Hyperkalemia - Market Insight, Epidemiology And Market Forecast - 2032

DelveInsight's 'Hyperkalemia - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Hyperkalemia, historical and forecasted epidemiology as well as the Hyperkalemia market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Hyperkalemia market report provides current treatment practices, emerging drugs, market share of individual therapies, and the current and forecasted 7MM Hyperkalemia market size from 2019 to 2032. The Report also covers current Hyperkalemia treatment practice, SWOT analysis, reimbursement, market access, 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, Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Hyperkalemia Understanding and Treatment Algorithm

Hyperkalemia Overview

According to National Kidney Foundation, High potassium (called "hyperkalemia") is a medical problem in which a person has excessive potassium in the blood, an important nutrient found in many foods. Potassium helps the nerves and muscles, including the heart, work correctly, but excessive potassium in the blood can be dangerous and cause serious heart problems

While mild hyperkalemia is usually asymptomatic, high potassium levels may cause life-threatening cardiac arrhythmias, muscle weakness, or paralysis. Symptoms usually develop at higher levels, 6.5-7 mEq/L, but the rate of change is more important than the numerical value. Patients with chronic hyperkalemia may be asymptomatic at increased levels, while patients with dramatic, acute potassium shifts may develop severe symptoms at lower ones; infants have higher baseline levels than children and adults.

Hyperkalemia occurs when renal potassium excretion is limited by reductions in glomerular filtration rate, tubular flow, distal sodium delivery, or the expression of aldosterone-sensitive ion transporters in the distal nephron.

The major risk factors for hyperkalemia are renal impairment - either AKI or advanced chronic kidney disease (CKD) - and any acquired or inherited defects in potassium excretion in the distal nephron. In CKD, hyperkalemia is typically encountered after the estimated glomerular filtration rate (eGFR) drops below 15 mL/min.

The most notorious consequence of hyperkalemia is potentially fatal cardiac dysrhythmia; however, several other consequences are worthy of discussion. Hyperkalemia is associated with increased mortality. Consequently, hyperkalemia-or the fear of hyperkalemia-may prompt prescribing practice changes (e.g., avoiding RAS blockade and MRAs). Finally, recent data show that hyperkalemia can cause renal tubular acidosis and contribute to peripheral neuropathy in CKD patients.

Hyperkalemia Diagnosis

For hyperkalemia, interviews, physical examinations, blood tests, urinalysis, electrocardiogram tests, etc., are conducted to understand the condition. These tests not only help determine the cause of hyperkalemia but also help determine treatment strategies.

A blood test measures the potassium concentration in the serum; if it is less than 3.5 mEq/L, it is called hypokalemia. In the medical examination, the medical history of symptoms and diseases that are likely to cause it is considered, such as the history of taking drugs, the contents of meals, etc., and perform a blood test to make a comprehensive diagnosis. The cause and severity of hypokalemia are investigated by examining the potassium concentration and excretion in urine, hormone tests such as aldosterone secreted from the adrenal glands, and electrocardiography to check the effects on the heart.

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Hyperkalemia Treatment

The treatment of hyperkalemia includes IV calcium, insulin/dextrose, beta-2 adrenergic receptor agonists, sodium bicarbonate infusion, cation-exchange resins, sodium polystyrene sulfonate, calcium polystyrene sulphonate, Patiromer, sodium zirconium cyclosilicate, and loop diuretics.

Albuterol is an effective treatment for hyperkalemia through beta-adrenergic induction of potassium (K+) uptake. In a randomized, double-blind, placebo-controlled prospective study, authors compared the K+ lowering effects of nebulized saline and equipotent bronchodilatory doses of albuterol (10 mg) and levalbuterol (2.5 mg) in healthy adult volunteers. Nine subjects entered each of the three study groups. Serum K+ was measured at baseline, at 30 min (immediately after treatment), at 60 min, and 90 min immediately after nebulization; only levalbuterol showed a significant decrease in potassium level. At 30 and 60 min after treatment, both albuterol and levalbuterol groups had significantly lower K+ values compared to the placebo.

Sodium polystyrene sulfonate (sold under the brand names SPS, KAYEXALATE, and KIONEX) is widely used to treat hyperkalemia. It is a synthetic cation-bound resin that exchanges sodium cations for potassium in the gastrointestinal (GI) lumen, resulting in increased fecal potassium excretion and decreased serum potassium levels. This drug was first introduced to treat hyperkalemia in two small uncontrolled case series in the early 1950s. The US Food and Drug Administration (FDA) approved it for the short-term treatment of hyperkalemia in 1958.

LOKELMA is a highly-selective, oral potassium-removing agent.

In March 2020, AstraZeneca's LOKELMA was approved in Japan for treating patients with hyperkalemia.

