Metabolomics services industry is the rising realm amongst stakeholders in pursuit of comprehensive molecular analysis and metabolite profiling.

The metabolomics market size is expected to grow at compounded annual growth rate (CAGR) of 14.9% during the forecast period.

Since the initiation of the Human Metabolome Project in 2005, the metabolomics technique has gathered significant attention from the industry stakeholders. It is worth mentioning that about 40,000 small molecules constitute the human metabolome. Further, 30% of the known genetic disorders are associated with small-molecule metabolism. Therefore, metabolome profiling can assist in obtaining a better understanding of the disease. The approach has also demonstrated to be capable of identifying new biomarkers (for diagnosis and prognosis) and novel drug targets. In fact, 50% of the total drug candidates are reported to emanate from pre-existing metabolites. Integration of metabolomics with development projects holds the potential to significantly improve the efficiency and success rate of drug discovery, owing to its ability to differentiate promising candidates in the early stages.  As a result, metabolomics has become an indispensable part of modern drug discovery and development process and disease diagnosis. Further, with the growing prominence of personalized medicine, there is an increased demand for rapid, highly sensitive and accurate quantification methods, such as metabolomics, to analyze clinical specimens.

Several methodologies are presently used to design metabolomics experiment, including targeted analysis, untargeted analysis, and identification of unknown metabolite. All the afore-mentioned approaches are discussed below.

Targeted Metabolomics

Targeted metabolite profiling is a method for quantifying a previously identified sample of metabolites with similar chemical / biological characteristics. Targeted metabolomics aims to provide maximum sensitivity and selectivity using internal or external reference compounds. It leverages understanding of a diverse set of metabolic enzymes, their kinetics, end products, and the known biochemical pathways in which the set of metabolites participate. This approach is often employed to determine the effect of genetic modifications or therapeutics in pharmacokinetic studies of drug metabolism.

Untargeted Metabolomics

Untargeted metabolomics, namely discovery metabolomics, represents the unbiased analysis of small molecules present in a biological sample, under specific conditions. It aims to detect the alterations in the global metabolomic profiles of control and test groups to generate a hypothesis. Untargeted metabolomics employs a top-down approach to analyze the entire metabolic network concerning a specific biological condition. Further, it has been successfully used to identify the severity of different types of asthma.

In general, metabolomics studies using untargeted approach encounter challenges in the identification of unknown metabolites. Therefore, further studies are required to re-analyze the generated data.

Unknown Metabolite Identification

An unknown metabolite is referred as a small molecule or metabolite which may be detected frequently in a biological sample but whose chemical characteristics has not been determined. Based upon the spectral data generated in a metabolomic experiment, these metabolites can be separated and quantified. The definitive identification of an unknown metabolite, instead of presumptive identification based on known mass or retention time, is a critical and decisive task that propels the analysis forward. Therefore, unknown metabolite identification has a significant impact on omics research and biomarker discovery.

Owing to the non-invasive nature and correlation of metabolomics studies with the phenotype, it is an ideal tool for the pharmaceutical and preventive healthcare industries. Metabolomics has already assisted in informed decision making for biomarker discovery and toxicology testing. Personalized medicine or precision medicine is an emerging field with the potential to develop novel and efficacious custom-based clinical therapies, wherein metabolomics holds a potential role. Plant biotechnology, microbial biotechnology, and nutrigenomics are among other areas where metabolomic research is being employed to generate deeper insights.

The following are the prominent areas within pharmaceutical / biotechnology / healthcare industry where metabolomics can be employed.

Biomarker Discovery: Metabolomics has been widely recognized for its application in biomarker discovery. It provides insight into unknown pathological conditions required in the pharmaceutical research of biomarkers.

Disease Diagnostics: Metabolomics analysis aims to identify the changes in the concentration of metabolites which have been altered either quantitatively or qualitatively between the normal and diseased sample.

Drug Discovery: Owing to the conceptual and technical overlap of metabolomics with elements of pharmaceutical research, it is now being integrated with the full length of drug discovery and development pipeline, from lead identification to post-approval monitoring.

Personalized Medicine: Personalized medicine or precision medicine is an emerging field with the potential to develop novel and efficacious custom-based clinical therapies wherein metabolomics holds a potential role. Prominent example of metabolomics enabling precision medicine include characterization of tumor phenotype in order to develop tailored cancer therapeutics.

Toxicological Testing: A notable use of metabolomics is the characterization of hazards by identifying toxicity patterns. In recent years, metabolomics has established itself as a novel method in the domain of regulatory toxicology for improving the safety profile evaluation of new compounds.

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