An unexciting market

Urinalysis not directly needed for COVID-19 testing is attempting to find relevance.

Urinalysis instruments and reagents not being needed for detecting the coronavirus, unlike their counterpart, the molecular diagnostics, the segment was drastically hurt ever since the virus reared its ugly head, and raged havoc across the world. However, the values of urinary disorders such as urinary tract infections, kidney disease, and diabetes vary when comparing urine samples of normal patients with those of COVID-19 patients. This mainly happens as the coronavirus affects the kidney organ.

According to a study published in Clinical Chemistry and Laboratory Medicine Journal, the urine sediment analysis revealed the presence of erythrocytes and casts in nearly half of the patients; and a sediment analysis of COVID-19 urine samples detected the presence of myoglobin casts or cellular debris casts, diffused erythrocyte aggregation, and obstruction in the lumen of glomerular, peritubular capillaries without platelets, red blood cell fragments, fibrin thrombi, or fibrinoid necrosis. A urinary sediment analysis study also in acute kidney injury associated with COVID-19 revealed a fair abundance of coarse granular casts and muddy brown granular casts in 75 percent of the cases, whereas half of the specimens revealed the presence of waxy casts, and a smaller fraction contained renal tubular epithelial cell casts.

Similar other studies made urinalysis analysis relevant at these times when other routine tests were at absymal low levels.
Urinalysis has always been a major diagnostic screening test in diagnosing and monitoring nephrological and urological conditions. Until recently, microscopic urine sediment analysis was the most widely accepted urinalysis methodology. However, this time-consuming methodology is associated with extensive analytical errors. Over the past 25 years, new automated technologies and informatics have greatly reduced the labor intensity of urinalysis and have created new technical possibilities.

New technological advances have paved the way for significant progress in automated urinalysis. Quantitative reading of urinary test strips using reflectometry has become possible, while complementary metal oxide semiconductor (CMOS) technology has enhanced analytical sensitivity and shown promise in microalbuminuria testing.

Microscopy-based urine particle analysis has greatly progressed over the past decades, enabling high throughput in clinical laboratories. Urinary flow cytometry is an alternative for automated microscopy, and more thorough analysis of flow cytometric data has enabled rapid differentiation of urinary microorganisms. Integration of dilution parameters in urine test strip readers and urine particle flow cytometers enables correction for urinary dilution, which improves result interpretation. Automated urinalysis can be used for urinary tract screening and for diagnosing and monitoring a broad variety of nephrological and urological conditions; newer applications show promising results for early detection of urothelial cancer.

The introduction of matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOF MS) has enabled fast identification of urinary pathogens. Automation and workflow simplification have led to mechanical integration of test strip readers and particle analysis in urinalysis.

As the information obtained by urinalysis is complex, the introduction of expert systems may further reduce analytical errors and improve the quality of sediment and test strip analysis. With the introduction of laboratory-on-a-chip approaches and the use of microfluidics, new affordable applications for quantitative urinalysis and readout on cell phones may become available.

The Indian market for urinalysis analyzers and reagents in 2020 is estimated at ₹145 crore. Reagents continue to dominate with an 80-percent share, valued at ₹145 crore. The market took a major hit in 2020, and continues to be on lower levels than 2019, since urinalysis has minimal role to play in COVID-19 testing or treatment.

The fully automated analyzers segment is estimated at ₹13.05 crore in 2020. In the semi-automated instruments category, amounting to ₹15.95 crore, the entry level instruments are marginally higher contributing 54 percent to the segment, by value.

One of most popular routine health-screening tests, 2020 has not been a great year for this segment. Molecular diagnostics, the mainstay for COVID-19 testing is completely different. A team in India comprising Supraja Sundaram, Mamta Soni, and Rajeev Annigeri have put forth their study that urine abnormalities predict acute kidney injury in COVID-19 patients. Their results suggest that urine analysis is a simple test, which can be used to predict development of AKI and mortality and may be used for risk stratification of COVID-19 patients, especially in low resource settings. With the opening of the lockdown, 2021 seems more promising, although not expected to reach 2019 levels.

The global urinalysis instruments and reagents market was valued at USD 12.41 million in 2020 and is expected to grow at a CAGR of 12.22 percent from 2020 to 2027 by Market Watch. This is primarily driven by the rising global prevalence of kidney diseases and urinary tract infections, growing geriatric population, introduction of technologically advanced diagnostics, and increasing adoption of point-of-care devices for urinalysis. However, the presence of ambiguous regulatory frameworks hinders growth.The instruments segment is anticipated to show the highest share in the urinalysis market over the next 6 years. The enhanced wireless communication along with the miniaturized instruments for POC urinalysis is contributing to the growth of the market. Such advancements enable the access to the urinalysis results at the same time across the hospital.

