Abstract
Pharma Majors Reluctant to Spend on Testing for Pediatric Use
The key challenge facing the pediatric market is "economics".
Children form a relatively small segment of the population, at about 20 to 25
percent of the total adult market in any region. Owing to the high cost of
developing drugs - estimated at over $800 million from discovery to
commercialization - pharmaceutical manufacturers are compelled to address the
larger markets first. This often means postponing or omitting drug testing for
children. Other issues that are related to testing in children have reinforced
this trend. These issues include the difficulty of recruiting child volunteers
for clinical testing and the higher rates of noncompliance in such tests. Patent
extensions for pediatric testing offered by the U.S. FDA have mitigated this
trend to an extent; however, many pharmaceutical manufacturers remain reluctant
to invest in pediatric testing.
This Frost & Sullivan strategic analysis offers gainful insights into
future trends in the pediatric pharmaceuticals market that can help investors
study growth patterns and obtain maximum return on investment.
New Pediatric Act and Patent Expansions Force Dramatic Change
"The market for pediatric drugs is likely to soon undergo dramatic
expansion due to the new U.S. Pediatric Research Equity Act that enables the FDA
to request drug data for children, as well as the growing realization that drugs
produce reactions that are markedly different in children than they do in
adults," says the analyst.
The growth rate is likely to be further enhanced by the availability of U.S.
patent extensions for the drugs whose manufacturers conduct pediatric studies
and also by the expansion of some contract research organizations into pediatric
drug testing. Increased publicity of the need for pediatric drug testing is
likely to promote awareness of the issue among physicians and patients, further
driving the market.
This growth, however, is expected to be mitigated by a variety of factors
including the development of vaccines to eliminate many widespread childhood
illnesses, relatively smaller market sizes for conditions primarily affecting
children - low birth weight infants, cystic fibrosis - and the low purchasing
power of patients in areas with the greatest number of children. In addition,
the global and regional economies that compel drug developers to create
blockbuster drugs while containing costs are likely to influence pediatric drug
testing. This pressure is anticipated to reduce with economic revival. However,
if the current economic malaise continues and growth remains limited, pressure
on the healthcare industry is likely to be strong, which will impact the drug
developer organization's willingness to commit funds for pediatric testing.
Global Revenues Expected to Grow with Clearance for Existing Products and
Introduction of New Products
With clearance given to several current pediatric products and the
introduction of new products specifically targeting children, revenues in this
market are expected to grow globally. Gains can be anticipated in sales of
allergy and respiratory products, anti-infectives, central nervous system (CNS)
drugs, and attention deficit hyperactivity disorder (ADHD) drugs. Sales of other
medicines such as obesity drugs are also likely to improve, as they receive
approval for use in children. Over-the-counter (OTC) drug sales are likely to
remain steady and are expected to grow on the strength of increased usage of OTC
children's ibuprofen, and other popular products.
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