Hyperphosphatemia Treatment Market

Market Overview

The global hyperphosphatemia treatment market size was valued at USD 1.3 billion in 2023 and is projected to reach USD 2.7 billion by 2032, registering a CAGR of 8.8% during the forecast period (2024-2032). The global increase in chronic renal illnesses is one of the primary factors driving the hyperphosphatemia treatment market share. 

Hyperphosphatemia treatment includes therapeutic interventions to manage and lower elevated phosphate levels in the bloodstream. Hyperphosphatemia is when the blood contains abnormally high levels of phosphate (phosphorus). It is frequently associated with chronic kidney disease (CKD), end-stage renal disease (ESRD), or other metabolic disorders.

The primary goal of hyperphosphatemia treatment is to restore phosphate levels to avoid complications like cardiovascular disease, bone disorders (such as renal osteodystrophy), mineral imbalances, and soft tissue calcifications. Dietary modifications to limit phosphate intake, pharmacological interventions such as phosphate binders, calcimimetics, vitamin D analogs, and dialysis in cases of severe kidney dysfunction are all possible treatment options.

Additionally, the prevalence of chronic illnesses is increasing, as is the number of senior individuals, which are two significant drivers of hyperphosphatemia treatment market growth. However, the FDA's tight regulations and the rise in pharmaceutical side effects for treating hyperphosphatemia may limit market growth. Furthermore, the market is expected to benefit financially from the enormous potential of emerging economies such as Brazil, South Africa, China, India, and others that have yet to realize their full potential.

Highlights

• Iron-based Phosphate Binders contribute significantly to the market by drug class.
• Hospital pharmacies generate the highest revenue share through the distribution channel.

Market Dynamics

Global Hyperphosphatemia Treatment Market Drivers:

Increasing Prevalence of Chronic Kidney Disease (CKD)

The growing incidence and prevalence of chronic kidney disease (CKD) worldwide are significant drivers of the hyperphosphatemia treatment market. CKD frequently causes impaired phosphate excretion, resulting in elevated serum phosphate levels. According to a study published in 2023, approximately 850 million people worldwide suffer from chronic kidney disease. The disease affects people of all ages and races, with disadvantaged populations being more vulnerable. Older people (34%), women (14%), and non-Hispanic Black adults (20%) have higher rates of CKD than younger people (6%), men (12%), and non-Hispanic Asian adults (14%). 

Furthermore, a study published in the Journal of the American Society of Nephrology estimated that 70-90% of patients with stage 3-5 CKD develop hyperphosphatemia due to impaired renal phosphate excretion. This high prevalence of hyperphosphatemia in CKD highlights the condition's significant clinical burden and the need for effective phosphate-management strategies to reduce associated complications.

Moreover, the rising prevalence of CKD significantly contributes to the rising incidence of hyperphosphatemia, increasing the demand for hyperphosphatemia treatments in clinical practice. As CKD remains a significant public health concern worldwide, the importance of early detection and treatment of hyperphosphatemia in improving patient outcomes cannot be overstated.

Global Hyperphosphatemia Treatment Market Restraints:

High Cost of Treatment

Hyperphosphatemia treatment can be costly, particularly for patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD) who require long-term care. The cost of medications like phosphate binders, calcimimetics, and dialysis procedures can place a significant financial strain on patients and healthcare systems, especially in areas with limited healthcare resources or inadequate insurance coverage. The average cost of phosphate binders for all causes is USD 9,723, with outpatient dialysis at USD 3,467, inpatient facilities at USD 2,527, and other Part A/B services at USD 2,732. A systematic review published in PLOS One discovered that the average monthly cost of phosphate binder therapy ranged from USD 150 to USD 500 per patient, depending on the medication and dosage regimen prescribed. 

Additionally, if sevelamer is used as the first-line phosphate binder in the United States, the cost of treating 270,000 dialysis patients will rise by more than USD 1 billion annually. However, a cost-benefit analysis indicates that combining treatment with an HMG-CoA reductase inhibitor and a calcium-containing phosphate binder is more cost-effective. High treatment costs can lead to medication noncompliance, treatment discontinuation, and ineffective hyperphosphatemia management, compromising patient outcomes and quality of life.

