全球分子品管市场：按产品类型、按分析物类型、按应用、按最终用户、按地区

2025 年全球分子品管市场价值估计为 2.233 亿美元，预计到 2032 年将达到 3.659 亿美元，2025 年至 2032 年的复合年增长率为 7.3%。

数字。 2025 年分子品管市场占有率（%），依地区划分

分子品管涉及透过样品、试剂和验证程序评估和监测分子诊断的品质。由于分子技术的进步和照护现场（POC）检测的日益普及，全球分子品管市场正在经历显着增长。个人化医疗需求的不断增长和全球实验室测试的集中化可能会推动对分子品质保证解决方案的需求。此外，为了确保检测结果的准确性和可靠性，人们越来越重视分子检测程序的标准化和协调，这也推动了一系列分子品管产品和服务的激增。

市场动态

全球分子品管市场的成长主要得益于分子诊断在各个疾病领域的应用不断扩大以及分子检测在临床决策中的应用日益增加。 PCR和次世代定序等分子技术的快速进步正在扩大其应用范围。感染疾病、癌症和遗传疾病的发生率日益上升，需要对分子检测进行严格的品质评估。美国《临床实验室改进修正案》（CLIA）等指南的实施，要求对分子诊断实验室进行认证和验证，进一步推动了品管的采用。然而，新兴国家的临床实验室面临预算限制，使得市场开发面临挑战。此外，复杂的法律规范和熟练专业人员的短缺也阻碍了市场的成长。正在开发具有增强的一致性和可重复性的新型分子品管，这将在不久的将来提供许多有利可图的机会。

本研究的主要特点

本研究报告对全球分子品管市场进行了详细分析，并以 2024 年为基准年，给出了预测期（2025-2032 年）的市场规模和复合年增长率。

它揭示了不同领域的潜在商机并解释了该市场的有吸引力的投资提案矩阵。

它还提供了对市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景以及主要企业采用的竞争策略的重要见解。

全球分子品管市场的主要企业根据公司亮点、产品系列、关键亮点、财务绩效和策略等参数进行分析。

研究中介绍的主要企业包括赛默飞世尔科技公司 (Thermo Fisher Scientific Inc.)、Bio-Rad Laboratories, Inc.、Microbiologics, Inc.、ZeptoMetrix Corporation、F. Hoffmann-La Roche Ltd.、雅培 Qualdott Laboratories)、Quidel Corporation、Qnostics、Manel Corporation、Qnoscan、Controla） O AS、Technopath Clinical Diagnostics、Randox Laboratories Ltd. 和 Hologic, Inc.

本报告的见解将使负责人和公司经营团队能够就未来的产品发布、类型升级、市场扩张和行销策略做出明智的决策。

全球分子品管市场报告迎合了该行业的各个相关人员，例如投资者、供应商、产品製造商、经销商、新进入者和金融分析师。

相关人员将透过用于分析全球分子品管市场的各种策略矩阵来做出决策。

目录

第一章 调查目的与前提条件

• 研究目标
• 先决条件
• 简称

第二章 市场展望

• 报告描述
  • 市场定义和范围
• 执行摘要

第三章市场动态、法规与趋势分析

• 市场动态
• 影响分析
• 主要进展
• 监管情景
• 产品发布/核准
• PEST分析
• 波特的分析
• 併购情景
• 产业趋势

4. 全球分子品管市场依产品类型划分（2020-2032 年）

• 独立控制
• 设备特定控制
• DNA定序与次世代定序

5. 全球分子品管市场依分析物类型划分（2020-2032 年）

• 单一分析物对照
• 多重分析控制

6. 全球分子品管市场按应用划分（2020-2032 年）

• 感染疾病诊断
• 肿瘤学检测
• 基因检测
• 微生物学
• 其他用途（如组织分型）

7. 全球分子品管市场依最终用户划分（2020-2032 年）

• 临床和诊断实验室
• 医院和诊所
• 学术研究所
• 合约研究组织
• 其他的

8. 全球分子品管市场按地区划分（2020-2032 年）

• 北美洲
• 拉丁美洲
• 欧洲
• 亚太地区
• 海湾合作委员会国家
• 以色列
• 其他中东地区
• 非洲

第九章 竞争格局

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• Microbiologics, Inc.
• ZeptoMetrix Corporation
• Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Quidel Corporation
• Qnostics
• Maine Molecular Quality Controls, Inc.
• Danaher Corporation
• Helena Biosciences Europe
• SERO AS
• Technopath Clinical Diagnostics
• Randox Laboratories Ltd.
• Hologic, Inc.

第 10 章分析师建议

• 命运之轮
• 分析师观点
• Coherent Opportunity Map（COM）

第 11 章 参考文献与调查方法

• 参考
• 调查方法
• 关于出版商

Global Molecular Quality Control Market is estimated to be valued at USD 223.3 Mn in 2025 and is expected to reach USD 365.9 Mn by 2032, growing at a compound annual growth rate (CAGR) of 7.3% from 2025 to 2032.

Figure. Molecular Quality Control Market Share (%), By Region 2025

Molecular quality control involves assessing and monitoring the quality of molecular diagnostics through samples, reagents, and validation procedures. Global molecular quality control market has witnessed significant growth due to advancements in molecular technology and growing adoption of point-of-care (POC) testing. Rising demand for personalized medicine and centralized lab testing worldwide can boost demand for molecular quality assurance solutions. Moreover, increasing focus on standardizing and harmonizing molecular testing procedures to ensure accuracy and reliability of test results boosts uptake of various molecular quality control products and services.

