Pediatric Drug Delivery

Recent recognition and industry acceptance of the unique therapeutic needs of pediatric patients has led to regulatory activity and development programs that are re-defining this market segment. The result has been a push by developers and formulators emphasizing pediatric drug delivery - the creation of formulations engineered and packaged specifically for children to meet the needs of pediatric patient populations. Several factors are driving the growth of the pediatric drug delivery as a business strategy. The pediatric sector is forecast to be one of the fastest growing drug markets over the next ten years. By circumventing the normal clinical trial and regulatory approval process, off-label prescribing and extemporaneous formulations add risk to pediatric prescribing. The growing availability of drugs targeted for childhood illnesses is focusing efforts on child-friendly delivery methods. To encourage drug developers to perform clinical testing in pediatric age groups for drugs anticipated to be used for children, the FDA has published special rules and guidance that include incentives. The European Commission adopted similar regulations in 2005. These factors are converging to drive developments in pediatric drug delivery.

Publication Date: December 2009

Summary of Contents

Executive Summary

Pediatric Drug Market Dynamics

Factors Driving the Pediatric Market

Prevalence of Solid Oral Dosage Form (SODF)

Alternatives to SODF

Competitive Landscape

The Pediatric Market

Market Segments

Infant

Children/Pre-Adolescent

Adolescent

Demographic Factors

Age-related Disease Factors

Pediatric Drug Design Factors

Age-Appropriate Formulations

Ease of Administration

Release Rate/Kinetics

Safety

Cost

Pediatric Formulation Technologies

Buccal & Transmucosal Films

Chewable Tablets

Product Strategies

Products and Pipeline Prospects

Fast-Dissolve Formulations

Proprietary Technologies

Commercial Products

Syrups & Liquids

Oral Sprays

Sublingual Formulations

Pediatric Formulation Factors

Dosing/Controlled Release

Matrix Technologies

Particle Engineering

Tablet/Capsule Technology

Taste Masking

Emerging Technologies

Analysis of Important Pediatric Therapeutic

Segments

ADHD

Allergies

Analgesics

Antibiotics

Antivirals

Asthma

Childhood Cancers

Cough/Cold Medications

Dermatology

Growth Deficiencies

Neurology

Vaccines

Market Factors

Extemporaneous Formulations

Regulations

Best Pharmaceuticals for Children Act

Pediatric Exclusivity

Pediatric Priority List

Pediatric Research Equity Act

European Regulation on Medicines for Children

Pediatric Drug Studies

Pediatric Re-labeling

Drug Patent Life and IP Factors

Business Risk and Opportunity Factors

Technology Differentiation

Pediatric Labeling

Product Branding

Formulation Approaches

Technology/Pharma Company Alliances

Pediatric Drugs - Sector Company Profiles

About Our Reports

Our reports are carefully researched and written to provide timely and insightful analysis of key factors and developments shaping the commercial marketplace. The focused nature of our publications is designed to allow readers to identify emerging demand and growth opportunities in selected markets. Numerous charts, tables and graphs complement the text, with evaluations and assessments of current and probable future market developments, technology issues and business factors - information necessary to compete effectively in the global marketplace.