Renal Biomarkers Market Size, Share and Trends 2024 to 2034

Renal Biomarkers Market Size and Forecast 2024 to 2034

The global renal biomarkers market size is calculated at USD 1.62 billion in 2024 and is projected to reach around USD 3.57 billion by 2034, expanding at a CAGR of 8.21% from 2024 to 2034. The renal biomarkers market is driven by rising demand for the evaluation of kidney function to determine the severity and nature of kidney injury.

Renal Biomarkers Market Key Takeaways

• North America led the renal biomarkers market with the largest market share of 48% in 2023.
• Asia Pacific is anticipated to witness the fastest growth in the market during the forecasted years.
• By biomarker, the functional biomarker segment held the biggest share of the market in 2023.
• By biomarker, the up-regulate protein segment is anticipated to show considerable growth in the market during the forecast period.
• By diagnostic technique, the enzyme-linked immunosorbent assay (ELISA) segment generated the highest share of the market in 2023.
• By diagnostic technique, the colorimetric assay segment is projected to witness the fastest growth in the market during the forecast period.
• By end-use, the diagnostic laboratory segment dominated the global market in 2023.
• By end-use, the hospital segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034.

U.S. Renal Biomarkers Market Size and Growth 2024 to 2034

The U.S. renal biomarkers market size is exhibited at USD 580 million in 2024 and is projected to hit around USD 1,310 million by 2034, growing at a CAGR of 8.38% from 2024 to 2034.

North America led the renal biomarkers market in 2023. The market is highly driven by the rising prevalence of kidney diseases in North America. 1 in 3 adults in the United States, which is about 35.5 million people, is at risk for kidney disease. The rising number of kidney diseases is directly proportional to the increasing rate of diabetes and hypertension. North America is home to major key players in diagnostics companies, laboratories, and research centers.

• Experts predict that by 2030, the diabetes number in the U.S. will reach 643 million, and by 2045, it will reach 783 million.

Asia Pacific is anticipated to witness the fastest growth in the renal biomarkers market during the forecasted years. The growing market factors in this region are increased incidence rates and technological advancements. The Asia Pacific Society of Nephrology (APSN) provides extensive guidelines for the management of diabetic kidney disease.

• In Asia, it is estimated that 434.3 million adults have chronic kidney disease. The leading countries in Asia are China, Taiwan, Japan, Nepal, and Pakistan. China had the highest number of CKD patients, with about 132.3 million cases.

Market Overview

A biomarker is a biological molecule found in blood, body fluids, or tissues. This helps the professional understand the body's response to the treatment given for a disease or condition. In the case of renal biomarkers, they estimate the patient’s kidney functions, and they are also used to evaluate pathogenic processes and pharmacological responses to therapy. Renal biomarker helps determine the glomerular filtration rate (GFR) of the kidney. Measurement of glomerular filtration rate helps in the diagnosis of chronic kidney disease, monitors the disease, and calculates the drug dosage. However, GFR can be measured in most clinical and research premises; therefore, filtration markers such as Serum Creatinine (SCr) and cystatin C (CysC) are used. Another biomarker, albuminuria, is known to predict a decline in kidney functions and the progression of the disease.

• According to the National Kidney Foundation, Chronic kidney disease (CKD) condition has affected about 37 million American adults—or 1 in 7. Yale medicine neurologist comments on this: diabetes is the major cause of kidney disease, followed by it is hypertension, which increases the number of cases.

How is AI Changing the Renal Biomarkers Market?

Artificial Intelligence (AI) in medicine is primarily divided into two categories virtual and physical. The application of virtual AI includes managing health records, diagnoses, prescribing medication, clinical decisions, determining mental health, and imaging analysis. Physical AI applications in the renal biomarkers market include the collection of data such as heart rate and blood pressure and image-based applications such as MRI scans or biopsies. The incorporation of AI in renal biomarkers comes under the visual application.

AI is still in the developing stage of the renal biomarkers market. It used machine learning algorithms to improve urinary tract infection detection using renal analysis to evaluate renal pathology during kidney transplantation. It is also used in risk prediction for chronic kidney disease. Acute kidney injury is a result of a sudden decrease in the glomerular filtration rate. Al helps healthcare professionals identify AKI at an early stage, which helps improve patient outcomes.

