Acute Kidney Injury Market Expected to Transform with Next-Generation Therapies and Strong Growth Through 2036 - DelveInsight

DelveInsight's "Acute Kidney Injury Market Insights, Epidemiology, and Market Forecast-2036′′ report offers an in-depth understanding of the Acute Kidney Injury, historical and forecasted epidemiology as well as the Acute Kidney Injury market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Acute Kidney Injury Market Report:
• The Acute Kidney Injury market size was valued approximately USD 6,230 million in 2022 and is anticipated to grow with a significant CAGR during the study period (2022-2036).
• In July 2026, biopharmaceutical company Dimerix expanded its clinical pipeline through the strategic acquisition of a Phase 2-ready drug candidate targeting Acute Kidney Injury (AKI). The asset complements Dimerix's focus on inflammatory and kidney diseases. With Phase 2 clinical trials prepared to commence, the company aims to rapidly advance this therapeutic option to address a major unmet medical need in hospital settings worldwide.
• In January 2026, Revelation Biosciences, Inc. (REVB) has secured a clear regulatory pathway for Gemini after reaching an agreement with the U.S. Food and Drug Administration that a single, well-controlled Phase 2/3 adaptive clinical trial could potentially support a future New Drug Application (NDA) for the treatment of Acute Kidney Injury.
• In November 2025, Mallinckrodt announced the completion of the planned spin-off of its Par Health generic pharmaceuticals and sterile injectable businesses. Moving ahead, Mallinckrodt will be known as Keenova Therapeutics and will focus on developing, manufacturing, and commercializing branded therapeutics that help patients with rare or unaddressed conditions live happier and healthier lives.
• In October 2025, AM-Pharma announced that the topline data of the Phase II clinical trial evaluating ilofotase alfa for the prevention of Cardiac Surgery-associated Renal Damage (CSA-RD) is expected in early 2026, and the full dataset will be presented thereafter at a scientific conference. The company is anticipated to initiate a pivotal Phase III trial for ilofotase alfa.
• In January 2025, SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company specializing in innovative therapies to reduce hyperinflammation's impact on vital organs, announced that Mayo Clinic has received approval to enroll participants in its NEUTRALIZE-AKI pivotal trial, increasing the total number of active trial sites to 15.
• The total market size of AKI in the 7MM was ~USD 4,900 million in 2025 and is projected to grow during the forecast period (2026-2036).
• According to the estimates, the highest market size of AKI is from the United States in 2025 and is anticipated to grow at a CAGR of 5.1%.
• Among EU4 and the UK, UK has the maximum revenue share in 2025, while Spain has the lowest market share.
• TIN816 is expected to achieve the largest market size among all therapies in Japan by 2036.
• According to DelveInsight's estimates, the total incident cases of AKI in the 7MM were approximately 23,076,000 in 2025.
• The total mortality-adjusted incident cases of AKI in the US were approximately 5.2 million in 2025.
• Among EU4 and the UK, UK accounted for the highest number of AKI cases, followed by Germany, whereas Spain accounted for the lowest number of cases in 2025.
• The stage-specific cases of AKI include Stage I, Stage II, and Stage III. Out of which, the maximum cases were reported in stage I AKI, followed by stage II and Stage III.
• Key Acute Kidney Injury Companies: Keenova Therapeutics (Mallinckrodt), Renibus Therapeutics, AstraZeneca, Alloksys, Guard Therapeutics, Ocelot Bio, Angion Biomedica/Vifor Pharma AM Pharma, Astellas Pharma, Sentien Biotechnologies, RegeneRx Biopharmaceuticals, and others
• Key Acute Kidney Injury Therapies: Terlipressin (TERLIVAZ), RBT-1, Ravulizumab, bRESCAP, RMC-035 (ROSgard), OCE-205, ANG-3777, Ilofotase alfa, ASP1128, SBI-101, Timbetasin, and others
• The Acute Kidney Injury market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Acute Kidney Injury pipeline products will significantly revolutionize the Acute Kidney Injury market dynamics.

Acute Kidney Injury Overview
Acute renal failure (ARF), sometimes referred to as acute kidney injury (AKI), is a medical illness typified by progressive azotemia that can occur with or without oliguria over the course of several hours or days. Acute kidney injury (AKI) is a medical condition characterized by a sudden decrease in kidney function and a transient, reversible rise in nitrogen waste products as determined by blood ureanitrogen (BUN) and serum creatinine levels over a period of hours to weeks.

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Acute Kidney Injury Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Acute Kidney Injury Epidemiology Segmentation:
The Acute Kidney Injury market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total Prevalence of Acute Kidney Injury
• Prevalent Cases of Acute Kidney Injury by severity
• Gender-specific Prevalence of Acute Kidney Injury
• Diagnosed Cases of Episodic and Chronic Acute Kidney Injury

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Acute Kidney Injury Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Acute Kidney Injury market or expected to get launched during the study period. The analysis covers Acute Kidney Injury market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Acute Kidney Injury Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Acute Kidney Injury Therapies and Key Companies
• Terlipressin (TERLIVAZ): Keenova Therapeutics (Mallinckrodt)
• RBT-1: Renibus Therapeutics
• Ravulizumab: AstraZeneca
• bRESCAP: Alloksys
• RMC-035 (ROSgard): Guard Therapeutics
• OCE-205: Ocelot Bio
• ANG-3777: Angion Biomedica/Vifor Pharma
• Ilofotase alfa: AM Pharma
• ASP1128: Astellas Pharma
• SBI-101: Sentien Biotechnologies
• Timbetasin: RegeneRx Biopharmaceuticals

Discover more about therapies set to grab major Acute Kidney Injury market share @ Acute Kidney Injury Treatment Landscape
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Acute Kidney Injury Market Strengths
• The pipeline of AKI is quite robust with diverse products strengthening the upcoming market.
• The treatment related adverse events are very nominal resulting into effective treatment options

Acute Kidney Injury Market Opportunities
• Several biomarkers such as NGAL, Cystatin-C, etc. are being tried and tested to diagnose AKI. Validation of these new biomarkers could provide additional tools to detect the onset and severity of kidney injury

Scope of the Acute Kidney Injury Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Acute Kidney Injury Companies: Keenova Therapeutics (Mallinckrodt), Renibus Therapeutics, AstraZeneca, Alloksys, Guard Therapeutics, Ocelot Bio, Angion Biomedica/Vifor Pharma AM Pharma, Astellas Pharma, Sentien Biotechnologies, RegeneRx Biopharmaceuticals, and others
• Key Acute Kidney Injury Therapies: Terlipressin (TERLIVAZ), RBT-1, Ravulizumab, bRESCAP, RMC-035 (ROSgard), OCE-205, ANG-3777, Ilofotase alfa, ASP1128, SBI-101, Timbetasin, and others
• Acute Kidney Injury Therapeutic Assessment: Acute Kidney Injury current marketed and Acute Kidney Injury emerging therapies
• Acute Kidney Injury Market Dynamics: Acute Kidney Injury market drivers and Acute Kidney Injury market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Acute Kidney Injury Unmet Needs, KOL's views, Analyst's views, Acute Kidney Injury Market Access and Reimbursement

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About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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