Routine urinalysis is a cost-effective, non-invasive test used as an indicator of health or disease. Urine chemistry can be completed in a number of different ways, ranging from manual reading of a visual urine test strip to the use of semi-automated analyzers to loading the sample on a fully automated urine chemistry analyzer. There is one thing that all methods have in common – a urine chemistry reagent strip or dipstick.

While urinalysis remains a routinely ordered laboratory test, today most of the emphasis focuses on automating urine microscopy to reduce manual, subjective microscopic work. Urine chemistry analysis is viewed by many as a screening tool that can help in the diagnosis of some common conditions such as urinary tract infections (UTIs), kidney or liver diseases, or diabetes, among others. It is important to remain focused on urine chemistry and better understand common test interferences.

There are several ongoing researches for early detection biomarkers that are expelled into the urine for diagnosis of cancer, fetal renal function, kidney diseases, Parkinson's, Alzheimer's, and also congenital heart disease. But while there have been many such studies, the medical community does not yet seem to be in agreement about which markers are best to use for particular disease states. And until there is some agreement, it is unlikely that vendors will make any large-scale moves toward offering those tests on an automated platform.

urinalysisurinalysis

Urinalysis as a whole is a pretty mature marketplace, but this still gives an avenue for growth and expansion – and one that no doubt every vendor will want to explore.

Indian Market Dynamics

The Indian market for urinalysis analyzers and reagents in 2016 is estimated at 138.45 crore. Reagents continue to dominate with an 83 percent share, valued at 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 8.83 crore, with integrated analyzers seeing maximum growth and now constituting a 51 percent share, valued at 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 3.23 crore and dominated by Sysmex, Beckman Coulter, Iris, and Dirui, while the urine chemistry instruments constitute the balance share, valued at 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 semi-automated analyzers segment is estimated at 14.62 crore, with entry-level analyzers contributing 5.62 crore, at 1250 units and high-throughput analyzers contributing 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. Consumables lead the product segment by accounting for majority of shares. The high market share of this segment is attributed 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. By type of test, the urinalysis biochemical test has held a large share so far, while the microscopic and sediments urinalysis segment will register a high growth rate.

urinalysis

North America dominates the urinalysis market, with approximately half of the world's procedures being done in the US, and is expected to see a stable growth over the next 8 years. Europe is the second-largest market for urinalysis. The increase in number of elderly population in this region is expected to drive the market. Asia-Pacific is another leading regional market and is projected to have the fastest growth, attributed to a rapidly increasing aging population, rise in consumer awareness, increasing prevalence of kidney and urinary diseases, favorable government policies, modernization of healthcare infrastructure, and growing medical tourism industry in developing nations.

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. However, high cost of research and development, shortage of laboratory staff, stringent government regulations, high cost of use of advanced analyzers, and lack of healthcare infrastructure are the key restraints for the market. Nonetheless, the huge base of the target population and unmet clinical needs in under-developed countries is likely to disclose the new avenues for urinalysis market in the near future.

The market is highly fragmented, with the top five companies accounting for a share of 41.7 percent in 2016. F. Hoffmann-La Roche Ltd., Beckman Coulter Inc., 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 Ltd.'s acquisition of GeneWEAVE BioSciences Inc.

Technology Trends

Even though urinalysis is one of the most commonly performed tests in the clinical laboratory, the technologies involved in performing urine testing have not changed much over the years. However, labs are now facing several challenges, among which shortage of skilled laboratory professionals is one of the major ones. They are trying to figure out how to get all of their work done with reduced lab resources, or how to accomplish more work with the same amount of resources. And because of that, they are looking for some type of automated solution that will essentially enable them to do more with less.

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.

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Urine chemistry testing. The great advantages of these tests done with test strips are that they are early indicators, fast and easy to perform, and very cost-effective. Although the common menu for urine chemistry testing is broadly accepted, researchers are keeping an eye out for additional disease markers detectable in urine. In some cases, manufacturers' test strips incorporate pads for additional analytes as a means of expanding the capabilities of the test system.

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.

