Hyperphosphatemia Market

DelveInsight’s ‘Hyperphosphatemia - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the Hyperphosphatemia, historical and forecasted epidemiology as well as the Hyperphosphatemia market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), Japan, China and Taiwan.

The Hyperphosphatemia market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Hyperphosphatemia market size from 2018 to 2030. The report also covers current Hyperphosphatemia 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.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan
• China
• Taiwan

 Study Period: 2018–2030

Hyperphosphatemia Disease Understanding and Treatment Algorithm

Hyperphosphatemia Overview

Hyperphosphatemia is a condition characterized by an increase in serum phosphate level above 4.5 mg/100 mL. The condition usually occurs due to a decrement in renal function, commonly among chronic kidney disease (CKD) patients, in which phosphate levels shoot up abnormally high. The condition may result from varying factors like an increase in phosphate intake, a decrease in phosphate excretion, or a disorder that shifts intracellular phosphate to extracellular space; the health of kidneys plays a crucial role as it is the kidneys that control the amount of phosphate in the blood. Moreover, phosphate absorption can also be increased with Vitamin D, leading to hyperphosphatemia through increased gut absorption of phosphate

Hyperphosphatemia Diagnosis

The condition is diagnosed by serum phosphate measurement with specific blood tests, which measure the levels of phosphate, calcium, magnesium, blood urea nitrogen, creatinine, vitamin D and parathyroid hormone. It is important to diagnose and find the underlying cause of hyperphosphatemia to treat and restore normal phosphate metabolism.

Hyperphosphatemia Treatment

Treatment for hyperphosphatemia depends on the underlying condition. For people with kidney disease, a combination of diet and medication is used to keep phosphate levels under control.

In patients with persistently or progressively elevated phosphate despite dietary phosphate restriction, phosphate binders are the agent of choice. These are also used concurrently with dietary restriction when phosphate levels at presentation are very high (greater than 6 mg/dl). Phosphate binders reduce the absorption of dietary phosphate in the gastrointestinal tract by exchanging the anion phosphate with an active cation (carbonate, acetate, oxyhydroxide, and citrate) to form a nonabsorbable compound that gets excreted in the feces.

Hyperphosphatemia Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Prevalent Cases of Chronic Kidney Disease, Diagnosed Prevalent Cases of Chronic Kidney Disease, Stage-specific Distribution of Chronic Kidney Disease, Prevalent Cases of End-Stage Renal Disease, Number of ESRD Patients Undergoing Dialysis and Prevalent Cases of Hyperphosphatemia in the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), Japan, China and Taiwan from 2018 to 2030.

This section provides a glimpse of the Hyperphosphatemia epidemiology in the 7MM, China and Taiwan.

• The total diagnosed prevalent cases of chronic kidney disease (CKD) in the seven major markets, China and Taiwan was estimated to be 27,063,599 in 2020.
• In the United States, the patients with Stage 3–5 CKD accounted for 2,317,671 in 2020.
• In 2020, in the United States, the prevalence of ESRD was 797,101 and patients with ESRD on dialysis accounted for 565,941 cases.
• The total prevalent population of Hyperphosphatemia in the 7 MM, China and Taiwan is expected to increase at a CAGR of 0.42% during the forecast period 2021–2030.
• The United States, in 2020, accounted for 481,050 prevalent cases of hyperphosphatemia in ESRD patients undergoing dialysis. Among EU5 countries, Germany had the highest number of prevalent cases of hyperphosphatemia in ESRD patients undergoing dialysis, which were 55,631 in 2020. Whereas, Spain accounted for the least number of prevalent cases of hyperphosphatemia in ESRD patients undergoing dialysis, which were 23,847 in 2020.
• Japan, China and Taiwan in 2020, accounted for 283,831, 487,163 and 73,208 prevalent cases of hyperphosphatemia.

Country-wise Hyperphosphatemia Epidemiology

The epidemiology segment also provides the Hyperphosphatemia epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, China and Taiwan.

