The Kidney Function Tests Market is expected to register a CAGR of 5.62% during the forecast period, with a revenue of approximately USD 950 million in 2020, and it is expected to reach USD 1,267 million by 2026.
Kidney function tests are simple procedures that generally use either the blood or urine to assist in identifying issues within the kidneys. The COVID-19 affects the kidney functioning of patients. According to Diagnostic Systems, 2020, over 40% of admitted patients with COVID-19 showed signs of abnormal kidney function, such as albuminuria or hematuria. The market is estimated to grow during the pandemic due to the increasing tests of corona-positive patients globally.
Additionally, as per the research study published in medRXiv, 2020, in adult patients, urinary shedding of COVID-19 was commonly detected in patients with moderate to severe disease. In children, urinary viral shedding of COVID-19 was reported among those who suffered from a mild form of COVID-19. Urinary viral shedding of COVID-19 was detected from day 1 to day 52 after the disease's onset.
Some factors driving the market growth include the rising prevalence of chronic kidney diseases, increasing awareness about the diagnostic methods for the proper functioning of the kidneys, and technological advancements in diagnostic machinery and tools.
According to the research article published in Kidney International, 2019, the total number of individuals with chronic kidney disease (CKD), acute kidney injury (AKI), and those on renal replacement therapy (RRT) exceeded 850 million, a concerning figure as it is twice the estimated number of people with diabetes worldwide, and more than 20 times higher than the number of individuals affected by AIDS/HIV worldwide. Thus, kidney diseases are one of the most common diseases worldwide, which is expected to boost the market growth as this will increase the demand for kidney function tests in the management of the disease.
Furthermore, diabetes and hypertension are considered the major factors for the growing burden of chronic kidney diseases globally. According to the International Diabetes Atlas Ninth Edition 2019, the proportion of people with type 2 diabetes is increasing in most countries. Additionally, nearly 79% of adults with diabetes were living in low- and middle-income countries, accounting for 1 in 5 of the people above 65 years who had diabetes.
There are a couple of differing types of kidney function tests that investigate various aspects of kidney functioning. A kidney function test is performed to ascertain if the kidneys are filtering waste products too slowly and to see if the kidneys are leaking proteins into the urine. Regular kidney function tests may help in identifying issues such as kidney disease in the early stages, making it possible to halt the progress of the disease. Kidney function tests include urine tests, blood tests, imaging tests, and kidney biopsy.
The market players are adopting various strategies such as product launches, developments, collaborations, acquisitions, mergers, and expansions to increase market share. For instance, in August 2020, RenalytixAI received approval from the US Food and Drug Administration (FDA) for its new KidneyIntelX assay. It is an AI-enabled clinical diagnostic test designed to diagnose and enhance the clinical management of Type II diabetes patients with fast-progressing kidney disease. The emergence of such technologically advanced products is expected to drive market growth over the forecast period. However, the high cost of diagnostic procedures and stringent regulations norms are expected to impede the market growth in the near future.
Key Market Trends
The Dipstick Test Segment is Expected to Hold a Major Market Share in the Kidney Function Tests Market
A dipstick is a kind of plastic stick with a range of chemicals on it in the form of stripes. The dipstick is dipped into the urine, and if the strip's color changes, it indicates the presence of abnormalities such as excess amounts of protein, blood, pus, bacteria, and sugar. This helps to detect a range of kidney and urinary tract disorders like chronic kidney disease, bladder infections, and kidney stones.
The report published by National Kidney Foundation Inc. in 2020 stated that people hospitalized with COVID-19 are at significant risk of acute kidney injury (AKI), which can lead to serious illnesses and even death. The same study found that patients with COVID-19, who were hospitalized between March 11 and April 26, 2020, were twice as likely to develop AKI compared to non-COVID patients who developed AKI during the same time period in 2019, which accounted for 56.9% versus 25.1%, respectively.
Furthermore, as per the above source, most patients with COVID-19-related acute kidney injury (AKI) still have low kidney function after recovery. Thus, the rising incidence of kidney failure and chronic renal dysfunction due to COVID is expected to promote the segment's growth over the forecast period due to the ease of the test and availability.
As per the University of California, San Francisco Report Statistics 2018, globally, 2 million people had End-Stage Renal Disease (ESRD). Therefore, the number of patients diagnosed with kidney diseases continues to extend at a rate of 5-7% per annum, thereby increasing the demand for kidney function tests worldwide.
