Brett McKitterick and Kamran Zamanian
The relative maturity of the large hip and knee markets has prompted medical device manufacturers to look for alternative sources of growth. Unlike the proven treatments that these market segments offer, solutions often do not exist for some aliments of the small joints, leaving the door open for device innovation.
The U.S. small joints market combines reconstructive implants for the small joints of the hands, wrists, feet, and ankles, as well as the plates, screws, and external fixation devices used during trauma surgery. The relatively easy regulatory pathway for introducing new devices to these markets has allowed new entrants to gain a foothold.
|2014 U.S. small joint market growth rate by segment.|
Thus, by the end of 2014, this market segment is projected to grow to $2.5 billion, according to a report published by iData Research Inc. (www.idataresearch.com) titled “The 2015 U.S. Small Bone and Joint Orthopedic Market.” Nevertheless, total joint replacement technologies have experienced slower innovation because of the associated costs and the time required for product introductions—a result of the long FDA approval process.
Reversed Devices and Shoulder Reconstructions
The nearly double-digit growth of the shoulder market in recent years is primarily the result of the increased use of reversed shoulder devices. Thousands of reversed devices will be implanted in the United States in 2014 to treat glenohumeral arthritis and proximal humeral fractures. The uptick in such implantations can be attributed to the fact that revered devices are widely indicated, including for patients suffering from massive rotator cuff tears. In such instances, the deltoid is surgically attached to the implant, providing strength for arm motion.
The average selling price of shoulder devices has declined across the board as procedural growth has placed a wider spotlight on them. However, reversed devices and associated revision products remain expensive, costing more than $9000.
In Europe and Canada, the implantation of stemless devices has expanded. Because they offer a less-invasive approach to shoulder surgery, the market for these devices is also expected to grow in the U.S. by 2016. The introduction of stemless products is expected to erode the market for anatomical and hemi shoulder implants. As the market continues to mature, the shoulder market may consolidate around reversed, revision, and stemless devices.
Trauma Procedures Drive Elbow Repairs
Because elbows are less prone to osteoarthritis than other joints, the elbow repair market consists primarily of devices used in trauma procedures. Numbering approximately 25,000 in the United States, the most common devices are plate and screw systems. Low-profile devices, these products are designed to be anatomically formed and can be affixed using screws that lock at variable angles. Growth in this market sector is mainly associated with population increases and with falls among the expanding aging population that result in severe fractures of the olecranon and distal humerus.
The fastest growing elbow repair segment produces radial head implants, which are used to treat fractures of the proximal radius. Device innovations in this sector include pyrocarbon products offered by Integra LifeSciences and a two-piece radio capitellum system designed by Small Bone Innovations, now a part of Stryker.
Wrist Fusions: The Gold Standard
Like elbow repairs, most hand and wrist procedures are associated with trauma. However, rheumatoid and posttraumatic arthritis also contribute to wrist issues. The wrist repair market is growing moderately, led by wrist fusions, ulnar head replacements, and external fixations.
Wrist replacements are not as necessary as ankle, shoulder, or elbow replacements because they are less critical for daily motion. Because total wrist replacements involve 12 different bones and are complex and difficult, less than 500 such procedures are conducted annually in the United States. In contrast, wrist fusions maintain digital functioning. As a result, wrist fusion devices are the second fastest growing market segment in the small-bone area, with a projected compound annual growth rate through 2021 in the double digits.
The distal radius plate segment is expected to represent nearly 70% of the hand and wrist market by the end of 2014. Because falls on outstretched arms are very common among an aging population, the implantation of distal radius plates is increasing. Such devices are usually implanted on the palmar side of the radius, reducing soft-tissue disruption.
Growth in the Foot and Ankle Market
The foot and ankle market in the United States has experienced the largest growth in the small-joint segment and is projected to post a 7.8% increase in 2014 alone. Success in this segment stems from increased attention from large players and new arrivals to the market. For new competitors, the foot and ankle market is easier to enter than other segments because it is easier to gain device approvals and less costly to introduce screw or digit implants. However, with only five players, the market for total ankle replacements remains tight.
