Cardiovascular care is still big medicine’s biggest business — but new players are rewriting the story

Cardiovascular disease does not always attract the same market excitement as oncology, obesity drugs or AI-led healthcare. But it remains the world’s biggest killer, and still one of healthcare’s largest and most active commercial battlegrounds. The World Health Organization’s latest factsheet says cardiovascular disease caused an estimated 19.8 million deaths in 2022, accounting for about 32% of all global deaths.

That scale helps explain why the sector stretches so far beyond old assumptions about statins and blood pressure tablets. The modern cardiovascular market spans blockbuster cholesterol-lowering drugs, heart failure therapies, implantable rhythm devices, catheter-based interventions, AI-assisted diagnostics, and a deep clinical pipeline still pushing into new targets such as lipoprotein(a), or Lp(a), and next-generation structural heart devices.

For investors, the point is not just that cardiovascular disease is widespread. It is that the business of treating it is broadening again.

A market shaped by drugs and devices

Pharma remains central. Cholesterol reduction is still a major commercial theme, but the market is no longer defined only by statins. Novartis AG (ADR) (NYSE:NVS) continues to build around Leqvio, its twice-yearly inclisiran therapy, and has been highlighting new data showing rapid LDL-C goal attainment in high-risk patients. Meanwhile, the industry is also pushing into Lp(a), a genetically driven cardiovascular risk factor that has become one of the most closely watched areas in cardiometabolic medicine. Phase 3 studies are under way for Amgen Inc (NASDAQ:AMGN, XETRA:AMG)’s olpasiran, Novartis’ pelacarsen, Eli Lilly and Co (NYSE:LLY)’s lepodisiran and Lilly’s oral candidate muvalaplin, each aimed at reducing cardiovascular risk in patients with elevated Lp(a).

Heart failure remains another major front. AstraZeneca PLC (LSE:AZN, NASDAQ:AZN) has positioned cardiovascular, renal and metabolic disease as a key growth engine, anchored by its Farxiga franchise across heart failure, chronic kidney disease and diabetes.

Then there is the GLP-1 wave, which is starting to redraw the boundaries of cardiovascular care. Semaglutide has already delivered around a 20% reduction in major cardiovascular events in high-risk patients, with benefits that do not appear to depend solely on weight loss. What began as an obesity and diabetes story is now a full-scale cardiovascular race, with oral GLP-1s and next-generation incretins rapidly moving into the same space.

But pharma is only half the story. Cardiovascular care is also a device business — and a very large one.

Medtronic PLC (NYSE:MDT, XETRA:2M6)’s cardiovascular portfolio generated about US$12.5 billion in FY25 revenue, spanning cardiac rhythm and heart failure, structural heart and aortic, and coronary and peripheral vascular. Boston Scientific Corp (NYSE:BSX, XETRA:BSX) reported roughly US$20 billion in full-year 2025 revenue and remains heavily exposed to heart and vascular technologies, while Abbott Laboratories (NYSE:ABT) also maintains a large cardiovascular device business, with multi-billion-dollar revenues across structural heart, electrophysiology and heart failure.

That matters because some of the most interesting growth areas in cardiovascular care now sit in minimally invasive procedures, electrophysiology, cardiac resynchronisation, structural heart repair and replacement, and software-led diagnostics.

Structural heart is still a high-stakes race

One of the clearest examples is transcatheter aortic valve replacement (TAVR), where incumbents Edwards Lifesciences Corp (NYSE:EW, XETRA:EWL) and Medtronic — with their Sapien and Evolut valve platforms, respectively — already hold strong positions. Edwards said in its third quarter 2025 update that TAVR sales reached US$1.15 billion for the quarter, up 12.4% year-on-year, underlining how large and commercially established the category has become.

Even in a market dominated by incumbents, ongoing innovation is creating openings for newer players such as Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR).

The ASX- and Nasdaq-listed structural heart company is advancing its DurAVR transcatheter heart valve through the PARADIGM pivotal trial, a head-to-head randomised controlled study designed to enrol about 1,000 patients across the United States, Europe and Canada. The trial is comparing DurAVR against commercially available TAVR systems, with a primary endpoint of all-cause mortality, stroke and cardiovascular hospitalisation at one year. FDA clearance to begin the US arm was secured in late 2025, and recruitment is now active, with first patients already enrolled and implanted.

Anteris is seeking to differentiate DurAVR in a field where established systems have largely evolved through incremental design changes and where clinicians often balance ease of delivery against valve performance. Its approach combines a balloon-expandable delivery system — preferred for its speed and control — with haemodynamic characteristics more typically associated with self-expanding valves, aiming to deliver improved blood flow while maintaining procedural familiarity.

In 100 severe aortic stenosis patients with small annuli — a cohort where prosthesis-patient mismatch is more common — the company reported encouraging safety and performance outcomes, with a mean effective orifice area of 2.2 square centimetres, a mean pressure gradient of 8.2 mmHg, no valve-related mortality, no moderate or severe paravalvular leak and prosthesis-patient mismatch in just 3% of patients.

Anteris’ position was strengthened further in January, when it completed a US$320 million capital raise that included a US$90 million strategic investment from Medtronic. That backing matters not just because it funds trial execution and manufacturing expansion, but because it offers a strong signal that even one of the market’s biggest incumbents sees value in differentiated innovation within TAVR.

Smaller players are finding narrower ways in

Anteris is not the only smaller listed company trying to carve out space in cardiovascular care.

EBR Systems Inc (ASX:EBR) has already crossed an important threshold, securing FDA approval for its WiSE cardiac resynchronisation therapy system in April 2025 and launching in the US, with the technology aimed at heart failure patients who cannot benefit from conventional lead-based CRT.

Imricor Medical Systems Inc. (ASX:IMR) is approaching the market from another angle: MRI-guided cardiac ablation. Its VISABL-AFL trial is assessing the safety and efficacy of atrial flutter ablation using its Vision-MR catheter in the iCMR environment, while the company said in its FY25 results that it has expanded the trial to additional US hospitals and submitted two PMA modules, with later submissions tied to completion of the study.

Artrya Ltd (ASX:AYA, OTC:AYAUF), meanwhile, sits in the diagnostics and software layer of the market. The company says its AI-powered platform analyses coronary CT scans to help detect and manage coronary artery disease, while recent presentations and external research have highlighted work on plaque-based risk assessment and newer automated tools aimed at improving heart attack prediction.

These are very different businesses, but they share a common point: smaller players in cardiovascular care do not need to outmuscle the giants across the whole market. They need to solve a specific problem well enough to matter — whether that is pacing difficult heart failure patients, improving structural valve performance, making ablation more precise or helping clinicians interpret imaging data earlier.

The pipeline is still busy

That is also why cardiovascular medicine still looks more dynamic than it sometimes gets credit for. ClinicalTrials.gov shows multiple late-stage studies under way not only in Lp(a), but also in broader cardiovascular risk reduction.

The next few years are unlikely to produce a single winner-takes-all story. More likely, they will bring a series of narrower gains across different parts of the market: drugs that target residual lipid risk more precisely, devices that make procedures less invasive or more durable, and software that improves diagnosis and patient selection.

For large incumbents, that means defending vast installed positions while still finding room to innovate. For emerging names, it means proving they can turn clinical promise into regulatory progress, commercial partnerships and real adoption.

And for investors, it is a reminder that cardiovascular disease may be one of medicine’s oldest stories — but commercially, it is still being rewritten.