After decades building the robotic surgery market, Intuitive Surgical will no longer have the field to itself in 2025.
Since gaining the first FDA clearance almost 25 years ago, da Vinci robots today are routinely used in numerous laparoscopic soft tissue procedures, including cardiac, urologic, gynecologic and general surgeries.
Now, dozens of newcomers are preparing to enter the arena, pursuing niches across the surgical landscape.
As the rollout of Intuitive Surgical’s da Vinci 5 system expands to a full launch later this year, the robotic surgery pioneer will continue to drive a shift in operating rooms from open surgery to minimally invasive procedures. That mainstream acceptance has also drawn competitive responses from Medtronic and Johnson & Johnson, two traditional suppliers of surgical instruments now embracing robotics.
Intuitive executives, on an earnings call last week, acknowledged that a new era of competition is on the horizon.
“Given the increasing choice customers have as competitors bring robotic systems to the market and seek geographical clearances, we may see capital selling cycles lengthen as customers evaluate alternatives,” said CFO Jamie Samath.
In orthopedic surgery, robotic-assisted implant procedures are expected to grow in the coming year, with Stryker and Zimmer Biomet introducing shoulder applications to their respective platforms.
Here are four trends in robotic surgery that medtech experts are watching this year:
1. Intuitive’s da Vinci 5 launch ramps up
The launch of Intuitive’s da Vinci 5 system, which is still limited as the company builds manufacturing capacity and supply, has exceeded analysts’ expectations.
“Four quarters in since they introduced da Vinci 5, and it's just been phenomenal out of the gate,” BTIG analyst Ryan Zimmerman said in an interview. “The adoptions are very strong, better than investors had expected, and we're not even in the full broad launch.”
More than 2,500 surgeons have used the new system, performing over 40 types of procedures, according to Intuitive. CEO Gary Guthart said the company’s top priority in 2025 is scaling up to a full da Vinci 5 launch.
Customers will also receive regular hardware and software upgrades, starting this year with digital features supported by the system’s significantly increased computing power.
With the release of da Vinci 5, Intuitive is preempting moves from key competitors such as Medtronic, whose Hugo robot launched in Europe in 2021 and is available in 25 countries worldwide.
Medtronic is now ready to take on the market leader in the U.S. The company plans a urology submission to the FDA within the first quarter of 2025 and is enrolling patients in clinical trials to support future U.S. indications for hernia and gynecology, CEO Geoff Martha said this month.
Intuitive’s large installed base will make it hard for any health system to disrupt its reliance on Intuitive’s robots, said Morningstar analyst Debbie Wang.
“I don’t see any competitive threats, including Hugo, that could really derail Intuitive and its rollout of da Vinci 5, considering how much the practitioners love the ease of da Vinci use and its design,” Wang said.
2. Medtronic aims for second place
Challenging Intuitive’s dominance in robotics may be daunting, but preventing further market share erosion in surgical instruments is motivating both Medtronic and J&J, analysts said.
“J&J and Medtronic had instrument businesses that for years were very good cash cows,” said Zimmerman. “They waited too long, and Intuitive became too big of a force and it passed them, and now they're struggling and scrambling to catch up.”
Intuitive’s surgical stapler business, for example, is now bigger than Medtronic’s and J&J’s, said Steve Bell, who advises medtech startups and is the former chief commercial officer at robot maker CMR Surgical. Bell noted that Intuitive is the biggest stapling company in the U.S.
With their instrument businesses under pressure, Medtronic and J&J have been compelled to respond. “They have to do something,” said Bell. “Otherwise, there’ll be nothing left for them within five to 10 years, because everything's going over to the robot. So they have to try.”
Medtronic, and eventually J&J, will give Intuitive competition in robotic surgery, he said, “but it won’t be meaningful.”
In November, J&J received the FDA’s go-ahead to begin a U.S. clinical trial for its Ottava surgical robot. J&J’s launch of a soft tissue robot has been beset by delays, analysts said in interviews, and remains at least two years away.
“They are just so far behind schedule. It's been unfortunate,” said Jeff Jonas, a portfolio manager with Gabelli Funds who focuses on healthcare.
A decade from now, Bell predicted, Intuitive will still control 70% of the robotic surgery market, with Medtronic and J&J claiming 10% each and smaller competitors splitting the remaining 10%.
Medtronic has set its sights on becoming a “strong No. 2 player” in surgical robotics, Martha told investors this month at the J.P. Morgan Healthcare Conference. “Usually, we're targeting No. 1, but right now we'll just target No. 2 here, and I think that'll be pretty good here over the immediate term,” the CEO said.
"These niche areas are where certain companies are finding success, and then some of them are competing on the modular concept of being smaller and easier to move around."
Ryan Zimmerman
BTIG analyst
3. Smaller developers eye niches
Alongside the medtech industry’s most prominent device makers are many smaller companies with ambitions in surgical robotics, and some could begin to make their mark in the U.S. this year.
“The pace of introduction of new systems is picking up,” said BTIG’s Zimmerman.
The robot makers will look to set themselves apart with unique design features or by establishing themselves in specialties where Intuitive does not have a major presence. “These niche areas are where certain companies are finding success, and then some of them are competing on the modular concept of being smaller and easier to move around,” Zimmerman said.
Among the companies that have secured FDA authorizations over the past year are CMR Surgical, Distalmotion, Virtual Incision, Moon Surgical, Medical Microinstruments and Procept Biorobotics.
Most recently, CMR received a de novo authorization for its Versius robot in October with an initial indication for gallbladder removal surgery, while Distalmotion in the same month won authorization for hernia repair. Procept’s system employs pressurized fluid to cut tissue in a procedure to treat enlarged prostate.
Even with Intuitive’s substantial lead in robotics, the worldwide surgical procedure market remains vastly underpenetrated, Zimmerman said, which will benefit new entrants.
“There is just tremendous opportunity. There's a lot of room for robots to continue to grow,” he said. “That's clear.”
Bell cautioned that with as many as 60 companies vying for some portion of the soft tissue robotic surgery market, not all will be successful. “You will see some of the smaller companies disappear. They're not all going to survive. They'll run out of funding this year, and they'll disappear,” Bell predicted.
4. Orthopedic robots will gain ground in ASCs
Growing use of surgical robots for outpatient procedures in ambulatory surgery centers is a trend that is bolstering orthopedic implant makers such as Stryker and Zimmer Biomet.
“For the orthopedic robots, there’s a huge rush to install them in ASCs, and I expect that to continue in 2025 as outpatient large joint replacement continues to grow,” said Morningstar’s Wang.
Also in the works this year, Stryker and Zimmer Biomet are adding shoulder features to their surgical robots.
“The shoulder indication is the next major step. However, it’s not clear to me whether application of the robot will help expand that market,” said Wang. “Shoulder replacement is tricky,” she noted, because the joint involves a complex network of muscles and tendons. “It’s not clear to me how the robot and/or software addresses this,” Wang said.
Spine surgery, on the other hand, has the potential to benefit from an expanding focus on robotics, according to Wang.
“Considering the efficacy of many spine surgeries is modest, at best, there’s potential for major improvement,” Wang said. “We do think Medtronic’s Mazor and Globus’ Excelsius can make a material difference.”
