Although prostate problems have plagued men for many years, the growing elderly population is now driving an unprecedented increase in caseloads and a corresponding need for improved treatments. One of the primary concerns is the rise in prostate cancer diagnoses. With more than two million American men currently living with prostate cancer and more than 200,000 new cases diagnosed each year, the market for diagnostic and therapeutic products to address this disease is substantial; more than $2 billion in the US in 2007.

Biomarker diagnostics are the linchpin of personalized medicine. But building a successful business around such tests is anything but straightforward, given the complexities associated with both their development and commercialization. Today's molecular diagnostic companies need to think carefully before they choose a "go it alone" strategy when developing a particular test. It may make more sense to forge a partnership with another diagnostic company or a drug developer with the goal of sharing costs and relative risks.

Diseases of the prostate constitute the second most prevalent type of chronic disease in the male population in the US. The recent report "US Markets for Diagnostic and Therapeutic Prostate Disease/Disorder Management Products," a report published in August 2007 by the Medtech Insight division of Windhover Information, details the state-of-the industry for companies working in benign prostatic hyperplasia, prostate cancer, and prostatitis. A brief excerpt on biomarkers for prostate cancer appears here.

Sysmex's break in the US with distribution partner Roche frees it to reap the rewards of building its own brand. It's betting that a best-of-breed strategy can help it double revenues by 2006 and increase margins. It's got a stellar reputation but it's in a tough market that doesn't leave much room for error.