March 1, 2007 (Vol. 27, No. 5)

Changes in the Proteomics Field Could Give Way to a CAGR of 17% until 2011

Protein biomarkers have become the hot application area for mass spectrometry (MS) and other proteomics-related technologies in the last few years. This move toward biomarkers and clinical proteomics research happened mainly in relation to their applications in the drug discovery and development process. The broader benefits relate to the abilities to generate richer information about a disease state, drug response, and the relation between the two. This insight can then be used for diagnostic, prognostic, or other purposes in the drug, diagnostics, and military/civil defense industries.

The most basic explanation for the current interest in biomarkers is their power to enable earlier diagnosis and more informed decisions in the beginning stages of drug development, as soon as Phase I trials.

In respect to markets and products, there is significant overlap among areas referred to as clinical proteomics, disease proteomics, pharmacodiagnostics, and pharmacogenomics. The distinctions sometimes become a matter of semantics. In fact, some are most accurately considered subsets of others. Some of the main types of biomarkers currently being developed include: antecedent markers, efficacy markers, prognostic markers, screening markers, staging markers, stratification markers, target markers, toxicity markers, translation markers, and surrogate markers.

Protein biomarkers are but one type of biomarker, which typically are found in the following types of patients’ samples: amniotic fluid, blood, serum, plasma, broncheoalveolar lavage fluid, cells, nipple aspirate fluid, saliva, synovial fluid, urine, and tissue.

Impact of Biomarkers and MS

Depending on how a company integrates biomarkers into its process, they could result in a number of benefits, including drugs being used for indications not originally envisioned, potentially bringing significant revenues with minimal marginal investment. Over time, the approval and acceptance of large numbers of standard biomarkers by physicians would completely change the healthcare system, based upon improved diagnostics, prognostics, theranostics, and other increasingly personalized medicine.

As the technologies advance and databases and knowledge about biomarkers grow, the benefits will likely converge and compound. This could create a “fax effect” where the value of biomarkers, as a result of data being mined, shared, and compared, would increase.

Although validated protein biomarkers often ultimately result in diagnostic tests using ELISA or immunohistochemistry in the clinic, some people have described MS as the future of molecular medicine. MS has the necessary abilities to rapidly identify biochemicals, such as DNA, proteins, or carbohydrates. Thus, it is currently being used as the workhorse for discovering and validating biomarkers in clinical research, whether for drug development or diagnostic applications. MS technology also far outperforms any alternative for this purpose due to its particular ability to identify large numbers of components in complex mixtures.

In the last decade, protein science has been revolutionized by the ever-increasing abilities of MS, along with bioinformatics and databases, which have allowed more rapid and larger-scale experiments. These increased capibilites have drawn large numbers of life science researchers to procure MS instruments or use available core lab facilities for proteomics experiments.

Proteins have also become the focus in much of biomarker research for largely the same reason that proteomics has become widespread in life science research—the proteins are usually actively involved in the actual mechanisms of the cell, while DNA is further removed and merely provides a form of blueprint for the proteins. They differ from DNA and other analytes in the sense that all disease states can probably be defined using proteins. They can also assist in the prediction of drug response or dosage in humans.

This has been somewhat of a shift from previous generations of biologists focusing mainly on DNA sequence and their mutations and largely ignoring splicing, post-translational modifications, copy number variation, methylation, and other widespread phenomena.

Recent Market Developments

The field of proteomics has grown rapidly in the last several years but has also undergone an evolution. The main method for protein separations prior to MS is still two-dimensional gel electrophoresis (2DGE) due to the unsurpassed ability to resolve thousands of proteins. At the same time, new methods based upon liquid chromatography have been providing new possibilities in areas where 2DGE lacks.

There are numerous applications for the tools falling within the realm of proteomics, but the one largest segment has been drug discovery. In this area, the tools were initially focused on early discovery phases, particularly target discovery. In the last few years, pharma in general has changed its strategy regarding the use of its proteomics resources to support more of the biomarker research in preclinical and clinical phases. A variety of consortia have been formed involving academia and/or pharma, to address the challenges faced in large-scale biomarker discovery and validation.

It is estimated that these shifts have resulted in significant growth in the market for MS and related services in protein biomarker applications, rising from $290 million in 2005 to $745 million in 2011 at a CAGR of 17%. The market for MS has been strongly affected by the changes taking place in the proteomics field. As protein biomarkers gain acceptance, particularly in the drug development process, trends in these areas will thus become increasingly important for companies involved in the market.

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