Chapter 1 Introduction to Pediatric Medicine
- Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of the Report
- Intended Audience
- Methodology and Information Sources
- Analyst's Credentials
- Related Reports
Chapter 3 Pediatric Market Dynamics
- Addressable Pediatric Population
- Off-Label Drug Use
- Areas of Unmet Clinical Need
- Market Resistors and Drivers
Chapter 4 Regulation of Pediatric Medicine
- The U.S.
- The E.U.
- Paediatric Committee
- Rewards and Incentives
- Procedural Guidelines
- Japan
- Australia
- Canada
- Switzerland
- The Impact of New Pediatric Legislation
- Alignment Between the FDA and EMA
Chapter 5 Challenges of Developing Pediatric Medicine
- Access to Pediatric Medicines
- Pediatric Clinical Trials
- Trial Designs
- Ethical Considerations
- Recruitment and Retention
- Age-Appropriate Formulations
- Product Approval
- The U.S.
- The E.U.
- Japan
- Pricing and Reimbursement
- The U.S.
- The E.U.
- Japan
Chapter 6 Opportunities for Pediatric Medicine
- Therapeutic Areas for Pediatric Drug Development
- Leading Therapeutics Categories
- Allergy and Respiratory Conditions
- Anti-Infectives
- Antidiabetes Therapies
- Central Nervous System, Neurology and Mental Health
- Oncology
- Orphan Drug and Rare Diseases
- Other Pediatric Therapies
- Vaccines
Chapter 7 Future Outlook for Pediatric Medicine
- Market Trends and Analysis
- Regional Trends and Analysis
- The U.S.
- Europe
- Japan
- Rest of World (ROW)
- Overall Conclusions
Chapter 8 Company Profiles
- Leading Pharmaceutical Companies
- Abbott Laboratories
- Astellas Pharma Inc.
- Astrazeneca Plc
- Bristol-Myers Squibb Co.
- Eli Lilly & Co.
- Forest Laboratories
- Gilead Sciences
- Glaxosmithkline Plc
- Hoffmann La Roche
- Merck & Co.
- Novartis Ag
- Pfizer
- Sanofi
- Shire Plc
- Sumitomo Dainippon Pharma Co.
- Teva Pharmaceuticals
- UCB
- Leading Biotechnology Companies
- Avexis
- Biomarin Pharmaceuticals
- Biogen Inc.
- Gw Pharmaceuticals
- Jacobus Pharmaceuticals
- Proqr Therapeutics Nv
- Regeneron Pharmaceuticals Inc.
- Stemline Therapeutics Inc.
- Vertex Pharmaceuticals Inc.
- Leading Pediatric Networks
- International Networks
- National Networks
- Medicines For Clinical Research Network - U.K.
- Medicines For Clinical Research Network - The Netherlands
- Finnish Investigators Network For Paediatric Medicines - Finland
- Pediatric Trials Network - U.S.
List of Tables
Summary Table: Global Pediatric Market, Through 2024
Table 1: Distributions of the World Population, by Age Group, 2018, 2025 and 2050
Table 2: Population Between 0 and 14 Years of Age, by Region, 2018
Table 3: Categories of Off-Label Use
Table 4: Examples of Common Off-Label Use in Children
Table 5: Key Areas of Unmet Pediatric Need To be Cited by the EMA, 2013
Table 6: Global Pediatric Market, by Region, Through 2024
Table 7: Comparison of the Main Feature of the U.S. Pediatric Incentive Programs, 2019
Table 8: Classification of Pediatric Age Categories in Europe and the U.S.
Table 9: Procedural Guidelines for Pediatric Drug Development for Europe and the U.S.
Table 10: Scientific Guidelines for Pediatric Drug Development for Europe and the U.S.
Table 11: Current Pediatric Legislative/Regulatory Initiatives
Table 12: Key Global Pediatric Initiatives
Table 13: Leading Causes of Death in Postneonatal Children, Risk Factors and Response, WHO 2019
Table 14: Priority Medicines for Children Under Five Years of Age
Table 15: Priority Medicines for Child Health and Survival in Need of R&D
Table 16: Top 10 Countries Ranked by Study Participation and Patient Enrollment for Studies on Drugs, 2007-2010
Table 17: Top 10 Countries Ranked by Study Participation and Patient Enrollment for Studies on Vaccines, 2007-2010
Table 18: U.S. Pediatric Networks
Table 19: Criteria for Reimbursement in Countries in the WHO European Region, 2017
Table 20: FDA Recently Approved Pediatric Drugs
Table 21: Pediatric Drugs Approved for Respiratory Conditions Through Pediatric Regulatory Pathways
Table 22: Global Sales of Top Five Pediatric Drugs Approved for Allergies and Respiratory Conditions, 2018
Table 23: Global Sales of Top Five Pediatric Drugs Approved for Allergies and Respiratory Conditions, by Region, 2018
Table 24: Global Sales of Top Five Pediatric Drugs Approved for Allergies and Respiratory Conditions, 2018
Table 25: Pediatric Drugs Approved for Infectious Diseases Through Pediatric Regulatory Pathways, 2018
Table 26: Sales of Anti-Infective Pediatric Drugs, 2018
Table 27: Global Sales of Top Five Pediatric Drugs Approved for Infectious Diseases, by Region, 2018
Table 28: Global Sales of Top Five Pediatric Drugs Approved for Infectious Diseases, 2018
Table 29: Leading Pediatric Antidiabetes Therapies, 2018
Table 30: Global Sales of Pediatric Drugs Approved for the Treatment of Diabetes by Route, 2018
