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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 118 Pages
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兒童用醫藥品的全球市場 Pediatric Medicines: Global Markets
出版日期: 2014年10月29日 內容資訊: 英文 118 Pages
簡介

兒童用醫藥品的全球整體市場規模在2013年為807億美元,預測在2014年大約達到838億美元,2019年將達到1,007億美元,顯示出3.8%的年複合成長率。

本報告以兒童用醫藥品的全球市場為焦點,基於2013年的調查資料,提供2014年到2019年這段期間轉變的分析及預測,並彙整影響市場發展的推動·阻礙因素和未滿足需求,法規環境和行政的影響,進入障礙,以兒童癌症,中樞神經系統障礙,發炎性疾病,代謝障礙,呼吸狀態,疫苗接種,病毒感染為首的各治療領域分析,主要企業簡介等最新的調查資訊。

第1章 簡介

  • 調查的目標和目的
  • 調查的實施理由
  • 報告的範圍
  • 推薦用戶層
  • 資訊來源
  • 分析師經歷
  • 相關BCC調查報告
  • BCC Research WEB網站
  • 免責事項

第2章 摘要

第3章 概要

  • 小兒科人口
  • 核准非適應症使用
  • 市場阻礙·推動要素
  • 可支援人口
  • 地區及療法別市場區隔

第4章 法規環境

  • 美國
  • 日本
  • 澳洲
  • 加拿大
  • 小兒科相關新法的影響

第5章 進入障礙

  • 安全合理價格的有效藥
  • 小兒科臨床實驗
  • 產品認證
    • 美國
    • 歐洲聯盟
    • 日本
  • 價格報酬
    • 美國
    • 歐洲聯盟
    • 日本

第6章 小兒科藥的進步

  • 小兒科藥物開發治療領域
  • 主要的治療對象
    • 過敏及呼吸狀態
    • 抗感染疾病
    • 中樞神經系統
    • 兒童用疫苗
    • 抗糖尿病治療
    • 稀少藥適用疾病
    • 兒童癌症
    • 其他小兒科治療領域

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
    • 綜合的結論

第8章 企業簡介

  • 有力小兒科醫藥品企業
    • PIERRE FABRE DERMATOLOGIE
    • SWEDISH ORPHAN BIOVITRUM (SOBI)
    • VIROPHARMA
  • 有力臨床研究機關
    • AGILITY CLINICAL, INC.
    • CLINIGENE INTERNATIONAL LIMITED
    • CONET (CLINICAL OPERATIONS NETWORK)
    • COVANCE INC.
    • INC RESEARCH
    • PAREXEL INTERNATIONAL CORP.
    • PPD
    • PREMIER RESEARCH
    • PSI CRO AG
    • QUINTILES
    • WWCT GLOBAL
  • 有力小兒科網路

第9章 參考資料

第10章 縮寫集

圖表一覽

目錄
Product Code: PHM170A

The global market for pediatric medicines reached $80.7 billion in 2013 and should reach $83.6 billion in 2014. This market is expected to reach about $100.7 billion by 2019, registering a compound annual growth rate (CAGR) of 3.8% from 2014 to 2019.

This report provides:

  • An overview of the global market for pediatric medicines.
  • Analyses of global market trends, with data from 2013 and 2014, and projections of CAGRs through 2019.
  • Discussion on market drivers and inhibitors, and the area of unmet clinical need.
  • Information on the regulatory environment and impacts of government.
  • Details pertaining to the barriers to entry for pediatric medicines.
  • Market analysis for therapeutic fields including childhood cancers, CNS disorders, inflammatory diseases, metabolic diseases, respiratory conditions, vaccinations, and viral infections.

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REPORT SCOPE

SCOPE OF REPORT

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.

