Hyperphosphatemia Market By Product Type (Calcium-Based Phosphate Binders, Non-Calcium-Based Phosphate Binders, Others); By Indication (Chronic Kidney Disease (CKD), End-Stage Renal Disease (ESRD), Acute Kidney Injury (AKI), Others); By End User (Hospitals, Dialysis Centers, Specialty Clinics, Homecare Settings, Pharmacies); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

The Global Hyperphosphatemia Market is projected to grow from $4.3 billion in 2024 to $5.7 billion by 2030, registering a CAGR of 4.8% during the forecast period. The market growth is fueled by the growing global dialysis population, increasing CKD awareness, and expanding reimbursement for novel agents.

 

 

Hyperphosphatemia Market Dynamics:

Market Drivers

Chronic kidney disease (CKD) remains a significant global public health issue, impacting over 75 million people worldwide. CKD is closely linked to other major health conditions, with diabetes the leading global cause of CKD being the primary factor driving its increasing prevalence.  Hyperphosphatemia is a frequent complication of CKD, impacting 50–74% of individuals with renal disorders. Since 2015, nearly 80% of in-center hemodialysis patients in the United States have received prescriptions for phosphate binders annually. In 2022, the Medicare FFS program allocated $86.5 billion for the care of older beneficiaries with CKD and $9.2 billion for younger beneficiaries with the condition. In China, recent epidemiological data indicate that CKD affects 10.8% of the adult population, equating to approximately 120 million individuals, with over one million patients in the terminal stage. In early 2025, China's National Medical Products Administration approved tenapanor for controlling serum phosphorus levels in dialysis patients with CKD who have an inadequate response or are intolerant to phosphate binders.

 

Market Opportunities

As the global CKD patient population continues to rise due to factors such as aging populations, increasing rates of diabetes and hypertension, and lifestyle-related conditions, the demand for effective phosphate binders and other treatment modalities is expected to increase. The market for hyperphosphatemia therapies is rapidly evolving with growing emphasis on pill burden reduction, non-calcium alternatives, and next-generation oral agents. Regulatory approvals of new therapies and expanding healthcare access in emerging markets are also contributing to broader treatment uptake. With projected triple-digit million-dollar sales by 2030, Tenapanor stands as a cornerstone innovation shaping the next era of phosphate management. Together, these dynamics create a robust and expanding opportunity for pharmaceutical companies and healthcare providers involved in managing hyperphosphatemia.

 

Market Restraints

Managing hyperphosphatemia in CKD remains a complex challenge despite the availability of various compounds. Current phosphate binders are associated with a high pill burden and significant costs, while also contributing to heavy metal accumulation, metabolic disturbances, and vascular calcifications. Aluminum poses significant toxicity concerns, while calcium-based binders are effective but may lead to hypercalcemia and vascular calcification. Lanthanum is absorbed in the gut, though its long-term tissue deposition appears clinically insignificant. Sevelamer helps reduce vascular calcification but has inconclusive efficacy data and potential gastrointestinal side effects. Iron-based binders offer effectiveness but may cause gastrointestinal discomfort and lack comprehensive long-term outcome data. Emerging inhibitors of intestinal phosphate absorption show promise with a lower pill burden, yet they require further clinical validation.

 

Hyperphosphatemia Treatment Pipeline -2025

Drug Candidate	Sponsor	Mechanism of Action	Development Stage	Target Population	Notable Updates
Oxylanthanum Carbonate (OLC)	Unicycive Therapeutics	Lanthanum-based phosphate binder utilizing nanoparticle technology	NDA under FDA review (PDUFA date: June 28, 2025)	CKD patients on dialysis with hyperphosphatemia	Demonstrated 50% reduction in pill burden and improved patient adherence in Phase 2 trials. NDA accepted by FDA; commercial launch anticipated in late 2025.
Tenapanor (XPHOZAH®)	Ardelyx	Sodium-hydrogen exchanger 3 (NHE3) inhibitor reducing intestinal phosphate absorption	Approved in U.S. (2023), Japan (2023), and China (2025)	CKD patients on dialysis with hyperphosphatemia	Approved in China in February 2025; marketed as Wan Ti Le. Also approved in the U.S. and Japan.
AP301	Shanghai Alebund Pharmaceuticals	Novel iron-based phosphate binder	Phase III (China); NDA planned	CKD patients with hyperphosphatemia	Phase III trials ongoing in China; NDA submission anticipated.
AP306	Shanghai Alebund Pharmaceuticals	Pan-phosphate transporter inhibitor (first-in-class)	Phase II (U.S. and China)	CKD patients with hyperphosphatemia	First-in-class agent; Phase II trials underway in the U.S. and China.
PHOZEVEL® (Tenapanor)	Kyowa Kirin	Sodium-hydrogen exchanger 3 (NHE3) inhibitor reducing intestinal phosphate absorption	Approved in Japan (2023)	CKD patients on dialysis with hyperphosphatemia	Approved in Japan in September 2023; marketed as PHOZEVEL®.

