Industry Trends The hemodialysis market is strongly tied to the number of hemodialysis procedures performed, and is expected to grow at a CAGR in the low single-digits over the forecast period until 2023. An average of marginally greater than a single bloodline set is used per hemodialysis treatment, which is due to the fact that

An AV fistula needle enables access to the patient’s circulatory system and permits the flow of blood from the patient, to the dialyzer’s blood compartment and then back into the patient’s bloodstream. An AV fistula needle is used for patients with either an AV fistula or an AV graft; however, they are not required for patients implanted with a dialysis catheter.

Arteriovenous (AV) is the most common method of access for hemodialysis treatment in patients that are suffering from end-stage renal disease (ESRD). AV access can be achieved via either AV fistula or AV graft. The fistula can be made in an extremity, typically in the forearm, where an artery and vein are surgically connected. This connection matures and strengthens over a period of four to six weeks. Native fistulae offer the best patency and durability, in addition to limiting complications such as post-dialysis bleeding and infection. A native fistula is the preferred access technique.

There are two main types of concentrates for hemodialysis: acid and bicarbonate (base). Treated water is mixed with acid and bicarbonate concentrates to form the dialysis fluid (dialysate). Hemodialysate (dialysate) is the fluid and solutes that flows through the dialyzer during a hemodialysis process. After the combination of the bicarbonate concentrate, acid concentrate and water, the final dialysate can contain two or three buffer components, which depend on the acid concentrate used. The buffers are bicarbonate from the bicarbonate concentrate, citrate and/or acetate from the acid concentrate.

Dialysis catheters are used for facilitating dialysis for patients whose kidneys are unable to properly filter water and waste. Most patients treated with dialysis have been diagnosed with end-stage renal disease (ESRD); however, patients suffering from acute kidney failure can also receive dialysis. Glomerular filtration rate (GFR) is a test used to assess kidney function. In turn, patients with chronically low GFRs are diagnosed with chronic kidney disease (CKD). When the GFR drops below the threshold, which is when kidney activity is less than 10% of normal levels, patients are considered to have progressed to Stage 5 CKD or ESRD. Patients with ESRD require a kidney transplant or dialysis. However, many ESRD patients are not suitable candidates for kidney transplants. In addition, there is a shortage of available organs; in the United States, only 20% of patients on waiting lists for kidney transplants will receive a kidney within the first year. Owing to advancement in dialysis technologies, patients receiving dialysis can survive for decades, barring other health problems. Despite this, patients on dialysis have a high mortality rate due to old age and multiple health conditions.

Lumen stenosis can occur due to the accumulation of thrombosis or plaque particles in a similar manner to peripheral arterial disease. The accumulation of these plaque particles has also been shown to cause calcification. Lumen stenosis is a considerable problem for both AV access surgical grafts and native fistulae because they have poor vessel patency. Due to their tendency to acquire blockages, AV access surgical grafts will require revascularization twice a year, and native fistulae will need to be cleared at least once a year.

A hemodialysis machine performs the critical tasks and drives hemodialysis treatments. A hemodialysis machine pumps blood from the body of the patient through a system of bloodlines and into the dialyzer. Dialysis fluids absorb toxins and excess water filtered out of the blood and then removes them from the body. The dialysis fluids are entered into the dialyzer through a separate cycle. Hemodialysis machines mix and monitor the dialysate used in each treatment. Dialysate is the dialysis fluid that serves to remove dangerous and unwanted waste products from the patient’s blood. A dialysis machine also adds an anti-coagulant drug into the blood.

Each hemodialysis treatment undergone by a patient requires the use of a dialyzer. The dialyzer employed by each treatment can be either a single-use or a reuse dialyzer. A single-use dialyzer will be adequate for a single treatment, after which it will be disposed of. A reuse dialyzer is adequate for use on multiple treatments of the same patient. In order to be reused, a reuse dialyzer needs to be reprocessed. The procedure of reprocessing comprises cleaning, testing, filling the dialyzer with sterilant, inspecting, labeling, storing and rinsing the dialyzer before it is used for the next treatment. During the reprocessing, a reuse dialyzer also undergoes a volume test to ensure that the fibers that transport the blood are not occluded, and a pressure test to ensure that the fibers of the dialyzer are not broken. All these steps are performed by automatic equipment, which is the role of the dialyzer reprocessing machine. After reprocessing, the reuse technician will visually inspect the dialyzer to ensure that all critical aspects are up to standard. If the dialyzer passes the final inspection, it will then be labeled, which will show the patients name, the number of times they have used the dialyzer, the date and time of its last reprocessing and the initials of the individual that reprocessed the dialyzer.

In the process of hemodialysis, the dialyzer performs the essential function of the kidney. During a hemodialysis treatment, the dialyzer will clean and remove the toxic substances from the blood. Blood can only be cleaned physically, not chemically. The patient’s blood is essentially filtered inside the dialyzer, and is channeled through the hollow fibers of the dialyzer. The walls of the hollow fibers consist of an ultra-thin membrane and various physical processes enable the removal of harmful molecules, while the critical elements of the blood are retained. The more exact a dialyzer and its membrane are at separating the important molecules from the harmful ones, the more effective the hemodialysis treatment will be.

A hemodialysis patient will be exposed to between 400 to 600 liters of water per week, through their dialysis treatments. To put this in perspective, a person with normal kidney function will be exposed to approximately 15 liters of water per week. To compound that fact, the intestinal barrier and stomach acid of a person offers protection from contaminated water better than the barrier imposed by the membrane of a dialyzer. Furthermore, a functioning kidney can further protect a normal individual by eliminating contaminants in the water; such protection is absent for a hemodialysis patient. As a result, the regulations that govern the purity of drinking water are not sufficient for patients on hemodialysis.

This report analyzes the volume of patients and treatments by type of dialysis in the United States between 2013 and 2023. This market is segmented into the following areas: Patient Population by Type of Dialysis (In-Center Hemodialysis Treatments, Home Hemodialysis Treatments, Peritoneal Dialysis Treatments), Treatments by Type of Dialysis (In-Center Hemodialysis Treatments, Home Hemodialysis Treatments, Peritoneal Dialysis Treatments)