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'Silent killer' osteoporosis
quietly on the increase
Osteoporosis currently affects 30 million people (predominantly women) worldwide
and if left untreated, can be fatal. Historically hormone replacement therapy (HRT)
has been used to help prevent the bone loss that leads to osteoporosis. However
recent negative study results have lead to a rapid decline in its use, which may
lead to a significant increase in the prevalence of osteoporosis.
A Women's Health Initiative (WHI) study found that while HRT did reduce the risk
of fractures due to osteoporosis, it also increased the risk of heart attack,
stroke, breast cancer and blood clots. Because of these findings there has been
a dramatic reduction in the use of HRT, which could leave thousands of women
unprotected from the increased risks of bone loss and fractures associated with
menopause.
Osteoporosis - often dubbed the 'silent killer' - is a disease in which bones
become fragile and more likely to break if not prevented or if left untreated.
Osteoporosis can progress painlessly until a bone breaks, typically in the hip,
spine or wrist. Any bone can be affected, but of particular concern are
fractures of the hip and spine. A hip fracture almost always requires
hospitalization and major surgery and it can impair a person's ability to walk
unassisted and may cause prolonged or permanent disability or even death.
Spinal or vertebral fractures also have serious consequences including loss of
height, severe back pain and deformity. Needless to say bone fractures as a
result of osteoporosis place huge financial pressure on national health
services.
In the US alone in 2001, the estimated national direct expenditures (hospitals
and nursing homes) for osteopathic and associated fractures was $17billion ($47
million per day), and the cost is rising.
Preventable with good defense
Osteoporosis is largely preventable for most people; the best defense against it
is building strong bones, particularly before the age of 30. Coupled with the
general bone loss that occurs after the age of 35, the lowered estrogen levels
in women after the menopause may cause loss of bone mass at a rate that is two
to four times faster than that seen before the menopause, leading to
osteoporosis, or porous bones.
While 20% of osteoporosis cases are in men, it is important that women
especially take recognized steps to preventing osteoporosis like getting enough
calcium and vitamin D, engaging in regular weight bearing exercise and avoiding
smoking and excessive drinking.
Increased awareness of the risks involved and better screening programs would
also allow potential sufferers to be identified sooner and thus receive
treatment to prevent the onset of osteoporosis.
While the results of the WHI lead to $850 million being wiped off the market
value of HRT in 2003, some opinion leaders spoken to by Datamonitor suggest
there could be an even greater price to pay:
"I think we are going to see an increase in osteoporosis and fractures from all
the women that have stopped taking their HRT, and then the pendulum will swing
back," commented one US opinion leader
Despite some reservations, the osteoporosis market is forecast to grow from $8.3
billion in 2003 to be worth $14.7 billion by 2014, according to Datamonitor
research. The growth of the market is expected to be driven by uplift after the
WHI and new product launches to 2009. Unfortunately it is difficult to get an
accurate gauge on the potential increase in prevalence due to the lack of
national screening programs and thus lack of national data available.
Fosamax leads the way, but for how long?
The current leading drug for osteoporosis is Merck & Co's Fosamax, however its
market share of 35% is expected to decline to 8.5% by 2014 as a result of patent
expiry and competition from cheaper generics. Fosamax belongs to the
bisphosphonates class of drug, which are considered the gold standard in
osteoporosis treatment, along with Aventis/P&G's Actonel which generated sales
of $940 million in 2003. Datamonitor predicts Actonel will become a blockbuster
($1 billion in sales) by year-end 2004.
There are currently two bisphosphonates in the late-stage development pipeline
for osteoporosis, Roche/GSK's Boniva and Novartis's Zometa: Boniva is expected
to hit the US market in 2005 and the European market in 2006. Datamonitor
predicts that Boniva will take market share from both Fosamax and Actonel
because it represents a new treatment option for those patients not responding
to currently available drugs, as well as offering a more convenient regimen to
improve compliance and therefore disease management.
Zometa is currently in Phase III trials and Datamonitor assumes that the
earliest launch of this indication will be in the US by 2008, where the product
will take share from Fosamax and its generics, as well as Actonel and other
drugs at a rate of 10% over three years. The annual IV dosing regimen will meet
a need in the market for greater compliance with therapy and have the potential
to target a niche, but often neglected, hospital population at high risk of bone
loss.
While these treatments help to treat osteoporosis following diagnosis, they can
also prevent the condition in those at risk. One of the greatest unmet needs in
this area remains primary prevention and the need for adequate testing programs
to identify those at risk, initiate treatment and prevent costly fractures later
in life.
Related research:
•
Commercial Insight: Osteoporosis and HRT - Novel Osteoporosis Drugs Counter
Generic Threat While HRT Players Regroup and Move Forward priced $15,200
•
Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications
Drive Market Growth priced $11,400
•
Disease Modifying Osteoarthritis Drugs - The Search for the 'Holy Grail'
Continues priced $1,900
To order these
reports contact peter.barfoot@bioportfolio.com or
telephone +44 1300 321501 or +1 415 680 2472 and a representative will get back
to you.
You can also
order on line at: http://www.bioportfolio.com/cgi-bin/acatalog/search.html
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