Pediatric Drug Development Market Pediatric drug development Market

Pediatric drug development Market - Industry Analysis and
Forecast by Radiant Insights, Inc
Although pediatrics represent around two-fifths of the global population the market for pediatric
medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric
legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma
industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high offlabel use of generic drugs (Milne & Bruss, 2008).
Since the introduction of pediatric legislation there has been a substantial investment in pediatric research
and the number of clinical trials performed in children has increased significantly. In the US more than
350 product labels include new pediatric information and more than 130 products have undergone a
pediatric focused post-labelling safety review. In Europe there has been 221 changes regarding the safety
and efficacy of medicines from the submission of old or new studies in children and 89 additions of
dosing information for children as a direct consequence of Paediatric Investigation Plans (PIPs).
To Get Full Report Click Here @ http://www.radiantinsights.com/research/pediatric-drugdevelopment-regulatory-challenges-and-commercial-opportunities
Despite the apparent success of the pediatric regulation, the submission of pediatric information is
complex and the incentives are often insufficient to encourage industry innovation (Rose & Della Pasqua,
2011). No new drugs can be registered in the EU without a detailed PIP being approved by the EMA's
Pediatric Committee (PDCO) (Rose, 2014). Without a PIP, the registration process for a new drug can be
blocked. In the US, the FDA has adopted a more pragmatic approach to pediatric drug development,
providing voluntary and mandatory routes for pediatric evaluation.
Many experts agree that there is significant room to improve the EU pediatric regulations and a revision
of the legislation is scheduled to take place in 2018. In the meantime, there is considerable potential for
the industry to develop pediatric formulations and doses of approved and generic medicines, particularly
for use in transition countries where access to high quality pediatric formulation is improving. In addition,
new commercial opportunities exist to develop medicines that target pediatric specific conditions in
neonates as well as rare and neglected diseases and pediatric vaccines.

Scope
- Pediatric medicines: an overview
- The pediatric population
- Underlying/key issues for pediatric drug development
- Unmet clinical needs