This ‘Hyperkalemia - Market Insights, Epidemiology, and Market Forecast-2030’ report delivers an in-depth understanding of the Hyperkalemia, historical and forecasted epidemiology as well as the Hyperkalemia market trends in Japan.
The Hyperkalemia market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted Japan Hyperkalemia market size from 2021 to 2030. The report also covers current Hyperkalemia 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.
Study Period: 2018-2030
Hyperkalemia Disease Understanding and Treatment Algorithm
Hyperkalemia is defined as a serum potassium concentration that is equal to or greater than 5.5 mEq/L from a non-hemolyzed whole blood sample. The normal potassium level in the blood is 3.5-5.0 mEq/L. Furthermore, it can be classified according to serum potassium into mild (5.5-6.5 mmol/L), moderate (6.5-7.5 mmol/L) and severe (>7.5 mmol/L) hyperkalemia.
Risk factors for hyperkalemia include several conditions such as chronic kidney disease, diabetes, congestive heart failure and certain medications that disrupt the potassium balance. Also, males are found to suffer more than females with Hyperkalemia.
The most common cause of hyperkalemia is pseudohyperkalemia, which does not reflect the true serum potassium levels. Pseudohyperkalemia is most commonly due to hemolysis of the sample causing intracellular potassium to be measured in the serum. Hemolysis is more common when a syringe is used as compared to a vacuum device.
While mild hyperkalemia is usually asymptomatic, high potassium levels may cause life-threatening cardiac arrhythmias, muscle weakness, or paralysis. Symptoms usually develop at levels higher levels, 6.5 mEq/L to 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.
The most notorious consequence of hyperkalemia is that of potentially fatal cardiac dysrhythmia. However, there are several other consequences worthy of discussion. Hyperkalemia is associated with increased mortality.
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.
The current treatment of hyperkalemia in the emergency department (ED) varies considerably because available pharmacologic agents have limited data supporting their efficacy. Following are the commonly used agents for the treatment of hyperkalemia in the emergent setting. In essence, a threefold approach to the treatment of hyperkalemia is currently adopted by clinicians:
Stabilization of the cardiac membranes using intra-venous calcium. The immediate goal of acute management in hyperkalemia is the stabilization of the membrane potential, with or without changing the serum potassium concentration;
Redistribution of potassium using intravenous insulin and beta-2 agonist. These pharmacologic therapies induce temporary but rapid redistribution of potassium into the intracellular space
Elimination of potassium from the body via hemodialysis, sodium-potassium exchange resin binders, and diuretics.
The effect of potassium on myocytes is counterbalanced by the concurrent calcium concentration such that intravenous calcium antagonizes hyperkalemia induced cardiac membrane excitability and protects the heart against arrhythmias. It is usually effective within minutes, as noted by an improvement in the ECG appearance or reversal of ECG ab-normality. It is generally accepted that intravenous (IV) calcium is indicated for potentially life-threatening ECG changes (absent P waves, wide QRS, sine-wave pat-tern), arrhythmias, or cardiac arrest. The dose can be repeated if there is no effect within 5-10 min.
Patiromer is the newest resin cleared by the FDA. It is a calcium exchange resin with more robust data to show efficacy and safety than SPS. PEARL-HF was a double-blinded, placebo-controlled study whose focus was on HF patients with an indication to start spironolactone.
Sodium zirconium cyclosilicate (Lokelma) is recently approved in Japan for the treatment of hyperkalemia. Japan’s Ministry of Health, Labour, and Welfare's approval was based on positive results from stand-alone studies in Japan and global clinical trial programs. It was also supported by DIALIZE, a global trial for end-stage renal disease patients on hemodialysis, which demonstrated the positive efficacy and safety of Lokelma in the management of hyperkalemia.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Population of Hyperkalemia, Gender-specific Diagnosed Prevalent 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 Japan from 2018 to 2030.
This section provides glimpses of the Hyperkalemia epidemiology in Japan.
- As per this analysis, total number of cases of Hyperkalemia in Japan was 503,103 in 2020. These cases of Hyperkalemia in Japan is expected to increase throughout the study period i.e. 2018-2030.
- As per The ’s analysis, there were 276,707 males and 226,397 females with hyperkalemia in 2020.