Global Hyperphosphatemia Treatment Market Opportunity:

Integration of Digital Health Technologies

Digital health technologies, such as mobile health applications, wearable devices, and telemedicine platforms, can improve the delivery and monitoring of hyperphosphatemia treatment. These technologies enable remote patient monitoring, real-time data collection, and personalized feedback, allowing for proactive interventions and improved treatment adherence. Healthcare providers and technology companies can work together to create innovative digital solutions that simplify hyperphosphatemia management and improve patient outcomes. Mobile health (mHealth) technologies have been demonstrated to assist patients with chronic kidney disease (CKD) in managing their condition. Telehealth and web-based technologies are two of the most common mHealth interventions for managing chronic diseases. These technologies can improve medication adherence, alleviate disease-related symptoms, and reduce rehospitalization and mortality.

Furthermore, the COVID-19 pandemic has accelerated the adoption of telemedicine and digital health technologies, with healthcare providers and patients increasingly turning to virtual care solutions to maintain continuity of care and reduce in-person interactions. According to a McKinsey & Company report, telehealth utilization increased 38 times in the United States during the first few months of the pandemic, demonstrating digital health's transformative potential in providing accessible and convenient healthcare services. Using these technologies, healthcare providers can provide more personalized and accessible care to patients with hyperphosphatemia, ultimately improving their quality of life and long-term health outcomes.

Regional Analysis

The global hyperphosphatemia treatment market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global hyperphosphatemia treatment market shareholder and is estimated to grow at a CAGR of 9.0% over the forecast period. The presence of many CKD patients undergoing dialysis in the region contributes to the market's high revenue. According to statistics published by the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) in May 2023, an estimated 808,000 people in the United States had End-Stage Renal Disease (ESRD), with 69% requiring dialysis. As a result, the abovementioned factors are expected to significantly increase the demand for hyperphosphatemia therapeutics during the forecast period. 

Furthermore, the increasing prevalence of hyperphosphatemia, as well as the development of osteoporosis and a variety of chronic kidney diseases, are driving the growth of the hyperphosphatemia therapeutic drug market in North America. According to a recent study by Block et al., despite efforts by patients, dietitians, and nephrologists to achieve the recommended serum phosphorus goal of 5.5 mg/dL, approximately 60% of American hemodialysis patients have phosphorus levels higher than this goal.

Asia-Pacific is anticipated to exhibit a CAGR of 9.3% over the forecast period. Calcium-based phosphate binders are more commonly prescribed in China, India, and other emerging markets than in developed countries. As the FDA approves more of these drugs and dialysis services expand in major countries, the demand for phosphate binders in the region grows. The prevalence of calcium-based phosphate binders in prescriptions distinguishes emerging countries from developed countries, and the significant increase in dialysis patients in Asia Pacific and a significant increase in dialysis patients are expected to boost demand during the period.

In addition, the Asia-Pacific market is expected to proliferate because of an aging population, osteoporosis cases, and changes in dietary habits. Hyperphosphatemia drugs are becoming more popular in Asia-Pacific as osteoporosis cases rise, which is the primary factor driving the market for these drugs. However, changing prescription patterns in these countries and a significantly larger patient population undergoing dialysis in the Asia Pacific are the primary factors expected to increase demand for hyperphosphatemia treatment in the region during the forecast period.

The European market is expected to generate significant revenue throughout the analysis period. The European Commission's increasing approval of hyperphosphatemia drugs, combined with an increase in the number of patients undergoing dialysis in major countries, is driving up demand in the region for iron-based and sevelamer-based phosphate binders. 

Latin America, the Middle East and Africa markets are booming as more companies enter these regions' untapped economies. The increasing number of distribution and supply agreements entered into by manufacturers across these regions is expected to aid in adopting hyperphosphatemia therapeutics. However, the Middle East and Africa are expected to have the smallest market for hyperphosphatemia medications due to low healthcare spending rates, a lack of public knowledge, and a need-based approach to treatment alternatives in this region. Saudi Arabia, South Africa, and the United Arab Emirates are among the most significant contributors to this region.

