Hyperphosphatemia Treatment Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 3.80 Billion |
| Market Size (2029) | USD 4.55 Billion |
| CAGR (2024 - 2029) | 3.67 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Hyperphosphatemia Treatment Market Analysis
The Hyperphosphatemia Treatment Market size is estimated at USD 3.80 billion in 2024, and is expected to reach USD 4.55 billion by 2029, at a CAGR of 3.67% during the forecast period (2024-2029).
Hyperphosphatemia, an electrolyte disorder, is characterized by elevated phosphate levels. This condition frequently arises from issues such as hypothyroidism, chronic kidney disease (CKD), and metabolic & respiratory acidosis. The market's expansion is fueled by the rising prevalence of these conditions, which elevate blood phosphate levels and lead to hyperphosphatemia. For instance, a March 2023 report from the International Society of Nephrology-Global Kidney Atlas (ISN-GKA) highlighted that in 2022, approximately 850 million individuals globally were affected by chronic kidney disease (CKD).
Moreover, a model analysis named IMPACT CKD, conducted by AstraZeneca and reported in April 2024, forecasts that by 2032, nearly 16.5% of the populace in eight nations, which are the United States, Brazil, the United Kingdom, Spain, Germany, the Netherlands, China, and Australia are projected to have chronic kidney disease (CKD). Notably, this projection includes a significant 59.3% uptick in advanced stages. Similarly, a study published in the Medicina Journal in May 2023 underscored that hyperphosphatemia is prevalent among CKD patients, impacting 50-74% of those with renal disorders. Such insights accentuate the heightened risk of hyperphosphatemia in CKD patients, subsequently fueling the demand for treatment products.
In response to this demand, market players are intensifying their research and development endeavors to introduce novel drugs and secure regulatory approvals for hyperphosphatemia treatments. For instance, in February 2024, Kyowa Kirin Co., Ltd. launched tenapanor (PHOZEVEL) in Japan. This drug, approved for adults grappling with chronic kidney disease (CKD) on dialysis, is tailored to mitigate hyperphosphatemia.
Similarly, in July 2024, the United States Food and Drug Administration (FDA) broadened the approval for Velphoro (sucroferric oxyhydroxide), a product from Fresenius Medical Care. These chewable tablets are indicated for individuals aged nine and older to regulate serum phosphorus levels in patients with chronic kidney disease (CKD) undergoing dialysis. Such strategic moves underscore companies' ambitions to amplify their market presence through regional drug availability. Thus, the surging prevalence of hyperphosphatemia, propelled mainly by chronic kidney disease (CKD) and bolstered by market players initiatives like drug approvals and launches, has spurred market growth.
However, this growth trajectory may encounter hurdles, primarily due to the potential side effects of the approved medications.
Hyperphosphatemia Treatment Market Trends
Sevelamer in Non-Calcium-Based Phosphate Binders Segment is likely to have Significant Growth in the Market Over the Forecast Period
The rising prevalence of kidney diseases is increasing investment and funding to explore and introduce new and effective treatments. One such treatment is sevelamer, a phosphate-binding medication that treats hyperphosphatemia in chronic kidney disease (CKD) patients. Numerous studies have validated sevelamer's safety and efficacy in managing elevated phosphate levels, increasing its demand throughout the study period. For instance, an April 2023 article in Kidney Diseases highlighted sevelamer carbonate's effectiveness and tolerability as a phosphate binder for advanced non-dialysis CKD patients with hyperphosphatemia in China.
Moreover, a May 2024 study in the International Journal of Nephrology and Renovascular Disease revealed that sevelamer manages hyperphosphatemia and enhances patient outcomes. Notably, both dialysis and non-dialysis-dependent CKD patients experienced reduced all-cause mortality. Such findings regarding sevelamer suggest a continued rise in demand among patients in the coming years.
With the rising demand for sevelamer, market players are increasingly launching generic versions. For instance, in March 2022, Lupin launched an 800 mg generic version of sevelamer hydrochloride tablets in the United States, targeting hyperphosphatemia treatment in CKD patients. The entry of generics is poised to enhance affordability and accessibility to hyperphosphatemia treatments, fueling the segment's growth.
In conclusion, sevelamer's proven safety and efficacy, combined with the emergence of generics, are likely to support its dominance owing to affordability. This positions sevelamer as a favored treatment choice, driving its adoption and demand in the forecast period.
North America is Expected to Witness Significant Growth Over the Forecast Period
North America is poised for significant growth in the hyperphosphatemia treatment market. This surge is attributed to the increasing prevalence of hyperphosphatemia among patients with renal disorders, a robust presence of market players, substantial investments in pipeline development, a well-established healthcare infrastructure, and elevated healthcare spending.
Research has established a connection between hyperphosphatemia and kidney disorders. For instance, a study published in May 2024 in the Nephrology Dialysis Transplantation Journal highlighted that over 43% of dialysis patients in the United States exhibit hyperphosphatemia, with serum phosphate levels surpassing 5.5 mg/dL. Thus, with the rising number of kidney disease patients, the prevalence of hyperphosphatemia is set to grow, boosting the demand for treatments to manage elevated phosphate levels.
Market players are actively investing in pipeline development and pursuing regulatory approvals. In June 2024, Unicycive, a clinical-stage biotechnology firm based in the United States, announced positive outcomes from its oxylanthanum carbonate (OLC) trial targeting hyperphosphatemia in dialysis patients suffering from chronic kidney disease. Furthermore, in November 2023, the United States Food and Drug Administration (FDA) granted Orphan Drug Designation to Ardelyx's XPHOZAH (tenapanor) for treating pediatric hyperphosphatemia. Such regulatory support is anticipated to broaden treatment avenues and bolster demand for these pharmaceuticals in the upcoming years.
