Hyperphosphatemia Treatment Market Size, Share & Trends Analysis Report By Drug Class (Sevelamer, Calcium-based Phosphate Binders, Lanthanum Carbonate, Iron-based Phosphate Binders, Non-Phosphate Binders), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Hyperphosphatemia Treatment Market Size

The global hyperphosphatemia treatment market size was valued at USD 1.49 billion in 2024 and is projected to grow from USD 1.62 billion in 2025 to reach USD 2.71 billion by 2033, exhibiting a CAGR of 6.63% during the forecast period (2025-2033). 

Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood, often resulting from kidney dysfunction, excessive phosphate intake, or underlying conditions like hypoparathyroidism. Treatment primarily focuses on reducing phosphate levels to prevent complications such as calcification in tissues and organs. Dietary phosphate restriction is a key strategy, where foods high in phosphorus, such as dairy products, processed foods, and certain meats, are limited.

Moreover, phosphate binders, such as calcium acetate, sevelamer, or lanthanum carbonate, may be prescribed to reduce phosphate absorption in the gut. For patients with severe cases or chronic kidney disease, dialysis may be necessary to help regulate phosphate levels. Managing the underlying cause, such as improving kidney function or addressing hormonal imbalances, is also crucial for effective treatment. Regular monitoring and consultation with a healthcare provider ensure proper management and prevention of complications.

Below graph represents the global incidence rate of hypoparathyroidism per 100,000 persons in 2023

Source: Published Articles and Straits Research

Hyperphosphatemia Treatment Market Trends

Increasing new and innovative product launches

Hyperphosphatemia, often linked to kidney disease and hypoparathyroidism, requires advanced and effective treatment options. The current trend of investing in innovative product development is significantly driving market growth as new launches continue to enhance treatment possibilities.

• For instance, in November 2024, Unicycive announced that the U.S. Food & Drug Administration (FDA) had accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a novel treatment for hyperphosphatemia.

Such innovative products not only expand the available treatment arsenal but also contribute to improved patient outcomes. Therefore, the continuous introduction of advanced medications is a key factor propelling the market forward.

Emergence of novel mechanism of action

The effective management of hyperphosphatemia, characterized by elevated phosphate levels in the blood, necessitates drugs with targeted and specific mechanisms of action. To address this, industry players are heavily investing in the development of treatments with unique pathways.

• A notable example is the FDA's approval of XPHOZAH (tenapanor) in February 2023. As a first-in-class phosphate absorption inhibitor, it is specifically designed to reduce serum phosphate levels in patients unresponsive to traditional phosphate binders.

This emergence of drugs with novel mechanisms of action underscores the growing demand for innovative solutions, driving further advancements and growth in the hyperphosphatemia treatment market.

Hyperphosphatemia Treatment Market Growth Drivers

Increasing regulatory support

The growing support from regulatory bodies plays a pivotal role in driving the hyperphosphatemia treatment market growth. Regulatory agencies are facilitating the approval of innovative drug molecules and finalized medications, encouraging researchers to intensify their focus on research and development. This supportive environment accelerates the introduction of effective treatments and enhances market growth.

For instance,

• In March 2022, Lupin received U.S. Food and Drug Administration (FDA) approval to launch Sevelamer Hydrochloride tablets (800 mg), a widely used phosphate binder.
• Likewise, in December 2023, Jemincare obtained FDA approval to conduct a clinical trial for JMKX003002, a novel treatment for hyperphosphatemia.

Such regulatory approvals not only validate the efficacy of new treatments but also foster innovation, driving significant market expansion.

High risk of chronic kidney disease in the geriatric population

The aging population is a major driver of market growth, as older adults are at a higher risk of developing chronic kidney disease (CKD), the primary cause of hyperphosphatemia. The prevalence of CKD increases with age, creating a surge in demand for effective treatment options.

• For example, CKD affects approximately 34% of individuals aged 65 years and above, compared to 12% in the 45-64 age group and 6% in those aged 18-44 years. The high susceptibility of the geriatric population to CKD underscores the need for frequent and effective hyperphosphatemia treatments, further fueling market demand.

By addressing regulatory advancements and the growing need for treatments in vulnerable populations, the market continues to experience robust growth.

Market Restraining Factor

Multiple side effects and drug-drug interactions

The presence of multiple side effects and potential drug-drug interactions associated with hyperphosphatemia medications significantly restrains market growth. These adverse reactions and interactions can diminish the demand for certain medications, limiting their widespread use.

