Published Date : 2023-04-11
Published Date : 2023-04-11
Updated On : 2024-01-09
Pages : 157
Thelansis’s “Acute Kidney Injury (AKI) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Acute Kidney Injury treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Acute Kidney Injury (AKI) is a sudden decline in kidney function, determined by elevated serum creatinine levels (indicating impaired kidney excretion) and reduced urine output (oliguria) within a 7-day timeframe. When AKI persists for over 3 months, it is termed Chronic Kidney Disease (CKD). It's noteworthy that AKI and CKD frequently coexist in patients with preexisting CKD. Acute Renal Failure (ARF) is a clinical syndrome characterized by the abrupt onset of kidney dysfunction, resulting in the accumulation of metabolic toxins and disturbances in fluid, electrolyte, and acid-base balance. The causes of AKI can be categorized into three groups: prerenal (due to reduced renal blood flow, often due to dehydration), intrinsic renal (stemming from kidney-related issues), and postrenal (resulting from inadequate urine drainage beyond the kidneys). In individuals with underlying chronic kidney disease, any factors, particularly dehydration, can lead to AKI alongside chronic renal impairment. Prerenal causes account for around 70% of community-acquired AKI cases. Various medications, such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs, can trigger prerenal AKI by affecting renal perfusion or glomerular filtration rate. These drugs can hinder the body's usual responses to dehydration and may result in reduced renal function. In prerenal AKI, kidney function typically returns to normal once adequate fluid levels are restored, the underlying cause is treated, or the causative medication is discontinued. AKI classification comprises prerenal AKI, acute postrenal obstructive nephropathy, and intrinsic acute kidney diseases. Only "intrinsic" AKI represents a true kidney disease, while prerenal and postrenal AKI are outcomes of non-kidney conditions that reduce glomerular filtration rate (GFR). If prerenal and postrenal conditions persist, they can eventually lead to cellular damage in the kidneys and, consequently, intrinsic renal disease. Risk factors for AKI encompass environmental, socioeconomic, cultural, care-related, acute exposures, and patient-related factors. Clinical presentation varies based on the cause and severity of renal injury, as well as any associated conditions. Most mild to moderate AKI patients exhibit no symptoms and are identified through laboratory tests. In severe cases, patients may experience listlessness, confusion, fatigue, loss of appetite, nausea, vomiting, weight gain, or edema. Severe AKI can also manifest as oliguria (urine output less than 400 mL per day), anuria (urine output less than 100 mL per day), or normal urine volumes (nonoliguric AKI). Additional presentations may include uremic encephalopathy (characterized by a decline in mental status, asterixis, or other neurological symptoms), anemia, or bleeding due to platelet dysfunction caused by uremia. Currently, AKI diagnosis relies on an acute reduction in GFR, indicated by an abrupt increase in serum creatinine levels and a decrease in urine output within a specific timeframe. The primary treatment option is dialysis and supportive care, as no drugs are approved for AKI treatment. Typically, these patients are managed in intensive care units, often with the assistance of nephrologists.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | ANG-3777 | Angion Biomedica Corp | Phase 2 |
2 | SCD-F40 | CytoPherx, Inc | Phase 2 |
3 | RMC-035 | Guard Therapeutics AB | Phase 2 |
4 | QPI-1002 | Quark Pharmaceuticals | Phase 2 |
5 | recAP | AM-Pharma | Phase 2 |
6 | LSALT Peptide | Arch Biopartners Inc. | Phase 2 |
7 | Suramin | Rediscovery Life Sciences | Phase 2 |
8 | Alprostadil liposome | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 2 |
9 | MIB-626 | Metro International Biotech, LLC | Phase 2 |
10 | R2R01 | River 2 Renal Corp. | Phase 2 |
Continued...
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Acute Kidney Injury (AKI) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Acute Kidney Injury (AKI) market scenario 2023 |
1.2.2. Acute Kidney Injury (AKI) market scenario 2028 |
1.2.3. Acute Kidney Injury (AKI) market scenario 2033 |
2. Acute Kidney Injury (AKI) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Acute Kidney Injury (AKI) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Acute Kidney Injury (AKI) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Acute Kidney Injury (AKI) management |
2.16. Market Opportunity for Acute Kidney Injury (AKI) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Acute Kidney Injury (AKI) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Acute Kidney Injury (AKI) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Acute Kidney Injury (AKI) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Acute Kidney Injury (AKI) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Acute Kidney Injury (AKI) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Acute Kidney Injury (AKI) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Acute Kidney Injury (AKI) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Acute Kidney Injury (AKI) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Acute Kidney Injury (AKI) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Acute Kidney Injury (AKI) Market Forecast 2023-2033 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Acute Kidney Injury (AKI) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Acute Kidney Injury (AKI) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Acute Kidney Injury (AKI) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Acute Kidney Injury (AKI) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |