From hemodialysis to portable devices and artificial kidneys

Dialysis is undergoing a paradigm shift from traditional hemodialysis to a realm of innovation, encompassing portable and wearable devices, as well as the groundbreaking development of artificial kidneys.

Dialysis, a long-standing technology that partially replicates kidney function, remains the standard treatment for kidney failure. However, its five-year survival rate of 50 percent is lower than that of many cancers, highlighting the need for advancements in renal replacement therapy (RRT).

The prevalence of kidney failure is increasing globally, with approximately 4.7 million patients receiving kidney replacement therapy in 2021. Factors, such as hypertension, diabetes mellitus, an aging population, and events like the Covid-19 pandemic, contribute to this growing number. While kidney transplantation is the only curative option for RRT, it is often limited by availability or patient eligibility, leaving many individuals reliant on hemodialysis or peritoneal dialysis.

The future of dialysis equipment is poised for a remarkable revolution as it shifts away from conventional hemodialysis toward an era defined by the integration of portable and wearable devices, alongside the groundbreaking development of artificial kidneys. This monumental shift aims to not only enhance patient convenience but also redefine treatment efficacy, while providing a remarkable leap forward in the quality of life for individuals facing kidney failure.

Portable and wearable devices in dialysis are set to empower patients with unparalleled mobility and flexibility. These cutting-edge innovations allow individuals to undergo dialysis treatments while effortlessly maintaining their daily routines, ushering in a new era of independence and well-being. By offering continuous or more frequent dialysis, wearable devices have the potential to unlock superior clinical outcomes, and elevate the overall patient experience to unprecedented levels.

Embarking on a path of extraordinary innovation, the future of dialysis equipment will witness the emergence of artificial kidneys. These remarkable bioengineered wonders aim to emulate the intricate functions of natural kidneys, propelling renal replacement therapy into a realm where lasting solutions transcend the boundaries of traditional dialysis treatments. Harnessing the power of regenerative medicine, bioengineering techniques, and cutting-edge organ-on-a-chip platforms, artificial kidneys hold the promise of rewriting the narrative surrounding kidney failure treatment. This seeks to provide better long-term health outcomes and free patients from the burden of multiple weekly dialysis sessions.

Indian market
Currently, Indian market is facing a demand-supply gap. According to the 2011 census, the population of India is 121 billion, with an estimated 3.7 million individuals suffering from end-stage renal disease (ESRD). However, a study conducted by the Indian Society of Nephrology in 2010 revealed that only 55,000 patients were undergoing dialysis. Each ESRD patient requires approximately 156 dialysis sessions annually until they receive a kidney transplant. Consequently, the potential market for dialysis in India is calculated at 577 million sessions per year, worth around ₹57,700 crore at a price point of ₹1000 per session.

Nevertheless, only 30 percent of ESRD patients are aware of their condition, and only 10 percent of those actually undergo dialysis. Therefore, the immediate addressable market accounts for only 3 percent of the total potential, which amounts to ₹1700 crore annually. The lower penetration of dialysis can be attributed to factors, such as the scarcity of medical practitioners, inadequate healthcare services, limited awareness of CKD, and the high cost of dialysis. Increasing awareness levels are expected to expand the market in the future.

The Indian dialysis equipment market is valued at ₹16,640 crore in 2022, expected to grow at a compound annual growth rate (CAGR) of 9.50 percent from 2022 to 2030 to reach an impressive revenue of ₹34,945 crore by 2030.

The government has taken several steps to support the development of the dialysis market in the country. These include the National Dialysis Services Program, which aims to increase access to dialysis services in underserved areas, and the National Health Policy, which aims to provide universal access to healthcare services, including dialysis. The government also provides financial assistance to patients for dialysis treatment through the National Health Mission.

Global market
The global dialysis equipment market is valued at USD 20.55 billion in 2023, expected to grow at a compound annual growth rate (CAGR) of 6.56 percent from 2023 to 2028 to reach an impressive revenue of USD 28.24 billion, according to Market Data Forecast.

The market for dialysis equipment has witnessed substantial growth in recent years due to various factors. One key driver is the global increase in the elderly population, which has resulted in a higher prevalence of chronic kidney disease and, consequently, a greater need for dialysis treatment. This demographic shift has significantly contributed to the expansion of the dialysis equipment market.

Furthermore, there has been a significant rise in research and development expenditures in the healthcare sector, particularly in relation to dialysis. This increased investment has led to the adoption of advanced technologies, thereby improving patient care and enhancing the effectiveness of dialysis treatments. The integration of innovative technologies into dialysis equipment has played a crucial role in driving the market growth.

Moreover, the escalating costs associated with kidney transplants on a global scale have led to a growing demand for affordable and portable dialysis equipment. As the expenses related to transplantation procedures continue to soar, many patients are opting for dialysis as a more accessible and cost-effective treatment alternative. Additionally, the expansion of healthcare infrastructure and the rising number of dialysis patients have contributed to the market’s growth.

