Even though the chronic kidney disease–mineral bone disorder (CKD-MBD) market is set to face several barriers to growth over the next decade, the anticipated launch of Ardelyx’s Tenapanor in the US market in 2020 may be an answer to the growing demand for novel CKD-MBD treatments, says GlobalData, a leading data and analytics company.
CKD-MBD is an umbrella term used to link renal osteodystrophy with mineral bone disorders and bone pathology associated with CKD. In 2017 alone, it was estimated that there were over 19 million diagnosed prevalent cases across the eight major markets (8MM*).
It is the second most investigated indication in the metabolic disorder therapy area across the markets. An analysis of data from GlobalData’s Pharma Intelligence Center reveals that CKD-MBD accounts for 7% of all genitourinary (including sex hormone therapy) clinical trials (n=330), with 112 completed clinical trials and 18 in planned/ongoing Phase II and Phase III interventional studies.
Gavin Davidson, Pharma Analyst at GlobalData, comments: “Although the early-stage (Phase I and earlier) CKD-MBD pipeline contains many novel therapeutics to address the disease, phosphate binders continue to dominate marketed therapies and the late-stage (Phase IIb and later) pipeline.”
In the late pipeline, Ardelyx’s novel agent tenapanor is poised to become the first NHE3 inhibitor for hyperphosphatemia in CKD-MBD and is expected to receive US FDA approval in 2020.
AJT-240 is the other novel agent in the late-stage pipeline. AJT-240, a calcium receptor (CASR) agonist, also possesses a novel mechanism of action for CKD-MBD but is set to exclusively enter the Japanese market, with no intentions stated by Sanwa Kagaku Kenkyusho regarding label extensions.
Throughout all phases of the CKD-MBD pipeline, biologics are only featured in the pre-clinical phase, with small-molecules dominating both marketed and late pipeline products.
Davidson concludes: “The major barrier to CKD-MBD market growth over the next decade is the loss of patent exclusivity of major drugs. In addition, market access and reimbursements for costly new therapies represent another notable barrier to market growth and present a stiff barrier to entry for new medications into the CKD-MBD space. Despite hurdles for new agents, GlobalData expects significant opportunities to remain for developers of drugs with novel mechanisms of action.”