The MedTech Dive Outlook on 2021

This story is part of a series exploring trends that will shape the industry in 2021. Read more here. 

The calendar signals a new year but the medtech industry in 2021 will feel the lingering effects, both positive and negative, from the global coronavirus pandemic. 

With the resurgence of the virus and emergence of new more contagious strains, COVID-19 will have major impacts on companies as much as 2020, albeit with the benefit of insights gleaned from the historic year and its unprecedented business environment.     

Earlier this month, medtech and diagnostics companies gathered virtually to discuss 2021 prospects at J.P. Morgan's annual healthcare conference. Executives painted a mixed picture with the first half of the year looking bumpier than the second half.

Not surprisingly, many companies are not providing 2021 guidance due to the uncertainty caused by COVID-19. However, Craig-Hallum analyst Alex Nowak noted recently that most of the companies his firm covers have spoken optimistically about a full recovery taking hold in 2021.

"The recovery though will not be outsized year/year growth in 1Q21-3Q21, but instead consistent levels of quarter/quarter gains throughout the year," Nowak wrote in a research note.    

Below are four big trends to watch in 2021 for the industry.

Elective procedures remain under pressure

Wall Street expects declines in elective care in the near term to continue as coronavirus cases keep rising. While the rollout of vaccines will likely help volumes, procedure comebacks are not expected until the second half of 2021, according to J.P. Morgan analysts.

To be sure, there will be winners and losers financially in this scenario.

"The ones affected were, to no surprise, those tied to elective procedures or were hospital-oriented," according to Nowak. "The real weakness was procedures that were not entirely critical (or critical and could be shifted outside the hospital), nor driven by higher income, such as spine surgery."

While Moody's expects procedure volumes will continue to recover in 2021 as patients who deferred procedures to treat chronic illnesses return to their healthcare providers, the investor service predicts demand will be volatile based on the spread of COVID-19.

Moody's expects transcatheter aortic valves, a key revenue driver, "will return to double-digit growth" for leaders such as Edwards Lifesciences and Medtronic.

Edwards on Wednesday reported that U.S. TAVR sales were actually down lower than Wall Street's expectations in the fourth quarter, and recent procedure slowdowns are expected to spill into 2021. However, CEO Michael Mussallem believes that the company will still hit its guidance of growing TAVR globally by 15-20% this year.

Medtronic warned earlier this month that due to the COVID-19 surge the company now expects overall business to be "roughly flat" this quarter, on an organic basis, instead of flat to slightly up. 

CEO Geoff Martha noted that Medtronic didn’t see much of a negative impact from the surge in coronavirus cases in October, November and even the first half of December. However, the medtech giant started to see "some impact" starting over the holidays. 

Nonetheless, Martha called hospitals more experienced at handling the current COVID-19 surge while maintaining capacity for non-coronavirus patients. He cited pockets in the U.S. and Europe "where it has slowed down a bit" in recent weeks.  

"It is more of an elective case pullback issue versus some other issue that's unique to Medtronic," Martha said. "Based on the feedback that we're getting from hospitals, we remain optimistic that this is going to be short lived."   

However, executives from Baxter and Boston Scientific appear to be more concerned about the ability of some hospitals to manage the coronavirus stresses on their health systems as the number of cases continue to rise.  

Baxter CFO Jay Saccaro at the recent J.P. Morgan conference described the current coronavirus surge as "volatile" and that Baxter will be taking "as much time as we possibly can to put together guidance." 

Boston Scientific expects a rebound in procedure volumes this year. However, the company is not providing 2021 guidance at this time. CEO Mike Mahoney told analysts that he expects “some COVID impact” and “softness” in the first quarter “given the market environment.” However, Mahoney said with the increasing rollout of COVID-19 vaccines in 2021 the situation will “improve each month.”    

Another banner year for COVID-19 testing

Demand for COVID-19 testing will continue to accelerate over the next year, with volumes remaining high until vaccines are widely distributed, according to Moody's.

