Orthopedic device companies faced familiar challenges in 2018. Payors, regulators and customers are demanding better clinical and economic outcomes, while legacy product lines are becoming commoditized and price erosion is impacting all segments of the orthopedic market. These pressures promise to be part of the orthopedic landscape for the foreseeable future, and in 2018 many companies refined their strategies to deal with the ongoing transformation of healthcare. Results were mixed among the largest companies as some stumbled operationally, while others overperformed, due in part to early adoption of technology and entry into high-growth segments.
Common strategic themes present in 2018 that will continue as part of the industry’s narrative in 2019 and beyond include connected ecosystems of products, flagship technology (e.g. robotics), portfolio-wide pull through and a growing shift to outpatient procedures.
Large companies are racing to build a connected ecosystem of products with a flagship technology, whether robotic or software-based, at its core. These systems aim to provide comprehensive solutions throughout the episode of care and offer the surgeon tools to improve procedure flow through analytics and pre-op planning; reduce waste; enable predictable, repeatable clinical outcomes and monitor patient rehabilitation. These ecosystems allow orthopedic companies to monopolize operating rooms and increase the disruptive cost of customers switching to other providers. Flagship technologies, particularly robotics, have been shown to be a significant factor in generating improved sales mix as they facilitate implant upselling and portfolio-wide pull through.
“Pulse is a foundational component of our end-to-end solution to not only enable predictable clinical and economic outcomes, but also pull through innovative procedural solutions to create market stickiness and increase the cost of disruption of switching to another provider.” –Chris Barry, NuVasive CEO
As the ecosystem strategy creates opportunities to take market share and improve sales mix, companies strive to be ready with a robust portfolio of up-to-date implants. Many players will pursue aggressive product launch cadences in 2019. Those with strong balance sheets may opt to buy their way into a differentiated product line, as we saw with Stryker’s acquisition of K2M and Smith & Nephew’s tuck-in acquisitions of Brainlab’s joint recon business, Ceterix Orthopaedics and Osiris Therapeutics in 1Q19.
A focus on outpatient centers offers an alternate growth vector for companies that either lack the resources to develop or purchase a robotics solution, or feel like the significant capital investment required of robotics is not a good fit for their customers. Like robotics, selling strategies for ambulatory surgery centers (ASCs) or hospital outpatient centers is a relatively new endeavor for orthopedic companies. Outpatient procedures, particularly in the U.S., are expected to grow rapidly as surgeons and ASCs demonstrate evidence of safety and efficiency and payors provide favorable reimbursement. Device company leadership has voiced some uncertainty about the rate of growth. Some surgeons have shared that they’ve received pushback from hospital administrators to not move procedures to an outpatient setting due to lower reimbursement. It’s largely expected that payors will align with the outpatient movement, and once that happens, procedures will move. Companies focusing in this area now will develop advantages over competitors as they’re able to refine outpatient-specific selling strategies.
Wright Medical CFO Lance Berry recently summarized the nuances of selling to outpatient centers, saying, “The cost of the product is part of it, but also, how do they keep their O.R.s full? That’s their biggest cost. And how do they attract the type of procedures and patients that they want to fill up the O.R.? What can you do to help them with their efficiency? And then they want options, and they’re willing to pay fine gross margins for the different options, but they may want a lower-cost option and a higher-cost option that they will make some decisions around. So, it’s not as simple as price.”
Looking deeper at market performance, Exhibit 1 details product segment sales, while Exhibit 2 shows market share by segment.
Exhibit 1: Product Segment Performance: 2018 vs. 2017 ($Millions)
Exhibit 2: 2018 Orthopedic Product Sales by Market Segment
The spine, knee and hip segments account for just over half the total market and grew slightly slower than the market total. These are mature segments where many legacy product lines have become commoditized in a crowded market. They are ripe for innovation and companies are shifting their focus to higher-growth areas within those segments, as we’re seeing with cementless knees and artificial discs.
Trauma and sports medicine benefit from increasing demand due to patient demographics. The older patient population continues to grow, while younger patients continue to be more educated about their healthcare choices and seek faster return to active lifestyles.
