With pipeline approvals of varying mechanisms and an influx of newly diagnosed patients, the chronic kidney disease (CKD)-hyperparathyroidism (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*), according to GlobalData, a leading data and analytics company.

Kajal Jaddoo, Pharma Analyst at GlobalData, comments: “The 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.

“Ardelyx’s tenapanor is a first-in-class sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor for dialysis-dependent patients with CKD-HP. Additionally, tenapanor has the potential to serve as an alternative therapy option for patients struggling to reach normal phosphorus range with the standard of care. In HPT, EA Pharma’s upacicalcet is administered intravenously, which will result in increased patient compliance.”

Historically, the CKD-HPT, HP, and HK disease space mainly consisted of reformulations of existing drugs and repurposed drugs from other disease markets.

Jaddoo continues: “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, and it also displays a slightly improved tolerability when compared to orally formulated cinacalcet. Similarly, in the CKD-HP space, existing players have focused on lowering the pill burden for patients by developing novel HP drugs. In the CKD-HK space, Vifor’s Veltassa (patiromer sorbitex calcium) and AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) are becoming preferred over potassium-binding resins.

GlobalData has identified five CKD drugs in late-stage clinical development (Phase IIb or later). These include a NHE3 inhibitor, a calcimimetic, and three phosphate binders.

Jaddoo adds: “While 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 may not benefit from them due to the challenges associated with gaining favorable reimbursement due to their anticipated high annual cost of therapy.”

*7MM – US, France, Germany, Italy, Spain, UK, and Japan