Hyperphosphatemia Drug Chapters

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

Hyperphosphatemia Marketed Drugs

Auryxia/Nephoxil/Riona: Akebia Therapeutics

Auryxia (ferric citrate), marketed as Nephoxil in Taiwan and Riona in Japan, is a phosphate binder indicated for controlling serum phosphorus levels in adult patients with CKD on dialysis. Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum. A Phase III clinical trial in China was completed in February 2021, and another Phase III trial in pediatric patients with hyperphosphatemia related to CKD is currently ongoing.

Product details in the report…

Velphoro/ P-TOL: Vifor Fresenius Medical Care Renal Pharma

Velphoro (polynuclear iron (III)–oxyhydroxide, sucroferric oxyhydroxide), marketed as P-TOL in Japan, is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood in adults with CKD on dialysis. Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is working towards regulatory approvals in several South-East Asian markets, with launches planned in 2021. In China, a Phase III trial was completed in August 2020, and VFMCRP intends to submit the Chinese New Drug Application to the National Medical Products Administration’s CDE at the end of 2021.

Product details in the report…

Kiklin: Astellas Pharma

Kiklin (bixalomer) are amine-functional polymers that decrease the serum phosphorus concentration by binding to phosphate in the gastrointestinal tract, thus inhibiting phosphate absorption into the human body. Phase III studies in patients on dialysis with CKD in Japan demonstrated Kiklin capsules’ clinical efficacy in decreasing serum phosphorus concentration, as well as a preferable long-term safety profile. It is approved in Japan for the treatment of hyperphosphatemia in patients with CKD.

Product details in the report…

Hyperphosphatemia Emerging Drugs

Ibsrela (tenapanor): Ardelyx

Ibsrela (tenapanor) – discovered and developed by Ardelyx – is a first-in-class, proprietary, oral medicine to control serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Ardelyx is conducting NORMALIZE, an ongoing extension study of the PHREEDOM Phase III monotherapy study. Ibsrela’s NDA is under review by the FDA, and the potential approval is expected in the second quarter of 2021. Tenapanor, if approved, would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake.

Product details in the report…

PT20: Shield Therapeutics

PT20 is a novel iron-based phosphate binder that has the potential to treat patients with hyperphosphatemia related to dialysis or non-dialysis dependent CKD. Discovered and initially developed through clinical Phase I by Medical Research Council (MRC) scientists based at the Human Nutrition Research Unit in Cambridge, UK, PT20 exhibited high specificity and efficacy in phosphate binding both in vitro and in vivo. PT20 has completed one pivotal study and now requires one further pivotal study, after which regulatory filings for marketing approval in the US and Europe would be expected to follow.

Product details in the report…

Hyperphosphatemia Market Outlook

Lowering the phosphate load and maintaining serum phosphorus levels within the normal range are considered the most important therapeutic goals to improve survival in CKD patients with improved quality of life. Treatment consists of diminishing intestinal phosphate absorption by a low phosphate diet and phosphate binders (PB). Dietary restriction of phosphate is effective both in pre-dialysis and in dialysis patients. In patients with persistently or progressively elevated phosphate despite dietary phosphate restriction, phosphate binders such as calcium-based binders, magnesium carbonate, sevelamer, lanthanum carbonate, ferric citrate, and sucroferric oxyhydroxide are the agent of choice. Drugs like Auryxia, Velphoro, Kiklin, Renvela, Renagel and others are approved for this indication. These are also used concurrently with dietary restriction when phosphate levels at presentation are very high (greater than 6 mg/dL).

The emerging pipeline of hyperphosphatemia looks really promising with the lead candidates in the late stages of clinical development (yet to be launched). The potential candidates with promising results in the late- or Phase III stage of clinical development include Ibsrela (Tenapanor) by Ardelyx and PT20 by Sheild Therapeutics.

From various studies, it is quite clear that pill burden in CKD patients (hemodialysis) has led to reduced treatment adherence and poor quality of life. Observing this scenario, some companies have come up with candidates with novel mechanisms of action to lower the pill burden in hyperphosphatemia patients, thereby improving their HR-QoL and clinical outcomes. The only challenge could be the reimbursement and patient support strategies with these therapies if the respective regulatory bodies do not provide patients with enough financial assistance.

