The “Hyperkalemia – Market Insight, Epidemiology and Market Forecast – 2030” drug pipelines has been added to ResearchAndMarkets.com’s offering.
This 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.
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 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 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.
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.
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.
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.
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.
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.
This section focuses 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.
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.
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.
Key Topics Covered
1 Key Insights
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
- Zeria Pharmaceutical/Vifor Pharma
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