Market Dynamics

Global molecular quality control market growth is primarily driven by growing molecular diagnostics applications across different disease areas coupled with increasing incorporation of molecular testing in clinical decision making. Rapid technological advancement in molecular techniques such as PCR and Next-Gen sequencing has expanded their scope of applications. Rising prevalence of infectious diseases, cancer and genetic disorders necessitates robust quality assessment of molecular assays. Implemented guidelines like CLIA (Clinical Laboratory Improvement Amendments) in U.S mandating accreditation and validation of molecular diagnostic labs further boosts adoption of quality controls. However, budgetary constraints of clinical laboratories in developing nations poses challenge for market players. Moreover, complex regulatory frameworks and lack of skilled professionals hampers the market growth. Ongoing development of novel molecular quality controls with enhanced consistency and reproducibility presents numerous lucrative opportunities in the near future.

Key features of the study

This report provides in-depth analysis of the global molecular quality control market, and provides market size (USD Million) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players

It profiles key players in the global molecular quality control market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies

Key companies covered as a part of this study include Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Microbiologics, Inc., ZeptoMetrix Corporation, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Quidel Corporation, Qnostics, Maine Molecular Quality Controls, Inc., Danaher Corporation, Helena Biosciences Europe, SERO AS, Technopath Clinical Diagnostics, Randox Laboratories Ltd., and Hologic, Inc.

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

Global molecular quality control market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global molecular quality control market.

Market Segmentation

• By Product Type Insights (Revenue, USD Mn, 2019 - 2032)
  • Independent Control
  • Instrument Specific Control
  • DNA Sequencing and Next-Generation Sequencing
  • Polymerase Chain Reaction
  • Others
• By Analyte Type Insights (Revenue, USD Mn, 2019 - 2032)
  • Single-Analyte Controls
  • Multi-Analyte Controls
• By Application Insights (Revenue, USD Mn, 2019 - 2032)
  • Infectious Disease Diagnostics
  • Oncology Testing
  • Genetic Testing
  • Microbiology
  • Other Applications (Tissue Typing, etc.)
• By End Users Insights (Revenue, USD Mn, 2019 - 2032)
  • Clinical & Diagnostic Laboratories
  • Hospitals and Clinics
  • Academic and Research Institutes
  • Contract Research Organizations
  • Others
• Regional Insights (Revenue, USD Mn, 2019 - 2032)
  • North America
  • U.S.
  • Canada
  • Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
  • Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
  • Africa
  • South Africa
  • North Africa
  • Central Africa
• Key Players Insights
  • Thermo Fisher Scientific Inc.
  • Bio-Rad Laboratories, Inc.
  • Microbiologics, Inc.
  • ZeptoMetrix Corporation
  • Hoffmann-La Roche Ltd.
  • Abbott Laboratories
  • Quidel Corporation
  • Qnostics
  • Maine Molecular Quality Controls, Inc.
  • Danaher Corporation
  • Helena Biosciences Europe
  • SERO AS
  • Technopath Clinical Diagnostics
  • Randox Laboratories Ltd.
  • Hologic, Inc.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Global Molecular Quality Control Market, By Product Type
  • Global Molecular Quality Control Market, By Analyte Type
  • Global Molecular Quality Control Market, By Application
  • Global Molecular Quality Control Market, By End Users
  • Global Molecular Quality Control Market, By Region

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Driver
  • Restraint
  • Opportunity
• Impact Analysis
• Key Developments
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario
• Industry Trends

4. Global Molecular Quality Control Market, By Product Type, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Independent Control
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Instrument Specific Control
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• DNA Sequencing and Next-Generation Sequencing
  • Polymerase Chain Reaction
  • Others

5. Global Molecular Quality Control Market, By Analyte Type, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Single-Analyte Controls
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Multi-Analyte Controls
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

6. Global Molecular Quality Control Market, By Application, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Infectious Disease Diagnostics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Oncology Testing
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Genetic Testing
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Microbiology
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Other Applications (Tissue Typing, etc.)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

7. Global Molecular Quality Control Market, By End Users, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Clinical & Diagnostic Laboratories
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Hospitals and Clinics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Academic and Research Institutes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Contract Research Organizations
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

8. Global Molecular Quality Control Market, By Region, 2020 - 2032, (USD Mn)

• Introduction
  • Market Share (%) Analysis, 2025, 2028 & 2032, (USD Mn)
  • Market Y-o-Y Growth Analysis (%), 2021 - 2032, (USD Mn)
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • U.S.
    • Canada
• Latin America
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
    • Middle East
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)

• GCC Countries
• Israel
• Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country/Region, 2020 - 2032, (USD Mn)
    • South Africa
    • North Africa
    • Central Africa

9. Competitive Landscape

• Thermo Fisher Scientific Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Bio-Rad Laboratories, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Microbiologics, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• ZeptoMetrix Corporation
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Hoffmann-La Roche Ltd.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Abbott Laboratories
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Quidel Corporation
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Qnostics
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Maine Molecular Quality Controls, Inc.
• Danaher Corporation
• Helena Biosciences Europe
• SERO AS
• Technopath Clinical Diagnostics
• Randox Laboratories Ltd.
• Hologic, Inc.

10. Analyst Recommendations

• Wheel of Fortune
• Analyst View
• Coherent Opportunity Map

11. References and Research Methodology

• References
• Research Methodology
• About us