ANALYSTS' CREDENTIALS

Dr. Bianca Piachaud-Moustakis has more than 10 years' experience as a freelance writer and research analyst specializing in pharmaceutical and healthcare intelligence and has worked for a number of business intelligence providers in the U.K. She has a broad range of writing experience ranging from international academic and practitioner journals to market intelligence reports and short articles, and is author of the book "Outsourcing Research and Development in the Pharmaceutical Industry: from Conceptualization to Implementation of the Strategic Sourcing Process," published by Palgrave Macmillan Publishers UK (2004).

Dr. Piachaud-Moustakis is also a reviewer for international peer-reviewed journals and works as a tutor on advanced-level business studies courses.

The practical pharmaceutical research experience of Dr. Cheryl L. Barton with a leading pharmaceutical company spans over 10 years; also, she has served as a Pan-European pharmaceutical analyst with a European bank. With her business, Dr. C.L. Barton Ltd., Dr. Barton provides independent, customized pharmaceutical thematic research to investment houses. Research reports combine independent scientific analysis with patient- and prescription-based models to forecast the potential sales growth of key developmental drugs and to isolate the key drivers within the pharmaceutical sector.

Table of Contents

CHAPTER 1 INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • SCOPE OF REPORT
  • INTENDED AUDIENCE
  • METHODOLOGY AND INFORMATION SOURCES
  • ANALYSTS' CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 SUMMARY

  • SUMMARY TABLE GLOBAL PEDIATRIC MARKET, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE GLOBAL PEDIATRIC MARKET, 2013-2019 ($ MILLIONS)

CHAPTER 3 OVERVIEW

  • PEDIATRIC POPULATION
  • TABLE 1 GLOBAL PEDIATRIC MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
  • FIGURE 1 HISTORIC ANNUAL GROWTH RATES OF PEDIATRIC THERAPEUTIC SEGMENTS, 2004-2006 (%)
  • TABLE 2 DISTRIBUTION OF WORLD POPULATION IN THE 0-14-YEAR AND 15-24-YEAR AGE GROUPS BY REGION, 2013 AND 2050 (%)
  • TABLE 3 DISTRIBUTION OF WORLD POPULATION BY REGION IN THE 0-14-YEAR AGE GROUP, 2013-2100 (%)
  • TABLE 4 DISTRIBUTION OF WORLD POPULATION IN THE 0-14-YEAR AGE GROUP, 2013-2100 (MILLIONS)
  • OFF-LABEL DRUG USE
  • TABLE 5 OFF-LABEL CATEGORIES
  • TABLE 6 TYPES OF STUDIES REQUIRED WHEN MAKING A PIP SUBMISSION (NUMBER/%)
  • AREAS OF UNMET CLINICAL NEED
  • TABLE 7 KEY AREAS OF UNMET PEDIATRIC NEED CITED BY THE EMA 2013
  • MARKET RESISTORS AND DRIVERS
  • TABLE 8 DIFFERENCES BETWEEN ADULT AND PEDIATRIC TRIAL DESIGN
  • TABLE 9 AIMS OF THE PEDIATRIC FORMULATIONS INITIATIVE
  • ADDRESSABLE POPULATION
  • TABLE 10 PERCENTAGE OF POPULATION BETWEEN 0 AND 14 YEARS OF AGE BY REGION, 2013 (%)
  • GEOGRAPHIC AND THERAPEUTIC SEGMENTATION
  • TABLE 11 COMMON PEDIATRIC DISORDERS IN THE U.S. IN 2010 (MILLION/%)

