April 1, 2008 (Vol. 28, No. 7)

New Technologies, Multiplexing Chief Among Them, Supplant This Assay Format as Workhorse

Very few assay formats on the market enjoy such a favorable reputation for performance, validation, and reproducibility as the ELISA. In the fast-paced life sciences and drug discovery fields, the fact that a technique has survived nearly 40 years denotes an incredible amount of continued trust in its performance level.

ELISA kit manufacturers boast that they perform a tremendous amount of validation and quality control with stringent requirements on each kit, ensuring that costly failures are kept to a minimum. With an extremely high level of inter- and intra-assay reproducibility, quality ELISA kits provide validated, publishable results for academics and proven lot-to-lot consistency for large studies by pharma firms.

Despite the technology’s solid reputation, the ELISA market has seen minimal growth over the past five years as researchers adopt newer technologies, especially the multiplex proteomic array platforms. Many studies that previously employed single-analyte ELISAs for target detection and quantification are now utilizing proteomic arrays for the convenience of multiplexing capabilities.

The ELISA, however, has assumed a new complementary role serving as the benchmark technology to multiplexing and other new assays, demonstrating that these product markets may be sustainable simultaneously. Researchers tend to use multiplex platforms to measure many targets at a time in a small number of samples and then switch to the ELISA technology to carefully measure many different samples for a selected target.

Additionally, researchers who do not need the advantages of multiplexing, lack the funding to purchase expensive array instrumentation and reagents, focus only on a few analytes, or require high assay sensitivity, continue to use ELISA kits. While the trend toward multiplex proteomic arrays has accounted for a declining growth rate in the overall ELISA market, unless newer platforms dramatically decrease in price and improve on sensitivity levels, the ELISA will continue to maintain a role in research.

Interestingly, ELISA providers have reacted to newer technologies in different ways. Determined to take advantage of the trend toward multiplexing, several companies have stalled expansion of their ELISA kit portfolios over the past five years in favor of focusing resources toward the development of multiplex or other new assay types. Other providers vehemently defend the complementary role of ELISAs to proteomic arrays and continue expansion of their ELISA lines while building multiplex assay portfolios as well.

Smaller companies without the R&D budgets to develop new multiplex assays have sought niche markets to penetrate to circumvent heavy competition. In general, new ELISA product introductions attempt to serve a different market sector than multiplex assays currently reach.

Companies that continue to bring unique ELISA products to the market are experiencing market share growth; companies abandoning ELISA product development are generally experiencing stagnant-to-negative growth for their ELISA lines, contributing to an overall decline in market revenues.

Commoditization of Products

In addition to growing competition with multiplex assays, providers are experiencing increased commoditization of widely available ELISA products. With over 60 providers participating in the research ELISA market, many companies offer assay kits and development components for the same popular analytes in protein families such as cytokines, chemokines, growth factors, and phosphoproteins.

Companies supplying these popular products may experience increasing price pressure from end-users, especially from those customers purchasing reagents in bulk quantities for large studies. While the leading ELISA providers cite customer loyalty and brand recognition for continued success of their commoditized products, smaller companies are likely to compete on price.

Assay quality and performance continue to be important characteristics that influence customer purchasing decisions; however, the mature state of the market implies that the gap between companies has narrowed enough that price-sensitive laboratories might opt for cheaper products over brand names.

Developing unique ELISA products and targeting niche markets appear to be successful strategies for overcoming both market erosion by newer technologies and increasing commoditization. Furthermore, companies with the resources to develop portfolios for new assay types may reap the benefits of diversification, including expansion of their customer bases and increased exposure for other product lines.

Nevertheless, the overall research ELISA market of $92.9 million in 2007 is expected to experience a decline, falling to $72.3 million by 2014 before stabilizing. The ELISA kit segment of the market is likely to experience the greatest erosion by proteomic array technologies, as the ELISA development components segment caters to price-sensitive laboratories unlikely to switch exclusively to more expensive technologies. The percentage of total research revenues generated by kits is expected to decrease as the percentage of revenues generated by development components increases.

Christianne Bird is a research analyst in the drug discovery technologies and clinical diagnostics group of Frost & Sullivan. Web: www.frost.com. E-mail: [email protected].

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