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Shrink to fit. Making urinalysis readily and efficiently available to clinicians has sometimes been simply a matter of space. Whether in central labs or patient care settings, few healthcare environments have space to spare for bulky instruments. So it is no wonder that manufacturers have been working hard to match the size and capabilities of their offerings to the varied needs of their customers. The small size of the analyzer means that users do not need a lot of bench space to have access to the accuracy and consistency of advanced technology in urine chemistry testing. Size considerations also influence the design of fully automated and integrated urinalysis instruments.

Walkaway capability. One measure of the impact of an automated lab system is its walkaway capability. The instrument allows technologists to load a specimen on the instrument, and then go do other things without hesitation, returning later to review the urinalysis results. This capability really minimizes technicians' hands-on time. Labs that are running 50 or more urine tests per day seek out instruments that provide good walkaway capability. A lab that busy unquestionably has many other things for its staff to be doing, and the premium for skilled laboratory labor is high, so maximizing walkaway time is important.

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, i.e., 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.

Integrating quality check. In recent years, healthcare groups and hospitals have taken ownership of an increasing number of freestanding healthcare clinics and physician practices, including their associated laboratories and diagnostic instruments. As a result, POC coordinators are finding themselves responsible for testing in a much greater variety of settings where patient care is being provided.

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. Not many modern lab instruments have avoided the trend toward greater connectivity, and today's urine analyzers are no exception. 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. The lockout features prevent unapproved users from initiating a test, while permitting specific number of lab-authorized users to perform testing. The system also enforces a restriction so that only the lab administrator can change analyzer settings. As health systems and hospital groups acquire and absorb physicians' offices and clinics into their larger networks, physician office laboratories and clinic labs have a greater need for connectivity with whatever information system the network is using.

Emerging Technologies

urinalysis

Emerging diagnostic platforms, such as biosensors, microfluidics, and lab-on-a-chip technology demonstrate the potential for expedited diagnosis using enhanced screening, molecular pathogen identification, and rapid antimicrobial susceptibility testing (AST). Most developments to date have been targeted toward decreasing the turnaround time and enhancing automated processing in the clinical laboratory, either to improve the yield of the screening assays, thereby reducing the workload of processing negative urine samples, or to improve the throughput for batch processing, as urine is the most common clinical sample. Molecular technologies such as MALDI–TOF are highly sensitive but are largely limited to clinical laboratories with considerable resources. Integrated multiplex-PCR platforms are amenable for POCT but are limited by the lack of quantitative pathogen identification and integrated phenotypic AST.

Next-generation sequencing platforms are emerging as promising tools for challenging clinical scenarios in which infectious agents and noninfectious aetiologies are among the differential diagnosis and a traditional culture-based approach has largely been ineffective. Integrated technology platforms that can be deployed at either POC or in a clinical laboratory and can provide timely diagnostic information (within 3 hours) to direct personalized antibiotic treatment are highly desired.

Biosensors. Advances in microtechnologies and nanotechnologies have resulted in the development of biosensors with integrated microfluidic-handling systems, capable of performing complex molecular assays that are required for detection of pathogens in biological matrices. Biosensors are characterized by fast response, high sensitivity, high selectivity, and the capacity for multiplexed detection. Biosensors are an excellent option for integration into diagnostic platforms as they enable manipulation of small fluid volumes, short assay time, low energy consumption, high portability, high throughput, and multiplexing. Furthermore, smartphones could be integrated into these technologies as the controller unit and readout instrument to enable low-cost, point-of-care applications for biosensors.

Microfluidics. It is a broad discipline that involves the manipulation of reagents and analytes at the micron scale. Appealing features of microfluidics for molecular diagnostics include low reagent and substrate volume, laminar fluid flow, fast thermal relaxation, reduced assay time, and low power consumption, which make these techniques ideal for sample preparation.

Droplet microfluidic devices are currently restricted to research laboratories, but have a high potential for translation for urine diagnostics as these systems have fluid handling and detection capacity. One challenge for clinical translation of droplet microfluidic systems is to produce a compact system that is simple for a laboratory technician to operate.

Microfluidics has transformative potential for accelerating AST, but adoption of these devices in the clinic is still in its infancy. Implementing microfluidic AST devices in clinical settings requires developments to improve accessibility and automation.

