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Threats and Opportunities Facing the PSA Testing Marketplace

Decision Resources, Inc, April 2005, Pages: 14


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Dramatic increases in the number of men screened for prostate cancer (CaP) and several key market drivers related to prostate-specific antigen (PSA) testing represent healthy market potential for companies active in the screening and diagnosis of CaP.

In this report, we describe the most recent available information concerning the impact of PSA screening on mortality, summarize current recommendations for use of the PSA test, and provide estimates of current PSA testing rates. We then profile the major companies that market PSA diagnostic tests and discuss emerging biomarkers that may find a role as an adjunct to PSA testing.

Business Implications
- Recent studies have defined several geographic and demographic subpopulations that are currently underserved by prostate-specific antigen (PSA) screening. In the United States, for example, scope for market growth exists by reaching uninsured and Hispanic men aged 50-65 and African-American men aged 65-74. These subpopulations represent an area of opportunity that could be tapped for PSA screening via direct-to-consumer advertising (for patient education) and clinician education.

- Urologists interviewed by Decision Resources say that elucidation of the relevance of PSA velocity and PSA doubling time may result in a larger number of PSA tests being performed; although only one PSA test (followed by biopsy) is necessary for a diagnosis of prostate cancer, measuring PSA velocity to determine aggressiveness requires that at least two tests be undertaken, therefore doubling market opportunity for PSA screens.

- Market growth for prostate cancer screening is likely being driven by repeat, rather than first-time, testing in the United States. Conversely, low rates of repeat testing are constraining market growth in the United Kingdom. The results of large randomized clinical trials (RCTs) due in 2008 may give more insight on the optimal frequency of PSA testing. The trials alone will not determine test frequency or changes in policy—their results will likely give additional information for critical appraisal by international experts.

- Tests that combine evaluation of serum PSA with other, emerging cancer-specific markers to achieve greater specificity could take significant market share from single-marker tests (e.g., total PSA, ratio of Free/Total PSA).

- According to physicians interviewed by Decision Resources, the number of patients being diagnosed via ad hoc screening is increasing dramatically in most of the major markets, and experts expect PSA screening by primary care physicians/general practitioners (PCPs/GPs) to continue its expansion through 2010. Among urologists, however, it has reached saturation (virtually all men over age 50 seen by a urologist undergo annual digital rectal exam [DRE] and PSA screening), and, therefore, this area does not present an opportunity for overall market growth.

- Sales of PSA diagnostics are likely to grow rapidly in Japan through 2010. According to the Japanese Foundation for Prostate Research, 36% of local authorities operate mass screening, and a further 17% plan to implement screening programs in the near future. Penetration of the Japanese market likely represents a significant growth opportunity.




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