Tag Archives: vertebroplasty

The biggest revenue streams in spine surgery are not the fastest growing

Put simply, regardless of the relative share, differences in market growth rates or other metrics, some spine surgery technologies will generate substantially more sales than others during the 2012 to 2020 timeframe.

Looking at the MedMarket Diligence, “Worldwide Spine Surgery Data Forecast, 2010-2020″, posterior pedicle screw fusion systems and artificial cervical discs will generate the largest revenue increases over this period, since even at modest growth rates the size of the penetrated market results in big gains from 2012 to 2020. In other words, while AxiaLIF represents one of the fastest growing spine surgery device markets, the aggregate change in AxiaLIF revenues from 2010 to 2020 is only $270 million versus $2.97 billion for posterior pedicle screw fusion systems, ¬†Here a growth rate of under 10% on such a large existing market greatly eclipses the absolute impact of a dramatic growth rate (i.e., >30%) of an emerging market.

Source: MedMarket Diligence, LLC; “Spine Surgery Worldwide Data Forecast, 2010-2020.” See link.

On a country-by-country basis, these differences are more pronounced.

Minimally invasive spine surgery patient registry (SMISS)

The Society for Minimally Invasive Spine Surgery (SMISS) has established a prospective registry to track the impact of minimally invasive spine surgery on patient outcomes.  According to Globus Medical, Inc., a private manufacturer of spine implants that has agreed to fund the registry, which will be a registry for the treatment of degenerative lumbar spondylolisthesis, degenerative disc disease, spinal stenosis, and degenerative scoliosis:

The registry will capture prospective clinical data from 10 to 15 clinical sites throughout the country, up to 250 patients, utilizing an electronic data capture program which will allow for "patient portals" to facilitate data collection from anywhere an internet connection is available. Patients will be followed for a minimum of 24 months looking at Health Related Quality of Life (HRQOL) and Quality Adjusted Life Years (QALY) outcomes, the rate and incidence of peri-operative and post-operative adverse events, radiographic correction and fusion rates as well as cost of treatment with the MIS approach.

Spine surgery technologies currently represent a $13 billion global market that will grow to $23 billion by 2020.  Despite price pressure in medical technologies, growth will continue due to innovations that enable mobility and reduce pain in a rapidly growing demographic of older patients.  (See MedMarket Diligence Report #M520.)

Vertebral Compression Fracture Treatment Technologies

From “Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020″, Report #M520, published 2011 by MedMarekt Diligence:

Vertebral compression fractures result primarily from osteoporosis and the consequent weakening of bones, including those in the spine. VCFs can result in tremendous back pain both in the short and long term. Because the injured vertebra is compressed and loses height, kyphotic deformity of that particular vertebra and the spine as a whole often results. Kyphosis in and of itself can produce pain long after the vertebral compression fracture has healed. As discussed earlier, several conditions can lead to osteoporosis, including estrogen deficiency, multiple myeloma, radiation therapy, and natural aging. Bones weakened either due to the primary disease process or as a result of treatment of such diseases are more prone to fracture. Common sites osteoporotic fracture include the spine, hip, and wrist.

The traditional treatment for VCFs is conservative care with back braces, bed rest, and analgesic medications for alleviating pain. Although given time the fracture eventually heals, the vertebral body remains in a collapsed, compressed state. This can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the so-called ‘downward spiral’ of vertebral osteoporosis.

In recent years, two minimally invasive procedures have been introduced to treat VCFs: vertebroplasty and kyphoplasty. The procedures are very different, in that vertebroplasty is designed to stabilize the break, while kyphoplasty attempts to both stabilize the break and bring the collapsed vertebra back to its original height. 

Companies with products in vertebroplasty and/or kyphoplasty on the market or under development include: Alphatec, ArthroCare, AscendX, Benvenue Medical, Biomet, BoneSupport, CareFusion, Cook, DePuy Spine, Dfine, Integra Spine, Lafitt, Medtronic, Orthovita, Osseon Therapeutics, Signus, Sintea, Skeltex, Soteira, Spine Wave, SpineAlign, Stryker, Synthes, Tecres, Teknimed, Vexim.