Orthobiologics faced a difficult 2018 due to payor and regulatory pressures that drove prices down, particularly in the U.S. Many companies observed increased volume in this segment, though not enough to offset eroding prices.
Against this backdrop of market dynamics, Exhibit 3 shows the 2018 performance of companies while Exhibit 4 shows market share for each company.
Exhibit 3: Product Segment Performance: 2018 vs. 2017 ($Millions)
Exhibit 4: 2018 Market Share: Top-Tier Players and All Others
Seven companies, or top-tier players as they’re referred to in this article, each posted over $1 billion in revenue last year and control 67% of the orthopedic market. Revenue growth performance among top-tier players was uneven compared to the market average.
DePuy Synthes and Zimmer Biomet account for 31% of the total market, but they struggled with operational and regulatory challenges. Both companies lost about 1% share compared to 2017. It may be worth noting, from an organizational philosophy perspective, that Johnson & Johnson CEO Alex Gorsky omitted orthopedics from his comments on the most vital aspects of healthcare in his fourth quarter earnings conference call. Zimmer Biomet has made progress in their distribution and financial recovery efforts, but is still targeting 2020 as their return to market growth.
Stryker was the primary beneficiary of DePuy Synthes’ and Zimmer Biomet’s share losses, gaining 1% of total market share in 2018. Stryker, NuVasive and, according to our estimates, Arthrex were able to leverage differentiated products and solid execution to navigate the market.
“The fact is, one of the biggest contributors to mix benefit inside of the space that we play is robotics.” –Bryan Hanson, Zimmer Biomet CEO
A common trait among the top-tier players is their investment in robotics, through internal development or by acquisition. DePuy Synthes, Medtronic, NuVasive, Smith & Nephew, Stryker and Zimmer Biomet all have robotic elements that can serve as the centerpiece of their product ecosystems. While not a robot, Arthrex’s Synergy Matrix system functions as the focus of its operating room platform.
The next tier of companies, those in the $400 million to $999 million range shown in Exhibit 5, all grew above the market average. Globus Medical and Wright Medical grew in the double digits, as they seem to have reached a near-optimal inflection point of size and flexibility. Both companies also have marquee- enabling technologies as part of their ecosystems that can drive sales. Wright Medical has had success with their PROPHECY and BLUEPRINT software suites, while Globus Medical is generating product pull through with their ExcelsiusGPS robotics platform.
Exhibit 5: 2018 Orthopedic Performance: Players Between $400MM and $999MM ($Millions)
To add context to growth performance, particularly that of companies with high single- or double-digit percentage increases, we’ve overlaid percentage and absolute revenue growth versus 2017. Exhibit 6 shows the relationship between absolute revenue growth and percentage growth for each. Arthrex, Globus Medical, NuVasive and Wright Medical all had percentage growth well above the market rate.
Exhibit 6: Growth Rates for 10 Largest Companies
However, Stryker’s performance is truly eye-catching as they were able to achieve high percentage growth on a $420 million revenue increase, more than two times greater than the next highest revenue increase. We expect Stryker to carry this momentum forward and, based on guidance provided in 4Q18, surpass Zimmer Biomet in 2019 for total orthopedic revenue.
Exhibit 7 details performance of companies between $100 million and $399 million in revenue.
Exhibit 7: 2018 Orthopedic Performance: Players Between $100MM and $399MM ($Millions)
Companies in the $200 million to $399 million tier were dragged down by orthobiologic companies Sanofi (-19.1%) and Seikagaku (-8.1%). Those two saw a combined $117 million revenue reduction compared to 2017. By excluding those two companies, we get a tier growth rate of 5.5%, far more in line with what we expect to see from smaller players.
Medacta, a standout performer in this tier, was able to drive double-digit growth by effectively selling in outpatient centers. The company emphasized its Propel Same Day Surgery Initiative, which includes single-use instruments and a suite of patient services. This strategy is a good fit for outpatient procedure operators who aim to increase daily case volume without additional overhead.