For example:

• Calcium acetate, a common treatment for hyperphosphatemia, has been shown to interact with several drugs, including Baloxavir Marboxil, Bictegravir, Digoxin, Ketoconazole, and Raltegravir, among others.

• Common side effects of calcium acetate include constipation, depression, muscle weakness, weight loss, increased urination, and partial loss of consciousness.

These side effects and interactions pose challenges in patient adherence to treatment regimens, which ultimately affects the overall market demand for such medications. As a result, the presence of these complications continues to slow down market growth as patients and healthcare providers seek safer, more effective alternatives.

Hyperphosphatemia Treatment Market Opportunities

Increasing awareness regarding hyperphosphatemia and associated problems

The rising awareness of hyperphosphatemia and its associated complications presents a significant opportunity. As hyperphosphatemia is often linked to chronic kidney disease and hypoparathyroidism, there is a growing need for educational initiatives to inform the public about these conditions and their management. Government bodies and nonprofit organizations are stepping up efforts to raise awareness through dedicated campaigns and events.

• For example, in March 2024, the American Kidney Fund launched an education and awareness campaign focused on managing high phosphorus levels, also known as hyperphosphatemia. Such initiatives help improve public knowledge about hyperphosphatemia, leading to better early detection, diagnosis, and treatment adherence.

This increased awareness creates a broader market for hyperphosphatemia treatments and presents a clear opportunity for growth in the sector.

Regional Insights

North America: Dominant region with 41.6% market share

North America holds the largest revenue share in the hyperphosphatemia treatment industry, driven by several key factors. The region benefits from a well-established healthcare infrastructure, which facilitates easy access to advanced treatments and ensures efficient delivery of care. Rising investments in research and development (R&D) have led to the development of innovative medications, further boosting the market's growth.

Moreover, the high prevalence of chronic kidney disease (CKD) in the region has contributed to increased demand for effective hyperphosphatemia treatments. The presence of major pharmaceutical players, such as Sanofi, Takeda Pharmaceutical Company Limited, Ardelyx, and Lupin, strengthens the market's position.

Asia-Pacific: Rapid growth in China, Japan, and India

Asia Pacific is expected to experience the fastest CAGR in the hyperphosphatemia treatment market. This growth is driven by the rising incidence of chronic kidney disease (CKD) and hypoparathyroidism, alongside increasing awareness of advanced treatment options. Moreover, significant investments in healthcare infrastructure are improving access to medical care and driving market expansion.

• For example, a 2024 publication by Elsevier estimates that the overall prevalence of CKD in Asia is around 434.3 million, highlighting the growing demand for effective hyperphosphatemia treatments and further strengthening the region’s market potential.

Countries Insights

• United States –The U.S. continues to lead the market, driven by substantial investments in research and development. The country also benefits from awareness campaigns by regulatory bodies, which educate the public about the disease, its complications, and treatment options. In April 2024, the American Kidney Fund launched a national kidney health equity media campaign to raise awareness of kidney disease, further promoting understanding and accessibility.
• Canada - In Canada, the rising prevalence of kidney diseases is driving the growth of the market. The increasing number of kidney disease cases is directly contributing to a higher demand for treatments. According to The Kidney Foundation of Canada, 2021 saw 4 million cases of kidney disease, with 1 in 10 Canadians affected. This high incidence underscores the need for hyperphosphatemia treatments and accelerates market growth.
• Mexico – Mexico’s market is largely driven by the high incidence of end-stage renal disease (ESRD), which is directly linked to hyperphosphatemia. The complications arising from ESRD significantly impact the demand for effective treatments. According to the NIH, Mexico had an incidence of 603 per million people in 2021, signaling a critical need for treatment solutions and fueling market growth in the region.
• Spain– In Spain, the growing awareness of chronic kidney disease (CKD) is propelling the market for hyperphosphatemia treatment. Increased knowledge about CKD complications and treatment options is encouraging more patients to seek care. In October 2023, Kidney Disease Improving Global Outcomes hosted a conference in Madrid to address CKD progression and gaps in personalized care, highlighting the country's commitment to enhancing patient education and care.
• Germany – Germany is witnessing a surge in hyperphosphatemia treatment demand due to an increasing number of chronic kidney disease (CKD) cases and hospitalizations. The rise in CKD cases has led to a higher incidence of hyperphosphatemia, necessitating more treatment options. According to the NIH, Germany had 48,011 CKD cases, driving the growing need for hyperphosphatemia treatments and contributing to market expansion in the country.
• Japan – Japan’s hyperphosphatemia treatment industry is expanding due to substantial investments in product launches by key market players. These new treatments are increasing the availability of diverse drug options for managing hyperphosphatemia. In February 2024, Kyowa Kirin launched PHOZEVEL tablets, designed to improve hyperphosphatemia in chronic kidney disease patients on dialysis. Such product expansions are driving market growth.

