In the US, end-stage kidney disease (ESKD), the final stage of chronic kidney disease (CKD), represents a growing burden, yet investment levels in the kidney care space remain constrained.
Research indicates that over 500,000 people in the US are living with ESKD. Despite this, research to better prevent, treat, and cure kidney diseases is just $19 per patient annually, lagging far behind other chronic conditions such as cancer and Alzheimer’s disease.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
For companies aiming to rethink existing kidney care paradigms, the economics around innovation demand careful rationalisation within a challenging investment landscape.
In the US and globally, CKD goes “mostly ignored”, according to a 2025 article in Nature, which highlights that without action, CKD is projected to become the fifth leading cause of years of life lost by 2040.
An American Society of Nephrology (ASN) report from November 2025 highlights that the US funding imbalance in kidney care has stalled progress, leaving dialysis as the default therapy for kidney failure, despite its “debilitating impact” and poor survival outcomes.
In turn, advocates are growing more vocal about shifting focus on to kidney care, and have urged the World Health Organization (WHO) to classify kidney disease as a non-communicable disease priority globally.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAccording to the National Kidney Foundation (NKF), this recognition would signal to global funders, researchers, and governments that kidney health must be treated with urgency. And with such recognition, advocates’ view is that it would help catalyse the development, and investment in, innovations to improve kidney care.
The resistance to innovation
While kidney care’s attention on the global stage is evidently lagging, in June 2025, Vantive, Baxter’s former kidney care division that was spun out in a $3.5bn divestment deal with global investment firm Carlyle in 2024, pledged to invest $1bn in the kidney care space.
Vantive intends to allocate the funds towards building out a more resilient, scalable supply infrastructure, and patient-centred innovation.
Andrew Shogan, executive vice president and chief business officer at Vantive, comments: “On the innovation side, we are simplifying therapy, enhancing user friendly device design, and expanding digital tools that strengthen connections between patients and care teams.”
With heart, kidney, and diabetes deeply intertwined, California-based company Aventyn is currently recruiting for a clinical trial (NCT07403669) to evaluate the efficacy of CHAPERONE, an artificial intelligence (AI)-based wearable that aims to reduce the burden of cardiovascular-kidney-metabolic (CKM) syndrome by providing users with greater awareness of risk factors, such as high blood pressure that contribute to kidney disease and CKM more broadly.
Kris Vijay, Aventyn’s CMO, argues that kidney care investment in the US is hindered by a stagnant reimbursement system for preventing the progression of kidney disease to ESRD, which discourages investment in “new, potentially more expensive, but better-performing digital health technologies”.
According to Vijay, this problem is exacerbated given that a small number of large dialysis organisations dominate the field, thus further reducing incentives for “risky, disruptive innovation” versus “maintaining the status quo”.
“Innovation in kidney care has been stymied due to the complexity of the organ,” says John Erbey, CEO of Roivios, a company developing a treatment for renal insufficiency.
Erbey’s view is that the high costs and long timelines associated with developing and testing new medical devices for kidney care have also slowed innovation.
“For years, dialysis and transplants have been the primary solutions, but they address only parts of the problem, leaving significant gaps in care,” he says.
Advancing dialysis clinic care
Shogan highlights that new solutions for kidney care must “fit seamlessly” into clinical workflows and align with reimbursement models in the US.
He adds: “Achieving scalable disruption requires innovations that not only deliver measurable clinical and operational value but also remove friction for patients, caregivers, and providers across the continuum of kidney care.”
Dialysis clinics represent the dominant approach to ESKD care. In developing its platform to improve the management of ESRD and ESKD patients’ vascular access when receiving dialysis, PatenSee is focused on unifying the fragmented US kidney care space and articulating the value of its system’s implementation in dialysis clinic care pathways.
The deterioration of a patient’s vascular access for dialysis can prove life-threatening, while complications cost the healthcare system.
According to Eileen Ke, interim US president at PatenSee, vascular access care is challenging because there is no single stakeholder with clear oversight of when a patient’s access is deteriorating or experiences a complication.
“This is why PatenSee’s vision is to create a seamless way to scan a patient’s vascular access and inform all of the relevant stakeholders about the status,” Ke says.
Regarding innovation in kidney care, Ke outlines that it has to make economic sense for multiple stakeholders involved in the care pathway.
“While a technology may make economic sense by reducing complications and resulting in better patient outcomes, it may not make economic sense for the dialysis clinic itself that has to pay for it,” Ke explains.
PatenSee’s platform is currently in development but looking ahead, post-US Food and Drug Administration (FDA) clearance, the company is aware that the economics for its system need to work in both a value-based and fee-for-service system.
Ke explains: “Within a value-based environment, if a patient suffers from a complication, the provider is responsible for the costs. In that case, if PatenSee works in the way that we expect, it’s easy to make a value argument to say that product averts the cost of vascular access complications.”
However, Ke highlights that PatenSee’s economic value must also make sense for dialysis clinics.
“For the clinic itself, if they’re getting paid X amount of money per dialysis session, we believe that we can increase the number of sessions that they can successfully conduct by keeping the patient out of the hospital and making sure that they’re coming in every time that they’re scheduled,” Ke says.
Addressing the transplant burden
While dialysis is important in kidney care, it is not a panacea; it is more of a life-preserving strategy. For patients with ESKD, kidney transplantation is ultimately the most effective means of restoring quality of life over the long-term.
However, kidney donor demand exceeds availability, while innovations like xenotransplantation (pig organ) remain a way out from reaching the market. Research indicates that in 2023, 25,000 people received transplants in the US; however, around 100,000 are still awaiting a transplant. Despite these alarming figures, many organs still go to waste.
Save for kidneys derived from young people who died early, most come from older individuals with comorbidities, raising questions arise about the kidney’s suitability.
A kidney’s viability is often assessed using the Kidney Donor Profile Index (KDPI). However, according to Accunea CEO Rob Learney, such measures can be highly subjective.
British medtech company’s RenoSure system is designed to provide live data using microdialysis technology to continuously measure a kidney’s biomarkers, helping surgeons to assess organ viability and reduce wastage.
Learney says: “The kidney is a dynamic organ, and things change in real time. For this reason, the current evaluative methodologies around getting a single spot measurement aren’t future focused. They’re the best we can do, but not how we should be doing things.”
According to Learney, RenoSure is designed to give surgeons a clearer view of whether a kidney is ‘worry-free’, or if a potential transplant is unlikely to be effective and needs to be discarded.
With RenoSure, Accunea is also trying to address ‘high risk’ kidneys. Known as expanded criteria donors (ECD) in the UK, these relate to kidneys originating from individuals over 55 with certain conditions such as high blood pressure, or donors over the age of 65.
“We want to make those ECD kidneys available,” Learney says. “If you were to take the kidney out of a high risk individual and test the kidney itself [using RenoSure], you may find that you open up a potential 5%-10% more kidney transplants.”
Despite RenoSure’s potential, Accunea has faced difficulty in attracting financing and getting the system to market.
According to Learney, the UK National Health Service (NHS) is a “bad buyer” of innovation, with procurement pathways that can be difficult to access.
“Funding in the UK is difficult because the investors don’t know if they’re going to get a return on investment, because you may never get procured,” Learney says.
Calling this a Catch-22 situation, Learney shares that as a result, more UK-based medtech companies, irrespective of their products in development, turn to private investment, or end up moving overseas.
Meanwhile, for kidney care technologies like RenoSure, other challenges relate to budget and spend.
Learney explains: “We know that one working kidney is worth about half a million pounds over its life, so you can’t really ask for very much money from that out in the market.”
In addition, Learney highlights that kidney transplants are relatively uncommon, so investors see a constrained market.
“They don’t see a market that’s going to suddenly explode and grow. They’ll see a company that’s ticking over, making maybe a couple of 10s of million, but that’s not interesting to them.”
Making a similar point to Ke, Learney adds that the economic models are difficult since the place that may see cost-saving due to a new solution, such as the dialysis unit, may not be the one (in RenoSure’s case, a transplant unit) that has to invest in it.
The future of kidney care
Research by the US Centers for Disease Control and Prevention (CDC) suggests that an estimated 37 million people in the US have CKD, yet 90% do not even realise this, given that symptoms tend not present until CKD’s later stages.
As with in-development solutions such as Aventyn’s CHAPERONE, the future of kidney care may hinge on preventative early-stage tools that target reduction in an individual’s development towards ESKD.
“The future of kidney care includes a personalised approach to reducing risk factors and addressing the individual concerns of each patient,” says Dr Ian Lentnek, medical director and leadership team for point of care at Siemens Healthineers.
“Additionally, earlier detection of disease using a variety of technologies including closer monitoring and AI-enhanced platforms will empower patients to take an active role in their disease management. For those that do progress to later-stage kidney disease, the use of both wearable and implantable technologies will likely help reduce the number of patients who become dependent on dialysis,” Lentnek continues.
The kidney care space is complex. It appears that the lack of recognition around CKD on the global stage, the entrenchment of dialysis as the dominant approach to ESKD, the organ’s complexity, investor appetite, limited technologies for early detection, and economic logistics all play a role in the space’s limited development relative to other chronic conditions.