In the $100 million to $199 million tier, companies generally grew well above the market rate as they benefitted from share loss among larger competitors, addressed gaps in their portfolios and moved into new geographic territories. SeaSpine, for example, pursued an aggressive launch cadence in 2018 which bolstered their portfolio and helped them attract higher quality, exclusive distributors. Amplitude Surgical, a French player, made strides towards commercializing their knee and hip products in the U.S.
Integra LifeSciences is an outlier in this tier, as shortfalls in their trauma revenue caused them to slip just below $100 million. Benefits from the realignment of their Extremity Orthopedics team are taking longer than expected to materialize while the salesforce looks to reestablish relationships with surgeons. However, based on their provided guidance, we expect Integra to be back over the $100 million threshold again in 2019.
Corin is an outlier of another type in this tier. In March 2019 they acquired OMNI, makers of the knee robotics platform called OMNIBotics. Combined with their existing Optimized Positioning System for hips, the acquisition gives Corin an arsenal of technology possessed by few other players in this tier and allows them to implement the ecosystem strategy common among top-tier players.
Geographically, the U.S. accounted for 62% of all orthopedic revenue, while EMEA totaled 24%. Asia Pacific and the rest of the world were 9.3% and 4.7%, respectively. Compared to previous years, the proportion of U.S.- and Asia Pacific-derived revenue increased while EMEA decreased. European markets were challenging for top-tier companies in 2018, particularly the U.K. and Germany, where issues like regulatory pressure and sales leadership turnover presented headwinds. We expect that Europe will continue to challenge orthopedic companies as they determine which products to keep on the market under the stringent Medical Device Regulation, which is to be enacted in 2020.
To no surprise, a general theme was the success of emerging markets in 2018, particularly those in Asia. Despite seasonal volatility, these markets allow companies to access new patient populations with legacy products and smaller capital investments. Zimmer Biomet’s Asia Pacific sales have overperformed for several quarters relative to their overall growth. Seikagaku, facing significant hurdles in the U.S., was able to successfully expand into rural and urban areas of China.
Japan and China figure prominently in the international strategies of many companies. Stryker, for instance, is laying the groundwork for future sales by building a training center in Hong Kong in anticipation of significant uptake of Mako in the region starting in 2020.
While top-tier players seek to expand internationally, smaller European companies are pushing hard to gain a foothold in the U.S. Amplitude Surgical performed its first U.S. knee implant procedure in September 2018, and soon after, Scandinavian company Episurf celebrated achieving their long-sought milestone of receiving an FDA Investigational Device Exemption for their Episealer knee implant. ulrich medical continues to launch new products in the spine market, generating double-digit growth in the U.S.
Looking ahead to 2019, we’re projecting orthopedic market growth of 3.5%, a slight reduction to our projections from last year. The struggles of DePuy Synthes and Zimmer Biomet, and to a lesser extent Medtronic, are felt industry-wide. The spine, knee and hip segments represent more than half of the total orthopedic market, and the growth rates of all three have decelerated. The increased procedure volumes observed by some companies in 2018 were due, in part, to a strong economy in which more people had healthcare coverage and disposable income for elective procedures. As the economy slows or faces a downturn, some portion of that increased volume will vanish.
These pressures are not new to orthopedic companies, however, and in 2018 many companies refined their strategies to attain success amid a transforming market. The proliferation of flagship technologies like robotics and navigation as the centerpiece of a connected product ecosystem, as well as the adoption of outpatient selling strategies and product mix, will be the story of the orthopedic industry in 2019 and beyond. The most successful companies will continue to iterate on both their enabling technologies and implantable devices while supporting them with a robust, ongoing pipeline of clinical research.
Medium to small players will also continue to seek higher quality distributors through innovative products and robust portfolios. They’ll seek more control over market access and product pricing by driving exclusivity among their distributors.
Mike Evers is ORTHOWORLD’s Market Analyst.
Orthopedic industry revenue reached $51 billion worldwide in 2018 and grew 3.5% over 2017, according to our estimates published in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.
Orthopedic device companies faced familiar challenges in 2018. Payors, regulators and customers are demanding better clinical and economic outcomes, while legacy...