Kyphoplasty is currently the bigger market, but trends in procedure volume, pricing and unit sales are causing the gap in global market between kyphoplasty and vertebroplasty to disappear during the forecast period.

 

Vertebro-kypho

Source: MedMarket Diligence, LLC; Report #M520.

 

 

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Evolution of spine surgery market is changing the landscape

The global market for spine surgery devices was estimated to be worth about $12.43 billion in 2010, and is forecast to reach approximately $23.90 billion by 2020, exhibiting a compound annual growth rate (CAGR) of 6.96% (2011-2020). The device segments comprising this total are:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems
  • Anterior Thoracolumbar Plate Systems
  • Anterior Lumbar Interbody Fusion (ALIF) devices
  • Transforaminal Lumbar Interbody Fusion (TLIF) devices
  • Posterior Lumbar Interbody Fusion (PLIF) devices
  • Axial Lumbar Interbody Fusion (AxiaLIF) devices
  • Interspinous Process Spacer (ISP)
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrix (DBM)
  • Bone Morphogenetic Proteins (BMPs)

This growth will be driven by a number of factors, including:

  • The ageing population worldwide
  • Increasing incidence of obesity
  • A growing middle class in developing countries, with the ability to pay out of pocket for spine surgery
  • Improving worldwide economy
  • Technological device enhancements, leading to improved surgical results
  • Developments in minimally invasive spine surgery (MISS) devices driving a strong increase in MISS, with its numerous advantages
  • In the US, improvements in reimbursement as clinical trials demonstrate the efficacy of treatments using the devices
  • US healthcare reform leading to medical insurance coverage for more people, allowing those suffering from intractable back pain to receive surgical treatment

As a result of aggregate growth and the differential growth rates of specific spine surgery product types, the landscape of spine surgery will change from 2011 to 2020. Although the aggregate growth is just under 7%, this is the net effect of all growth rates that range, individual product segments, from a decline of 5% in CAGR to an increase of over 30% CAGR.

 

Global Spine Surgery Market by Product Type, 2011 & 2020

Source: "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities, 2010-2020", Report #M520, MedMarket Diligence, LLC.

Spine surgery technologies gaining/losing ground on each other

One thing to keep in mind about the spine surgery market is that, without exception, each and every technology continues to grow from the underlying procedure volume and even if prices are declining (as they are in some cases) the resulting market is also increasing as a result of procedure volume increases.

Hence, for the sake of highlighting where the growth stands out, it is useful to see the change in each technology's share of the total market over the 2010 to 2020 period.

Below is illustrated the change in percent of total market between 2010 and 2020 for each of the key technologies in spine surgery. First among these in gaining relative share are lumbar artificial discs and posterior pedicle screw fusion systems.

 

 

Source: MedMarket Diligence, LLC; Report #M520, "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities, 2010-2020".

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Spine surgery largely unfazed by recent market challenges

Few medical device markets have demonstrated the kind of staying power — prices, procedure growth, market growth — shown by spine surgical technologies.  The swelling caseload of new patients, the persistent clinical need and the stream of innovations from manufacturers in this arena have enabled growth rates that have not recently been seen in most other device markets.

Of course, the market has been pinched by insurer pushback on some procedures (e.g., fusion when degenerative disc disease is involved), price pressures on some established devices and, in the U.S., regulatory reform that is long in coming.

A definite kind of demand inelasticity exists in spine disorders and trauma that has enabled it to be an area in which manufacturers have been able to succeed despite the capital restrictions and recessionary forces that have plagued markets since at least 2008.

Spine surgery technologies are comprised of the following discrete segments:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems
  • Anterior Thoracolumbar Plate Systems
  • Anterior Lumbar Interbody Fusion (ALIF) devices
  • Transforaminal Lumbar Interbody Fusion (TLIF) devices
  • Posterior Lumbar Interbody Fusion (PLIF) devices
  • Axial Lumbar Interbody Fusion (AxiaLIF) devices
  • Interspinous Process Spacer (ISP)
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrix (DBM)
  • Bone Morphogenetic Proteins (BMPs)

Below is an exhibit (drawn from the 2011 MedMarket Diligence worldwide report on spine surgery) illustrating the different growth in spine surgery technology segments.

