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.

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.)

Degenerative disk disease

spine-disksThe 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.)
 

 

Degenerative disc diseases, implications for spinal surgery technolologies

Below is an excerpt from "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017," report #M510 from MedMarket Diligence.

Degenerative Disc Diseaseslumbar-vertebra
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.

Spinal Stenosis
Spinal stenosis results from the progressive combined narrowing of the central spinal canal, the neurorecesses, and the neuroforaminal canals. The narrowing of the spinal canal may result from bulging or protrusion of the intervertebral disc annulus or from other factors. Spinal stenosis increases a patient’s risk for acute neurological injury. Symptoms of spinal stenosis include pain, motor weakness, or paresthesia.

Spinal stenosis involving the cervical and thoracic regions can contribute to neurological injury. When it involves the lumbar spine, spinal stenosis is most commonly linked with midline back pain and radiculopathy. In the United States, CT and MRI studies in patients who exhibit no symptoms and are younger than 40 years indicate a 4% to 28% occurrence of spinal stenosis. Most patients over the age of 60 exhibit spinal stenosis to some degree. Internationally, nations with large numbers of older citizens tend to have a higher occurrence of the disease.

Osteoporosis
Osteoporosis, a systemic skeletal disorder characterized by low bone mass and loss of bone tissue, leads to weak and fragile bones. People with osteoporosis are at increased risk of fractures, especially in the hip, spine, and wrist. Women make up 80% of all osteoporosis sufferers.

Because bone loss typically occurs without symptoms, osteoporosis is often called the “silent disease.” Many people are unaware that they have the disease until a bump or fall results in a fracture or a collapsed vertebra. These collapsed vertebrae might manifest themselves in severe back pain, loss of height, or in spinal deformities such as the stooped posture characteristic of kyphosis.

A combination of genetic and environmental factors leads to the development of the disease, which is typically classified into Types I, II, and III. Type I, or postmenopausal, osteoporosis is believed to result from deficiencies in estrogen or testosterone. These deficiencies accelerate bone loss; they can also cause bone to be more sensitive to the effects of parathyroid hormone, which speeds calcium release from bone. In the five to seven years following menopause, women can lose up to 20% of their bone mass, which makes them much more likely to develop the disease. Type II osteoporosis, also known as senile osteoporosis, occurs in people late in life due in part to decreased formation of bone. Type III osteoporosis occurs as an effect of certain medications like glucocorticoids or other conditions that cause bone loss. Worldwide, according to the International Osteoporosis Foundation, the disease affects about 1 in 3 women and about 1 in 8 men. In Type I and Type II osteoporosis, women are affected more often than men. Both sexes exhibit equal incidence for Type III.

Researchers have found that genetic factors play a key role in the pathogenesis of osteoporosis by regulating phenotypes that predispose to fracture. Most of the genes remain to be discovered. Important findings to emerge over recent years include the observation that different genes are responsible for the regulation of bone mineral density (BMD) in both genders and at different skeletal sites, and that many of the genes that are mutated in rare bone diseases such as osteopetrosis and sclerosing bone dysplasias also seem to contribute to the regulation of BMD in the normal population. Future research may look at better defining the functional mechanisms by which candidate gene polymorphisms affect bone cell function and bone mass.

In the United States, about 10 million people have osteoporosis. Of this total, eight million are women. According to estimates from the National Osteoporosis Foundation, 14 million Americans will be diagnosed with osteoporosis by 2020. If current trends continue, an additional 47 million will be at high risk of developing the disorder. The disease is cited as the primary cause in an estimated 1.5 million or more bone fractures annually. This total includes about 700,000 vertebral fractures, 250,000 wrist fractures, 300,000 hip fractures, and 300,000 fractures at other sites. For people over the age of 50, one in two women and one in four men will have an osteoporosis-related fracture in their lifetime.