Orthopedic device companies faced familiar challenges in 2018. Payors, regulators and customers are demanding better clinical and economic outcomes, while legacy product lines are becoming commoditized and price erosion is impacting all segments of the orthopedic market. These pressures promise to be part of the orthopedic landscape for the foreseeable future, and in 2018 many companies refined their strategies to deal with the ongoing transformation of healthcare. Results were mixed among the largest companies as some stumbled operationally, while others overperformed, due in part to early adoption of technology and entry into high-growth segments.
Common strategic themes present in 2018 that will continue as part of the industry’s narrative in 2019 and beyond include connected ecosystems of products, flagship technology (e.g. robotics), portfolio-wide pull through and a growing shift to outpatient procedures.
Large companies are racing to build a connected ecosystem of products with a flagship technology, whether robotic or software-based, at its core. These systems aim to provide comprehensive solutions throughout the episode of care and offer the surgeon tools to improve procedure flow through analytics and pre-op planning; reduce waste; enable predictable, repeatable clinical outcomes and monitor patient rehabilitation. These ecosystems allow orthopedic companies to monopolize operating rooms and increase the disruptive cost of customers switching to other providers. Flagship technologies, particularly robotics, have been shown to be a significant factor in generating improved sales mix as they facilitate implant upselling and portfolio-wide pull through.
“Pulse is a foundational component of our end-to-end solution to not only enable predictable clinical and economic outcomes, but also pull through innovative procedural solutions to create market stickiness and increase the cost of disruption of switching to another provider.” –Chris Barry, NuVasive CEO
As the ecosystem strategy creates opportunities to take market share and improve sales mix, companies strive to be ready with a robust portfolio of up-to-date implants. Many players will pursue aggressive product launch cadences in 2019. Those with strong balance sheets may opt to buy their way into a differentiated product line, as we saw with Stryker’s acquisition of K2M and Smith & Nephew’s tuck-in acquisitions of Brainlab’s joint recon business, Ceterix Orthopaedics and Osiris Therapeutics in 1Q19.
A focus on outpatient centers offers an alternate growth vector for companies that either lack the resources to develop or purchase a robotics solution, or feel like the significant capital investment required of robotics is not a good fit for their customers. Like robotics, selling strategies for ambulatory surgery centers (ASCs) or hospital outpatient centers is a relatively new endeavor for orthopedic companies. Outpatient procedures, particularly in the U.S., are expected to grow rapidly as surgeons and ASCs demonstrate evidence of safety and efficiency and payors provide favorable reimbursement. Device company leadership has voiced some uncertainty about the rate of growth. Some surgeons have shared that they’ve received pushback from hospital administrators to not move procedures to an outpatient setting due to lower reimbursement. It’s largely expected that payors will align with the outpatient movement, and once that happens, procedures will move. Companies focusing in this area now will develop advantages over competitors as they’re able to refine outpatient-specific selling strategies.
Wright Medical CFO Lance Berry recently summarized the nuances of selling to outpatient centers, saying, “The cost of the product is part of it, but also, how do they keep their O.R.s full? That’s their biggest cost. And how do they attract the type of procedures and patients that they want to fill up the O.R.? What can you do to help them with their efficiency? And then they want options, and they’re willing to pay fine gross margins for the different options, but they may want a lower-cost option and a higher-cost option that they will make some decisions around. So, it’s not as simple as price.”
Looking deeper at market performance, Exhibit 1 details product segment sales, while Exhibit 2 shows market share by segment.
Exhibit 1: Product Segment Performance: 2018 vs. 2017 ($Millions)
Exhibit 2: 2018 Orthopedic Product Sales by Market Segment
The spine, knee and hip segments account for just over half the total market and grew slightly slower than the market total. These are mature segments where many legacy product lines have become commoditized in a crowded market. They are ripe for innovation and companies are shifting their focus to higher-growth areas within those segments, as we’re seeing with cementless knees and artificial discs.
Trauma and sports medicine benefit from increasing demand due to patient demographics. The older patient population continues to grow, while younger patients continue to be more educated about their healthcare choices and seek faster return to active lifestyles.
