With pipeline approvals of varying mechanisms and an influx of newly diagnosed patients, the chronic kidney disease-hyperparathyroidism (CKD-HPT), hyperphosphatemia (HP) and hyperkalemia (HK) market is expected to grow at a 6.9% compound annual growth rate (CAGR) from 2020 to 2030 in the seven major markets (7MM), namely the US, France, Germany, Italy, Spain, UK and Japan.

CKD is a chronic condition in which patients suffer from an irreversible and progressive loss in renal function over many months or years, ultimately resulting in end-stage renal disease and the requirement for renal replacement therapy. The Centres for Disease Control and Prevention (CDC) states that around 96% of people with kidney damage, or mild to moderately reduced kidney function, are oblivious to having CKD.

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The Kidney Disease Improving Global Outcomes and National Kidney Foundation define CKD as damage or abnormality in kidney structure or function, resulting in detrimental health outcomes or a glomerular filtration rate of less than 60ml/min/1.73m² over a period of more than three months. GlobalData expects that the US will contribute the most to the growth of the CKD-HPT, HP and HK market due to the higher prevalence of CKD in this market, as well as the substantially higher cost of prescription medications in the US compared with the EU and Japan.

The CKD-HPT, HP and HK disease space has historically consisted mainly of reformulations of existing drugs and repurposed drugs from other disease markets. For example, in the calcimimetic space, Amgen’s Parsabiv (etelcalcetide) is an intravenous formulation that is thought to offer a major advantage in the dialysis setting in terms of patient compliance. Parsabiv also displays a slightly improved tolerability compared to orally formulated cinacalcet.

In the CKD-HP space, existing players have focused on lowering the pill burden for patients by developing novel HP drugs. Vifor’s Veltassa (patiromer sorbitex calcium) and AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) are becoming preferred over potassium-binding resins, such as calcium polystyrene sulfonate and sodium polystyrene sulfonate, because they have fewer compliance issues and preferable safety profiles.

The level of unmet need in the CKD- HPT, HP and HK market is high overall, and the greatest need is for therapies with novel mechanisms of action and improved compliance. The currently available drug classes consist of calcimimetics, phosphate binders and potassium binders. GlobalData’s Pharma Intelligence Centre Drug Database has identified five CKD drugs in late-stage clinical development (Phase IIb or later). These include a sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, a calcimimetic and three phosphate binders.

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The potential launch of these late-stage pipeline agents will increase the number of pharmacological treatment options that can be offered to CKD patient populations with high unmet need. Some patients, however, may not benefit from them due to the challenges associated with gaining favourable reimbursement due to their anticipated high annual cost of therapy. The figure below outlines the key unmet needs in this space rated according to their level of attainment in the current and future CKD-HPT, HP and HK market, through the end of the forecast period (where 1 = low attainment and 5 = high attainment). The unmet needs are also stratified by level of importance (high, moderate or low).

GlobalData believes it will be easier for new drug entrants to capture CKD-HP market share if they offer a novel mechanism of action or help to reduce pill burden for patients. For example, many key opinion leaders (KOLs) interviewed by GlobalData expressed strong positive opinions about Ardelyx’s tenapanor, a first-in-class NHE3 inhibitor for dialysis-dependent patients with CKD-HP.

Tenapanor is an inhibitor of NHE3, which is found in the kidneys and acts to regulate sodium absorption and secretion in the body under normal physiological conditions. Tenapanor also has the potential to serve as an alternative therapy option for patients struggling to reach normal phosphorus range with the standard of care.

Phosphate binders currently in late-stage development include Shield Therapeutics’ PT20, OPKO’s Alpharen (fermagate) and Unicycive’s RenaZorb (lanthanum dioxycarbonate). These pipeline agents aim to improve patient compliance by reducing pill burden and by demonstrating that they have the potential for clinical superiority over existing phosphate binders, such as sevelamer.

In the HPT space, EA Pharma’s calcimimetic, upacicalcet, is administered intravenously, which will result in increased patient compliance. KOLs have emphasised that clinical trials focusing on direct comparisons with established therapies are needed, but it is still likely that some portion of Kyowa Hakko Kirin’s Orkedia (evocalcet) will be replaced by upacicalcet.