OpportunityAnalyzer: Late-Stage Chronic Kidney Disease
(CKD) – Opportunity Analysis and Forecasts to 2017
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 EU. 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.
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 fulfill 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?
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
Interviewed experts report pipeline agents to have clinical advantages and expect them to
partially address some key unmet needs. Remaining opportunities will be seized by future
players who invest in considerable innovations through agents with novel mechanism of actions.
GlobalData expects late-stage clinical trials to remain focused on biochemical endpoints in
reduction of serum phosphorus or iPTH. GlobalData expects novel biomarkers, such as fibroblast
growth factor 23 (FGF-23), to allow the detection of phosphorus imbalance in patients with
earlier stage 3 or 4 disease, therefore broadening the potential patient population eligible for
treatment with phosphate binders.
Develop and design your in-licensing and out-licensing strategies through a review of pipeline
products and technologies, and by identifying the companies with the most robust pipeline.
Develop business strategies by understanding the trends shaping and driving the global late-stage
CKD therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market
segments, and companies likely to impact the global late-stage CKD therapeutics market in the
Formulate effective sales and marketing strategies by understanding the competitive landscape
and by analysing the performance of various competitors.
Identify emerging players with potentially strong product portfolios and create effective counter-
strategies to gain a competitive advantage.
Organize your sales and marketing efforts by identifying the market categories and segments that
present maximum opportunities for consolidations, investments and strategic partnerships.
List of Companies:
Fresenius Medical Care
Mitsubishi Pharma Europe
More details about this report can be seen by visiting
Keywords: chronic kidney disease (CKD), treatment of hyperphosphatemia, secondary
hyperparathyroidism, CKD therapeutics market