- In Japan, the maximum number of Hyperkalemia patients fall in the age group of 65-79 years, which was 209,618 in 2020. However, the least number of patients fall in the age group of 18-64 Years, which was 120,138 in 2020.
- As per The ’s analysis, there were 364,750 patients affected with mild cases and 99,111 with moderate cases and 39,242 cases severe hyperkalemia respectively by 2020.
- In 2020, there were 283,735 cases of CKD, 169,781 cases of Heart Failure, 239,734 cases of Diabetes, and 326,150 cases of Hypertension associated with Hyperkalemia.
Country Wise-Hyperkalemia Epidemiology
The epidemiology segment also provides the Hyperkalemia epidemiology data and findings across Japan.
Hyperkalemia Drug Chapters
This segment of the Hyperkalemia report encloses the detailed analysis of the marketed and pipeline drugs/devices. It also helps to understand the 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 Marketed Products
Lokelma (Sodium zirconium cyclosilicate): AstraZeneca
Lokelma is a highly-selective, oral potassium-removing agent. The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label trials, which showed that for patients receiving Lokelma, the onset of action was at 1.0 h and the median time to achieving normal potassium levels in the blood was 2.2 h, with 92% of patients achieving normal potassium levels within 48 h from baseline. The treatment effect was maintained for up to 12 months. The patents of Lokelma are expected to expire by 2019-2035 in the US, 2033-2034 in China, 2032 in the EU, and 2032-2036 in Japan.
Hyperkalemia Emerging Technique
ZG-801 (Patiromer/Veltassa): Zeria Pharmaceutical/Vifor Pharma
Patiromer (ZG-801) is an oral, non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion. It acts within the gastrointestinal tract, binding to potassium in exchange for calcium. The potassium is then removed from the body through the normal excretion process. In clinical trials, patiromer reduced serum potassium levels and the recurrent hyperkalemia risk in patients with chronic kidney disease (CKD) and/or diabetic nephropathy with or without heart failure (HF), allowing the majority of patients to continue receiving renin-angiotensin-aldosterone system (RAAS) inhibitors (drugs that inhibit the renal excretion of potassium) for up to 52 weeks. The drug was approved in the US in 2015 and is now approved in several other countries, including those of the EU, for the treatment of hyperkalemia in adults. Phase II trials are being conducted in Japan for ZG-801, a therapeutic agent for hyperkalemia in-licensed from Vifor (International) AG of Switzerland.
RDX013 is a novel, small molecule program for the potential treatment of hyperkalemia. The drug approach works by leveraging the GI tract’s natural ability to secrete potassium into the gut’s lumen to reduce serum potassium levels. This mechanism differs significantly from the potassium binders currently in the market. For a potassium binder to work, it must be present when dietary potassium is ingested so that the agent can bind the potassium and prevent its absorption in the gut. This results in the need for large quantities of binder in order to bind the large amounts of potassium in the diets of most individuals. In contrast, in the preclinical models, the company observed that a small amount of drug could cause potassium to be secreted into the gut’s lumen. Ardelyx announced that it had completed a Phase I clinical study evaluating the safety and pharmacodynamics of RDX013 in 112 healthy volunteers. The Phase I clinical study data showed that RDX013 was generally safe and well-tolerated and that a decrease in urine potassium and an increase in stool potassium excretion were observed in subjects treated with RDX013.
Hyperkalemia Market Outlook
The treatment of hyperkalemia includes intravenous 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.
In Japan, the approved therapies for hyperkalemia include Lokelma (sodium zirconium cyclosilicate), sodium polystyrene sulfonate, and calcium polystyrene sulphonate. Apart from Lokelma, both the therapies were approved in the 90s, and their generic versions are available in the market; they are also available in different formulations. In January 2013, Astellas Pharma launched Argamate 89.29% granule (calcium polystyrene sulfonate) in Japan to treat hyperkalemia.
The patent protection of Lokelma in Japan might expire during 2032-2036. The market of hyperkalemia is not well organized as no updated guidelines and recommendations are available for patients. The launch of Lokelma in the market will benefit patients depending on off-label and therapies that are not well examined for their safety and efficacy.
Zeria Pharmaceutical got the rights of patiromer (ZG-801/Veltassa) from Vifor Pharma to develop and commercialize it in Japan for the treatment of hyperkalemia. As patiromer is already approved in the major markets, it will likely be approved in Japan soon and emerge as competition to Lokelma in the Japanese market.
