Growth in Surgical Lower Back Pain Treatment Expected Due to Clinical Efficacy Evidence and U.S. Medical Policy Change. Substantial Market Opportunity for SI-BONE, Globus Medical.
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A positive change in medical device reimbursement policy, i.e. a Category 1 CPT code, coupled with a robust patient backlog and extensive clinical evidence, has the minimally invasive sacroiliac joint fusion market poised for significant growth, comparing 2014 values to 2020 projections.
According to a newly published report by iData Research (www.idataresearch.com), one specific medical device reimbursement policy change will result in significant relief for some lower back pain sufferers. Recent published studies point to sacroiliac joint dysfunction as being responsible for up to 30-35% of lower back pain cases. In response to this need, SI-BONE has released the iFuse Implant System, a sacroiliac (SI) joint fusion device that received FDA approval in November 2008.
The key to near term growth in the SI joint fusion market will be the patient backlog. “In 2014, we see around 8,000 procedures being performed. By 2020, that number is projected to exceed 50,000 surgeries in the U.S.”, explains Dr. Kamran Zamanian, CEO of iData. However growth in SI joint fusion procedures performed is not expected to be gradual or uniform during the forecast period.
Diagnosis of SI joint dysfunction, however, has been at the center of significant controversy and uncertainty. Such diagnoses often depend on patient feedback, which may be unreliable. Many medical practitioners have been reluctant to diagnose SI joint dysfunction as a source of their patient’s lower back pain. Currently, the most reliable form of diagnosis includes a combination of patient history, physical exam, provocative testing maneuvers and SI joint injections which together enable clinicians to rule out other causes and identify the SI joint as the source of pain. This SI joint dysfunction diagnosis process may act as a market limiter in the years to come. However, assuming good diagnosis is more broadly adopted, the SI joint fusion market segment, which today comprises less than 5% of the overall spine market is projected to comprise closer to 20% by 2021.
Currently in the U.S., the SI joint fusion medical device market is dominated by SI-Bone, with the vast majority of the market share. However, in 2014, Globus Medical had significantly more market presence for minimally invasive spinal implants as a whole, and also held the second leading position in the SI joint fusion market. In 2014, Globus Medical was among the top 5 market leaders for the minimally invasive spinal implant market along with DePuy Synthes, NuVasive, Medtronic and Stryker.
More on the U.S. Minimally Invasive Spinal Implant Market
The newly-published iData report entitled “U.S. Market for Minimally Invasive Spinal Implants 2015” includes segments for spinous process fixation, facet fixation, MIS interbody fusion, MIS pedicle screws and MIS sacroiliac joint fusion. The full report also includes detailed analyses of procedure numbers for each segment, as well as provides a comprehensive look at units sold, market value, forecasts, market shares, and success strategies of major players in each market and segment.
Dylan Freeze, Senior Orthopedic Research Analyst for the U.S. Minimally Invasive Spinal Implants 2015 market report at iData