CHAPTER 4 REGULATORY LANDSCAPE

  • THE UNITED STATES
  • TABLE 12 COMPARISON OF THE MAIN FEATURES OF THE U.S. PEDIATRIC INCENTIVE PROGRAMS
  • FIGURE 2 MAJOR MILESTONES OF PEDIATRIC LEGISLATION IN THE U.S. 1994 - 2012
  • THE EUROPEAN UNION
  • FIGURE 3 GENERAL PRINCIPLES GUIDING PEDIATRIC DRUG DEVELOPMENT - THE ICH E-11 GUIDELINE
  • FIGURE 4 MAJOR MILESTONES OF PEDIATRIC LEGISLATION IN THE EU 1997 - 2007
    • PEDIATRIC INVESTIGATION PLAN 3
    • TABLE 13 CLASSIFICATION OF PEDIATRIC AGE CATEGORIES IN THE EU AND THE U.S.
    • PEDIATRIC COMMITTEE
    • REWARDS AND INCENTIVES
    • TABLE 14 PROCEDURAL GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT FOR EUROPE AND THE U.S.
    • TABLE 15 SCIENTIFIC GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT FOR EUROPE AND THE U.S.
  • JAPAN
  • AUSTRALIA
  • CANADA
  • TABLE 16 CURRENT LEGISLATIVE / REGULATORY PEDIATRIC INITIATIVES ACROSS KEY COUNTRIES GLOBALLY
  • THE IMPACT OF NEW PEDIATRIC LEGISLATION
  • TABLE 17 KEY GLOBAL PEDIATRIC INITIATIVES

CHAPTER 5 BARRIERS TO ENTRY

  • ACCESS TO SAFE, AFFORDABLE AND EFFECTIVE MEDICINES
  • TABLE 18 PRIORITY MEDICINES FOR CHILDREN UNDER FIVE YEARS OF AGE FOR MAJOR CAUSES OF MORTALITY, MORBIDITY, PALLIATIVE CARE AND CHILD SURVIVAL
  • TABLE 19 PRIORITY MEDICINES FOR CHILD HEALTH AND SURVIVAL IN NEED OF FURTHER RESEARCH AND DEVELOPMENT
  • PEDIATRIC CLINICAL TRIALS
  • FIGURE 5 PEDIATRIC AND ADULT TRIALS AS A PERCENTAGE, 2009-2013 (%)
  • TABLE 20 TOP 10 COUNTRIES RANKED BY STUDY PARTICIPATION AND PATIENT ENROLLMENT FOR STUDIES ON DRUGS 2007-2010 (NUMBER)
  • TABLE 21 TOP 10 COUNTRIES RANKED BY STUDY PARTICIPATION AND PATIENT ENROLLMENT FOR STUDIES ON VACCINES 2007-2010 (NUMBER)
    • TRIAL DESIGNS
    • ETHICAL CONSIDERATIONS
    • RECRUITMENT AND RETENTION
    • AGE-APPROPRIATE FORMULATIONS
  • PRODUCT APPROVAL
    • UNITED STATES
    • EUROPEAN UNION
    • JAPAN
  • PRICING REIMBURSEMENT
    • UNITED STATES
    • EUROPEAN UNION
    • JAPAN

