Urinalysis has been an integral part of pathology since ages, yet traditionally it occupies a corner space in any medium to bigger laboratory. But in recent years, urinalysis has been quietly tiptoeing into a new era, using automated urine microscopy and urine chemistry to their full potential. Automation has become a standard norm in the industry and new demand in the market is mostly for such analyzers. Demand for reagents continues to grow, especially with the need to cater to a large installed base of IVD instruments.

Considering the vast scope, majority of the labs/hospitals are moving toward automation to provide cost-effective results with high quality. Mid- to large-size laboratories mainly look out for speed and accuracy. Hence, automated analyzers that provide objective evaluation of urine samples are gaining momentum with their ease of operation and faster turnaround time. The continuous-loading analyzers offer added advantages over strip readers such as higher memory, LIS, throughput, and QC.

On the other hand, sedimentation analyzers are proving to be more efficient to those laboratories where the sample load is quite high. Portable and battery-operated urinalysis stimulates the growth of the urine sediment analyzers. In addition, non-dipstick analytes could develop an opportunity for growth. Market trends include development of low-cost urine analyzers and innovations in wthe electronic industry, such as increased memory and enhanced computing power. However, maintaining a comprehensive diagnostic interpretation would be a challenge. Factors such as stringent and varied regulatory environment that delays the launch of product and low adoption rate of fully automated solutions in developing countries might also hinder the growth of the market.

Indian Market

The Indian market for urinalysis instruments and reagents in 2015 is estimated at Rs.114.65 crore. Reagents continue to dominate with 83 percent share, valued at Rs.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.

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 a consumer, whose capacity to pay is limited. However, the gap between entry-level semi-automated instruments and high-throughput semi-automated instruments is closing.

In 2015, India imported 639 units of urine chemistry analyzers estimated at 
USD 379,558. China is the largest supplier accounting for imports worth USD 140,568 followed by Poland and South Korea at 
USD 111,370 and USD 63,989 respectively.

Global Market

Global urinalysis instrument market was estimated at USD 1.37 billion in 2015 and Grand View Research forecasts it to reach USD 2.14 billion by 2022. The huge base of the target population and the observed high, unmet clinical needs in the under-developed regions provide the market with a large pool of opportunities for potential growth. To capitalize on these opportunities, the development of diagnostic tools that can respond to these unmet clinical needs at an affordable price is mandatory.

Furthermore, the growing prevalence of sedentary lifestyle in individuals fuels the epidemic in many regions. However, the lack of adequate healthcare infrastructure in low-income countries is a major restraint in the adoption of the latest diagnostic tools for urinalysis. The provision for carrying out rapid and accurate diagnosis with improved ease-of-use is the core strategy adopted by the key market players for catering to the unmet clinical needs in these regions.

Technological advancements in the instruments are estimated to accentuate the growth of this segment with a CAGR of over 7 percent over the next six years. Fully automated urine strip readers and automated urine sediment analyzers represent the technologically advanced instruments available in the market.

Moreover, the development of wireless communication and miniaturized PoC urinalysis instruments is a boon to the market. These advancements provide single-level access to the results throughout the hospital at the same time.

The growing prevalence of target diseases, such as diabetes, kidney diseases, and urinary tract infections (UTIs) 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.

Urinalysis is found to have the highest application in the diagnosis of UTI with a market share of over 25 percent in 2015, majorly owing to the high prevalence of hospital-acquired urinary tract infections, especially in females, and efficient diagnosis by urinalysis.

Clinical laboratories segment was the largest end-use segment accounting for over 40 percent of the market share in 2015 and their dominion is expected to continue over the forecast period. High procedure volumes associated with these establishments are the primary reasons attributing to its high share.

The rising trend of automation being used in the urine analysis diagnostics is anticipated to provide an ancillary force for the growth of point-of-care and self-testing-based urinalysis devices. The home care segment is estimated to witness a significant growth in the coming decade owing to the aforementioned factors.

