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OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) – Opportunity Analysis and Forecasts to 2017

OpportunityAnalyzer: Late-Stage Chronic Kidney Disease (CKD) – Opportunity Analysis and Forecasts to 2017

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Published by Sarah Clark
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?
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.
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.
Key Benefits
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 future.
Formulate effective sales and marketing strategies by u
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?
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.
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.
Key Benefits
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 future.
Formulate effective sales and marketing strategies by u

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Published by: Sarah Clark on Nov 11, 2013
Copyright:Attribution Non-commercial

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 Late-stage 
 (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 hyperparathyroidis
 (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?
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. 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.
Key Benefits
 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 
 in the future. 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:
 AbbVie Amgen Ardelyx Deltanoid Pharmaceuticals Fresenius Medical Care Galenica Keryx Biopharmaceuticals Mitsubishi Pharma Europe  Nektar Therapeutics OPKO Health Sanofi/Genzyme Shield Therapeutics Shire Pharmaceuticals Spectrum Pharmaceuticals Vidasym Vifor Pharmaceuticas

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