分子品质控制市场机会、成长动力、产业趋势分析及 2025-2034 年预测

2024 年全球分子品质控制市场价值为 2.152 亿美元，预计 2025 年至 2034 年期间的复合年增长率为 6.8%。分子品质控制是分子诊断的重要参考材料，可确保测试结果的准确性、一致性和可靠性。这些控制在实验室中发挥着至关重要的作用，有助于监控检测性能、识别潜在错误并遵守严格的监管准则。随着医疗保健提供者越来越依赖分子检测来检测传染病、癌症检测和基因分析，对精准诊断解决方案的需求不断增长是推动市场扩张的主要因素。此外，传染病和遗传疾病发生率的不断上升也增加了分子诊断持续进步的必要性。

2023 年，分子品质控制市场价值为 2.035 亿美元。根据产品类型，市场分为独立控制和仪器特定控制。独立控制部门在 2024 年的收入为 1.167 亿美元，预计到 2034 年的复合年增长率为 6.7%。独立控制与测试套件分开製造，从而能够客观评估分子检测性能。这些控制可协助实验室检测批次间差异、试剂不稳定性和仪器故障，确保结果可靠且一致。他们还支持外部品质评估计划和能力测试，这对于满足监管标准至关重要。

根据分析物类型，市场分为单分析物控制和多分析物控制。单一分析物控制部分在 2024 年占据了 58.4% 的市场份额，创造了 1.257 亿美元的收入。这些控制可以精确监测特定的目标分析物，最大限度地降低与多分析物控制相关的交叉反应风险。它们的高稳定性确保了长期一致的性能，减少了检测的变异性并支持分子检测的品质保证。

从应用角度来看，市场分为传染病诊断、肿瘤检测、基因检测等领域。 2024 年，传染病诊断领域占了 48.2% 的市场。分子诊断在早期病原体检测中发挥着至关重要的作用，甚至在症状出现之前。分子品质控製作为潜在试剂降解或检测失败的早期检测机制，对于确保这些快速检测的长期准确性至关重要。

根据最终用途，市场分为医院、诊断实验室、学术和研究机构、合约研究组织和其他使用者。诊断实验室部门占 2024 年总收入的 34.5%。这些实验室处理大量传染病、肿瘤学和遗传疾病的分子测试，使其成为分子品质控制的主要采用者。

2024 年，北美的收入为 8,710 万美元，预计到 2034 年将达到 1.647 亿美元。美国以 2023 年 7,550 万美元的收入领先该地区。美国传染病和癌症盛行率的上升是推动分子品质控制需求的关键因素，此外 FDA 的严格规定也确保了分子诊断测试的准确性。

目录

第一章：方法论与范围

第二章：执行摘要

第三章：行业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 癌症和传染病发生率上升
    • 分子诊断的应用日益广泛
    • 分子诊断技术进步
    • 对准确诊断测试的需求不断增长
  • 产业陷阱与挑战
    • 分子品管服务成本高
    • 有限的报销政策
• 成长潜力分析
• 监管格局
• 技术格局
• 未来市场趋势
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第五章：市场估计与预测：按产品，2021 年至 2034 年

• 主要趋势
• 独立控制
• 仪器专用控制
  • 聚合酶连锁反应
  • DNA测序和NGS
  • 其他仪器专用控制

第六章：市场估计与预测：依分析物类型，2021 年至 2034 年

• 主要趋势
• 单一分析物对照
• 多分析物控制

第七章：市场估计与预测：按应用，2021 年至 2034 年

• 主要趋势
• 传染病诊断
• 肿瘤学检测
• 基因检测
• 其他应用

第八章：市场估计与预测：依最终用途，2021 年至 2034 年

• 主要趋势
• 医院
• 诊断实验室
• 学术和研究机构
• 合约研究组织
• 其他最终用途

第九章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：公司简介

• Anchor Molecular
• Bio-Rad Laboratories
• Bio-Techne Corporation
• Fortress Diagnostics
• Microbiologics
• Microbix Biosystems
• Maine Molecular Quality Controls
• Quidelortho Corporation
• Qiagen
• Randox Laboratories
• Seegene
• Thermo Fisher Scientific
• Zeptometrix

