The Evolution of the Spine Market: Nonfusion Devices Overcome Obstacles

11/3/2009

The market for spinal nonfusion devices is set to explode over the next five years, drastically changing the landscape of the US spinal implant market. Designed to allow for greater range of motion following surgery, nonfusion devices will enjoy increased demand over the next five years as the over-40 population in the US multiplies.

This baby-boomer demographic is more active than ever, and will thus demand solutions to chronic pain that will enable them to maintain a certain amount of activity. On the patient side, benefits such as shorter hospital stays and recovery times, along with preserved motion in the spine, will serve to fuel demand for nonfusion procedures. While physicians have been slow to adopt these newer technologies over the more established spinal fusion, favorable reimbursement and supportive clinical data will prompt higher adoption rates than in the past. The combination of these factors will fuel brisk growth in the US spinal nonfusion market.

In terms of medical devices, surgically treating back or neck pain—which, among the aging demographic, is typically the result of degenerative disc disease and osteoarthristis—can include spinal fusion or nonfusion. The more established treatment method, spinal fusion, involves the permanent union of two or more vertebrae to immobilize and stabilize the spine. Although some minimally invasive fusion techniques have emerged, established fusion procedures are often associated with lengthy recovery and months of pain and discomfort. Nonfusion technologies have thus emerged as alternative methods of treating chronic pain. Spinal nonfusion procedures can include a number of different technologies, including dynamic stabilization, artificial discs, nuclear disc prostheses, annulus repair devices, and facet arthroplasty devices.

Although some nonfusion devices have been available on the US market for some time, their adoption has been somewhat limited to this point. A dearth of clinical data supporting the technology has resulted in many surgeons continuing to perform the procedure they are most comfortable with; namely, spinal fusion. Fusion devices accounted for about 94% of market revenues in 2008, with nonfusion devices garnering just over 6% of market revenues. To combat this stall in adoption, manufacturers of spinal nonfusion devices have been conducting large-scale clinical trials, the results of which are expected to be released over the next five years. Early results suggest that data will be favorable, stimulating expectation that adoption will expand.

As of 2008, however, there existed a limited amount of long-term clinical trial evidence that clearly displays the ability of spinal nonfusion implants to withstand the natural forces of the body and not wear down easily. Because many new technologies are targeted to younger patients (those in their 40s and 50s) who are concerned that a spinal fusion will limit spinal motion, the ability of an implant to last more than 20 years is even more critical than for older patients. As a result, extensive clinical results demonstrating the durability and efficacy of spinal nonfusion devices will be required in order for device adoption to be widespread. The expected release of favorable clinical data in the coming years will allow manufacturers to indulge in price increases and improve the reimbursement environment, which will further bolster market value.

Surgeon reluctance to go through time-consuming training has also limited the spinal nonfusion market in the past. Many surgeons are comfortable with spinal fusion as a primary method of alleviating severe back pain, and are therefore not inclined to switch to another technique that requires additional training and a longer initial procedure time. With patient demand for nonfusion growing, however, more surgeons will enroll in training sessions in order to appease their patients.

Manufacturers will aid this process by spending time and money to develop and commercialize such technologies and investing in physician training programs. These trends were made evident at the 2008 North American Spine Society meeting in Toronto, Canada, where a large percentage of discussions focused on the use of artificial discs in spinal nonfusion. Industry sources have indicated that some patients have already postponed spinal fusions in the hope of being able to withstand the pain until a select motion-preserving device is available.

In 2008, revenues in the spinal nonfusion device market totaled just over $265 million, a small number compared to the almost $4 billion garnered by spinal fusion devices. With patient demand, surgeon acceptance, and supportive clinical data breaking down the obstacles that have traditionally hindered this market, revenues will skyrocket over the next five years, exceeding $1.7 billion by 2013. Although penetration of spinal nonfusion technologies will occur at the expense of spinal fusions, the latter device type will remain the largest segment of the US spinal implant market, as the majority of spine surgeons will continue to consider spinal fusion as the gold standard surgical treatment for chronic back pain relief.

Medtronic Spinal and Biologics, DePuy Spine, Synthes Spine, and Zimmer Spine are the key players in the nonfusion device market, with Medtronic dominating revenues in 2008. The company has strong holdings across the spinal implant market, and has been first-to-market in a number of important segments. Despite being the first company to market with a lumbar artificial disc (LAD), DePuy Spine has struggled in the nonfusion market due to complications associated with the device. DePuy’s struggle led Synthes to enact a much more cautious rollout of its ProDisc-L LAD. Although Zimmer has experienced some pains in implementing its new physician payment plan—enacted following the Physician Payment Sunshine Act—the company remains in a relatively strong position for nonfusion devices, owing largely to the success of its Dynesys device. IQ

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