Orthobiologics faced a difficult 2018 due to payor and regulatory pressures that drove prices down, particularly in the U.S. Many companies observed increased volume in this segment, though not enough to offset eroding prices.
Against this backdrop of market dynamics, Exhibit 3 shows the 2018 performance of companies while Exhibit 4 shows market share for each company.
Exhibit 3: Product Segment Performance: 2018 vs. 2017 ($Millions)
Exhibit 4: 2018 Market Share: Top-Tier Players and All Others
Seven companies, or top-tier players as they’re referred to in this article, each posted over $1 billion in revenue last year and control 67% of the orthopedic market. Revenue growth performance among top-tier players was uneven compared to the market average.
DePuy Synthes and Zimmer Biomet account for 31% of the total market, but they struggled with operational and regulatory challenges. Both companies lost about 1% share compared to 2017. It may be worth noting, from an organizational philosophy perspective, that Johnson & Johnson CEO Alex Gorsky omitted orthopedics from his comments on the most vital aspects of healthcare in his fourth quarter earnings conference call. Zimmer Biomet has made progress in their distribution and financial recovery efforts, but is still targeting 2020 as their return to market growth.
Stryker was the primary beneficiary of DePuy Synthes’ and Zimmer Biomet’s share losses, gaining 1% of total market share in 2018. Stryker, NuVasive and, according to our estimates, Arthrex were able to leverage differentiated products and solid execution to navigate the market.
“The fact is, one of the biggest contributors to mix benefit inside of the space that we play is robotics.” –Bryan Hanson, Zimmer Biomet CEO
A common trait among the top-tier players is their investment in robotics, through internal development or by acquisition. DePuy Synthes, Medtronic, NuVasive, Smith & Nephew, Stryker and Zimmer Biomet all have robotic elements that can serve as the centerpiece of their product ecosystems. While not a robot, Arthrex’s Synergy Matrix system functions as the focus of its operating room platform.
The next tier of companies, those in the $400 million to $999 million range shown in Exhibit 5, all grew above the market average. Globus Medical and Wright Medical grew in the double digits, as they seem to have reached a near-optimal inflection point of size and flexibility. Both companies also have marquee- enabling technologies as part of their ecosystems that can drive sales. Wright Medical has had success with their PROPHECY and BLUEPRINT software suites, while Globus Medical is generating product pull through with their ExcelsiusGPS robotics platform.
Exhibit 5: 2018 Orthopedic Performance: Players Between $400MM and $999MM ($Millions)
To add context to growth performance, particularly that of companies with high single- or double-digit percentage increases, we’ve overlaid percentage and absolute revenue growth versus 2017. Exhibit 6 shows the relationship between absolute revenue growth and percentage growth for each. Arthrex, Globus Medical, NuVasive and Wright Medical all had percentage growth well above the market rate.
Exhibit 6: Growth Rates for 10 Largest Companies
However, Stryker’s performance is truly eye-catching as they were able to achieve high percentage growth on a $420 million revenue increase, more than two times greater than the next highest revenue increase. We expect Stryker to carry this momentum forward and, based on guidance provided in 4Q18, surpass Zimmer Biomet in 2019 for total orthopedic revenue.
Exhibit 7 details performance of companies between $100 million and $399 million in revenue.
Exhibit 7: 2018 Orthopedic Performance: Players Between $100MM and $399MM ($Millions)
Companies in the $200 million to $399 million tier were dragged down by orthobiologic companies Sanofi (-19.1%) and Seikagaku (-8.1%). Those two saw a combined $117 million revenue reduction compared to 2017. By excluding those two companies, we get a tier growth rate of 5.5%, far more in line with what we expect to see from smaller players.
Medacta, a standout performer in this tier, was able to drive double-digit growth by effectively selling in outpatient centers. The company emphasized its Propel Same Day Surgery Initiative, which includes single-use instruments and a suite of patient services. This strategy is a good fit for outpatient procedure operators who aim to increase daily case volume without additional overhead.
