REPORT SCOPE
INTRODUCTIONn
Most people at one point or another have experienced back pain. The pain usually lasts for only a short duration and then resolves itself with little or no medical attention. For others, however, the pain is unresolving, chronic, and severe, and may involve neurological symptoms, including radiating pain or numbness down an arm or leg. For these relatively few sufferers, surgical intervention may be necessary.
As individuals age, the effects of wear and tear on the body accumulate. This is true of the spine. Degenerative changes, not a single traumatic blow, are the cause of most cases that result in spinal surgery. These degenerative changes can be evidenced radiographically in nearly all people, although only a small percentage of these changes will produce symptomatic conditions. The world’s population is aging at an unprecedented rate, and as this continues, the rate of degenerative spinal conditions is also expected to escalate.
Surgical treatment of spinal conditions has been marred in controversy. Fusion, a treatment largely abandoned by other orthopedic disciplines because of the resulting limited range of motion, is still the treatment of choice for spinal surgical intervention. Innovation in both devices and techniques in spine surgery was largely stagnant in the 1980s and early 1990s. Technological advances in both surgical approaches and spinal implants, however, are once again flourishing, making spine the fastest-growing segment of the global orthopedics market.
This growth, although driven in part by escalating procedural volume, is also the result of excitement in emerging technologies in the non-fusion, or motion-preservation, segment. Initial euphoria has been dampened both by hardware durability issues and reimbursement challenges, but hope persists that the motion preservation market will drive future expansion in the spine industry through positive patient outcomes and economic efficiencies resulting from less-invasive surgeries. Biologics is another rapidly evolving segment of spinal orthopedics that is garnering great enthusiasm. Its growth prospects are high for making current techniques more effective and possibly altering the future landscape of spine surgery with the creation of technologies that actually regenerate spinal components.
STUDY GOALS AND OBJECTIVES
The technologies in this report—implantable spinal prosthetics and hardware—are pivotal to improving the quality of life for the tens of millions worldwide who suffer from back pain and neurological deficit resulting from common spinal conditions. Advances in these devices and their implantation techniques can improve the cost benefit of treatment of spinal conditions.
The objectives of this report are to present a comprehensive analysis of the market for these orthopedic products and forecast their commercial potential through 2015.
This report will:
- Assess the prevalence of common spinal conditions and trends affecting their projected future incidence
- Examine current procedure volumes and associated expenditures, as well as projected increases in demand by technique
- Analyze the current market and forecast demand for implantable spinal surgical devices
- Describe the regulatory framework and its effect on the introduction of new devices into the spinal market both in the U.S. and abroad
- Analyze trends in patent applications and issued patents for innovations that will be altering the spinal marketplace
- Examine the drivers that will affect future utilization and rate of adoption of the implants, including demographic changes, reimbursement policy, clinical considerations, and R&D
- Identify the product manufacturers that will drive innovation, their market share, and other industry players
REASONS FOR DOING THE STUDY
The world’s population is aging at an unprecedented rate. Aging populations face increased rates of arthritic and degenerative conditions. This trend is particularly pronounced upon examination of the prevalence of back pain and underlying spinal conditions.
The convergence of the following trends represents the motivation for this report:
- The worldwide growth of the senior population will strain the capabilities of healthcare providers and the financial resources of healthcare payers.
- Patients are increasingly less likely to accept “aging pains” as they wish to maintain a more active lifestyle even with advancing age.
- Obesity, which is also increasing globally, will similarly contribute to higher rates of back pain and degenerative conditions.
- Advances in biologics, materials, imaging techniques, and the biomechanical understanding of the spine will enable treatment of spinal conditions with a focus on preservation of natural range of motion.
- To contain costs while simultaneously facing an increased procedural volume, focus is shifting toward improving instruments and techniques to reduce the invasiveness of surgery, thereby shortening hospital stays and hastening recovery.
- Increased focus is being placed on the cost benefit of surgical procedures and implants.
SCOPE OF REPORT
This report is a business analysis that has the primary purpose of examining trends in the market for spinal surgical devices, specifically arthroplasty products and implanted instrumentation hardware. The report includes sections on the following topics:
- Current prevalence of common spinal problems, trend analysis, and factors influencing future incidence
- Market analysis by surgical procedure, including annual incidence, trend analysis, and factors influencing future predicted surgical volume
- Global demand by device and projected future trends by device category
- Risk factors and other drivers that will affect the future incidence of spine surgery and related utilization of spinal surgical devices
- U.S. and international regulation of spinal devices
- Patent analysis
- Market share and information on key device manufacturers
INTENDED AUDIENCE
This report is intended for anyone interested in better understanding the role of the rapidly growing spine segment of the broader orthopedic and biologic markets. Executives, consultants, trade associations, and marketing professionals in the medical device industry, health insurance industry, orthopedics and biologics fields, and ambulatory surgery and broader hospital sector would benefit from this report. Additionally, stock analysts, VC funders, and investors focused on the spine segment or those who are interested in expanding markets for orthopedic implants, minimally invasive surgical instrumentation and techniques, and biologic applications would also benefit. Manufacturers and distributors of the technology discussed in this report are also an intended audience.
INFORMATION SOURCES
BCC Research reviewed reports, white papers, technical product specifications, and studies produced by industry, trade associations, corporations, professional organizations, payers, governments, healthcare providers, and peer-reviewed journal articles. Various original data sources were analyzed. Data were compiled from the U.S. Census Bureau, U.S. Patent and Trademark Office, the Department of Health and Human Services, and sub-agencies, including the FDA medical device data registry, CMS, AHRQ, CDC, and the National Center for Health Statistics. International data sources included WHO, OECD, Eurostat, Spine Tango, and databases from various countries’ federal statistics offices. Interviews were conducted with industry sources, consultants, manufacturers, surgeons, and researchers.
ANALYST CREDENTIALS
Lori Solomon is a freelance medical reporter. She co-authored the BCC market research report Technologies for Long-term Care and Home Healthcare: Global Markets (HLC079A).
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DISCLAIMER
The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal, or accounting advice; nor should it serve as a corporate policy guide, laboratory manual, or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or its use.
