因检测
• 其他

第 8 章分子品质控制的全球市场：按最终用户划分

• 摘要
• 诊断实验室
• 医院
• 体外诊断药物生产商和合约研究机构
• 学术/研究机构
• 其他最终用户

第 9 章分子品质控制的全球市场：按地区划分

• 摘要
• 北美
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 其他亚太地区
• 世界其他地区
  • 拉丁美洲
  • 中东/非洲

第10章全球分子品质管制市场竞争格局

• 摘要
• 企业市场排名
• 供应商情况
• 主要发展策略

第11章公司简介

• Abbott Laboratories
• Roche Diagnostics
• Thermo Fisher Scientific
• Qiagen
• Beckman Coulter
• Siemens Healthineers
• Bio-Rad Laboratories
• Agilent Technologies

第12章主要进展

• 产品发布/开发
• 併购
• 业务扩展
• 合作伙伴与联盟

第13章附录

• 相关研究

Molecular Quality Controls Market Size And Forecast

Molecular Quality Controls Market size was valued at USD 204.18 Million in 2023 and is projected to reach USD 339.19 Million by 2031, growing at a CAGR of 6.55% from 2024 to 2031. Molecular quality controls comprise standards and processes used to verify the reliability and correctness of molecular biology techniques like polymerase chain reaction (PCR) and DNA sequencing. These controls include the use of known, preset samples with certain genetic traits that serve as benchmarks for validating the performance of laboratory equipment, reagents, and overall assay conditions. The primary objective is to uncover any irregularities or flaws in the molecular testing process, ensuring the accuracy and reproducibility of the results.

Furthermore, they play an important role in medical diagnostics to provide accurate patient diagnoses, in forensics to maintain DNA profiling integrity for the criminal justice system, and in research, labs to validate studies and contribute to scientific discoveries across multiple disciplines.

Molecular Quality Controls Market Dynamics

The key market dynamics that are shaping the Molecular Quality Controls Market include:

Key Market Drivers

Rising Demand for Accurate Diagnostics:

There is an increasing demand for accurate diagnostics and customized medicines for early diagnosis of offer on-time treatment. As a result, molecular tests play an important role in these domains, and implementing quality controls increases the dependability of test results, instilling greater confidence in the accuracy of diagnoses and treatment decisions.

Increasing Prevalence of Chronic Diseases:

Another motivating aspect is the growing prevalence of chronic diseases like cancer, diabetes, and infectious disorders. As the burden of these illnesses increases, so does the demand for molecular diagnostics, necessitating the implementation of comprehensive quality controls to ensure diagnostic test accuracy and reliability.

Advancements in Molecular Technologies:

Advances in molecular technologies, particularly next-generation sequencing (NGS) and digital PCR, help to drive industry expansion. These technological developments necessitate the establishment of customized quality controls adapted to their specific needs, ensuring the accuracy of tests performed using these advanced technologies.

Key Challenges:

Limited Awareness and Adoption:

Limited knowledge and adoption of robust quality controls provide a significant challenge. While there is a growing interest in advanced diagnostics, knowledge of the need and advantages of tight quality controls may not be universal, particularly in resource-constrained settings. This lack of awareness can lead to the underutilization of controls, compromising the accuracy and dependability of test results.

Stringent Regulations and Complex Implementation:

The application of strict rules by regulatory agencies like the FDA and EMA is a two-edged sword. While these rules are necessary to ensure the accuracy and reliability of molecular diagnostics, they also add to the costs and complexity for both manufacturers and end users. Smaller laboratories with limited resources may find compliance more difficult, limiting their capacity to properly follow these rules.

Fragmented Market:

The wide range of control types supplied by many manufacturers makes it difficult for consumers to compare and select the best controls for their unique requirements. The lack of common control materials and reference values across platforms and assays hampers quality control procedures and prevents smooth integration into multiple diagnostic processes.

Key Trends:

Growing Adoption in Point-of-Care Settings:

Another significant development is the increased use of point-of-care (POC) diagnostics. As molecular testing becomes more accessible to patients, there is a demand for portable and user-friendly quality control systems designed for decentralized settings. This is consistent with the general trend of personalized and tailored controls, indicating a shift toward adapting control solutions to specific laboratory needs and tests. As a result, the increased use of point-of-care (POC) diagnostics is a significant development in the molecular quality market.

