Market Growth Expected to Average Ten Percent Annually Through 2015, According to Millennium Research Group
Global Information Inc. presents a new market research report, "European Markets for Spinal Implants 2011" by Millennium Research Group.
According to MRG, the global authority on medical technology market intelligence, recent issues with some motion preserving technologies along with the introduction of new regulatory standards will impede market growth in the nonfusion segment of the $570 million European spinal implant market.
Although the increased use of nonfusion technologies such as cervical artificial discs have contributed to growth, many physicians have switched back to performing spinal fusions for their patients because of poor clinical results associated with the use of other spinal nonfusion technologies, such as interspinous process decompression devices and nuclear disc prostheses. In addition, European regulations governing the sale of medical devices are growing more stringent, reflecting a greater emphasis on device safety. Procuring the CE mark, required to market a device in the European Union, will now be more difficult.
"Historically, procuring CE marking for a device was not as challenging as getting FDA approval, as European authorities relied on post-market feedback to evaluate efficacy," said MRG analyst Mashkur Reza. "As a result, companies, including those based in the US, would introduce newer technologies in Europe to garner clinical feedback on the devices as well as use the revenues to help fund US clinical trials. The new CE mark approval process will require more pre-clinical data than before and will certainly deter the introduction of new spinal nonfusion devices. These devices are often the product of small innovative companies that lack funding to conduct extensive clinical trials."
Despite these obstacles, the continued demand for motion preservation and the gradual introduction of newer devices will continue to drive growth, resulting in average market growth of approximately ten percent through 2015. Facet arthroplasty and annular repair procedures, two newer nonfusion technologies, are currently available only in Germany but are expected to become available across the rest of the region soon. The introduction of these devices will significantly increase market growth in the nonfusion market, resulting in double-digit growth in 2014 and 2015.