Recent studies indicate that about 1 of 13 postmenopausal women with osteoporosis who exhibit no fractures initially are likely to suffer a spinal fracture within one year. Related statistical models indicate that spinal fracture prevalence among these women increases rapidly over time if the condition is left untreated. Results of other studies indicate that 1 out of 5 postmenopausal, osteoporotic women who suffer an initial spinal fracture will experience another spinal fracture within a single year.

According to figures supplied by the National Osteoporosis Foundation, the estimated national direct expenditures for osteoporosis totaled $17 billion in 2001. By 2020, the cost of fall injuries is projected to reach $32.4 billion. The incidence of osteoporotic fractures—and the costs associated with them—increases with age. As life expectancy increases for much of the world’s population, these costs will multiply exponentially.

Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an inflammatory disease of unknown cause. Common symptoms include fatigue, malaise, and morning stiffness. The disease primarily affects the peripheral joints; because it causes joint destruction, it often leads to significant morbidity.
Although an infectious cause has been speculated, to date no organism has been proven responsible for initiating the disease.

Rheumatoid arthritis is linked to various autoimmune responses, but it remains unclear if autoimmunity is a primary or secondary event. The disease has a significant genetic component, with up to 90% of RA patients exhibiting a shared epitope of the LLA-DR4/DR1 cluster. Although the disease is observed in children and the elderly, it typically peaks in persons between the ages of 35 and 50. Females are two to three times more likely to develop rheumatoid arthritis than are males. Smoking cigarettes or cigars increases the risk for developing rheumatoid arthritis by up to 50 percent. The prevalence rate for the disease worldwide is about 1%, and the incidence is about 3 cases per 10,000 population. Because worldwide frequency of the disease is relatively constant, it is thought that a ubiquitous infectious agent may play a causative role.

 

Non-fusion spinal surgery

One of the most exciting areas in spinal surgery today is the non-fusion area. Surgeons and engineers are creating devices that can be implanted to treatment various spine conditions without fusion, thus allowing the patient to retain at least some movement and flexibility that would otherwise be lost by fusing vertebrae together. Although fusion is still the gold standard for, for example, treatment of DDD, more and more, non-fusion products, including dynamic stabilization devices (or motion preservation devices) and total disc replacement (TDR) are becoming the treatment of choice, especially for the younger, more active patient.

Disc arthroplasty, which refers to replacement of a damaged disc with an artificial device intended to closely mimic the natural disc, is finding increased use as an alternative to spinal fusion. If it works, disc replacement seems to relieve the patient’s pain while retaining more range of motion than a fusion. The theoretical advantages have not yet been clinically proven, although biomechanical testing seems to confirm the advantages, and multicenter studies of both cervical and lumbar prostheses have shown short-term results equivalent to fusion. What is not known is whether disc arthroplasty will indeed reduce the knock-on degeneration of adjacent vertebral segments, and for how long the replacement disc will remain effective, since many potential patients are under the age of 60 years. Therefore, experts have advised physicians to inform their patients that this is still a somewhat experimental procedure and that the long term effects are unknown at this time.

Developers of Prosthetic Disc Nuclei

Developers of Prosthetic Disc Nuclei

(note: product development status of above is provided in report #M510)

Source: MedMarket Diligence, LLC; Report #M510 

There is a significant difference between nuclear disc replacement and nuclear disc arthroplasty. Nucleus replacement is similar to any other joint replacement: a damaged biological joint is removed and replaced with a manufactured device designed to imitate as closely as possible the characteristics and functions of the biological joint. However, nucleus replacement is not as simple as it may sound, because the vertebral disc is a complex, living system, and making any artificial changes to it can lead to a cascade of other conditions. Nucleus arthroplasty motion preservation technology, on the other hand, goes far beyond ‘just’ replacing a disc. It involves a comprehensive approach to the treatment of DDD, including not only the nucleus implant technology, but the criteria for appropriate patient selection, the surgical techniques and the post-op rehabilitation regimen. Some companies are developing prosthetic nuclear discs; others, such as Raymedica, are focusing upon the development of the entire nucleus arthroplasty system.

