Renal Biomarkers Market

Market Overview

The global renal biomarkers market size was valued at USD 1,119.82 million in 2022. It is estimated to reach USD 2,158.11 million by 2031, growing at a CAGR of 7.56% during the forecast period (2023–2031).

Biomarkers are substances that can be measured objectively and analyzed to determine whether a patient's kidney function is normal or abnormal. Biomarkers can also evaluate pathogenic processes or pharmacological responses to therapeutic interventions. Therefore, they are essential to the identification and prognosis of acute kidney injury (AKI) and chronic kidney disease (CKD).

Biomarkers can be cells found on a urinalysis, proteins, microRNAs, genes, lipids, metabolites, or proteomic patterns. In the case of CKD, in particular, biomarkers are typically those that can be used to assess the kidney's glomerular filtration rate (GFR). This decline denotes a decline in renal function. GFR measurement is essential for CKD diagnosis, illness monitoring, and drug dosage determination. The main indicators to calculate GFR include blood urea nitrogen (BUN), urine albumin/protein, serum creatinine (SCr), and volume excretion.

Market Dynamics

Global Renal Biomarkers Market Drivers

Rising Prevalence of Various Kidney-Related Diseases 

Growing incidences of kidney-related diseases are anticipated to boost the growth of the renal biomarkers market. For instance, as per data stated by World Kidney Day, a collaborative initiative of the International Federation of Kidney Foundations (IFKF) and the International Society of Nephrology (ISN) in 2020, kidney disease currently affects around 850 million population worldwide. As per the estimates, one in ten adults has chronic kidney disease (CKD). The global burden of CKD is currently increasing and is anticipated to rank as the fifth most significant factor in years of life lost globally by 2040.

Furthermore, as per the Health Resources and Services Administration's Division of Transplantation data collected in February 2022, around 24,670 patients received a kidney transplant in 2021, and 90,483 were waiting for the transplantation at the global level. These factors are driving developments in advanced diagnostics to accelerate disease diagnosis in the early stage, thereby driving market growth.

High Prevalence of Diabetes and High Blood Pressure, the Leading Cause of Renal Diseases

Diabetes can cause a kidney disease called diabetic nephropathy. One of the most typical causes of renal failure is acknowledged to be this. Diabetic nephropathy is observed to occur in around one-third of patients with diabetes. Moreover, diabetes patients frequently have CKD. Kidney disease can result from both type 1 and type 2 diabetes.

On the other hand, the first comprehensive global analysis of trends in hypertension (high blood pressure) detection, prevalence, treatment, and control, led by Imperial College London and WHO, found that the proportion of adults aged 30-79 who have hypertension increased from 650 million in 1990 to 1.28 billion in 2019. Moreover, hypertension is an established risk factor for chronic CKD and end-stage renal disease. The abovementioned factors are crucial in the renal biomarker market growth over the forecast period.

Global Renal Biomarkers Market Restraint

Issues Related to Regulatory and Reimbursement Systems

Regulatory authorities established by the respective governments of countries around the world regulate the biomarkers market through stringent regulatory policies to ensure access to safe, appropriate, and affordable products along with ensuring the capacity of the product to fulfill the medical purpose for the public, which affects the manufacturers in terms of late approvals, leading to delays in product launches and sometimes, product recalls which are estimated to restrict the growth of the renal biomarkers market around the world during the forecast period. Biomarker testing adoption is further hampered by reimbursement issues, many of which are country-specific. The lack of reimbursement for testing and the availability of testing facilities are the key obstacles to the market's growth.

Global Renal Biomarkers Market Opportunities

Rapid Technological Advances in the Field of Genetics

The recently discovered applications of innovative technologies, such as functional genomics, proteomics, and biofluid profiling, have uncovered several new factors emerging as predictive biomarkers of acute kidney injury (AKI) and chronic kidney disease (CKD). Urinary proteins, such as neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and liver-type fatty acid-binding protein (L-FABP), are among the most promising factors. An improved understanding of the complex pathophysiologic processes underlying CKD progression has also provided discriminatory biomarkers of CKD progression, which remain under active evaluation.
According to the study published in bioRxiv, titled 'Multiplexed Cell-Based Diagnostic Devices for Detection of Renal Biomarkers Using Genetic Circuits' in 2021, the number of synthetic biology-based solutions used in the medical industry is increasing yearly. For example, whole-cell biosensors have shown to be useful instruments in developing low-cost, portable, customized medicine alternatives to traditional approaches. The rising customized medicine approaches have further boosted the growth of genetics in kidney diseases, thereby creating opportunities for market growth.

