The different options available for patients of end-stage renal disease (ESRD) include dialysis (hemodialysis or peritoneal dialysis) or kidney transplantation. Dialysis helps to remove the excessive waste products (including urea and creatinine), fluid, and salt from the body.
Hemodialysis apparatus includes:
- Dialysis solution (dialysate);
- Tubing for transport of blood and dialysis solution; and
- Hemodialysis machine to power and mechanically monitor the procedure.
Dialyzers consist of polyurethane capsule or shell, within which hollow fibers or parallel membrane plates are suspended. The fibers or plates function as a semipermeable membrane across which blood and dialysate flow. Solutes move across the membrane along a concentration gradient (diffusion – smaller molecules) and solvent drag (convection – larger molecules) between the patient’s intravascular compartment and the dialysis fluid. Hemodialysis cleanses the blood mainly by diffusion technique. Fluid removal occurs via a hydrostatic pressure gradient across the dialyzer membrane, which is generated by the dialysis machine.
Though in most HD units single usage of dialyzer is preferred as it reduces the risk of infection and improves the efficiency of dialysis, however, due to cost implications reuse is often done in Indian setup. Dialyzer reprocessing involves four steps: rinsing and cleaning, performance testing, disinfection, and sterilization. Dialyzer reprocessing may be performed manually or with the use of automated equipment.
Dialyzer membrane consists of unmodified cellulose (cuprophan or cuprophane), substituted cellulose, cellulosynthetic, and synthetic noncellulose. Synthetic noncellulose membranes are more biocompatible as compared to cellulose membranes and include polyacrylonitrile (PAN), polysulfone, polycarbonate, polyamide, and polymethylmethacrylate (PMMA) membranes.
Dialysate consists of a combination of various different components including sodium, potassium, calcium, magnesium, chloride, bicarbonate, glucose with water to produce the final solution of dialysate.
The most common contaminants include bacteria, endotoxins, aluminum, copper, and chloramines, all of which can cause various complications. To eliminate these and other contaminants, water may be treated with a combination of various different purification methods including reverse osmosis, deionization resins, and activated charcoal (RO system).
Dialyzer synthetic tubing (arterial line) carries blood from the arteriovenous access to the dialyzer (via dialyzer inlet), whereas a venous line simultaneously carries dialyzed blood (via dialyzer outlet) back to the patient.
Dialyzer machine includes a blood pump to move blood between patient and dialyzer, a delivery system to transport dialysis solution, and monitoring devices. Pressure monitors, guard against excessive suction of blood from, and excessive resistance of blood return to, the patient’s vascular access site. Additional quintessential monitoring devices in the machine include air detector and air trap device to prevent air from entering the circuit, solute concentrate measurement device, temperature sensor, and dialysate urea sensor.
Hemodiafiltration (HDF) is a blood purification method that incorporates a convective, adsorptive-type driving force (with a specially designed filter for more solute removal) in addition to diffusional type. The transmembrane pressure (maintained by a suction pump) causes patient’s plasma to flow across the membrane, pulling large-molecular-weight uremic toxins across the membrane as well. HDF requires the addition of a purified or sterile substitution fluid to be infused back (pre- or post-dialysate) into the blood (via a pump connected to the external dialysate circuit) to replace the outflowing uremic plasma water.
Advantages over standard HD. Enhanced middle- or large-molecule uremic solute clearance, better maintenance of blood pressure and hemoglobin, improved phosphorous clearance, lesser chances of infection as HDF uses ultrapure water, higher clearance of cytokines and other inflammatory mediators, improvement of nutritional parameters of the patient. Retrospective studies have also indicated a survival and cardiovascular benefit of HDF over HD.
Disadvantages. In 4 hours of HDF, an extra 30 L of replacement fluid is infused directly to the patient (versus HD). HDF is at least 1.5 times more expensive (ultrapure water in larger quantity) than HD in Indian scenario and also removes some essential beneficial compounds from the body including protein, albumin, vitamin C, amino acids, peptides, calcium, and the like.
