Summary
Common infectious disorders are widespread among children and include skin conditions, respiratory and gastrointestinal infections. Similarly, chronic noninfectious illnesses, relating to emotional, mental and metabolic conditions such as diabetes and obesity, are increasingly prevalent among children and adolescents. However, the pharmaceutical market has long been underserved and undervalued and, depending on the disease and age of the child, up to 80% of children are still treated off label or medications are not available in age-appropriate formulations.
During the past two decades, tremendous efforts have been made by the regulators to encourage pharmaceutical companies to develop pediatric medicines, in particular those that target orphan drugs for rare and ultrarare diseases. The introduction of new regulations and legislation has resulted in a dramatic increase in the number of new therapeutic options for patients in this disease category over the past few years. Designing, recruiting and running pediatric clinical trials and identifying appropriate endpoints remains a challenge, and several large clinical research organizations now offer specialist services in this area.
Even though there are significant challenges and costs associated with the development of ageappropriate formulations, medicines to treat pediatric conditions are becoming more widely available in both the developed and developing world across a range of therapeutic areas including infectious diseases, central nervous system and mental disorders, cardiovascular conditions, immuneinflammatory diseases and oncology.
The global market for pediatrics is estimated to reach approximately REDACTED in 2018 and is expected to grow at a REDACTED compound annual growth rate from the current value of REDACTED in 2019 to REDACTED in 2024. In geographical terms, North America still remains the single largest regional market for pediatric medicines, followed by Europe, which trails significantly behind its North American counterpart. However, in global terms, growth in the pediatric market segment is currently being led by the Asia-Pacific region, which is projected to occupy a far greater market share in the coming years; this is especially so for China. Other rapidly growing countries include India and those in the Southeast Asia region.
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.
Table of Contents
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