Spine Market Overview

Low back pain is a major health concern and the most common reported pain among the U.S. adult population.¹ Nearly 50% of the 220 million adults in the United States experience an episode of low back pain each year. For 10% to 15% of these people, the pain becomes chronic (lasting for longer than 6 months). The economic burden of low back pain is enormous. In 1998, the estimated direct healthcare expenditures on patients with back pain the United States reached $90 billion.²

Chronic low back pain can be a complex condition with a multitude of potential sources of the pain. Diagnosis of the cause of the pain is complicated by the fact that a specific diagnosis can only be made in 20% of cases based upon neurological evaluation and imaging studies alone.³ Conditions diagnosed through these means include intervertebral stenosis, degenerative disc disease, disc herniation or prolapse, spondylothesis, and vertebral compression fractures, among others. Traditional treatments of these conditions include laminectomy, discectomy, fusion, and kyphoplasty and represent the core of the $3.8 billion orthopedic spine market.⁴ In recent years, motion preserving technologies such as artificial disc replacement, interspinous spacers, and dynamic stabilization technologies have been introduced as alternatives to fusion for some patients with these conditions.

For the 80% of patients who cannot be diagnosed through imaging and radiographic studies, other diagnostic procedures must be performed. Researchers have utilized diagnostic nerve blocks and disc provocation studies (discography) to discover that in approximately 40% of these cases, or 4 million patients annually, the back pain is attributable to disruptions of the internal structure within the intervertebral discs.⁵ This condition, referred to as discogenic pain, currently has no widely accepted therapy other than surgical spinal fusion.