The hyperphosphatemia market in the 7MM is projected to grow, driven by rising chronic kidney disease (CKD) prevalence and an expanding patient pool. US had the largest Hyperphosphatemia market size ~USD 2400 million in the 7MM. Hyperphosphatemia, defined as elevated serum phosphate levels (>4.5 mg/100 mL), commonly affects CKD patients due to impaired renal function. The United States accounted for nearly 50% of total cases in 2023 and represents the largest market, followed by the EU4, the United Kingdom, and Japan. Hyperphosphatemia market growth is expected from improved uptake of existing drugs, increased awareness, and the anticipated launch of advanced therapies, including one-time gene treatments. In 2023, the U.S. had about 600,000 end-stage renal disease (ESRD) patients on dialysis, a number expected to rise. Approved phosphate binders include KIKLIN, AURYXIA/RIONA, and VELPHORO/P-TOL. Recently, XPHOZAH gained FDA approval for dialysis patients intolerant to binders, while Oxylanthanum Carbonate (OLC) is emerging as a promising therapy.
DelveInsight’s “Hyperphosphatemia Market Insights, Epidemiology, and Market Forecast–2034” report delivers an in-depth assessment of Hyperphosphatemia, covering historical patterns, future epidemiological projections, and market performance across the United States, the EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The study outlines current treatment practices, pipeline therapies, market share distribution, and the anticipated market size from 2020 to 2034 across the seven major markets. It also explores existing treatment pathways, major market drivers and challenges, and the unmet clinical needs that shape strategic opportunities and define the market’s overall growth potential.
The $4B Hyperphosphatemia market is evolving fast with new therapies like XPHOZAH & OLC. Get DelveInsight’s latest Hyperphosphatemia Market Forecast (2020–2034) for growth trends, pipeline insights & strategic opportunities @ Hyperphosphatemia Market Outlook
Some facts of the Hyperphosphatemia Market Report are:
- According to DelveInsight, The hyperphosphatemia market in the 7MM was valued at approximately USD 4 billion in 2023.
- Leading Hyperphosphatemia companies working in the market are Phosphate Therapeutics, Bayer, Shire, Kyowa Kirin Co Ltd, Shanghai Alebund Pharmaceuticals Limited, Ardelyx, Kissei Pharmaceutical Co. Ltd., Taisho Pharmaceutical Co. Ltd., Sanofi, Chugai Pharmaceutical, Astellas Pharma Inc., Alebund Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, KDL Inc., Denver Nephrologists, CM&D Pharma Limited, Daiichi Sankyo and others.
- Key Hyperphosphatemia Therapies are Oxylanthanum Carbonate (OLC), KIKLIN, VELPHORO/P-TAL, AURYXIA/ RIONA, and many others.
- In June 2025, Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
- In June 2025, Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies.
- In February 2025, Ardelyx Gains Approval for Tenapanor to Treat hyperphosphatemia. Ardelyx has announced that China’s National Medical Products Administration (NMPA) has approved tenapanor for controlling serum phosphorus levels in dialysis patients with chronic kidney disease (CKD).
Hyperphosphatemia Overview
Hyperphosphatemia is a condition characterized by abnormally high phosphate levels in the blood, most commonly seen in patients with chronic kidney disease (CKD) due to impaired phosphate excretion. Elevated phosphate disrupts mineral balance, leading to complications such as vascular calcification, bone disorders, and cardiovascular disease. Management typically includes dietary phosphate restriction, phosphate binders, dialysis, and emerging therapies aimed at improving phosphate regulation. Despite available treatments, many patients struggle to achieve optimal phosphate control, highlighting a significant unmet need. Ongoing research and newer therapeutic approaches aim to improve outcomes and reduce long-term complications associated with this condition.
Access in-depth insights on Hyperphosphatemia key players, therapies, market drivers, barriers, and opportunities across the 7MM @ Hyperphosphatemia Clinical Trials and FDA Approvals
Hyperphosphatemia Market Outlook
In the hyperphosphatemia landscape, companies such as Unicycive Therapeutics are advancing lead candidates through various stages of clinical development to expand treatment options. The 7MM market is largely driven by the use of phosphate binders (both calcium-based and calcium-free) along with off-label therapies. In 2023, the United States accounted for the largest share, with a market size of approximately USD 2,400 million. Within the EU4 and the UK, Germany contributed the most, with around USD 150 million.
Hyperphosphatemia Market Drivers
- Growing CKD and ESRD prevalence: Rising rates of chronic kidney disease and end-stage renal disease are increasing the patient pool requiring long-term phosphate management.
- Advancements in phosphate binders: Newer binders with improved tolerability, reduced pill burden, and fewer side effects are enhancing treatment adherence.
- Increased awareness and screening: Improved diagnostic practices and early CKD detection are expanding treatment uptake.
- Technological innovation in dialysis: Better dialysis techniques help manage phosphate levels more effectively, supporting market growth.
- Pipeline developments: Novel therapies targeting phosphate absorption and regulation offer promising opportunities for improved outcomes.
Hyperphosphatemia Market Barriers
- High pill burden and poor adherence: Many available binders require large doses, reducing patient compliance.
