The Exciting World of Biomarkers

From being physiological indicators such as body temperature, blood pressure and heart rates, Biomarkers or biological markers have now come a long way! They have evolved to be excellent tools in the hand of a biologist driving innovation, improving efficiency of processes, saving costs and actually helping critical decisions in the drug discovery and clinical medicine arena. In recent years, they have gained immense popularity as measurable indicators of the normal physiological state, the presence and severity of diseased state and also for tracking the pharmacological responses through therapeutic interventions (Definition of Biomarker NIH 1998).

Slowly and steadily, biomarkers have taken up playing a leading role in disease detection, progression and control for many areas of public health concern.

Apart from the conventional research, drug discovery or diagnostics fields, biomarkers have influenced the top trends in healthcare industry. Today’s world of personalized medicine and targeted therapeutics depend heavily on biomarker discovery and characterization. The approximately 232 billion USD personalized medicine market is said to be growing at roughly 11% CAGR (Price Waterhouse Coopers’ report http://www.prnewswire.com/news-releases/232-billion-personalized-medicine-market-to-grow-11-percent-annually-says-pricewaterhousecoopers-78751072.html). Targeted therapeutics is considered to be the costliest segment especially for cancer treatments. The oncology drugs segment is approaching 100 billion $ and therapies are becoming more and more targeted and innovative leading to new segments like preventive cancer vaccines. And this is just one application. New drug development in all areas relies heavily on the use of biomarkers. Furthermore, the advances in bioinformatics, which have given better and better tools for research have helped biomarker research move to a higher level. The advancing field of companion diagnostics, which is expected to reach $8,730.7 million by 2019 by growing at a CAGR of 22.7%, too has contributed to the need and demand for biomarkers.

And how is all this achieved through simple molecules once restricted to the domains of test tubes? It’s by determining the change in expression of the biomarker – it’s up regulation or down regulation via gene expression, being correlated to the risk, progression of a disease, or to the susceptibility of a disease to a given treatment.

Several molecular biomarkers are being used for analysis, from cells to genes, RNA and gene products- the proteins, enzymes and hormones to specific antigens associated with cells or even antibodies secreted by the cells in response to stimulus.

Given their multiple roles, biomarkers can well be categorized as diagnostic biomarkers helping diagnosis of an existing disease (example – CRP protein or HBsAg), or disease- related biomarkers such as predictive markers which indicate the risk of contracting a disease (like BRCA1) or help assess the response to a particular treatment, prognostic markers which speak about the progress of a disease with or without treatment (like the CD4 antigen) and drug-related biomarkers which give information on the probable effect of treatment on patient indicating whether a drug will be effective in a specific patient, how the patient’s body will respond to it and process it. Biomarkers can also act as surrogate end points in place of natural ones, for evaluating the benefits of a particular treatment. Here, a laboratory or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint, e.g. Blood glucose or tumour size etc.

The discovery of biomarkers has been facilitated by the rapid advancement in technologies and availability of several tools. The use of modern day approaches of high through put and “omics” technologies in drug development- the genomics, proteomics, lipidomics, transcriptomics and metabolomics approaches have resulted in the identification of several biomarkers which further go through a stringent process of validation. The Omics technologies have the largest share in biomarker development compared to imaging technologies and bioinformatics. Once validated, they move on to further safety and efficacy studies done by preclinical and clinical evaluations, before being accepted as drug therapies by regulatory processes.

From the diagnostics perspective, biomarkers can be profiled using the genomics as well as proteomics approach using well standardized, accurate technologies such as PCR, molecular imaging technologies and microarray analysis to mass spectrometry, chromatography, to older and time tested immunological techniques like western blots and ELISA. The latest techniques being applied for biomarker analysis include personalized genome sequencing using NGS, miRNA and siRNA sequencing, SNP analysis and more which contribute towards a better understanding of disease process and its progression, treatment and control. The ideal biomarker is one which can be estimated accurately, safely, cheaply using non-invasive techniques if possible.

Given the rapid pace at which biomarkers are being discovered and taken up for diverse applications, the Global Biomarkers Market can be estimated to be a 40.8 billion market by 2018, and is said to be growing at a CAGR of 18.5% from 2013 to 2018. The emerging markets are the APAC countries – India and China where the growing economies are fueling healthcare spending and research.

There are several key players in the market actively involved in Biomarker research and development. The Molecular Medicine Laboratories (MML) function at Roche is a partner of excellence in the discovery and development of biomarkers. GlaxoSmithKline Plc. (U.K.) signed a pact with UK based Epistem for developing biomarkers for fibrosis. Eli Lilly Oncology focuses on speeding innovation and improving outcomes for individual patients, and boasts one of the largest clinical pipelines in the oncology industry through biomarker research. GE Healthcare and Merck are also among the important players in the field, besides Johnson & Johnson (U.S.), Siemens Healthcare (Germany), Abbott Laboratories Inc. (U.S.), Affymetrix Inc. (U.S.), Epigenomics AG (Germany), Eisai Co. Ltd. (Japan), Bio-Rad Laboratories Inc. (U.S.) and more.

The trends clearly indicate a worldwide shift to more and more efficient diagnostic and therapeutic applications thereby improving healthcare for all.

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