Pediatric drug development Market - Regulatory challenges, commercial opportunities

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Pediatric Drug Development - Regulatory
Challenges and Commercial Opportunities www.bigm
arketresearch.com
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Report Description
About Pediatric drug development
Market Although pediatrics represent around
two-fifths of the global population the market
for pediatric medicines remains relatively small
(accounting for lt10 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
off-label 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.
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nges-and-commercial-opportunities-market
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Report Description
About Pediatric drug development Market 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). 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 EMAs 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.
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Report Description
About Pediatric drug development Market 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.
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Report Description
Scope - Pediatric medicines an overview - The
pediatric population - Underlying/key issues for
pediatric drug development - Unmet clinical
needs - Current landscape - Regulation and
legislation - Global harmonization - Strategic
considerations for developing pediatric
medicines - Clinical trial considerations -
Pediatric formulation issues Enquiry about
Report _at_ http//www.bigmarketresearch.com/report-e
nquiry/132507
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Report Description
Scope - Pediatric networks - Patient access -
Commercial opportunities - Generic formulations
and dosage forms - Rare and neglected diseases -
Pediatric vaccines
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Report Description

• Key Reasons to Purchase
• Reviews the current regulatory landscape and
  helps sponsors to understand the potential impact
  of FDA SIA regulations and the variations between
  EU regulation on global pediatric plans
• Identifies the key challenges associated with
  pediatric drug development and the ways to
  overcome these hurdles
• Assesses what issues need to be addressed in
  order to improve access to pediatric medicines
  and commercial opportunities in transition
  countries based on KOL insights
• - Analyses different strategies to develop
  age-appropriate medicines in niche therapeutic
  fields in neonates, rare and neglected pediatric
  diseases and pediatric vaccines.

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Table Of Content
Executive summary How commercially attractive is
pediatric drug development? Why should pharma
invest in pediatric medicines? Methodology Pediatr
ic medicines an overview The pediatric
population Underlying/key issues for pediatric
drug development Unmet clinical needs Current
landscape Regulation and legislation Global
harmonization Strategic considerations for
developing geriatric medicines Clinical trial
considerations Pediatric formulation issues Get
complete TOC here _at_ http//www.bigmarketresearch.c
om/pediatric-drug-development-regulatory-challenge
s-and-commercial-opportunities-market
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