BURLINGTON, Mass., Jan. 28, 2014 /PRNewswire/ -- Decision Resources Group finds that, after an initial decline driven by generic and biosimilar competition in the G7 markets and changes in reimbursement practices in the United States, the total chronic kidney disease (CKD) market will return to growth, achieving total sales of $11.7 billion in 2022 compared with $11 billion in 2012. This market forecast includes erythropoietin-stimulating agents (ESAs), phosphate binders, calcium mimetics, active vitamin D analogues, antihypertensive agents, IV irons and emerging CKD therapies for the CKD non-dialysis and dialysis patient populations.
Other key findings from the Pharmacor Chronic Kidney Disease report:
- ESAs, a dominant presence in the CKD-associated anemia market, will come under pressure from the launch of novel biosimilars in all markets and an increasingly hostile reimbursement environment in the United States. Although the ESAs will retain the largest market share in 2022, this will have diminished significantly compared with the start of the 2012–2022 forecast period.
- The launch and uptake of novel drugs during the next ten years will be the largest driver of market growth. Of the emerging therapies with novel mechanisms of action, the hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors will have the biggest impact on the CKD market.
- Based on their potential to offer a lower-cost, safer, orally administered alternative to ESAs—HIF-PH inhibitors—should capture considerable sales by 2022, with FibroGen/AstraZeneca/Astellas's roxadustat forecast to launch as first-in-class in 2018.
- Other agents in development include AbbVie's atrasentan for diabetic nephropathy and Amgen's velcalcetide, an IV calcium mimetic, which will provide an alternative to cincalcet (Amgen's Sensipar/Mimpara, Kyowa Hakko Kirin's Regpara) for CKD patients with secondary hyperparathryoidism.
Comments from Decision Resources Group Director Matthew Scutcher, Ph.D.:
- "Hypertension, diabetes and an aging population are key drivers behind a forecasted increase in patients with CKD in all seven major markets under study, which further increases the opportunities in this disease area."
- "Unfortunately, most products in late-stage development do not treat the underlying condition but most do offer some advantages over existing agents and thus should compete strongly in the marketplace."
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