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市場調查報告書

兒童用醫藥品的全球市場

Pediatric Medicines: Global Markets

出版商 BCC Research 商品編碼 317508
出版日期 內容資訊 英文 169 Pages
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兒童用醫藥品的全球市場 Pediatric Medicines: Global Markets
出版日期: 2019年11月29日內容資訊: 英文 169 Pages
簡介

全球兒童用醫藥品市場規模,預計從2019年的926億美元,到2024年達到1,166億美元,預計從2019年到2024年期間以4.7%的年複合成長率擴大。

本報告提供全球兒童用醫藥品市場相關調查,市場現狀及近幾年的發展趨勢,等新的法律和配合措施的兒童用醫藥品為中心環境的變化,市場趨勢,主要的治療、地區的課題,已開發國家、新興國家的機會,及主要企業等相關分析。

第1章 簡介

第2章 摘要

第3章 市場動態

  • 對象兒童的人口
  • 未認證核可藥的非適應症使用
  • 未滿足臨床需求領域
  • 市場阻礙、推動要素

第4章 法規環境

  • 美國
  • EU
  • 兒童用醫藥品委員會
  • 利潤、獎勵
  • 手續指南
  • 日本
  • 澳洲
  • 加拿大
  • 瑞士
  • 小兒科相關新法的影響
  • FDA和EMA間的調整

第5章 兒童醫藥品開發的課題

  • 兒童醫藥品的點閱存取
  • 兒童臨床實驗
  • 臨床實驗設計
  • 倫理的關懷
  • 採用、維繫
  • 根據年齡的處方
  • 產品認證
  • 價格、醫療費償付

第6章 兒童用醫藥品的機會

  • 兒童用醫藥品開發治療領域
  • 主要的治療對象
    • 過敏及呼吸狀態
    • 抗感染疾病
    • 抗糖尿病治療
    • 中樞神經系統、神經、心理健康
    • 癌症
    • 稀少藥、罕見疾病
    • 其他小兒科治療領域
    • 疫苗

第7章 未來發展預測

  • 市場趨勢及分析
  • 地區趨勢及分析
    • 美國
    • 歐洲
    • 日本
    • 其他地區
    • 結論

第8章 企業簡介

  • 主要的醫藥品企業
    • 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
    • 大日本住友製藥
    • TEVA PHARMACEUTICALS
    • UCB
  • 主要的生物科技企業
    • AVEXIS
    • BIOMARIN PHARMACEUTICALS
    • BIOGEN INC.
    • GW PHARMACEUTICALS
    • JACOBUS PHARMACEUTICALS
    • PROQR THERAPEUTICS NV
    • REGENERON PHARMACEUTICALS INC.
    • STEMLINE THERAPEUTICS INC.
    • VERTEX PHARMACEUTICALS INC.
  • 主要的小兒科網路
  • 國際網路
  • 國家的網路

第9章 參考資料

第10章 縮寫集

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目錄
Product Code: PHM170B

Report Highlights:

The global pediatric market should grow from $92.6 billion in 2019 to reach $116.6 billion by 2024 at a compound annual growth rate (CAGR) of 4.7% for the period of 2019-2024.

U.S. region as a segment of global pediatric market should grow from $42.5 billion in 2019 to reach $57.3 billion by 2024 at a CAGR of 6.1% for the period of 2019-2024.

Europe region as a segment of global pediatric market should grow from $24.9 billion in 2019 to reach $31.2 billion by 2024 at a CAGR of 4.6% for the period of 2019-2024.

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

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
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