Hyperphosphatemia Treatment Market Size, Share & COVID-19 Impact Analysis, By Product (Sevelamer, Calcium-based Phosphate Binders, Iron-based Phosphate Binders, Lanthanum Carbonate, Others and Non-phosphate Binders); By Distribution Channel (Hospital Pharmacy, Retail Pharmacies, and Online Pharmacies) and Regional Forecasts, 2021-2028

The global hyperphosphatemia treatment market size was USD 2.36 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with hyperphosphatemia treatment witnessing a moderately negative demand shock across all regions amid the pandemic. Based on our analysis, the global market witnessed a growth of 2.0% in the year 2020, as compared to the average year-on-year growth during 2017-2019. The market is projected to grow from USD 2.46 billion in 2021 and is expected to reach USD 3.53 billion in 2028 at a CAGR of 5.3% in the 2021-2028 period. The sudden rise in CAGR is attributable to the market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Hyperphosphatemia is an electrolyte disorder in which there is an elevated level of phosphate in the blood. This condition occurs in almost 90% of end-stage renal disease patients going through dialysis. Hyperphosphatemia therapeutics such as phosphate binders are used to reduce the gastrointestinal absorption of phosphorus. The most commonly prescribed phosphate binders are calcium salts, but these may produce hypercalcemia. Similarly, there are several phosphate binder drug classes used such as sevelamer, lanthanum carbonate, magnesium-based phosphate binders, and iron-based phosphate binders.

Hyperphosphatemia drugs market is expected to witness significant growth owing to the increasing prevalence of Chronic Kidney Diseases (CKD) globally. Kidney disease affects around 850 million people worldwide. One in ten adults has chronic kidney disease (CKD). Moreover, during 2018-2019, as per the Centers for Disease Control and Prevention (CDC), 15% of U.S. adults, or 37 million people, are estimated to have CKD. Hence, owing to the aforementioned factors, the hyperphosphatemia therapeutics market is expected to witness a positive growth trajectory during the forecast period.

Disruption in Industry Operation and Increasing Mortality Rate of CKD Patients to Hamper Growth amid COVID-19

The novel coronavirus (COVID-19) outbreak in late December 2019 has been an unprecedented event globally. The virus has affected millions of patients in more than 150 countries worldwide, and various countermeasures have been deployed to combat the rapid spread of COVID-19 infection in different countries. COVID-19 is an unprecedented public health emergency affecting every industry.

The current global COVID-19 pandemic played an obstructive role in the growth of this market. It has triggered a severe disruption in the functioning of various industries by impacting several integral aspects related to the smooth functioning of businesses. In the midst of the pandemic, most industries are struggling to mitigate the adverse effects of the impact, which could shift the world economy to a potential recession. The global hyperphosphatemia drugs market is no different!

COVID-19 adversely and disproportionately impacts the patient population with higher hospitalization and mortality rates, which leads to a negative impact on the future hyperphosphatemia treatment market revenue growth. Furthermore, all around the globe, the supplier crisis is creating a myriad of unexpected consequences. Despite years of development and optimization, the rapid collapse of supply chains exposes the vulnerabilities of global businesses to sweeping black-swan events, such as the COVID-19 pandemic. The overall impact of coronavirus is anticipated to considerably diminish capital expenditures and organizational revenue as impacts start to solidify within more organizations.

LATEST TRENDS

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Gradual Shift from Phosphate Binders to Non-phosphate Binders is the Latest Market Trend

Optimal phosphate control in CKD patients under dialysis is extremely challenging. Despite the extraordinary developments made in dialysis techniques over the years, the control of phosphate levels in dialysis patients has not been substantially enhanced. Moreover, phosphate binders are associated with several side effects. Hence, with an aim to enhance the treatment option for hyperphosphatemia, researchers are focusing on the development of novel hyperphosphatemia therapeutics and accordingly updating the treatment guidelines. The treatment option for hyperphosphatemia is further anticipated to witness a shift from phosphate binders to non-phosphate binders, such as Tenapanor, an inhibitor of the hydrogen/ sodium exchanger isoform 3 (NHE3) is being studied for the treatment of hyperphosphatemia. The drug is anticipated to be launched by 2021. 

DRIVING FACTORS

Growing Number of Patients on Dialysis to Boost Demand for Hyperphosphatemia Treatment

The increasing prevalence of chronic kidney diseases across the globe is one of the major factors supporting the growth of the market. The global burden of CKD is growing, and by 2040, it is projected to become the 5th most common cause of years of life lost globally. The increasing incidence of CKD has further boosted the total number of patients on dialysis worldwide. As per the National Kidney Foundation Inc., in 2018, 785,883 Americans had kidney failure and needed a kidney transplant and dialysis. Five hundred fifty-four thousand thirty-eight of these patients received dialysis to replace the kidney function.

Almost all dialysis-dependent kidney failure patients experience hyperphosphatemia at some point in their lifetime. Additionally, as per the National Center for Biotechnology Information (NCBI), 80-85% of the patients on dialysis experiencing hyperphosphatemia are treated with phosphate binders. Hence, the growing prevalence of chronic kidney ailments will significantly support the market expansion during the forecast period.

Increasing Number of Products Entering Developing Economies to Propel Growth

The growing number of drug launches across developing economies is set to boost the hyperphosphatemia treatment market growth. For instance, in April 2021, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced positive results from a phase-III study in China for Velphoro (PA21) in lowering serum phosphorus in adult patients with CKD on dialysis. Furthermore, in July 2020, Emcure Pharmaceuticals launched India’s first generic version of sucroferric oxyhydroxide (Dynulta) for the treatment of hyperphosphatemia. Hence, the increasing product approvals are likely to significantly stimulate the growth of the market especially in emerging countries.

