Having succeeded in sequencing the human genome, researchers are now turning to unraveling the multidimensional and dynamic collection of human proteins. The goal of proteomics is to identify all the proteins, then understand their ranges of expression in different cell types, as well as characterize modifications, interactions, and structure. Though far from being fully mapped, the proteome is already yielding drug targets and information on disease states and drug response.

Proteomics incorporates protein chemistry and a convergence of analytical approaches, primarily mass spectroscopy, 2-D gel electrophoresis, and microarray technologies. According to several recent market research reports, the market for these technologies will show double-digit growth over the next four or five years.

"The three major trends are automation, miniaturization, and integration," says Nate Cosper, industry manager for discovery and diagnostics at market research firm Frost & Sullivan. Miniaturization includes the rapidly expanding use of microarray, biochip, and microfluidics technologies.

High-throughput analysis has become a common, although sometimes problematic, approach, with researchers trying to balance reproducibility, speed, and scale. "Throughput is important, but researchers are focusing their efforts on generating the highest quality data," Cosper says.

"Another key challenge is the creation of modular and integrated systems," he says. "Proteomic tools need to work together to make the research process easier." Technologies must be flexible and functional, he adds, not to mention accurate, fast, and reproducible. Because proteomics research has the potential to produce voluminous amounts of data, information management is also crucial.

Researchers in the area of functional proteomics are challenged to validate results, suggests Frost & Sullivan research analyst Sinead Igoe. Contradictions and inaccuracies plague available information, particularly in protein-protein interaction databases.

For example, researchers are confronting difficulties in studying post-translational modifications, she explains, and are concerned about the sensitivity of technologies and about changes occurring during sample preparation.

Among proteomics technologies, the mass spectroscopy market is the largest, with estimated sales of roughly $850 million per year and greater than 10% annual growth. The fastest growing market, at more than 30% per year, is for protein microarrays and chips, now worth about $100 million. Gel electrophoresis is a midsized market at $300 million per year but is expected to grow nearly 15% annually. And methodologies for protein structure determination occupy a market of about $100 million per year and are expected to grow about 10% per year.

"The proteomics industry will grow at a faster rate than the overall pharmaceuticals market," Cosper concludes, "because the technologies have only begun to experience the potential adoption rates that we believe are ultimately available."

Developers of proteomics technologies include many small technology and instrumentation firms. Meanwhile, the user base includes both small drug discovery and most large pharmaceutical companies. The big companies are adopting proteomics internally, in core labs or throughout their R&D operations, Cosper believes, but they still look externally to access novel technologies.

Drug developers are driven by the desire to understand disease mechanisms and find protein markers or expression patterns for monitoring drug response and treatment. However, such clinical uses of proteomics for diagnosis or prognosis have yet to become routine or robust. Other drivers include improved target identification and validation--understanding cell pathways and communication--and the growing regulatory interest in pharmacogenomic and related proteomic data.

While the interest in what proteomics offers is high, the technology must still prove its worth. "Spending in the pharmaceutical market will be increasingly monitored, creating a challenge for the adoption of proteomics technologies," Cosper says. However, he adds, "the clinical diagnostics market is of a similar size and offers substantial opportunity for growth."

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