RENAL BIOMARKERS MARKET ANALYSIS

The global renal biomarkers market is estimated to be valued at US$ 1,476.2 million in 2023 and is expected to exhibit a CAGR of 8.2% during the forecast period (2023-2030).

Analysts’ Views on Global Renal Biomarkers Market:

Over the forecast period, there will be an increase in the need for and demand for renal biomarkers due to the incidence of chronic kidney disorders and an increase in the geriatric population. For instance, in November 2021, according to the Centers for Disease Control and Prevention, chronic kidney disease (CKD) is more common in people aged 65 years or older (38%) than in people aged 45–64 years (12%) or 18–44 years (6%). CKD is slightly more common in women (14%) than men (12%). CKD is more common in non-Hispanic Black adults (16%) than in non-Hispanic White adults (13%) or non-Hispanic Asian adults (13%). About 14% of Hispanic adults have CKD.

Figure 1. Global Renal Biomarkers Market Share (%), by Biomarker Type, 2023

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Global Renal Biomarkers Market – Driver

Rising incidence of chronic kidney diseases and growing geriatric population

Rising incidence of chronic kidney diseases is expected to boost the growth of the global renal biomarkers market over the forecast period. For instance, according to an article in british medical journal in January 2020, the number of dialysis patients on the kidney transplant waiting list as of December, 2017 marked a third consecutive year of decline with an 8.8% reduction from the previous year, to 75,745 candidates, 85% of whom were awaiting their first kidney transplant. The waiting period increases the prevalence of CKD.

Product Launch from the key players

Over the forecast period, key players' newly released products typically drive the renal biomarkers market. For instance, on May 16, 2023, Aravive, Inc., a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, announced positive new data from the Phase 1b portion of the ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell cancer (ccRCC) and new data from a biomarker high subgroup.

Figure 2. Global Renal Biomarkers Market Value (US$ Million), by Region, 2023

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Global Renal Biomarkers Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global renal biomarkers market over the forecast period. North America is estimated to hold 47.5% of the market share in 2023. The North America renal biomarkers market is expected to witness significant growth in the coming years, driven by factors such as the increasing prevalence of CKD and geriatric population leading to the demand for renal biomarkers for kidney disease diagnosis. Consequently, the market for renal biomarkers is expected to increase further during the next years.

Global Renal Biomarkers Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with the transportation of drugs from one place to another.

However, the COVID-19 pandemic had a positive impact on the global renal biomarkers market. For instance, in August 2022, according to an article published in the Journal of Renal Failure, an article stated that SARS-CoV-2 can infect the renal tubular epithelium directly, which may enhance the clinical value of urinary NGAL (Neutrophil gelatinase-associated lipocalin) as an AKI (Akute Kidney Injury) marker among patients with COVID-19.

Global Renal Biomarkers Market Segmentation:

The global renal biomarkers market report is segmented into Biomarker Type, Technique, End user and Region.

By Biomarker Type, the renal biomarkers market is segmented into Functional Biomarkers and Up-Regulated Proteins. Out of which, the functional biomarkers segment is expected to hold a dominant position in the global renal biomarkers market during the forecast period and the Cystatin C which is one of the segments of functional biomarkers is expected to dominate over the forecast period. For instance, in March 2021, according to an article published in the Journal of Scientific Reports, suggests that Cystatin C-based estimations of kidney function performed better than creatinine-based ones in patients with primary neuromuscular disease but most importantly, all evaluated equations overestimated kidney function, especially in patients with reduced kidney function. Therefore, kidney function should be measured by gold-standard methods when precision and accuracy are needed.

By Technique, the renal biomarkers market is segmented into Enzyme Linked Immunosorbent Assay (ELISA), Particle-Enhanced Turbidimetric Immunoassay, Calorimetric Assay, Chemiluminescent Enzyme Immunoassay, and Liquid Chromatography-Mass Spectrometry. The ELISA segment is expected to dominate the market over the forecast period and this is due to the increasing usage for the diagnosis of chronic kidney diseases.

By End User, the renal biomarkers market is segmented into diagnostics labs, outpatient clinics, research centers and hospitals. The hospital segment is expected to dominate the market over the forecast period and this is attributed to the increasing prevalence of kidney diseases. For instance, in May 2020, according to Pan American Health Organisation, in 2019 the mortality in region-wide kidney diseases account for 254,028 total deaths, 131,008 deaths in men, and 123,020 deaths in women. The age-standardized death rate due to kidney diseases was estimated at 15.6 deaths per 100,000 population. Age-standardized death rates from kidney diseases vary across countries from a high in Nicaragua (73.9 deaths per 100,000 population) to a low in Canada (5.0 deaths per 100,000 population).

Among all segmentation, the End user segment has the highest potential due to the increasing product launch by the key market players. For instance, in July 2022, Healthy.io, a health care company, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home use of the Minuteful Kidney test. The FDA has never before approved a smartphone-powered at-home test to measure the albumin to creatinine ratio (ACR).

Global Renal Biomarkers Market Cross Sectional Analysis:

Rising incidence of chronic kidney diseases in emerging economies is also expected to boost demand for renal biomarkers in North America market region. For instance, in March 2022, according to the Centers for Medicare & Medicaid Services (CMS), the prevalence of CKD had increased over time, from 15% in 2012 to 25% in 2020, and also stated that the two main causes of CKD are diabetes and hypertension.