North America dominated the overall urinalysis market in 2015. The major driver identified for the large market share includes presence of key market players in the region such as Alere, Inc., Siemens Healthcare, Bio-Rad, and Beckman Coulter. Moreover, introduction of automated urine sediment analyzers such as digital flow morphology and fluorescence flow cytometry coupled with high healthcare expenditure in this region, which is around 14 percent of the GDP, is responsible for the high growth potential of this market.

Asia-Pacific is expected to witness the fastest growth with a CAGR of around 8 percent over the next six years. The increasing penetration rate of advanced urine analyzers, the presence of local urine analyzer manufacturers, and a large base of the target population with unmet clinical needs are expected to reinforce the market growth.

Raghavan, General Manager-Marketing & Business Development, Transasia Bio-Medicals Limited
Industry Speak
Need of Technical Know-How: Urinalysis in Indian Labs

Urinalysis helps clinicians provide accurate and timely diagnosis of various diseases. The global urinalysis market is expected to reach USD 1286 million by 2019 from USD 892 million in 2014, at a CAGR of 7.6 percent. The market is segmented on the basis of products, test types, applications, end users, and regions. Depending on the workload, labs make use of visual or automated strips. Also, chain labs and large hospitals are now switching to sediment analyzers for microscopic analysis.

On technology trends

Manual urine microscopy is a long and tedious process and is generally not considered as a very accurate method, as results are prone to human errors. In recent years, automation is preferred because it provides for accuracy and standardization of results. Automated microscopy is particularly useful as digital imaging allows evaluation of the entire urine sample and enumeration of RBCs, WBCs, crystals, or any other pathological sediment. It is possible to obtain clear and precise pictures of the cells through the digital imager, which aids in proper categorization of the cells. The results can be easily stored and accessed for future reference. At any given time, the laboratory personnel can cross verify to check if the parameters are identified and reported correctly. Once checked, results are released, interfaced, and reported to clinician/patient.

On key growth drivers

Aging population is a leading precursor for the growth of this market. The geriatric population needs frequent urinalysis for detection of various age-related diseases.

On buyer's perspective

Most laboratories still do not use a uniform set of parameters for complete urinalysis. Depending on local clinical requirements and costing, chemical analysis is done for 2, 4, 5, 8, or 10 parameters using dipsticks/urine strips. The workload usually defines the need for using automated strip readers. Automated strip and sediment analyzers will gain greater acceptance, if affordable cost per test is offered.

On challenges and opportunities

Clinical significance and interpretation guidance during urine strip testing is a major challenge for laboratory technicians. Users should be able to understand the possible reason for attaining false results so that they can interpret and report clinically acceptable results. The use of test strips at para-clinics of gynecologists, nephrologists, and diabetologists is a major growth opportunity.

On future outlook

Advanced training programs are the need of the hour for technicians to interpret urine strip and sediment results. This will increase the reliability for urinalysis as an important screening test at all levels of diagnosis.

Raghavan
General Manager-Marketing & Business Development,
Transasia Bio-Medicals Limited

Technology Update

Automation is a key technological advancement affecting the efficiency and accuracy delivered by the new-generation urinalysis instruments and hence, the persistent demand for novel urinalysis instruments and consumables. For instance, the automatic bench-top and portable biochemical urine analyzers, automated urine sediment analyzers, and automated microscopic urine analyzers are the next-generation, advanced instruments anticipated to foster the urinalysis market growth.

The introduction of CLIA-waived urine reagent strips such as CLIA-URS-10, CLIA-URS-10-3PROMO, and CLIA-URS-10-10 provide for an effective screening tool for rapid testing in urine analysis which are estimated to enhance the usage rates of urinalysis reagents thus accentuating the market growth over the next six years. The target population base for urinalysis market is increasing owing to factors such as the rising prevalence of target diseases, misdiagnosis, and low awareness levels pertaining to urine analysis in low-income countries. High incidences of obesity coupled with hypertension, diabetes, and other chronic disorders foster the growth of the urinalysis market.