Regional Analysis

North America Dominates the Global Market

Based on region, the global renal biomarkers market is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

North America is the most significant global renal biomarkers market shareholder and is estimated to exhibit a CAGR of 7.74% during the forecast period. The U.S. has the largest market share in North America. The number of medicine labels, including molecular biomarker information approved by the US FDA, has significantly increased during the last ten years. Almost all pharmaceutical companies work on molecular biomarker studies, either independently or in collaboration with other businesses. The rising incidence of chronic kidney disease among Americans is one of the primary drivers behind the increased usage of renal biomarkers for accurate diagnosis and to propel the market expansion in this field. For example, the Centers for Disease Control and Prevention (CDC) anticipated that almost 37 million people in the United States—more than 1 in 7 people—have chronic renal disease in 2021. (CKD). Furthermore, the aging population in the United States is more susceptible to chronic kidney illnesses, fueling an increase in demand for early-stage diagnosis and efficient treatment, helping the market expand.

Europe is predicted to grow at a CAGR of 7.16% over the forecast period. Germany dominates the European regional market. According to a study titled "Costs of patients with chronic kidney disease in Germany" that will be published in Plos One in April 2020, the prevalence of CKD in the adult German population is projected to range between 2% and 7%. The high prevalence of CKD in the German population will lead to increased adoption of renal biomarker tests, thereby driving the growth of this market in Germany. Furthermore, rising product launches demonstrating the effectiveness of kidney biomarker tests in the renal biomarkers market by the German players will lead to increased adoption of these tests, thereby driving market growth in Germany. For instance, in August 2020, SphingoTec GmbH, a diagnostics firm, released preliminary data demonstrating that their real-time kidney function biomarker penKid is a reliable biomarker for the diagnosis of Acute Kidney Infection in babies.

Asia-Pacific is predicted to grow considerably over the forecast period. In this region, China held the greatest market share. The market for renal biomarkers in China is estimated to be driven by a few factors, including a surge in the frequency of kidney illness, an increase in the testing of biomarkers for chronic kidney disease, and an increase in hypertension. According to the study published in BMC Nephrology in April 2020, the overall adjusted prevalence of Chronic Kidney Disease (CKD) was 16.8%, the prevalence of Diabetic Kidney Disease (DKD) was 3.5%, and in persons with diabetes, the total prevalence of CKD was 48%. The rising prevalence of CKD and DKD will also lead to increased adoption of renal biomarker testing in China, thereby driving the market's growth.

In the Middle East and Africa, factors such as the rising prevalence of kidney disease in these countries and the rising prevalence of diabetes, among others, are expected to propel the expansion of the renal biomarkers market. For example, according to the report published in the Saudi Journal of Kidney Diseases and Transplantation, titled 'Renal Data from the Arab World Dialysis in Kuwait: 2013-2019' in August 2020, in Kuwait, the total number of end-stage renal disease patients receiving dialysis in 2019 was 2230, up 6% over the previous year. In addition, the dialysis prevalence was 465 per million people, while dialysis incidence was 100 per million. Moreover, according to the International Diabetes Federation 2021, the total adult population in South Africa living with diabetes is 4,234.0 thousand in 2021, and the number is expected to reach 5,445.2 in 2030 and 7,464.0 in 2045. Such a high prevalence of diabetes in South Africa will lead to increased adoption of renal biomarker testing, as diabetes is a major contributor to renal diseases, thereby driving the market's growth.

Segmental Analysis

Based on biomarker type, the global renal biomarkers market is bifurcated into functional biomarkers, up-regulated proteins, and other biomarker types. 