CHAPTER 6 ADVANCES IN PEDIATRIC MEDICINES

  • THERAPEUTIC AREAS FOR PEDIATRIC DRUG DEVELOPMENT
  • FIGURE 6 THERAPEUTIC AREAS FOR PEDIATRIC DRUG APPROVALS SINCE THE IMPLEMENTATION OF PEDIATRIC REGULATIONS
  • LEADING THERAPEUTIC TARGETS
    • ALLERGY AND RESPIRATORY CONDITIONS
    • FIGURE 7 APPROVED ALLERGY AND RESPIRATORY TREATMENTS
    • TABLE 22 PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013 ($ MILLIONS)
    • TABLE 23 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013 ($ MILLIONS/%) 6
    • TABLE 24 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS BY REGION, 2013 ($ MILLIONS)
    • TABLE 25 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013 ($ MILLIONS/%)
    • ANTI-INFECTIVES
    • FIGURE 8 APPROVED PEDIATRIC ANTI-INFECTIVES
    • TABLE 26 PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013 ($ MILLIONS)
    • TABLE 27 GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS, 2013 ($ MILLIONS)
    • TABLE 28 GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS APPROVED BY REGION, 2013 ($ MILLIONS)
    • TABLE 29 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES, 2013 ($ BILLIONS/%)
    • CENTRAL NERVOUS SYSTEM
    • FIGURE 9 APPROVED PEDIATRIC CNS MEDICATIONS
    • TABLE 30 PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013 ($ MILLIONS)
    • TABLE 31 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS, 2013 ($ MILLIONS)
    • TABLE 32 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS BY REGION, 2013 ($ MILLIONS)
    • TABLE 33 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013 ($ MILLIONS/%)
    • PEDIATRIC VACCINES
    • FIGURE 10 APPROVED PEDIATRIC VACCINES
    • TABLE 34 LEADING PEDIATRIC AND ADOLESCENT VACCINES WORLDWIDE, 2013 ($ MILLIONS)
    • TABLE 35 GLOBAL SALES OF VACCINES BY AGE/INDICATION, 2013 ($ MILLIONS)
    • TABLE 36 GLOBAL SALES OF PEDIATRIC VACCINES BY REGION, 2013 ($ MILLION)
    • TABLE 37 GLOBAL SALES OF TOP FIVE PEDIATRIC/ADOLESCENT VACCINES, 2013 ($ MILLIONS/%)
    • ANTIDIABETIC THERAPIES
    • FIGURE 11 APPROVED PEDIATRIC ANTIDIABETIC THERAPIES
    • TABLE 38 LEADING PEDIATRIC ANTIDIABETIC THERAPIES, 2013 ($ MILLIONS)
    • TABLE 39 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY ROUTE, 2013 ($ MILLIONS/%)
    • TABLE 40 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY REGION, 2013 ($ MILLIONS)
    • TABLE 41 GLOBAL SALES OF TOP FIVE PEDIATRIC ANTIDIABETIC DRUGS, 2013 ($ MILLIONS/%)
    • ORPHAN DRUG DISEASES
    • TABLE 42 APPROVED PEDIATRIC ORPHAN DRUGS IN THE U.S., 2006-2009 ($)
    • FIGURE 12 ORPHAN DRUG DESIGNATIONS RECEIVING FDA MARKETING APPROVAL, 2000-2009 (NUMBER)
    • TABLE 43 PEDIATRIC (CATEGORY 1) DISEASES WITH MOST DESIGNATIONS (NUMBER)
    • FIGURE 13 ORPHAN PEDIATRIC PRODUCT APPROVALS, BY THERAPEUTIC CATEGORY (%)
    • FIGURE 14 ORPHAN PEDIATRIC PRODUCT APPROVALS BY DRUG TYPE, 2000-2009 (%)
    • TABLE 44 PEDIATRIC ORPHAN DRUGS IN CLINICAL DEVELOPMENT BY ORPHAN DISEASE, COMPANY, PRODUCT AND PHASE
    • TABLE 45 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS BY THERAPY AREA, 2013 ($ MILLIONS)
    • TABLE 46 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS BY REGION, 2013 ($ MILLIONS/%)
    • TABLE 47 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS, 2013 ($ MILLIONS)
    • PEDIATRIC ONCOLOGY
    • TABLE 48 GLOBAL APPROVED PEDIATRIC ONCOLOGY AGENTS IN EUROPE 2004-2014
    • TABLE 49 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ONCOLOGY CONDITIONS, BY REGION, 2013 ($ MILLIONS)
    • TABLE 50 GLOBAL SALES OF TOP FIVE PEDIATRIC ONCOLOGY DRUGS, 2013 ($ MILLIONS) 9
    • OTHER PEDIATRIC THERAPIES
    • TABLE 51 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR OTHER CONDITIONS, BY REGION, 2013 ($ MILLIONS/%)
    • FIGURE 15 OTHER THERAPEUTIC AREAS OF PEDIATRIC PRODUCT APPROVAL

