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 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.

Startup and early stage spine surgery companies

If there is a more robust area of medtech development — one with more success in creating clinical and market value while resisting pricing pressures — than spine surgery, I would be surprised.

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.

Early Stage / Startup Spine and Orthopedic Surgery Companies

 

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

ForSight Labs, LLC

2005

Ophthalmic device company incubator

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

Small Bone Innovations, LLC

2004

Orthopedic technology focus on small bones and joints (hand, wrist, elbow).

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:  MedMarket Diligence, Report #M510 (Worldwide Spine Surgery 2008-2017) and the Medtech Startups Database.

 

Spine surgery shift in patient caseload and technologies

In the global market for spine surgery products/technologies, there is a progressive caseload shift away from spine fusion and toward alternative technologies are less invasive, provide more flexibility in the spine, minimize pain, and/or provide other benefits.  Accordingly, 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.

This 2009 and 2017 pie charts illustrating the spine surgery market by product type 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.
 

spine-2009-2017-sm

 

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

 

Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
     
  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and their expansion to new clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are in applications too numerous to mention..
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

 

 

 

Spine surgery technologies shifting; growth in total disc replacement, interbody spacers, kypho/vertebroplasty

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.

The chart below shows the percent shares (sales) 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.

spine-market-segment-shares

Source: MedMarket Diligence, LLC; Report #M510, "Worldwide Spine Surgery, 2008-2017."

Insurer targeting low hanging fruit — spine surgeries

HealthPartners in Minnesota is planning to begin next month requiring surgeons to advise patients of less expensive alternatives to spine surgery for treatment of their low back pain. 

At $25,000 per surgery for the roughly 600 procedures it covered in 2007, HealthPartners paid $15 million for procedures that, it believes, in some cases were not not justified by the evidence.

Spine surgery is not yet the target of widespread cost-cutting initiatives by insurers, but with a growing patient population combining with minimally invasive technologies that expand the number of patients amenable to the procedure to further burden insurers, it is clear that HealthPartners’ moves will be replicated by other payers.

What will come from this will be a series of actions and reactions:

  1. the inevitable backlash by physicians against patient care being administered by CPAs.
  2. marketing campaigns by devices companies indicating high clinical efficacy of their approaches
  3. marketing campaigns by these or other device compaies indicating the lowered long term cost of their approaches
  4. responses like those noted by Dr. Kevin Pho (of kevinmd.com/blog reknown) who highlights the method by the UK’s National Health Service to get physicians to buy into reform, suggesting a similar possibility for the U.S.

These dynamics (and others spun off of them) will be the subject of debate in the U.S. over the next few years as the economy, the latent need for healthcare reform and a new administration in the White House will clearly propel reform from the abstract idea spine surgeons have previously understood to a very tangible impact on their practices and their patients’ options.


See also the MedMarket DIligence Report #M510 on Worldwide Spine Surgery.

 

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.

 

 

 

 

Products, technologies and markets in spine surgery worldwide

Below is a report from MedMarket Diligence on the worldwide market for spine surgery technologies. The report is described at link.

Spine Surgery Worldwide 2008-2017: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017

· 380 pages · 190 Exhibits · 98 Company Profiles · Report #M510 · Published March 2008

This report details the complete range of products and technologies in, spine surgery, the surgical management of spine disorders, diseases and trauma, from 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.

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 diseases and disorders of the spine, encompassing congenital disorders, inflammatory and infectious diseases; degenerative diseases; herniations, stenoses, myelopathies and other "mechanical" disorders of the spine; spinal trauma; tumors of the spine; and others. The report characterizes 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 manufacturer offerings. The report details products and technologies under development and markets for each in spine surgery. The report provides a current and forecast assessment of the worldwide markets for these technologies, with geographic segmentation by U.S. & Canada, European Union (detailing France, United Kingdom, Germany, Italy and Spain), Japan and Rest of World. The report provides emphasis on the market impact of new technologies through the coming decade, profiling nearly 100 active companies in this industry, with comprehensive detail on key companies, providing data on their current products, current market position and products under development.

(For more information, contact Patrick Driscoll, patrick at mediligence dot com, or tel: 949-859-3401.)

Asia-Pacific Markets for Spine Fusion Growing More Slowly

The markets which encompass Asia-Pacific are generally somewhat more mature markets which have seen these products and have been using these technologies. Hence, for spinal fusion, for example, the tendency away from fusion and towards intermediate treatments will be seen in the years to come.

Fusion markets in this region, at over $80 million annually in 2008, are growing at about 6% annually, but through the forecast period (to 2017), that annual growth rate will slip to only 4%.

Source:  MedMarket Diligence, Report #M510
Source: MedMarket Diligence, Report #M510

However, the non-fusion markets in this region are demonstrating annual growth in excess of 21%, illustrating the progressive displacement of traditional fusion procedures by procedures that are less invasive, result in greater mobility and have better long-term prognosis for spine patients.

 


The MedMarket Diligence report #M510 is described in detail at here. The report may be ordered online for instant download or may be ordered via Google Checkout, below.