Down the Road

Urinalysis may be the oldest form of clinical testing, but that does not mean the field is done making advances to improve patient care. There is still plenty of life left in this mature field – and maybe some surprise achievements still to be found down the road. The next frontier of urine testing may not look like traditional urinalysis, even though it is using urine specimens. There may be new types of devices and instruments involved, and they may approach specimens from an entirely new angle.

However, implementation of any rapid diagnostic test should be used as a complement to thorough clinical evaluation. The analyzers brought to market must maintain cost effectiveness and ease of use to receive greatest benefit from rapid diagnosis.

A. Sivaguru,Product Specialist, CPC Diagnostics Pvt. Ltd.
Industry Speak
Recent Advances in Clinical Chemistry Automation

Automation in lab has witnessed a tremendous growth over the last few years. Today we are able to see a wide range of chemistry analyzers in both hospitals and laboratories. These chemistry analyzers range from entry-level automation to high-throughput analyzers. In recent years, we find huge demand for chemistry analyzers with medium throughput ranging from 200 to 250 tests/hour. This demand is either due to the increase in workload in smaller laboratories or the customers' interest for starting mid-sized laboratories. The analyzers that are preferred by the customers these days lie within its versatility and potential to perform both biochemistry and ISE parameters. Another feature which is expected is the availability of system pack reagents, which most of the mid-sized analyzers lack these days.

Talking about all these trends in the field of analyzers, it is time to speak about the product recently launched, i.e., Turbochem240. It is a compact mid-throughput bench-top analyzer for clinical chemistry and turbidimetry.

The instrument possesses an inbuilt barcode system to enable automatic reagent and sample identification. Washing is more effective with the help of two wash sinks and special programmable wash protocol to avoid carry over. Unique mixing is done by dip-and-sip technique to ensure effective mixing. On-board auto serial dilution for calibrators in Turbochem240 comes handy to do multi-point calibrations.

High water consumption is a major concern in mid-throughput auto analyzers. Most of the mid-sized analyzers consume more than 7–8 liters in an hour whereas Turbochem240, with the help of its intelligent eight-stage washing and drying protocol, brings down the water consumption to 4–5 liters.

ichem 240 – a specially designed system pack for Turbochem240 is manufactured by Jeev Diagnostics, a joint venture between CPC and Awareness Technology Inc. USA. These are ready-to-use reagents, barcoded and easy to handle. These reagents pass through stringent quality control and have got an on-board stability of around 30 days for most of the parameters.

CPC through its online remote support tool, i-track ensures and delivers immediate solutions for both preventive and predictive maintenance, which enhances the uptime and extends the mean time between failures. CPC also has a network of service engineers located across the country.

A. Sivaguru
Product Specialist,
CPC Diagnostics Pvt. Ltd.

Kumar Amitabh,Product Manager, Alere Medical Pvt. Ltd.

"Urinalysis is a diagnostic physical, chemical, and microscopic examination of a urine sample (specimen) and is a common clinical test for adult and pediatric patients. Analysis of the urine aids in the diagnosis of disease. Many types of tests are used in analyzing the urine in order to determine whether it contains abnormal substances indicative of disease. Urinalysis has proven itself as a procedure that can be performed relatively quickly and easily, while providing the doctor with lots of useful information. Urine specimens are readily available and are obtained noninvasively; hence urine testing is well suited for all age group patients. The procedure involves no pain or discomfort, only normal urination, enabling early detection and diagnosis that reduces the scale and cost of treatment. Improving diagnostics is dependent on more efficient use of existing capacity and quicker uptake of new cost-effective testing which can be achieved through urinalysis."

 

Kumar Amitabh
Product Manager,
Alere Medical Pvt. Ltd.

Varun Kumar Sharma,Sr. Area Sales Manager North (IVD),Mindray Medical India Pvt. Ltd.
Industry Speak
From Uroscopy to Urine Particle Flow Cytometry

Urinalysis has been an integral part of pathology since ages, yet traditionally it occupied a corner space in any medium to bigger laboratory. Despite the fact that urinalysis can provide lots of vital information, yet limitations of manual methods including microscopy have affected its clinical utility to a great extent. Biochemical analysis with reagent strips improved the scenario to some extent but challenges remained in microscopy area.