"This will benefit companies that sell diagnostic tests, like Abbott Laboratories and Becton Dickinson, as well as life science companies that provide reagents used in these tests like Thermo Fisher Scientific," Moody's analysts wrote in their 2021 outlook for the global healthcare sector. 

Despite the rollout of coronavirus vaccines, Abbott, Hologic and Quidel are ramping up their manufacturing capabilities in anticipation of another banner year for COVID-19 testing. CEOs from the diagnostic makers laid out their coronavirus test plans earlier this month at J.P. Morgan. 

Hologic CEO Stephen MacMillan said the company has more than doubled its molecular diagnostic manufacturing capacity and is investing to more than triple capacity from 25 million tests in the fourth quarter of 2020 to 75 million tests per quarter by the second quarter of 2022. 

"Everybody thought as soon as vaccines came, testing is going to go away. I think everybody is now seeing the realities of rolling out vaccines, of distribution chains. There is so much more complexity," MacMillan said. "This market, we believe, continues to grow and continues to be strong. And while it will certainly come down at some point, we believe it's going to be stronger for longer."  

Abbott CEO Robert Ford said he expects high demand and volume for tests throughout 2021. The company is near completion of capacity expansion at U.S. manufacturing sites, which Ford estimated will enable production of tens of million more of its BinaxNOW COVID-19 antigen tests per month for sale to schools, workplaces, and pharmacies.

Quidel's QuickVue SARS test, a pregnancy test-style antigen diagnostic that like Abbott's BinaxNOW delivers results in minutes, is the focus of an at-home coronavirus testing effort.   

"We are now anticipating a QuickVue SARS OTC at-home approval, which would not require a prescription," CEO Doug Bryant said at the conference. "We think it's the future of the company."  

Early in 2021, Quidel hopes to have QuickVue tests available as OTC at home products. The company plans to manufacture as many of the diagnostics that it can this year.  

Tuck-in acquisitions poised to take off

While M&A slowed last year due to the coronavirus pandemic, a report from consultancy EY predicts medtech dealmaking to jump in 2021 as companies are armed with a record high of roughly $500 billion in financial firepower. So far this year, the industry has seen a flurry of activity.

Hologic kicked the trend off in January with an acquisition of Somatex Medical for $64 million, and less than a week into 2021 added its second tuck-in with the acquisition of Biotheranostics for $230 million. PerkinElmer struck a deal to buy tuberculosis test provider Oxford Immunotec for $591 million and Thermo Fisher Scientific announced it will acquire privately-held molecular diagnostic maker Mesa Biotech for $450 million in cash.

The biggest deal over the first weeks of January was Steris' purchase of Cantel Medical in a cash and stock acquisition of approximately $4.6 billion, followed by Boston Scientific's announcement that it will purchase cardiac monitoring company Preventice Solutions in a $925 million deal and Philips' plans to acquire Capsule Technologies for a cash consideration of $635 million.   

At Boston Scientific, strategic tuck-ins remain the company’s "number one priority" when it comes to capital deployment with a focus on high-growth adjacent markets, CEO Mike Mahoney said earlier this month, noting $1.9 billion in cash on hand as of the end of last year. He also said the company will continue to be active with its venture capital portfolio "which has historically served as well as a nice pipeline" for M&A.     

Medtronic's Martha said that the medtech giant plans to continue to look for M&A opportunities in 2021 after the company last year accelerated its momentum for tuck-in acquisitions, announcing seven such deals with a combined total consideration of over $1.6 billion. 

Baxter CEO Joe Almeida said the company continues to "think very seriously" and to "evaluate" M&A this year. "I'm not in a position to tell you affirmatively that 2021 is the year of M&A," he remarked, though it is part of the medtech's playbook.

While some companies will look for tuck-in acquisitions, a handful of deals over $1 billion should be expected, according to John Babbitt, EY's MedTech leader for the Americas. In addition, EY sees several subsectors as top targets in 2021 for M&A activity including diagnostics, digital health, and remote patient monitoring.  

