급성 신손상(AKI) : 신규 요법, 미충족 수요 및 TPP 인사이트 보고서(2026년)

Acute Kidney Injury (AKI) Emerging Therapy and TPP Insights

Thelansis's "Acute Kidney Injury (AKI) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Acute Kidney Injury (AKI) Overview

Acute kidney injury (AKI) is a rapid decline in renal function defined by an abrupt reduction in glomerular filtration rate, worsening azotemia, and frequent oliguria. It is classified by KDIGO criteria into three progressive stages based on serum creatinine spikes and urine output drops. Pathophysiology spans prerenal hemodynamic insufficiency (sepsis, volume depletion), intrinsic parenchymal damage (ischemic or nephrotoxic acute tubular necrosis), and postrenal obstructive uropathy. Severe cases manifest with critical fluid overload, metabolic acidosis, and life-threatening hyperkalemia. Diagnosis relies on tracking output volumes alongside urine microscopy and renal ultrasound. While primary management centers on optimizing perfusion, managing fluid balances, and removing nephrotoxins, severe cases historically default to standard continuous renal replacement therapy (CRRT). Crucially, the care paradigm has moved past passive mechanical clearance. Novel biomarkers like NGAL and cell-cycle arrest markers (TIMP-2/IGFBP-7) are now integrated into standard high-risk surgical care bundles to detect subclinical stress long before creatinine shifts. Furthermore, critical care has entered a new era with the FDA's groundbreaking approval of Quelimmune, a selective cytopheretic device that integrates with CRRT to filter and deactivate hyper-inflammatory neutrophils. By directly halting the systemic immune cascade that drives organ failure, these targeted immunomodulatory interventions drastically reduce long-term dialysis dependence and chronic kidney disease progression.

Key Highlights

• In Germany, incident AKI cases are projected to increase from approximately 152,260 in 2025 to 155,034 by 2035.
• AKI remains a major cause of hospitalization and is associated with significant morbidity, mortality, and healthcare burden.
• Elderly patients and individuals with chronic kidney disease continue to represent high-risk populations.
• Early diagnosis and timely intervention are critical to preventing progression to chronic kidney disease and kidney failure.
• Increasing adoption of biomarker-based monitoring and critical care management is improving patient outcomes.

Market Overview

• The Germany AKI market is projected to grow from approximately $105 MN to $230 MN by 2035.
• Market growth is supported by:
• Rising hospitalization rates and critical care utilization
• Increasing adoption of renal monitoring and supportive therapies
• Market expansion is driven by growing awareness of kidney injury prevention and management.
• Future growth will depend on novel renal protective therapies and early diagnostic technologies.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• M2RLAB SL
• Hope Biosciences LLC
• CalciMedica, Inc.
• AstraZeneca
• Arch Biopartners Inc.
• Novartis Pharmaceuticals
• EnnovaBio
• Bilix Co., Ltd.
• Noorik Biopharmaceuticals AG
• Vantive Health LLC

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

6. Regulatory and Reimbursement Environments (by country and payer insights)

7. Appendix (e.g., bibliography, methodology)