According to the publisher, the Hyperkalemia market is expected to change in the study period 2018-2030.
This section includes a glimpse of the Hyperkalemia Japan market.
- The market size of Hyperkalemia in Japan market was USD 132.77 million in 2020.
- In Japan, there is only one approved therapy for Hyperkalemia, and other management includes, off-labeled drugs and generics of potassium binders.
- The market size generated by Lokelma in 2020 was USD 4.42 million.
- ZG-801 (Patiromer) is estimated to enter the market in 2024.
- As per this analysis, among both therapies, Lokelma (sodium zirconium cyclosilicate) is expected to capture decant or higher market share as compared to ZG-801 (Patiromer) because of higher onset of action, no- black box warning and it is already approved while ZG-801 is still in development.
Market Outlook for Seven Major Markets
This section provides the total Hyperkalemia market size and market size by therapies in Japan.
Hyperkalemia Drugs Uptake
This section focusses on the rate of uptake of the potential drugs that are expected to get launched in the market during the study period 2018-2030. The analysis covers 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, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of 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 clinical and premarket clinical studies. 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 Hyperkalemia emerging therapies.
Competitive Intelligence Analysis
The publisher performs 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 the descriptive overview of Hyperkalemia, explaining its causes, signs and symptoms, pathogenesis, 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 Japan drug outreach.
- The report provides an edge while developing business strategies by understanding trends shaping and driving the Japan Hyperkalemia market.
- Hyperkalemia market is anticipated to increase for the study period 2018-2030.
- Among the emerging products, Lokelma (sodium zirconium cyclosilicate) is projected to lead the market with the largest market share in 2030.
- In the coming years, the Hyperkalemia 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 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. Launch of emerging therapies will significantly impact the Hyperkalemia market.
- the in-depth analysis of the pipeline assets across different stages of development, different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, 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
- 10-Years Forecast
- Japan 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
- Market Drivers and Barriers
- SWOT Analysis
Key Questions Answered
- What was the Hyperkalemia market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Hyperkalemia total market size as well as market size by therapies across Japan during the forecast period (2021-2030)?
- What are the key findings pertaining to the market across Japan?
- At what CAGR, the Hyperkalemia market is expected to grow at Japan level during the forecast period (2021-2030)?
- What would be the Hyperkalemia market outlook across Japan during the forecast period (2021-2030)?
- What would be the Hyperkalemia market growth until 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 Hyperkalemia?
- What is the historical Hyperkalemia patient pool in Japan?
- What would be the forecasted patient pool of Hyperkalemia in Japan?
- What will be the growth opportunities across Japan with respect to the patient population pertaining to Hyperkalemia?
- At what CAGR the population is expected to grow across Japan during the forecast period (2021-2030)?
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 Hyperkalemia 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 Hyperkalemia?
- How many therapies are developed by each company for the treatment of Hyperkalemia?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of Hyperkalemia?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hyperkalemia 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 Hyperkalemia and their status?
- What are the key designations that have been granted for the emerging therapies for Hyperkalemia?
- What are Japan historical and forecasted market of Hyperkalemia?
Reasons to Buy
- The report will help in developing business strategies by understanding trends shaping and driving the Hyperkalemia.
- To understand the future market competition in the Hyperkalemia market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Hyperkalemia in 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 Hyperkalemia market.
- To understand the future market competition in the Hyperkalemia market.