Major challenges were no standardization in centrifugation; no standardization in slide preparation; no standardization in slide review; very difficult to manage sample workflow in large labs; and no proper documentation or data management.

We at Mindray have a core belief that innovation is the only way ahead and we have been successful in bringing refreshing technologies in various fields of healthcare, including urine sediment analysis.

In our EH urine sediment analyzer series, we employ certain unique technologies to bring ease in urinalysis.

CPTR (Coordinate positioning tracking recognition). It uses low-power lens – 1010 (100-fold enlarged) and high-power lens – 1040 (400-fold enlarged). Low-power lens can screen negative samples (takes 10 images), detect and count particles, remembers the coordinates, also identifies casts and epithelial cells. And high-power analysis can Identify RBC, WBC, crystals, yeast, small round cells, and casts classification.

DIF (Dynamic intelligent focusing). It ensures accurate recognition and clarity of images. Once images are captured, image morphology is analyzed by MV (machine vision technology), which offers whole view field microscopic images of sediment.

  • lClosest to the gold standard – manual microscopy
  • lProvides both LPF and HPF images
  • lOperators can review the images to make modification or custom more classification

With above mentioned intuitive methods, we have been able to counter traditional roadblocks in urinalysis and look for a rapidly emerging market in urine sediment analysis.

Varun Kumar Sharma
Sr. Area Sales Manager North (IVD),
Mindray Medical India Pvt. Ltd.

Grieston Fonseca,Asst. Product Manager-Urinalysis & Microbiology,Transasia Bio-Medicals Ltd.
Industry Speak
Technologies to Transform Urinalysis

The global urinalysis market is expected to reach USD 1.91 billion by 2021 from USD 1.32 billion in 2016. Based on the type of test, the urinalysis market is segmented into biochemical urinalysis and sediment urinalysis. The biochemical urinalysis segment has accounted for the largest share of the global urinalysis market in 2016.

On technology trends

Urinalysis results are often marred by variations in method and manual intervention. Automation is transforming urinalysis by improving reproducibility and increasing productivity. Automated methods of urine microscopy provide increased sensitivity for detection of WBCs, RBCs, and bacteria. This in turn results in improved screening out of the false negative results and obtaining more accurate results, leading to enhanced lab efficiency.

On key growth drivers

The rapidly growing geriatric population and rising prevalence of kidney diseases and urinary tract infections are the key factors propelling the growth of this market. Diabetes is estimated to be the fastest growing application segment with a CAGR of over 10 percent owing to a surge in the demand for automated and user-friendly urinalysis products for long-term diabetes management. The home healthcare segment is anticipated to grow at a substantial rate of over 7.5 percent due to availability of technologically enabled point-of-care urinalysis systems. Government policies to promote health awareness accompanied by health insurance industry expansion may positively influence growth.

On buyer's perspective

Surge in demand and rising competition has brought down the cost of test strips/dipsticks for chemical urinalysis. Availability of newer platforms offering different technologies for sediment analysis is soon expected to reduce the costs for complete automation as well.

On challenges and opportunities

Urine test strip results need to be correlated with other parameters as well. It is very important to take into consideration the patient clinical history and subsequent urine culture results while reporting. Moreover, labs are faced with challenges in variation of urine test strip results with those of manual chemical tests and microscopy. These challenges can be eliminated to some extent by use of automation and proper training of the technicians.

POCT-based urine test strip readers in ambulances and para clinics can provide major boost to the segment. The government is planning primary diagnostic screening programs through PPP, which will provide tremendous opportunities.

On future outlook

As mentioned earlier, clinical correlation of urine test results with higher reference tests like urine microbiology culture, etc., is important to understand the significance of urinalysis in screening for major diseases.

Grieston Fonseca
Asst. Product Manager-Urinalysis & Microbiology,
Transasia Bio-Medicals Ltd.

Harshad Bhanushali,Product Manager-Instruments,DiaSys Diagnostics India Pvt. Ltd.
Industry Speak
Urinalysis Testing – Frontline Diagnostic Tool

Urinalysis testing is used as the frontline diagnostic tool in the diagnosis of various metabolic abnormalities and UTIs. Urinalysis is also used as a disease-management tool for the treatment of chronic diseases such as diabetes, chronic kidney disease (CKD), and urinary bladder cancer. Rising kidney diseases owing to change in food consumption habits, accompanied by growing concerns from geriatric population, are among major industry drivers.

