I’ve been tracking the spinal implant business for several years now, watching with interest – and growing dismay – as more and more patients have been getting more and more hardware implanted into their backs.
Why dismay?
Well, there have been problems with implants corroding, poor outcomes for a number of patients, inconsistent results, and unacceptable infection rates [opens pdf], much of this may be due to a basic problem – we don’t know much about why spines degenerate, are injured, cause pain, and/or ‘fail’, and thus solutions may well not address underlying problems.
This from the AMA:
“The lack of basic science understanding of spine degeneration, such as knowledge about genetics and biochemical and biophysical causes of pain, may be one reason why engineering structural principles alone have not led to success.”
Nonetheless, innovation marches forward, at an annual rate of better than 7%.
This from research firm GlobalData’s new report, “Spinal Implants – Global Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016”. [emphasis is mine]
“The global market for spinal implants is forecast to grow from $6.5 billion in 2009 to about $10.3 billion by 2016, with a Compound Annual Growth Rate (CAGR) of 7%. The global spinal fusion implants market is expected to reach a size of $9 billion by 2016. The market size in 2009 was $5.9 billion and is expected to grow at a CAGR of 6%. The global market for spinal non-fusion implants is expected to grow to $1.2 billion by 2016 from $606m in 2009 with a CAGR of 11%. The spinal fusion implants segment is the biggest in terms of market size, contributing about 90% of the revenue for the spinal implants market category.
…the other major factor driving growth in the market for spinal implants is the introduction of many new innovative products by various device manufacturers. More than 200 products are currently in different stages of development and are expected to be introduced in the market soon. By the end of the calendar year 2012, more than 150 products which are currently in different stages of clinical development are expected to get the necessary approvals and be ready for market launch. These products have various applications such as dynamic stabilization, artificial disc replacement, disc nucleus replacement and orthobiologics. The arrival of these products in the market is expected to drive the demand for spinal implants in the future.
The US is the Biggest Market for Spinal Implants and is expected to be driven by High Patient Awareness
The US is the biggest market for spinal implants. The market size for spinal implants within the US was about $3.8 billion in 2009 and is expected to reach $5 billion by 2016, with a CAGR of 7% in this period…
Medtronic, Inc. is the Leader in the Global Spinal Implants Market
Medtronic is the leader in the global spinal implants market with a share of 32%. The revenue of the company from spinal implants is about $2.1 billion. Medtronic has a large product portfolio in the spinal implants category and includes products such as the Prestiege Cervical Disc, CD Horizon Legacy Spinal System, Infuse Bone Graft and LT-Cage Device, Kyphon Balloon Kyphoplasty, and X-Stop Spacer. The other major players in this market are DePuy Inc., Synthes Inc., Stryker Corporation, NuVasive Inc., and Biomet Inc. There are also a growing number of start-ups which are expected to enter the market in the near future, and are predicted to flood the market with a slew of innovative and advanced products for the treatment of various spine problems.”
What does this mean for you?
For payers, probably higher loss costs, and for patients, questionable outcomes.
Oct
29
The basic problem here is that it has been known for at least a decade that 51% of low back surgeries fail.FBSS (failed back surgery syndrome) results in exponentially multiplied continuing medical costs including costs for medication, pain management and imaging.
I would love to see outcomes on another costly product….Spinal Cord Stimulators….The insurer pays for a “trial” then the implant. The costs can be upward of $65,000 for product placement (not counting the monthly supplies, office visits, recalibrations, etc), only to see the patients fail time and time again, then the insurers have to pay to have them surgically removed. Up to 3 surgeries for the patients and increased costs to the W/C carriers. It would be interesting to see studies of outcomes in w/c and non-w/c patients with this product.
Great article. In conversations that I have had with pain management physicians and research regarding this matter, it appears one can build a tolerance to a SCS, and there is little evidence to support recurring re-implantation of this device as an effective long term treatment modality.