![]() |
市場調查報告書
商品編碼
1951250
診斷質譜和層析法市場 - 全球產業規模、佔有率、趨勢、機會和預測(按產品類型、應用類型、檢體類型、測試類型、地區和競爭格局分類),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 |
||||||
全球診斷質譜和層析法市場預計將從 2025 年的 15.7 億美元成長到 2031 年的 26.3 億美元,複合年成長率為 8.98%。
這些診斷技術採用分析方法分離、鑑定和測量生物物質,用於新生兒篩檢、內分泌學、毒理學等臨床應用。該領域的成長主要受以下因素驅動:慢性病發病率的上升(需要精準的生物標記追蹤)以及個人化醫療的蓬勃發展(需要高靈敏度的診斷設備)。這些因素推動了耐用、高通量系統的應用,從而最大限度地減少誤差,進而刺激了臨床應用市場的成長。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 15.7億美元 |
| 市場規模:2031年 | 26.3億美元 |
| 複合年成長率:2026-2031年 | 8.98% |
| 成長最快的細分市場 | 質譜分析 |
| 最大的市場 | 北美洲 |
然而,檢查室自建檢測法規環境的變化對市場發展構成重大障礙,因為這些診斷方法嚴重依賴質譜和層析法。遵守嚴格的新聯邦法規給實驗室帶來財務壓力和營運不確定性。根據美國臨床實驗室醫學學會 (ADLM) 2024 年的數據,48% 的受訪檢查室計劃停止提供某些實驗室自建檢測方法,原因是新法規帶來的成本和管理負擔。因此,這種監管負擔顯著抑制了這些先進診斷技術的持續應用和普及。
高解析度質譜技術的創新正在改變診斷方式,並推動從傳統免疫檢測到液相層析法質譜聯用平台的過渡。這些技術進步滿足了轉化體學和臨床研究中對更高靈敏度和多重分析能力的迫切需求。例如,賽默飛世爾科技在2024年6月的新聞稿《推出革命性質譜儀,推進臨床研究》中宣布,其新型Stellar質譜儀的定量靈敏度比現有標準提高了10倍,可檢測的化合物數量也增加了5倍。這種性能的提升使得低豐度生物標記的精確檢測成為可能,從而促進了可靠的基於質譜的分析方法在醫療機構中的廣泛應用。
此外,毒理學檢測和治療藥物監測需求的成長也推動了市場發展。這些領域需要進行明確鑑定的複雜樣本數量激增,迫使實驗室擴大處理能力。質譜分析對於區分處方藥和非法藥物以及識別標準篩檢方法常常遺漏的檢體篡改至關重要。根據Quest Diagnostics於2024年5月發布的《2024年藥物檢測指數》,預計2023年美國工人尿液檢體無效率將比前一年激增45.2%,凸顯了先進確認檢測的迫切性。主要企業正持續利用這些技術來獲取可觀的收入以滿足這一需求。例如,安捷倫科技公司報告稱,其診斷和基因組學部門2024年的總收入將累計16.5億美元。
全球診斷質譜和層析法市場面臨的主要障礙之一是檢查室自建檢測(IDT)法規環境的變化。檢查室經常使用質譜和層析法開發先進的內部檢測方法,而這些方法現在受到聯邦政府日益嚴格的審查。將這些檢測方法歸類為醫療設備需要進行臨床檢驗、建立品管體系,並嚴格遵守上市前審查通訊協定。行政和合遵循成本的指數級成長給各機構帶來了巨大的營運不確定性,導致它們暫停對新分析設備的投資並減少檢測項目。
因此,實驗室為了降低財務風險,正日益整合服務,導致診斷設備的潛在市場萎縮。這些嚴格的監管措施對依賴這些技術提供專科護理的醫院影響尤其顯著。檢查室2024年的報告顯示,60%的受訪醫院無法滿足聯邦指南中關於「未滿足需求豁免」的要求。這項數據凸顯了營運方面存在的巨大障礙,而無法獲得豁免檢查室停止提供關鍵檢測,從而降低了對高科技診斷系統的需求。
人工智慧 (AI) 的整合使得對複雜生物數據的深度分析成為可能,從而徹底改變了診斷工作流程。製造商正致力於數位轉型,將智慧演算法整合到質譜系統中,以實現即時錯誤檢測和自動化方法創建。這項進展滿足了臨床檢查室在面對多組體學應用帶來的數據爆炸時對效率的迫切需求。作為這項策略重點的佐證,島津公司於 2025 年 5 月發布的《截至 2025 年 3 月的會計年度財務業績簡報》顯示,其研發支出較上年增加了 74 億日元,其中一部分用於數位轉型項目,以提升分析績效。
同時,無層析法分離質譜技術的興起標誌著與傳統液相層析法系統的決裂,尤其是在高通量治療藥物監測領域。省去層析法分離步驟可縮短分析時間並減少溶劑用量,從而促進質譜技術在常規臨床診斷中的廣泛應用。隨著主要企業加速收購專業企業,將快速直接分析解決方案納入其產品組合,這一趨勢正愈演愈烈。例如,布魯克公司在2025年4月發布的新聞稿《布魯克宣布收購RECIPE多數股權》中指出,目標公司RECIPE在2024年實現了超過1500萬美元的營收,凸顯了醫療保健領域對獨立於供應商、無需層析法分離的診斷檢測方法日益成長的需求。
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: