Mass spectrometry is increasingly arriving in local clinical settings and has enabled various diagnostic analyses and study of functional genomics, metabolomics, and proteomics that facilitate development of a cost-effective analytic platform for analysis of samples. Instrument design has downsized significantly, allowing for simplified, standardized diagnostic kits to replace lab testing.

Advances in mass spectroscopy technology continue to increase both speed and resolution at an incredible rate. Advancements include miniaturization of mass spectrometry instruments and increasing automation of the entire spectrometric unit to reduce human efforts and improve efficiency of the instruments.

Moreover, the technological innovation over the recent past has enabled the ease of measuring and distinguishing separate contributions of molecules. 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 further fuel the adoption of clinical mass spectrometry devices.

Indian Market Dynamics

 The Indian mass spectrometers market is estimated at Rs. 260 crore in 2016. Triple quadrupoles dominate with a 48 percent share, with Q-Trap contributing about 17 percent in this category. This is closely followed by high-resolution mass spectrometry (HRMS), including Q-TOF and Orbitrap at a 32 percent share. MALDI-TOF continues to be popular, contributing
12 percent to the market. Single quadrupole and ion trap constitute about 4 percent of the market. Fourier transform ion cyclotron resonance mass spectrometers (FTICR-MS) have gradually become obsolete.

AB Sciex, with major presence in triple quadrupole, HRMS, and MALDI TOF, has a commanding market share. Thermo Fisher followed by Waters, Agilent, Shimadzu, Bruker, and Perkin Elmer has major presence in the market.

 This segment is poised to grow over the next couple of years with the enforcement of stringent regulations. The Indian authorities are seriously looking at the level of residual, pesticides, enzymes across various segments, including melamine added in milk. The market trend is toward qualifying residuals, and quantifying impurities.

Advancing Technologies and Potential Applications

Recent advances in clinical research and MS technology promise even more sophisticated extensions to current clinical applications and potential new LDTs.

MALDI-IMS now supports direct tissue analysis with diagnostic potential and reduced analysis time. Pathologists are now able to examine biological tissue directly, detecting cancerous tissue in real time during an operation using MS with smart electroknives. Mass spectrometry imaging (MSI) enables histologists to define tissue types by chemical composition rather than structure.

 By distinguishing and measuring the separate contributions of molecules such as 25-hydroxy vitamins D2 and D3 and thyroid hormones, MS/MS methods have enabled clinical laboratories to overcome the limitations of immunoassays caused by nonspecific antibody binding and cross-reactivity with metabolites. Endocrinologists are also now investigating a lab-on-a-plate method to predict the risk of a heart attack and stroke in diabetes patients more accurately. Application of MS technology in clinical and translational research is opening up new lines of discovery in blood-based biomarkers, tumor markers, and even endogenous metabolites as new disease biomarkers.

More sensitive urine screening methods capable of detecting designer drugs are available in the market, and vendor investments assure continued development. Some clinical research and forensic toxicology laboratories already use high-resolution, accurate-mass (HRAM) or TOF MS, for multianalyte drug screens. Whereas triple quad-based techniques can quantitate targeted analytes, newer HRAM systems can simultaneously detect and deliver the full product ion spectrum, and retain high selectivity with greater resolution and mass accuracy.

Advanced mass spectrometry methods are producing novel functional assays. Liquid chromatography MS/MS using online solid-phase extraction (XLC-MS/MS) was used to develop a plasma renin activity (PRA) assay for monitoring mineralocorticoid therapy and screening hypertensive individuals for primary aldosteronism (PA). A further LC-MS/MS method for quantifying iothalamate in plasma and urine can accurately assess the glomerular filtration rate (GFR) in early stages of renal dysfunction to screen potential kidney donors.

Analyte multiplexing and automation deliver superior and highly reproducible data to simplify increasingly sophisticated LDT methods and support clinical test validation.

Outlook

Mass spectrometry, as the leading technology for the characterization of macromolecules, is likely in the coming years to produce breakthrough advances in the diagnosis and understanding of a host of recalcitrant diseases. Given the limitations of large and complex instruments of the past, it is clear that the direction of evolution of these devices will be toward greater specialization with attendant simplification.


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