 

Hyperphosphatemia Market: Recent Developments

• On February 26, 2025, Ardelyx, Inc. announced that China’s Center for Drug Evaluation of the National Medical Products Administration has approved a New Drug Application for tenapanor. The drug is intended to regulate serum phosphorus levels in patients with CKD on dialysis who have an inadequate response to or intolerance to phosphorus binders. This approval activates a $5 million milestone payment to Ardelyx as part of its licensing agreement with its Chinese collaboration partner, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma).

 

• On July 24, 2024, the US Food and Drug Administration expanded its approval of Velphoro (sucroferric oxyhydroxide) to include patients as young as 9 years old. Previously approved only for adults, the drug helps manage serum phosphorus levels in individuals with CKD undergoing dialysis. The expanded approval was based on data from a Phase 3 study involving pediatric patients with hyperphosphatemia and advanced CKD, demonstrating its efficacy in younger populations.

 

 

• On February 19, 2024, Kyowa Kirin Co., Ltd. announced the upcoming launch of PHOZEVEL® Tablets (tenapanor hydrochloride, development code KHK7791) in Japan on February 20. Licensed from Ardelyx, Inc., the medication is designed to improve hyperphosphatemia in chronic kidney disease patients undergoing dialysis.

 

• On February 2, 2023, Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on kidney disease treatments, announced an exclusive licensing agreement with Lotus Pharmaceutical, a leading global pharmaceutical company. The partnership aims to develop and commercialize Renazorb® (lanthanum dioxycarbonate) in the Republic of Korea. Renazorb is Unicycive’s innovative phosphate-binding agent designed for the treatment of hyperphosphatemia in patients with CKD.

 

Hyperphosphatemia Market Segmentation: A Comprehensive Overview

By Product Type

• Calcium-Based Phosphate Binders

• Non-Calcium-Based Phosphate Binders

• Others

 

By Indication

• Chronic Kidney Disease (CKD)

• End-Stage Renal Disease (ESRD)

• Acute Kidney Injury (AKI)

• Others (e.g., tumor lysis syndrome)

 

By End User

• Hospitals

• Dialysis Centers

• Specialty Clinics

• Homecare Settings

• Pharmacies (Retail & Online)

 

By Region

• North America

• Asia-Pacific

• Europe

• Latin America

• Middle East Africa

 

Segmentation Analysis – Hyperphosphatemia Market

By Product Type

Calcium-based binders, such as calcium acetate and calcium carbonate, have traditionally held a significant share of the market due to their low cost and wide availability However, concerns over the risk of hypercalcemia and vascular calcification, particularly in patients with CKD, have led to a gradual shift toward non-calcium-based binders. These include agents like sevelamer, lanthanum carbonate, and ferric citrate, which are increasingly preferred for their improved safety profiles and efficacy. Sevelamer and calcium-based phosphate binders have been the most frequently prescribed phosphate binders in the United States, with a slight increase in the use of calcium-based options since 2017. In 2021, sevelamer and calcium-based binders represented 23% and 44% of all phosphate binder prescriptions, respectively, while their combination accounted for 11% of prescriptions. The "others" category consists of newer or less common formulations, such as iron-based or polymer-based binders, which are gaining attention through ongoing R&D and could represent a growth opportunity in the future.

