Pediatric Medicines: Global Markets
Report Scope:
This new report on pediatric medicine will provide a brief overview on the current status of the industry and recent developments. It presents the changing environment in terms of new legislation and implementation of global pediatric plans. The report analyzes market trends and identifies key therapeutic and geographical challenges and rising opportunities in the developed and developing world. Finally, the report provides insights on how all stakeholders have an essential interest in prioritizing pediatric drug development targets and improving access to safe and effective medicines to children across the globe.
Report Includes:
- 55 tables
- An overview of the global markets for pediatric medicines within the pharmaceutical industry
- Analyses of the global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024
- Discussion on market drivers, off-label use, novel formulations and areas of unmet clinical need and emerging countries
- Market analysis for therapeutic fields including neonates and paediatrics childhood cancers, CNS disorders, infectious diseases, immune inflammatory diseases, metabolic diseases, respiratory conditions, vaccinations
- Regulatory environment and incentives for pediatric development
- Profiles of major companies of the industry, including Abbott Laboratories, GlaxoSmithKline, Novartis AG, Sanofi and Vertex Pharmaceuticals Inc.
- 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 BCC Research Reports
- Chapter 2 Summary and Highlights
- 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.
- Chapter 9 Appendix: Acronyms
- Chapter 10 References
- 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 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