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Mass Spectrometers

Automation to drive MS market ahead

The automation and integration that will transform LC-MS/MS into an integral and cost-effective part of medical diagnostics are technically feasible, as demonstrated by the partial automation on the market today.

Mass spectrometry has developed over the past 20 years, from a purely academic tool to a technique used in the majority of analytical labs. Increases in sensitivity and resolution, along with ongoing developments in seamless software workflows and capabilities, are the main forces behind this development.

MALDI-MS has recently developed into a standard laboratory technique for identifying enriched bacterial and fungal cultures. MS is one of the most well-known clinical uses of mass spectrometry. MS revolutionizes microbiology labs due to its quicker identification time than traditional methods. The workflow for identifying microorganisms has been further revolutionized by the use of MALDI-ToF MS.

Recent advances in paper spray ionization mass spectrometry (PSI-MS) have created new possibilities for clinical pathogen diagnosis research. The ability of PCR-MS, another quickly developing technique, to directly identify known pathogens from clinical specimens is being used. Additionally, portable miniaturized MS equipment opens up a wider range of potential applications with relatively quick and highly accurate methods to detect viral compounds. FDA has approved the identification of a small subset of microorganisms as of now, but the recent pandemic may encourage the use of MS in the detection of additional viruses and microbes.

The Indian mass spectrometers market is estimated at ₹385 crore in 2021 with 268 units. Single- and triple-quadrupoles dominate the Indian market with a combined share of 74.6 percent by quantity and 63 percent by value.

Within the segment, triple quadrupoles are by far the preferred systems. A triple quadrupole instrument differs from an instrument with a single quadrupole analyzer in that it is a tandem system, with two quadrupole mass analyzers, with a third quadrupole positioned in between to act as a collision cell. Basically, the quadrupoles act as filters, so at the end of the process, users only have the element of interest reaching the detector. The main difference between single-quadrupole and triple-quadrupole is that the latter enables more specific analyses in complex matrices by improved interference removal. The vendors are working toward reducing manual sample-preparation time and method-development time as this contributes to standardization, which saves time and increases productivity.

Indian mass spectrometers vendors

Segment

Major Players

Single quadrupole Waters, Shimadzu, Agilent, and Thermo Fisher
Triple quadrupole SCIEX, Waters, Shimadzu, Agilent, Thermo Fisher, and PerkinElmer
Ion trap Thermo Fisher
Q trap SCIEX
MALDI-TOF &
MALDI TOF-TOF
Bruker and Shimadzu
HRMS (includes
Q TOF and Orbitrap)
Thermo Fisher, SCIEX, Waters, Agilent, Bruker, and Shimadzu
ADI Media Research

Food-safety laboratories are large customers for triple-quadrupole systems. They measure nutritional, toxic, and essential elements in food samples, and are utilized to trace concentrations of elements, as contaminations, adulterations, and toxic elements in food. Mass spectrometry is being widely used to analyze molecules in pharmaceutical drugs, biosimilars, phytoproducts, and regenerative medicines. Moreover, increasing emphasis on environmental testing for pollution control is also augmenting market growth.

Orbitraps are increasingly being utilized more widely for applications in forensic toxicology, food safety, drug-monitoring research, pharmacokinetics, environmental analysis, as well as various qualitative analyses in pharma and academia. A huge range of products is now available, and is heavily discounted with prices declining steadily. The popularity of performing quantitative, qualitative, and screening analyses, using Orbitrap mass analyzer technology over the Maldi-TOF, is growing rapidly. The coupling of a MALDI-type ion source to a linear ion trap and an Orbitrap mass analyzer offers high-accuracy mass measurements compared to common MALDI-TOF/TOF instruments. Contrary to MALDI-TOF/TOF, the fragmentation of peptides in the new hybrid mass spectrometer is less efficient due to the generation of predominantly singly charged ions by the MALDI process. Therefore, data from two MALDI instruments, TOF/TOF and Orbitrap, are often combined into a single data set in order to obtain accurate precursor masses as well as superior MS/MS spectra.

MS/MS technology enables improvements in and consolidation of metabolic screening methods to detect amino acid disorders (e.g., PKU, maple syrup urine disease, and homocystinuria) among new-born, and does so with a low false-positive rate. MS/MS technology expands the metabolic disorder-screening panel by incorporating an acylcarni­tine profile, which enables detection of fatty acid oxidation disorders and other organic acid disorders. MS/MS can reliably analyze approximately 20 metabolites in one short-duration run (i.e., ~2 minutes) and provide a comprehensive assessment from a single blood-spot specimen.

MS/MS technology can be integrated effectively into a new-born screening program. The Indian industry is pushing for this to be made mandatory in India too.

Screening for multiple disorders in a single analytical run by using MS/MS requires that program administrators and laboratorians choose which types of conditions are to be screened. For example, laboratory A uses MS/MS to detect amino acids only; laboratory B uses MS/MS to detect acylcarnitines only; and laboratory C screens for both. In addition, other technical concerns must be addressed before MS/MS technology can be integrated effectively into a new-born screening program, including deciding which analytes to use in characterizing each disorder. The Indian industry is pushing for this to be made mandatory in India too. A regulatory authority, independent of the ministry of health and family welfare, may need to be in place to take decisions as these.

The HRMS segment is estimated at ₹57.75 crore, with 35 units. Orbitrap constitutes 60 percent of the market, and quadrupole time-of-flight (QTOF) technology, the balance 40 percent, by units. In India, Thermo Fisher is the leader in this segment.

Clinical applications of mass spectrometry continue to expand. Arguably, one of the most exciting areas where clinical mass spectrometry is making inroads is precision medicine and the transition from sick care to well care, through tracking of biomarkers that objectively measure wellness and the early onset of diseases.

The power of this technique lies in its speed, high throughput, specificity, and ability to identify, quantitate, and characterize unknown molecules.

Historically, MS was limited to small molecules. However, thanks to recent expansions of the technique, a myriad of biological samples can now be studied. The invention of matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) MS is one such advancement. While traditional ionization methods use harsh thermal vaporization techniques, making them incompatible with the characterization of large biomolecules, MALDI-TOF resolves this issue by embedding the sample in a small organic compound matrix before using an ultraviolet laser to ionize and desorb the sample. Another is the addition of a liquid chromatography (LC) step to physically separate the sample before subjecting it to electrospray ionization and analysis by MS. This technique often also incorporates a tryptic digest step (LC-MS/MS).

These advancements in MS technology have provoked an upsurge in the potential applications of MS in biological laboratories – from identification of microbes to shotgun proteomics studies to personalized medicine, and many more. Mass spectrometers are fast becoming an essential enabling technology for the next generation of modern medicines and an integral component of clinical laboratories, owing to their versatility, specificity, high throughput, and ability to detect and quantify unknown components and highly complex samples.

The automation and integration that will transform LC-MS/MS into an integral and cost-effective part of medical diagnostics are technically feasible, as demonstrated by the partial automation on the market today. All that remains is for technology providers and regulators to step up and meet the demand.

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