 Spectrum --
June 2008
 Introduction:
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.
Anemia treatment: erythropoietin-stimulating agents
(ESAs), emerging agents, biosimilars.
ESA safety issues: risk in cancer patients, risk in
chronic kidney disease patients, effects on ESA sales, restrictions on use and
reimbursement.
Outlook for the anemia market: Other factors affecting
the market, outlook by geographic region.
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