The World Health Organization (WHO) predicts that by 2020, chronic diseases will account for about three-fourths of all deaths across the globe. As urinalysis plays an integral role in the diagnosis of such diseases, the urinalysis market is expected to grow significantly in the near future.

The growing prevalence of these target diseases and the introduction of technologically advanced, rapid, non-invasive, and user-friendly tools for urinalysis are estimated to be the major growth drivers of this market.

Asia-Pacific urinalysis market share is expected to witness growth of over 7 percent CAGR up to 2023, mainly due to demand across India and China. Increase in advanced urine analyzers adoption, coupled with large number of untapped population, is forecast to present attractive growth opportunities.

The urinalysis market is broadly classified into product type, test type, applications, end-user, and region. On the basis of product type, it is subdivided into consumables and instruments. The consumables segment accounts for the largest share of the global market. Key reasons to influence demand of consumables segment leading to global revenue is increasing test strips and reagents usage due to self-awareness. Dipstick, disposables, and reagents are the major consumables in the industry.

The major end users of urinalysis systems include hospitals and clinics, research laboratories and institutes, diagnostic laboratories, and home care settings. Clinical laboratories are the dominant segment and account for around 35 percent of the global share. Growing concerns pertaining to hygiene and cleanliness, accompanied by increase in number of hospitals and healthcare centers, should positively drive demand.

Based on applications, the global urinalysis market is segmented into disease diagnostics and pregnancy tests. The disease diagnosis application segment is projected to witness the highest CAGR in the coming years owing to factors such as increasing research for the development of new urinalysis tests for better, early diagnosis of chronic diseases and increasing incidences of chronic diseases.

Harshad Bhanushali
Product Manager-Instruments,
DiaSys Diagnostics India Pvt. Ltd.

Pravin Gundewar,Product Manager-Urinalysis & Biochemistry,Sysmex India Pvt. Ltd.
Industry Speak
Urinalysis Automation – Need of the Hour

Urinalysis market in India is dominated by urine chemistry and is broadly used with limited differentiation between products. Traditional urine microscopy is done by the manual process, which is time consuming and requires a trained medical technician to characterize particles and cells based on their morphology. Also sediment analysis by manual microscopy has lot of limitations.

Need for Automation

Automated urinalysis offers the benefits of convenience, efficiency, and increased sensitivity for detecting renal and urinary tract abnormalities. The true value may lie in the ability to efficiently screen and report out urine samples that lack pathologic findings. In our experience at a large clinical lab, about 70–90 percent of urine samples can thus be screened and reported without the need for a confirmatory manual microscopy, saving a considerable amount of time and labor. Automated sediment analyzers provide improved standardization over manual microscopy.

Advanced Solution for Automation of Urinalysis

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Fluorescence flow cytometry – a proven technology used in high-end cell counters since a long time, offers laboratories with a breakthrough in standardization and automation of urinalysis.

Immediate analysis on native urine without the need for pre-treatment enhances laboratory workflow and reduces turnaround time. It provides standardization in urinalysis that complies with ISLH guidelines. Urinalysis by flow cytometry helps in sensitive detection of UTI and differentiation of hematuria (isomorphic RBC and dysmorphic RBC information).

Future of Urinalysis

Urine sediment automation has been globally available for more than a decade, but in India it has actively started since the last 4 years. Sysmex is the first company to educate the customers on advantages of automation in urine sediment analysis. Now this concept is penetrating in the segment and by the end of this year, the installation base of automated sediment analyzers, with or without integrated urine chemistry, will touch 200.

Total automation in urinalysis will bring quality urinalysis results into labs and bring standardization in urinalysis testing, impacting patient care as a whole.

Pravin Gundewar
Product Manager-Urinalysis & Biochemistry,
Sysmex India Pvt. Ltd.

Sanjaymon KR,General Manager: Business Development,Agappe Diagnostics Ltd.
Industry Speak
Moving toward Localization of the Strips

Urine chemistry market is growing at a faster rate compared to the last decade where the specimen growth was only 4–5 percent annually. The last 5 years have shown a good growth in the segment with CAGR of ~20 percent.