CHAPTER 7 FUTURE OUTLOOK

  • MARKET TRENDS AND ANALYSIS
  • TABLE 52 GLOBAL SALES OF PEDIATRIC DRUGS BY THERAPY AREA, THROUGH 2019 ($ MILLIONS)
  • REGIONAL TRENDS AND ANALYSIS
    • THE U.S.
    • FIGURE 16 ESTIMATED U.S. PEDIATRIC PRODUCT SALES MARKET SHARES, 2019 (%)
    • TABLE 53 U.S. SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
    • EUROPE
    • FIGURE 17 ESTIMATED EUROPEAN PEDIATRIC PRODUCT MARKET SHARE, 2019 (%)
    • TABLE 54 EUROPEAN SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
    • JAPAN
    • FIGURE 18 ESTIMATED JAPANESE PEDIATRIC PRODUCT MARKET SHARE, 2019 (%)
    • TABLE 55 JAPANESE SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
    • REST OF WORLD (ROW)
    • FIGURE 19 ESTIMATED REST OF WORLD PEDIATRIC PRODUCT MARKET SHARES, 2019 (%)
    • TABLE 56 REST OF WORLD SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
    • OVERALL CONCLUSIONS

CHAPTER 8 COMPANY PROFILES

  • LEADING PEDIATRIC COMPANIES
    • PIERRE FABRE DERMATOLOGIE
    • SWEDISH ORPHAN BIOVITRUM (SOBI)
    • VIROPHARMA
  • LEADING CLINICAL RESEARCH ORGANIZATIONS
    • AGILITY CLINICAL, INC.
    • CLINIGENE INTERNATIONAL LIMITED
    • CONET (CLINICAL OPERATIONS NETWORK)
    • COVANCE INC.
    • INC RESEARCH
    • PAREXEL INTERNATIONAL CORP.
    • PPD
    • PREMIER RESEARCH
    • PSI CRO AG
    • QUINTILES
    • WWCT GLOBAL
  • LEADING PEDIATRIC NETWORKS
    • INTERNATIONAL NETWORKS
      • European Network of Paediatric Research (Enpr-EMA)
      • Global Research in Pediatrics (GRiP)
      • Programme for Global Paediatric Research (PGPR)
    • NATIONAL NETWORKS
    • Medicines for Clinical Research Network (MCRN) - United Kingdom
    • Medicines for Clinical Research Network (MCRN) - Netherlands
    • Finnish Investigators Network for Paediatric Medicines (FINPEDMED) - Finland
    • Pediatric Trials Network (PTN) - United States