Segmental Analysis

The global hyperphosphatemia treatment market is segmented based on drug class and distribution channel.

The market is further segmented by drug class into Sevelamer, Calcium-based Phosphate Binders, Lanthanum Carbonate, Iron-based Phosphate Binders, and Non-Phosphate Binders.

The iron-based phosphate binders segment dominated the hyperphosphatemia treatment market share in 2023, and it is expected to grow at a significant CAGR during the forecast period. Iron-based phosphate binders, such as ferric citrate, are newer agents approved for treating hyperphosphatemia in CKD patients on dialysis. In addition to binding to phosphate in the gut, iron-based binders can boost iron stores and improve iron deficiency anemia, which is common in CKD patients. Ferric citrate is a phosphate binder and an iron supplement, making it helpful in treating hyperphosphatemia and iron deficiency.

However, iron-based binders can cause gastrointestinal side effects such as constipation and darkening of the stool. The segment's dominance is due to solid sales of products from well-known brands such as Auryxia and Velphoro. Furthermore, manufacturers' increased emphasis on protecting their products from generic competition has fueled the segment's expansion. 

The non-phosphate binders segment is expected to grow significantly over the forecast period. Non-phosphate binders are medications that indirectly lower phosphate levels or target other aspects of mineral metabolism to manage hyperphosphatemia. Calcimimetics, such as cinacalcet, reduce serum phosphate levels by inhibiting parathyroid hormone (PTH) secretion and bone resorption. Calcimimetics are especially useful in patients with CKD-associated secondary hyperparathyroidism, where elevated PTH levels cause phosphate retention and bone mineral disturbances. While not direct phosphate binders, these agents play an essential role in the overall phosphate management of CKD patients.

In addition, the only non-phosphate binder that has been approved is XPHOZAH (tenapanor). Ardelyx plans to market its product XPHOZAH by October 2023. The medication is quite effective in lowering serum phosphate levels in adult patients. This factor will be responsible for the segment's expansion over the forecast period.

By Distribution Channels, the market can further bifurcate into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.

Hospital pharmacies dominated the global hyperphosphatemia treatment market share. Hospital pharmacies are essential in providing hyperphosphatemia medications to patients receiving inpatient care, especially those undergoing dialysis or other renal replacement therapies. Hospital pharmacies ensure timely access to phosphate binders and other medications as part of healthcare providers' comprehensive treatment plans. Hospital pharmacists work closely with nephrologists, nurses, and other healthcare team members to optimize medication therapy, track treatment outcomes, and address drug-related concerns or side effects.

Additionally, the segment's dominance stems primarily from the many patients seeking dialysis treatment at hospital facilities. Furthermore, emerging economies such as India, where treatment costs are a critical factor, have seen a significant increase in dialysis patients in these settings. As a result, the large number of patients in hospital facilities is expected to drive the segment's growth. 

The online pharmacies segment is expected to have the fastest CAGR during the forecast period. Online pharmacies, also known as internet pharmacies or mail-order pharmacies, provide an alternative distribution channel for hyperphosphatemia medications by allowing patients to order prescriptions online and have them delivered to their homes. Online pharmacies offer convenience and accessibility, especially for patients with mobility issues or who live in remote areas with limited access to traditional brick-and-mortar pharmacies. Patients can browse medication options, compare prices, and place orders online, often taking advantage of reduced pricing and home delivery services. However, patients must select reputable online pharmacies that follow regulatory guidelines and prioritize patient safety and confidentiality.

Furthermore, the segment's expansion is due to an increasing shift in the patient population in metropolitan and capital cities toward e-commerce platforms to obtain drugs to treat hyperphosphatemia. A rapid increase aids the segment's growth in the number of online pharmacies, with significant e-commerce companies entering the lucrative segment in both developed and emerging markets.

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