Various factors have contributed to the heightened demand for dialysis equipment, including the prevalence of weight loss due to loss of appetite among patients, the adoption of advanced dialysis technologies, the increasing sedentary lifestyle, higher instances of acidosis and heart failure, and the growing number of patients with end-stage renal disease (ESRD). The preference for dialysis over kidney transplantation has also influenced the market positively.

However, there are challenges and limitations that may impede the growth of the global dialysis equipment market in the period from 2023 to 2028. These include the high costs associated with purchasing dialysis equipment and undergoing treatment procedures. Additionally, stringent regulatory requirements, including delays in obtaining licenses from health authorities, can hinder the timely release of new equipment and contribute to increased market prices.

It is expected that the dialysis equipment market will continue to experience rapid growth in the coming years, driven by substantial investments in research and development. However, the recent coronavirus pandemic has significantly impacted various industries, including dialysis equipment, due to travel bans and other restrictions. As a result, companies in this sector may face challenges in the foreseeable future.

Regional insights
North America dialysis equipment market dominated the global market accounting for a 29.8-percent share in 2022. It is driven by well-developed healthcare infrastructure and supportive reimbursement policies. Besides, the increased awareness of the benefits of dialysis, and the easy availability of these machines promotes the regional market’s growth.

Across Asia-Pacific, China has emerged as the dominant player accounting for a significant market share of around 64.6 percent of East Asia dialysis equipment market in 2022. The country has made substantial investments in its healthcare infrastructure, with a particular focus on expanding dialysis centers. The government has implemented measures to encourage the population’s utilization of medical facilities, including dialysis services. This increased emphasis on healthcare spending has had a positive impact on the dialysis equipment industry in China.

Major players
Major companies are developing portable dialysis machines that can be used at home. Some of the prominent players are Baxter, Asahi Kasei Corporation, Fresenius Medical Care AG & Co. KGaA, Cantel Medical, Rockwell Medical, B. Braun Melsungen AG, Nipro, Hemoclean Co., Ltd., Quanta, and Outset Medical, Inc.

Recent advances and their potential applications
Emerging technologies have the potential to revolutionize the field of dialysis equipment and provide new tools for diagnosing and treating kidney disorders. Some of the emerging technologies likely to have a significant impact include:

PeritoneX® is a groundbreaking innovation in peritoneal dialysis (PD) that aims to enhance patient safety and expand access to home dialysis. This in-line connection device is designed to internally disinfect dialysis tubes within the PD system, significantly reducing the risk of peritonitis, an infection of the peritoneal membrane, commonly caused by bacteria entering the patient’s body from touch or air contaminations of PD supplies during treatment setup.

In a laboratory setting, PeritoneX managed a greater than five-log reduction against various bacteria with potential to cause peritonitis. Moreover, patients may be at less of a risk for secondary contamination while using PeritoneX, given that they can continue to receive treatment with the connector in place.

Relavo, Inc., a private medical devices company, focusing on infection-prevention in home dialysis, had been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for USD 1,000,000 in April 2022. In February 2023, NSF again gave an investment to Relavo to further develop its PeritoneX® technology to make peritoneal dialysis (PD) safer for patients.

Portable hemodialysis machines. In recent times, various manufacturers have developed portable and compact machines to enhance patient autonomy, making home dialysis more convenient compared to older technologies. These devices offer patients the freedom to make personalized dietary choices and adjust their treatment schedules to fit their lifestyles, rather than having to revolve their lives around dialysis, as is often the case in traditional in-center settings where the facility sets the schedule.

Wearable artificial kidney (WAK). WAK is an innovative device that integrates a miniaturized dual-channel battery-operated pulsatile pump and dialysate regenerative technology. Since its inception, Gura and colleagues have continuously worked on different iterations of the WAK, culminating in the latest version. Preliminary pilot studies using prototype 1 have demonstrated the device’s effectiveness and safety in terms of solute clearance and fluid removal.

To further enhance its capabilities, version 2.0 was developed with the goal of enabling patients to use the device for up to 24 hours a day, providing a wearable solution for extended-hours hemodialysis as an alternative to the conventional thrice-weekly hemodialysis schedule.

However, a clinical trial involving 10 patients, conducted over a 24-hour period, had to be prematurely terminated due to technical issues associated with the device. These issues included tube kinking, fluctuation in blood and dialysate flow rates, clotting, hemolysis, suboptimal dialysis due to ammonia saturation of the sorbent column, gas bubbles in the circuit, problems with the battery, and the occurrence of premature ventricular contractions in five subjects.

In an effort to address the shortcomings of its predecessor, the newer WAK 3.0 version, weighing only 2 lbs. and equipped with a rechargeable battery, has recently been granted a patent approval. Ongoing studies involving patients will evaluate the viability and effectiveness of this updated model.

Automated wearable artificial kidney in PD (AWAK-PD). In June 2023, AWAK Technologies (AWAK) and Singapore General Hospital (SGH) announced the launch of a pre-pivotal clinical trial with the enrolment of their first subject to study the safety and efficacy of an improved automated wearable artificial kidney peritoneal dialysis (AWAK PD) device. A wearable and ultra-portable peritoneal dialysis (PD) system, it allows patients with end-stage kidney disease to have dialysis on the go and has been granted breakthrough device designation by the US Food and Drug Administration (FDA). The device utilizes a system to recycle peritoneal dialysate, consisting of urease enzymes that convert urea to ammonia. It also incorporates sorbents, such as zirconium phosphate, which adsorb ammonia, potassium, calcium, and magnesium, along with other cations. Additionally, zirconium carbonate is employed to absorb hydrogen ions, phosphate, fluoride, and heavy metals.