CHAPTER 9 REFERENCES

CHAPTER 10 ACRONYMS

LIST OF TABLES

  • SUMMARY TABLE GLOBAL PEDIATRIC MARKET, THROUGH 2019 ($ MILLIONS)
  • TABLE 1 GLOBAL PEDIATRIC MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
  • TABLE 2 DISTRIBUTION OF WORLD POPULATION IN THE 0-14-YEAR AND 15-24-YEAR AGE GROUPS BY REGION, 2013 AND 2050 (%)
  • TABLE 3 DISTRIBUTION OF WORLD POPULATION BY REGION IN THE 0-14-YEAR AGE GROUP, 2013-2100 (%)
  • TABLE 4 DISTRIBUTION OF WORLD POPULATION IN THE 0-14-YEAR AGE GROUP, 2013-2100 (MILLIONS)
  • TABLE 5 OFF-LABEL CATEGORIES
  • TABLE 6 TYPES OF STUDIES REQUIRED WHEN MAKING A PIP SUBMISSION (NUMBER/%)
  • TABLE 7 KEY AREAS OF UNMET PEDIATRIC NEED CITED BY THE EMA 2013
  • TABLE 8 DIFFERENCES BETWEEN ADULT AND PEDIATRIC TRIAL DESIGN
  • TABLE 9 AIMS OF THE PEDIATRIC FORMULATIONS INITIATIVE
  • TABLE 10 PERCENTAGE OF POPULATION BETWEEN 0 AND 14 YEARS OF AGE BY REGION, 2013 (%)
  • TABLE 11 COMMON PEDIATRIC DISORDERS IN THE U.S. IN 2010 (MILLION/%)
  • TABLE 12 COMPARISON OF THE MAIN FEATURES OF THE U.S. PEDIATRIC INCENTIVE PROGRAMS
  • TABLE 13 CLASSIFICATION OF PEDIATRIC AGE CATEGORIES IN THE EU AND THE U.S.
  • TABLE 14 PROCEDURAL GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT FOR EUROPE AND THE U.S.
  • TABLE 15 SCIENTIFIC GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT FOR EUROPE AND THE U.S.
  • TABLE 16 CURRENT LEGISLATIVE / REGULATORY PEDIATRIC INITIATIVES ACROSS KEY COUNTRIES GLOBALLY
  • TABLE 17 KEY GLOBAL PEDIATRIC INITIATIVES
  • TABLE 18 PRIORITY MEDICINES FOR CHILDREN UNDER FIVE YEARS OF AGE FOR MAJOR CAUSES OF MORTALITY, MORBIDITY, PALLIATIVE CARE AND CHILD SURVIVAL
  • TABLE 19 PRIORITY MEDICINES FOR CHILD HEALTH AND SURVIVAL IN NEED OF FURTHER RESEARCH AND DEVELOPMENT
  • TABLE 20 TOP 10 COUNTRIES RANKED BY STUDY PARTICIPATION AND PATIENT ENROLLMENT FOR STUDIES ON DRUGS 2007-2010 (NUMBER)
  • TABLE 21 TOP 10 COUNTRIES RANKED BY STUDY PARTICIPATION AND PATIENT ENROLLMENT FOR STUDIES ON VACCINES 2007-2010 (NUMBER)
  • TABLE 22 PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013 ($ MILLIONS)
  • TABLE 23 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013 ($ MILLIONS/%)
  • TABLE 24 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS BY REGION, 2013 ($ MILLIONS)
  • TABLE 25 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013 ($ MILLIONS/%)
  • TABLE 26 PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013 ($ MILLIONS) 6
  • TABLE 27 GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS, 2013 ($ MILLIONS) 6
  • TABLE 28 GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS APPROVED BY REGION, 2013 ($ MILLIONS)
  • TABLE 29 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES, 2013 ($ BILLIONS/%)
  • TABLE 30 PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013 ($ MILLIONS)
  • TABLE 31 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS, 2013 ($ MILLIONS)
  • TABLE 32 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS BY REGION, 2013 ($ MILLIONS)
  • TABLE 33 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013 ($ MILLIONS/%)
  • TABLE 34 LEADING PEDIATRIC AND ADOLESCENT VACCINES WORLDWIDE, 2013 ($ MILLIONS)
  • TABLE 35 GLOBAL SALES OF VACCINES BY AGE/INDICATION, 2013 ($ MILLIONS)
  • TABLE 36 GLOBAL SALES OF PEDIATRIC VACCINES BY REGION, 2013 ($ MILLION)
  • TABLE 37 GLOBAL SALES OF TOP FIVE PEDIATRIC/ADOLESCENT VACCINES, 2013 ($ MILLIONS/%)
  • TABLE 38 LEADING PEDIATRIC ANTIDIABETIC THERAPIES, 2013 ($ MILLIONS)
  • TABLE 39 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY ROUTE, 2013 ($ MILLIONS/%)
  • TABLE 40 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY REGION, 2013 ($ MILLIONS)
  • TABLE 41 GLOBAL SALES OF TOP FIVE PEDIATRIC ANTIDIABETIC DRUGS, 2013 ($ MILLIONS/%)
  • TABLE 42 APPROVED PEDIATRIC ORPHAN DRUGS IN THE U.S., 2006-2009 ($)
  • TABLE 43 PEDIATRIC (CATEGORY 1) DISEASES WITH MOST DESIGNATIONS (NUMBER)
  • TABLE 44 PEDIATRIC ORPHAN DRUGS IN CLINICAL DEVELOPMENT BY ORPHAN DISEASE, COMPANY, PRODUCT AND PHASE
  • TABLE 45 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS BY THERAPY AREA, 2013 ($ MILLIONS)
  • TABLE 46 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS BY REGION, 2013 ($ MILLIONS/%)
  • TABLE 47 GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS, 2013 ($ MILLIONS)
  • TABLE 48 GLOBAL APPROVED PEDIATRIC ONCOLOGY AGENTS IN EUROPE 2004-2014
  • TABLE 49 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ONCOLOGY CONDITIONS, BY REGION, 2013 ($ MILLIONS)
  • TABLE 50 GLOBAL SALES OF TOP FIVE PEDIATRIC ONCOLOGY DRUGS, 2013 ($ MILLIONS)
  • TABLE 51 GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR OTHER CONDITIONS, BY REGION, 2013 ($ MILLIONS/%)
  • TABLE 52 GLOBAL SALES OF PEDIATRIC DRUGS BY THERAPY AREA, THROUGH 2019 ($ MILLIONS)
  • TABLE 53 U.S. SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
  • TABLE 54 EUROPEAN SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
  • TABLE 55 JAPANESE SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)
  • TABLE 56 REST OF WORLD SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019 ($ MILLIONS)