• In September 2023, Aiosyn, a medical software company launched a new artificial intelligence kidney suite for renal disease research. The biopharma and research organisations can utilise AI-powered computational pathology algorithms to analyse kidney structures and quantify lesions that affect kidney health.

Renal Biomarkers Market Growth Factors 

• Kidney transplant: Biomarker helps in decision-making regarding donor selection and kidney graft monitoring.
• Early detection: Biomarkers provide data on biological processes and disease states that help in the early identification of endocrine dysfunction.
• Convenience: An ideal biomarker is simple to handle, has a short detection time, high sensitivity, and a lower rate of false positive results.
• Sample amount: A minimal amount of small is required for the investigation of kidney biomarkers.
• Cost-effectiveness: It is by far the fastest and most affordable method to vaguely estimate kidney functions.

Market Scope

Market Dynamics

Driver

Increase in renal disorder

The demand for the renal biomarkers market services is increasing due to the rising number of renal disorder cases globally. The most common leading causes of chronic kidney disorders are diabetes and high blood pressure. Untreated diabetes damages the blood vessels in the kidneys that filter waste from the blood; this leads to damage to the kidneys. High blood pressure constricts and narrows the blood vessels present in the kidney, which slows down the blood flow and eventually stops the kidney from working. Chronic kidney disease is clinically silent or asymptomatic (no signs or symptoms) for a long period; therefore, biomarkers are the best method for diagnosing, evaluating, and treating CKD.

• A recent study states that older adults (65 years and older) are more susceptible to chronic kidney diseases. For amccurate assessment of CKD, renal biomarkers is a reliable source for timely intervention and management of the disease.

Restraint

Variability

Variability arises when biomarkers are used to determine the presence of disease, rate of exposure, and susceptibility in the renal biomarkers market. These factors vary from person to person. The main reason for fluctuating results within individuals is due to laboratory errors or unique conditions. Measurement errors are quite common, but another reason for improper biomarker results is the individual rate of exposure, consumption of any drugs or medication, or diet affects the results. Professionals investigate these factors to understand the main cause of variability.

Opportunity

Clinical research

Biomarkers have extensive potential to transform clinical research departments in the foreseeable future. Renal biomarker provides real-time, objective data on patient health and treatment outcomes. With advanced technology and regulatory framework, the renal biomarkers market is expected to witness the integration of digital biomarkers in clinical research. Digital biomarker devices will help recognize hidden insights, touchpoints, and connections. The data collected using this will offer strategic direction to drug development for manufacturing companies in clinical research. The digital biomarker tools include a smartwatch and sensor-embedded wearable device, which collects data passively.

• Neurocast, an Amsterdam-based company develop a digital biomarker – Neurokeys. This device analyses typing patterns on smartphones which provides valuable insight into neurological conditions such as MS, depression, and Alzheimer’s disease.
• A study to develop a digital biomarker to predict the beginning of acute kidney injury on an hourly basis for 25 hours, using routinely collected clinical data. This study has been ethically approved by the UK Health Research Authority.

Biomarker Insights

The functional biomarker segment held the biggest share of the renal biomarkers market in 2023. Functional biomarkers offer an analysis of the physiological activity of the body. This specific kind is used in drug development studies; therefore, this is used to assess the effects of targeted and modified treatment activity over disease. This method is applied in clinical trials, patient diagnostics, and disease progression research. Functional biomarkers are widely observed in clinical practice as they highlight the performance, social and economic status, some pathologies, and the presence of addition within a patient.

The up-regulate protein segment is anticipated to show considerable growth in the renal biomarkers market during the forecast period. Up-regulated protein biomarkers serve as potential early diagnostic biomarkers. Up-regulated protein is a process that takes place within the cell that is triggered by a signal. This course of action results in increased expression of one or more genes along with the protein encoded in the gene. For instance, when a cell is deficient in some receptor. Un-regulated protein provides receptor protein to synthesize and transport to the membrane of the cell, and hence, the sensitivity of the cell returns to normal.

