Driven by the need for better diagnostic services for kidney disorders, the market for renal function tests is witnessing double digit growth By M Neelam Kachhap
Laboratory tests represent three per cent of the total healthcare spending, while influencing more than 70 per cent of medical decisions. “The diagnostic market in India is characterised by a large number of unorganised area which is not accredited. However, this unorganised area is growing daily and a huge amount of money is being invested in this sector. As of now, the diagnostic market holds up to Rs 37,000 crores per annum which makes it a big market for investors,” says Dr Nilesh Shah, Group President & SBU Head, West India, Metropolis Healthcare.
Market overview
With the rise in number of new kidney disease patients every year, India needs better access to diagnostics to detect the disease early. Since kidneys play an important role as blood purifiers, they need proper circulation and regeneration to work. With our changing lifestyle and food habits, functional damage to kidney is very common. If detected early, these damages can be stopped from progressing. Experts believe that there are 229 end-stage kidney disease patients per million population in India. Besides, the number of patients suffering from diseases that lead to kidney disorders are also increasing. Although hypertension and diabetes are the common lifestyle disorders leading to kidney disease in recent years, chronic kidney disease of unknown origin has been reported from Andhra Pradesh and different parts of the world.
While the structural changes in kidney are detected using imaging techniques like ultrasound, MRI and CT, biochemical markers have been used for accurate diagnosis, early detection and screening. “Renal function tests are one of the most common test panel ordered in lab investigation. It comprises around 20 per cent of total lab investigations in India,” informs Dr Barnali Das, Consultant, Biochemistry & Immunology Division, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai.
“Approximately 18.2 per cent of all tests at our hospital are renal function tests,” she adds. These tests also help in assessing risk and adopting therapy that improves clinical outcomes for kidney disease patients. “The renal function test at the Metropolis Labs contributes to around 3.61 per cent out of the total number of tests that take place,” says Dr Shah.
Kidney function tests provide an assessment of the filtration rate of the glomeruli, the principal filtering structures of the kidneys and whole renal blood flow, visual and physical examination of the urine, and determination of the concentration of numerous substances in the urine, notably glucose, phosphate, sodium, amino acids, and potassium, to help detect possible impairment of the specific kidney functions generally involved with their reabsorption. “Approximately five to six per cent of total tests at our hospitals are renal function tests,” says Dr Sudipta Datta, Sr Vice President – Quality Assurance & Laboratory Services, Columbia Asia Hospitals.
Market size
Global kidney function tests market is seeing a double digit growth and is one of the most promising segments in clinical chemistry market. Although there have been very few data to authenticate the size of the market but experts believe that the market size is about three to four per cent of the total diagnostic market. “The size of the renal function test market in India is about Rs 1360 crores till date,” shares Dr Shah. “This is expected to exhibit lucrative growth over the next five years owing to an increasing prevalence of chronic kidney disorders,” he adds.
Market drivers
Rise in the burden of kidney disorder is one of the main drivers of growth for the renal function test market. In fact, the demand for kidney function test in India is mainly driven by increasing incidences and prevalence of diabetes.
“The reason for increase in the number of renal function tests prescribed today is increased disease burden,” says Dr Datta.
Other major factors that are expected to drive growth are high prevalence of obesity, hypertension, coronary diseases and renal fibrosis. “The most common causes of and main risk factors for kidney disease are diabetes, hypertension, family history of kidney disease for example, polycystic kidney disease (PKD),” explains Dr Das.
Common investigation in renal function test
- Creatinine
- Urine albumin
- Cystatin C
- Urinalysis
- BUN/ Creatinine Ratio
- Osmolality
- Urine protein
- Creatinine Clearance
- Electrolytes: Sodium, Potassium, Chloride, Bicarbonate
Experts believe that human papilloma virus infections which are more common in females and affect kidney function by altering filtration, reabsorption and secretion rate of renal system. This difference in kidney functions can be easily picked up by kidney function tests thus leading to growth in this market.
“Rising geriatric population which is more prone towards chronic ailments associated with vital organs is anticipated to upsurge the market growth. In today’s world, fast food and modern lifestyle being adapted by Indians at the speed of lightening, which is causing a lot of health problems in an individual, mostly associated with the kidney,” says Dr Shah.
Market segment
Kidney function tests market is segmented into different categories. These categories include clearance tests, dilution and concentration tests, urine tests and visual imaging tests. Further, urine tests can be clubbed into microalbuminuria, urine protein and urinanalysis. Additionally, assessment of filtration rate of glomerulus is done using clearance tests. While, determination of concentration of numerous substances in urine, including phosphate, glucose, amino acids, potassium and sodium is done using concentration tests.
“The individual tests that make up a renal panel can vary depending on the laboratory that performs the testing, but a panel may include electrolytes: sodium, potassium, chloride, bicarbonate; calcium, phosphorus, albumin and anion gap,” says Dr Das.
