Emerging therapies for Acute Kidney Injury (AKI), including RBT-1, OCE-205, and others, are anticipated to drive significant growth in the AKI market in the coming years.
DelveInsight has released a new report, “Acute Kidney Injury – Market Insights, Epidemiology, and Market Forecast 2034”, offering a comprehensive overview of AKI, including historical and projected epidemiology, as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
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During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Some of the key facts of the Acute Kidney Injury Market Report:
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Currently, no pharmacological treatments have been specifically approved for Acute Kidney Injury (AKI). Management is primarily supportive, relying on renal replacement therapy (RRT) and off-label use of drugs such as ACE inhibitors, ARBs, diuretics, and NSAIDs.
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The incidence of AKI is rising, particularly among patients with acute medical conditions or those undergoing major surgeries. In 2022, there were an estimated 14.6 million mortality-adjusted AKI cases among hospitalized patients across the seven major markets (7MM), with the U.S. accounting for the largest share at roughly 39% of cases. That same year, the U.S. represented about 65% of the AKI market, a share expected to increase through 2034.
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Significant clinical developments are underway. In December 2023, SeaStar Medical began patient enrollment for its NEUTRALIZE-AKI trial evaluating the cell-targeted Selective Cytopheretic Device (SCD) in critically ill adults requiring continuous kidney replacement therapy, with an interim enrollment milestone reached in June 2024 and a DSMB review anticipated in mid-2025. In October 2023, Renibus Therapeutics dosed the first patient in its pivotal Phase III PROTECT trial for RBT-1, aimed at mitigating post-operative complications after cardiac surgery, with top-line results expected by mid-2025 and an NDA submission planned for early 2026.
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Key companies driving innovation in the AKI space include Atox Bio, AM-Pharma Holding, Quark Pharmaceuticals, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Cerenis Therapeutics, Alloksys, Vifor Pharma, and others. Promising therapies in development include RBT-1, OCE-205, and additional pipeline candidates expected to expand treatment options and improve patient outcomes.
Acute Kidney Injury Overview
Acute Kidney Injury (AKI) is marked by a rapid loss of kidney function, typically indicated by a temporary increase in nitrogenous waste products, such as blood urea nitrogen (BUN) and serum creatinine, over hours to weeks.
Symptoms may include nausea, vomiting, fatigue, dizziness, and lower back pain. Some patients, however, may show no obvious symptoms or only experience general, non-specific signs not directly tied to kidney function.
Acute Kidney Injury Market Insights
Diuretics are commonly used to manage Acute Kidney Injury, with loop diuretics being the most frequently prescribed. Furosemide, in particular, is widely utilized at different stages of AKI because of its potent ability to enhance the excretion of water and electrolytes, as long as some kidney filtration function remains.
Acute Kidney Injury Market Outlook
The Acute Kidney Injury (AKI) therapeutics market is being propelled by a growing pipeline of drugs with novel mechanisms and the increasing incidence of the condition. This emerging pipeline is poised to transform a treatment landscape currently dominated by renal replacement therapy (RRT) and off-label use of ACE inhibitors, ARBs, diuretics, and NSAIDs, as there are still no approved targeted pharmacotherapies for AKI.
Comorbidities such as cardiovascular disease, hypertension, diabetes, chronic kidney disease (CKD), and impaired renal recovery further heighten the risk of AKI. While traditional approaches remain prevalent, the market is expected to evolve with new therapies targeting AKI caused by complications like sepsis, cardiac surgery, and delayed graft function.
Pipeline candidates are increasingly addressing specific AKI subtypes, including hepatorenal syndrome-associated AKI (HRS-AKI), sepsis-induced AKI, and post-cardiac surgery AKI. These innovative therapies have the potential to substantially reduce unmet medical needs in AKI care.
Key players driving these advancements include Renibus Therapeutics (RBT-1), Ocelot Bio (OCE-205), AM-Pharma (Ilofotase alfa), and Guard Therapeutics (RMC-035), among others. Their efforts are focused on improving patient outcomes and lowering mortality in hospitalized AKI patients. Overall, the AKI therapeutics market is projected to experience steady growth throughout the 2024–2034 forecast period.
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Acute Kidney Injury Emerging Drugs
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RBT-1: Renibus Therapeutics
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OCE-205: Ocelot Bio
Scope of the Acute Kidney Injury Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Acute Kidney Injury Companies: Atox Bio, AM-Pharma Holding, Quark-Pharmaceuticals, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Cerenis Therapeutics Alloksys, Vifor Pharma, and others
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Acute Kidney Injury Therapies: RBT-1, OCE-205, and others.
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Acute Kidney Injury Therapeutic Assessment: Acute Kidney Injury current marketed and Acute Kidney Injury emerging therapies
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Acute Kidney Injury Market Dynamics: Acute Kidney Injury market drivers and Acute Kidney Injury market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
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Acute Kidney Injury Unmet Needs, KOL's views, Analyst's views, Acute Kidney Injury Market Access and Reimbursement
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Key benefits of the Acute Kidney Injury Market Report:
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The Acute Kidney Injury market report covers a descriptive overview and comprehensive insight of the Acute Kidney Injury Epidemiology and Acute Kidney Injury market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Acute Kidney Injury market report provides insights into the current and emerging therapies.
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The Acute Kidney Injury market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Acute Kidney Injury market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Acute Kidney Injury market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Acute Kidney Injury Patient Share (%) Overview at a Glance
5. Acute Kidney Injury Market Overview at a Glance
6. Acute Kidney Injury Disease Background and Overview
7. Acute Kidney Injury Epidemiology and Patient Population
8. Country-Specific Patient Population of Acute Kidney Injury
9. Acute Kidney Injury Current Treatment and Medical Practices
10. Unmet Needs
11. Acute Kidney Injury Emerging Therapies
12. Acute Kidney Injury Market Outlook
13. Country-Wise Acute Kidney Injury Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Acute Kidney Injury Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Related Reports:
Acute Kidney Injury Pipeline Insights, DelveInsight
"Acute Kidney Injury Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Acute Kidney Injury market. A detailed picture of the Acute Kidney Injury pipeline landscape is provided, which includes the disease overview and Acute Kidney Injury treatment guidelines.
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