New Report Analyzes Market Growth and Examines Adoption of "Rapid" Methods

March 1, 2003 - According to a new Market Report, the global Pharmaceutical (Pharma) and Personal Care Products (PCP) Industries conducted more than 375 million microbiological tests last year at a cost of over $1.2 billion. The testing volumes are leveling off in the PCP Sector but are poised for continued growth in the Pharma Sector. On the other hand, the PCP Sector has been quicker to adopt "rapid" microbiology methods. Similarly, the geographic regions outside of North America also appear to be moving more quickly towards the adoption of these newer methods.

"Pharma/PCP Micro: Global Review of Microbiological Testing in the Pharmaceutical and Personal Care Products Industries", provides detailed information about testing practices for both of these sectors covering: which type of samples are collected and from where; which organisms are tested; a review of microbiological confirmation/ID practices; and a review of the methods used for analysis. Current and future (through 2007) microbiology testing volumes and market value are also provided. The Report concludes with a thorough review of the competitors in this market.

The Report is based on extensive global market research with field interviews from Pharma and PCP production facilities in 15 countries. In addition, input from key industry, regulatory, and support experts has also been included.

For each of these Sectors the microbiology testing volume was quite similar in 2002 with Pharma representing 50.6% of total tests and PCP representing 49.4%. However, the Report thoroughly examines the marked differences between the Sectors when looking at the mix of samples collected (product vs. water vs. environmental samples) and organisms tested.

Second only to the Food Processing Industry in terms of total microbiology testing volume, the Pharma and PCP industries are experiencing fundamental change as they cope with increased regulatory pressure, globalization, and market/economic pressures. The Report delves into the adoption of "rapid" microbiology testing, which represents only one of the ways these industries are addressing the aforementioned pressures. "Over 80% of the companies interviewed indicate that microbiology results are limiting their company's ability to take timely actions and, as a result, these companies desire faster methods," says Tom Weschler, President of Strategic Consulting. Stemming from this need, so far, 62% of these companies have conducted evaluations of newer, "rapid" methods.

Some of these Pharma/PCP companies have moved well beyond evaluation of "rapid" methods to adoption and implementation. For others, however, they have met with mixed results and are still on the sidelines.

There are a number of hurdles companies face as they consider adoption of these newer methods with validation and regulatory concerns leading the list. "At issue for many is the comparison of results from traditional methods to the output from these "rapid" methods," says Weschler. "Rapid" methods, many times, are based on different technology which can then require a change in data interpretation. In addition, some of the newer methods limit the ability to confirm and/or ID presumptive positives, which requires a deviation from the normal practice of many.

On the other hand, a number of Pharma/PCP companies are moving forward determinedly with "rapid" methods simply because they need faster time-to-results on their microbiology tests. They value the economic benefits of faster results including less value added to in-process problems and/or the faster shipment of product inventories.

For further information on the Pharma/PCP Micro Report please contact Tom Weschler at Strategic Consulting, Inc. by phone (USA EST +1-802-457-9933), email (weschler@strategic-consult.com), or by visiting their website at http://www.strategic-consult.com

In Europe please contact Alan Hulme in the UK at +44-20-7924-4053 or by e-mail at
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