RESTRAINING FACTORS

Poor Medication Adherence among Patients due to High Pill Burden to Limit Market Growth

Poor adherence to treatment due to the high pill burden among dialysis patients is one of the major factors restricting the market growth. For instance, as per an article published by the National Center for Biotechnology Information (NCBI), a dialysis patient on average is expected to take 10 to 12 altered types of medications. The daily pill burden from phosphate binders is four or more pills for almost 80% of patients, which causes adverse effects such as gastrointestinal intolerance. Hence, such factors are anticipated to limit the adoption of phosphate binders among CKD patients, thereby limiting the market growth.

SEGMENTATION

By Product Analysis

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Sevelamer Segment Projected to Dominate in Forthcoming Years

The sevelamer segment accounted for a dominant share of the global market in 2020. A shift in preference of healthcare providers from calcium-based phosphate binders owing to disadvantages of these products, including higher pill-burden, risk of cardiovascular complications, and comparatively lower absorption in elderly patients, has been pivotal in the higher demand for sevelamer-based phosphate binders in developed and emerging countries.

Iron-based phosphate binders have witnessed rising demand from healthcare providers owing to the limited documented evidence for the safety profile of long-term use of sevelamer, along with other distinct benefits of iron-based drugs. This, combined with the introduction of new branded and generic products in this class by key players, is boosting the availability of these drugs in developed and emerging countries.

By Distribution Channel Analysis

Hospital Pharmacy Segment to Hold Significant Market Share

Among distribution channels, the hospital pharmacy segment dominated the market in 2020. High shares of the segment are primarily due to the large number of patient pools seeking dialysis treatment in hospital facilities across the globe. Furthermore, emerging economies, such as India, where treatment price is one of the crucial factors, have witnessed a significant number of dialysis patient volumes in these settings. Thus, the robust number of patients in hospital facilities is set to support segmental growth.

The online stores segment is expected to grow at a higher CAGR during the forecast period. The growth is attributed to the increasing shift of the patient population in metropolitan and capital cities towards e-commerce platforms for the procurement of drugs in the treatment of hyperphosphatemia. This is further augmented by the rapid growth in the online pharmacies segment, with leading e-commerce giants entering the lucrative segment in developed and emerging countries.

REGIONAL INSIGHTS

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The hyperphosphatemia drugs market in North America held dominant shares and stood at USD 1.09 billion in 2020. High revenues are due to the presence of a large number of CKD patients in the region undergoing dialysis. According to the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), an estimated 610,000 people in the region were suffering from End-Stage Renal Disease (ESRD) in 2020, out of which an estimated 468,000 patients underwent dialysis. Hence, the aforementioned factor is anticipated to significantly boost the hyperphosphatemia therapeutics market in the forecast period.

The market in Europe is projected to register considerable revenue across the analysis period. The rising number of approvals for these drugs by the European Commission, along with the surging number of patients undergoing dialysis in major countries, is leading to the higher demand for iron-based and sevelamer-based phosphate binders in the region.

The market of hyperphosphatemia treatment in Asia Pacific is anticipated to witness lucrative growth during the forecast timeframe. The market in China, India, and other emerging countries, is characterized by the higher prescription share of calcium-based phosphate binders, as compared to developed countries. However, the changing prescription patterns in these countries, along with a significantly higher patient population undergoing dialysis in Asia Pacific, are the major factors set to boost demand in the region during 2021-2028.  

The Latin America and the Middle East & Africa markets are booming due to the growing number of players penetrating the untrodden economies in these regions. The increasing distribution and supply agreement across these regions is set to further support the revenue growth of this market.

KEY INDUSTRY PLAYERS

Growing Demand For Iron-based Phosphate Binders to Boost Demand for Vifor Pharma Management Ltd.’s Brand Velphoro

The market for hyperphosphatemia treatment is fragmented in nature. Sanofi is one of the leaders in the market, followed by Takeda Pharmaceutical Company Limited, Vifor Pharma Management Ltd., and Akebia Therapeutics Inc. Vifor Pharma Management Ltd. held a significant portion of the market with its brand Velphoro, an iron-based phosphate binder. The company held a significant market share in 2020. High shares of the company are majorly due to the growing demand for iron-based phosphate binders globally.

LIST OF KEY COMPANIES PROFILED:

• Sanofi (Paris, France)


• Takeda Pharmaceutical Company Limited (Tokyo, Japan)


• Astellas Pharma Inc. (Tokyo, Japan)


• Akebia Therapeutics, Inc (Massachusetts, U.S.)


• Vifor Pharma Management Ltd. (Zurich, Switzerland)


• Lupin Limited (Mumbai, India)


• Ardelyx, Inc. (California, U.S.)


• Unicycive Therapeutics Inc. (California, U.S.)


• Keryx Biopharmaceuticals (Massachusetts, U.S.)


• Zeria Pharmaceutical (Chuo City, Japan)


• Other Prominent Players

KEY INDUSTRY DEVELOPMENTS:

• April 2021- Ardelyx, Inc. announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd., has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia.


• April 2021- Vifor Fresenius Medical Care Renal Pharma announced positive results from a phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro (PA21) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment.


• December 2020- Unicycive Therapeutics, Inc., announced a licensing agreement with Spectrum Pharmaceuticals for Renazorb, a product to treat hyperphosphatemia in patients with (CKD).

REPORT COVERAGE

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The global hyperphosphatemia treatment market research report provides a detailed analysis of the industry. It focuses on key aspects, such as leading companies, product type, and distribution channel. Besides this, it offers insights into the market trends, impact of COVID-19, and the prevalence of CKD, among other key insights. In addition to the factors mentioned above, the market report encompasses several factors that have contributed to the growth of the market over recent years.

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