Source: MedMarket Diligence Report #M520.

Posterior pedicle screw fusion systems currently represent the largest share of the global spine technology market, a dominance that will persist through the forecast period based on its large established base. However, as is evident in the uptake of new spine technologies, there is ample opportunity for participants in all but a few sectors that are declining in absolute or relative terms.

Spine surgery technologies: changes in market composition

 

Markets for products in spine surgery show a decline in spine fusion and total disc replacement, but an increase in intraspinous process spacers and nucleus replacement.  Although the exhibit below displays this only for Asia/Pacific markets, the trend is true globally.

asia-pacific-spine-fusion

Source:  Exhibit 3-107 is taken from MedMarket Diligence report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

 

Despite the recent challenge to vertebroplasty, indicating that its results are equivalent to controls, kyphoplasty offers a more progressive approach, via balloon expansion, to disc compression.

Minimally invasive spine surgery becoming technology-enabled

While patient concerns remain a significant driver in the development of minimally invasive techniques, technological advances in surgical instrumentation have transformed the theoretical to the practical. Advanced fluoroscopy, or x-ray imaging during surgery, has markedly improved the accuracy of incisions made and hardware placed. A variety of endoscopes, camera-tipped wands, can be inserted through small incisions and provide the surgeon with excellent visualization of the operative site. New surgical instruments were developed to work in tandem with endoscopes. The past several years have brought numerous innovations to spine surgery. These innovations include the development of imaging systems that interpret anatomical data for three-dimensional display; the use of lasers, ultrasonic frequencies, and high-pressure water jets remove tissue; and new monitoring devices that help the surgeon to optimally position instrumentation as well as to warn of potentially damaging neural contact during a procedure. Spine operations that lend themselves particularly well to minimally invasive approaches are intervertebral disc decompressions and discectomies. Progress has been made in adapting certain kinds of spinal fusion procedures to a minimally invasive approach, and certain forms of scoliosis of the thoracic spine have been treated with minimally invasive surgery.

mis-spine

Source:  MedMarket Diligence, LLC; Report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

MIS has many enthusiastic supporters. However, caution needs to be exercised, as even though a technique is less traumatic, if the rate of successful spinal fusion is much lower, then there is really not an advantage. Also, it has yet to be demonstrated that minimally invasive spine fusion systems actually cause better outcomes than some other surgical techniques used in the traditional open approach.

Increasingly, minimally invasive techniques are becoming the preferred method for autologous bone graft procedures. Traditional procedures involve the surgeon making a 3- to 5-inch incision to harvest bone from the patient’s hip area, and some studies have shown that complications arise in nearly a third (31%) of these patients. These studies also show that about 27% of patients still feel pain in the hip area up to two years after the surgery.
 

 

Why the spine surgery market is so strong

The global spine market is large, active and growing rapidly in revenues. Several dynamic forces, in addition to the aging of the population, are expected to affect the market and treatments during the next several years. While spinal fusion will always have a place, its share of the treatment market is expected to decline. Newer treatments such as total disc replacement and nuclear arthroplasty will erode the spinal fusion market, as these and other treatments which preserve spinal motion gain favor over the invasive and traumatic fusion of two or more spine segments.

Fundamentally, demographics are a huge driver of spine surgery growth, but the number and variety of different spine disorders and diseases supports and ongoing need for treatments, technologies and products.

Below are select data in support of the huge and growing worldwide spine surgery market (drawn from report #M510).

 

Number & Percentage of U.S. Population over Age 65, 1910–2050

spine-demographics

Source:  U.S. Bureau of the Census and MedMarket Diligence report #M510.

 

 

Congenital Disorders of the Spine

 

Disorder
Description
 
Kyphosis (hyperkyphosis)
Exaggerated curvature. Excessive kyphosis results in “hunchback” appearance. Can result from segmentation or formation defects.
Lordosis
Exaggerated curvature. Excessive lordosis results in “swayback” appearance. Usually appears in lumbar spine.
Scheuermann’s Kyphosis
Hyperkyphotic deformity observed in from 1% to 8% of children over the age of 20 or 11. Typically appears in thoracic spine.
Scoliosis
Lateral curvature of the spine exceeding 10°. Primary age of onset between 10 and 15 years. Scoliosis in females much more likely to require treatment as it progresses.

 

Source: MedMarket Diligence report #M510.

 

Inflammatory and Infectious Diseases of the Spine

 

Disorder
Description
Discitis
An inflammation of the disk space often related to infection. Most commonly appears in lumbar region.
Sacroiliitis
Also called Sacroiliac Joint Injury. Can result from inflammation, infection, trauma, or other causes.
Arachnoiditis
Describes inflammation of the meninges and subarachnoid space. Can result from bacterial, fungal, viral or parasitic agents; can also result from surgery or the administration of intrathecal agents.

 

Source: MedMarket Diligence report #M510.

 

Degenerative Diseases of the Spine

 

Degenerative Disease
Description
 
Degenerative Disc Disease (DDD)
Can encompass degradation of bony architecture, discs,
or supporting muscles and ligaments of the spine.
Frequency increases with age.
Spinal Stenosis
Narrowing of the spinal canal, neurorecesses, and
neuroforaminal canals at any part along the spinal axis.
Can result from disc protrusion or other degenerative
factors.
Osteoporosis
Systemic skeletal disorder characterized by low bone
mass and loss of bone tissue. Especially prevalent in
postmenopausal women
Rheumatoid Arthritis
An inflammatory disease of no known cause that
primarily affects the peripheral joints. The disease has a
significant genetic component.

 

Source: MedMarket Diligence report #M510.

Mechanical Disorders of the Spine

 

Mechanical Disorder
Description
Herniated Disc
Refers to the bulging or protrusion of the interior disc nucleus against or through the wall of the intervertebral disc. Predominantly appears in the lumbar spine.
Spinal Stenosis
Narrowing of the spinal canal, neurorecesses, and neuroforaminal canals at any part along the spinal axis.
Often due to age-related degenerative changes.
Myelopathy
Usually refers to symptomatic compression of the spinal cord itself, sometimes linked to spinal stenosis.
Radiculopathy
Describes symptoms associated with compression of the nerve roots of the spine, often due to disc herniations or other factors.
Spondylolysis
Describes bony overgrowths or spurs (osteophytes) on vertebra, often linked to aging.
Spondylolisthesis
Describes the (usually) forward slippage of a vertebra relative to the one below. Most frequently occurs in the lumbar spine.

Source: MedMarket Diligence report #M510.

 

 

 

Minimally invasive and open spine surgery procedures

Drawn from the MedMarket Diligence report, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

A traditional, “open” surgical spine procedure typically involves the surgeon making a long incision, from either an anterior or posterior approach, dissecting and retracting layers of tissue as needed to provide both visualization and access to the affected area. For many kinds of operations—instrumented spinal fusion the most notable—open procedures remain the norm due to the demands of positioning, attaching, and configuring fixation devices. A higher rate of patient postoperative complications and a longer recuperative time period are thought to result from many open procedures, however. These findings have helped to drive the development of minimally invasive techniques—and instrumentation—for certain kinds of operations; in the near future, new minimally invasive technologies and techniques will likely change the approach to operations currently performed with traditional means.