 

Spine Surgery Startups Run the Gamut of Innovation

Startups in the field of spine surgery and related technologies (neuromodulation, pain management, etc.) this decade cover a breathtaking number of new technologies seeking to address every possible improvement in restoring spine stability or preserving motion, reducing pain, reducing surgical invasivenes, improving long term outcomes and other improvements.  (Note, data in table is drawn from report #M510, published in March 2008, so does not include even newer spine companies — Spine 21, PercuFlex Corp., TransCorp Medical — or even name changes, like Raymedica to Centinel Spine.)

Spine and Other Orthopedic Company Startups

 

Company

Year founded

Area of interest
3Cor Medical, Inc.

2002
Distraction screws for plating and interbody fusions.

Allez Spine LLC

2003

Pedicle screw systems and cervical plating systems for use in spine surgery.
AOI Medical, Inc.

2005
Develops innovative orthopedic medical devices for spine and trauma markets

Archus Orthopedics

2002

Total Facet Arthroplasty System® (TFAS®), an articulating joint prosthesis.
Baxano, Inc.

2005
Tools that restore spine function and preserve healthy tissue

Cartilix, Inc.

2004

Biomaterials for repair of tissues in articular joints.
CoreSpine Technology LLC

2005
Spinal arthroplasty

Creaspine

2005

Instrumentation and devices for use in spine surgery.
Custom Spine, Inc.

2003
To create the next generation of surgeon-friendly spinal implants.

Eden Spine, LLC

2006

Motion-preserving spine therapies.
Expandis Ltd.

2002
Minimally invasive orthopedic surgery instrumentation.

Facet Solutions, Inc.

2003

Facet arthroscopy
Globus Medical, Inc.

2003
To drive significant technological advancements across the complete suite of spinal products including Fusion, MIS, Motion Preservation and Biomaterials.

IB Medical LLC

2006

Static compress device technology in spine surgery.
Innovative Spinal Technologies, Inc.

2002
Spine surgery technologies.

InteliFUSE, Inc.

2005

Shape memory technology for bone fracture fixation/fusion and bone remodeling
MI4 Spine, LLC

2006
Minimally invasive spinal instrumentation.

NBI Development, Inc.

2007

Implantable spine neuromodulation devices.
OrthoMEMS, LLC

2005
Implant systems for spine and orthopedic applications using MEMS and wireless technology.

Ouroboros Inc.

2005

Medical devices for minimally invasive spinal fusion
Paradigm Spine, LLC

2005
Non-fusion interspinous spinal implant.

PNIR (Peripheral Nerve Injury Repair), LLC

2008

Implant technologies for peripheral nerve repair.
RE Spine, LLC

2007
Intervertebral disc and facet joint prosthesis in spine surgery.

Signus Medical LLC

2004

Pioneering the introduction of new biomaterials such as PEEK-Optima®, and research into the next generation of materials
Spartek Medical, Inc.

2006
Motion preserving spine fusion implant, inserted minimally invasively, for treatment of degenerative disc disease.

Spinal Elements, Inc. (formerly Quantum Orthopedics, Inc.)

2003

Working with prominent surgeons to develop medical device technologies in the areas of spine arthroplasty (joint motion preservation) and spinal fusion.
Spine Form, LLC

2005
Medical device technology based on treatment of scoliosis.

SpineForm, LLC

2004

Spine staple
SpineFrontier, Inc.

2006
Spine implant technologies.

SpineMatrix, Inc.

2006

Spinal imaging to improve diagnosis of lower back pain.
SpineMedica Corp.

2005
Device technologies for spine and chronic back pain.

Spinus LLC

2005

Instruments for neurological, orthopedic and spine surgery.
Vertebral Technologies, Inc.

2005
Biocompatible polymers for joint restoration within the spine

Vertebron

2003

Developing several product for spinal fusion and fixation (arthrodesis), as well as new products and intellectual property (IP) that focus on motion preservation (arthroplasty) and dynamic stabilization.
Vertech, Inc.