Digital, remote tech adoption to grow

Last year, the need to create safe physical distances between healthcare workers and COVID-19 patients prompted medtechs to modify how their devices are used, including remote programming and monitoring. This year, executives say they will continue to adopt many of the features, which are becoming permanent offerings.

Martha said Medtronic will be increasingly incorporating the technology across its product portfolio.  

“You are already seeing this with the advances we have made in remote monitoring and remote programming of many of our devices. We have added advanced capabilities to cardiac rhythm devices, diabetes insulin pumps, and ventilators, just to name a few,” Martha said.

Abbott's Ford said his company is continuing to adopt remote care and digital health technologies as a result of the pandemic, which has accelerated the trend. However, Ford made the case at J.P. Morgan that the benefits of such tech goes beyond just COVID-19.

"It allows for much more proactive management. We see that in some of our portfolio. It can decrease the response time, especially if you've got like an urgent care situation. It can really bring that response time down lower, cuts up a lot of the logistical issues, the challenges of in-person, and then ultimately can lead to lower healthcare cost," Ford said.

He pointed to the FDA's approval in July of the Gallant implantable cardioverter defibrillator family of devices to help manage heart rhythm disorders, which offer Bluetooth technology and a new patient smartphone app for improved remote monitoring.   

Boston Scientific in 2021 is also looking to build on “healthcare digital adoption” by accelerating and expanding its remote technology capabilities, according to CEO Mahoney.  

The company has “leveraged COVID” to accelerate its digital investments and capabilities in such focus areas as clinical trials, customer engagement, mobile solutions, medical education and remote case support, Mahoney said. 

Boston Scientific’s initiatives include remote case support and virtual reality solutions, remote monitoring of clinical trials, as well as teleproctoring and virtual medical education.     

“We see these platforms as a key catalyst for growth and structural and cost savings opportunities over time, and continue to expand our footprints and these digital capabilities,” Mahoney added.   

This story is part of a series exploring trends that will shape the industry in 2021. Read more here.

The coronavirus pandemic has spurred an explosion in telehealth and digital health as patients stayed out of hospitals and doctors' offices to slow the spread of the virus turned to virtual care.

As a result, the healthcare landscape has significantly changed over the last 10-11 months and companies are making moves to capitalize on the rise of tech-driven services and wearable devices.

Patients embraced devices like continuous glucose monitors and insulin pumps in recent years before the pandemic, and companies in these markets like Dexcom and Insulet or Medtronic and Abbott Laboratories have remained successful despite the economic volatility throughout 2020.

Now, Wall Street and industry see 2021 as a watershed moment for diabetes technology. Along with plans to expand into new markets, nearly every major player in the CGM and insulin pump space have product launches this year, one of which J.P. Morgan said could be the year's biggest for industry.

As the CGM and insulin pump markets gain momentum, companies like Dexcom and Insulet point to a large, under-penetrated patient population as the largest growth opportunity.

In 2018, about 34 million people in the U.S. had diabetes, or 10.5% of the population, and another approximately 88 million adults were estimated to be pre-diabetic, according to a 2020 report from the Centers for Disease Control and Prevention. Nearly 8 million more were estimated to have diabetes but were not diagnosed. 

The World Health Organization estimates that there are about 422 million people with diabetes across the globe. Much like other chronic illnesses, these numbers are expected to grow as the global population ages.

As both patients and providers rely more and more on virtual care, digitally-based diabetes management stands to gain further momentum.

Turning to tech

Traditionally, diabetes is managed with finger sticks to read blood glucose levels and insulin injections for patients who require them. But newer wearable devices like CGMs and insulin pumps are changing the diabetes market.

CGMs can automatically monitor blood glucose levels throughout the day and warn users when levels get too high or too low, and pumps can deliver insulin to patients without requiring the patient to administer an injection or multiple injections throughout the day.

Insulet CEO Shacey Petrovic contends the industry is at an "inflection point," where the tech has evolved and improved as patients have further embraced virtually-based services.