In May 2018, the US FDA approved LOKELMA to treat adults with hyperkalemia, in the same year the European Commission granted marketing authorization to treat adults with hyperkalemia.

VELTASSA (Patiromer) offers effective and well-tolerated long-term management of hyperkalemia in CKD and chronic heart failure (HF) patients.

In October 2015, VELTASSA was approved by the US FDA to treat hyperkalemia in the US and has been available to patients in the US since December 2015.

The European Commission granted a marketing authorization valid throughout the EU for VELTASSA in July 2017.

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Hyperkalemia Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent cases of Hyperkalemia, Gender-specific Diagnosed Prevalent cases of Hyperkalemia, Age-specific Diagnosed Prevalent cases of Hyperkalemia, Severity-specific Diagnosed Prevalent cases of Hyperkalemia, and Comorbidities-specific Diagnosed Prevalent cases of Hyperkalemia scenario of Hyperkalemia in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

Key Findings

• In 2021, the total diagnosed prevalent cases of Hyperkalemia were estimated to be approximately 5,517,046 cases in the 7MM. These cases are expected to increase by 2032 at a CAGR of 2.8% during the study period (2019-2032).
• Among the 7MM, the United States accounted for nearly 79% of the total diagnosed prevalent cases of Hyperkalemia in the 7MM in the year 2021 which are expected to increase further by 2032.
• Among EU4 and the United Kingdom, Germany had the highest total diagnosed prevalent cases of Hyperkalemia with approximately 212,445 cases in 2021, while Spain had the lowest diagnosed prevalent population of Hyperkalemia with approximately 15,918 cases in 2021.
• In 2021, the diagnosed prevalent population of Hyperkalemia in Japan was found to be approximately 696,891 cases, which is expected to change for the study period of 2019-2032.
• According to estimates based on DelveInsight's epidemiology model for Hyperkalemia, the gender distribution of the disease suggests a male predominance across the 7MM, with approximately 3,016,271 male and 2,500,774 female cases in the 7MM in 2021.
• According to estimates based on DelveInsight's epidemiology model for Hyperkalemia, in the US, the age-specific cases of the disease suggest that the 18-64 years age group make up the majority of the Hyperkalemia cases, followed by 65-79 years age-group. While the least cases were in the = 80 age group.

Hyperkalemia Epidemiology

The epidemiology segment also provides the Hyperkalemia epidemiology data and findings across the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

Hyperkalemia Drug Chapters

The drug chapter segment of the Hyperkalemia report encloses a detailed analysis of Hyperkalemia marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Hyperkalemia clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Hyperkalemia Emerging Drugs

The potential drugs that are expected to launch in the forecasted period include PATIROMER (ZG-801) and others.

RDX013 (Ardelyx): RDX013 is a novel, small-molecule program for the potential treatment of hyperkalemia. RDX013 pharmacologically targets potassium secretion through the gut lumen, thus lowering serum potassium levels. RDX013 program may provide nephrologists and cardiologists with an opportunity to treat hyperkalemia chronically without reducing the dose of these medications by utilizing an effective potassium secretagogue to treat hyperkalemia in a small, convenient pill format.

Products detail in the report…

List of products to be continued in the report…

Hyperkalemia Market Outlook

The treatment of hyperkalemia includes IV calcium, insulin/dextrose, beta-2 adrenergic receptor agonists, sodium bicarbonate infusion, cation-exchange resins, sodium polystyrene sulfonate, calcium polystyrene sulphonate, Patiromer, sodium zirconium cyclosilicate, and loop diuretics.

Albuterol is an effective treatment for hyperkalemia through beta-adrenergic induction of potassium (K+) uptake. In a randomized, double-blind, placebo-controlled prospective study, authors compared the K+ lowering effects of nebulized saline and equipotent bronchodilatory doses of albuterol (10 mg) and levalbuterol (2.5 mg) in healthy adult volunteers. Nine subjects entered each of the three study groups. Serum K+ was measured at baseline, at 30 min (immediately after treatment), at 60 min, and 90 min immediately after nebulization; only levalbuterol showed a significant decrease in potassium level. At 30 and 60 min after treatment, both albuterol and levalbuterol groups had significantly lower K+ values compared to the placebo.

Sodium polystyrene sulfonate (sold under the brand names SPS, KAYEXALATE, and KIONEX) is widely used to treat hyperkalemia. It is a synthetic cation-bound resin that exchanges sodium cations for potassium in the gastrointestinal (GI) lumen, resulting in increased fecal potassium excretion and decreased serum potassium levels. This drug was first introduced to treat hyperkalemia in two small uncontrolled case series in the early 1950s. The US Food and Drug Administration (FDA) approved it for the short-term treatment of hyperkalemia in 1958 (Parks & Grady, 2019).

