The recombinant erythropoietin-stimulating agents (ESAs) revolutionized treatment of severe anemias, and the
anemia market prospered—until accumulating data indicated that ESA treatment may be detrimental to patient
survival. Black box warnings, tighter restrictions on ESA use and reimbursement, and significant decline in
ESA sales ensued. Can the market survive this crisis and return to prosperity?
Get the Answers You Need to Shape Your Strategy
Concerns about the safety of ESAs have increased steadily since 2004, when the first of several studies
suggesting that ESAs have negative effects on patient survival were published. What specific safety
concerns are associated with ESA treatment? How has the FDA responded to these safety concerns?
How has Medicare responded? What are market-leading companies doing to address safety
concerns? Do the pipelines contain possible successors to the ESAs? Which emerging agents look most
promising?
In 2007, worldwide sales of ESAs totaled $11.6 billion, a significant, 10% decline from sales in 2006. Which
of the three major markets accounts for most ESA sales? Which three companies claim the biggest
shares of the anemia market worldwide? What are the sales-leading ESAs today? In light of the serious
safety concerns and regulatory reactions, what are the likely prospects for current and emerging
ESAs? What are the market leaders doing to defend their positions in the anemia market?
Other factors, specifically the entrance of biosimilars and new agents, will affect the anemia market in the
next five to ten years. How will the anemia market evolve in the three different regions: the United
States, Europe, and Japan? How will the availability of biosimilars (already approved) in Europe affect
the sales of branded agents in that market? What factors are delaying the approval of biosimilars in
the United States? Which third-generation agent, legally trammeled in the United States, may capture
a significant share of the European market by 2010?
Scope
Overview of anemia: types of anemia and causes, prevalence, chronic kidney disease-associated
anemia, chemotherapy-induced anemia.
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