Mass Spectrometry and Chromatography in Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Sample Preparation, Mass Spectrometry, Chromatography), By Application Type (Therapeutic Drug Monitoring, Vitamins, Hormones, Methylmalonic Acid, Immunosuppressants, Others), By Sample Type (Blood, Urine, Serum, Plasma, Saliva), By Testing Type (Laboratory-Developed Tests, Commercial Assays), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.57 Billion
CAGR (2026-2031)	8.98%
Fastest Growing Segment	Mass Spectrometry
Largest Market	North America
Market Size (2031)	USD 2.63 Billion

Market Overview

The Global Mass Spectrometry & Chromatography in Diagnostics Market will grow from USD 1.57 Billion in 2025 to USD 2.63 Billion by 2031 at a 8.98% CAGR. Mass spectrometry and chromatography in diagnostics utilize analytical technologies to separate, identify, and quantify biological components for clinical applications, including toxicology, endocrinology, and newborn screening. The market is primarily driven by the increasing prevalence of chronic diseases requiring precise biomarker monitoring and the growing demand for personalized medicine, which necessitates high-sensitivity diagnostic tools. These factors support the adoption of robust systems capable of delivering high-throughput results with minimal error rates, fostering market expansion across clinical settings.

A significant challenge impeding broader market growth is the evolving regulatory landscape concerning laboratory-developed tests, which frequently employ these technologies. Compliance with stringent new federal oversight creates operational uncertainty and financial strain for testing facilities. According to the Association for Diagnostics & Laboratory Medicine, in 2024, forty-eight percent of surveyed laboratories indicated they would discontinue specific laboratory-developed tests due to the administrative and financial burdens of new federal regulations. This regulatory pressure poses a substantial barrier to the continued availability and integration of these advanced diagnostic solutions.

Key Market Drivers

Technological advancements in high-resolution mass spectrometry are fundamentally reshaping diagnostic capabilities, driving a transition from traditional immunoassays to liquid chromatography-mass spectrometry systems. These innovations address the critical need for higher sensitivity and multiplexing capacity in clinical research and translational omics. For instance, according to Thermo Fisher Scientific, June 2024, in the 'Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research' press release, the new Stellar mass spectrometer achieves 10X the quantitative sensitivity for five times more compounds at scale compared to existing technologies. This leap in performance enables laboratories to detect low-abundance biomarkers with unprecedented precision, facilitating the broader adoption of robust MS-based workflows in healthcare settings.

The surge in therapeutic drug monitoring and toxicology testing further catalyzes market growth, as laboratories face increasing volumes of complex samples requiring definitive identification. Mass spectrometry is indispensable for distinguishing illicit substances from prescribed medications and detecting sample manipulation that standard screens might miss. According to Quest Diagnostics, May 2024, in the '2024 Drug Testing Index', the rate of invalid urine specimens in the general U.S. workforce increased 45.2% in 2023 compared to the previous year, highlighting the growing necessity for advanced confirmatory testing. To support these expanding diagnostic demands, major industry players maintain substantial revenue streams dedicated to these technologies; according to Agilent Technologies, in 2024, the Diagnostics and Genomics Group generated $1.65 billion in full-year revenue.

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Key Market Challenges

The evolving regulatory landscape regarding laboratory-developed tests constitutes a primary challenge hampering the growth of the Global Mass Spectrometry & Chromatography in Diagnostics Market. Mass spectrometry and chromatography platforms are frequently employed to design complex, in-house diagnostic assays that must now adhere to heightened federal oversight. The shift toward regulating these tests as medical devices imposes extensive requirements for clinical validation, premarket review, and quality systems. This sudden escalation in compliance costs and administrative obligations creates acute operational uncertainty, prompting testing facilities to freeze capital expenditure on new analytical instrumentation and reduce their test menus.

This regulatory pressure directly restricts the addressable market for diagnostic equipment as laboratories consolidate services to mitigate financial risk. The stringency of the new rules disproportionately affects hospitals that rely on these technologies for specialized patient care. According to the Association for Diagnostics & Laboratory Medicine, in 2024, sixty percent of surveyed hospitals stated they would be unable to comply with the requirements associated with the unmet need exceptions under the federal framework. This data highlights the severity of the operational barrier, as the inability to utilize such exemptions forces laboratories to discontinue essential testing services, thereby dampening the demand for advanced diagnostic systems.

Key Market Trends

The Integration of Artificial Intelligence for Enhanced Data Analysis is rapidly transforming diagnostic workflows by enabling more sophisticated interpretation of complex biological datasets. Manufacturers are increasingly prioritizing digital transformation to embed intelligent algorithms directly into mass spectrometry platforms, facilitating automated method development and real-time fault detection. This shift addresses the critical need for streamlined operations in clinical laboratories, where data volume from multi-omics applications is expanding exponentially. According to Shimadzu Corporation, May 2025, in the 'Presentation Slides for the fiscal year ended March 31, 2025', the company reported a year-over-year increase of 7.4 billion yen in research and development expenses, a portion of which was strategically allocated to digital transformation initiatives to strengthen its analytical capabilities.