Diagnostic Technique Insights

The enzyme-linked immunosorbent assay (ELISA) segment generated the highest share of the renal biomarkers market in 2023. The Enzyme-linked immunosorbent assay antibody tests are highly projected for a common autoimmune kidney disease that can lead to kidney failure. This is a laboratory technique, and there are plenty of variations in the tests that are used. One of the more common is to detect and measure antibodies. Other uses are estimating hormone levels, tracking disease outbreaks in the community, screening blood donations, and detecting non-medical drugs.

• In MAY 2024, a study published in the New England Journal of Medicine and presented at the 61st ERA Congress in Stockholm, Sweden, conducted across Europe and the U.S., claims a novel approach combining immunoprecipitation with enzyme-linked immunosorbent assay (ELISA) to steadily detect anti-nephrin autoantibodies.

The colorimetric assay segment is projected to witness the fastest growth in the renal biomarkers market during the forecast period. Colorimetric test is used in the detection of infection-causing microorganisms and antimicrobial resistance. It offers sensitive, rapid, selective, and economical diagnostic tests that are critical to starting the right treatment. The colorimeter assay is used in hospitals and laboratories to analyze biochemical samples, such as urine, cerebrospinal fluids, plasma, and biochemical samples. This technique is widely used to determine serum components, proteins, glucose levels, and various biochemical compounds quantitatively.

• In March 2024, Flinders University launched a new portable colorimetric paper test strip reader that uses a camera and image processing software to automatically obtain a reading. this device offers more regular monitoring of the patients for disease progression and for screening high-risk populations for early interventions.

End-user Insights

The diagnostic laboratory segment dominated the global renal biomarkers market in 2023. Laboratory diagnostics are widely performed to check for kidney diseases. American Clinical Laboratory Association supports clinical laboratories in the diagnosis and management of kidney health. Glomerular filtration rate (GFR) is performed to check kidney functions. The urine test checks albumin (a protein that passes when the kidney is damaged). Blood Urea Nitrogen (BUN) and creatinine A levels indicate early signs of kidney diseases. Cystatine C helps to predict the high accuracy of at-risk patients developing CKD and AKI. The innovative diagnostic laboratory also assists in kidney transplantation and avoids unnecessary biopsies.

The hospital segment is expected to grow at the fastest rate in the renal biomarkers market during the forecast period of 2024 to 2034. The hospital had only blood and urine tests available on the premises. For more detailed results, the patient is recommended to visit a diagnostic laboratory. With the provided urine sample, doctors examine the presence of bacteria, pus, or blood in the urine. A blood test determines how well the kidney removes waste, toxins, and extra fluid from the blood.

Recent Developments

• In December 2023, BioPorto Diagnostic AS, an in-vitro diagnostics company, launched ProNephro AKI (NGAL), the first acute kidney injury biomarker tester for pediatric use from the age of 3 months to 21 years. The aim is to help doctors identify a patient's risk of developing or having persistent AKI within 49-72 hours.
• SphingoTec GmbH, a diagnostics company, collaborated with Boditech Med Inc. and launched an innovative kidney function biomarker penKid. The company claims that Penkid increases kidney function assessment, overperforming the standard diagnostic test currently used.

Renal Biomarkers Market Companies

• Abbott Laboratories
• Beckman Coulter Inc.
• BioMérieux
• BioPorto Diagnostics AS
• BIO-RAD LABORATORIES INC.
• F. HOFFMANN-LA ROCHE LTD.
• Randox Laboratories Ltd
• SEKISUI MEDICAL CO., LTD.
• Siemens Healthineers AG
• Sphingotec GmbH
• THERMO FISHER SCIENTIFIC INC.

Segments Covered in the Report

By Biomarker

• Functional Biomarker
• Up-regulated Protein
• Other Biomarker

By Diagnostic Technique

• Enzyme-linked Immunosorbent Assay
• Colorimetric Assay
• Particle-enhanced Turbidimetric Immunoassay (PETIA)
• Chemiluminescent Enzyme Immunoassay (CLIA)
• Liquid Chromatography Mass
• Spectrometry (LC-MS)

By End-user

• Hospital
• Diagnostic Laboratory
• Other

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa