Acute Kidney Injury Aki Market
DelveInsight’s ‘Acute Kidney Injury (AKI) - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the Acute Kidney Injury (AKI), historical and forecasted epidemiology as well as the Acute Kidney Injury (AKI) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), And Japan.
The Acute Kidney Injury (AKI) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Acute Kidney Injury (AKI) market size from 2018 to 2030. The report also covers current Acute Kidney Injury (AKI) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Acute Kidney Injury (AKI) Disease Understanding and Treatment Algorithm
Acute Kidney Injury (AKI) Overview
Acute Kidney Injury (AKI) (AKI), also known as acute renal failure (ARF) is a condition characterized by azotemia that progresses over several hours or days, with or without oliguria. 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 the course of hours to weeks. The disease leads to abrupt loss of kidney function, leading to the retention of waste products, electrolyte disturbances, and volume status changes. According to the Kidney Disease: Improving Global Outcomes (KDIGO), AKI is defined as any of the following (not graded):
- Increase in serum creatinine (SCr) by = 0.3 mg/dl (= 26.5 µmol/l) within 48 hours.
- Increase in SCr to = 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.
- Urine volume < 0.5 ml/kg/hour for 6 hours.
In 1802, William Heberden termed the first description of AFR, Ischuria renalis. At the beginning of the twentieth century, ARF termed as Acute Bright’s disease was described in William Osler’s Textbook for Medicine (1909), to be “as a consequence of toxic agents, pregnancy, burns, trauma or operations on the kidneys”. During the First World War, the syndrome was named war nephritis and was reported in several publications. The syndrome was forgotten until the Second World War when Bywaters and Beall published their classical paper on crush syndrome. Acute tubular necrosis (ATN) was the term that was used to describe this clinical entity, because of histological evidence for patchy necrosis of renal tubules at autopsy. For many years in clinical practice, the terms ATN and ARF were used interchangeably. However, it is Homer W. Smith who is credited with the introduction of the term AKI, in a chapter on AKI related to traumatic injuries in his 1951 textbook. The kidney-structure and function in health and disease. Until recently, a precise biochemical definition for ARF was missing. As a consequence, there was no consensus on the diagnostic criteria, resulting in multiple different definitions. A 2002 survey revealed at least 35 definitions in the scientific literature.
Acute Kidney Injury (AKI) Diagnosis
The diagnosis of AKI is traditionally based on a rise in serum creatinine and/or fall in urine output. The definition has evolved from the Risk, Injury, Failure, Loss, End-stage (RIFLE) criteria in 2004 to the AKI Network (AKIN) classification in 2007. In 2012, both were merged resulting in the Kidney Disease Improving Global Outcomes (KDIGO) classification. Accordingly, AKI is diagnosed if serum creatinine increases by 0.3 mg/dl (26.5 μmol/l) or more in 48 h or rises to at least 1.5-fold from baseline within 7 days. ARF stages are defined by the maximum change of either serum creatinine or urine output. The importance of both criteria was confirmed in a recent study in >32,000 critically ill patients which showed that short- and long-term risk of death or renal replacement therapy (RRT) were greatest when patients met both criteria for ARF and when these abnormalities persisted for longer than 3 days.
Acute Kidney Injury (AKI) Treatment
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 include:
- Temporary hemodialysis,
- Medicines to control the amounts of vitamins and minerals in blood,
- Treatments to keep the right amount of fluid in the blood
More often, post hospitalization, a kidney-friendly diet plan is recommended to help the kidneys continue to heal.
Acute Kidney Injury (AKI) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Population of Acute Kidney Injury (AKI) (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 United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan.
- This section provides glimpse of the AKI epidemiology in the 7MM.
- In 2020, the incident population of AKI in the 7MM was 10,907,615. The mortality adjusted incident population of AKI in hospitalized patients in the seven major market, was estimated to be 6,544,569 in 2020.
- The United States encompasses the highest incident population of AKI in hospitalized patients, compared to EU5 and Japan. In the United States, mortality adjusted incident population of AKI in hospitalized patients accounted for 2,231,147 in 2020.
- In 2020, in the United States, there were 1,584,114, 401,606, and 245,426 cases of stage I, stage II, and stage III AKI respectively.
- In the US, the age group of 60–84 accounted for the highest cases in 2020, followed by 85+ years. In contrast, the least cases were found in the age group of 18–59. In 2020, there were 312,361, 1,004,016, and 914,770 cases, for the age groups 18–59 years, 60–84 years, and 85+ years, respectively.
- Epidemiology assessed for AKI showed that Germany accounted for the highest mortality-adjusted incident population of AKI in hospitalized patients in EU5, followed by the UK in 2020. The number of total mortality adjusted incidence of AKI in hospitalized patients is anticipated to be 906,731, 544,235, 506,725, 235,769 and 796,443 in 2020, for Germany, France, Italy, Spain, and UK, respectively.
- Epidemiology assessed for AKI showed that Japan, in 2020, accounted for the second-highest mortality-adjusted incident population of AKI in hospitalized patients in 7MM, about 1,323,519 cases.
Country Wise- Acute Kidney Injury (AKI) Epidemiology
The epidemiology segment also provides the Acute Kidney Injury (AKI) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Acute Kidney Injury (AKI) Drug Chapters
The drug chapter segment of the Acute Kidney Injury (AKI) report encloses the detailed analysis of AKI mid and late-stage pipeline drugs. It also helps to understand the AKI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Acute Kidney Injury (AKI) Emerging Drugs
RESCAP (Rescuing Alkaline Phosphatase), is an endogenous enzyme based on Alkaline Phosphatase (AP) a naturally occurring protein present in the body. It works as prophylactic and therapeutic anti-inflammatory protein that prevents ischemic injury by neutralizing and detoxifying inflammatory triggers that may derail the immune system. In acute settings, RESCAP triggers enhanced endogenous production of AP by the body, thereby boosting innate defense systems. bRESCAP is the type of RESCAP based on calf intestine from BSE free countries. It has a fast onset of action, a high dosing efficacy and a short residence time in the body (half-life of a few minutes), which makes the drug ideal for acute clinical disorder treatments. The drug is under development by Alloksys in phase IIb/III for the treatment of AKI after cardiopulmonary bypass. RESCAP also has potential applications in the prevention and curing of chronic inflammatory diseases, such as Rheumatoid Arthritis, Cystic Fibrosis, Diabetes, and neuro-degenerative diseases.
The drug has been investigated by Alloksys for the immune response in patients undergoing cardiac surgery and has a potential to treat patients with AKI.
Product details in the report…
ANG-3777 (BB3): Angion Biomedica
ANG-3777 is a small molecule hepatocyte growth factor/scatter factor (HGF/SF) being developed by Angion Biomedica. ANG-3777 is currently in a phase III trial for the treatment of Acute Kidney Injury (AKI) associated with delayed graft function and a phase II trial for Acute Kidney Injury (AKI) associated with cardiac surgery. The company anticipates that the topline phase II data for ANG-3777 in AKI associated with cardiac surgery involving cardiopulmonary bypass surgery could be expected in second half of 2021. The company plans to initiate phase III for the same indication by first quarter of 2022. While, the topline phase III data for ANG-3777 in transplant-associated AKI, also known as delayed graft function could be expected by the year end. The company plans to submit NDA by 2022.
Product details in the report…
Teprasiran (QPI-1002): Quark Pharmaceuticals
Teprasiran (QPI-1002) is a nuclease-resistant, synthetic double-stranded RNA oligonucleotide designed to temporarily inhibit the expression of the proapoptotic gene p53, via activation of the RNA interference (RNAi) pathway being developed by Quark Pharmaceuticals. Its development is based on the proprietary concept for temporary and reversible inhibition of p53 for therapeutic purposes. P53 is a stress-response gene activated by DNA damage, hypoxia, oxidative stress, and other conditions, leading to the induction of cell cycle arrest, cell senescence or apoptosis. QPI-1002 is under development by Quark Pharmaceuticals in phase III for the treatment of delayed graft function (DGF) and for the treatment of Acute Kidney Injury (AKI) following cardiac surgery. Subject to study results, Quark is preparing for an NDA submission for the AKI indication.
