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市場調查報告書

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1616826

分子品質控制市場規模：依產品類型、分析物類型、應用、最終用戶、地區、範圍和預測

Molecular Quality Controls Market Size By Product, By Analyte Type, By Application, By End User, By Geographic Scope And Forecast

出版日期: 2024年06月24日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

分子品質控制市場規模及預測

2023 年分子品質控制市場規模為 2.0418 億美元，預計 2024 年至 2031 年複合年增長率為 6.55%，到 2031 年將達到 3.3919 億美元。分子品質控制包括用於驗證聚合□鍊式反應 (PCR) 和 DNA 定序等分子生物學技術的可靠性和準確性的標準和流程。這些控制涉及使用具有特定遺傳特徵的已知預設樣本，並作為驗證實驗室設備、試劑和整體測定條件的性能的基準。主要目標是檢測分子檢測過程中的詐欺和缺陷，並確保結果的準確性和可重複性。

此外，在醫療診斷中提供準確的患者診斷，在法醫學中保持刑事司法系統DNA 分析的完整性，在研究機構中驗證研究並跨越多個學科，它在為科學做出貢獻方面發揮著重要作用。

分子品質控制市場動態

塑造分子品質控制市場的關鍵市場動態

主要市場驅動因子

對準確診斷的需求不斷增加：

人們對準確診斷和定製藥物以實現早期診斷和及時治療的需求日益增長。因此，分子檢測在這些領域發揮重要作用，品質控制提高了檢測結果的可靠性，並增加了對診斷和治療決策準確性的信心。

慢性病盛行率增加：

癌症、糖尿病和傳染病等慢性病的盛行率不斷上升也是一個原因。隨著這些疾病負擔的增加，對分子診斷的需求也隨之增加，需要全面的品質控制實踐以確保診斷測試的準確性和可靠性。

分子技術的進步：

分子技術的進步，特別是新一代定序 (NGS) 和數位 PCR，正在推動產業擴張。隨著這些技術的發展，有必要根據每個人的需求建立客製化的品質控制，以確保使用這些先進技術進行的測試的準確性。

主要挑戰

認識與採用有限：

知識有限且實施嚴格的品質控制是一項重大挑戰。儘管人們對先進診斷方法的興趣日益濃厚，但對嚴格品質控制的必要性和好處的瞭解可能並不普遍，特別是在資源匱乏的環境中。這種意識的缺乏可能會導致控制系統的利用不足，並損害測試結果的準確性和可靠性。

嚴格的規定和複雜的實施：

FDA 和 EMA 等監管機構執行嚴格的規則是一把雙面刃。雖然這些法規對於確保分子診斷的準確性和可靠性是必要的，但它們也增加了製造商和最終用戶的成本和複雜性。對於資源有限的小型實驗室來說，合規可能會更加困難，這可能會限制他們正確遵守這些法規的能力。

細分市場：

許多製造商提供的控制器種類繁多，使消費者很難比較和選擇最適合其要求的控制器。跨平台和檢測缺乏通用的控制物質和參考值阻礙了品質控製程序，並阻礙了多個診斷過程的順利整合。

主要趨勢：

擴大護理點採用範圍：

另一個重要的發展是床邊診斷 (POC) 診斷的擴大使用。隨著分子檢測變得越來越容易為患者所接受，需要針對分散環境設計的便攜式、易於使用的品質控制系統。這與個人化和客製化管理的整體趨勢是一致的，並且代表了向使管理解決方案適應特定實驗室需求和測試的轉變。因此，越來越多地使用即時診斷 (POC) 已成為分子品質市場的重要發展。

專注於自動化和效率：

對自動化和效率的關注是一種持續的趨勢，實驗室擴大採用自動化技術來簡化程序並提高整體效率。這種自動化趨勢延伸到了品質控制，製造商部署自動化控制系統來消除人為錯誤並提高數據一致性，最終使分子測試更加可靠。

分子品質控制市場的區域分析

分子品質控制市場的詳細區域分析如下：

北美：

預計北美將在預測期內主導分子品質控制市場。北美在分子品質控制市場的主導地位是由於其擁有完善的醫療保健基礎設施以及專注於遵守嚴格監管框架的產品開發和研發活動的市場參與者。

該地區擁有強大且先進的醫療保健系統，擁有現代化的實驗室和診斷技術。該基金會為分子品質標準的傳播創造了有利的環境，確保診斷測試的可靠性和準確性。

北美地區遵循食品藥物管理局 (FDA) 規定的嚴格規定。這些法規促進了品質控制解決方案的實施，並鼓勵標準化、高品質的分子診斷文化。我們對監管合規性的承諾提高了我們診斷結果的有效性和可靠性，並有助於我們在該地區的市場領導地位。

此外，北美是雅培實驗室和羅氏診斷等有影響力的市場參與者的所在地，它們對市場動態產生了重大影響。這些行業參與者正在為該地區的技術發展和創新做出貢獻，為全球分子品質控制市場鋪平道路。

歐洲：

人們越來越認識到自動化整合的好處和品質控制的重要性，這促使該地區強大的醫療保健系統採用分子品質控制來遵守當今嚴格的法規。

具有現代診斷能力的強大醫療保健系統的存在有望為採用分子品質控制創造理想的環境。

嚴格的監管框架確保實驗室測試方法的高水準品質保證。由於歐洲政府優先考慮患者安全和準確診斷，因此對可靠的分子品質標準的需求仍然很高。

此外，自動化和品質控制技術的改進在歐洲變得越來越普遍。自動化不僅提高了效率，還減少了人為錯誤的可能性，並符合該地區維護高分子診斷標準的承諾。所有這些因素結合起來，使歐洲在分子品質控制市場上佔據了第二主導地位。

亞太地區：

由於醫療基礎設施的快速增長以及所有年齡層的慢性病的增加，特別是老齡化人口的增加，預計亞太地區在市場估計和預測期內將快速增長。除此之外，政府以及跨國和地區品質控制製造商提供的支援和資金在推動當前市場擴張方面發揮重要作用。

隨著對先進醫療設施和診斷能力的投資增加，該地區的醫療保健基礎設施顯著增長。這種擴展對於新分子診斷技術的引入和應用至關重要，並產生了品質控制的需求。

人們對慢性病的認識不斷提高，對可靠診斷的重視程度不斷提高，推動了該地區對分子品質控制的需求。隨著人們健康意識的增強，對可靠、準確的診斷設備的需求將會增加，對品質控制的需求也會增加。

此外，亞太地區國際和區域品質控制製造商的存在增加了可及性和可用性，從而促進了分子品質控制市場的成長。

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.

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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.

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