Focus on Automation and Efficiency:

The emphasis on automation and efficiency is an ongoing trend, with laboratories increasingly implementing automated technology to streamline procedures and improve overall efficiency. This emphasis on automation extends to quality control, with manufacturers implementing automated control systems to eliminate human error and enhance data consistency, ultimately increasing the reliability of molecular testing.

What's inside a VMR industry report?

Our reports include actionable data and forward-looking analysis that help you craft pitches, create business plans, build presentations and write proposals.

Molecular Quality Controls Market Regional Analysis

Here is a more detailed regional analysis of the Molecular Quality Controls Market:

North America:

North America is estimated to dominate the Molecular Quality Controls Market during the forecast period. North America's dominant position in the Molecular Quality Controls Market is driven by the presence of well-established healthcare infrastructure and market players who are focusing on developing products and conducting research and development activities in compliance with, tight regulatory frameworks.

The region has a solid and advanced healthcare system, along with modern laboratories and diagnostic technologies. This foundation creates a climate suitable to the widespread use of molecular quality standards, which ensure diagnostic test reliability and correctness.

North America follows severe regulatory regulations, as shown by the Food and Drug Administration (FDA). These regulations promote the implementation of quality control solutions, encouraging a culture of standardized and high-quality molecular diagnostics. The commitment to regulatory compliance improves the legitimacy and dependability of diagnostic results, which contributes to the region's leading market position.

Furthermore, the presence of prominent market players like Abbott Laboratories and Roche Diagnostics in North America has a significant impact on market dynamics. These industry players contribute to the region's technological developments and innovation, paving the way for the worldwide molecular quality control market.

Europe:

Growing awareness regarding the benefits of integration of automation and importance of quality control is encouraging the strong healthcare systems to adopt molecular quality controls complying with the current stringent regulations in the region.

The presence of robust healthcare systems with modern diagnostic capabilities is anticipated to create an ideal environment for the adoption of molecular quality controls.

A tight regulatory framework, ensures a high level of quality assurance in laboratory testing methods. As European governments prioritize patient safety and precise diagnosis, the need for dependable molecular quality standards remains high.

Furthermore, automation and improved quality control technologies have become increasingly popular in Europe. Automation not only increases efficiency but also reduces the chance of human error, which aligns with the region's commitment to maintaining high molecular diagnostic standards. A confluence of all these factors enables Europe hold second dominant position in the Molecular Quality Controls Market.

Asia Pacific:

Asia Pacific is estimated to grow at the highest CAGR in the molecular quality control market during the forecast period owing to booming healthcare infrastructure tackle the increasing incidences of chronic diseases among all age groups, especially growing ageing population. In addition to this, the support and funding provided by government and the multinational and regional quality control manufacturers play a crucial role in bolstering the expansion of the current market.

The region's healthcare infrastructure has grown significantly, with greater investment in sophisticated medical facilities and diagnostic capabilities. This expansion is critical for the adoption and application of new molecular diagnostics technologies, generating the need for quality controls.

Rising awareness of chronic diseases, as well as an increased emphasis on reliable diagnostics, drive the region's demand for molecular quality controls. As populations become more health-conscious, the demand for dependable and precise diagnostic instruments grows, boosting the need for quality controls.

Furthermore, the presence of both international and regional quality control producers in the Asia Pacific area improves accessibility and availability, leading to the growth of the Molecular Quality Controls Market.

Molecular Quality Controls Market: Segmentation Analysis

The Molecular Quality Controls Market is segmented based on Product, Analyte Type, Application, End User, And Geography.

Molecular Quality Controls Market, By Product

• Independent Controls
• Instrument- Specific Controls
• Polymerase Chain Reaction (PCR)
• DNA Sequencing & NGS
• Other Technologies

Based on Product, the market is segmented into Independent Controls and Instrument-Specific Controls. The independent controls segment is estimated to dominate the Molecular Quality Controls Market during the forecast period. The independent controls product segment dominates the Molecular Quality Controls Market due to its adaptability and broad applicability. Independent controls allow laboratories to evaluate and validate a variety of molecular biology procedures, such as PCR, DNA sequencing, and nucleic acid amplification. These controls take the form of well-characterized samples with known genetic traits, allowing labs to properly monitor and troubleshoot their testing processes. As a result, the dominance of the independent controls product market emphasizes its vital role in maintaining the correctness and reliability of molecular diagnostic and research results.

