Biomarkers Increasingly Influence Diagnostics and Drug Development

Increased diagnostic spending is reducing the overall costs on therapy and enormous research is underway to bring to the market, biomarker-based screening tests that are simple, easy-to-use, and non-invasive. Prime areas of focus include the early diagnosis of cancer, cardiovascular disorders, and neurodegenerative disorders, such as Alzheimer's disease and Parkinson's disease.

Biomarkers are being incorporated into several stages of drug discovery and development as they bear the potential to accelerate preclinical and clinical development. Furthermore, theranostic applications have penetrated the market, paving the way for the integration of biomarker applications in the diagnostics and pharmaceutical industry.

New analysis from Frost & Sullivan, a global growth consultancy company, finds that advances in techniques for identifying, developing, and validating biomarkers are continuously enhancing the efficiency and productivity of the drug development industry. Biomarkers also enable elucidation of drug mechanisms, analysis of the drug efficacy and safety, and characterization of patient populations for clinical trials and clinical trial outcomes.

Although current technology platforms have discovered several biomarkers, the requirement of a validation method that possesses the ability to serve the purpose and regulatory conditions hinder further development. Therefore, due to the major bottleneck at biomarker validation, the rate of biomarker discovery exceeds that of preliminary support by many folds.

Discovery of novel markers, based on global genomic or proteomic analysis, is still very new. However, thousands of acknowledged biomarkers have been identified. Yet, relatively fewer have crossed over to be integrated in drug discovery programs or clinical application stages due to the lack of validated biomarkers.

The '-omics' technology platforms integrated with systems biology approach hold the key to biomarker identification and are poised to take the industry by storm, said Frost & Sullivan research analyst Sandhya Kamath. A third generation of '-omics' or the metabolomics is underway, which takes advantage of biochemical pathway information and holds potential to deliver cost-effective technologies to the market.

However, with the clinical market questioning the specificity and sensitivity of new biomarkers, the degree of acceptance is fairly low with new technologies such as microfluidics-based separation. Furthermore, on the application front, pharmaceutical companies are waiting to see if other companies are able to reap benefits from biomarker studies. This presents a major setback to the biomarker advancement as it can take years to demonstrate the significant financial impact on drug discovery efforts.

There is also a growing concern in the field of drug discovery regarding cost and duration of clinical trials that are reaching enormous proportions. Although biomarkers initially increase the cost of clinical development, as larger biomarker portfolios are developed and other drug discovery technologies are integrated, the cost and duration of clinical development are likely to drop.

It is essential for companies to invest more in the validation phase of biomarker research to successfully bring to the market reliable, specific and sensitive biomarkers, said Mr. Kamath. Biomarkers have huge potential for diagnostic markets, provided routine clinical diagnostics shed all skepticism and adopt the biomarker approach.


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