2 Executive Summary of Hyperkalemia
3 Disease Background and Overview: Hyperkalemia
3.2 Symptoms of Hyperkalemia
3.3 Causes of Hyperkalemia
3.3.2 Increased Potassium Intake
3.3.3 Cellular shift
3.3.4 Disturbance in Renal Potassium Excretion
3.3.5 Decreased distal delivery of sodium
3.3.6 Mineralocorticoid deficiency
3.4 Pathophysiology of Hyperkalemia
3.4.1 Hyperkalemia from trans-cellular potassium shifts
3.4.2 Hyperkalemia from defective potassium excretion in the distal nephron
3.4.3 Hyperkalemia from defective extrarenal potassium excretion
3.5 Consequences of Hyperkalemia
3.5.1 Cardiac dysrhythmia: mechanism
3.5.2 Peripheral neuropathy
3.5.3 Renal tubular acidosis
3.5.4 Consequences of hyperkalemia in patients receiving dialysis
3.6 Diagnosis of Hyperkalemia
3.6.2 Physical examination
3.6.3 Blood test
4 Patient Journey
5 Epidemiology and Patient Population
5.1 Key Findings
5.2 KOL Views
5.3 Epidemiology Methodology
6 Japan Epidemiology
6.1 Assumptions and Rationale
6.1.1 Total Diagnosed Prevalent Population of Hyperkalemia in Japan
6.1.2 Gender-specific Diagnosed Prevalent of Hyperkalemia in Japan
6.1.3 Age-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan
6.1.4 Severity-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan
6.1.5 Comorbidities-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan
7 Current Treatment and Medical Practices
7.1 Treatment Algorithm
8 Unmet needs
9 Marketed Drugs
9.1 Lokelma (Sodium zirconium cyclosilicate): AstraZeneca
9.1.1 Drug Description
9.1.2 Regulatory Milestones
9.1.3 Clinical Development
9.1.4 Safety and Efficacy
9.1.5 Product Profile
10 Emerging Drugs
10.1 Key Cross Competition
10.2 ZG-801 (Patiromer/Veltassa): Zeria Pharmaceutical/Vifor Pharma
10.2.1 Product Description
10.2.2 Other Developmental Activities
10.2.3 Clinical Development
10.2.4 Safety and Efficacy
10.2.5 Product Profile
10.3 RDX013: Ardelyx
10.3.1 Product Description
10.3.2 Other Developmental Activities
10.3.3 Clinical Development
10.3.4 Safety and Efficacy
10.3.5 Product Profile
11 Hyperkalemia: Japan Market Analysis
11.1 Key Findings
11.2 Market Methodology
11.3 Key Market Forecast Assumptions
12 Japan Market Outlook
12.1 Japan Market Size
12.1.1 Total Market size of Hyperkalemia in Japan
12.1.2 Market Size of Hyperkalemia by therapies in Japan
13 Market Drivers
14 Market Barriers
15 SWOT Analysis
16 Reimbursement and Market access
17.2 Report Methodology
18 Publisher Capabilities
20 About the Publisher
List of Tables
Table 1 Summary of Hyperkalemia, Market, Epidemiology, and Key Events (2018-2030)
Table 2 Total Diagnosed Prevalent Population of Hyperkalemia in Japan (2018-2030)
Table 3 Gender-specific Diagnosed Prevalent of Hyperkalemia in Japan (2018-2030)
Table 4 Age-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Table 5 Severity-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Table 6 Comorbidities-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Table 7 Lokelma; Clinical Trial Description, 2021
Table 8 Comparison of emerging drugs under development
Table 9 ZG-801, Clinical Trial Description, 2021
Table 10 RDX013, Clinical Trial Description, 2021
Table 11 Key Market Forecast Assumptions for Veltassa (Patiromer)
Table 12 Key Market Forecast Assumptions for Lokelma
Table 13 Japan Market Size of Hyperkalemia in USD Million (2018-2030)
Table 14 Market Size of Hyperkalemia by therapies in Japan, in USD Million (2018-2030)
List of Figures
Figure 1 Serum Potassium Levels in Hyperkalemia
Figure 2 Maintenance of differential sodium and potassium concentration between cells and surrounding extracellular fluid
Figure 3 Symptoms of Hyperkalemia
Figure 4 Pharmacologic agents and conditions that can lead to hyperkalemia
Figure 5 Pathogenesis of hyperkalemia: mechanisms in the distal nephron.
Figure 6 Mechanism of cardiac arrhythmia in hyperkalemia
Figure 7 KOL Views
Figure 8 Total Diagnosed Prevalent Population of Hyperkalemia in Japan (2018-2030)
Figure 9 Gender-specific Diagnosed Prevalent of Hyperkalemia in Japan (2018-2030)
Figure 10 Age-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Figure 11 Severity-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Figure 12 Comorbidities-specific Diagnosed Prevalent Cases of Hyperkalemia in Japan (2018-2030)
Figure 13 Hyperkalemia management algorithm
Figure 14 Unmet needs
Figure 15 Market Size of Hyperkalemia in Japan, USD Millions (2018-2030)
Figure 16 Market Size of Hyperkalemia by Therapies in Japan, in USD Million (2018-2030)
Figure 17 Market Drivers
Figure 18 Market Barriers
Figure 19 SWOT analysis