Dialyzer Market

Market Overview

The global dialyzer market size was valued at USD 3.65 billion in 2023. It is estimated to reach USD 5.67 billion by 2032, growing at a CAGR of 5.03% during the forecast period (2024–2032). The global dialyzer market is primarily boosted by the surging prevalence of chronic kidney diseases (CKD), which can subsequently lead to end-stage renal disease (ESRD). The patient suffering from this disease increases the demand for dialysis treatment and, subsequently, the dialyzers. Moreover, there has been a surge in the advancement and development of novel dialyzers, enhancing treatment efficiency. This is anticipated to create opportunities for market expansion.

A dialyzer is commonly known as an "artificial kidney." They are alternatively referred to as dialysis machines or hemodialyzers. The primary purpose of this medical procedure is to eliminate surplus waste and fluid from the bloodstream in cases where the patient's kidneys are no longer capable of carrying out this task. Dialyzers consist of a thin, fibrous substance. The fibers create a selectively permeable barrier, allowing tiny particles and liquids to pass.

The dialyzer has four ports, i.e., one inlet and one outlet port for blood and dialysate. The semipermeable dialysis membrane acts as a barrier between the blood and dialysate compartments. The membrane facilitates transport through two mechanisms: diffusion, often known as dialysis, and convection, also known as ultrafiltration. Small solutes are primarily eliminated through diffusion, while bigger components like β2-microglobulin are more efficiently eliminated through convection.

Market Dynamics

Global Dialyzer Market Drivers

Increasing Prevalence of CKD and ESRD

A gradual loss of kidney function is the hallmark of Chronic Kidney Disease (CKD). This progressive illness can lead to a number of complications, such as anemia, hypertension, cardiovascular disease, bone disease, and metabolic acidosis. End-stage renal disease (ESRD) is the ultimate phase of chronic kidney disease (CKD), characterized by the kidneys' insufficient functioning, necessitating dialysis or transplantation for a better quality of life. As per a publication in Elsevier, chronic kidney disease is a gradual illness that impacts over 10% of the global population, totaling over 800 million people.

Due to several factors, CKD and ESRD are projected to become more common. These include the aging population, the growing occurrence of diabetes and hypertension, lifestyle factors including obesity, smoking, and physical inactivity, as well as environmental variables such as pollution and climate change. Consequently, the rising occurrence of CKD and ESRD generates a substantial need for dialysis therapy and dialyzers, leading to the expansion of the dialyzer market.

Rising Demand for Home-Based Dialysis Treatment

Home-based dialysis treatment refers to a form of dialysis where the patient can carry out the procedure at their home, either by themselves or with the help of a caregiver. Home-based dialysis treatment has numerous benefits compared to in-center dialysis treatment, including convenience, flexibility, comfort, independence, cost-effectiveness, enhanced quality of life, and improved clinical outcomes. Home-based dialysis therapy can use peritoneal dialysis (PD) or home hemodialysis (HHD).

Moreover, the surge in demand for home-based dialysis treatment is propelled by factors such as the growing knowledge and education of patients and caregivers, advancements in technology and enhancements in home dialysis devices and dialyzers, government initiatives and policies that provide support, and the increasing preference of patients for self-care and customized treatment. The growing need for dialysis therapy at home drives the demand for dialyzers, particularly high-flux and disposable ones, which are more suited for home use.

Global Dialyzer Market Restraint

High Cost of Dialysis Treatment 

Dialysis treatment is an expensive and prolonged medical process requiring periodic visits to the dialysis clinic or acquiring dialysis equipment and consumables for home usage. The cost of dialysis therapy is dependent upon factors such as the modality of dialysis, the specific dialyzer used, the frequency and duration of dialysis sessions, the geographical location and accessibility of dialysis services, as well as the insurance coverage and reimbursement regulations. As per a publication in PubMed, the mean yearly expense for dialysis treatments per individual in the United States is roughly USD 40,000.