Table 31: Global Sales of Pediatric Drugs Approved for the Treatment of Diabetes, by Region, 2018
Table 32: Global Sales of Top Five Pediatric Antidiabetes Drugs, 2018
Table 33: Pediatric Drugs Approved for the Treatment of CNS, Neurology and Mental Health, 2018
Table 34: Global Sales of Pediatric Drugs Approved for CNS, Neurology and Mental Health, 2018
Table 35: Global Sales of Pediatric Drugs Approved for CNS, Neurology and Mental Health, by Region, 2018
Table 36: Global Sales of Top Five Pediatric Drugs Approved for the Treatment of CNS, Neurology and Mental Health, 2018
Table 37: Pediatric Drugs approved for the Treatment of Cancer, 2018
Table 38: Global Sales of Pediatric Drugs Approved in Oncology, by Region, 2018
Table 39: Global Sales of Top Five Pediatric Oncology Drugs, 2018
Table 40: Approved Pediatric Orphan Drugs in the U.S., 2006-2018
Table 41: Pediatric Orphan Drugs in Clinical Development by Orphan Disease, Company, Product and Phase, 2019
Table 42: Global Sales of Pediatric Drugs Approved in Orphan Conditions, by Therapy Area, 2018
Table 43: Global Sales of Pediatric Drugs Approved in Orphan Conditions, by Region, 2018
Table 44: Global Sales of Top Five Pediatric Drugs Approved in Orphan Conditions, 2018
Table 45: Global Sales of Pediatric Drugs Approved for Other Conditions, by Region, 2018
Table 46: Leading Pediatric and Adolescent Vaccines Globally, 2018
Table 47: Global Sales of Vaccines, by Age/Indication, 2018
Table 48: Global Sales of Pediatric Vaccines, by Region, 2018
Table 49: Global Sales of Top Five Pediatric/Adolescent Vaccines, 2018
Table 50: Global Sales of Pediatric Drugs, by Therapeutic Area, Through 2024
Table 51: U.S. Sales of Pediatric Drugs, by Therapeutic Area, Through 2024
Table 52: E.U. Sales of Pediatric Drugs, by Therapeutic Area, Through 2024
Table 53: Japanese Sales of Pediatric Drugs, by Therapeutic Area, Through 2024
Table 54: Rest of World Sales of Pediatric Drugs, by Therapeutic Area, Through 2024
List of Figures
Summary Figure: Global Pediatric Market, 2018-2024
Figure 1: Number of Children Under Age 18 in the U.S. and Percentage of the Total Population 2000-2050
Figure 2: Health Status for Children Under Age 18 Years, by Selected Characteristic, 2018
Figure 3: Adjusted Percentages of Hay Fever, Respiratory Allergies, Food Allergies and Skin Allergies for Children Under Age 18 years, by Age Group, 2018
Figure 4: Number of Orphan Indications Approved in the U.S. since the Orphan Drug Act, 1983-2018
Figure 5: Differences between Adult and Pediatric Drug Design
Figure 6: Aims of the Pediatric Formulations Initiatives
Figure 7: Evolution of Pediatric Legislation in the U.S., 1994-2012
Figure 8: General Principles Guiding Pediatric Drug Development, ICH E11 Guidelines, 2010
Figure 9: Evolution of Pediatric Legislation in Europe
Figure 10: Medical Needs for Pediatric Medicines
Figure 11: Pediatric and Adult Trials as a Percentage of Total Trails, 2010-2018
Figure 12: Medical Needs for Orally Available Pediatric Medicines
Figure 13: FDA Process for Seeking Pediatric Drug Approval
Figure 14: FDA Process for Seeking Pediatric Drug Approval
Figure 15: FDA Process for Expedited Pediatric Drug Approval
Figure 16: Therapeutic Areas for Pediatric Drug Approvals Since the Implementation of Pediatric Regulations
Figure 17: Allergies and Respiratory Conditions for Which Pediatric Medicines Have Been Approved
Figure 18: Number of Medicines in Development for Allergies and Respiratory Diseases
Figure 19: Aniti-Infective Conditions for Which Pediatric Medicines Have Been Approved
Figure 20: Approved Pediatric Antidiabetes Therapies for Type 2 Diabetes
Figure 21: CNS, Neurology and Mental Health Conditions for Which Pediatric Medicines Have Been Approved
Figure 22: Top Five Cancer Sites Associated with Mortality, by Age, 1975-2010
Figure 23: Number of Orphan Drug Designations Applications, Designations and Approved Orphan Products, 1983-2018
Figure 24: Orphan Approvals, by Therapeutic Area, 2018
Figure 25: Orphan Approvals in 5-Year Periods, by Therapeutic Area, 1993-2017
Figure 26: Designated Orphan Medicines for the Treatment of Children and Adults, 2018
Figure 27: EMA Opinions on PIPs and Waivers, 2014-2018
Figure 28: Other Therapeutic Areas of Pediatric Product Approvals
Figure 29: Conditions for Which Vaccines Have Been Approved
Figure 30: Recommended Immunization Schedule for Persons Aged 0 Through 18 Years in the U.S., 2018
Figure 31: Estimated Global Pediatric Product Market Shares, by Therapeutic Area, 2024
Figure 32: Estimated U.S. Pediatric Product Market Shares, by Therapeutic Area, 2024
Figure 33: Estimated E.U. Pediatric Product Market Shares, by Therapeutic Area, 2024
Figure 34: Estimated Japanese Pediatric Product Market Shares, by Therapeutic Area, 2024
Figure 35: Estimated Rest of World Pediatric Product Market Shares, by Therapeutic Area, 2019
