Urinalysis is one of the most commonly ordered laboratory tests, since it is useful in the diagnosis and monitoring of renal and urinary tract diseases. A sample of urine holds key information about the health of a person. Although associated with significant labor and training requirements, manual microscopy remains the gold-standard methodology for urine sediment analysis; however, automated instruments are now becoming a valuable tool in the clinical lab. Automated urinary sediment analyzers are indispensable in terms of improved standardization of measurement and more efficient working.

Various studies have suggested that automated analyzers are very useful for ruling out the presence of pathologic particles in urine. Currently, manufacturers are continually developing new products for urinalysis and intend to deliver a degree of automation that will bring efficiencies and improve turnaround times to reduce labor-intensive and time-consuming urine analysis.

Indian Market Dynamics

 The Indian market for urinalysis analyzers and reagents in 2016 is estimated at Rs. 138.45 crore. Reagents continue to dominate with an 83 percent share, valued at Rs. 115 crore, in 2016 saw a 21 percent increase over 2015. The reagents may be further segmented as 22 percent being used by semi-automated instruments and 78 percent by fully automated ones. The overall market has seen an increase in all segments, albeit there is a gradual transition to fully automatic analyzers, and average unit prices are also on a decline.

The fully automated analyzers segment is estimated at Rs. 8.83 crore, with integrated analyzers seeing maximum growth and now constituting a 51 percent share, valued at Rs. 4.5 crore. This segment is dominated by Beckman Coulter, Sysmex, and Dirui. The urine sediments fully automated instruments have a market share of 36.6 percent, valued at Rs. 3.23 crore and dominated by Sysmex, Beckman Coulter, Iris, and Dirui, while the urine chemistry instruments constitute the balance share, valued at Rs. 1.1 crore and catered to by Dirui, Siemens, and Roche.

There is a new breed of vendors who are gradually making their presence felt. They are able to offer products at extremely competitive prices and are looking at cornering some small tenders. These aggressive players include Alere, URIT, Piramal, Mission (Peerless), Teco Diagnostics, and Avantor.

The semiautomated analyzers segment is estimated at Rs. 14.62 crore, with entry-level analyzers contributing Rs. 5.62 crore, at 1250 units and high-throughput analyzers contributing Rs. 9 crore, at 600 units. Dirui and Transasia dominate this segment. Agappe, Rapid Diagnostics, Iris Healthcare, and Arkray also have presence in this segment.

There is a distinct effort being made by the vendors in creating awareness about the advantage of automation, particularly for urine sediment analyzers. While manual microscopic sediment examination is labor-intensive, time-consuming, and lacks standardization in high-volume laboratories, automated systems are important in terms of time saving and standardization. They simplify laboratory workflow, improve standardization, traceability, and diminish human errors and workload.

Global Market Dynamics

  The global urinalysis market is projected to grow from a valuation of USD 980.1 million in 2016 to USD 1.5 billion in 2024, reflecting a steady CAGR of 5.4 percent, estimates Transparency Market Research. Emergence of portable and battery-operated urinalysis instruments, and increase in adoption of urinalysis in emerging economies is expected to create new opportunities for the urinalysis market.

Consumables lead the product segment by accounting for majority of shares attributing to the introduction of new and advanced reagents and dipsticks, wide use of disposables in urinalysis testing and research, and the utilization of disposables at a larger scale in the market. The instrument segment is expected to expand at a CAGR of 6.8 percent from 2016 to 2024, emerging as one of the most promising product segments.

The market is highly fragmented, with the top five companies accounting for a share of 41.7 percent in 2016. F. Hoffmann-La Roche, Beckman Coulter, Siemens Healthineers, Bayer Healthcare, and Sysmex Corporation have been dominating the scene owing to various business strategies. Acquisition is one of the most successful and widely chosen growth strategies adopted by players to strengthen their position in the market. A case in point would be F. Hoffmann-La Roche's acquisition of GeneWEAVE BioSciences.

Technology Trends

Over the past decade, laboratorians and clinicians have contributed to a long list of requisite features that manufacturers are now working to incorporate into the latest versions of their urinalysis systems. The result is a growing diversity of instruments, shaped especially to meet the needs of those who conduct urine-based testing, in whatever healthcare setting they may be working.

Microscopic examination. Recently, the application of flow cytometry or camera-based optical technologies has opened the door to less time- and labor-consuming methods of examination, which has traditionally been performed manually.  Today, there are a variety of technologies available for sediment analysis. More and more laboratories are looking for automated urine sediment analysis as they may decrease the inter-individual variation and reduce the manual review rate.

Integration. As part of the drive for automation and to do more with less, in the past 5 years or so, laboratories have started looking for integration, that is, combining urine chemistry with urine sediment analysis. When combined, these analyzers may provide a rapid and accurate screening in routine urine analysis. Several companies have partnered to create integrated systems to offer their customers, thus meeting the needs of mid- to high-volume laboratories very nicely.

Quality check. Today, instruments incorporate safety features such as a QC lockout, which prevents an operator from performing a urine test without the instrument first passing required QC tests. This feature helps to ensure that the analyzer remains accurate, reliable, and convenient in daily use.

The greater the sophistication of the urinalysis system, of course, the greater the demands on the QC functions built into its instruments. But manufacturers have taken on the challenge of simplifying and automating such QC functions to keep operators' direct involvement to a minimum.

Connectivity. More and more instruments are being designed in such a way that full feature access depends on technologies that connect instruments to one another as well as to the facility's LIS. Even the smallest benchtop urine analyzer incorporates connectivity capabilities as well as other IT-driven features. Today, analyzers feature easy data management, including a port for data transfer to an external computer or LIS, and safety and backup systems with unique lockout features.

Outlook

The goal of any clinical diagnostic test procedure is to provide critical information in a timely manner so that appropriate actions may be taken, ultimately improving patient outcomes. Automation in urine analyzers enables labs to eliminate operator-to-operator variability, and can also make it possible to look at more fields, to quantify results that were previously qualitative, or to provide more-detailed analysis than would have been possible using manual testing. Diagnostics manufacturers will continue to resolve issues so that labs can do more with less and the automated urine analysis technologies will continue to improve.


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