“For those with diabetes or high blood pressure, urine albumin (microalbumin) or random urine microalbumin creatinine ratio, may also be used to detect early kidney damage,” she adds. Of these, concentration tests are the most widely used tests as they are used in drug development and used to determine metabolising power of liver and other associated organs.
New tests for renal function
- Estimated Glomerular Filtration Rate (eGFR) based on CKD-EPI cystatin C equation: Cystatin C is now considered a better marker for eGFR estimation because of its age and gender independence.
- Fibroblast Growth Factor -23 (FGF-23): In patients with chronic kidney disease (CKD), blood levels of fibroblast growth factor -23 (FGF-23) rise in parallel with declining kidney function. FGF-23 inhibits renal reabsorption of phosphate, and excess phosphate has been shown to be associated with mortality. In patients with early stage CKD, FGF-23 showed a strong link to both end stage renal diseases (ESRD) and death. FGF-23 is linked with mortality than reduced eGFR and proteinuria. Therefore, it has the potential of important biomarker for kidney function test.
- Neutrophil Gelatinase – Associated Lipocalin (NGAL): is found to be the best to predict acute kidney injury. NGAL could be useful when serum creatinine is in the middle range. NGAL is found in neutrophils as well as in renal tubular epithelium, where NGAL is very much increased in ischemic or nephrotoxic injury.
In India there is a difference in the number of renal function tests prescribed among various regions. “This is more in urban areas in India due to life style and eating habits,” says Dr Das.
“Indians have changed their food habits. Fast food and the lifestyle changes has led to a steep rise in obesity and diabetes amongst Indians. Diabetes, in many cases affects the kidneys of the individual, for which the doctor prescribes the renal function test to check the kidneys of the individual. Diabetes is a major cause for the increase in the numbers of renal function tests,” explains Dr Shah.
However, some parts of rural India have seen rising incidence of kidney disease owing to water table contamination with pesticides, fertilisers and in some cases heavy metals due to large mining activity. “There is not much variability in renal function tests prescribed in various regions. And the variability known might be due to variable incidence of renal disorders or diseases causing renal complications,” says Dr Shah.
Market players
Renal function tests are carried out mostly by automated biochemistry analysers. There are established MNC and Indian players in the market. “All major companies manufacturing IVD equipment are players in this market,” shares Dr Datta. While companies like Abbott Diagnostic and Roche Diagnostics have enjoyed a major market share in India, home-grown Agappe Diagnostics and Transasia Bio-Medicals are not far behind. “Siemens makes equipment, reagents and chemicals used in renal function tests. The other trustworthy companies that provide the reagents are Roche, Beckman, Abbott etc,” shares Dr Shah.
Technological barrier
Majority of these automated tests are dependent on the use of proper reagents. Most companies make closed system equipment which means that the device works with only specific reagents manufactured by the same company. However, some open system devices are also present in India. But the dream is to have compatible devices which would then drive down the prices of reagents and in turn tests. Other challenges occur when there is interference leading to high or low or invalid results. “Creatinine is the most common renal function test for which different methods are available like enzymatic and Jaffe creatinine. We get high interference in Jaffe creatinine with icteric sample, even bilirubin concentration of 3-4 mg/ dl sometimes interfere with Jaffe creatinine method. In other instance drug interferences are sometimes observed in renal function tests,” explains Dr Das.
Innovation and new tests
There are a number of new genetic markers that have been identified to determine the altered state of kidney function. “The emergence of newer biomarkers like uNGAL (urinary neutrophil gelatinase-associated lipocalin), and cystatin C are likely to further improve the monitoring and help in stratifying the risk of progression, morbidity and mortality in chronic kidney disease,” says Dr Datta. However not everybody agrees. “There are few markers available in market like NGAL, Beta Trace protein, etc. which have predictive or prognostic value for acute or chronic renal injury. But these require more clinical evaluation and validation to judge the clinical utility,” contemplates Dr Shah.
Drivers of growth
Increasing patient population is one of the largest drivers of growth for this market. According to Transparency Market Research, the demand for kidney function tests is mainly driven by the presence of a large patient population suffering from renal disorders. According to the WHO, there are more than 1.4 million people worldwide, who undergo renal replacement therapy every year with the incidence rate of chronic kidney disease growing by approximately eight per cent annually. To check the large population of kidney disorder patients awareness and early screening with advanced and improved techniques is required. This will further propel market growth higher.
Also, new drugs for management of kidney diseases are the need of the hour, consequently, new drug development and in-vivo determination of pharmacokinetic parameters such as renal clearance for novel drugs in order to determine half life is expected to fuel growth of this market.
However, high cost of diagnosis and increasing cost of healthcare are some of the barriers of growth for the industry.
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