Despite the barriers preventing entry into the total ankle replacement segment, this segment is the fastest growing part of the foot and ankle market. It is growing for two reasons. First, replacements—in contrast to fusions—enable patients to move their ankles, and second, the replacement devices themselves are considered efficacious, heightening public confidence in them.
Education has also contributed to the overall growth of the foot and ankle market—reflected in the increasing number of podiatrists that can perform such procedures and in growing public awareness that there are options for treating such conditions as hammertoe and bunions. For example, approximately, 60 million people in the United States suffer from hammertoe deformities. However, while most cases are treatable nonsurgically, many people are unaware of surgical options. The shift from simple K-wire devices to hammertoe implants with a higher average selling price will drive double-digit growth in this segment through 2021.
Nickel-Infused Staple Fixation Takes Over
Surgical staples used in bone fixation procedures are available in either titanium or nitinol, a titanium-nickel alloy that can change shape depending on temperature. Essentially, staples made from nitinol compress a bone osteotomy with greater and more reliable force than do titanium staples. In fact, one study indicates that titanium staples may cause a distractive force-inhibiting fusion.
Thus, nitinol-based devices are rapidly eclipsing standard titanium devices. The market is favoring nitinol because temperature-sensitive nitinol staples improve bone fusion. The material is also being explored for use in fusing digits of both the hand and foot. Among the companies offering three- and four-pronged staples used in carpal fusions is BioPro Implants.
Focused Players Gain Share
|DePuy Synthes continues to lead the U.S. small joints market, although its lead in the shoulder, elbow, hand and wrist, and foot and ankle markets has been shrinking slowly in recent years.|
There is a strong overlap of trauma products in the small joints market, allowing companies that perform well to leverage their reputations, distribution networks, and experience. Thus, DePuy Synthes continues to lead the U.S. small joints market, although its lead in the shoulder, elbow, hand and wrist, and foot and ankle markets has been shrinking slowly in recent years—a decline that is expected to continue. In part, this decline can be attributed to companies’ increased focus in defined markets. Companies that have experienced focused growth include DJO Surgical in the shoulder reconstruction market, Acumed with its plate systems in the elbow and hand and wrist market, and Stryker with its Memometal line of staples.
In the foot and ankle market, Wright Medical has performed well after selling its Ortho Recon hip and knee business to MicroPort. Meanwhile, the company has steadily increased its share in the foot and ankle space and is on a path to become the market leader.
Other strong performers in the U.S. joint market include Biomet and Stryker, which can leverage their distribution networks and trauma experience. The close of Zimmer’s purchase of Biomet in the first quarter of 2015 for $13.35 billion should enable the company to follow behind DePuy Synthes, if not lead the U.S. small joints market.
Collectively, the small joints market in the United States has experienced and will continue to experience steady growth. Shoulder reconstructions using reversed implants and total ankle replacements using foot and ankle devices will lead the market. In all categories, opportunities in this dynamic sector abound for marketing a range of technologies, from stemless shoulder devices and total wrist replacements to hammertoe and bunion devices and nitinol-based fusion products.
Brett McKitterick is a market research analyst at Vancouver, BC–based iData Research Inc. and was the lead researcher for the 2015 U.S. Small Bone and Joint Orthopedic Devices Market report. Currently, he leads research on U.S. orthopedic biomaterials. He received a BS degree in biology, coupled with a commerce minor, from the University of British Columbia. Reach him at [email protected]
Kamran Zamanian is the founding partner, president, and CEO of iData Research Inc. He has more than 25 years of experience in international medical device, pharmaceutical, and dental sales; marketing research; business development; product development; and general and executive management. He has worked with fortune 500 companies in the United States, Canada, Germany, the UK, France, Spain, Italy, Poland, Japan, China, South Korea, Australia, Brazil, and Mexico. Reach him at [email protected]