Acute Kidney Injury (AKI) - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The incidence of AKI is on the rise, particularly in individuals with acute illnesses and potentially those undergoing significant surgical procedures.
• Currently, there are no targeted pharmacotherapies approved for the treatment of AKI. At present, the therapeutic market size of AKI is mainly dominated by the use of RRT and off-label drugs, which include various classes such as ACE inhibitors, ARBs, Diuretics, and NSAIDs.
• Total mortality-adjusted incident cases of AKI in hospitalized patients in the 7MM accounted for approximately 14.6 million in 2022.
• In 2022, the market size of AKI was highest in the United States among the 7MM, accounting for approximately USD 65% million, which is further expected to increase by 2034.
• In December 2023, SeaStar Medical announced enrollment of patients in the NEUTRALIZE-AKI pivotal clinical trial of its cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with AKI requiring continuous kidney replacement therapy (CKRT).
• In October 2023, Renibus Therapeutics announced that the first patient had been dosed in the pivotal Phase III PROTECT trial of RBT-1 for patients with post-operative complications in cardiac surgery. Top-line results are expected in mid-2025. NDA filing is anticipated by early 2026.

This report delivers an in-depth understanding of the AKI, historical and forecasted epidemiology as well as the AKI market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

AKI market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM AKI market size from 2020 to 2034. The report also covers current AKI treatment practices/algorithms, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

AKI Disease Understanding and Treatment Algorithm

Acute Kidney Injury Overview

AKI is commonly defined as an abrupt decline in renal function, clinically manifesting as a reversible acute increase in nitrogen waste products measured by blood urea nitrogen (BUN) and serum creatinine levels over hours to weeks. Signs and symptoms of AKI include nausea, vomiting, weakness, dizziness, and, pain in the lower back. Some patients are asymptomatic (no noticeable symptoms) and others may have generalized non-specific (not specific to kidneys) symptoms.

Acute Kidney Injury Diagnosis

The history and physical examination are important in determining the etiology of AKI. The history can identify nephrotoxic medications or a systemic illness contributing to impaired renal function. The physical examination should focus on evaluating intravascular volume status. Skin rashes may indicate an underlying condition (e.g., systemic lupus erythematosus, atheroembolism/vasculitis) or exposure (e.g., drug rash suggesting acute interstitial necrosis) leading to acute kidney injury. The diagnosis of AKI is traditionally based on a rise in serum creatinine and/or a fall in urine output. The laboratory assessment includes the measurement of serum creatinine level, urinalysis, renal biopsy, urine electrolytes, and others.

Acute Kidney Injury Treatment

The therapeutic strategies for AKI based on the KDIGO guidelines and bundles of care are limited and mostly supportive. The clinical approach should begin with hemodynamic stabilization, the early identification of AKI complications, its cause, and its treatment. Hemodynamic stabilization is of critical significance because autoregulation mechanisms are impaired in AKI. The treatment for AKI depends on the cause of the condition. Most people need to stay in the hospital during treatment and until the recovery of the kidneys. Some possible treatments apart from temporary hemodialysis include medicines to control the amounts of vitamins and minerals in the blood, and treatments to keep the right amount of fluid in the blood. There is no approved treatment for AKI, the current treatment practices use conventional therapies (vasopressor, diuretics, statins, and others) and Renal Replacement Therapies (RRT).

AKI Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Population of AKI in Hospitalized Patients, Mortality Adjusted Incident Population of AKI in Hospitalized Patients, Stage-specific Incident Population of AKI, and, Age-specific Incident Population of AKI in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• The total Mortality-adjusted Incident Cases of AKI in the 7MM comprised 14.6 million cases in 2022 and are projected to increase during the forecast period.
• The total Mortality-adjusted Incident Cases of AKI in the United States were approximately 5.7 in 2022.
• The US contributed to the largest incident population of AKI, accounting for ~ 39% in the 7MM in 2022.
• Among EU4 and the UK, Germany accounted for the highest number of AKI cases, followed by France, whereas Spain accounted for the lowest cases in 2022.
• The stage-specific cases of AKI include Stage I, Stage II, and, Stage III. Out of which maximum cases were reported in stage I AKI followed by stage II and Stage III.

AKI Drug Chapters

The drug chapter segment of the AKI report encloses a detailed analysis of AKI emerging (Phase-III and Phase II and Phase I/II) pipeline drugs. It also helps to understand the AKI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

RBT-1: Renibus Therapeutics

RBT-1 by Renibus Therapeutics is an investigational drug that upregulates anti-inflammatory, antioxidant, and iron-scavenging pathways, activating a cytoprotective preconditioning response to reduce the risk of postoperative complications and improve patient outcomes following cardiothoracic surgery. The RBT-1-mediated pharmacologic preconditioning is thought to induce broad organ protection, thereby mitigating the risks of postoperative complications and improving both short- and long-term outcomes. In July 2023, Renibus Therapeutics announced that the US FDA granted Breakthrough Therapy Designation to RBT-1 for the reduction in risk of postoperative complications in patients undergoing cardiothoracic surgery and confirmed its alignment with the company’s planned Phase III pivotal trial. In October 2023, Renibus Therapeutics announced that the first patient had been dosed in the pivotal Phase III PROTECT trial of RBT-1. Top-line results are expected in mid-2025. NDA filing is anticipated by early 2026.

