Kidney health and awareness:
It is difficult to forget our middle school biology classes, where we learned that the heart is the pump and the kidneys are the body’s filters — both vital components of a healthy body. Nevertheless, it would seem that most people are not as aware of kidney health as they are of cardiac health. Most people relate “kidney disease” directly to renal failures, transplants, and dialysis. In reality, chronic kidney disease (CKD) is a rather slow process wherein the kidney progressively loses its ability to filter waste and toxins from the blood, eventually reaching a stage called end stage renal disease (ESRD).
In 2016, kidney disease emerged as the ninth leading cause of death in the United States. Of note, it is possible to treat CKD if detected at an early stage; however, most CKD cases are diagnosed in advanced or ESRD stages, where the patients require transplants or dialysis to survive. This is partly because the symptoms of CKD do not show up at earlier stages, which prevents patients from going through a thorough clinical checkup. In addition, even if some clinics are able to detect early signs of CKD, they mostly refer patients to primary care physicians (PCPs), who are more available than nephrologists but generally less aware of CKD management. This suggests that, at present, many patients and healthcare providers at large lack awareness of renal health. For instance, a CDC report from early 2019 stated that 37 million U.S. adults are currently estimated to have CKD, but 90% of them aren’t aware of their deteriorating kidney health.
Global cause and market:
There are multiple causes of CKD, with leading factors being diabetes and hypertension, which together account for roughly 73% of diagnosed cases. Along with the global prevalence of diabetes, the population receiving dialysis and kidney transplants is also on the rise (currently 2 million worldwide). This indicates that the potential market for renal replacement therapies (RRTs) could be quite substantial. RRT is currently the standard-of-care treatment for kidney failures caused by CKD as well as acute kidney injury (AKI, a reversible form of kidney failure). Over 80% of ESRD patients in the United States receive RRT, while around 4% of all critically ill patients require RRT as a result of developing AKI in intensive care units.
RRT includes but isn’t limited to various blood-filtration techniques, such as peritoneal dialysis, intermittent hemodialysis, and continuous renal replacement therapy (CRRT). According to a recent market research report, the global dialysis equipment market is forecast to exceed USD 25 billion by 2024, with North America being the largest target market (estimated to reach USD 7 billion by 2024). Some of the major players in this business include Allmed Group (United Kingdom), Asahi Kasei Medical (Japan), B. Braun (Germany), and Baxter (United States). One of the most recent breakthroughs in this market is the FDA’s 510(k) clearance of Baxter’s PrisMax system, which is an evolution of their PRISMAFLEX technology that provides CRRT to patients with AKI.
Downsides and alternatives to the current renal replacement therapies:
Current forms of renal replacement therapies include hemodialysis, peritoneal dialysis, and CRRT. Hemodialysis products already encompass 80% of the market, whereas the markets for peritoneal dialysis and CRRT are rapidly growing at compound annual growth rates of 7.8% and 7.0%, respectively. However, these current forms of care are extremely expensive and negatively impact patients’ quality of life by putting substantial financial burdens on families and reducing the patients’ autonomy. Patients have to be confined to a machine for several hours a day, three days a week. Moreover, they have to take 20-30 medications a day with restrictions on water and fluid intake. On top of that, these treatments often have poor clinical outcomes. On the other hand, the availability of donor kidneys is extremely low. In the United States, the average wait time for a patient to receive a first kidney transplant is 3.6 years, and over 3,000 new patients are added to the waiting list each month.
To combat this situation, researchers at Cedars-Sinai Medical Center successfully developed a wearable artificial kidney (WAK), which is a portable mini dialysis machine worn outside of the body. This 11-lb device uses less than 400 mL of fluid and had been tested to improve patient outcomes in a preliminary prospective clinical study. The WAK team now plans to conduct two more multicenter trials for FDA approval.
The future – Next generation innovations supporting kidney health:
An ideal solution to the current limitations in renal replacement therapies and the severe shortage of transplantable kidneys would be replacing the dysfunctional kidney with a truly artificial one, not just a wearable dialysis device. Artificial kidney research is now gaining popularity in regenerative and personalized medicine. For instance, 3D printing of a kidney has been a reality since 2011, although researchers are still improving the 3D printing technology for kidneys and other organs. Some companies are already working on implanting 3D-printed biomaterials in humans, although we are likely still two decades away from realizing widespread use of functional 3D-printed organs.
A recent notable development in artificial kidney research a miniaturized hemodialysis system called iHemo, which uses the heart as a pump to drive the filtration and dialysis overnight. Researchers from The Kidney Project (a collaborative effort between Vanderbilt University Medical Center and the University of California, San Francisco), who developed iHemo, now plan to upgrade this technology to an implantable artificial kidney.
iHemo and fourteen other innovations were recently selected as finalists in a tech competition called Redesign Dialysis Phase I, which was organized by KidneyX, a collaboration between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology, whose aim is to help innovate and commercialize new technologies to support renal health. Out of 165 innovations, 15 finalists were awarded a monetary prize of USD 75,000 to fund each of their future developments. Among other winners of the competition, AKTIV (Ambulatory Kidney to Improve Vitality), invented by University of Washington’s Center for Dialysis Innovation, is also noteworthy, as it is a low-cost, wearable, patient-friendly dialysis system that is water-efficient and requires a minimal amount of blood thinners.
How bright is the future of renal health?
The kidney health sector is undoubtedly witnessing major advances at present. However, most of these innovations are still in the research stages and are unlikely to be market-ready within the next decade, given major commercialization costs and stringent regulatory policies for new medical devices. It currently takes up to 7 years for a medical device to receive FDA approval. In addition, manufacturers also need to conduct cost-effectiveness trials to attract insurance providers. Investment in the market of medical devices in the United States is rather low compared to biopharmaceuticals (USD 3.8 billion vs USD 8.1 billion in 2016). Unfortunately, the funding situation in renal health care is even more challenging. According to a Government Accountability Office report from 2017, only USD 564 million out of NIH’s total USD 30 billion budget was allocated to kidney research (less than 2%), whereas Medicare’s spending for CKD and ESRD patients exceeded USD 98 billion in 2015.
Luckily, government authorities are now making better policies to improve renal healthcare. NIH started a Kidney Precision Medicine Project in 2017 for research on the pathophysiology of several kidney disorders, with the hope of advancing targeted nephrology treatments. U.S. President Donald Trump recently issued an executive order to raise awareness of kidney health, improve home-dialysis systems, and support upcoming innovations. Hopefully these efforts will have a positive impact on the commercialization of upcoming renal therapies and enable breakthroughs in future research.
Featured image courtesy of Museum of Veterinary Anatomy FMVZ USP via Wikipedia.