Because traditional pumps are more expensive and cumbersome, patients are not as willing to use them, according to Petrovic. The CEO said that recent smaller wearable pumps that have similar health outcomes to traditional care have helped fuel the change in patient behavior.

Because of this shift, the CEO does not view Insulet as competing in a defined insulin pump market but creating a market that may have not been there because the majority of users are dependent on injections, not pumps. Approximately 80% of the company's users are patients that inject insulin multiple times a day.

Petrovic said that the company has doubled its patient population to hundreds of thousands over the last five years.

Jake Leach, Dexcom's chief technology officer, outlined a similar story that fueled the company's success in recent years — the technology improved, costs dropped, and patients became more willing to use CGMs.

Petrovic and Leach said that while patient behavior was changing before the pandemic, the recent rise of virtual care has boosted CGM and pump adoption.

Both companies have remained successful in 2020 as others were harder hit by the pandemic. Dexcom's stock price increased from $238.54 to $366.89 over the last 12 months, and Insulet's grew from $193.51 to $275.03. Petrovic said during a November earnings call that Insulet should beat pre-pandemic expectations in 2020.

2021 product launches

The next step for diabetes care is connecting the CGMs and insulin pumps together through what is called a closed-loop system, which requires less direct involvement for patients in managing their diabetes. An algorithm, which companies have developed independently or license with partners, connects the devices and allows them to work together.

Tandem's Control-IQ technology was the first FDA-cleared algorithm for use with a fully interoperable, automated insulin dosing system. However, competitors in the space are now catching up.

Insulet has developed an algorithm of its own and will use it with its Omnipod 5 automated insulin pump to connect with CGMs like Dexcom's G6 system. Petrovic said that the company plans to receive FDA approval and launch the product in the first half of 2021.

To further ease of use for patients, the pump will transmit data to an application on patients' cell phones. Petrovic said that the product will be available first with Androids when launched and then, ultimately, iPhones.

J.P. Morgan analysts wrote that this product is one of the company's most important launches and one of the biggest for medtech this year. The pump may provide patients with a better option to Tandem's because it is tubeless and comes at a cheaper cost as it will be offered directly through a pharmacy as opposed to the durable medical equipment (DME) channel.

Meanwhile, after pushing back the product launch in 2020, Dexcom plans to launch its G7 CGM system at the end of 2021 with a further rollout in 2022, according to Leach. The product will be key for the company to hit its projection of doubling revenue by 2025.

Leach said that closed-loop systems are where the market is headed, and while it won't be needed by everyone with diabetes, about 50% of Dexcom's users will eventually be on the system.

Competing with medtech leaders

Analysts have been high on both Insulet and Dexcom, with J.P. Morgan analysts picking Insulet as a top small-cap company in a 2021 outlook and William Blair analysts writing that Dexcom should meet or beat expectations going forward.

Both, however, have to compete in a market with larger medtechs like Medtronic and Abbott.

Abbott's FreeStyle Libre CGM system has been a continual bright spot for the company and remained successful last year. CEO Robert Ford said during a fourth-quarter earnings call that FreeStyle Libre sales grew 50% in the U.S. in 2020 and 40% outside of the U.S., with international sales alone eclipsing $2 billion.

For comparison, Dexcom CEO Kevin Sayer projected during the J.P. Morgan healthcare conference that 2021 revenue will land in a range between $2.21 billion to $2.31 billion, representing growth of 15-20%.

Medtronic, the only company in the space to own both a CGM and insulin pump, has also recently re-prioritized its diabetes portfolio and invested in the more tech-driven management approach.

In June, the company received a $337 million investment from the private investment firm Blackstone Life Sciences to develop four undisclosed diabetes products, and Medtronic in August bought up Companion Medical, which has the only FDA-cleared insulin pen that can combine with a management smartphone application.

