Riddle Me This - Riddle Me That, Where are the Spine Markets At?

It has been said that the apple doesn’t fall far from the tree. In the spine industry, perhaps the market doesn’t fall far from the diagnosis. What are the largest spine diagnosis groups that could lead to potential market opportunities? Let’s go out on a limb, because that’s where we’ll find them.

By examining spine diagnosis trends, we can identify potential market opportunities. Economically speaking, a spine diagnosis today will give the product markets a chance to solve the problem tomorrow. Medical device companies should be keenly aware of trends in diagnoses in their area of the marketplace, and the demographics driving them.

It’s time to shake the diagnoses out of the tree.

The tree we are going to shake is the PearlDiver Patient Cost and Utilization database. In examining the 20 most common spinal diagnoses, four categories become apparent. They are: disc displacements (herniations), degenerative disc disease (DDD), vertebral dislocations, and spondylosis (see Table 1). More strikingly, diagnoses in these four areas comprise over 70% of the top 20 diagnoses! Beyond this, the cervical and lumbar regions of the spine arise to claim the majority of disorders. Let’s look at each category individually.

Table 1: PearlDiver Patient Cost and Utilization Database

Disc Displacements
Based on an analysis of the PearlDiver database, the largest diagnosis group is disc displacement (herniation), which makes up 29.4% of the 20 most common diagnoses in the database. The cervical, thoracic, and lumbar regions are all represented in this category.

Table 2: Percentage of Disc Displacement Diagnoses  

Lumbar disc herniation leads the way and comprises over 17% of the top 20 diagnoses. As one would expect, this is also the most common spinal diagnosis in the database. Not surprisingly, fusion is most commonly performed in the lumbar region. According to the PearlDiver database, the posterior approach accounts for just over 70% of all lumbar fusions, followed by the anterior approach.

While fusions are the most common surgical approach to lumbar disc herniation and DDD, artificial disc technology is also available. One such artificial disc is the Charité. The FDA approved the Charité for single-level L4–L5 and L5–S1 implantation as of October 2004. Artificial discs could grow in popularity, depending on surgeon training and acceptance.

Figure  1: Lumbar Fusion by Approach

Cervical disc herniation, while significant, is seen less than half as often as its equivalent in the lumbar region, on a percentage basis. The market for cervical fusion and artificial disc technologies is significant. According to the PearlDiver database, cervical fusion is the most common inpatient procedure for cervical spondylosis, disc herniation, and DDD. Cervical fusion sits a close second to lumbar fusion in terms of procedures and is performed from an anterior approach over 94% of the time.

Cervical disc herniation will not only continue to provide opportunities for medical device companies, but for outpatient care as well. Many spine surgeries that were once inpatient are moving to the outpatient side. These include percutaneous discectomy and cervical arthrodesis below the C2 vertebra. According to the American Hospital Association, 63% of all surgeries occurred on an outpatient basis in 2004.

Disc herniation has helped create a frenzy of innovation with respect to cervical artificial discs and several such devices are undergoing FDA clinical trials. Two examples are Medtronic Sofamor Danek’s Bryan cervical artificial disc, and Stryker’s Cervicore artifical disc. In an article entitled Total Disc Arthroplasty: The Wave of the Future, Dr. Brian Subach of the Virginia Spine Institute related that “clearly arthroplasty for spinal disc disease has revolutionized our thinking about the degenerative process.”

Figure 2: Cervicore Artificial Disc-Stryker

*Cervicore Artificial Disc—Stryker

Degenerative Disc Disease
The second largest market is DDD, comprising over 21% of the top 20 diagnoses. According to the PearlDiver database, DDD strikes males most often between the ages of 45 and 49. Females are diagnosed more often than males with a peak between the ages of 55 and 59.

Table 3: Percentage of Degenerative Disc Disease

The theme is recurring. The lumbar and cervical areas are at it again! DDD causes pain from inflammation and instability within the spine. As a vertebral disc ages, it loses its moisture content and decreases in height. Proteins from the nucleus pulposis can come in contact with the nerves and also cause inflammation. The term “degenerative” can be misleading. A diagnosis of DDD does not mean that the condition will necessarily get worse. However, DDD can lead to other, more serious disorders such as stenosis and spondylolisthesis.

Vertebral Dislocations
Three is the charm. The third market is in vertebral dislocations—ouch! First-degree dislocations without spinal cord injuries can often heal themselves with the assistance of traction and bracing. However, a third-degree dislocation with spinal cord damage can lead to a discectomy or fixation by interbody fusion. Vertebral dislocations can also lead to a decompression procedure such as a laminectomy, partial facetectomy, or a foraminotomy.

Table 4: Percentage of Vertebral Dislocations

According to an article entitled Spinal Fractures published by the Mayfield Clinic & Spine Institute, “most fractures occur from car accidents, falls, gunshot, or sports.” The article defines a dislocation as “when ligaments and/or discs connecting two vertebrae together are stretched or torn ... the bones may come out of alignment.” Dislocations can also include vertebral compression fractures.

According to the PearlDiver database, closed dislocations of multiple cervical vertebrae occur in women 62% of the time. Dislocations tend to display a broader age distribution than other spine diagnoses. This is in part because age is not the primary factor leading to their occurrence. Below is an age breakdown of annual diagnoses in women. Within the chart, two potential patient markets can be discerned and will potentially require different methods of treatment, based on age. The first is comprises the 5- to 30-year-olds, where traumatic causes of dislocations are common. Occurrences in the second group, being made up primarily of the baby boomer generation, are in part, age dependent. Diseases such as osteoporosis and spine tumors can contribute to dislocations in this age group.

Figure 3: Female Occurrences of Vertebral Dislocations

Spondylosis
>Last but not least! Spondylosis (spinal osteoarthritis) can affect all three regions of the spine. In the PearlDiver database, we have seen the condition predominately in the cervical and lumbar regions. The formation of osteophytes (bone spurs) often accompany the condition.

Table 5: Percentage of Spondylosis Diagnoses

Surgery is seldom needed to treat spondylosis, because more conservative treatments work well. In an article available at SpineUniverse.com entitled Spondylosis: How Doctors Treat Spinal Osteoarthritis, Dr. John Regan relates that “Non-surgical treatment is successful 75% of the time.” Spondylosis may present opportunities in conservative care or minimally-invasive surgical techniques.

The Tree Has Spoken
We shook the markets out of the tree. Opportunities exist in disc herniation, DDD, vertebral dislocations, and arthritic conditions such as spondylosis. Demographic trends will underscore growth in these diagnoses. Based on these trends, capital inflows and investment will provide financing for continued technological innovation as the product markets address the opportunities.