Decades ago, urinalysis was an important tool in the clinical diagnostic toolkit, and it was widely understood to provide the clinician a wealth of information on a patient's condition. It is no secret that urinalysis has been a bit behind in terms of technological advancements, remaining largely unchanged since its early days. With the advent of newer, more descriptive, and more specific serum tests and methodologies, the focus on urinalysis has slipped away, along with precious capital budget funds and educational focus. But the underappreciated discipline just might be primed for a resurgence of sorts, and, as more attention is paid to the quality of test results obtained and the resulting impact on patient care, the oldest form of clinical testing could still offer advances to improve patient care.
In a few years – or perhaps more than a few, but in the foreseeable future – urine may again become the specimen of choice for detecting cancer and other diseases with a genetic component, with the next generation of urinalysis analyzers looking more like their immunoassay or chemistry cousins than the traditional urinalysis platform. New parameters and new clinical applications could be introduced to the market as study evidence builds to support the routine clinical use of urinary biomarkers. In the meantime, advances in automated urine sediment analysis could provide benefits to clinicians that were previously only seen with traditional manual microscopy, bridging the gap between the old and the new, and bringing urinalysis back into the spotlight.
Indian Market Dynamics
The Indian market for urinalysis instruments and reagents in 2015-16 was valued at 114.65 crore. Reagents continue to dominate with 83 percent share, valued at 95 crore.
India is perhaps the last market to have shifted from manual to urine sediment and integrated analyzers, with about 100 installations having taken place in the last three years. Siemens (including Bayer), Dirui, Sysmex, Transasia, and Roche hold sway on this market. Vendors are in a transition phase and are introducing new models gradually. Alere, Beckman Coulter, and Bio-Rad, which are leaders globally, have yet to gain appreciable market share in India.
In spite of this global trend gradually making inroads into the Indian labs, semi-automated instruments continue to have a 66 percent presence in the Indian market, which is dominantly characterized by the consumer, whose capacity to pay is limited. However, the gap between entry-level semi-automated instruments and high-throughput semi-automated instruments is closing.
The urinalysis testing may be viewed as three primary segments – urine chemistry, urine microscopy, and urine culture. Advancement of automated technologies will blur this distinction, with urine cultures being performed increasingly in the same laboratories as urine chemistry and urine microscopy tests and eventually becoming part of the urinalysis market.
Dipstick urinalysis is one of the cornerstones of point-of-care testing, which is relatively inexpensive, robust, easy to perform, painless to patients, and available worldwide. The strip is one of the best options that can be used as a preventative measure and offers a perfect way to get an accurate diagnosis in shorter time. Probably the most significant advancement in urinalysis dipstick testing in recent time was the development of a chemical method for the detection of urine creatinine. With the use of these sophisticated strips which allow urine creatinine to be measured, the spot urine samples can be used for high-precision urine protein measurement, thus avoiding influences from urine dilutions or concentrations.
A typical chemistry module has features available that enable the machine to perform 12 or more chemistry tests simultaneously. Some machines have the ability to hold 200 or more dipstick strips at a time. The modules also include measurement of specific gravity by refractometer. They contain dual wavelength reflectance technology, with color compensation automatically eliminating interferences. The analyzers incorporate technologies like flow imaging and auto-particle recognition (APR) to auto-classify and quantify 12 types of urine particles as well as sub-classification of other urine particles. All urine particles are digitally imaged for recognizable results, automating microscopy completely with no sample preparation.
Automation ensures standardized and traceable results. Systems with continuous loading of test strips, easy user interface, and flexible software settings are the pre-requisites for urinalysis work area automation. Another key differentiator is bi-directional interface, which helps in the integration of urinalysis work area into a lab information system. Multi-parameter urinalysis combined with automation ensures faster processing of urinalysis samples. This enables labs to focus on pathologically relevant samples and enhance quality of reporting.
Future changes may come in the areas of improved reagent performance, miniaturization of urine analyzers, product format changes, and reagent-less detection. These developments may be driven by the need to reduce sample handling while increasing the amount of clinically relevant information obtained from a given sample.
Indian Market Dynamics is based on market research conducted by Medical Buyer in July 2016.