Boston, MA -- (SBWIRE) -- 12/06/2013 -- Late-stage chronic kidney disease (CKD), encompassing stage 4 and 5 CKD, is a disease that manifests in a host of co-morbidities. Of these, bone and mineral metabolism disorders are some of the most commonly treated and have significant impact on morbidity and mortality of patients. This report focuses on the current treatment landscape, unmet needs, pipeline and remaining opportunity in the late-stage CKD market with a focus on the treatment of hyperphosphatemia and secondary hyperparathyroidism (SHPT). GlobalData expects the late-stage CKD market to undergo significant flux over the next five years in the US and 5EU. This changeable landscape is a consequence of a number of contributory factors, including the patent expiries of market leading hyperphosphatemia brands, and the expected launch of three new entrants to the market. GlobalData expects US and European healthcare reimbursement reforms to have a drastic impact on the dialysis-dependent CKD market. This is particularly the case in the US, where the treatment landscape for dialysis care has changed significantly due to the 2011 inclusion of IV drugs to the Medicare dialysis reimbursement bundle. This bundle is likely to be expanded to include oral treatments during the study period of the report (2012-2017) and will thus have a major constraining impact on sales for oral drugs in this market.

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Highlights

Key Questions Answered

- Based on interviewed KOL expert GlobalData has identified the major unmet needs in the late-stage CKD markets. What are the unmet needs for late-stage CKD patients with hyperphosphatemia and SHPT? Will the drugs under development fulfil the unmet needs of the late-stage CKD market?
- GlobalData anticipates the launch of new agents for the treatment of hyperphosphatemia and SHPT. Will these treatments address the key unmet needs identified by KOLs? What opportunities will remain for developers of novel treatments for these co-morbidities?
- How will the changing reimbursement environment in the US dialysis-dependent market impact the sales of marketed and pipeline products? What strategies are companies developing in order to gain traction in this increasingly constrained market?

Key Findings

- The late-stage CKD therapeutics market (hyperphosphatemia and SHPT), in the 6MM is forecasted to decline from $1.88bn in 2012 to $1.66bn in 2017, at a CAGR of -2.5%. This decline is attributed to the loss of patent protection for major brands and tightening reimbursement environment for oral treatments in dialysis patients.
- With the expected launch of three novel pipeline agents, the dialysis CKD market segment is due to become increasingly competitive over the forecast period as these agents enter a heavily genericized market.

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