BK Virus Testing Market: By Sample Extract (Blood and Urine), By End User (Hospitals, Diagnostic Centers, and Others), and Geography

BK Virus Testing Market size was valued at USD 259.1 million in 2023 and is poised to grow at a 12.7% CAGR from 2024 to 2030. The test is ordered for the detection and quantification of the BK virus in the blood or urine. Determination of BK viral load helps diagnose and treat BK virus-related morbidity. BK virus is rarely known to cause a disease but is typically associated with patients who have had a kidney transplant. However, many people who are infected with the BK virus do not show any symptoms. And in case the symptoms do appear, they are mild, such as a respiratory infection or fever. 

The quantification range of this assay is 200 to 100,000,000 IU/mL (2.30 log to 8.00 log IU/mL), with a limit of detection (95% detection rate) at 12 IU/ml. An "Undetected" test result indicates the absence of BK virus (BKV) DNA in the urine. For instance, the increase in the prevalence of the BK virus among adults raises the diagnosis which drives the market. A regular unhealthy lifestyle damages the kidney and lungs which reflect the increase in transplantation numbers across the world showing the generation of BK virus which leads increase in the testing of the virus. The high cost of tests is the major factor that hinders the growth of the BK virus test market. 

BK Virus Testing Market Key Developments:

• In February 2021, Roche announced the U.S. Food and Drug Administration (FDA) 510K clearance of stabilized urine samples to be used with the cobas® BKV Test on the cobas® 6800/8800 Systems.
• In October 2021, Posoleucel (Viralym-M, ALVR105) was approved by the US Food and Drug Administration (FDA) as an Orphan Drug Designation (ODD) for the treatment of virus-associated hemorrhagic cystitis (HC).
• In February 2021, Roche stated the U.S. Food and Drug Administration (FDA) 510K clearance of stabilized urine samples to be used with the cobas® BKV Test on the cobas® 6800/8800 Systems.
• In June 2019, ALVR 105 received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for Viralym-M (ALVR105), a lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, for treating hemorrhagic cystitis (HC) caused by BK virus in adults and children following allogeneic hematopoietic stem cell transplantation (HSCT)