OCE-205: Ocelot Bio

Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has the potential to improve outcomes for patients with complications of end-stage liver disease (ESLD). OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in treating ESLD. In August 2022, Ocelot Bio announced that the US FDA granted ODD to OCE-205 for the treatment of hepatorenal syndrome. Ocelot Bio has completed the enrolment of patients in a Phase II clinical trial of OCE-205 in hepatorenal syndrome with acute kidney injury (HRS-AKI).

Drug Class Insights

Patients suffering from AKI are often prescribed diuretics, with loop diuretics being the most commonly recommended class of dialectics. Furosemide, which is a potent loop diuretic, is frequently used in different stages of AKI since it offers the possibility of eliminating large amounts of electrolytes and water as long as the kidneys are capable of filtration.

AKI Market Outlook

A robust pipeline with a novel mechanism of action and increasing incidence are major market drivers of the AKI market. Additionally, the AKI pipeline is also expected to change the current dynamics of the market, which presently comprises biologics and molecules with new mechanisms of action.

Currently, there are no targeted pharmacotherapies approved for the treatment of AKI. At present, the therapeutic market size of AKI is mainly dominated by the use of RRT and off-label drugs, which include various classes such as ACE inhibitors, ARBs, Diuretics, and NSAIDs.

Various comorbidities like cardiovascular disease, hypertension, diabetes mellitus, pre-existing CKD, renal recovery, and others increase the risk of AKI in these patients. As mentioned earlier, the current market of AKI is majorly dependent on RRT and conventional therapies like NSAIDs, ACE inhibitors, ARBs, diuretics, etc. However, this might change in the future, as there are various emerging therapies in the pipeline targeting AKI caused by comorbidities like sepsis, cardiac surgery, delayed graft function, and others. The pipeline of AKI possesses novel candidates targeting HRS-AKI, post cardiac surgery, and AKI due to sepsis are diversifying the treatment options that can reduce the current unmet need in AKI. The current emerging pipeline consists of key players including Renibus Therapeutics (RBT-1), Ocelot Bio (OCE-205), AM-Pharma (Ilofotase alfa), Guard Therapeutics (RMC-035), and others who are developing their products to address the patient population and reduce mortality rates in hospital settings. Overall, the AKI therapeutics market is further expected to increase in the forecast period (2024-2034).

• The total market size of AKI in the 7MM was ~USD 6.23 billion in 2022 and is projected to grow during the forecast period (2024-2034).
• According to the estimates, the highest market size of AKI is from the United States, in 2022 and is anticipated to grow at a CAGR of 4.1%.
• Among EU4 and the UK, Germany has the maximum revenue share in 2022 while Spain has the lowest market share.
• The market size of AKI in Japan was USD 35 million in 2022 which is expected to rise during the forecast period (2024-2034).

AKI Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to be launched in the market during the study period 2020-2034. The analysis covers AKI market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- AM-Pharma’s therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (Ilofotase alfa) constructed from two naturally occurring human isoforms of the AP enzyme.

AKI Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for AKI emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, Center for Critical Care Nephrology, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or AKI market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Center for Kidney Diseases, Department of Rheumatology, Department of Nephrology, etc., were contacted. Their opinion helps understand and validate AKI epidemiology and market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

In January 2017, the Centers for Medicare and Medicaid Services published that end-stage renal disease (ESRD) facilities will be able to furnish dialysis services to AKI patients. The provision provides Medicare coverage and payment to both hospital-based and freestanding ESRD facilities for renal dialysis services furnished to beneficiaries with AKI. Medicare will pay ESRD facilities for dialysis treatment using the ESRD Prospective Payment System (PPS) base rate adjusted by the wage index. In addition to the dialysis treatment, the ESRD PPS base rate pays ESRD facilities for the items and services that are renal dialysis services, and there will be no separate payment for those services. Specifically, this includes renal dialysis drugs, biologicals, laboratory services, and supplies that are included in the ESRD PPS base rate when furnished by an ESRD facility to an individual with AKI.

Scope of the Report

• The report covers a descriptive overview of AKI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the AKI epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for AKI is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the AKI market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM AKI market.

AKI Report Insights

AKI Report Insights

• Patient Population
• Therapeutic Approaches
• AKI Pipeline Analysis
• AKI Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

AKI Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• AKI Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

AKI Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the AKI market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the AKI total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM and which country will have the largest AKI market size during the study period (2020-2034)?
• At what CAGR, the AKI market is expected to grow at the 7MM level during the study period (2020-2034)?
• What would be the AKI market outlook across the 7MM during the study period (2020-2034)?
• What would be the AKI market growth till 2034 and what will be the resultant market size in the year 2034?
• What are the disease risk, burden, and unmet needs of AKI?
• What is the historical AKI patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• What would be the forecasted patient pool of AKI at the 7MM level?
• What will be the growth opportunities across the 7MM concerning the patient population of AKI?
• Out of the above-mentioned countries, which country would have the highest incident population of AKI during the study period (2020-2034)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of AKI?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of AKI?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the AKI therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for AKI and their status?
• What are the key designations that have been granted for the emerging therapies for AKI?
• What are the 7MM historical and forecasted market of AKI?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the AKI.
• To understand the future market competition in the AKI market and Insightful review of the SWOT analysis of AKI.
• Organize sales and marketing efforts by identifying the best opportunities for AKI in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the AKI market.
• To understand the future market competition in the AKI market.