 

 

 

By Indication

The market is primarily driven by CKD and end-stage renal disease (ESRD), as both conditions are closely associated with disrupted phosphate metabolism. CKD accounts for the largest segment. According to the CDC, CKD impacts over 1 in 7 adults in the U.S., affecting an estimated 35.5 million people. The disease’s chronic nature and global prevalence necessitates long-term management strategies including phosphate control. ESRD, particularly among patients undergoing dialysis, also contributes substantially due to the need for tight phosphate regulation. Over 500,000 individuals in the United States are living with ESRD. Acute kidney injury (AKI) represents a smaller segment, with demand stemming from short-term phosphate elevation in hospitalized patients. Additionally, hyperphosphatemia can result from conditions such as tumor lysis syndrome, making up a niche segment of the market.

 

 

By End Users

Hospitals dominate in the treatment of acute or severe hyperphosphatemia cases, particularly among in-patients. Dialysis centers are also a key segment, as phosphate binders are routinely prescribed to patients with ESRD receiving hemodialysis. Specialty clinics, including nephrology practices, play a significant role in the long-term outpatient management of CKD. Homecare settings are growing in importance due to the rise in home dialysis and the broader trend toward decentralized care. Pharmacies—both retail and online—serve as a convenient channel for ongoing medication refills, with online platforms gaining popularity due to increased digital adoption and patient convenience.

 

By Region

North America leads the hyperphosphatemia market, supported by a high prevalence of CKD, advanced healthcare infrastructure, and widespread reimbursement coverage. Approximately 35.5 million people in the United States are affected by kidney disease. More than 90,000 Americans are on the kidney transplant waiting list, yet in 2024, only 28,492—approximately one in four—received a transplant. Additionally, 6,418 living donor transplants were performed in the U.S. last year. Medicare covers payment for all renal dialysis services provided to ESRD beneficiaries receiving outpatient maintenance dialysis under the ESRD Prospective Payment System (PPS).

 

 

The Asia-Pacific region is the fastest-growing, driven by rising rates of diabetes and kidney disease, a growing elderly population, and gradual improvements in healthcare access. The Western Pacific has a diabetes prevalence rate of 11.9%, surpassing the global average of 10.5%. In South Asia, diabetes prevalence is projected to rise by more than 150% between 2000 and 2035, with China and India experiencing the highest cases. CKD may affect up to 434 million individuals across the eastern, southern, and southeastern regions of Asia, with China and India bearing the greatest disease burden, closely aligned with diabetes prevalence.

 

Europe maintains a steady market position with a strong focus on non-calcium-based therapies and supportive public healthcare systems. In Latin America, the market is expanding moderately, constrained by limited access to specialized renal care but supported by increasing diagnosis rates. Meanwhile, the Middle East and Africa region currently holds the smallest market share, though improvements in healthcare infrastructure and growing awareness are expected to contribute to future growth.

 

Key Players in the Hyperphosphatemia Market:

• Ardelyx

• Unicycive Therapeutics

• Alebund Pharmaceuticals

• Fresenius Medical Care

• OPKO Health

• Vifor Pharma (CSL)

• Shield Therapeutics

• Takeda (Forsenol)

• Keryx Biopharmaceuticals, Inc.

• Sanwa Kagaku Kenkyusho

 

Hyperphosphatemia Market Report Coverage

Report Attribute	Details
Forecast Period	2024 – 2032
Market Size Value in 2024	USD 4.3 Billion
Revenue Forecast in 2030	USD 5.7 Billion
Overall Growth Rate	CAGR of 4.8% (2024 – 2030)
Base Year for Estimation	2023
Historical Data	2017 – 2021
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Indication, By End User, By Geography
By Product Type	Calcium-Based Phosphate Binders, Non-Calcium-Based Phosphate Binders, Others
By Indication	Chronic Kidney Disease (CKD), End-Stage Renal Disease (ESRD), Acute Kidney Injury (AKI), Others
By End User	Hospitals, Dialysis Centers, Specialty Clinics, Homecare Settings, Pharmacies
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Germany, Japan, China, India, UK, Brazil, etc.
Market Drivers	Rising prevalence of CKD and ESRD, demand for phosphate binders, aging population
Customization Option	Available upon request