The Global Molecular Quality Controls Market was valued at USD 215.2 million in 2024 and is projected to expand at a CAGR of 6.8% from 2025 to 2034. Molecular quality controls serve as essential reference materials in molecular diagnostics, ensuring accuracy, consistency, and reliability in test results. These controls play a critical role in laboratories by helping monitor assay performance, identify potential errors, and comply with stringent regulatory guidelines. The rising demand for precise diagnostic solutions is a major factor fueling market expansion, as healthcare providers increasingly rely on molecular testing for infectious diseases, cancer detection, and genetic analysis. Additionally, the growing incidence of infectious diseases and genetic disorders has amplified the need for continuous advancements in molecular diagnostics.

In 2023, the molecular quality controls market was valued at USD 203.5 million. Based on product type, the market is categorized into independent controls and instrument-specific controls. The independent controls segment held USD 116.7 million in revenue in 2024 and is projected to grow at a CAGR of 6.7% through 2034. Independent controls are manufactured separately from test kits, enabling objective evaluation of molecular assay performance. These controls help laboratories detect batch-to-batch variations, reagent instability, and instrument malfunctions, ensuring reliable and consistent results. They also support external quality assessment programs and proficiency testing, which are crucial for meeting regulatory standards.

By analyte type, the market is segmented into single-analyte and multi-analyte controls. The single-analyte controls segment accounted for 58.4% of the market share in 2024, generating USD 125.7 million in revenue. These controls allow for precise monitoring of specific target analytes, minimizing cross-reactivity risks associated with multi-analyte controls. Their high stability ensures consistent performance over time, reducing assay variability and supporting quality assurance in molecular testing.

In terms of application, the market is divided into infectious disease diagnostics, oncology testing, genetic testing, and other areas. The infectious disease diagnostics segment held 48.2% of the market in 2024. Molecular diagnostics play a crucial role in early pathogen detection, even before symptoms manifest. Molecular quality controls are essential in ensuring the accuracy of these rapid assays over time by serving as an early detection mechanism for potential reagent degradation or assay failures.

Based on end use, the market is segmented into hospitals, diagnostic laboratories, academic and research institutes, contract research organizations, and other users. The diagnostic laboratories segment accounted for 34.5% of total revenue in 2024. These laboratories handle large volumes of molecular tests for infectious diseases, oncology, and genetic disorders, making them primary adopters of molecular quality controls.

North America accounted for USD 87.1 million in revenue in 2024 and is expected to reach USD 164.7 million by 2034. The US led the region with USD 75.5 million in revenue in 2023. The increasing prevalence of infectious diseases and cancer in the country is a key factor driving demand for molecular quality controls, alongside stringent FDA regulations ensuring the accuracy of molecular diagnostic tests.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of cancers and infectious diseases
    • 3.2.1.2 Growing adoption of molecular diagnostics
    • 3.2.1.3 Technological advancements in molecular diagnostics
    • 3.2.1.4 Rising demand for accurate diagnostics testing
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High cost of molecular quality control services
    • 3.2.2.2 Limited reimbursement policies
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Independent controls
• 5.3 Instrument-specific controls
  • 5.3.1 Polymerase chain reaction
  • 5.3.2 DNA sequencing and NGS
  • 5.3.3 Other instrument-specific controls

Chapter 6 Market Estimates and Forecast, By Analyte Type, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Single-analyte controls
• 6.3 Multi-analyte controls

Chapter 7 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Infectious disease diagnostics
• 7.3 Oncology testing
• 7.4 Genetic testing
• 7.5 Other applications

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals
• 8.3 Diagnostic laboratories
• 8.4 Academic and research institutes
• 8.5 Contract research organizations
• 8.6 Other end use

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Anchor Molecular
• 10.2 Bio-Rad Laboratories
• 10.3 Bio-Techne Corporation
• 10.4 Fortress Diagnostics
• 10.5 Microbiologics
• 10.6 Microbix Biosystems
• 10.7 Maine Molecular Quality Controls
• 10.8 Quidelortho Corporation
• 10.9 Qiagen
• 10.10 Randox Laboratories
• 10.11 Seegene
• 10.12 Thermo Fisher Scientific
• 10.13 Zeptometrix