According to a new Millennium Research Group (MRG; Waltham, Massachusetts) report, the global spinal nonfusion technology market will increase from roughly $400 million in 2008 to almost $2 billion by 2013.

The report finds this market will be fueled by increased product approvals across the U.S., Europe, and Asia Pacific. An increase in average selling prices prompted by sales of these premium-priced nonfusion devices will further add to the market growth, the report notes.

There are seven different segments in the spinal nonfusion market – the interspinous process decompression devices, pedicle screw-based dynamic stabilization systems, cervical artificial discs, lumbar artificial discs, nuclear disc prostheses, annulus repair devices facet arthroplasty devices. Two of these segements – the nuclear disc prostheses and the facet arthroplasty segments – are not even expected to enter the U.S. until 2011, Deanna Vankessel, an analyst at MRG, told Medical Device Daily. Once that happens, there will be several new technologies providing a service to the patients that haven't been available in the U.S. before, she said.

While spinal fusion devices – the competing technology to nonfusion devices – are now widely available in the U.S. and globally, there is a growing interest in nonfusion devices, Vankessel said. "Now people are starting to really get into nonfusion," she said, adding that not just the surgeons, but also the patients, are taking an interest in this new technology because it allows them to maintain motion in their spine. That is especially important to younger patients, she said. "We're going to see some interesting things in the next few years."

With the highest average selling prices of all three regions, the U.S. contributed the majority of revenues to the global spinal nonfusion technology market in 2008, despite being a young market compared to Europe, the MRG report noted. The spinal nonfusion technology market is more developed in Europe, with a larger number of firms competing on price. Also, many of the devices lack full reimbursement in Europe, which contributes to lower pricing because many patients are unwilling to pay the full price of the nonfusion technology. Although the number of spinal nonfusion procedures performed in Europe was 80% of the volume observed in the U.S. in 2008, price differences resulted in a total European market value of less than half of that in the U.S. market, according to the report.

New products, such as the M6-L lumbar artificial disc from Spinal Kinetics (Sunnyvale, California) and the Barricaid annulus repair device from Intrinsic Therapeutics (Woburn, Massachusetts), will be released across the three regions and will lead to an intensification of marketing and training efforts on the part of manufacturers to promote the efficacy of spinal nonfusion treatments, the report said.

"As more surgeons become familiar with long-term clinical data and receive training on the techniques, an increasing number will adopt spinal nonfusion treatments in their practice and concerns regarding long-term efficacy will recede," Vankessel said. "The release of new spinal nonfusion products will result in an influx of favorable clinical data and increased marketing of these new devices and technologies, fueling physician awareness and adoption."

Spinal Kinetics reported the implantation of the first patient with the company's M6-L artificial lumbar disc earlier this year. According to the company, the disc is an advanced-generation artificial disc designed to replace an intervertebral disc damaged by disc degeneration. The company said it is the only replacement disc that replicates the anatomic structure of a natural lumbar disc by incorporating an artificial nucleus and annulus. Together, the nucleus and annulus are designed to provide the same motion characteristics of a natural disc. The device's compressible polymer nucleus is designed to simulate the function of the native nucleus, while the surrounding multi-layer high tensile strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions, Spinal Kinetics said (Medical Device Daily, Feb. 24, 2009).

In April Intrinsic Therapeutics received a CE mark for its Barricaid anular prosthesis for use in reconstructing soft tissues of the spine. According to the company, the Barricaid is a partial disc prosthesis that enables surgeons to directly reconstruct the annulus of the intervertebral disc in patients with lumbar disc herniations and sciatica as part of a standard, minimal access discectomy procedure. Intrinsic noted that the device offers a new surgical strategy by reconstructing the annulus and anchoring it to the vertebral body for a more secure solution (MDD, April 23, 2009).

Interestingly, Vankessel said that in Europe, only the Spanish and Italian spinal nonfusion markets are expected to be negatively impacted by the global economic recession. "Both of these countries are hindered more severely by the negative economy because many hospital budgets were slashed to cut costs and some hospitals weren't even receiving their budgets until over halfway into the year," she said. This caused the hospitals to be very careful with high priced procedures, such as nonfusions, she said.

Vankessel also noted that in the Asia Pacific, the Australian government stopped public reimbursement for both cervical and lumbar artificial discs in 2008. This caused an extremely large drop to procedures for these two segments in the country, she said.

MRG's Global Markets for Spinal Nonfusion Technologies 2009 report evaluates the performance of the spinal nonfusion technology market from 2007 to 2013 in the U.S., Europe and Asia Pacific. Each chapter includes an examination of artificial disc, dynamic stabilization, annulus repair, nuclear disc prosthesis, and facet arthroplasty procedures, as well as average selling prices and sales segmented by procedure. The report also contains an account of the drivers and limiters that will impact the market and analysis of the leading competitors.

Amanda Pedersen; 229-471-4212