The treatment of acute hyperkalemia is empirical and off-label since ZS-9 is unavailable in several countries; among the off-label therapies, insulin plus dextrose had better efficacy than glucose (Yang et al., 2019).

Treatment of chronic hyperkalemia is primarily based on reducing or discontinuing RAASi therapy according to currently available guidelines and potassium binders. Current chronic hyperkalemia treatments fail to discontinue RAASi therapy limits the patient's ability to manage the underlying disease.

The lack of consensus statements regarding hyperkalemia limits the creation of standard treatment protocols, resulting in a discrepancy in hyperkalemia management. The market is deficient in the compound that can be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Unlike marketed drugs, the upcoming emerging drug RDX013 (Ardelyx) is a first-in-class potassium secretagogue (an agent that promotes the secretion of hormones, neurohormones, chemical neurotransmitters, enzymes, or other molecules synthesized and secreted by cells) that helps in lowering potassium levels. This investigational molecule completed the Phase III clinical trial in March 2022, with the Phase III trial results impending. RDX013 significantly increases fecal K+ excretion being potassium channel modulators, thereby providing a new approach to managing serum K+ in patients vs. commonly prescribed K+ binders.

Another approved drug in the market, VELTASSA (Zeria Pharmaceutical/Vifor Pharma), has pending approval in Japan for hyperkalemia. To date, the trial stays active in the recruiting phase and is expected to be completed by the end of 2022. The approval of VELTASSA in Japan may not face any problems as the drug is already approved in the US and Europe with positive results.

Considering the current market scenario, off-labels have captured a major chunk, and the already approved drugs have associated complications, making the pharmaceutical companies invest in research to develop a new mechanism of action with more convenient and useful options considering patients on other medications and those having chronic or severe hyperkalemia.

Key Findings

• The market size of Hyperkalemia in the seven major markets was approximately USD 1,198 million in 2021, which is further expected to increase by 2032.
• The market size in the 7MM will increase at a CAGR of 5.7% due to increasing prevalence of the disease.
• Among the 7MM countries, the US accounted for the highest market size of Hyperkalemia with USD 970 million in 2021 which is likely to increase by 2032.
• Among EU4 and the United Kingdom, Germany accounted for USD 49 million in 2021, followed by the United Kingdom with USD 38 million in the same year, while Spain accounted for the lowest market with USD 4 million in 2021.
• Japan accounted for USD 127 million in 2021, which is expected to increase by 2032.

The United States Market Outlook

This section provides the total Hyperkalemia market size and market size by therapies in the United States.

EU4 and the United Kingdom Market Outlook

The total Hyperkalemia 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 Hyperkalemia market size and market size by therapies in Japan are provided.

Hyperkalemia Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Hyperkalemia market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Hyperkalemia market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and the 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.

Hyperkalemia Development Activities

The report provides insights into different therapeutic candidates in the phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

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

Reimbursement Scenario in Hyperkalemia

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Hyperkalemia 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 a descriptive overview of Hyperkalemia, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Hyperkalemia epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Hyperkalemia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Hyperkalemia 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 Hyperkalemia market.

Report Highlights:

• The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the Hyperkalemia market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Hyperkalemia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Hyperkalemia. The launch of emerging therapies will significantly impact the Hyperkalemia market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Hyperkalemia Report Insights

• Patient Population
• Therapeutic Approaches
• Hyperkalemia Pipeline Analysis
• Hyperkalemia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Hyperkalemia Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Hyperkalemia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hyperkalemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• SWOT analysis

Key Questions

Market Insights:

• What was the Hyperkalemia market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Hyperkalemia total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Hyperkalemia market size during the forecast period (2022-2032)?
• At what CAGR, the Hyperkalemia market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Hyperkalemia market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Hyperkalemia market growth till 2032 and what will be the resultant market size in the year 2032?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Hyperkalemia?
• What is the historical Hyperkalemia patient pool in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What would be the forecasted patient pool of Hyperkalemia at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Hyperkalemia?
• Out of the above-mentioned countries, which country would have the highest prevalence population of Hyperkalemia during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Hyperkalemia along with the approved therapy?
• What are the current treatment guidelines for the treatment of Hyperkalemia in the US and Europe?
• What are the Hyperkalemia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Hyperkalemia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Hyperkalemia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Hyperkalemia?
• 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 Hyperkalemia and their status?
• What are the key designations that have been granted for the emerging therapies for Hyperkalemia?
• What is the 7MM historical and forecasted market for Hyperkalemia?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving Hyperkalemia.
• To understand the future market competition in the Hyperkalemia market.
• Organize sales and marketing efforts by identifying the best opportunities for Hyperkalemia in the United States, EU4 (Germany, France, Italy, 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 Hyperkalemia market.
• To understand the future market competition in the Hyperkalemia market.