Furthermore, the high expense associated with dialysis therapy imposes a substantial economic hardship on patients and their families, particularly in low- and middle-income nations where access to dialysis services and health insurance coverage are restricted. The excessive expense of dialysis treatment also impacts the profitability and long-term viability of dialysis providers and dialyzer manufacturers, who must contend with escalating operational costs, regulatory adherence, and competitive pricing. Hence, the excessive expense associated with dialysis treatment impedes the expansion of the dialyzer market.

Global Dialyzer Market Opportunities

Technological Advancements

The dialyzer market has a significant opportunity for growth through technological breakthroughs in dialyzer design and performance. These advancements are focused on enhancing the efficiency, safety, and convenience of dialysis treatment and dialyzers. Hence, the market players are introducing innovative devices. For instance, in November 2022, Nextkidney, a MedTech firm based in Bussum, the Netherlands, announced the successful development of Neokidney, the world's inaugural portable hemodialysis system. Neokidney, as reported by the Dutch business, is currently in the advanced research stage and is anticipated to be introduced in the Netherlands by 2024.

Additionally, in January 2021, Quanta Dialysis Technologies Ltd, a British medical technology company specializing in dialysis products and services, announced that it had obtained 510(k) clearance from the US Food and Drug Administration to sell its SC+ hemodialysis system. The SC+ system is known for its compact size, user-friendly design, and excellent performance. By achieving this crucial milestone, Quanta is ready to introduce its portable device to the American market. This device can deliver a dialysis dose equivalent to the current standard of care. Moreover, it is designed to be compact and user-friendly, making it suited for various care settings.

Regional Analysis

Based on region, the global dialyzer market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global dialyzer market shareholder and is expected to expand substantially during the forecast period. The regional expansion is propelled by the widespread occurrence of CKD and ESRD, the extensive acceptance of dialysis, prominent dialyzer manufacturers, and the advantageous reimbursement policies for dialysis in the region. Based on a 2023 study from the CDC, it is anticipated that around 35.5 million individuals, or 14% of US adults, have chronic kidney disease (CKD). This disease has a higher prevalence among individuals who are 65 years of age or older, with approximately 34% of the elderly population in the USA affected by it. Similarly, the prevalence of diabetes in the United States is 38.4 million individuals, accounting for 11.6% of the population. Diabetes is the primary factor contributing to renal disorders, leading to an elevated likelihood of developing CKD and ESDR. Therefore, there is an increasing demand for dialyzers.

Furthermore, the market participants are introducing new products in this market to enhance their position. For instance, in December 2020, Medtronic plc introduced the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine to the U.S. market. After receiving commercial authorization from the U.S. Food and Drug Administration (FDA) earlier this year, the first Carpediem™ systems have been installed. They are already being used at Cincinnati Children's Hospital Medical Center. The Carpediem™ system, the first type, is designed for patients with acute renal injury or fluid overload who require hemodialysis or hemofiltration therapy.

Similarly, in March 2022, Nipro Medical Corporation (Nipro), a prominent manufacturer and supplier of renal, vascular, and medical-surgical products, introduced the SURDIAL™ DX Hemodialysis System to the U.S. market. The SURDIAL™ DX is an advanced hemodialysis system that aims to provide patients and clinicians with an exceptional dialysis treatment experience. These factors contribute to the growth of the regional market.

Asia-Pacific is expected to experience significant growth. The region offers substantial growth opportunities due to its substantial patient population, escalating healthcare investments, and increasing awareness regarding renal disorders. Moreover, numerous institutes and organizations in this region are experiencing a significant increase in research and development efforts to create improved and highly efficient devices. For instance, in 2019, a group of Japanese researchers created a compact dialysis device that is the size of a briefcase. This technology is designed to be used by those with renal disease and is intended to be particularly useful in emergencies where medical assistance is limited. As per the researchers, the device is significantly smaller than traditional portable dialysis machines, around the size of a little fridge. It is 30 centimeters in height, 18 centimeters in width, and 12 centimeters in depth. The apparatus weighs between 3 to 4 kilos, including batteries.

