![]() |
市场调查报告书
商品编码
1951250
诊断质谱和层析法市场 - 全球产业规模、份额、趋势、机会和预测(按产品类型、应用类型、检体类型、测试类型、地区和竞争格局划分),2021-2031年Mass Spectrometry and Chromatography in Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By Application Type, By Sample Type, By Testing Type, By Region & Competition, 2021-2031F |
||||||
全球诊断质谱和层析法市场预计将从 2025 年的 15.7 亿美元增长到 2031 年的 26.3 亿美元,复合年增长率为 8.98%。
这些诊断技术采用分析方法分离、鑑定和测量生物物质,用于新生儿筛检、内分泌学、毒理学等临床应用。该领域的成长主要受以下因素驱动:慢性病发病率的上升(需要精准的生物标记追踪)以及个人化医疗的蓬勃发展(需要高灵敏度的诊断设备)。这些因素推动了耐用、高通量系统的应用,从而最大限度地减少误差,进而刺激了临床应用市场的成长。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 15.7亿美元 |
| 市场规模:2031年 | 26.3亿美元 |
| 复合年增长率:2026-2031年 | 8.98% |
| 成长最快的细分市场 | 质谱分析 |
| 最大的市场 | 北美洲 |
然而,检查室自建检测法规环境的变化对市场发展构成重大障碍,因为这些诊断方法严重依赖质谱和层析法。遵守严格的新联邦法规给实验室带来财务压力和营运不确定性。根据美国临床实验室医学学会 (ADLM) 2024 年的数据,48% 的受访检查室计划停止提供某些实验室自建检测方法,原因是新法规带来的成本和管理负担。因此,这种监管负担显着抑制了这些先进诊断技术的持续应用和普及。
高解析度质谱技术的创新正在改变诊断方式,并推动从传统免疫检测到液相层析法质谱联用平台的过渡。这些技术进步满足了转化体学和临床研究中对更高灵敏度和多重分析能力的迫切需求。例如,赛默飞世尔科技在2024年6月的新闻稿《推出革命性质谱仪,推进临床研究》中宣布,其新型Stellar质谱仪的定量灵敏度比现有标准提高了10倍,可检测的化合物数量也增加了5倍。这种性能的提升使得低丰度生物标记的精确检测成为可能,从而促进了可靠的基于质谱的分析方法在医疗机构中的广泛应用。
此外,毒理学检测和治疗药物监测需求的成长也推动了市场发展。这些领域需要进行明确鑑定的复杂样本数量激增,迫使实验室扩大处理能力。质谱分析对于区分处方药和非法药物以及识别标准筛检方法常常遗漏的检体篡改至关重要。根据Quest Diagnostics于2024年5月发布的《2024年药物检测指数》,预计2023年美国工人尿液检体无效率将比前一年激增45.2%,凸显了先进确认检测的迫切性。主要企业正持续利用这些技术来获取可观的收入以满足这一需求。例如,安捷伦科技公司报告称,其诊断和基因组学部门2024年的总收入将累计16.5亿美元。
全球诊断质谱和层析法市场面临的主要障碍之一是检查室自建检测(IDT)法规环境的变化。检查室经常使用质谱和层析法开发先进的内部检测方法,而这些方法现在受到联邦政府日益严格的审查。将这些检测方法归类为医疗设备需要进行临床检验、建立品管体系,并严格遵守上市前审查通讯协定。行政和合遵循成本的指数级增长给各机构带来了巨大的营运不确定性,导致它们暂停对新分析设备的投资并减少检测项目。
因此,实验室为了降低财务风险,正日益整合服务,导致诊断设备的潜在市场萎缩。这些严格的监管措施对依赖这些技术提供专科护理的医院影响尤其显着。检查室2024年的报告显示,60%的受访医院无法满足联邦指南中关于「未满足需求豁免」的要求。这项数据凸显了营运方面存在的巨大障碍,而无法获得豁免检查室停止提供关键检测,从而降低了对高科技诊断系统的需求。
人工智慧 (AI) 的整合使得对复杂生物数据的深度分析成为可能,从而彻底改变了诊断工作流程。製造商正致力于数位转型,将智慧演算法整合到质谱系统中,以实现即时错误检测和自动化方法创建。这项进展满足了临床检查室在面对多组体学应用带来的数据爆炸时对效率的迫切需求。作为这项策略重点的佐证,岛津公司于 2025 年 5 月发布的《截至 2025 年 3 月的财年财务业绩简报》显示,其研发支出较上年增加了 74 亿日元,其中一部分用于数位转型项目,以提升分析绩效。
同时,无层析法分离质谱技术的兴起标誌着与传统液相层析法系统的决裂,尤其是在高通量治疗药物监测领域。省去层析法分离步骤可缩短分析时间并减少溶剂用量,从而促进质谱技术在常规临床诊断中的广泛应用。随着主要企业加速收购专业企业,将快速直接分析解决方案纳入其产品组合,这一趋势正愈演愈烈。例如,布鲁克公司在2025年4月发布的新闻稿《布鲁克宣布收购RECIPE多数股权》中指出,目标公司RECIPE在2024年实现了超过1500万美元的营收,凸显了医疗保健领域对独立于供应商、无需层析法分离的诊断检测方法日益增长的需求。
The Global Mass Spectrometry & Chromatography in Diagnostics Market is projected to expand from USD 1.57 Billion in 2025 to USD 2.63 Billion by 2031, reflecting a compound annual growth rate (CAGR) of 8.98%. These diagnostic technologies employ analytical methods to isolate, identify, and measure biological substances for clinical uses such as newborn screening, endocrinology, and toxicology. Growth in this sector is largely propelled by the rising incidence of chronic conditions that demand accurate biomarker tracking, alongside a surge in personalized medicine requiring highly sensitive diagnostic instruments. Such drivers encourage the deployment of durable, high-throughput systems that minimize errors, thereby stimulating market growth within clinical environments.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 1.57 Billion |
| Market Size 2031 | USD 2.63 Billion |
| CAGR 2026-2031 | 8.98% |
| Fastest Growing Segment | Mass Spectrometry |
| Largest Market | North America |
However, the shifting regulatory environment regarding laboratory-developed tests serves as a major obstacle to market progression, as these diagnostics often utilize mass spectrometry and chromatography. Adhering to rigorous new federal mandates introduces financial pressure and operational unpredictability for testing laboratories. Data from the Association for Diagnostics & Laboratory Medicine in 2024 reveals that 48% of surveyed labs plan to stop offering certain laboratory-developed tests because of the costs and administrative workload associated with the new regulations. Consequently, this regulatory burden significantly hinders the sustained adoption and availability of these sophisticated diagnostic technologies.