- Gastrointestinal side effects: Common issues like nausea, constipation, and bloating limit long-term use of several therapies.
- Limited therapeutic alternatives: Current treatment options are often similar in mechanism, offering minimal differentiation.
- Cost and reimbursement challenges: High treatment costs and variable reimbursement policies in different regions restrict access.
- Persistent unmet needs: Achieving optimal phosphate control remains difficult for many patients, hindering overall treatment effectiveness.
Interested to know how the emerging diagnostic approaches will be contributing in increased Hyperphosphatemia diagnosed prevalence pool? Download report @ Hyperphosphatemia Patient Pool
Hyperphosphatemia Epidemiology
The Hyperphosphatemia epidemiology section provides insights into the historical and current Hyperphosphatemia patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. In 2023, the United States recorded the highest prevalence of hyperphosphatemia in the 7MM, with ~500,000 cases, alongside ~2.4 million CKD stage 3–5 patients. Japan ranked second, contributing ~300,000 cases, while Germany led among the EU4 and the UK with ~56,000 cases.
Hyperphosphatemia Epidemiology Segmentation:
- Total Prevalent Cases of Chronic Kidney Disease (CKD)
- Total Diagnosed Prevalent Cases of CKD
- Stage-specific Distribution of CKD
- Total Prevalent Cases of End-Stage Renal Disease (ESRD)
- Number of ESRD Patients Undergoing Dialysis
- Total Prevalent Cases of Hyperphosphatemia
Hyperphosphatemia Drugs Uptake
VELPHORO/P-TOL (Fresenius Medical Care/Vifor Pharma)
VELPHORO (sucroferric oxyhydroxide) received approval in the US in 2013 and in Europe in 2014, and has since expanded globally. In Japan, it is marketed as P-TOL through Kissei since 2018. Now available in more than 30 countries, the treatment supports over 100,000 patients each year. Its iron-based formulation offers effective phosphate binding with a comparatively lower pill burden.
KIKLIN (Astellas Pharma)
KIKLIN, an amine-functional polymer (bixalomer), was introduced in 2012 for dialysis-dependent CKD patients and later received a broader indication in 2016 for all CKD-associated hyperphosphatemia. It works by binding dietary phosphate within the gastrointestinal tract, reducing absorption and helping maintain serum phosphate levels.
Oxylanthanum Carbonate (OLC, Unicycive Therapeutics)
OLC is an innovative nanoparticle-based phosphate binder designed to significantly reduce pill burden through smaller, more manageable tablets. Phase II studies have demonstrated favorable safety and tolerability. Unicycive plans to pursue FDA approval via the 505(b)(2) pathway, leveraging existing data to expedite development.
Discover how VELPHORO, KIKLIN, and OLC are shaping the Hyperphosphatemia market. Get insights on drug uptake trends, pipeline shifts, and growth opportunities. Download your sample report now! @ Hyperphosphatemia Medication and Companies
Hyperphosphatemia Therapeutics Assessment
Major key companies are working proactively in the Hyperphosphatemia Therapeutics market to develop novel therapies which will drive the Hyperphosphatemia treatment markets in the upcoming years are Phosphate Therapeutics, Bayer, Shire, Kyowa Kirin Co Ltd, Shanghai Alebund Pharmaceuticals Limited, Ardelyx, Kissei Pharmaceutical Co. Ltd., Taisho Pharmaceutical Co. Ltd., Sanofi, Chugai Pharmaceutical, Astellas Pharma Inc., Alebund Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, KDL Inc., Denver Nephrologists, CM&D Pharma Limited, Daiichi Sankyo and others.
Discover how leading pharma innovators are reshaping the Hyperphosphatemia treatment algorithm with novel therapies? Download sample report @ Hyperphosphatemia Clinical Trials and FDA Approvals
Hyperphosphatemia Report Key Insights
1. Hyperphosphatemia Patient Population
2. Hyperphosphatemia Market Size and Trends
3. Key Cross Competition in the Hyperphosphatemia Market
4. Hyperphosphatemia Market Dynamics (Key Drivers and Barriers)
5. Hyperphosphatemia Market Opportunities
6. Hyperphosphatemia Therapeutic Approaches
7. Hyperphosphatemia Pipeline Analysis
8. Hyperphosphatemia Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Hyperphosphatemia Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Hyperphosphatemia Competitive Intelligence Analysis
4. Hyperphosphatemia Market Overview at a Glance
5. Hyperphosphatemia Disease Background and Overview
6. Hyperphosphatemia Patient Journey
7. Hyperphosphatemia Epidemiology and Patient Population
8. Hyperphosphatemia Treatment Algorithm, Current Treatment, and Medical Practices
9. Hyperphosphatemia Unmet Needs
10. Key Endpoints of Hyperphosphatemia Treatment
11. Hyperphosphatemia Marketed Products
12. Hyperphosphatemia Emerging Therapies
13. Hyperphosphatemia Seven Major Market Analysis
14. Attribute Analysis
15. Hyperphosphatemia Market Outlook (7 major markets)
16. Hyperphosphatemia Access and Reimbursement Overview
17. KOL Views on the Hyperphosphatemia Market
18. Hyperphosphatemia Market Drivers
19. Hyperphosphatemia Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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