Ali Dianaty, vice president of product innovation for Medtronic's diabetes portfolio, said that the company is looking to a more "consumer electronics" approach to the diabetes business, with products being released or updated on a more annualized basis.

The device giant also plans to have a product launch in 2021: the MiniMed 780G pump system. The system will also be able to connect with a CGM to determine when insulin injections are needed. While the product is available in Europe, Dianaty said Medtronic is waiting for FDA approval. He would not provide a specific timeline due to delays because the agency is prioritizing COVID-19 applications.

Once approved, he said the rollout should be rapid as users need to just update the pumps that they already own with the new management system.

Dianaty said that one benefit of having both a CGM and a pump is that the company owns the algorithm and all the data coming through on the backend. However, he acknowledged a hurdle of not partnering with other CGM companies if customers settle on one product, potentially limiting growth. For example, on the insulin pump side, Insulet is working with both Dexcom and Abbott. Meanwhile, on the CGM side, Dexcom is working with both Tandem and Insulet.

When it comes to competing among larger companies with deeper pockets, Leach said that Dexcom was not concerned and plans to focus specifically on CGM users.

"Our perspective is that there's a lot of opportunity," Leach said. "There's multiple players in the market, they all have a slightly different approach to the products, and I think our approach is to remain the technology leader and drive forward with solutions that are right for the user."

UBS analysts echoed a similar sentiment in a recent report, writing that Dexcom's G7 product will be able to compete with FreeStyle Libre despite Abbott's size and CGM success.

Patient & global expansion

One competitive advantage that analysts have called out is that both Insulet and Dexcom have targeted the pharmacy channels to reach more users. The strategy drops the price of their devices but allows for a more direct and faster connection to customers compared to the DME channel.

Dexcom has made the pharmacy a key strategy shift, with plans to eventually sell about 75% of CGMs through the channel by the end of this year. And J.P. Morgan analysts said that Omnipod 5 will be the only pump available at a pharmacy, dropping its price to $150-$200 per year versus multiple hundreds of dollars a year. The pump also eliminates the need to pay about $1,000 every four years for traditional hardware.

Dianaty said that Medtronic's CGMs and pumps are primarily sold through the DME channel, but the company is looking more towards pharmacies and will be "opportunistic" in the space.

Along with the Omnipod 5 launch, expanding into international markets is a priority for Insulet in 2021 as it will significantly grow the company's potential patient base.

Petrovic said that among their current markets — the U.S., Canada, Israel, about 12 countries in Europe and one or two in the Middle East — there are 10-11 million potential patients. The CEO would not provide an estimate on how much of that population is Insulet's addressable market, but said the number is a small sample compared to where the international market can reach.

"Massive markets remain unscratched or untapped by us, [such as] all of Asia Pacific, all of Latin America," Petrovic said. "There's a lot of work underway at the company now to assess those markets ... because it's a big growth driver for us over the next several years."

There is still room for innovation amid all the growth in the diabetes space. Petrovic, Leach and Dianaty all said that with closed-loop systems or singular wearables, patients still need to notify when they have meals or input information, which can cause complications around how much insulin to deliver to patients as levels change while eating.

Insulet is advancing its algorithm to better adjust for meal times, and Medtronic's 780G system is designed to adjust for any complications that can come from users inputting inaccurate information. The company is also looking at technology from the 2019 acquisiton of the behavior monitoring company Klue, which can track hand movement to signify when people are taking bites.

All of the companies said that addressing this meal-time hurdle is the next step of where the technology is headed. 

"Our goal is to make diabetes go away … That's fundamentally what we're trying to do for our customers and our patients," Dianaty said. "In order to do that, you basically have to manage all aspects of diabetes, and the one place, the Holy Grail that's remaining is dealing with meals."

This story has been updated to clarify the figure for Insulet users taking insulin multiple times a day.

This story is part of a series exploring trends that will shape the industry in 2021. Read more here.

Transcatheter aortic valve replacement has dominated the structural heart world in recent years, with the market currently valued at about $5 billion and the procedure becoming the primary form of aortic valve replacement in the U.S.