Market Driver
Innovations in high-resolution mass spectrometry are transforming diagnostic potential, encouraging a shift from conventional immunoassays to liquid chromatography-mass spectrometry platforms. These technological strides meet the urgent demand for enhanced sensitivity and multiplexing capabilities within translational omics and clinical research. Illustrating this progress, Thermo Fisher Scientific announced in a June 2024 press release titled 'Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research' that their new Stellar mass spectrometer offers ten times the quantitative sensitivity for five times as many compounds compared to current standards. Such performance improvements allow for the precise detection of low-abundance biomarkers, thereby promoting the widespread implementation of reliable MS-based processes in medical facilities.
Additionally, the market is bolstered by rising needs in toxicology testing and therapeutic drug monitoring, where labs must process growing volumes of intricate samples that demand conclusive identification. Mass spectrometry is essential for differentiating between prescribed drugs and illicit substances, as well as identifying sample tampering often overlooked by standard screening methods. According to the '2024 Drug Testing Index' by Quest Diagnostics in May 2024, invalid urine specimen rates in the U.S. workforce jumped by 45.2% in 2023 relative to the prior year, underscoring the urgent need for sophisticated confirmatory testing. Leading companies continue to secure significant revenue from these technologies to meet this demand; for example, Agilent Technologies reported that its Diagnostics and Genomics Group produced $1.65 billion in total revenue for 2024.
Market Challenge
A major obstacle restricting the Global Mass Spectrometry & Chromatography in Diagnostics Market is the changing regulatory environment for laboratory-developed tests. Laboratories often use mass spectrometry and chromatography to create sophisticated in-house assays, which are now subject to increased federal scrutiny. Classifying these tests as medical devices necessitates rigorous adherence to clinical validation, quality control systems, and premarket review protocols. This sharp increase in administrative duties and compliance expenses generates significant operational instability, causing facilities to pause investments in new analytical tools and curtail their testing offerings.
Consequently, the potential market for diagnostic instruments shrinks as laboratories merge services to limit financial exposure. The harshness of these regulations creates a disproportionate impact on hospitals dependent on these technologies for specialized care. As reported by the Association for Diagnostics & Laboratory Medicine in 2024, 60% of hospitals surveyed indicated they could not meet the criteria required for unmet need exceptions within the federal guidelines. This statistic underscores the magnitude of the operational hurdle, as the failure to qualify for exemptions compels labs to stop providing critical tests, which in turn reduces the demand for high-tech diagnostic systems.
Market Trends
Diagnostic workflows are being revolutionized by the integration of Artificial Intelligence, which allows for deeper analysis of intricate biological data. Manufacturers are focusing on digital transformation, embedding smart algorithms into mass spectrometry systems to enable real-time error detection and automated method creation. This development meets the urgent demand for efficiency in clinical labs facing an explosion of data from multi-omics applications. Evidence of this strategic focus is seen in Shimadzu Corporation's 'Presentation Slides for the fiscal year ended March 31, 2025' from May 2025, which reported a 7.4 billion yen year-over-year rise in R&D spending, partly designated for digital transformation efforts to enhance analytical performance.
Simultaneously, the rise of Chromatography-Free Mass Spectrometry Techniques marks a departure from standard liquid chromatography systems, especially within high-throughput therapeutic drug monitoring. Removing the chromatographic separation phase allows labs to cut analysis times and solvent use, thereby increasing the accessibility of mass spectrometry for everyday clinical diagnostics. This trend is gaining momentum as leading companies purchase specialized businesses to add rapid, direct-analysis solutions to their offerings. For instance, Bruker Corporation's April 2025 press release, 'Bruker Announces Majority Acquisition of RECIPE,' noted that the acquired company achieved over $15 million in 2024 revenue, highlighting the rising demand for vendor-neutral, chromatography-free diagnostic assays in the healthcare sector.
Report Scope
In this report, the Global Mass Spectrometry & Chromatography in Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Mass Spectrometry & Chromatography in Diagnostics Market.
Global Mass Spectrometry & Chromatography in Diagnostics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: