Patent Reform Storm Impacts Renal Companies


By David J. Dykeman andDanielle T. Abramson, PhD

A Rapidly Expanding Market

An aging global population coupled with unhealthy lifestyle and dietary choices are the leading causes of renal disorders. Driven by advancements in kidney stone treatments, incontinence devices and renal dialysis equipment, the global nephrology and urology devices market is projected to grow by 6.9 percent annually and will reach $18 billion by 2015.1

 One of the most common disorders affecting the urinary tract is kidney stones, with approximately 10 to 12 percent of men and 5 to 7 percent of women in the U.S. being diagnosed with a kidney stone annually.2 According to the National Institute of Diabetes and Digestive and Kidney Diseases, in the U.S. alone, an estimated 2 to 2.7 million cases of urolithiasis are diagnosed each year.3 Over the next five years, the market for urinary stone management devices is forecast to continue to grow due to increased urinary stone cases, adoption of more cost-effective minimally invasive stone removal techniques and next-generation lithotripsy and medical device technologies.4 In 2011, the urinary stone management market was more than $423 million, and is expected to grow to over $500 million in 2016.5

The urological catheters sector is expected to see growth with the introduction of new minimally invasive catheters that improve treatment while reducing complications. The global urological catheters market is forecast to exceed $3 billion by 2017. 6

Similarly, the number of dialysis patients in the U.S. continues to grow each year as more kidney patients require ongoing dialysis to maintain renal function. While the main cause for chronic kidney failure is often dietary habits, the availability of kidney transplants from donors cannot meet the demand. Consequently, the hemodialysis market is growing based on a larger patient population, the phase-out of reusable dialyzers and the increased use of non-membrane home dialysis.7

Finally, incontinence devices continue to fuel growth due to the rising incidence of urinary incontinence. In 2008, incontinence devices contributed 63 percent to the nephrology and urology devices market value of $11.3 billion.8

The renal market is seeing consolidation of competitors through mergers and acquisitions. In 2011, a major player was Fresenius Medical Care which acquired two competing dialysis competitors for $2 billion — Liberty Dialysis LLC ($1.7 billion) and American Access Care Holdings ($385 million).9 Over the last three years, Fresenius has also acquired International Dialysis Centers from Euromedic International, and APP Pharmaceuticals Inc. The consolidation trend in the renal device and equipment sectors will likely continue, and many of these deals will be driven by a desire to control barriers to market entry, especially patent portfolios.

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