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.

Urinalysis strip manufacturers have been converting most of their customers to automated systems that read the urine strip. These systems use cell-counting principle similar to that used in flow cytometry and can be used for bacteria detection and enumeration of RBCs, WBCs, epithelial cells, hyaline casts, and other flagged parameters.

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 International Society for Laboratory Hematology (ISLH) guidelines. Urinalysis by flow cytometry helps in sensitive detection of UTI and differentiation of hematuria (isomorphic RBC and dysmorphic RBC information).

Closed urine collection systems are new to urinalysis. The closed sampling system eliminates the need for transferring specimens from the collection cup in the lab and makes the sample available for automated transfer to urinalysis systems.

Automated urinalysis systems incorporate features that enable a complete integrated chemical and microscopic analysis, generally minimizing errors that occur with subjective interpretation of color change on dipsticks or cell counts done by microscopy. Features of these automated systems include automatic mixing of the specimen before each aspiration, archiving of both the results and images upon which the result was generated (to enable easy retrieval of these images and results), and automatic flagging of samples for follow-up testing. Quality of results may also be improved since samples can be processed more efficiently and closer to their collection time, decreasing the likelihood of cell lysis, microbial contamination, or precipitation from prolonged storage.

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.

Kumar Amitabh, Product Manager-Infectious Diseases, Alere Medical Private Limited
Industry Speak
Test Strips - A Step toward Unconventional Testing

Urine analysis is one of the cognitive fronts of diagnostic medicine. This traditional pillar of laboratory diagnostic belongs to the basic screening programs for evaluation of patients of nearly all medical subspecialties. In spite of the automatic, frugal, and rapid development of quantitative and highly differentiated blood tests, the value of qualitative urine analysis is often underestimated. In view of an increasing number of patients with chronic renal diseases, it seems useful to discuss possible future strategies in urine analysis considering the recent methodological and technological developments.

Preliminary screening to exclude non-diseased patients is where the qualitative aspect finds its most prominent use. The qualitative tests with high-diagnostic specificity have sufficed as a basis for their adaptation for primary diagnosis. In addition, these tests can be applied in therapy control in medical practice and self-monitoring. Qualitative testing of urine samples is of diagnostic value only if proper sampling and pre-analytical handling of samples is assured. Performance of the analysis close to the patient offers multiple advantages since they are less time-consuming, offer pre-selection of non-diseased subjects, and offer better control of pre-analytical steps.

The replacement of chemical urine tests by test strips has acted as a step toward the unconventional. The detection limit is adapted to the respective diagnostic needs, aiming high-diagnostic specificity to exclude non-diseased patients. Alere is emerging as a one-point solution for urine chemistry with a broad range of products which includes urine strips, analyzers, and controls.

Recently, the company has launched a new version of urine chemistry analyzer with unique features. Its state-of-the-art design and highly innovative analyzer will offer significant advantage over all available urine analyzers in the market.

Kumar Amitabh
Product Manager-Infectious Diseases,
Alere Medical Private Limited

R Suraj Kumar, Senior Divisional Manager, Customer Support Division, CPC Diagnostics
Industry Speak
i-TRACK - The Ideal Remote Maintenance Tool

In the present, day market scenario, every end-user expects immediate solution, irrespective of the nature of problem. High demand from the patients for immediate results makes it an absolute necessity for instruments to be in working condition at all times. CPC ensures and delivers immediate solutions during breakdowns and provides predictive maintenance to all customers through its online remote support tool, iTRACK. Its support tool is readily available for all end-users across the length and breadth of the country. Be it at St Joseph's Hospital, Baramulla, Kashmir or Dr. Sukumar Hospital in Kulasekaram, Kanyakumari district of Tamilnadu, iTrack support is available on the click of the mouse.