The functional biomarker segment dominates the global market and is anticipated to grow at a CAGR of 7.35% over the forecast period. The functional biomarker segments are further sub-segmented into serum creatinine, serum cystatin C, and urine albumin. Serum creatinine is the most widely used laboratory test for kidney function and is used to derive the eGFR (estimated Glomerular Filtration Rate) as an indicator of kidney function. It is also used as an ideal indicator for determination of chronic kidney diseases. In addition, Cystatin is a protein produced in the body by the cells. Cystatin C concentration in the blood is entirely dependent on kidney function. Albumin is synthesized in the parenchymal cells of the body. The blood plasma, cerebrospinal fluid (CSF), and urine have around 50% albumin in the body. The urine albumin segment is driven by the availability of these biomarkers through major companies across the market.

The up-regulated protein segment is further sub-segmented into neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, and interleukin 18. NGAL (Neutrophil Gelatinase Associated Lipocalin) is a novel biomarker to diagnose acute renal injury (AKI) early. Kidney injury molecule-1 (T-cell immunoglobulin; mucin-containing molecule) is a type 1 transmembrane protein. KIM-1 is up-regulated in the kidney's dedifferentiated proximal tubule epithelial cells after ischemic or toxic injury. Interleukin 18 (IL-18) is an 18kDa novel cytokine identified as a co-stimulatory factor for producing interferon-γ (IFN- γ) in response to toxic shock. The precursor 24kDa molecule of IL-18, which lacks a signal peptide and needs to be broken down to form an active molecule, is produced during IL-18 synthesis.

Based on diagnostic technique, the global renal biomarkers market is bifurcated into enzyme-linked immunosorbent assay, colorimetric assay, particle-enhanced turbidimetric immunoassay (PETIA), chemiluminescent enzyme immunoassay (CLIA), and liquid chromatography-mass spectrometry (LS-MS).

The enzyme-linked immunosorbent assay segment owns the highest market share and is predicted to exhibit a CAGR of 7.19% over the forecast period. ELISA tests can be done quickly and are easy to carry out since they are designed to handle many samples in parallel rapidly. They represent a very popular choice for evaluating various research and diagnostic targets. The diagnostic kit DNlite-IVD103 has received the CE IVD mark and is authorized for sale in the European Union, according to a July 2020 announcement from Taiwan's Bio Preventive Medicine Corporation (BPM), a cutting-edge in-vitro diagnostic (IVD) firm. The "DNlite-IVD103" diagnostic test for stopping the progression of diabetic kidney disease is the first ELISA (Enzyme-linked Immunosorbent Assay) diagnostic kit to be made available globally.

Measuring a compound's concentration in a solution using a coloring agent is known as a colorimetric test. The colorimetric assay method is widely used in diagnostic laboratories and hospitals to diagnose different diseases. Due to their wide availability, there is a rapid growth in the number of improved colorimetric assay techniques for measuring protein concentrations to detect kidney diseases.

Based on end-user, the global renal biomarkers market is divided into hospitals, diagnostic laboratories, and others. 

The diagnostic laboratories segment is the most significant contributor to the market and is anticipated to exhibit a CAGR of 8.21% over the forecast period. The increasing prevalence of kidney diseases, initiatives by the government, and strategies undertaken by the major market players are the major factors fueling the increase in diagnostics laboratories, thereby increasing the tests performed in these diagnostic laboratories. With the automation and growing emergence of robotics in diagnostic laboratories, a transformation has increased productivity and lowered the cost of tests. Furthermore, the market of renal biomarkers usage in laboratories is expected to increase due to the collaboration between the manufacturers and laboratories to produce innovative products.

Hospitals play a vital role in renal diagnosis tests, as most patients visit hospitals due to kidney disorders. The startup cost is not prohibitive for most hospitals, given diagnostics' important clinical and financial benefits. Hence, most large-scale and middle-scale hospitals have inbuilt laboratories to diagnose kidney diseases. The major advantage of the diagnosis within the hospitals is that the results are easily accessible to the healthcare professionals to make the required decision.

Recent Developments

• December 2022- Journey Biosciences, Inc. announced the launch of its flagship product NaviDKD, a biomarker-based blood test that predicts long-term renal complications in diabetic patients. The only screening method that provides people with diabetes with an early warning of the risk of developing kidney injury.
• November 2022- Revelation Biosciences Inc. announced that a recently completed exploratory biomarker analysis revealed clinical development plans for REVTx-300 in treating CKD and AKI.