In the $100 million to $199 million tier, companies generally grew well above the market rate as they benefitted from share loss among larger competitors, addressed gaps in their portfolios and moved into new geographic territories. SeaSpine, for example, pursued an aggressive launch cadence in 2018 which bolstered their portfolio and helped them attract higher quality, exclusive distributors. Amplitude Surgical, a French player, made strides towards commercializing their knee and hip products in the U.S.
Integra LifeSciences is an outlier in this tier, as shortfalls in their trauma revenue caused them to slip just below $100 million. Benefits from the realignment of their Extremity Orthopedics team are taking longer than expected to materialize while the salesforce looks to reestablish relationships with surgeons. However, based on their provided guidance, we expect Integra to be back over the $100 million threshold again in 2019.
Corin is an outlier of another type in this tier. In March 2019 they acquired OMNI, makers of the knee robotics platform called OMNIBotics. Combined with their existing Optimized Positioning System for hips, the acquisition gives Corin an arsenal of technology possessed by few other players in this tier and allows them to implement the ecosystem strategy common among top-tier players.
Geographically, the U.S. accounted for 62% of all orthopedic revenue, while EMEA totaled 24%. Asia Pacific and the rest of the world were 9.3% and 4.7%, respectively. Compared to previous years, the proportion of U.S.- and Asia Pacific-derived revenue increased while EMEA decreased. European markets were challenging for top-tier companies in 2018, particularly the U.K. and Germany, where issues like regulatory pressure and sales leadership turnover presented headwinds. We expect that Europe will continue to challenge orthopedic companies as they determine which products to keep on the market under the stringent Medical Device Regulation, which is to be enacted in 2020.
To no surprise, a general theme was the success of emerging markets in 2018, particularly those in Asia. Despite seasonal volatility, these markets allow companies to access new patient populations with legacy products and smaller capital investments. Zimmer Biomet’s Asia Pacific sales have overperformed for several quarters relative to their overall growth. Seikagaku, facing significant hurdles in the U.S., was able to successfully expand into rural and urban areas of China.
Japan and China figure prominently in the international strategies of many companies. Stryker, for instance, is laying the groundwork for future sales by building a training center in Hong Kong in anticipation of significant uptake of Mako in the region starting in 2020.
While top-tier players seek to expand internationally, smaller European companies are pushing hard to gain a foothold in the U.S. Amplitude Surgical performed its first U.S. knee implant procedure in September 2018, and soon after, Scandinavian company Episurf celebrated achieving their long-sought milestone of receiving an FDA Investigational Device Exemption for their Episealer knee implant. ulrich medical continues to launch new products in the spine market, generating double-digit growth in the U.S.
Looking ahead to 2019, we’re projecting orthopedic market growth of 3.5%, a slight reduction to our projections from last year. The struggles of DePuy Synthes and Zimmer Biomet, and to a lesser extent Medtronic, are felt industry-wide. The spine, knee and hip segments represent more than half of the total orthopedic market, and the growth rates of all three have decelerated. The increased procedure volumes observed by some companies in 2018 were due, in part, to a strong economy in which more people had healthcare coverage and disposable income for elective procedures. As the economy slows or faces a downturn, some portion of that increased volume will vanish.
These pressures are not new to orthopedic companies, however, and in 2018 many companies refined their strategies to attain success amid a transforming market. The proliferation of flagship technologies like robotics and navigation as the centerpiece of a connected product ecosystem, as well as the adoption of outpatient selling strategies and product mix, will be the story of the orthopedic industry in 2019 and beyond. The most successful companies will continue to iterate on both their enabling technologies and implantable devices while supporting them with a robust, ongoing pipeline of clinical research.
Medium to small players will also continue to seek higher quality distributors through innovative products and robust portfolios. They’ll seek more control over market access and product pricing by driving exclusivity among their distributors.
Mike Evers is ORTHOWORLD’s Market Analyst.
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Mike Evers is a Senior Market Analyst and writer with over 15 years of experience in the medical industry, spanning cardiac rhythm management, ER coding and billing, and orthopedics. He joined ORTHOWORLD in 2018, where he provides market analysis and editorial coverage.