Segmentation Analysis

The global market for hyperphosphatemia treatment is segmented into drug class, route of administration, disease condition, and distribution channel.

By Drug Class

The non-calcium-based phosphate binders segment leads the market due to first-choice drugs for the treatment of hyperphosphatemia. In addition to this, companies are investing in the manufacturing of generic non-calcium-based phosphate binders to be available in the market.

• For instance, in May 2024, Strides received U.S. Food and Drug Administration approval for Sevelamer Carbonate tablets, 800 mg. This approval consolidates the Company's position in the Sevelamer segment by complementing the existing approval of Sevelamer for Oral Suspension.

By Route of Administration

The oral segment dominates the global hyperphosphatemia treatment industry due to the most preferred dosage form having better patient compliance and the availability of multiple forms categorized under oral dosage forms, such as tablets, capsules, powders, and granules.

Below table represents various marketed preparations for hyperphosphatemia treatment

Source: Drug Bank, Company Websites, and Straits Analysis

By Disease Condition

The chronic kidney disease (CKD) segment leads the market, driven by its high global prevalence. CKD impairs the kidneys' ability to excrete phosphorus, leading to hyperphosphatemia due to the accumulation of phosphates in the body. This results in a growing demand for treatments aimed at managing hyperphosphatemia.

• According to the National Institutes of Health (NIH), CKD affects over 800 million people worldwide, representing more than 10% of the global population, highlighting the critical need for effective treatment options.

By Distribution Channel

The drug stores & retail pharmacies segment dominates the market, generating the highest revenue. This is largely due to the widespread availability of both over-the-counter (OTC) and prescription medications, making it convenient for patients to access treatments. Additionally, the need for proper counseling due to drug interactions and side effects further supports the prominence of this distribution channel. Patients often prefer retail pharmacies as they offer easy access to essential medications, contributing to the segment’s market dominance.

Company Market Share

Key players in the market are actively investing in new product launches through robust R&D efforts. These innovations are aimed at enhancing the effectiveness of existing treatments and addressing unmet needs in managing hyperphosphatemia. Companies are focusing on developing drugs with novel mechanisms of action, improving safety profiles, and reducing side effects to increase patient compliance.

Ardelyx: An emerging provider in the hyperphosphatemia treatment market

Ardelyx is an emerging player in the global market, renowned for its innovative first-in-class medicines that aim to revolutionize patient care. The company is focused on addressing critical needs in the treatment of hyperphosphatemia by developing therapies that offer unique mechanisms of action.

Recent Development by Ardelyx:

• In May 2024, Ardelyx presented additional data supporting its first-in-class drug, XPHOZAH (tenapanor), at the National Kidney Foundation’s 2024 spring clinical meetings. The presentation highlighted the drug’s potential to effectively manage hyperphosphatemia in patients with chronic kidney disease (CKD) by targeting phosphate absorption in the gut.

Analyst Opinion

As per our analyst, the market is experiencing rapid growth driven by several key factors. The increasing prevalence of chronic kidney disease (CKD) and hypoparathyroidism, both of which are primary causes of hyperphosphatemia, has significantly raised the demand for effective treatment options. Moreover, market players are ramping up investments in research and development to introduce new molecules with innovative mechanisms of action.

This is complemented by a rise in the manufacturing of generic medicines, making treatments more accessible and affordable. The approval of new drugs by the U.S. Food and Drug Administration (FDA) has further accelerated the market, flooding it with a variety of treatment options for patients. However, the market also faces challenges, including the high cost of some novel therapies and the complexities surrounding drug interactions and side effects, which can hinder patient compliance.

Moreover, the variability in healthcare infrastructure and medication access in certain regions, especially in emerging markets, poses a barrier to widespread adoption. Despite these challenges, the overall outlook for the hyperphosphatemia treatment industry remains positive, with continued advancements in drug development and increased awareness helping to overcome these hurdles.

Recent Developments

• June 2024 – Alebund Pharmaceuticals received a Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) for AP306. This promising therapy is currently in clinical development and targets the treatment of hyperphosphatemia in individuals with chronic kidney disease (CKD).
• September 2024 – The National Kidney Foundation (NKF) launched a new online educational tool aimed at empowering individuals living with chronic kidney disease (CKD) to better understand their condition. This tool provides personalized resources based on an individual's health status, offering valuable information on managing CKD and preventing complications like hyperphosphatemia.