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市场调查报告书
商品编码
1698243
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Molecular Quality Controls Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025-2034 |
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。
市场范围 | |
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起始年份 | 2024 |
预测年份 | 2025-2034 |
起始值 | 2.152亿美元 |
预测值 | 4.135亿美元 |
复合年增长率 | 6.8% |
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。
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.
Market Scope | |
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Start Year | 2024 |
Forecast Year | 2025-2034 |
Start Value | $215.2 Million |
Forecast Value | $413.5 Million |
CAGR | 6.8% |
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.