Global Renal Biomarkers Market: Key Developments

In October 2021, (GlaxoSmithKline) GSK, Plc., a multinational pharmaceutical and biotechnology company, showcased significant scientific advances in renal care at the American Society of Nephrology Kidney Week 2021. GSK presented data on BENLYSTA for the treatment of lupus nephritis, including healthcare resource utilization and cost analyses for both lupus nephritis and systemic lupus erythematosus.

On March 17, 2022, the diagnostic company, SphingoTec GmbH (SphingoTec) and Rivaara Labs Pvt Ltd., a development-focused molecular diagnostics company, announced that they have entered into a multi-year distribution agreement for the commercialization of SphingoTec’s point of care diagnostic solutions in the Indian subcontinent. The Nexus IB10 analyzer and its portfolio of rapid tests allow convenient assessment of biomarkers relevant to critical care conditions such as sepsis, acute kidney injury, cardiogenic shock, acute heart failure, and myocardial infarction.

In June 2022, Nordic Bioscience, a biomarker company, announced the strengthening of its ongoing collaboration with F. Hoffmann-La Roche Ltd.,  a multinational healthcare company for the development of proprietary biomarkers involved in tissue breakdown and build-up. Under the collaboration, Nordic Bioscience will transfer unique and proprietary blood-based biomarkers to Roche Diagnostics to be implemented on the automated COBAS platform. Nordic Bioscience's (Extracellular Matrix ) ECM biomarkers are unique and essential for all chronic diseases involving tissue fibrosis inflammation and kidney diseases. The collaboration will facilitate better clinical decisions in drug development and patient selection as well as enrichment for precision medicine and ultimately improve patient outcomes.

In May 2021, Novo Nordisk A/S, a global healthcare company presented results from RESCUE, a phase 2 randomized, double-blind, placebo-controlled clinical trial assessing the effect of once-monthly, investigational ziltivekimab, an interleukin-6 (IL-6) inhibitor, on biomarkers of inflammation. The trial showed a significant reduction of multiple inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease (CKD) and elevated high-sensitivity C-reactive protein (hsCRP), representing high cardiovascular risk.

Global Renal Biomarkers Market: Key Trends

Rising demand for kidney disease diagnosis, increasing collaboration agreement between the key players, and launch of new products.

Due to the increase in the demand for diagnostic tools for kidney diseases, key players in the market are undergoing various strategic development over the forecast period.

Players in the market are focused on developing feline renal biomarkers. For instance, in February 2020, Antech Diagnostics, a part of Mars Petcare, launched Antech SDMA (symmetric dimethylarginine), a feline renal biomarker for early diagnosis, staging and monitoring of chronic kidney disease.

Global Renal Biomarkers Market: Restraint

Limitations Associated With Renal Biomarkers

Because it is impossible to adhere to the same guidelines that would apply to the use of indicators that are not biological, many research using biomarkers are never finished. Any biomarker development should take place prior to or concurrent with the usual design of any clinical trial or epidemiological study. A thorough analysis of the biomarkers' validity in relation to the disease's stage is required. So proper selection of biomarker for diagnosis to be used. For instance, in April 2021, an article published in the Journal of Nephrology , therenal biomarkers have several disadvatages such as Laboratory errors, inaccuracy, Normal range difficult to establish and Ethical responsibility.

Low sensitivity and specificity

Low sensitivity and specificity of biomarkers is expected to hinder the growth of the global renal biomarkers market over the forecast period. For instance, in November 2021, according to an article published in the Journal of Contemporary Practice in Clinical Chemistry, an article states that the creatinine assay is subjected to interference because of intake of certain drugs or because of certain pathophysiological states including hyperbilirubinemia and diabetic ketoacidosis. Serum Creatinine is nonspecific in conditions such as prerenal azotemia where creatinine levels can rise without tubular injury. Because of all these undesirable limitations of creatinine as a marker, there has been a great deal of interest in the identification of improved biomarkers for kidney injury.

Global Renal Biomarkers Market - Key Players

Major players operating in the global renal biomarkers market include Beckman Coulter, Inc., Thermo Fisher Scientific Inc., Abbott Laboratories, Bioporto Diagnostics A/S, Astute Medical, Inc., Randox Laboratories, Sphingo Tec GmbH, Siemens Healthineers AG, Eli Lilly and Company, and Novartis AG.

Global Renal Biomarkers Market– Definition

Renal biomarkers are substances found in the blood or urine that can provide information about the functioning of the kidneys. Renal biomarkers play an important role in the diagnosis and monitoring of kidney diseases. They can also help to predict the risk of kidney injury in patients undergoing certain. Biomarkers can be proteins, lipids, microRNAs, genes, metabolites, proteomic patterns, or cells present on a urinalysis. In Chronic Kidney Disease (CKD) specifically, biomarkers usually are those that can be used to determine the glomerular filtration rate (GFR) of the kidney, a fall in which represents a decrease in kidney function. Measurement of GFR is necessary for a diagnosis of CKD, as well as for monitoring the disease and calculating drug dosage.