Traditional "Open" Spine Surgery Procedures

 

Name of Procedure
Clinical Indications to Perform Procedure
Anterior Cervical Discectomy and Fusion (ACDF)
An intervertebral disc in the cervical spine bulges or herniates, exerting pressure on an adjacent nerve root. Procedure also used to remove tumors, osteophytes, or vertebral fracture fragments from the spinal canal.
Anterior Lumbar Interbody Fusion (ALIF)
Herniated intervertebral disc in the lumbar spine.
Cervical Corpectomy
Narrowing of the cervical spinal canal due to growth of bone spurs or the ligament behind the vertebral bodies, where an anterior cervical discectomy does not address the entire area of neural compression.
Cervical Foraminotomy
Space through which a spinal nerve root branches off from the cervical spinal canal is too narrow, exerting pressure on the root
Cervical Laminoplasty
Cervical spinal canal is painfully restrictive due to injury or disease.
Decompressive Lumbar Laminectomy
Abnormal bone spurs or rough intervertebral disc edges exert pressure on spinal nerve roots or the cauda equina, a nerve root bundle at the end of the spinal cord.
Interbody Fusion with Cages
Performed to remove a damaged intervertebral disc and fuse the vertebrae above and below the disc space.
Posterior Lumbar Interbody Fusion (PLIF)
Herniated intervertebral disc in the lumbar spine.
Spinal Fusion
Indicated in a variety of instances to unite two or more bony segments so that they grow together
Posterolateral Gutter Spine Fusion
Indicated in a variety of instances to unite two or more bony segments so that they grow together. This approach has a high level of success due to the rich vascular network present in the posterolateral spinal region.
Transforaminal Lumbar Interbody Fusion (TLIF)
Performed to remove a damaged intervertebral disc and fuse the vertebrae above and below the disc space.

Source: MedMarket Diligence, report #M510

Minimally Invasive Procedures

While patient concerns remain a significant driver in the development of minimally invasive techniques, technological advances in surgical instrumentation have transformed the theoretical to the practical. Advanced fluoroscopy, or x-ray imaging during surgery, has markedly improved the accuracy of incisions made and hardware placed. A variety of endoscopes, camera-tipped wands, can be inserted through small incisions and provide the surgeon with excellent visualization of the operative site. New surgical instruments were developed to work in tandem with endoscopes. The past several years have brought numerous innovations to spine surgery. These innovations include the development of imaging systems that interpret anatomical data for three-dimensional display; the use of lasers, ultrasonic frequencies, and high-pressure water jets remove tissue; and new monitoring devices that help the surgeon to optimally position instrumentation as well as to warn of potentially damaging neural contact during a procedure. Spine operations that lend themselves particularly well to minimally invasive approaches are intervertebral disc decompressions and discectomies. Progress has been made in adapting certain kinds of spinal fusion procedures to a minimally invasive approach, and certain forms of scoliosis of the thoracic spine have been treated with minimally invasive surgery.

MIS has many enthusiastic supporters. However, caution needs to be exercised, as even though a technique is less traumatic, if the rate of successful spinal fusion is much lower, then there is really not an advantage. Also, it has yet to be demonstrated that minimally invasive spine fusion systems actually cause better outcomes than some other surgical techniques used in the traditional open approach.

Increasingly, minimally invasive techniques are becoming the preferred method for autologous bone graft procedures. Traditional procedures involve the surgeon making a 3- to 5-inch incision to harvest bone from the patient’s hip area, and some studies have shown that complications arise in nearly a third (31%) of these patients. These studies also show that about 27% of patients still feel pain in the hip area up to two years after the surgery.
 

Minimally Invasive Spine Surgery Procedures

 

Name of Procedure
Goal of Procedure
Vertebroplasty
Performed to treat fractured or collapsed vertebra
Kyphoplasty
Performed to lessen or eliminate pain due to an osteoporotic compression fracture of the vertebra
Microscopic Discectomy
Performed to relieve pressure on spinal nerve roots caused by a ruptured intervertebral disc
Disc Decompression
Performed to remove extruded portions of an uncontained herniated disc or to remove nuclear disc material causing a bulge in a contained herniation. Decompressing the disc relieves pressure on adjacent nerve roots.
Endoscopic Scoliosis Surgery
Performed to correct abnormal lateral curvature; this is an alternate procedure for certain forms of scoliosis appearing in the thoracic spine

Source: MedMarket Diligence, report #M510