Molecular Quality Controls Market, By Analyte Type

• Single-Analyte Controls
• Multi-Analyte Controls

Based on Analyte Type, the market is segmented into Single-Analyte Controls and Multi-Analyte Controls. The single-analyte controls segment is estimated to dominate the market over the forecast period. Single analyte controls dominate the analyte-type segment of the Molecular Quality Controls Market due to their focus and specialization. Single analyte controls are used to assess the performance of molecular assays that target individual analytes, such as single genes or biomarkers. This precision is especially useful for assuring the quality and dependability of diagnostic procedures and research experiments targeting specific genetic markers. Therefore, the prevalence of single analyte controls emphasizes their significance in ensuring the quality and reliability of molecular testing techniques.

Molecular Quality Controls Market, By Application

• Infectious Disease Diagnostics
• Oncology Testing
• Genetic Testing
• Others

Based on Application, the market is segmented into Infectious Disease Diagnostics, Oncology Testing, Genetic Testing, and Others. Infectious disease diagnostics application is estimated to hold the majority share in the forecast period in the Molecular Quality Controls Market owing to critical role of accurate and reliable testing in managing infectious diseases. Molecular quality controls play an important role in guaranteeing the accuracy of diagnostic assays used to detect infectious agents such as bacteria, viruses, and fungus. Strong quality controls are especially important in infectious disease diagnostics since false-positive or false-negative results can have an influence on patient treatment, public health actions, and the overall success of disease management measures. Thus, the infectious disease diagnostics segment has become a focus point for the application of molecular quality standards, driving its dominance in the market.

Molecular Quality Controls Market, By End User

• Diagnostic Laboratories
• Hospitals
• IVD Manufacturers & Contract Research Organizations
• Academic & Research Institutes
• Other End Users

Based on End User, the market is segmented into Diagnostic Laboratories, Hospitals, IVD Manufacturers & Contract Research Organizations, Academic & Research Institutes and Other End Users. Diagnostic Laboratories is estimated to hold the majority share in the forecast period in the Molecular Quality Controls Market. The diagnostic laboratories end user segment dominates the Molecular Quality Controls Market because of its vital function in delivering accurate and trustworthy diagnostic results. Diagnostic laboratories lead the way in medical testing, using molecular tools like PCR and DNA sequencing to diagnose diseases and profile patients. The dominance of the diagnostic laboratories end user segment highlights the critical role of molecular quality controls in maintaining diagnostic accuracy standards and, as a result, the overall efficacy of healthcare systems.

Key Players

• The "Molecular Quality Controls Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Qiagen, Beckman Coulter, Siemens Healthineers, Bio-Rad Laboratories, Agilent Technologies, Danaher Corporation, Eurofins Scientific, Luminex Corporation, Promega Corporation, Myriad Genetics, Oxford Nanopore Technologies, Illumina, Inc., Invitae Corporation, Covance Laboratories, SeraCare Life Sciences, ACIES Biomedical, and ZeptoMetrix.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

• In January 2024, Abbott announced a collaboration agreement with Personalis, Inc. to develop and market liquid biopsy controls for next-generation sequencing (NGS) experiments. This collaboration aims to improve the accuracy and reliability of liquid biopsy tests for cancer identification and monitoring.
• In January 2024, Roche Diagnostics introduced its new AmpliRun Control Set, which provides a comprehensive solution for quality control in qPCR experiments. This collection comprises controls for a variety of target genes, allowing laboratories to validate analytical performance and assure consistent results.
• In January 2024, Qiagen announced the availability of new QuantiTect viral load controls for SARS-CoV-2, hepatitis B virus (HBV), and cytomegalovirus. These controls address the increased need for precise monitoring of viral infections in clinical settings.
• In December 2023, The FDA authorized Luminex Corporation's xMAP Control Pak for Human Cytokine/Chemokine Panel. This clearance enables clinical laboratories to use these controls to conduct standardized quality assessments in immunoassay applications.
• In December 2023, Eurofins Scientific, a major provider of food, environmental, and pharmaceutical testing services, announced the purchase of Celsis Limited, which specializes in quick microbiological testing solutions. This acquisition solidifies Eurofins' leadership in the molecular quality control market for the food and beverage industry.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL MOLECULAR QUALITY CONTROLS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL MOLECULAR QUALITY CONTROLS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL MOLECULAR QUALITY CONTROLS MARKET, BY PRODUCT