The Emergence of Chromatography-Free Mass Spectrometry Techniques constitutes a distinct shift away from traditional liquid chromatography-based systems, particularly for high-throughput therapeutic drug monitoring. By eliminating the chromatographic separation step, laboratories can significantly reduce solvent consumption and analysis time, making mass spectrometry more accessible for routine clinical diagnostics. This trend is gaining commercial traction as major industry players acquire specialized firms to integrate rapid, direct-analysis kits into their portfolios. According to Bruker Corporation, April 2025, in the 'Bruker Announces Majority Acquisition of RECIPE' press release, the acquired entity generated 2024 revenues of more than $15 million, underscoring the growing market demand for vendor-agnostic, chromatography-free diagnostic assays in healthcare settings.

Segmental Insights

Based on market analysis from reputable industry sources, the Mass Spectrometry segment is identified as the fastest-growing category within the Global Mass Spectrometry & Chromatography in Diagnostics Market. This rapid expansion is primarily driven by the technology's superior sensitivity and specificity compared to traditional immunoassays, allowing for the precise quantification of low-abundance biomarkers in complex biological samples. Clinical laboratories are increasingly adopting these systems to support Therapeutic Drug Monitoring and newborn screening, ensuring compliance with rigorous accuracy standards required by regulatory bodies such as the FDA. Furthermore, technological advancements in automation and high-resolution analysis are accelerating the integration of mass spectrometry into routine clinical workflows, thereby facilitating the shift toward personalized medicine.

Regional Insights

North America holds the leading position in the Global Mass Spectrometry & Chromatography in Diagnostics Market, driven by an extensive healthcare infrastructure and substantial investment in biomedical research. The region benefits from a dense concentration of pharmaceutical and biotechnology companies that utilize these technologies for drug development and clinical testing. Furthermore, established regulatory frameworks from the U.S. Food and Drug Administration (FDA) and adherence to Clinical Laboratory Improvement Amendments (CLIA) standards ensure rigorous quality control. The widespread integration of mass spectrometry into routine newborn screening and toxicology protocols also sustains this market dominance.

Recent Developments

• In December 2024, Roche announced that it had received CE mark approval for its cobas Mass Spec solution, marking a significant advancement in clinical diagnostics. This system, which includes the cobas i 601 analyzer and the Ionify reagent pack, was designed to bring the accuracy of mass spectrometry into routine laboratory settings. The initial approval covered assays for steroid hormones, with plans to expand the menu to include testing for vitamin D metabolites and therapeutic drugs. By automating and standardizing these complex workflows, the company aimed to integrate mass spectrometry with existing clinical chemistry and immunochemistry platforms to enhance patient care.
• In June 2024, Thermo Fisher Scientific unveiled the Stellar mass spectrometer, a new instrument engineered to bridge the gap between scientific discovery and clinical application. This system combined rapid throughput with high sensitivity to support translational omics research and the verification of biomarkers, including proteins and metabolites. The technology allowed researchers to validate biological insights at the scale required for precision medicine development. By offering a liquid chromatography-mass spectrometry solution that streamlined verification workflows, the company sought to accelerate the translation of basic science into actionable clinical research outcomes and personalized therapies.
• In May 2024, Shimadzu Scientific Instruments released the LCMS RX series of triple quadrupole mass spectrometry systems to address the rigorous demands of routine analysis. These instruments were designed with integrated hardware and software technologies to ensure high stability and sensitivity while lowering laboratory operating costs. Key features included an advanced ionization source for improved reliability and an ecology mode to reduce power consumption. This product launch provided laboratories with a robust tool for precise data acquisition, supporting various applications that require dependable analytical performance in dynamic testing environments.
• In January 2024, Agilent Technologies entered into a strategic collaboration with Incyte to develop companion diagnostics in the fields of hematology and oncology. This partnership leveraged Agilent’s extensive expertise in assay development and global regulatory approvals to support the clinical development and commercialization of Incyte’s therapeutic portfolio. The collaboration focused on creating diagnostic tests that evaluate biomarker expression, enabling the identification of patients most likely to benefit from targeted treatments. This initiative highlighted the critical role of precise diagnostic tools in advancing personalized medicine and improving health outcomes for patients with cancer and other chronic conditions.

Key Market Players

• Thermo Fisher Scientific
• Agilent Technologies
• Waters Corporation
• Shimadzu
• Bruker
• PerkinElmer
• LECO Corporation
• Analytik Jena
• Promega

By Product Type	By Application Type	By Sample Type	By Testing Type	By Region
Sample Preparation Mass Spectrometry Chromatography	Therapeutic Drug Monitoring Vitamins Hormones Methylmalonic Acid Immunosuppressants Others	Blood Urine Serum Plasma Saliva	Laboratory-Developed Tests Commercial Assays	North America Europe Asia Pacific South America Middle East & Africa

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:

• Mass Spectrometry & Chromatography in Diagnostics Market, By Product Type:

• Sample Preparation
• Mass Spectrometry
• Chromatography

• Mass Spectrometry & Chromatography in Diagnostics Market, By Application Type:

• Therapeutic Drug Monitoring
• Vitamins
• Hormones
• Methylmalonic Acid
• Immunosuppressants
• Others

• Mass Spectrometry & Chromatography in Diagnostics Market, By Sample Type:

• Blood
• Urine
• Serum
• Plasma
• Saliva

• Mass Spectrometry & Chromatography in Diagnostics Market, By Testing Type:

• Laboratory-Developed Tests
• Commercial Assays

• Mass Spectrometry & Chromatography in Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE