Late-stage chronic kidney disease (CKD) induced hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) therapeutics market is set to grow from $4.2bn in 2016 to $10.5bn in 2026 at a compound annual growth rate (CAGR) of 9.5%, according to a report by GlobalData.
Titled ‘OpportunityAnalyzer: Late – Stage Chronic Kidney Disease’, the report covers the seven major markets of the US, France, Germany, Italy, Spain, the UK and Japan.
Sales of new HK agents and Amgen’s calcimimetic, Parsabiv, are expected to dominate the market during the forecast period. A second-generation IV calcimimetic for dialysis-dependent HPT patients, Parsabiv is anticipated to cover the market exclusivity loss incurred due its in-house predecessor Sensipar (cinacalcet).
Existing options from all therapeutic classes are reported to be characterised by patient compliance issues, such as pill burden of phosphate and potassium binders, gastrointestinal (GI) toxicity in calcimimetics and life-long administration of vitamin D sterols.
However, current corporate strategies lack the means to meet this unmet need as recent advancements have been suboptimal with non-novel techniques and no transformative therapies, states Jesus Cuaron, healthcare analyst at GlobalData.
Even though resins are being used as the standard of care for non-emergency acute and chronic CKD-induced HK patients who are adhering to diet and lifestyle modifications and/or reducing potassium intake, they come with various concerns that make them inappropriate for heart failure and CKD patients.
These treatments have an unpredictable onset of action, adverse GI effects, bad taste and a sodium/calcium presence, leading the way for new HK agents with better clinical profiles.
Released in the US market in 2016, Vifor’s Veltassa is considered to be the only new HK agent with more positive clinical data and preferable patient compliance compared to resins’ outcomes for CKD-induced HK patients.
Also, Amgen’s Parsabiv is reported to have demonstrated superior results in a comparative study with cinacalcet, and encouraging data during placebo-controlled studies. It has also been assessed in various Phase III clinical trials and the findings are said to promote physician confidence in its capability to treat HPT dialysis patients.
As Parsabiv is an IV calcimimetic, it will avoid the compliance issues observed with oral cinacalcet, and is expected to occupy a critical market position for secondary HPT, adds Cuaron.