3D low-cost equipment for automated peritoneal dialysis therapy. An affordable and innovative 3D equipment solution has been developed specifically for automated peritoneal dialysis (APD) therapy. This system provides cost-effective options for patients in need of APD treatment by utilizing 3D printing technology, which effectively reduces production costs while maintaining the necessary functionality. The primary objective of this new machine design is to enhance the infusion and drainage of dialysate fluid during dialysis therapies. This is achieved by replacing disposable cassettes with peristaltic pumps that allow for regulated and constant flow control.

Furthermore, additional elements have been incorporated into the system to increase its measurement capacity. These elements enable the determination of input and output flows, as well as the detection of turbidity levels during the post-infusion process, effectively mitigating the risk of peritonitis in patients. While the machine already demonstrates improved programming and implementation of mechanisms for therapy execution, the potential for further cost reduction through additional device integration or parameter modification in various therapy types could generate a more significant impact, ultimately making treatments accessible to a broader population.

Bio-artificial kidney. The bio-artificial kidney is an advanced medical device that aims to replicate the functions of a natural kidney. It combines the principles of both engineering and biology to create an artificial system capable of filtering blood and performing other essential kidney functions. It produces an ultrafiltrate that undergoes specialized processing, allowing for the reabsorption of water and electrolytes while eliminating concentrated waste.

Additionally, the bio-artificial kidney incorporates metabolic, endocrine, and immunoregulatory functions, mimicking critical physiological processes of a healthy kidney. This innovative technology has the potential to significantly impact the management of end-stage kidney disease by reducing inflammation, mitigating atherogenesis, and minimizing the progression of renal osteodystrophy. The ideal bio-artificial kidney should be small, lightweight, capable of regulating acid-base balance, electrolytes, and possess appropriate safety mechanisms, particularly for volume control. Some examples of bio-artificial kidneys are the renal-assist device (RAD), the bio-artificial renal epithelial cell system (BRECS), the human nephron filter, and the implantable kidney (the Kidney Project).

The Kidney Project intends to replace dialysis with an implantable bioartificial kidney, one that not only provides better long-term health outcomes but also frees patients from a lifetime of three 4-hour dialysis sessions per week. The ultimate solution would be for everyone on dialysis to receive a new kidney, but there are not enough donor organs available for transplants. So, the work to create an implantable substitute that would replicate the kidney more closely, has been going on since 2004.

The Kidney Project is one of a handful of programs around the world that is attempting to replace conventional dialysis with portable or implantable artificial kidneys. The effort is boosted by the KidneyX prize, a collaboration between the US Department of Health and Human Services and the American Society of Nephrology, which provides money to jump-start innovation in the field. Finding sufficient funding to move the projects along, however, remains a struggle. The Kidney Project needs approximately USD 10 million to reach the first human clinical trial in the next 3 to 4 years.

Implantable artificial kidney (IAK). The implantable artificial kidney (IAK) aims to achieve waste elimination and maintain fluid balance in the body. It combines filtration devices with kidney epithelial cells to replicate the functions of a natural kidney. The IAK has the potential to provide therapeutic benefits without the need for immunosuppression drugs, offering advantages over transplantation. Challenges remain in determining the optimal cell mass and surface area for long-term effectiveness.

Treatment of the future. Exciting new research Waterless Artificial Kidney is currently underway, pushing the boundaries of medical innovation and bringing us closer to groundbreaking advancements in the field. US Kidney Research Corporation supports the research and plans to market the world’s first tabletop artificial kidney, based on a prototype that will ultimately be developed by the Kurtz-Hestekin-Ludlow team.

With substantial funding and the help of expertise team, a prototype device is being created to fit on a desktop, providing convenience and flexibility for patients. This innovation has the potential to offer kidney disease patients more options, greater independence, and a significant reduction in healthcare costs. By enabling daily at-home or office-based treatments with reduced cardiovascular stress, patient quality of life and lifespan may improve.

Moreover, the environmental benefits are substantial, as the elimination of billions of gallons of wastewater from dialysis treatments would reduce strain on water treatment facilities. The development of a waterless artificial kidney would also contribute to a significant reduction in carbon emissions associated with water purification systems, dialysate solutions, and dialyzers, making it particularly advantageous in regions with limited water resources.

What lies ahead?
The future of dialysis equipment is poised for remarkable advancements, with the development of portable and wearable devices, artificial kidneys, and innovative technologies, including PeritoneX®. These innovations have the potential to revolutionize the treatment of kidney failure, offering patients greater convenience, independence, and improved outcomes. With the ongoing research and investment in this field, the future holds promising possibilities for enhancing the quality of life for individuals facing kidney disease, and reducing the burden on healthcare systems worldwide.