In many Western markets, spine surgery represents a mature market, with significant penetration of potential patients and caseload. Manufacturers have been able to produce innovations that have been able to command respectable premiums for a long time, and while they still represent some of the strongest growth rates in medical technology, overall revenue growth rates in spine surgery have been squeezed by procedure limitations and pressure on pricing.
Not so much the case in Asia/Pacific, Central/Latin America, and markets elsewhere in the world, where double digit spine surgery growth rates are the evident now, and will continue for the near future.
Below is illustrated the top growth (2014-2021) combinations of technologies and regional markets in spine surgery, in descending order.
The MedMarket Diligence report, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021” (link), 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 the current and forecast market to 2021, by region/country, of procedures and manufacturer revenues.
Minimally invasive implants
Geographic market detail:
North America — United States, Canada
Europe — Germany, France, Spain, Italy, United Kingdom
Asia/Pacific — Japan, India, China
Central and Latin America
Rest of World
Selected (published report includes over 100 companies) list of companies included in the report:
Advanced Spine Fixation Systems Inc
Alphatec Spine (Scient’x Groupe S.A.)
Beijing Montagne Medical Device Co.
Biedermann Motech GmbH & Co. KG
BIOTEK – Chetan Meditech Pvt. Ltd
Bonovo Orthopedics Inc
Dieter Marquardt Medizintechnik GmbH
ESKA Implants AG
Japan Medical Dynamic Marketing (MDM) INC
Kyocera Medical Corporation
Medtronic Spinal and Biologics
Medyssey Spine Ltd (Zimmer)
Nakashima Medical Co. Ltd
Norer Medical Group (Xinrong Best Medical Instrument Co. Limited)
Onur MEDiKAL San. Ve Tic Ltd. Sti.
Orthopaedic & Spine Development
Seohancare co. ltd
Ulrich GmbH & Co.KG
Wright Medical Technology
For complete details on this report, including ordering online, see link.
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.
(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)
Medtech manufacturers interested in “growth” markets need to consider the relative versus absolute. Nascent markets can growth from $1 million sales in year 1 to $2 million in year 2, obviously a 100% increase. But in multi-billion markets, a $1 million increase will elicit a yawn from all but the smallest manufacturers.
Just as an exercise, I ranked the growth rates for sales of wound closure products detailed in our Report #S192 by both the absolute sales growth from 2014 to 2018 and the compound annual growth rate over this period. To reveal the differences even further, I ranked all combinations of geographic area and wound closure product type. Partial results — just the top growth rankings, since the list is too long to show all — are shown side by side below (click on the chart to see a more legible version).
Wound Closure Sales Growth, Absolute and Relative, 2014-2018
Advanced technologies are frequently developed in well developed economies, then migrate to other economies over time. Consequently, relatively new technologies tend to be more dominant in the well developed economies while relatively old technologies tend to be more dominant in the developing economies.
Case in point, surgical sealants for wound management versus surgical tapes, the former relatively new (and advanced) and the latter relatively old.
Aside from demonstrating clinical utility in wound sealing and closure on their own, sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.
Sales of surgical sealants and glues have become as common in some surgical procedures as sutures and staples in well developed markets (U.S., Europe and Japan), but their use continues to expand in both stand alone and adjunctive use with other wound closure. Emerging markets, especially in Asia will drive nearly double these growth rates. All told, the global surgical sealants and glues market will eclipse $2 billion by 2018 on compound annual growth of 9.4%.
Drawn from our recent report on the global market for wound closure products, Report #S192, the distribution of the technologies on the market now, and in the future, for wound closure encompassing sutures & staples, tapes, hemostats, sealants & glues and vascular closure devices reveals the continued migration of advanced technologies (vascular closure, hemostats, glues & sealants) from western economies to the developing markets. Simultaneously, the more well established technologies (tapes, sutures & staples) are showing modest growth in western economies and robust growth in developing economies.
Below are illustrated the percentage of total worldwide market for each wound closure technology type by country/region.
Technologies emerge, gain clinical acceptance, grow in caseload and become the standard of care. Then new technologies emerge, developed to improve on or eclipse established technologies. They gain acceptance and the cycle continues.
The pace of technology and market development in the products used in wound closure — sealants, glues, hemostats, sutures/staples, tape, and vascular closure devices — follow this path as characteristically as any medtech market. However, the pace of adoption varies both by technology type and geographic location. Consequently, there is a pretty wide range of compound annual growth rates in the sales of these product globally, regionally and by country.
Below illustrates the highest growth segment-geography combinations in the wound closure market. This frequently illustrates that novel technologies more rapidly penetrate well developed economies, which can sustain the initial high premium pricing of novel technologies, then progressively migrate to less well developed economies. (For the sake of direct comparison, the high and low growth graphics are shown on the same scale.)
Wound closure is a critical element of the overall wound management process. Indeed it is the most critical step in the sense that, if not accomplished promptly and effectively, can result in adverse outcomes ranging from chronic wound formation, infection and, unfortunately, death.
Sealants and glues have become an entrenched, though not dominant, aspect of routine clinical practice in wound closure. These technologies have demonstrated efficacy that has warranted their use independent of other closure technologies, such as traditional sutures and staples, or as adjuncts to them, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.
Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.
Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.
These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.
It is useful to categorize surgical sealants, glues, and hemostats on the basis of their primary components and/or their intended use. The market for these products can be broken down (and has been done so in report #S192) by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.
The global market for products in wound closure is comprised of large, well established, and relatively low growth segments like sutures/staples; the low volume, low growth segments like surgical tapes; and the smaller, higher growth segments like vascular closure, hemostats, and surgical sealants/glues:
Growth and Size of Major Wound Closure Market Segments
Sales ($millions) are 2014; Growth is CAGR 2013-2018.
Source: MedMarket Diligence, LLC; Report #S192 (published October 2014).
The MedMarket Diligence report #S192, “Worldwide Market for Surgical Sealants, Glues, and Wound Closure, 2013-2018: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples, vascular closure, hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The Report provides full year actual data from 2013 and, for available companies, quarterly data from 2014. The report provides a worldwide forecast to 2018 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.