In 2021 and beyond, industry is setting its sights on new heart valve opportunities that could grow to be multiples of the TAVR market: transcatheter mitral valve replacement and repair.

Often in the shadow of the aortic market, mitral has a larger potential patient population, and companies with successful structural heart businesses like Abbott Laboratories and Edwards Lifesciences have secured leading positions in the market as it begins to take off.

Analysts and industry agree that the mitral and, later on, related tricuspid valves market will hit $3 billion by 2025 with mitral making up the majority of the projection.

Mitral regurgitation, or MR, is the leakage of blood flow back into the atrium of the heart. MR is the most common type of valvular disease and impacts about 2% of the global population, according to the National Center for Biotechnology Information.

Coupled with a large patient population is a low treatment rate compared to aortic stenosis. According to Edwards, just 2% of patients who need mitral interventions are treated with either surgery or a transcatheter procedure, compared to the 10-12% of patients who require aortic intervention that receive TAVR.

This large, under-penetrated patient base is why analysts and industry believe the space can hit the 2025 projection and grow significantly beyond that mark.

Jefferies equity analyst Raj Denhoy said that the market, which he estimated is currently valued at about $800 million, could grow in multiples of the 2025 projection. Denhoy added that eventually, the mitral market could also grow to be multiples of the TAVR market, which he projected to be close to $10 billion by 2025.

"It is really one of the next big opportunities," Denhoy said. "I mean, it's already a big opportunity — $800 million —but it's going to continue to grow for a long time to come."

This year has already brought a boost for the mitral space. CMS last week expanded coverage for transcatheter edge-to-edge procedures for patients with secondary mitral regurgitation, which could more than double the U.S. patient base eligible under previous coverage rules.

As companies have turned their focus to the mitral valve, cardiac surgeons have seen procedures increase.

Joseph Cleveland, a cardiac surgeon with the University of Colorado’s Anschutz Medical Center, said that after previously being more cautious of transcatheter mitral repair, general cardiologists are increasingly recommending patients for the procedure.

Matthew Romano, director of the Mitral Valve Clinic at the University of Michigan, similarly said that the mitral procedures are picking up and will grow over the next several years because "the current technology is offering a therapy for patients who otherwise may not be ideal surgical candidates, hopefully reducing their mortality risk and improving quality of life."

Much like TAVR procedures, transcatheter mitral procedures offer patients a minimally invasive alternative to open-heart surgery.

Romano, who is participating in Edwards and Abbott mitral device trials, said that even with the growth in procedures and the expansion of potential patients, open-heart surgery is still the "gold standard" and the challenge for transcatheter procedures will be producing similar results. 

Abbott v. Edwards

Currently, Abbott is the clear leader of the mitral market. A version of MitraClip, the company’s mitral valve repair device, has been available in Europe since 2008 and the U.S. since 2013; it is still the only transcatheter mitral repair device approved for the U.S.

The product has become a top driver across Abbott’s structural heart portfolio. MitraClip brought in about $690 million in sales in 2019 and should bring in about $670 million in 2020, according to J.P. Morgan. Meanwhile, Abbott's entire structural heart business brought in about $1.4 billion in 2019 and was on a similar trajectory at the close of the third quarter last year.

Neil Moat, the chief medical officer of Abbott's structural heart business, said the mitral's growth opportunity is not just the fact that patients with mitral disease outnumber those with aortic stenosis, but patients are also often undertreated.

"Even before the era of TAVR ... penetration of treatment for mitral valve disease was much less than in the aortic valve," Moat said, adding that the number of potential patients will only continue to grow as the global population ages.

Over 100,000 patients have been treated so far with MitraClip, and while the company has launched MitraClip G4 in Europe and the U.S., fifth and sixth versions of the product are being developed, according to Moat.

The company's position as leader in the space may not be guaranteed as the market grows. After Edwards built itself on the success of its TAVR business, the company is launching a transcatheter mitral valve repair system of their own, called Pascal, and has made the market a key priority.

