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Global Spine Surgery Finding Double Digit Growth from Innovation, Economics, and Clinical Trends According to MedMarket Diligence Report

[August 21, 2015 — Mission Viejo  CA — MedMarket Diligence has published its 2015 global report on spine surgery. For details, see link.]

Decades of clinical research and medtech innovation have combined to offer solutions for every segment of the spine.  Economics and innovation have also made spine surgery one of the strongest growth of all medtech markets. MedMarket Diligence’s new global report on spine surgery device markets reveals opportunities for established, emerging, and potential medtech players.

Screen Shot 2015-08-24 at 2.03.50 PM

Screen Shot 2015-08-24 at 2.10.34 PMThe $9.17 billion global market for cervical fusion, thoracolumbar Implants, MIS spine fusion, interbody fusion, and orthobiologics has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology. The global market for spine surgery devices is detailed in the MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021.” See Report #M540.

“While this market may be dominated by the bigs — Medtronic, DePuy, Stryker, Zimmer-Biomet, et al. – there remains more than enough business in spine technology to attract a remarkably large number of mid-tier and smaller market participants,” says Patrick Driscoll of MedMarket Diligence. “And there are ample participants who do not accept the status quo, by aggressively innovating and introducing clinical and economic improvement in spine surgery.”

Spine fusion is the fastest growing technology in spine surgery and with growth in spine surgery being fastest in the Asia-Pacific and Central/Latin America, the growth of spine fusion in those areas is double-digit. The improvements in spine surgery and technology development have produced steady growth in volumes of surgeries, supported by reimbursement and clinical outcomes (and the increasingly active aging population). Spine surgery, with its exponential growth, has been the answer to an orthopaedic industry seeking to optimize earnings and add value for shareholders.

The MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World,” (report #M540) is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge.

The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery. The report provides a current and forecast assessment by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade.

The report profiles 38 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development. The products and activities of numerous additional startup and emerging companies are also detailed in the report.

The report is described in detail at http://www.mediligence.com/rpt/rpt-m540.htm and may be ordered for immediate download from https://www.mediligence.com/store/page51.html.


Until August 28, 2015, Report #M540 is available for $500 off the list price. See Spine Surgery 2015 (M540) $500 off early release

Global Markets for Medical Devices in Spine Surgery, Forecast to 2021

The market for spinal implants and associated spinal fusion products has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology.

Prior to these developments, the orthopedic industry had traditionally regarded spinal surgery as a “Cinderella” segment that — far from being a major market segment — was almost regarded as a service area supporting a relatively small number of highly specialized surgeons focusing on the clinical issues associated with the vertebral column. In contrast, by the beginning of the new millennia it became clear that an orthopaedic industry seeking to provide optimized earnings and value to share holders had identified this area as a major unmet need in which the demand to resolve an increasingly wide range of spinal conditions was growing exponentially.

In response to these developments, and in recognition that the market for spinal implants and associated spinal fusion products was and is growing, orthopedic companies have realigned their strategic approach by:

  • Providing greater resources to further product development.
  • Expanding of sales and marketing resources
  • Growing new and emerging geographic regions

It is anticipated that, collectively, these elements will further open the door to the development of implantable devices that can identically reproduce the elements of the spine that need to be reinforced or replaced by artificial. Accordingly, use of spinal fusion and instrumentation is anticipated to increase in the foreseeable future and continue to represent a better than average growth area in medtech.

 

 

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Source: MedMarket Diligence, LLC; Report #M540


MedMarket Diligence, LLC, has completed an analysis entitled, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2020”. The report (#M540) will be published August 21, 2015, and will be downloadable in PDF and available in print for single, site, and global licenses. The report is described in detail, with a complete table of contents and list of exhibits, at link.

Global Market For Medical Device Technologies in Spine Surgery, 2014-2021

MedMarket Diligence is completing a global analysis of spine surgery technologies, scheduled for publication in August/September:

Global Market For Medical Device Technologies in Spine Surgery, 2014-2021:
Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” See link.

This report is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery.The report provides a current and forecast to 2021 by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade. The report profiles 75 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development.

See the full description and table of contents at Report #M540.

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 Map

Spine surgery is a broad area of clinical practice encompassing treatments for many different conditions encompassing degenerative disc and other spinal diseases, congenital and adult spinal deformities, autoimmune diseases of the spine, and the many different conditions of spinal trauma.

Therefore, the range of approaches to addressing spine disease and trauma is equally broad.

Below is a rough outline of spine surgery treatments, drawn from our 2011 Worldwide Spine Surgery report:

Source: MedMarket Diligence Report #M520.

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.