Government-backed reimbursement benefits for hyperphosphatemia treatments are likely to enhance adoption rates, propelling market expansion. For example, in December 2023, Ontario's Ministry of Health announced that Health Canada approved a lifetime reimbursement for Sucroferric Oxyhydroxide (Velphoro), an iron-based phosphate binder from Fresenius Medical Care. Such reimbursement incentives are projected to boost the number of patients pursuing hyperphosphatemia treatments in forthcoming years.
Therefore, North America's hyperphosphatemia treatment market is set for significant growth, driven by the increasing prevalence of kidney disease, proactive measures from industry players, and supportive reimbursement policies.
Hyperphosphatemia Treatment Industry Overview
The hyperphosphatemia treatment market is semi-consolidated due to the presence of some key players operating globally and regionally. The competitive landscape includes an analysis of a few international and local companies that hold considerable market share and are well known. They include Sanofi, Astellas Pharma Inc., Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Company Limited, Ardelyx, and others. These companies are actively investing in their research and development activities to accelerate the clinical development of pipeline candidates and seeking regulatory approvals across various regions to expand their product presence and maintain their market position.
Hyperphosphatemia Treatment Market Leaders
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Sanofi
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Astellas Pharma Inc
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Ardelyx
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Alebund Pharmaceuticals
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Kyowa Kirin Co., Ltd.
*Disclaimer: Major Players sorted in no particular order
Hyperphosphatemia Treatment Market News
- September 2024: Unicycive Therapeutics, Inc. filed a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC), targeting hyperphosphatemia treatment in dialysis-dependent chronic kidney disease (CKD) patients.
- June 2024: Alebund Pharmaceuticals received Breakthrough Therapy Designation (BTD) from China National Administration Medical Products Administration (NMPA) for AP306, which is under clinical development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).
Hyperphosphatemia Treatment Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Prevalence of Chronic Kidney Disease (CKD)
4.2.2 Growing Research and Development Activities Coupled with Product Approvals
4.3 Market Restraints
4.3.1 Adverse Effects and Side Effects of Treatments
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Drug Class
5.1.1 Phosphate Binders
5.1.1.1 Calcium-Based Phosphate Binders
5.1.1.2 Non-Calcium-Based Phosphate Binders
5.1.1.2.1 Sevelamer
5.1.1.2.2 Lanthanum Carbonate
5.1.1.2.3 Iron-Based Phosphate Binders
5.1.1.2.4 Others (Aluminum Hydroxide, Magnesium Carbonate, and Others)
5.1.2 Non-phosphate Binders
5.1.3 Others
5.2 By Distribution Channel
5.2.1 Hospital Pharmacies
5.2.2 Retail Pharmacies
5.2.3 Online Pharmacies
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Kyowa Kirin Co., Ltd.
6.1.2 Alebund Pharmaceuticals
6.1.3 Ardelyx
6.1.4 Kissei Pharmaceutical Co., Ltd.
6.1.5 Torii Pharmaceutical Co.,Ltd
6.1.6 Sanofi
6.1.7 Takeda Pharmaceutical Company Limited
6.1.8 Astellas Pharma Inc
6.1.9 Mitsubishi Tanabe Pharma Corporation
6.1.10 Lupin
6.1.11 Unicycive
6.1.12 Fresenius Medical Care
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Hyperphosphatemia Treatment Industry Segmentation
As per the scope, hyperphosphatemia, characterized by elevated phosphate levels in the blood, can arise from various factors, including advanced chronic kidney disease, hypothyroidism, and both metabolic and respiratory acidosis. Effective management of hyperphosphatemia typically involves a combination of dietary phosphate restrictions, appropriate dialysis, and medications.
The hyperphosphatemia treatment market is segmented into drug class, distribution channel, and geography. By drug class, the market is segmented into phosphate binders, non-phosphate binders, and others. The phosphate binders drug class includes calcium-based phosphate binders and non-calcium phosphate binders. The non-calcium-based phosphate binders are divided into sevelamer, lanthanum carbonate, iron-based phosphate binders, and others. The others include aluminum hydroxide, magnesium carbonate, and others. By distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (USD) for all the above segments.
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Hyperphosphatemia Treatment Market Research FAQs
How big is the Hyperphosphatemia Treatment Market?
The Hyperphosphatemia Treatment Market size is expected to reach USD 3.80 billion in 2024 and grow at a CAGR of 3.67% to reach USD 4.55 billion by 2029.
What is the current Hyperphosphatemia Treatment Market size?
In 2024, the Hyperphosphatemia Treatment Market size is expected to reach USD 3.80 billion.
Who are the key players in Hyperphosphatemia Treatment Market?
Sanofi, Astellas Pharma Inc, Ardelyx, Alebund Pharmaceuticals and Kyowa Kirin Co., Ltd. are the major companies operating in the Hyperphosphatemia Treatment Market.
Which is the fastest growing region in Hyperphosphatemia Treatment Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Hyperphosphatemia Treatment Market?
In 2024, the North America accounts for the largest market share in Hyperphosphatemia Treatment Market.
What years does this Hyperphosphatemia Treatment Market cover, and what was the market size in 2023?
In 2023, the Hyperphosphatemia Treatment Market size was estimated at USD 3.66 billion. The report covers the Hyperphosphatemia Treatment Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Hyperphosphatemia Treatment Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Hyperphosphatemia Treatment Industry Report
Statistics for the 2024 Hyperphosphatemia Treatment market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Hyperphosphatemia Treatment analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