Product details in the report…
EA-230: Exponential Biotherapies
EA-230 is being developed by Exponential Biotherapies, is an intravenously administered chemically synthesized linear peptide, a derivative of the human pregnancy hormone used for immunomodulation. As per the company, EBI has recently completed a placebo-controlled, combined phase IIa and phase IIb clinical study with patients undergoing elective CABG‐surgery (n=180). EBI is currently laying the groundwork for a pivotal phase III clinical trial. As EA-230 is a first-in-class peptide drug with significant and beneficial hemodynamic and renal effects, a pivotal phase III clinical trial will focus on the capacities of EA-230 to improve blood-vessel permeability and contractility under various conditions of surgery and intensive care. After successful completion of the Phase III trial, the company aims at applying for market authorization.
Product details in the report…
Acute Kidney Injury (AKI) Market Outlook
Among the seven major markets, the United States has reported having maximum incident cases of AKI. Though the incidence of AKI is high across the US, the condition is often undiagnosed, ultimately leading to a lower treatable pool (when compared to the total incident population of the disease) that contributes to the market size of AKI.
Robust pipeline with a novel mechanism of action and increasing incidence are major market drivers of 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 Renal Replacement Therapy (RRT) and off-label drugs, which include various classes such as ACE inhibitors, Angiotensin II-Receptor Blockers (ARBs), Diuretics, and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Management of AKI involves fluid resuscitation, avoiding nephrotoxic medications and contrast media exposure, and correcting electrolyte imbalances. Despite harmonization in clinical definition and staging, identification of novel renal biomarkers for clinical use, and progress in understanding the underlying pathophysiology, there remains a major unmet medical need. The current market persists with various unmet needs related to diagnosis and effective treatment, including lack of approved therapies for sepsis AKI and high affordability.
- This section includes a glimpse of the AKI 7MM market.
- The total market size is calculated by including the market size of both emerging and current therapies. The total market size in the 7MM for AKI was estimated to be USD 5,436 million in 2020 during the study period 2018–2030.
- In the 7MM, most of the share in the current market was captured by the United States, which was USD 2,786.7 million, while the second-highest revenue generator was Japan, taking nearly USD 840.4 million in its box, in 2020. The dynamics are anticipated to change during the forecast period, i.e., 2021–2030, owing to the launch of more effective drugs with clinically improved outcomes.
- Among the 7MM countries, the US accounts for the largest market size for AKI. The growth of market size for AKI is attributed to emerging therapies. The market size for AKI was USD 2,786.7 million in 2020.
- Among the EU-5 countries, Germany accounted for the highest market size of AKI in 2020. The market size of AKI in the EU5 was USD 1,809 million in 2020, inclusive of current treatment regimens. The lowest market is estimated to be covered by Spain, which accounts for USD 142.6 million in 2020.
- The market size for AKI in Japan was calculated to be USD 840.4 million in 2020.
The United States Market Outlook
This section provides the total Acute Kidney Injury (AKI) market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Acute Kidney Injury (AKI) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Acute Kidney Injury (AKI) market size and market size by therapies in Japan are provided.
Acute Kidney Injury (AKI) Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the AKI market or expected to get launched in the market during the study period 2018–2030. The analysis covers AKI market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Acute Kidney Injury (AKI) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for AKI emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Acute Kidney Injury (AKI) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the 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 are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the AKI; 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 Injury market.