The sale of strips in India do not correlate with the total tests performed annually; this is because of the fact that still 60 percent of the strips are read visually and majority of the customers are cutting the strips reducing the consumption of the strips.

The majority of the sales in urine strips come from the glucose and protein strips, which well correlate with the increase in the diabetic population in India.

Multi-parameter urine strips having 11 to 14 parameters are becoming popular, and it is one of the reasons for the increase in the urine strip reader sales. Handheld systems are also available mainly for the clinician’s office. More players are entering this market with affordable hardware. This market is highly price sensitive and only few players are able to give quality solutions to the customer. It is estimated that urine analysis systems will have a market of Rs. 58 crore in the year 2017.

Urine sediment system which is used for urine sediment analysis is slowly gaining acceptance in the market. One of the reasons for the slow growth in this segment is the high cost of the instrument, consumables, and the cost per test. Majority of the urine estimations are performed in the medium-segment laboratories and the test cost to the patient is very low, which is one of the major reasons for the slow growth in the sediment analyzer segment. Only few systems are installed in India mainly in the corporate segment where the sample volume is very high and there is total laboratory automation.

One of the major growth factors in this segment is the cost of the urine strips, which at present mainly depends on import. With the current growth rate, it is expected that the urine strips reagents business will have a market of Rs. ~200 crore in the year 2017, and the Indian manufacturers are moving toward localization of the strips, which is going to boost the growth in the coming years.

Sanjaymon KR
General Manager: Business Development,
Agappe Diagnostics Ltd.

Dr Somika Sethi,Laboratory Director,Delhi Heart & Lung Institute,New Delhi
Second Opinion
Innovation in Urinalysis

Urinalysis is the detailed analysis of urine to diagnose and treat certain diseases. Urinalysis is performed on small amount of fresh urine, and various physical and chemical parameters are observed. In order to perform urinalysis, different urine analyzers are used with consumables, reagent strips, and various chemicals.

The laboratory environment has been characterized by ongoing rapid and dramatic innovation since the 1980s. Innovation in laboratory technology, which includes both new tests and advances in equipment and testing techniques, has made testing more efficient and automated.

In recent development, analyzers that enable individuals to perform urinalysis via a smartphone have come up. The system works in conjugation with dipsticks for analyzing color changes in the dipstick and providing results.

Not only this, in future just a simple trip to the bathroom can provide up-to-date and useful knowledge to individuals about their overall health. The E-Urinal is a concept-urinal designed by Royce Zhang. The design features a touch screen attached to the top of the urinal that requires interaction before urination. Once the session begins, the individual urinates into the smart-urinal where the built-in sensors analyze the urine in real time. The smart-urinal takes various measurements to provide an overall health score.

By having this technology accessible to the public on a daily basis, individuals will be alerted the moment their urine shows signs of a particular disease (such as kidney failure). This will allow people to get help and treatment immediately and in turn increase their chances of making a full recovery. The smart-urinal will save time and money. Having the smart-urinal in place for early detection will allow doctors to treat the patients before the disease progresses. For example, if the smart-urinal detected the early signs of kidney failure the patient could begin taking medicine before the kidneys actually fail. This could save a patient from having to get a kidney transplant. Lastly, instead of peeing in a cup at a doctor visit, the smart-urinal could enhance this unconformable experience.

The key players in the urinalysis market include Beckman Coulter (US), Roche Diagnostics (Switzerland), Siemens AG (Germany), Sysmex (Japan), and Arkray, Inc. (Japan).

Dr Somika Sethi
Laboratory Director,
Delhi Heart & Lung Institute,
New Delhi

Dr Th. Dhabali Singh,Managing Director,BABINA Diagnostics, Imphal
Second Opinion
Market Trends – Urinalysis

Urine analysis happens to be one of the most commonly ordered tests by clinicians for assessing the urologic conditions of patients and comprise almost one-third of all lab tests. The easiest and most cost-effective device used in urine analysis is paper or dipstick, which allows quantitative or semi-quantitative analysis of urine samples in the shortest possible time by simple observation. The global urinalysis market is expected to reach USD 1.28 billion by 2019 from USD 0.89 billion in 2014, growing at a CAGR of 7.6 percent from 2014 to 2019. Based on the product type, the global urinalysis market has been segmented into instruments and consumables. The instruments segment has been categorized into chemistry analyzers, microscopy analyzers/sediments analyzers (or an integrated one), and portable analyzers. End users in the urinalysis market are hospitals, independent laboratories, physician practices, and at point-of-care (PoC).

