GlobalData Plc

Sales for chronic kidney disease (CKD)-induced hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) therapeutics were estimated to be $4.2bn across the seven major markets (7MM*) in 2016. This is expected to grow to $10.5bn in 2026, at a Compound Annual Growth Rate (CAGR) of 9.5%, according to GlobalData, a leading data and analytics company.

The company’s report: ‘OpportunityAnalyzer: Late – Stage Chronic Kidney Disease’ states that over the forecast period, the most prominent wave of sales increases will come from the launch of new HK agents and the calcimimetic, Parsabiv, which will counteract the loss of market exclusivity of its in-house predecessor, Sensipar (cinacalcet).

One of the most prominent clinical issues surrounding the HPT, HP, and HK space is patient compliance with current therapy options. This is observed across the board for all available therapeutic classes, whether in the form of the pill burden of the phosphate and potassium binders, gastrointestinal (GI) toxicity in the calcimimetics, or the life-long administration of vitamin D sterols.

Jesus Cuaron, PhD, Healthcare Analyst at GlobalData, comments: “Although patient compliance is an area with the highest unmet needs, the present trend in corporate strategy highlights the fact that recent advancements have been suboptimal, as they involve non-novel approaches to improve current treatment options by developing ‘me-too’ drugs instead of transformative therapies.”

Resins have been considered the standard of care for treating non-emergency acute and chronic CKD-induced HK patients following diet and lifestyle modifications and/or lowering potassium intake. However, resins have an unpredictable onset of action, adverse GI effects, bad taste, and a sodium or calcium presence, which have made nephrologists uneasy when prescribing these treatments in heart failure and CKD patients. As such, the arrival of new HK agents with preferable clinical profiles has been long awaited.

Cuaron continues: “Currently, there is only one novel HK agent on the market, Vifor’s Veltassa, which launched in the US in 2016. Key opinion leaders agree that Veltassa has more robust positive clinical data and preferable patient compliance for patients suffering CKD-induced HK compared to outcomes seen with resin treatment.”

Amgen’s Parsabiv is a second-generation IV calcimimetic for the treatment of dialysis-dependent HPT patients. Parsabiv is vying for a robust launch into the HPT market. Parsabiv has been evaluated in several Phase III studies, and has shown superior results in a head-to-head study against the first-in-class calcimimetic, cinacalcet, as well as encouraging results from placebo-controlled studies, all of which instil physician confidence in Parsabiv’s capability to treat HPT dialysis patients.

Cuaron adds: “Parsabiv is the first IV calcimimetic in the HPT arena and will thus avoid the associated compliance issues observed with oral cinacalcet. We believe that it will acquire a critical market position, revolutionizing the treatment of secondary HPT.”

Information based on GlobalData’s report: OpportunityAnalyzer: Late – Stage Chronic Kidney Disease – Opportunity Analysis and Forecasts to 2026

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

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