國家科學及技術委員會新竹科學園區管理局

About 1.7 million people suffer from global chronic renal failure or end stage renal diseases which leads to a massive demand for renal disease related testing. Among the patients of end stage renal disease, about 90% of the patients require hemodialysis three times a week while 9% of the patients adopt home peritoneal dialysis. Peritoneal dialysis can be further divided into continuous ambulatory peritoneal dialysis (CAPD) and continuous cyclic peritoneal dialysis (CCPD), based on the time of treatment.

Hemodialysis treatment is the most widely accepted treatment method and the United States is the leading country that adopts such method, followed by Japan and Germany. Taiwan’s acceptance to hemodialysis is also higher than peritoneal dialysis. Hong Kong is the most effective country worldwide to promote peritoneal dialysis, which accounts for 83% of all patients undergoing dialysis. Additionally, New Zealand, Australia and Canada are also considerably effective in the promotion peritoneal dialysis. However, the treatment and care costs associated are considerably enormous regardless of the treatment method.

In the example of Taiwan and similar to Japan, there are about 70,000 patients undergoing dialysis. For this reason, the Health Insurance Administration has already included hemodialysis in the items of diagnosis related groups. In the example of general outpatient hemodialysis, the national health payment points are 3,912 points/session while the actual price upon review and approval is NT3,325/session. The points for the abovementioned items include technical fees, inspection, medication, general materials, special materials, special medication costs (including EPO), and blood transmission for renal anemia. Additionally, if patients also suffer from high blood pressure and diabetes, the related medicine used at dialysis will also be included in the diagnosis related groups, and therefore other special consumable materials may not be applied for costs. The TFDA data shows that the overall claimed points for renal costs in Taiwan in 2012 were 375 billion points with an average of NT0.85 per point claimed. The overall renal dialysis costs reached 32 billion NT Dollars, which leads to huge burden for the medical expenses in health insurance. 

1. Global Hemodialysis Industry Overview

The global renal dialysis market can be divided into products and services, whereas the global renal dialysis market reached 77.8 billion US Dollars in 2012 and is estimated to reach 83.6 billion US Dollars by 2013. Such enormous growth potential is primarily related to the increase of aging population suffering high blood pressure and diabetes in addition to the economic recovery in Asia and East Europe. The United States is still considered the world’s largest market for hemodialysis medical equipment, followed by Europe since it covers more countries. Among the Asian countries, Japan has become the third largest hemodialysis market due to the large population and the aging population over 60 years or older accounts for 29% of the total population. Other Pan-Pacific countries in Asia become the fourth largest hemodialysis market, including Taiwan and China.

The theory of hemodialysis applies principles of diffusion and osmosis to diffuse the toxins or wastes in blood to the renal solution and discharged off the body according when the blood flows through the artificial kidney (known as the artificial semipermeable membrane). The existing hemodialysis treatment requires the use of dialysis machine with accompanying consumable medical materials including: dialyzer known as artificial kidney, blood tubing set, fistulous needle, dialysate, arteriovenous access graft, pump, renal catheter, medical powder, saline, and protection field. Major medicines include EPO, Heparin, Vitamin D, high blood pressure drugs, and diabetes drugs.

Dialyzer is known as renal machine that is a critical instrument for supporting the vitality of patients suffering from renal failure. It uses blood to pump arterial blood through needle, blood tube and dialyzer, and then back to the veins of the patients. The fundamental technique of blood purification comes from the development of hemodialyzer, hence most new blood purification treatment products such as the clinical use on albumin dialysis in liver, septicemia, and high cholesterol treatment all rely on the manufacturing technology of hemodialyzer. The major companies that produce hemodialyzers include Toray, Nikkso, Nippro, and JMS from Japan, Fresenius Medical Care (FMC) from Germany, Baxter and Althin from the United States, and Gambro from Swenden.

Hemodialyzer (also known as artificial kidney) uses semipermeable membrane as tube or micro hollow fibers. It is generally formed by 6,000 to 15,000 micro hollow fibers which include the hollow fiber membrane and tubing structure. After the blood has been drained out, the blood will pass through the micro hollow tubes in inner layer, from top bottom to the out layers of the hollow tube in up bottom direction. The blood and the dialysate flow in opposite direction, using diffusion to clear uremia and dehydrate excess water from the body using venous pressure and negative pressure. Hence, the fundamental performance of dialyzer, the materials of hollow fiber membrane, the size of holes, hole precision and distribution, and the quantity of fiber membrane, are related to the assembly quality. Due to the high-tech and high-capital threshold for medical industries in of R&D and manufacturing in artificial kidneys, there are only five big corporations worldwide are committed in this industry, include FMC, Gambro, Baxter, Asahi, and Toray. 

Hemodialysis tubing is formed by arterial and intravenous tubing that requires sterilization validity with sealed package. It is provided to dialysis patients as the connection between blood circulation and dialyzer during hemodialysis. The product is disposable and can be used only once. Due to the lower technical threshold of this consumable, there are many companies in Taiwan and foreign companies that produce such products, including JMS and FMC.

Apart from the dialyzer, the dialysate (renal solution) is another element for the renal dialysis process, which consumption is enormous while the quality of dialysate also affects the effect of purification. The principle of hemodialysis is to purify the blood inside the body with the use of large amount of dialysate. Foreign companies of such products include Gambro from Sweden and Renal from the United States.

2. Development Overview and Direction for Hemodialysis Industry in Taiwan 

The artificial kidney (dialyzer) has been one of the key imported items for Taiwan in the past. Excelsior Medical and Hi-Clearance Inc. are the two leading agencies for renal dialysis related equipment in Taiwan. The companies control the back-end channels and marketing through investing and operating dialysis centers. Major manufacturers are committed to the production of peripheral related consumables and components, including Bioteq blood tubing sets, administration set, protective shield, Sunder blood tubing sets, piercing needles, administration sets, Perfect Medical scalp needle, hemodialysis tube sets, blood transfusion device, administration device, and syringe . Excelsior and Chi Sheng focus on renal solution solutions. Moreover, Q.S. Control Group also set up factories for blood purification, hemodialysis loop system and related application products and components,

Under the continuous growing trends of renal dialysis market in Asia, more companies are committed to the R&D of such market, including the technical cooperation between SDMI and Polymerex Medical Corp (PMC) which develops the PTA application on the AV Shunt failure pressure meter and catheter accessories for patients undergoing renal dialysis. Fu-Ta Textile Co., Ltd. is also committed in the development of key materials for artificial kidney – medical fiber. Taiyen allied with Hoxen to set up a plant in Southern Taiwan Science Park and produces renal solution. Hexen also purchased German machines to design and produce artificial kidneys. Currently, Sunder Biomedical Technology also set up an assembly factory for artificial kidneys in Tianjin in efforts to access future market in China.

Although the demand for global hemodialysis market increases annually, new brands or new suppliers must be equipped with advantages in costs and quality in order to access the international market under the monopoly of large international corporations. Due to the medical equipment expenses only account for 15% while the renal dialysis services reach as high as 85%, suppliers should also take consideration of service and channel based cooperation apart from seeking or developing renal devices in Taiwan, in order to search for opportunities to lead the development of manufacturing and marketing through services.