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Despite the safety queries associated with the glitazones
(thiazolidinediones), oral antidiabetic agents are a therapy
area in full expansion, set to become the leading market
within the next 10 years.
According to IMS HEALTH's World
Review, the therapeutic class Oral Antidiabetics (A10B)
was the 10th largest class in 1999, with a growth
rate of 23%.
IMS HEALTH's Sales report, through retail pharmacies, for
A10B gives a total market value of $3,793 million for the
year to March 2000 (countries included are USA excluding
Mail Order, Canada, Germany, Italy, France, Spain, UK, Japan,
Brazil, Mexico, Argentina, Australia and New Zealand).
For the top eight countries (USA, Japan, UK, Germany, France,
Spain, Italy and Canada), the oral antidiabetic market has
grown in value from $0.7 million in 1989 to $3,150 million
in 1999, North America now accounting for 63% of sales,
Japan 11% and the top five European territories 26%.
The leading product on the market is Glucophage (metformin).
Initially launched in France in 1959 by Lipha (now part
of Merck KGaA) for the treatment of non-insulin dependent
diabetes, it was not launched in the USA until 1995. Bristol-Myers
Squibb markets Glucophage in the USA. Glucophage now has
a 28% market share and has been growing at a 44% rate in
the 12 months to March 2000.
The second best-selling product is still Warner-Lambert's
Rezulin (troglitazone), licensed for the US market from
Sankyo, with 12% of the market. It has been declining at
a 24% rate, following the decision by the licensee to withdraw
the product in March due to reports of liver toxicity, including
liver failure leading to death.
The third leading product is Basen (voglibose), launched
in 1994 by Takeda, and accounting for 7.7% of the market
though only available in Japan.
The health issues associated with Rezulin have cast some
doubts about the success of the two new glitazones
launched in 1999 in the USA: Avandia (rosiglitazone)
from SmithKline Beecham (co-marketed with Bristol-Myers
Squibb), and Actos (pioglitazone) from Takeda (co-promoted
by Eli Lilly).
After Avandia initially received a negative opinion in October
1999 from the EU Committee for Proprietary Medical Products
(CPMP), SB has intensified its clinical trial programme
and collection of post-launch data. Avandia was finally
approved in the EU in March. In May, SB reported that a
thorough review of the Avandia post-launch data had confirmed
its safety.
As of March 2000, Avandia had captured a 4.8% share of the
key 12 markets and Actos has 3.1%. Both drugs have surpassed
the one million prescription mark, and were featured heavily
at the American Diabetes Association 60th Scientific Sessions
meeting, held in San Antonio earlier in June.
World Oral Antidiabetic Sales in US$
Source: Monthly
MIDAS
Monthly MIDAS covers the world's largest
pharmaceutical markets, both retail and hospital (including
USA, Japan, top European countries, top South American countries,
Australia and New Zealand and South Africa).
As the new glitazones are preparing to launch in Europe,
IMS HEALTH's Medical
Dynamics can be used to study the use of oral antidiabetics
in the USA and Europe, and in particular to examine the
current coprescription patterns in the two markets.
Coprescription is defined as two or more products prescribed
at the same time for the same condition (products can be
co-prescribed with themselves in different forms or strengths).
In the USA, the leading products tend to be prescribed with
other antidiabetics. This is particularly true of Glucophage,
Actos and Avandia.
Coprescribing
of Oral Antidiabetics in the USA
Source: Medical Dynamics
Coprescribing
of Oral Antidiabetics in Italy
Source:
Medical Dynamics
In comparison, the situation in Italy is
quite different. Firstly, there is much less coprescribing
in general, and of the coprescribing which does occur cardiovascular
drugs feature prominently.
Medical Dynamics data is derived from doctor-patient consultations
and the treatment given. The data is collected from a representative
sample of doctors practising in the primary care sector
of each country monitored.
The launch of the new glitazones in Europe are expected
to drive the market forward. IMS HEALTH's forecasting tool
Pharmacast
& Beyond predicts a total market worth $7,391.70 millions
in 2009 - 160% growth over 1999, for the top eight markets.
Diabetes is still a condition that is largely under-diagnosed,
and its treatment will benefit from multiple therapy. It
is expected to become the leading diagnosis, ahead of hypertension,
within 10 years.
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