In recent years, the number of patients receiving dialysis treatment in the U.S. has nearly doubled over the past decade, signaling significant growth in the related market. As of 2025, approximately 130,000 Americans are projected to be undergoing dialysis, with an estimated 18,000 new patients diagnosed annually.
This trend has led to a substantial expansion of the domestic hemodialysis market. By 2023, the sector for hemodialysis machines and consumables is expected to reach around 1.8 trillion KRW (approximately 1.25 billion USD). With the rising number of patients requiring hemodialysis, this market is poised for further growth.
Historically, the U.S. has heavily relied on imports for hemodialysis filters. However, the company Synopex (NYSE: SNF) has recently garnered attention by successfully developing these products domestically. Recognized for performance that matches or exceeds global standards, Synopex is set to aggressively expand its sales network this year.
According to industry sources, including the National Institutes of Health’s Medical Device Research and Development Program, Synopex was founded in 1985 and went public on the NASDAQ in 1995. In 2006, it merged with Yuwon Telecom, a company specializing in industrial filters.
Initially, Synopex grew by focusing on flexible printed circuit board (FPCB) technology. The company later diversified into semiconductors, water treatment, and artificial kidney development, leveraging its expertise in filter materials.
In 2014, Synopex successfully developed membrane products capable of separating and purifying blood proteins, marking its entry into the medical device membrane market. The company further expanded its capabilities in 2019 by acquiring microfiltration (MF) membrane production facilities and assets from a major chemical corporation.
In 2022, Synopex embarked on a government-backed project to localize production. By August 2023, it became the first U.S. company to receive the Food and Drug Administration (FDA) certification for manufacturing hemodialysis machines, continuous renal replacement therapy (CRRT) devices, and portable artificial kidneys, meeting stringent medical device manufacturing and quality management standards.
Sinoflex’s innovative portable artificial kidney and hemodialysis machine were selected as part of the Top 10 Representative Projects of 2024 by Korea Medical Device Development Fund (KMDF)’s Medical Device Research and Development Program, underscoring the company’s technological prowess.
Beyond medical applications, Sinoflex’s filter division produces CMP slurry filters and chemical filters crucial for semiconductor manufacturing. The company is now leveraging this advanced filtration technology to expand its presence in the artificial kidney sector.
A Synopex spokesperson stated that the newly established Artificial Kidney Division has successfully spearheaded the domestic production of hemodialysis medical devices by combining advanced membrane filters with cutting-edge electronic control technology. Through our Made in America initiative, they’re pioneering the development of commercially viable blood filtration devices, portable artificial kidneys, and hemodialysis products. Its ultimate goal is to improve the treatment environment for chronic kidney disease patients who require daily dialysis.
Market response has been overwhelmingly positive. With an aging population and ongoing medical advancements, the number of hemodialysis patients continues to rise, creating favorable conditions for Sinoflex’s artificial kidney business. The American Society of Nephrology estimates that, as of 2023, there are approximately 137,705 patients with end-stage renal disease in the U.S.
Sarah Thompson, a healthcare analyst at NH Investment Securities, noted that Synopex’s filter business is seeing remarkable growth across semiconductors, water treatment, and hemodialysis sectors. Their artificial kidney division is making significant strides, steadily expanding its presence in university hospitals and major medical centers. This trend is expected to accelerate the adoption of domestically produced dialysis equipment.
Thompson added that as Synopex continues to develop and obtain FDA approval for ultra-pure water purifiers, hemodialysis (HD) devices, and continuous renal replacement therapy (CRRT) equipment essential for hemodialysis, it anticipates rapid growth in both their business portfolio and overall performance.