New regulatory standards and issues with motion preserving technologies will impede nonfusion spinal market growth in Europe, according to a report from Millennium Research Group.
European regulations for medical device sales have grown stricter and place greater emphasis on device safety, which makes gaining approval more difficult. The new process requires more pre-clinical data than before, which will make bringing spinal nonfusion devices to the market more difficult in the future, especially for small companies without the funds to conduct large clinical trials, according to the report.
The $570 million spinal implant market has seen an increase use of nonfusion technologies, such as cervical artificial discs, but many physicians seem to have switched back to performing spinal fusions due to poor clinical results for nonfusion technology. Surgeons have become more skeptical of devices associated with intersinous decompression and nuclear prostheses for use during surgery.
The group predicts a 10 percent growth through 2015, driven by the demand for motion preservation devices.
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The $570 million spinal implant market has seen an increase use of nonfusion technologies, such as cervical artificial discs, but many physicians seem to have switched back to performing spinal fusions due to poor clinical results for nonfusion technology. Surgeons have become more skeptical of devices associated with intersinous decompression and nuclear prostheses for use during surgery.
The group predicts a 10 percent growth through 2015, driven by the demand for motion preservation devices.
Related Articles on Device Markets:
Medtronic Held 44% of the Bone Graft Substitute Market in 2010
Global Orthopedic Instrumentation Market to Exceed $47B by 2015
Millennium Research Group: Orthopedic Extremities Market to Generate $4.6B by 2015