Introduction:
Last Updated 24 August 2010 Osteoporosis and osteopenia raise the risk of suffering a
fracture. Fractures are a substantial public health and financial burden, and
significant unmet need remains in the osteoporosis therapy market for safer,
more efficacious treatments. The launch of key therapies, coupled with
modifications in physician prescribing behavior, will lead to important market
changes over the 2009-2019 forecast period.
The recent approval of denosumab (Amgen/GlaxoSmithKline’s
Prolia)—an innovative RANKL inhibitor—has important implications for the
osteoporosis market. In this report, we analyze physician perception of
denosumab and how it is likely to be positioned in the osteoporosis market; we
discuss the ways in which this positioning will affect existing therapies such
as the current market leader, risedronate (Sanofi-Aventis/Warner Chilcott’s
Actonel), and other agents in the bisphosphonate class.
Questions Answered in This Report:
*
Denosumab has been approved, in Europe and the United States,
for the treatment of osteoporosis in postmenopausal women.
What rate of
uptake will denosumab experience, and how extensive will its penetration of the
osteoporosis market be? What impact will denosumab’s six-monthly administration
have on more frequently dosed current agents?
*
Several agents will go off patent during the first half of the
forecast period including risedronate, zoledronate (Novartis’s
Reclast/Aclasta), and raloxifene (Eli Lilly’s Evista).
Will these emerging
generics act as a barrier to the uptake of novel agents? Which agents offer
improved efficacy, strong safety profiles, or more convenient administration
and will displace established agents?
*
Compliance with treatment for osteoporosis and
osteopenia is poor. Physicians highlight less frequently dosed agents as a
method of improving patient compliance.
Will agents offering less frequent
dosing, such as six-monthly denosumab or yearly zoledronate, be able to capture
market share from weekly and monthly oral bisphosphonates?
*
Pfizer have withdrawn an application to allow marketing of
bazedoxifene in Europe under the name Brilence owing to the company’s inability
to find a suitable comarketing partner.
What does this withdrawal mean for
the market potential of bazedoxifene and for the SERM class as a whole?Scope:
Markets covered: United
States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 24 country-specific interviews with
thought leaders.
Epidemiology: Number of total, diagnosed, and
drug-treated prevalent cases of osteoporosis and osteopenia in the major
pharmaceutical markets over 2009-2019.
Population segments in market forecast: osteopenia and
osteoporosis.
Emerging therapies: Phase II: 9 drugs; Phase III: 3
drugs; preregistration: 1 drugs; registered: 1 drugs. Coverage of 4 select preclinical
and Phase I products.
Alternative market scenarios: If the results of Phase
III trials indicate that odanacatib offers fracture prevention superior to the
bisphosphonates.