Spine surgery is a relatively mature market — all segments of the spine can be treated, significant share has been garnered by a few major companies, and there are no radically new technologies disrupting current market positions. Yet, trends in the patient population, the active innovation by all companies (see further, below, on market shares per region), the fact that it remains an invasive procedure (even the best minimally invasive approaches have room for improvement), and the accelerating migration of advanced spine technologies to developing non-U.S. markets are all reasons why this “mature” market is anything but stagnant.
Success in applying minimally invasive approaches to spine fusion has opened up procedure volumes for more patients, resulting in the fastest growing area of spine fusion sales. Fusion devices are strong worldwide, with the non-U.S. markets lagging in volumes, but growing at markedly faster rates.
Below is illustrated the segment growth rates for major geographic regions.
The result of the faster non-U.S. growth is that the dominance of U.S. spine surgery markets will decline over the next decade. Below is the change in the share of the global spine surgery market represented by each reach from 2014. For example, the U.S. market will lose 6% of the global market between 2014 and 2021, while Asia-Pacific will gain roughly 5%.
The big players (Medtronic, DePuy, Stryker, Zimmer-Biomet) cumulatively control a large swath of the spine surgery market, yet many millions of dollars streams to hungry and innovative smaller spine companies. For example, below is the distribution of market shares for cervical fusion globally.
[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.
The $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 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.
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.
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.
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.)
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.
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:
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
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 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.
The mechanics of bipedalism—walking on two legs—is often cited as a factor in the development of degenerative disease of the lumbar spine. Over a normal lifespan, humans endure microtraumas and undergo bodily changes that either alter or redistribute biomechanical forces unevenly on the lumbar region, resulting in lower back pain. The stresses and microtraumas associated with lumbar degenerative disk disease (LDDD) degrade the many structures that stabilize the spine, from the bony architecture to the intervertebral discs to the complex array of supporting muscles and ligaments. Changes to the structure of the intervertebral disc contribute to the condition. The collagen (protein) structure of the annulus fibrosis weakens over time, and the water and proteoglycan (PG) content of the disc decreases. These changes diminish the disc’s ability to handle mechanical stresses. In the end analysis, many factors, including genetic, inflammatory, traumatic, and infectious, likely work together to initiate LDDD.
The back pain associated with LDDD occurs with equal frequency among men and women. Peak incidence is around the age of 40. Estimates indicate that 175.8 million days of restricted activity each year are attributed to back pain. The condition accounts for more lost productivity than any other, with estimates running around 89 million lost work days per year. According to the National Center for Health Statistics, 14.3% of new patient visits to primary care physicians are for lower back pain, and about 13 million physician visits are made in connection with back pain complaints.
The above is a brief excerpt from the MedMarket Diligence Report #M510, "Spine Surgery Worldwide 2008-2017: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017." This report details the complete range of products and technologies in spine surgery, including the surgical management of spine disorders, diseases and trauma, with treatments including use of grafts, demineralized bone, fusion, stabilization, disc replacement, nucleus replacement, vertebroplasty, kyphoplasty, imaging, minimally invasive surgical technologies, energy-based therapies and biologics. The report details current clinical and technology developments in the huge and rapidly growing spine surgery technologies worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. (See link for complete report description, table of contents, and list of exhibits.)