LIST OF FIGURES

  • SUMMARY FIGURE GLOBAL PEDIATRIC MARKET, 2013-2019 ($ MILLIONS)
  • FIGURE 1 HISTORIC ANNUAL GROWTH RATES OF PEDIATRIC THERAPEUTIC SEGMENTS, 2004-2006 (%)
  • FIGURE 2 MAJOR MILESTONES OF PEDIATRIC LEGISLATION IN THE U.S. 1994 - 2012 2
  • FIGURE 3 GENERAL PRINCIPLES GUIDING PEDIATRIC DRUG DEVELOPMENT - THE ICH E-11 GUIDELINE
  • FIGURE 4 MAJOR MILESTONES OF PEDIATRIC LEGISLATION IN THE EU 1997 - 2007
  • FIGURE 5 PEDIATRIC AND ADULT TRIALS AS A PERCENTAGE, 2009-2013 (%)
  • FIGURE 6 THERAPEUTIC AREAS FOR PEDIATRIC DRUG APPROVALS SINCE THE IMPLEMENTATION OF PEDIATRIC REGULATIONS
  • FIGURE 7 APPROVED ALLERGY AND RESPIRATORY TREATMENTS
  • FIGURE 8 APPROVED PEDIATRIC ANTI-INFECTIVES
  • FIGURE 9 APPROVED PEDIATRIC CNS MEDICATIONS
  • FIGURE 10 APPROVED PEDIATRIC VACCINES
  • FIGURE 11 APPROVED PEDIATRIC ANTIDIABETIC THERAPIES
  • FIGURE 12 ORPHAN DRUG DESIGNATIONS RECEIVING FDA MARKETING APPROVAL, 2000-2009 (NUMBER)
  • FIGURE 13 ORPHAN PEDIATRIC PRODUCT APPROVALS, BY THERAPEUTIC CATEGORY (%)
  • FIGURE 14 ORPHAN PEDIATRIC PRODUCT APPROVALS BY DRUG TYPE, 2000-2009 (%)
  • FIGURE 15 OTHER THERAPEUTIC AREAS OF PEDIATRIC PRODUCT APPROVAL
  • FIGURE 16 ESTIMATED U.S. PEDIATRIC PRODUCT SALES MARKET SHARES, 2019 (%)
  • FIGURE 17 ESTIMATED EUROPEAN PEDIATRIC PRODUCT MARKET SHARE, 2019 (%)
  • FIGURE 18 ESTIMATED JAPANESE PEDIATRIC PRODUCT MARKET SHARE, 2019 (%)
  • FIGURE 19 ESTIMATED REST OF WORLD PEDIATRIC PRODUCT MARKET SHARES, 2019 (%)
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