Currently, more than 550 end-users are connected to iTrack across the country and every new installation of fully automated system from CPC is packaged with iTRACK facility by default. When it comes to the success rate, out of the total calls received, 99 percent of the application calls and more than 90 percent of technical calls are solved through iTRACK.

With respect to predictive maintenance, the condition-monitoring process identifies and alerts the iTRACK team, in case of a significant change in instrument parameter and thus preventing possible fault. The team has also been able to provide online training to customers on any aspect of the functioning and usage of the instrument.

All customer support personnel are being provided with high-speed TABs so that they can connect to customer at any given time and even when they are on the move and this makes iTRACK facility available 24×7 all through the year.

With all kinds of developments in technology, iTRACK ensures immediate and better solutions to all its customers.

R Suraj Kumar
Senior Divisional Manager,
Customer Support Division, CPC Diagnostics

Rajesh Patel, Head-Business Operations, Meril Diagnostics
Industry Speak
AMH - A Unique Diagnostic Marker for Ovarian Function

Anti-Mullerian Hormone (AMH) is a 140 kDa glycoprotein that is produced during normal embryogenesis by the Sertoli cells of the embryonic testis. It causes involution of the Mullerian duct and inhibits female gonadogenesis by inducing apoptosis of target gonadal cells. AMH causes apoptosis of specific Mullerian-inhibiting substance (MIS) receptor bearing cells, while having no effect on cells without receptors.

AMH is secreted by the Sertoli cells in males. During embryonic development in males, AMH is responsible for Mullerian duct regression. AMH continues to be produced by the testes until puberty and then decreases slowly to residual post-puberty values. In females, AMH is produced by the granulosa cells of small growing follicles from the 36th week of gestation onwards until menopause when levels become undetectable. Potential clinical applications of low-end AMH have been published in premature ovarian insufficiency, ovarian tumors, menopause, and many more.

Based on the levels of AMH, the health quotient of ovarian follicular reserve could be determined. Hence, it is an extremely sensitive marker for ovarian function and an efficient means for the diagnosis of granulose cell tumors. is Meril offers picoAMH enzyme-linked immunosorbent assay kit that promises low-end detection of AMH that is important in many gynecological treatments and research applications. picoAMH ELISA kit facilitates quantitative measurement of ultra-low concentrations of AMH in human serum and other biological fluids. The kit is perfectly suited to measure declining levels of AMH in studies of gonadotoxicity, oncofertility, primary ovarian insufficiency, premature ovarian aging, and menopause that can be considered as the next step to a negative AMH test. picoAMH with a measuring range of 2.0 to 11,000 pg/mL and analytical sensitivity of < 2 pg/mL is the only kit to measure AMH in this range.

It detects the full length and enhanced biologically active non-covalent complex forms of human AMH ensuring accuracy and reproducibility assay-to-assay and lot-to-lot.

Features include specificity and consistency of AMH detection, no detectable cross reactivity to other isoforms of AMH, different conformations of AMH, or other TGF-ß superfamily hormones; and no interference by complement or heterophilic antibodies. Monoclonal antibody pair used in the assay is specific for human AMH and does not detect rat, mouse, porcine, equine, bovine, canine, and ovine AMH. Optimized for dilution in the well; assay can be performed with as little as 5 μL sample size for higher concentrations of AMH, or up to 50 μL of sample when sensitivity down to ~2 pg/mL is required. A picoAMH from Meril Diagnostics promises timely diagnosis and assistance to clinicians for designing therapy that is suitable, safe, and effective.

Rajesh Patel
Head-Business Operations,
Meril Diagnostics

A Kumaran, Senior Area Sales Manager, Mindray Medical India Private Limited
Industry Speak
Countering Traditional Roadblocks

Urinalysis is usually considered to be the most cost-effective and valuable diagnostic procedure available as an initial test for the diagnosis and monitoring of a wide range of disease states. It is also invaluable in ruling out certain disorders (such as UTI, diabetic ketoacidosis, etc.)

