Current Scenario and Future Prospects Of Dialysis Devices Global Market
Dialysis is the treatment method for the patients with end-stage renal disease (ESRD) or kidney injury until they get kidney transplanted and, for life-time in case of transplanted-kidney rejection and lack of kidney donors. Dialysis often involves diverting blood to a machine that performs the major function of the kidneys with the help of a dialyzer by removing wastes and excess fluid from the blood and then returns the cleansed blood to the patient’s body. The treatment helps to keep the patient body’s electrolytes such as sodium, potassium and chloride in balance. The dialysis devices global market is expected to reach more than 19 billion in 2022 with a CAGR of 4.8% as estimated by IQ4I Research.
Increasing number of ESRD patients & substantial healthcare expenditure on the treatment of ESRD, growing number of patients suffering from diabetes and hypertension, rise in aging population, rising adoption of dialysis procedures over renal transplants, technological advancements and new product launches are driving the market growth whereas the risk and complications associated with dialysis such as low blood pressure, anaemia and infection, product recalls, reimbursement cuts for dialysis in North America and limited reimbursements for dialysis in developing countries, stringent regulatory policies for the approval of new dialysis devices and global efforts to cost containments are hampering the market growth.
The dialysis devices global market by type is mainly segmented into hemodialysis (HD) and peritoneal dialysis (PD) devices. HD requires a man-made membrane (dialyzer) is used to filter wastes and remove extra fluid from the blood whereas the PD uses the natural filter called peritoneum which lines the wall of the peritoneal cavity of abdomen. Both HD and PD are equally effective for most people. However, the selection of PD or HD mainly depends on patient motivation, distance from an HD unit, physician and/or nurse recommendation, and patient education. Hemodialysis devices include hemodialysis machines and their consumables such as dialyzers, concentrates, access products, bloodlines etc., whereas the peritoneal dialysis consists of machines, dialysates and transfer sets. Hemodialysis segment held the largest share in 2015 and is expected to reach $14,453 million by 2022 and the peritoneal dialysis segment expected to grow at highest CAGR of 6.9% during the forecast period as estimated by IQ4I Research.
Based on modalities, the HD can be segmented as conventional, short daily and nocturnal hemodialysis. Conventional is usually done 3 times per week for about 4 hrs, short daily is 6-7 times per week for 1.5-3 hrs at a time and nocturnal is three nights per week for 6-10 hrs at a time. Recent observations showing that an increase in frequency of dialysis and longer dialysis treatment sessions result in better patient outcomes with fewer side effects when compared with conventional method which in turn creating demand for the former modes of treatment. The peritoneal dialysis can be segmented as continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). CAPD can be done by patents themselves whereas the APD uses a machine called a Cycler, which performs exchanges automatically during night. Among the peritoneal dialysis modalities, CAPD is most preferred by the patients with ESRD due to its affordability over APD.
Companies like Fresenius, Baxter and B.Braun are manufacturing dialysis devices and also offering dialysis services to maintain their leadership position which in turn giving substantial competition to the other players in the market. In addition, these companies are also launching new products, acquiring start-up companies & small players, and expanding their business in emerging markets, for instance, in November 2015, Fresenius opened new R&D facility in China to make its world-leading dialysis treatments and technologies more widely available to the patients in China and other emerging markets, and in June 2015, B. Braun acquired Lauer Membran Wassertechnik GmbH, a water treatment systems manufacturing company in Germany to expand their portfolio of water treatment systems for dialysis. However, these companies are depending on secondary source to provide expanded therapies such as home nocturnal dialysis, for instance, Fresenius made an agreement with NxStage under which the Fresenius purchases the NxStage System One (only FDA approved home nocturnal dialysis machine) and related supplies for home hemodialysis therapy in the United States.
The changing population dynamics, economic conditions, technological development, fewer alternatives and increasing awareness of the dialysis are forcing dialysis devices manufacturing companies to invest continuously in research and innovative therapies. But high initial investments for product innovation and global efforts for cost containment are creating pricing pressures. However, stringent regulatory requirements, high capital investments and competition from vertically integrated players such as Fresenius, Baxter and B.Braun are creating strong entry barriers to the new entrants which help the existing players to maintain their shares in the market. In addition, the existing companies facing little demand from the supply side, but in case of difficulty to obtain the secondary source of suppliers, the companies are establishing supply agreements that protect their continuity of supply.
Technological advancements in dialysis are mainly observed in dialysis machines and dialyzers, for instance, Ashahi Kasei, is offering REXEED S series (high flux) and REXEED L series (low flux) dialyzers with REXBRANE membrane, a polysulfone membrane, the most bio-compatible membrane in the market and the membrane has a patented hydrophilic gel layer on the inner surface to minimize the blood membrane interaction and plays an important role in anti-coagulation. In addition to these technological advancements, there are few break-through technologies such as wearable artificial kidney (WAK), implantable artificial kidney (IAK) and Electronic Percutaneous Anastomosis Technology for Haemodialysis (ePATH) which are under development stage and take several years to come into the market if they complete the safety and efficacy studies successfully.
The dialysis devices global market by geography is divided into North America, Europe, Asia-Pacific and Rest of the World (RoW). Europe region commanded the largest market share in 2015 and expected to reach $5,960 million by 2022, at a low CAGR. Increasing incidence of end-stage renal disease (ESRD), increasing hemodialysis facilities, increasing aging populations and increasing awareness of dialysis therapies are driving the European dialysis devices market growth. However, Asia-Pacific region is expected to grow at a highest CAGR of 7.6% during the forecast period due to growing number of ESRD patients, increasing healthcare expenditure, increasing awareness of healthcare, and refining healthcare infrastructure in the emerging countries, such as India and China.
Major players in dialysis devices global market include Asahi Kasei Corp. (Japan), B. Braun Melsungen AG (Germany), Baxter International, Inc. (U.S.), Fresenius SE & Co. KGaA (Germany), JMS Co. Ltd. (Japan), Kawasumi Laboratories (Japan), Nikkiso Co., Ltd. (Japan), Nipro Corporation (Japan), NxStage Medical Inc. (U.S.) and Toray Industries Inc. (Japan).
Some of the other companies operating in dialysis devices global market are Allmed Medical GmbH (Germany), Amecath (Egypt), Angiodynamics (U.S), Arrow International Inc. (U.S.), Ballya International Limited (China), Cantel Medical Corp. (U.S.), Chengdu Weilisheng Biotech Co., Ltd (China), Cook Medical (U.S.), Dialife SA (Switzerland), Farmasol (Turkey), GPC Medical Ltd. (India), KIMAL Plc. (U.K.), Medical Components, Inc. (U.S.), Medionics International Inc. (Canada), Merit Medical Systems, Inc. (U.S.), MITRA Industries (India), Newsol Technologies Inc. (Canada), Outset Medical (U.S.), and Weigao Group (China).