Introduction:
The group of bone marrow disorders known as
myelodysplastic
syndromes (
MDS) is a niche indication with few approved
therapies. Approval of azacitidine (Celgene’s Vidaza), decitabine (Eisai’s
Dacogen), and lenalidomide (Celgene’s Revlimid) in the United States has
revolutionized clinical management of MDS and has generated interest in
the development of novel emerging therapies.
Questions Answered in This Report:
*
Interviewed thought leaders tell us that clinical management of
MDS depends on clinical risk.
How do hematologists define risk populations?
What are the distributions of MDS patients within different risk groups?
How do drug-treatment rates vary across these populations, and how will they
change in the future?
*
Azacitidine has demonstrated an improvement in overall survival
compared with conventional-care regimens; however, decitabine failed to show a
clinically significant improvement in overall survival.
How will this
difference affect use of the hypomethylating class of agents? How have thought
leaders reacted to this news? Why do experts believe that this discrepancy
occurred considering the fact that azacitidine and decitabine are similar
molecules?
*
We forecast that azacitidine and lenalidomide will launch in
Europe and Japan for the treatment of MDS.
How will the launch of these
therapies affect the percentage of MDS patients receiving drug treatment? How
will these agents affect current medical practice in these markets?
*
Thought leaders tell us that there are few emerging therapies
with the potential to revolutionize current MDS treatment.
Which emerging
therapies are most promising? How can novel therapies enter the MDS
market? Will novel therapies threaten sales of currently used agents?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 22 country-specific interviews with
thought leaders.
Epidemiology: Diagnosed incidence and diagnosed
prevalence of low-risk, intermediate-risk, high-risk, and del(5q) MDS
populations in 2007, 2012, and 2017.
Population segments in market forecast: Low-risk,
high-risk, and del(5q), based on groupings of MDS patients with specific MDS
subtypes.
Emerging therapies: Select Phase II: 11 drugs; Phase
III: 1 drug; preregistration: 0 drugs; registered: 4 drugs.
Market forecast features: Using a prevalence-based
market analysis, we forecast population sizes and drug sales for three
commercially significant patient segments through 2017.
Alternative market scenarios: Launch of decitabine in
Europe and Japan for high-risk MDS patients, capturing the same patient share
as azacitidine. Launch of a novel histone deacetylase inhibitor in combination
with a hypomethylating agent in the seven major markets under study.