Chronic Kidney Disease-Mineral Bone Disorders (CKD-MBD): Competitive Landscape to 2027
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 8 major markets (The US, France, Germany, Italy, Spain, the UK, Japan and China). It is the second most investigated indication in the metabolic disorder therapy area across the markets.
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. 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.
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.
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, significant opportunities remain for developers of drugs with novel mechanisms of action.
The report Chronic Kidney Disease-Mineral Bone Disorders (CKD-MBD): Competitive Landscape to 2027, provides an assessment of the pipeline, clinical, and commercial landscape of CKD-MBD. Overall, minimal changes are expected to overall disease treatment, with exceptions being the launch of the novel NHE3 and novel CASR in the US and Japan markets respectively.
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