2007
Device to ease the pain of compression fractures of the spine by separating spinal bones and injecting fast-hardening cement.

Vertiflex (fka DK Spine Technology, Inc.)

2004

Medical devices for spine surgery

 

Source:  Report #M510, Spine Surgery Worldwide.

The Spine Market: Big, Growing and Persistently Device-Intensive

[Having covered a very wide range of medical technology markets, spanning cardiology to gastroenterology, biotechs to devices and disposables/reusables/"reposables" to capital equipment, I have to note that the spine surgery market is really unique among all of them — resistant to cost containment, persistently device-oriented, and subject to tremendous innovation all the same. In some ways, spine surgery may be the last bastion of medical device development, clinging as it does to its inherent need for products that are structural in nature and therefore keeping at bay the wholesale intrusion of biotechs and pharmaceuticals. – P. Driscoll]


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.  

The total global spine surgery market includes includes devices for spinal fusion, bone graft substitutes, total disc replacement, nuclear arthroplasty (also known as nucleus replacement) vertebroplasty, kyphoplasty, interspinous process spacers and devices for image guided surgery.  The combined market will have a compound annual growth rate (CAGR) of over 14% through 2017. 

As has been the historical precedent, many devices are first launched outside of the US, primarily in the European Union, where the product approval process is less strenuous than in the US. Therefore, a number of new products, such as nucleus replacement, have sales outside of the US but no sales here, or very modest US sales due to use as an investigational or humanitarian device.

Worldwide, spinal fusion is expected to always be a tool for the orthopedic surgeon, but as a procedure it is starting to yield market share to other, more motion-preserving devices and procedures. In addition, motion-preserving technologies are filling the treatment gap between lumbar back pain treated with non-surgical means, and multi-segment spinal fusion. Motion-preserving devices also leave the option of fusion open as more of a last resort treatment, if needed. As technology advances, populations age and surgeons gain experience with new treatments, these trends are expected to continue.

In dollar terms, spine fusion revenues are expected to be flat as bone graft substitutes, total disc replacement and vertebroplasty/kyphoplasty begin to replace some spinal fusion procedures. Nucleus replacement, a market in its infancy, will also be increasing during the period covered in this study, but will remain a relatively modest sub-segment of the entire market.

Global Spine Surgery Market by Percentage and Segments, 2008-2017

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

The exhibit above shows the percent shares (by USD) of the product segments. This graph shows more dramatically the predicted shift from spinal fusion towards other technologies. One of the drivers of this trend is the desire by Baby Boomers to remain active into their later years. This means that they will be more likely to opt for a total disc replacement, for example, in order to keep spinal fusion as a more drastic, final solution if all else fails.

Another factor behind the growth of the global spine market is the increasing prevalence of obesity, especially in developed countries. Obesity puts added strains on the vertebrae and increases the rate of normal wear. While the rate of obesity seems now to be slowing in some countries, it is expected to remain a significant factor through at least 2017.
Innovation as a factor refers both to the plethora of new designs and devices being patented and produced, and the new materials under development which go into some of those devices. Critics suggest that some of these devices are a technology looking for a market. Years are usually required to conduct the testing and to obtain market approval through the FDA or other regulatory approvals such as the CE mark in the EU, or approval by the Japanese medical device authorities. Further years of surgeon experience using the new devices with patients will determine which devices are winners in the race, and which fall out of usage. Nevertheless, there are a number of start-up companies in the US and outside of the US which are working to develop devices in hopes of meeting a significant need and reaping the rewards. Patients are frequently the beneficiaries of this research and development, and hence innovation is a powerful driver of the global market.
Baby boomers, in addition to requesting spinal treatments which will allow them to return to their normal, active lifestyle, are also increasingly requesting minimally invasive or minimal access surgery. MIS device revenues are expected to increase due to this growing demand.