Urine is tested manually in a lab by selecting the appropriate reagent strip and completely immersing all reagent pads into the sample and then reading the color formed manually with the chart printed on the bottle. In such manual practices, reading is affected by improper lighting at work place or different color discrimination by the user. There is a lot of variability like timing and expertise on analysis. To overcome these manual strips reading errors, urine chemistry analyzers are used which read the color development on the test pads at very specific times, in a perfect light environment, and report the results in an unambiguous manner. This standardization helps to eliminate variables introduced by various people comparing the colors at non-standardized times in variable light environments, and eliminates the possibility of manual reporting errors. From the simple instruments that read one strip at a time, through those that can read a new strip every six seconds, these systems increase the efficiency of urine chemistry testing.

Apart from these, challenges also remain in the microscopic examination. Major challenges in urine microscopy include no standardization in centrifugation, slide preparation, and slide review; very difficult to manage sample workflow in large labs; no proper documentation or data management, etc. 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 chemistry and sediment analysis. Mindray UA 600T analyzer provides a high throughput of 600 strips per hour with automatic used-strip collection and alarm to empty the waste tray. It has an extended memory of 2000 samples. In EH urine sediment analyzer series, we employ unique technologies like coordinate positioning tracking recognition (CPTR) and dynamic intelligent focusing (DIF) to bring ease in urine sedimentation study.

EH 2080 provides whole-view field microscopic images of the sediment using MV (machine vision) technology. It enables users to continuously load 80 tubes with inbuilt barcode reader facility and data storage capacity of 10 lac test reports including pictures. Expansion of EH range is also possible, as it can receive data from urine chemistry analyzer and integrate into a single urinalysis report.

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

A Kumaran
Senior Area Sales Manager,
Mindray Medical India Private Limited

A Kumaran, Senior Area Sales Manager, Mindray Medical India Private Limited
Second Opinion
Small to Mid-Sized Labs Driving the upward Trend

Clinical laboratories are integral parts of the healthcare industry as a large part of physician's diagnoses are dependent on laboratory tests. With hospital stays of patients getting shorter and contact time between patients and physicians getting short, clinical laboratory services which gather, interpret, and deliver precise information to physicians at the right time are witnessing an increase in demand. Major drivers for clinical laboratory services market include rising incidence rates of chronic diseases, growing global base of geriatric population, and increasing patient awareness levels pertaining to disease diagnosis.

Clinical laboratory services market is segmented on the basis of tests into human and tumor genetics, clinical chemistry, medical microbiology, and cytology and other tests. Growing prevalence of lifestyle diseases such as liver disorders, blood disorders, and cardiovascular diseases is the key factor accounting for its large share. Increasing incidence rates of drugs abuse cases and growing demand for point-of-care tests are also expected to drive the clinical chemistry-based clinical laboratory services market.

India's clinical laboratory market is currently worth over USD 7 billion
 in annual revenues (approximate data) and is likely to grow into a USD 30-35 billion market by 2022, driven by durable demographics and economics. It is witnessing exponential growth, with small to mid-sized laboratories driving the upward trend. However, it is not the mushrooming of new small sized laboratories that will fuel the growth. The adaptation of new business models by existing mid-sized and regional laboratories will propel the proliferation. The industry has seen several new business models surfacing in the last decade. Whether it is the franchise model or bulk volume model or outsourcing model, growth in laboratory footprint is achievable only by looking beyond the conventional model of physician referrals. In every model, the essential part is making the laboratory tests patient-centric. Patient awareness and education has drastically improved in the last few years owing to easy access to information via the Internet. Hence, placing the patient at the core of the laboratory business is the most imperative step in increasing business and taking it to the next level. I anticipate exciting times ahead and expect to see several new innovative models to come into play.

Dr Charandeep Singh Sahni
Director,
Helix Pathlabs, Mohali


 

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