Clinical mass spectrometry serves as a quantitative and qualitative analytical tool for assessment of complex mixtures in all the phases of drug development, including identification of the lead compound and their conformational details. Clinical laboratories use automation for the management of large number of samples through, either total automation systems or high level analyzer automation that are offered by clinical mass spectrometers such as Matrix Assisted Laser Desorption/Ionization (MALDI-TOF). These automated platforms assist effective processing of increasingly large workloads. Thus, clinical laboratories are among the largest end users of this technique. Moreover, the advancement in technology over the recent past, has enabled the ease of measuring and distinguishing separate contributions of molecules such as thyroid hormones and 25-hydroxyl vitamins D2 and D3. Application of translational research in the field of mass spectrometry has resulted in the discovery of blood-based biomarkers, endogenous metabolites, tumor markers, and new disease biomarkers. These advancements are expected to fuel adoption of clinical mass spectrometry devices.
Clinical diagnostic mass spectrometers have the capacity to analyze a limited range of samples such as biomarkers, proteins or drug molecules at once, even in cases of low concentrations thus, making them a valuable tool for diagnostic medical laboratories. Furthermore, it allows researchers to determine pharmacokinetic profiles of drugs that are administered in microdoses. The technology shift from traditional systems to high-resolution technologies such as the Quadrupole-Time of Flight (Q-TOF) mass spectrometry is expected to grow rapidly due to its benefits of accuracy, improved resolution, and sensitivity for clinical diagnostic applications.
The global clinical mass spectrometry market is estimated to be valued at US$ 4,982.5 million in 2017 and is expected to witness a CAGR of 7.3% over the forecast period (2017 – 2025).
Mass spectrometry enables various diagnostic analyses and study of functional genomics, metabolomics, and proteomics that facilitate development of a cost-effective analytic platform for analysis of samples. The automated laboratory systems provide several high-end functionalities such as MassEXTEND primer extension and nano liter dispensing of samples on to the spectroCHIPS, and data analysis using pre-loaded workstations that make the task of the clinicians and testing personnel easy and less tedious. Ease of management, quick results, and less complex functionality of these facilities are associated with low costs. Apart from cost- effectiveness, improved quality assays, simplicity, automation, and data reliability, increased sensitivity, reduced cross-reactivity & non-specific binding, and significantly low downtime are advantages offered by mass spectrometers over conventional immunoassays. Moreover, major capital investments associated with the set up and maintenance of these devices poses as a major restraint for the global market growth. Mass spectrometers are largely unaffordable for small diagnostic clinics and laboratories, especially in emerging economies. Moreover, these mass spectrometry methods are labor intensive and require technically skilled professionals. The dearth of these skillful operators is also a constraint for the global clinical mass spectrometry market growth.
Advancements in technology includes miniaturization of mass spectrometry instruments and increasing automation of the entire spectrometric unit to reduce human efforts and improve efficiency of the instruments. The fully automated analyzer launched by Thermo Fisher in June 2017, is a step closer to achieve entirely automated systems in the mass spectrometry market that can be customized easily to be compatible with the laboratory information systems.
North America held the maximum share of clinical mass spectrometry market in 2016, owing to the presence of major key players and strategic collaborations. The second largest market share is provided by Europe. Under the Federation of analytical Chemistry and Spectrometry Societies, American Society for Mass Spectrometry was formed in 1969, with over 7,500 scientists working together to make advancements in the clinical applications of mass spectrometry and allied topics in academic, industrial, and governmental laboratories. This in turn, creates a strong network of research base in North America thus, contributing to swift growth of the clinical mass spectrometry market. Asia Pacific is also expected to grow at a substantial rate due to increased investments in R&D by various players and government bodies along with the introduction of new in-house manufacturing and R&D facilities.
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