(Albany, US) On October 30, 2026, DelveInsight’s “Acute Kidney Injury Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Acute Kidney Injury (AKI) market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.
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Key Takeaways from the Acute Kidney Injury Report
In July 2026, Dimerix expanded its clinical pipeline through the acquisition of a Phase 2-ready drug candidate targeting AKI, with Phase 2 trials prepared to begin.
In November 2025, Mallinckrodt completed the spin-off of its Par Health generic and sterile injectable businesses and is now known as Keenova Therapeutics, focused on branded therapeutics for rare conditions.
In October 2025, AM-Pharma said topline Phase II data for ilofotase alfa in the prevention of cardiac surgery-associated renal damage were expected in early 2026, with a pivotal Phase III trial anticipated.
AstraZeneca expects data from the Phase III ARTEMIS trial of ravulizumab in cardiac surgery-associated AKI (CSA-AKI) in H2 2026.
The AKI market was about USD 4,900 million across the 7MM in 2025, and DelveInsight estimates about 23 million total incident AKI cases in the 7MM in 2025.
Treatment remains largely supportive, driven by renal replacement therapy and off-label drugs, with terlipressin (TERLIVAZ) the only FDA-approved targeted therapy, specifically for hepatorenal syndrome-associated AKI (HRS-AKI).
Leading Acute Kidney Injury companies include Fresenius Medical Care, Baxter International, Medtronic, B. Braun Melsungen AG, Nikkiso Co., Ltd., Nipro Corporation, Asahi Kasei Medical, AM-Pharma, Atox Bio, Guard Therapeutics, Quark Pharmaceuticals, Angion Biomedica Corp., Pharmazz, Inc., Durect Corporation, Kringle Pharma, bioMérieux, BioPorto Diagnostics, Renalyx, Purespring Therapeutics, Maze Therapeutics, Sentien Biotechnologies, and others.
Promising therapies include terlipressin (TERLIVAZ), RBT-1, ravulizumab (ULTOMIRIS), ilofotase alfa, QUELIMMUNE, LSALT Peptide, TIN816, and others.
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Acute Kidney Injury Overview
Acute Kidney Injury (AKI) is a sudden decline in kidney function occurring within hours or days, leading to accumulation of waste products, electrolyte imbalance, and fluid overload. It is common in hospitalized patients, particularly in intensive care units. Causes include reduced blood flow to the kidneys, direct kidney damage from toxins or infections, and urinary tract obstruction. Major risk factors include sepsis, major surgery, dehydration, diabetes, hypertension, chronic kidney disease, and exposure to nephrotoxic drugs. Diagnosis relies on serum creatinine and urine output, urinalysis, imaging, and occasionally biopsy. Treatment focuses on the underlying cause and supportive care, including fluid and electrolyte management, with dialysis in severe cases.
Common features include:
Reduced urine output
Rising serum creatinine
Fluid overload
Electrolyte imbalance
Accumulation of waste products
Acute Kidney Injury Emerging Drugs Profile
Terlipressin (TERLIVAZ): Keenova Therapeutics (Mallinckrodt) TERLIVAZ is a vasopressin analog for HRS-AKI, a rapidly progressive, life-threatening form of renal failure in advanced liver disease. Approved by the FDA in 2022 as the first therapy specifically indicated for HRS-AKI, it received CMS new technology add-on payment effective October 1, 2023. Currently, the drug is marketed.
RBT-1: Renibus Therapeutics RBT-1 is an investigational therapy that upregulates anti-inflammatory, antioxidant, and iron-scavenging pathways, activating a cytoprotective preconditioning response to reduce postoperative complications after cardiothoracic surgery. It is being evaluated in the Phase III PROTECT study. Currently, the drug is in Phase III.
Ravulizumab (ULTOMIRIS): AstraZeneca Ravulizumab is a long-acting C5 complement inhibitor that provides immediate, complete, and sustained complement inhibition. It is being studied in the Phase III ARTEMIS trial for CSA-AKI, with data expected in H2 2026. Currently, the drug is in Phase III.
Ilofotase Alfa: AM-Pharma Ilofotase alfa is being developed for the prevention of cardiac surgery-associated renal damage. Topline Phase II data were expected in early 2026, with a pivotal Phase III trial anticipated. Currently, the drug is in Phase II.
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Acute Kidney Injury Market Drivers
Rising AKI incidence: AKI is increasingly common in hospitalized and critically ill patients, including those with sepsis, trauma, cardiovascular disease, or major surgery.
Growing chronic disease burden: Diabetes, hypertension, and chronic kidney disease raise AKI risk and expand the patient pool.
Aging population: Older adults are more susceptible to kidney dysfunction, increasing demand for dialysis, medications, and supportive care.
Large unmet need: The scarcity of targeted therapies and reliance on supportive care are attracting investment in novel drugs and biomarkers.
Active late-stage pipeline: Candidates such as RBT-1, ravulizumab, and ilofotase alfa are targeting inflammation, complement activation, and oxidative stress.
Better diagnostics and awareness: Improved diagnostic tools and clinical awareness are enabling earlier identification of AKI.
Reimbursement support: Mechanisms such as CMS NTAP for TERLIVAZ help hospitals adopt innovative therapies.
Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Acute Kidney Injury Market Drivers and Barriers
Acute Kidney Injury Market Barriers
Supportive-care-dominated treatment: Dialysis and off-label drugs are entrenched and low-cost, setting a high bar for new therapies.
Difficult clinical development: AKI is heterogeneous, with varied causes and settings, making trial design and endpoints challenging.
Late and difficult diagnosis: Creatinine-based detection lags injury, limiting windows for preventive or early intervention.
Limited approved targeted options: TERLIVAZ is approved only for HRS-AKI, and its path involved multiple Complete Response Letters.
Pipeline setbacks and uncertainty: Trial timelines have slipped and outcomes are uncertain, adding risk for developers.
High cost and reimbursement pressure: Hospital budgets and payer scrutiny limit uptake of expensive therapies.
Competition from devices and procedures: Renal replacement therapy and device makers hold a strong position in acute care.
Scope of the Acute Kidney Injury Report
Coverage: 7MM (US, EU4, UK, Japan)
Companies: As listed above
Therapies: Terlipressin (TERLIVAZ), RBT-1, ravulizumab (ULTOMIRIS), ilofotase alfa, QUELIMMUNE, LSALT Peptide, TIN816, and others
Assessment by Product Type: Mono, Combination, Mono/Combination
Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Contents
Introduction
Executive Summary
Acute Kidney Injury: Overview
Pipeline Therapeutics
Therapeutic Assessment
DelveInsight’s Analytical Perspective
Late Stage Products (Phase III): RBT-1 (Renibus Therapeutics), Ravulizumab (AstraZeneca)
Mid Stage Products (Phase II): Ilofotase Alfa (AM-Pharma)
Early Stage Products (Phase I): None currently
Preclinical and Discovery Stage Products
Inactive Products
Key Companies
Key Products
Unmet Needs
Market Drivers and Barriers
Future Perspectives and Conclusion
Analyst Views
Appendix
About Us
About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.
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