Key Findings

This section includes a glimpse of the Hyperphosphatemia 7MM, China and Taiwan market.

• The market size of Hyperphosphatemia in the seven major markets, China and Taiwan was estimated to be USD 3,976 Million in 2020, which is expected to show a positive growth at a CAGR of 4.54% during the study period 2018–2030.
• The United States accounted for the largest market size of USD 2,231 Million in 2020 of Hyperphosphatemia throughout the study period of 2018–2030, in comparison to EU5 (Italy, Germany, France, Spain, the UK), Japan, China and Taiwan.
• Among the EU5 countries, Germany had the highest market size with USD 131 Million in 2020, while Spain had the lowest market size with USD 56 Million in 2020.
• Japan, China and Taiwan Hyperphosphatemia market accounted for USD 739, 479 and 75 Million, respectively in 2020.

The United States Market Outlook

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

EU-5 Market Outlook

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

China Market Outlook

This section provides the total Hyperphosphatemia market size and market size by therapies in China.

Taiwan Market Outlook

The total Hyperphosphatemia market size and market size by therapies in Taiwan are provided.

Hyperphosphatemia Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Hyperphosphatemia market or expected to get launched in the market during the study period 2018–2030. The analysis covers Hyperphosphatemia 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.

Hyperphosphatemia 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 Hyperphosphatemia emerging therapies.

Competitive Intelligence Analysis

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

Report Highlights

• In the coming years, the Hyperphosphatemia 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 Hyperphosphatemia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Positive results by major key players Ardelyx and Shield Therapeutics may increase market size in the coming years, assisted by an increase in the Hyperphosphatemia incident population pool.

 Analyst Comments

• Owing to the launch of emerging therapies, we assume a slight decline on the patient shared on the current Phosphate Binders (PBs). We assume a slight and not major impact on these therapies as the emerging drugs are expected to be given both as mono as well as adjunctive therapies.
• Probability of success on mid-stage drug PT-20 has been kept on a lower side as compared to Tenapor as the Shield Therapeutics needs to conduct a late stage study for getting an approval, whereas Tenapenor's NDA has already been accepted by the FDA.

Hyperphosphatemia Report Insights

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

Hyperphosphatemia Report Key Strengths

• Ten Years Forecast
• 7MM, China and Taiwan Coverage
• Hyperphosphatemia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hyperphosphatemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Hyperphosphatemia market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Hyperphosphatemia total market size as well as market size by therapies across the 7MM, China and Taiwan during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM, China and Taiwan and which country will have the largest Hyperphosphatemia market size during the forecast period (2021–2030)?
• At what CAGR, the Hyperphosphatemia market is expected to grow at the 7MM, China and Taiwan level during the forecast period (2021–2030)?
• What would be the Hyperphosphatemia market outlook across the 7MM, China and Taiwan during the forecast period (2021–2030)?
• What would be the Hyperphosphatemia 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?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Hyperphosphatemia?
• What is the historical Hyperphosphatemia patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), Japan, China and Taiwan?
• What would be the forecasted patient pool of Hyperphosphatemia at the 7MM, China and Taiwan level?
• What will be the growth opportunities across the 7MM, China and Taiwan with respect to the patient population pertaining to Hyperphosphatemia?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Hyperphosphatemia during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM, China and Taiwan during the forecast period (2021–2030)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Hyperphosphatemia along with the approved therapy?
• What are the current treatment guidelines for the treatment of Hyperphosphatemia in the US and Europe, Japan, China and Taiwan?
• What are the Hyperphosphatemia 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 Hyperphosphatemia?
• How many therapies are developed by each company for the treatment of Hyperphosphatemia?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Hyperphosphatemia?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hyperphosphatemia 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 Hyperphosphatemia and their status?
• What are the key designations that have been granted for the emerging therapies for Hyperphosphatemia?
• What are the 7MM, China and Taiwan historical and forecasted market of Hyperphosphatemia?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving Hyperphosphatemia.
• To understand the future market competition in the Hyperphosphatemia market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Hyperphosphatemia in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), Japan, China and Taiwan.
• 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 Hyperphosphatemia market.
• To understand the future market competition in the Hyperphosphatemia market.