- In the coming years, the AKI market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
- The companies and academics are working to assess challenges and seek opportunities that could influence AKI R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- Positive results by major key players Angion Biomedica and Quark Pharmaceuticals may increase market size in the coming years, assisted by an increase in the AKI incident population pool.
- Since AKI is associated with multiple critical care complications such as cardiac surgery, DGF, sepsis, and many more, no targeted pharmacotherapies have been approved for AKI treatment. Consequently, the treatment solely depends on the existing off-label therapeutic options, such as diuretics, NSAIDs, RRT, etc., which have been used for decades.
- As there is no therapeutic cure to the disease, the risk of AKI is usually prevented by identifying patients at risk, reviewing medications, and reducing the exposure of patients to nephrotoxic drugs. The current treatment approach for such patients needs to be on the preventive side rather than on the curative side. Therefore, the emerging drugs such as bRESCAP, ANG-3777 for AKI-associated with cardiac surgery, QPI-1002, and Ruconest (Conestat alfa) are aiming to prevent the risk of AKI rather than providing therapeutic support after the cause of AKI.
- Amongst upcoming emerging therapies, ANG-3777 and teprasiran (QPI-1002) for DGF indication are expected to get approval earlier than AKI-associated with cardiac surgery. ANG-3777 has received the Fast Track and Orphan Drug designation by the US FDA and is planning to submit NDA by 2022 for DGF. QPI-1002, on the other hand, has been granted Orphan Drug designation by the US FDA and EU and is aiming to support NDA submission for the DGF indication. Besides, recAP and bRESCAP are also among the key players in the late phases of development and are expected to enter the market soon.
Acute Kidney Injury (AKI) Report Insights
- Patient Population
- Therapeutic Approaches
- Acute Kidney Injury (AKI) Pipeline Analysis
- Acute Kidney Injury (AKI) Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Acute Kidney Injury (AKI) Report Key Strengths
- Ten Years Forecast
- 7MM Coverage
- Acute Kidney Injury (AKI) Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Acute Kidney Injury (AKI) Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- What was the Acute Kidney Injury (AKI) market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Acute Kidney Injury (AKI) total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
- What are the key findings pertaining to the market across the 7MM
- Which country will have the largest Acute Kidney Injury (AKI) market size during the forecast period (2021–2030)?
- At what CAGR, the Acute Kidney Injury (AKI) market is expected to grow in the 7MM during the forecast period (2021–2030)?
- What would be the Acute Kidney Injury (AKI) market outlook across the 7MM during the forecast period (2021–2030)?
- What would be the Acute Kidney Injury (AKI) market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- What is the disease risk, burden and unmet needs of Acute Kidney Injury (AKI)?
- What is the historical Acute Kidney Injury (AKI) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
- What would be the forecasted patient pool of Acute Kidney Injury (AKI) at the 7MM?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Acute Kidney Injury (AKI)?
- Out of the above-mentioned countries, which country would have the highest incident population of Acute Kidney Injury (AKI) during the forecast period (2021–2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the treatment of Acute Kidney Injury (AKI) along with the approved therapy?
- What are the current treatment guidelines for the treatment of Acute Kidney Injury (AKI) in the US, Europe and Japan?
- What are the Acute Kidney Injury (AKI) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of Acute Kidney Injury (AKI)?
- How many therapies are developed by each company for the treatment of Acute Kidney Injury (AKI)?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of Acute Kidney Injury (AKI)?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acute Kidney Injury (AKI) therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Acute Kidney Injury (AKI) and their status?
- What are the key designations that have been granted for the emerging therapies for Acute Kidney Injury (AKI)?
- What are the 7MM historical and forecasted market of Acute Kidney Injury (AKI)?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Acute Kidney Injury (AKI).
- To understand the future market competition in the Acute Kidney Injury (AKI) market and an Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Acute Kidney Injury (AKI) in the US, Europe (Germany, Spain, Italy, France, 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 Acute Kidney Injury (AKI) market.
- To understand the future market competition in the Acute Kidney Injury (AKI) market.