- Siemens
- Beckman Coulter
- Roche
- Abbott
- Sysmex
- Nova Biomedical
- Urit Medical
- Arkray
- Opti Medical
- Acon Laboratories
- 77 Elektronika
- Randox Laboratories
(Note: The list of the major players will be updated with the latest market scenario and trends)
Recent developments by key players in Kidney Function Tests Market:
In July 2022- The United States Food and Drug Administration (FDA) granted Healthy.io 510(k) clearance for the Minuteful Kidney test at home. The FDA has cleared this as one of the first smartphone-powered at-home assays to measure albumin to creatinine ratio (ACR).
The prevalence of renal disorders such as chronic kidney disease, polycystic kidney disease, and acute kidney injury is rising, which is one of the main drivers of the market for kidney function tests. Chronic renal illness, associated with high healthcare expenses, mortality, and morbidity, affects 47 million Americans. Because this condition can advance slowly to severe stages, early detection is crucial for implementing effective therapy; as a result, the market is rising in demand for kidney function diagnostic tests. For patients with risk factors, such as hypertension, diabetes, and a history of cardiovascular disease, several guidelines advise at least annual screening with urine albumin/creatinine ratio, whole-blood creatinine, and urinalysis. This is further fueling the market's growth. Moreover, the increased use of digital urinalysis is another sign of the growing need for home diagnostics, driving market expansion. For instance, a digital health start-up from Israel named Healthy.io recognized the trend and developed an at-home smartphone urine test that has been FDA-cleared to help those who want to test their kidneys for proteins. With early detection, kidney disease complications are less likely to happen. Dip.io, disposable cups, and test strips are combined with a smartphone camera to analyze and read the company's pee test results. Rise in R&D initiatives for the development of novel products are also projected to significantly speed up the market growth. However, severe government regulations limiting the use of specific treatments in kidney tests may hinder the market's growth. A kidney test must be performed to look for any indicators that a person may have chronic kidney disease (CKD). As a result, the function test is subject to several strict governmental regulations and must pass through rigorous approval processes. For instance, if the patient has CKD and requires a kidney transplant, it could be challenging for both the patient and the hospitals to follow the proper documentation or bonds mandated by the government legislation. The market for kidney function testing is anticipated to grow slowly due to stringent transplantation rules.