During a recent J.P. Morgan presentation, CEO Michael Mussallem stressed the opportunity for both mitral and tricuspid valves, both of which make up Edwards' overall market projection of $3 billion by 2025. The company is running three clinical trials for the Pascal device: two for mitral repair and one for tricuspid.

Bernard Zovighian, corporate vice president for Edwards' transcatheter mitral and tricuspid therapies business, said that Pascal's launch in Europe has gone well and the product is available in over 10 countries. However, Edwards does not expect U.S. approval for Pascal until the end of 2022, putting off a product launch and revenue contribution to 2023.

Despite Abbott's lead, Zovighian said that there is still a large opportunity in mitral as MitraClip has been studied for a small percentage of the potential patient population. While Zovighian would not project a specific long-term estimate, he said that Edwards expects the market to be "significantly bigger" beyond 2025.

"A lot of promise. A lot of patient need. But a lot to do, still, to make sure we make mitral a big market," Zovighian said. "I am very confident it will happen."

While Abbott and Edwards have both developed tricuspid products — Edwards with Pascal and Abbott's TriClip device, which is built on a MitraClip design — Cleveland questioned if the tricuspid market would take off until a device is developed specifically for the valve.

Potential hurdles for growth

Both Moat and Zovighian said that the complexity of the disease requires a broader portfolio of devices to suitably treat patients, and both companies are developing transcatheter valve replacement devices along with their repair devices. However, Cleveland said that due to the complexity of the mitral valve, the replacement market and treatments are improving but still in "nascent stages."

Managing the anatomical features of the mitral valve and reaching the valve are both more challenging than aortic procedures, according to Romano. Furthermore, once the valve is reached, the device must be placed and secured, which can be more difficult than in the more rigid, calcified aortic valves.

Both surgeons said that the valve's complexity compared to the aortic valve have also contributed to the slower development of the market and could present challenges for device development. These challenges could also be a hurdle to a widespread rollout and adoption of mitral valves and procedures compared to the speed of TAVR adoption.

However, Cleveland said device technology and improvements in other areas like cardiac electronic imaging are quickly catching up to the valve's complexities, allowing surgeons to more easily conduct the procedure.

"I'm always a guarded optimist when it comes to technology. I kind of never bet against it because it seems like a group of smart engineers with enough venture capital can seem to almost overcome everything," Cleveland said.

Prioritizing the mitral space

Analysts have faith that Edwards can be a suitable rival for Abbott and steal market share away from the company over the coming years, but Abbott's lead is still significant.

While analysts project that MitraClip sales alone should mirror past performances of near $700 million, Edwards projected that global sales for transcatheter mitral and tricuspid therapies will double in 2021 to about $80 million.

A catch-up for Edwards, however, could come from its relationship with surgeons built through its large presence in TAVR and the benefit of being the new option for surgeons, according to Cleveland.

Evercore analyst Vijay Kumar said that Edwards' success will be dependent on solid clinical data from the trials being conducted for both repair and replacement devices.

Even with solid results, the Edwards timeline may make it difficult to catch Abbott in the near-term. If the mitral market hits the 2025 projection, about $2 billion will be made up by Abbott and $500 million by Edwards, according to Kumar.

Abbott's head start may also pay off sooner rather than later. CMS' recent reimbursement expansion for secondary MR could double or triple MitraClip’s U.S. patient base. Meanwhile, Edwards is still working for the U.S. approval of Pascal.

Medtronic and Boston Scientific are also working on transcatheter mitral products, but those are still three to four years away from being launched, Kumar said.

This distance leaves Edwards and Abbott alone to fight for market share for the foreseeable future, which could be strategically crucial for both companies.

"For Edwards, [the mitral market] is of paramount importance because, again, it is the next chapter of the story for that company," Jefferies’ Denhoy said. "For Abbott, it's one of the growth drivers for them for the last several years, so they are acutely focused on it as well."