Globally, the rising government initiatives for the attention and treatment of kidney diseases are the key driving factors within the dipstick test segment. In addition, the rising geriatric population and growing investments in the field of kidney function testing are driving the segment's growth. For instance, in January 2020, Sweden-based Elypta AB raised a fund worth USD 7.0 million to develop a urine test for kidney cancer. Additionally, in February 2019, Healthy.io raised USD 18 million for at-home urinalysis tests in the Series B funding led by Aleph, with participation from Samsung’s Next and individual investors. Thus, owing to the above-mentioned factors, the segment is likely to witness growth over the forecast period.
North America Dominates the Market and is Expected to Remain the Same in the Forecast Period
Some of the factors driving the market growth in the North American region include better healthcare infrastructure, increasing diseases that can be diagnosed by urine tests, and high-quality diagnostic tests that are widely available.
The effect of the coronavirus was drastic in the region, especially in the United States. John Hopkins Division of Nephrology suggested that COVID-19-related kidney damage should follow up with tests to ensure kidney function is returning to normal. With the COVID-19 patients count increasing drastically in the country, so is the demand for these tests in the country.
According to the Canadian Organ Replacement Register Annual Statistics 2019, 1 in 10 Canadians had kidney disease, accounting for 4 million people. The leading cause of kidney failure was diabetes in the country.
Additionally, according to the Centers for Disease Control and Prevention 2021, more than 1 in 7, that is 15% of adults or 37 million people in the United States, are estimated to have chronic kidney disease, which is more common in people aged 65 years or older. Therefore, the increasing geriatric population increases the risk of them developing chronic kidney disease. A urine test is done to check the presence of albumin in the urine. Albumin is a protein that can pass into the urine when the kidneys are damaged. The kidneys are damaged due to comorbidities like diabetes, high blood pressure, and heart diseases. There is a huge burden of these diseases in the region, leading to increasing diagnosis for kidney function tests, in turn boosting the market growth.
The increasing product launches and growing advancements in urinalysis in the region are boosting the market. For instance, in March 2019, the US Food and Drug Administration (FDA) approved a smartphone-based at-home urine test that enables patients with chronic diseases, urinary tract infections, or high-risk pregnancies to monitor their health using a testing method, Dip.io urinalysis test system, developed by Israeli-based Healthy.io. Thus, owing to the above-mentioned factors, the studied market is expected to grow in the North American region during the forecast period.
The Kidney Function Tests Market is fragmented in terms of competition, and it consists of several major players. In terms of market share, a few major players are currently dominating the market. Some companies currently dominating the market include F.Hoffmann-La Roche Ltd, ACON Laboratories Inc., 77 Elektronika Kft, Nova Biomedical, and Quest Diagnostics.
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1.2 Scope of the Study
4.2 Market Drivers
4.2.1 Rising Prevalence of Chronic Kidney Diseases
4.2.2 Increasing Awareness about the Diagnostic Methods for the Proper Functioning of the Kidney
4.2.3 Technological Advancements in Diagnostic Machinery and Tools
4.3 Market Restraints
4.3.1 High Cost of Diagnostic Procedures
4.3.2 Stringent Regulations Norms
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5.2 By Test Type
5.2.1 Urine Tests
188.8.131.52 Urine Protein Tests
184.108.40.206 Creatinine Clearance Tests
220.127.116.11 Microalbumin Tests
5.2.2 Blood Tests
18.104.22.168 Serum Creatinine Tests
22.214.171.124 Glomerular Filtration Rate Tests
126.96.36.199 Blood Urea Nitrogen Tests
5.3 By End User
5.3.1 Hospitals and Clinics
5.3.2 Diagnostic Laboratories
5.3.3 Other End Users
5.4.1 North America
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.4.4 Middle East & Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle East & Africa
5.4.5 South America
184.108.40.206 Rest of South America
6.1.1 F.Hoffmann-La Roche Ltd
6.1.2 URIT Medical Electronic Co. Ltd
6.1.3 Arkray Inc.
6.1.4 Abbott Laboratories
6.1.5 Nova Biomedical
6.1.6 Sysmex Corporation
6.1.7 ACON Laboratories Inc.
6.1.8 77 Elektronika Kft
6.1.9 Randox Laboratories
6.1.10 Quest Diagnostics
6.1.11 bioMérieux SA
6.1.12 Laboratory Corporation of America Holdings
A selection of companies mentioned in this report includes:
- F.Hoffmann-La Roche Ltd
- URIT Medical Electronic Co. Ltd
- Arkray Inc.
- Abbott Laboratories
- Nova Biomedical
- Sysmex Corporation
- ACON Laboratories Inc.
- 77 Elektronika Kft
- Randox Laboratories
- Quest Diagnostics
- bioMérieux SA
- Laboratory Corporation of America Holdings