Sales of drugs used in the treatment of chronic kidney disease (CKD) are set to decline in the major world markets to 2017, after which they will return to growth, achieving total sales of $11.7 billion compared with $11 billion in 2012, according to new forecasts.
The market’s slide up to 2017 will be driven by competition from generics and biosimilars in the G7 markets - US, Japan, France, Germany, Italy, UK and Canada - and also by changes in US reimbursement practices, says the study, from Decision Resources. But growth in the market will resume after that date, driven by the uptake of novel agents, it forecasts.
The study looks at CKD treatments including erythropoietin-stimulating agents (ESAs), phosphate binders, calcium mimetics, active vitamin D analogues, antihypertensive agents, intravenous (IV) irons and emerging therapies for the CKD non-dialysis and dialysis patient populations.
It forecasts that ESAs, a dominant presence in the CKD-associated anemia market, will come under pressure from the launch of novel biosimilars in all markets and an increasingly hostile reimbursement environment in the US. Although ESAs will still retain the largest slice of the market in 2022, their share will have diminished significantly compared with the start of the 2012-22 forecast period.
It also expects the launch and uptake of novel therapies during the next 10 years to be the largest driver of market growth and that, of the emerging therapies with novel mechanisms of action, the hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors will have the biggest impact on the CKD market.
Based on their potential to offer a lower-cost, safe and orally-administered alternative to ESAs, the HIF-PH inhibitors should capture considerable sales by 2022, says the study, and it expects FibroGen/AstraZeneca/Astellas’ roxadustat to launch as first in class in 2018.
Other agents in development include AbbVie’s atrasentan for diabetic nephropathy and Amgen’s velcalcetide, an IV calcium mimetic, which will provide an alternative to cincalcet (Amgen’s Sensipan/Mimpara, Kyowa Hakko Kirin’s Regpara) for CKD patients with secondary hyperparathyroidism.
“Hypertension, diabetes and an ageing population are key drivers behind a forecast increase in patients with CKD in all seven major markets under study, which further increases the opportunities in this disease area,” comments Decision Resources group director Matthew Scutcher.
“Unfortunately, most products in late-stage development do not treat the underlying condition, but most do offer some advantages over existing agents and thus should compete strongly in the marketplace,” Dr Scutcher adds.