A single hemodialysis session in India with a new dialyzer can cost between `1800 and 3400 (versus 500 dollars in the USA), while a reuse session would cost between `1600 to 2700. The cost of single-use hemodiafiltration would range between `3200 and 4500. If there are no cost constraints, HDF is a preferred option to conventional HD and most big dialysis units in India are progressively increasing the numbers of HDF machines (Nipro/Fresenius).
In our Dialysis unit, we have a total of 18 HD machines (14 for negative patients, 3 for hepatitis C patients, and 1 machine for hepatitis B or HIV) and 2 HDF machines. We have budgeted two more HDF machines for the current financial year.
Market trends. As kidney transplant is still an elusive procedure in India, most patients are put on hemodialysis. The driving force for the ever-increasing demand of dialysis equipment is the exponential rate of growth of non-communicable diseases like diabetes, obesity, and hypertension; and the continuous increase in the geriatric population (most likely to suffer from ESRD). India dialysis market was valued at USD 3.1 billion in 2017. The global kidney dialysis equipment market is touted to accumulate USD 16.5 billion at a stupendous 5.7 percent CAGR (compound annual growth rate) during the assessment period (2018–2023). Hemodialysis segment accounted for over 90 percent revenue share in 2017, and is projected to grow over the forthcoming years. In center, dialysis accounted for more than 70 percent share in 2017.
Market challenges. Consistent innovation in the dialysis equipment market is leading to creation of complex systems that patients and clinicians are having trouble getting accustomed to. The greatest challenge is the lack of instructive training and ease of accessibility of the equipment.
Portable dialysis equipment. Quanta Dialysis Technologies, a United Kingdom organization, has invented a compact portable dialysis machine called the SC+ which is less prone to infections. Outset Medical Inc., a US-based healthcare company has innovated and created Tablo, in which treatment data can easily be sent to cloud storage through wireless connectivity, to perform real-time dialysis.
George Institute of Global Health in Australia recently won an award for developing the world’s first affordable dialysis machine, which uses only a solar panel, a water purifier, and a care station. Key market players of the dialysis equipment market are moving toward miniaturization of the machines due to the ease of its portability and for providing a more affordable form of hemodialysis at home.
Latest in Indian dialysis equipment market:
Duty Exemptions/Union Budget 2016 entailed details of various duty exemptions on certain dialysis equipment thus cutting costs significantly.
National Dialysis Service Program. Announced in the Budget 2016, this program has the potential of increasing the growth of public dialysis equipment (in all district hospitals) to approximately 17 percent as opposed to the current 5 percent growth.
Current challenges in the dialysis equipment market in India:
Hike in import duty. The government recently announced a hike in the import duty which will negate any benefits of duty exemptions. This is because 70 percent parts of a complete dialysis are still imported in India.
Operational constraints. equipment such as Reverse Osmosis (RO) facilities, accessory equipment, dialysis beds, continuous supply of water, and availability of trained technicians and nurses are of scarce supply. Even though duty exemptions will make it easier for district hospitals to get dialysis equipment, they will also require supporting equipment to effectively treat kidney patients.
Indian dialysis Market
Currently some players in the Indian dialysis equipment market include Fresenius, B Braun, Baxter-Gambro, and Nipro. At present, business in the Indian dialysis market is valued as USD 50.0 billion and is expected to grow further. One of the latest developments in the market is the proposed launch of portable dialysis system by Medtronic. Such a machine will be easily transportable in rural India and will require less water, less treatment, and less technician expertise.
Fresenius Kabi and DaVita will augment dialysis market growth in the near future. Fresenius Kabi has focused its efforts on providing superior-quality dialysis. Baxter is implementing strategic initiatives to add improvement in dialysis devices. However, complications associated with dialysis treatment may restrain business growth in upcoming years.