Technology Trends

While the visual strip analysis continues to be dominant in the urinalysis market, in the last few years, we have seen gradual growth in the preference for automated or semi-automated instruments. With automated analyzers, the chances of error in reading by the naked eye in visual strips are minimized significantly. The newer equipment also comes with print-ready features and has on-board quality control (QC).

The fully automated instruments have barcode readers integrated into them, which allow easy identification of patients and other demographic details. Added with features like the ability to integrate with laboratory automation system (LIS), these instruments provide an easy walk-away and hands-free capability, minimizing the laboratory technologist’s intervention.

Smart reagents enable temperature and humidity checks and also easy lot-specific calibration of all analytes. Smart strips are featured with watermarks such as hologram or 2-D barcodes that include details like lot number, expiry date, lot calibration, etc.

PoC urinalysis offers fast and accurate results with a wide menu of analytes including (but not limited to) albumin, protein, creatinine, glucose, and urea.

Key Growth Drivers

Increased spending on healthcare and the fast-growing diagnostics sector are major growth drivers. Demand for urinalysis instruments for drug abuse is also on the rise. There is also a gradual shift in the preference from manual analysis to more sophisticated and fully automated instruments.

Dr Th. Dhabali Singh
Managing Director,
BABINA Diagnostics, Imphal

Dr Sanjay Ingle,Regional Technical Head-Mah, MP, and Gujarat, Apollo Diagnostics, Pune
Second Opinion
New Technologies Promise A Dynamic Future

To my mind, few tests have the ability to provide information that can detect and potentially prevent the presence of organ and life-threatening disease the way a urinalysis can. Moreover, urinalysis is a test that has meaning not only at diagnosis but throughout the patient’s course. A lot of people have fallen into the trap of thinking, It’s just urine. Urinalysis remains a potent screening tool for the clinician. No other laboratory test can provide as much information on the status of metabolic, renal, infectious, and urologic functions in the body. Chemistry alone cannot detect casts, crystals, cells, and bacteria, which are critical for early diagnosis of many disease states. Indeed, in an era when failure to quickly detect hospital-acquired infections such as catheter-associated urinary tract infections (CAUTIs) means the loss of significant revenue to a hospital, the need to integrate urine chemistry testing with urine particle analysis is paramount.

Urine qualitative/semiquantitative tests with reagent-strips and microscopic examination (sediments) are most popular and basic clinical laboratory tests. However, the accuracy and precision of those tests have not been more reliable than that of clinical chemistry or hematology, mainly due to the instability of urine specimen and subjective analysis procedure. Automated analyzer with compact size and high quality of both reagent-strip method and sediments (formed elements or particles) has been commonly used in many laboratories and guidelines on urinalysis of JCCLS (Japan), NCCLS (USA), and ECLM (EU) are publishing in succession recently. These advances are expected to lead to a solution for those problems in the urinalysis field. Automated systems have enabled the counting of particles in urine to be standardized. Their superiority over traditional sediment analysis has been well documented, but they have not gained wide acceptance. The reason for this is that sediment analysis has been performed and interpreted for decades. There is also the potential for new biomarkers for ATN, such as NGAL and KIM-1, and urologic cancers along with more traditional urine chemistry tests such as creatinine and µALB to be added to routine urinalysis.

Many labs conclude that the benefit of upgrading a urinalysis workstation will offset the space required. Moreover, there are new systems looming on the horizon which will truly “do more with less” – less space. These integrated platforms require half the bench space of older platforms.

Urinalysis has a dynamic future. New technology for instrumentation, new biomarkers, and new appreciation for the importance of urinalysis in modern medicine are combining to bring the focus back to where laboratory testing started so long ago – while also bringing urinalysis into the 21st century.

Dr Sanjay Ingle
Regional Technical Head-Mah, MP, and Gujarat,
Apollo Diagnostics, Pune


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