Initially, the technique was regarded as a necessary, labor-intensive procedure that provided invaluable but limited information for clinicians. However, in recent years, various innovations have been introduced, and new technologies have been integrated to improve the clinical outcomes of the technique with high-accuracy testing instruments and reagents. Recently, a new generation of analyzers that integrates and automates the two primary functions: chemistry and microscopic particle analysis have been introduced. For instance, the UN-2000 is an integrated system manufactured by Sysmex Corporation. It features the UD-10, a urinalysis digital imaging system, and the UF-5000, a fully automated urine particle analyzer, to increase the efficiency of the urine particle analysis. AVE Science & Technology manufactures the AVE-772 integrated urinalysis analyzer, a combination of a urine-formed elements analyzer and a urine analyzer. This system can analyze 11-14 parameters in the sample with microscopic measurements of cells, including RBCs, WBCs, epithelial cells, crystals, casts, mucus, yeast, and bacteria. Significant advances have been made by improving the quantitative reading of urinary test strips, integrating dilution parameters in test strip readers, and adopting reflectometry and complementary metal-oxide-semiconductor (CMOS) technology to enhance analytical sensitivity.

Key players operating in the global urinalysis market include Urit Medical Electronic Ltd., Acon Laboratories, 77 Elektronika Kft, Beckman Coulter, Sysmex Corporation, Roche Diagnostics, Seimens Healthineers, Arkray Inc., Bio-Rad Laboratories, Quidel Corporation, Cardinal Health, Dirui and Alere Inc.

To gain a significant market share in the global urinalysis market, the key players are now focusing on adopting strategies such as product innovations, mergers & acquisitions, recent developments, joint ventures, collaborations, and partnerships.

For instance, in August 2020, Sysmex America signed an exclusive agreement with Siemens Healthineers that grants North American rights to distribute and service Siemens Healthineers Clinitek Novus automated urine analyzer for hospital and reference laboratory use.

Over the past 25 years, new automated technologies and informatics have greatly reduced the labor intensity of urinalysis, and have created new technical possibilities.

Although dry-chemistry technology for urinary test strips has made limited progress, advances in electronic detection have considerably improved. An interesting recent evolution is the use of smartphones for reading and interpreting urine test strip results. According to the reflectance theory, the reciprocal value of reflectance readings is proportional to the concentration of the measured analyte.

In manual microscopy, several steps, such as centrifugation, decantation, and re-suspension, led to cellular lysis and loss. Progress in informatics and computer technology has enabled the development of automated microscopy based on pattern recognition.

Urine particle flow cytometers (UFCs) have improved count precision and accuracy, compared with visual microscopy and offer significant labor reduction. Clinical studies using UFCs have focused on diagnosis and monitoring of urinary tract infection; localization of the sites of hematuria; and diagnosis, monitoring, and exclusion of renal disease. Depolarized side-scattered light was introduced to improve crystal sensitivity and to better discriminate between RBCs and crystals; however, in contrast to microscopy-based readers, differentiation of crystals is not possible. A popular approach is combining test strips with UFCs for screening purposes either using both strips and UFC or by utilizing the urine strips for parameters unrelated to the UFC-analysed particles. As mechanical coupling of UFCs and test strip readers has been introduced, expert systems now take advantage of the combined information and apply user – definable decision criteria. This implementation significantly reduces microscopy review rates and saves time and labor cost.

In view of the great demand for the development of cost-effective portable readers, pocket-sized urine strip readers can be combined with dipsticks in a device that is capable to send digital information using a smartphone, offering a solution for detecting urological or nephrological diseases in regions with limited availability of experts. Advances in microfluidics have enabled the development of chip-based assays, which might change urinalysis in the years to come. Alongside conventional urinalysis applications integrated microfluidic chips show promise for the quantitative detection of bladder cancer cells in urine. Similarly, microfluidic paper devices have been described for detecting bacteria causing UTIs and sexually transmitted diseases in urine specimens.

Over the past 20 years, automated urinalysis has undergone a technical evolution. In this respect, automated test strip reading provides added value. Further integration of existing technologies may contribute to reduce turn-around times. Consolidation of clinical laboratories has also led to a reduction of their number and has increased the distance between patient and laboratory; this trend creates a major pre-analytical challenge. Despite improvements in standardization, most of errors in urinalysis occur outside of the analytical phase; pre-analytical steps, in particular, are much more vulnerable. As analytical variation has been greatly reduced, more efforts need to be focused on the pre-analytical phase.

The analyzer market continues to be as impacted as the rest of the lab industry with the uncertainty and unpredictability that ensues with the current state of affairs. While the extent of the impact brings ambiguity, the need for clinical laboratory solutions to support medical professionals remains constant.

Regardless of what the future holds for the urinalysis instruments market, the one thing that remains constant is change. And as changes in disease detection and management keep coming, the lab industry and its analyzers will keep meeting the challenges that the new trends present.