Furthermore, the market participants are strategically increasing their presence in this region by offering innovative products to exploit unexplored opportunities. For instance, in September 2019, Fresenius Medical Care, the global dialysis products and services leader, introduced its 4008ATM dialysis machine in China. The device is specifically crafted to integrate Fresenius Medical Care's stringent quality requirements while minimizing expenses for healthcare systems and catering to expanding market demands. Fresenius Medical Care hopes the 4008ATM will enable more Chinese patients with end-stage renal disease (ESRD) to access high-quality, life-sustaining dialysis therapy. All these factors contribute to expanding the regional market.

Segmental Analysis

The global dialyzer market is bifurcated into flux type, usage type, and end-user.

Based on flux type, the global dialyzer market is segmented into high-flux and low-flux dialyzers. 

The high-flux dialyzer segment dominates the global market. The high-flux dialyzers had the highest market share and are projected to experience the most rapid growth in the forecast period. High-flux dialyzers' improved efficiency and compatibility effectively eliminate large and medium molecules, such as beta-2 microglobulin, from the blood. These dialyzers enable advanced hemodialysis techniques, such as hemodiafiltration and online hemodialysis.

High-flux dialyzers have membranes with bigger pore sizes, allowing for the efficient elimination of larger molecules that regular dialyzers may not effectively remove. It is crucial for individuals undergoing long-term hemodialysis to be aware that the buildup of specific larger toxins can lead to difficulties as time goes on. Moreover, high-flux dialyzers are the preferred choice for home-based dialysis treatment because they reduce the frequency and duration of dialysis treatments. They also provide improved clinical outcomes and enhance the quality of life for patients.

Based on the usage type, the global dialyzer market is bifurcated into disposable and reusable dialyzers.

Disposable dialyzers are made with one use in mind: they are meant to be used for a single hemodialysis session and then discarded. Disposable dialyzers provide numerous benefits, including minimizing the risk of infection and preventing cross-contamination among patients. They also eliminate the necessity for extensive sterilizing protocols after each use. Moreover, disposable dialyzers enhance safety and efficiency in the hemodialysis procedure. The Government Kilpauk Medical College (KMC) Hospital implemented a new policy in December 2021, mandating the usage of dialysis equipment for a single patient only. Under the Chief Minister's Comprehensive Health Insurance Scheme (CMCHIS), a new disposable dialyzer and AV tubings would be utilized for each dialysis procedure. These initiatives are expected to stimulate the expansion of the segment.

Based on end-users, the global dialyzer market is bifurcated into in-center and home dialysis. 

The in-center dialysis segment owns the highest market share. The increasing demand for in-center dialysis is driven by the presence of skilled medical personnel in hospital-based dialysis centers, leading to improved patient care and expanding the market. Moreover, due to the escalating prevalence of kidney disorders, there is a growing need for dialysis devices at these facilities. Thus, there has been a significant increase in the installation of additional dialysis machines at these facilities. For instance, in October 2020, the Nephrology department at Father Muller Medical College Hospital increased its dialysis capacity by adding three advanced dialysis machines to its existing fleet.

Recent Developments

• August 2023- Quanta Dialysis Technologies®, a medical technology company dedicated to improving the accessibility of kidney care, announced that it obtained clearance from the U.S. Food and Drug Administration (FDA) for an expanded indication of the Quanta Dialysis System hemodialysis devices.
• August 2023- Fresenius Medical Care, the global leader in offering products and services for individuals with kidney diseases, received clearance from the U.S. Food and Drug Administration (FDA) for Versi®HD with GuideMe Software. This innovative software provides a redesigned self-guided interface for the company's VersiHD chronic home hemodialysis (HHD) system.