Calcium Acetate Market

The rise in demand for therapeutics to treat phosphate is a major driver of the global calcium acetate market. Chronic kidney disease (CKD) is one of the main causes of the demand for phosphate-lowering therapies. Kidney function decreases in CKD, and the daily intake of phosphate is not easily removed by the kidneys, leading to high blood phosphate levels. Hyperphosphatemia is an independent risk factor for cardiovascular morbidity and mortality among patients with late-stage renal diseases. Calcium acetate has been the primary phosphate binder, as it is absorbed in the gut and thus goes straight to the intestine, where it makes phosphate insoluble by combining with it.

Calcium overload, leading to cardiovascular side effects, is a major factor limiting the use of calcium acetate in the pharmaceutical sector. Most systemic accumulations of calcium are caused by the use of calcium-based phosphate binders, which can lead to the adverse condition known as hypercalcemia, characterized by an increased risk of vascular calcification. Such health conditions become severe for patients with chronic kidney disease (CKD) and co-existing cardiovascular complications. Due to this, the available clinical guidelines in most regions recommend that calcium-based binders be restricted in patients with pre-existing hypercalcemia or clinical signs of arterial calcification. Non-calcium binders such as sevelamer and lanthanum carbonate are the first options, which have better safety profiles regarding calcium balance.

Emerging markets, particularly in the Asia Pacific and Latin American regions, present a significant opportunity for growth of the calcium acetate market. These markets are currently witnessing a rapid increase in the prevalence of CKD, driven by aging populations and rising incidences of diabetes and hypertension. CKD prevalence in China alone accounts for tens of millions of individuals, with a significant proportion of this subset progressing to end-stage disease requiring dialysis. In many of these markets, cost remains a primary factor in determining treatment choice. Cheaper calcium-based phosphate binders, such as calcium acetate and calcium carbonate, are preferred over newer, non-calcium-based treatments.

Regulatory compliance remains one of the most complex and expensive challenges for calcium acetate manufacturers, especially in the pharmaceutical and food sectors. Calcium acetate must conform to very strict standards in terms of pharmacopeia specifications such as USP, EP, BP, and JP when used as a phosphate binder or excipient. These specifications typically set limits for heavy metals, residual solvents, microbial load, and elemental impurities at very low levels, in conformity with the ICH Q3D guidelines. These specifications require the implementation of very extensive purification procedures, validated analytical methods, and continuous quality monitoring, which greatly increases the cost of manufacturing.