• 5.1 Overview
• 5.2 Instrument-Specific Controls
• 5.3 Independent Controls

6 GLOBAL MOLECULAR QUALITY CONTROLS MARKET, BY ANALYTE TYPE

• 6.1 Overview
• 6.2 Single-Analyte Controls
• 6.3 Multi-Analyte Controls

7 GLOBAL MOLECULAR QUALITY CONTROLS MARKET, BY APPLICATION

• 7.1 Overview
• 7.2 Infectious Disease Diagnostics
• 7.3 Oncology Testing
• 7.4 Genetic Testing
• 7.5 Others

8 GLOBAL MOLECULAR QUALITY CONTROLS MARKET, BY END USER

• 8.1 Overview
• 8.2 Diagnostic Laboratories
• 8.3 Hospitals
• 8.4 IVD Manufacturers & Contract Research Organizations
• 8.5 Academic & Research Institutes
• 8.6 Other End Users

9 GLOBAL MOLECULAR QUALITY CONTROLS MARKET, BY GEOGRAPHY

• 9.1 Overview
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 U.K.
  • 9.3.3 France
  • 9.3.4 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Rest of Asia Pacific
• 9.5 Rest of the World
  • 9.5.1 Latin America
  • 9.5.2 Middle East & Africa

10 GLOBAL MOLECULAR QUALITY CONTROLS MARKET COMPETITIVE LANDSCAPE

• 10.1 Overview
• 10.2 Company Market Ranking
• 10.3 Vendor Landscape
• 10.4 Key Development Strategies

11 COMPANY PROFILES

• 11.1 Abbott Laboratories
  • 11.1.1 Overview
  • 11.1.2 Financial Performance
  • 11.1.3 Product Outlook
  • 11.1.4 Key Developments
• 11.2 Roche Diagnostics
  • 11.2.1 Overview
  • 11.2.2 Financial Performance
  • 11.2.3 Product Outlook
  • 11.2.4 Key Developments
• 11.3 Thermo Fisher Scientific
  • 11.3.1 Overview
  • 11.3.2 Financial Performance
  • 11.3.3 Product Outlook
  • 11.3.4 Key Developments
• 11.4 Qiagen
  • 11.4.1 Overview
  • 11.4.2 Financial Performance
  • 11.4.3 Product Outlook
  • 11.4.4 Key Developments
• 11.5 Beckman Coulter
  • 11.5.1 Overview
  • 11.5.2 Financial Performance
  • 11.5.3 Product Outlook
  • 11.5.4 Key Developments
• 11.6 Siemens Healthineers
  • 11.6.1 Overview
  • 11.6.2 Financial Performance
  • 11.6.3 Product Outlook
  • 11.6.4 Key Developments
• 11.7 Bio-Rad Laboratories
  • 11.7.1 Overview
  • 11.7.2 Financial Performance
  • 11.7.3 Product Outlook
  • 11.7.4 Key Developments
• 11.8 Agilent Technologies
  • 11.8.1 Overview
  • 11.8.2 Financial Performance
  • 11.8.3 Product Outlook
  • 11.8.4 Key Developments
  • 11.9 Danaher Corporation
    • 11.9.1 Overview
    • 11.9.2 Financial Performance
    • 11.9.3 Product Outlook
    • 11.9.4 Key Developments
  • 11.10 Eurofins Scientific
    • 11.10.1 Overview
    • 11.10.2 Financial Performance
    • 11.10.3 Product Outlook
    • 11.10.4 Key Developments

12 KEY DEVELOPMENTS

• 12.1 Product Launches/Developments
• 12.2 Mergers and Acquisitions
• 12.3 Business Expansions
• 12.4 Partnerships and Collaborations

13 APPENDIX

• 13.1 Related Research