The total chronic kidney disease (CKD) anemia drug market size for the 8MM* in 2019 was valued at $4.7bn, defined as sales of major branded and biosimilar drugs, as well as iron products that are commonly prescribed in CKD anemia patients. By 2029, CKD anemia drug sales across these markets are expected to grow to $6.6bn, representing a compound annual growth rate (CAGR) of 3.4% over the 10-year forecast period, according to GlobalData, a leading data and analytics company.

GlobalData’s report, ‘Chronic Kidney Disease Anemia: Global Drug Forecast and Market Analysis to 2029’, Reveals that this growth will be driven mainly by the anticipated approval and launch of the novel hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class, however, it will likely be tempered by marked biosimilar erosion of a number of top-selling currently marketed branded erythropoiesis-stimulating agents (ESAs).

Although, ESAs are forecast to remain the highest-grossing drug class in 2029, this drug class will have a negative CAGR of 2.9%. These market dynamics will occur against a backdrop of a moderate growth of global CKD anemia prevalent cases over a 10-year forecast period (2019-2029), with approximately 2.6 million drug treated cases across the 8MM in 2029.

Kelly Lambrinos, Managing Analyst at GlobalData, comments: “A significant growth factor of the CKD anemia market will be the launch and uptake of novel HIF-PHIs. This novel class of drugs, which includes several recently approved and late-stage candidates, is expected to have steady uptake across the 8MM*, as they are anticipated to address some of the main unmet needs in the space. On the contrary, the patent expiry of leading branded ESAs as well as subsequent patient share erosion by biosimilars will constitute as the major barrier to further growth.”

The CKD anemia market is relatively well-established; many physicians believe that the existing therapies, namely ESAs, effectively control anemia for most patients. However, despite several options, there is still room for improvement and innovation within the CKD anemia treatment space.

Lambrinos continues: “While ESAs have improved the treatment for patients with CKD anemia, their safety profiles are not ideal. As injectable ESAs often stimulate epoetin to supraphysiologic levels, which subsequently associates their use with increased cardiovascular risks, safer treatment options for CKD anemia is one significant unmet need for the condition.”

The CKD anemia pipeline is considered weaker than some other indications, however, there is considerable excitement around the potential of HIF-PHIs for the treatment of CKD anemia.

Lambrinos adds: “HIF-PHIs represent a novel oral class of drugs and their market entry, according to key opinion leaders (KOLs), is a much anticipated and much-needed addition to a relatively stagnant market. However, the majority of KOLs opined that while HIF-PHIs have demonstrated some encouraging data so far, they await longer-term safety data to solidify their position within the CKD anemia treatment paradigm.”

* 8MM: US, 5EU (France, Germany, UK, Spain, Italy), Japan, China