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  4. > Pediatric Medicines: Global Markets

Pediatric Medicines: Global Markets

  • October 2014
  • -
  • BCC Research
  • -
  • 118 pages

REPORT HIGHLIGHTS

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.

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.

Table Of Contents

Pediatric Medicines: Global Markets
Chapter- 1: INTRODUCTION - Complimentary 3

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 2

Table Summary : GLOBAL PEDIATRIC MARKET, THROUGH 2019
Figure Summary : GLOBAL PEDIATRIC MARKET, 2013-2019

Chapter- 3: OVERVIEW 17

PEDIATRIC POPULATION
OFF-LABEL DRUG USE
AREAS OF UNMET CLINICAL NEED
MARKET RESISTORS AND DRIVERS
ADDRESSABLE POPULATION
GEOGRAPHIC AND THERAPEUTIC SEGMENTATION

Chapter- 4: REGULATORY LANDSCAPE 16

THE UNITED STATES
THE EUROPEAN UNION
JAPAN
AUSTRALIA
CANADA
THE IMPACT OF NEW PEDIATRIC LEGISLATION

Chapter- 5: BARRIERS TO ENTRY 15

ACCESS TO SAFE, AFFORDABLE AND EFFECTIVE MEDICINES
PEDIATRIC CLINICAL TRIALS
PRODUCT APPROVAL
PRICING REIMBURSEMENT

Chapter- 6: ADVANCES IN PEDIATRIC MEDICINES 33

THERAPEUTIC AREAS FOR PEDIATRIC DRUG DEVELOPMENT
LEADING THERAPEUTIC TARGETS

Chapter- 7: FUTURE OUTLOOK 9

MARKET TRENDS AND ANALYSIS
REGIONAL TRENDS AND ANALYSIS
OVERALL CONCLUSIONS

Chapter- 8: COMPANY PROFILES 11

LEADING PEDIATRIC COMPANIES
LEADING CLINICAL RESEARCH ORGANIZATIONS
LEADING PEDIATRIC NETWORKS

Chapter- 9: REFERENCES 10


Chapter- 10: ACRONYMS 2

List of Tables

Summary Table : GLOBAL PEDIATRIC MARKET, THROUGH 2019
Table 1 : GLOBAL PEDIATRIC MARKET BY REGION, THROUGH 2019
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
Table 5 : OFF-LABEL CATEGORIES
Table 6 : TYPES OF STUDIES REQUIRED WHEN MAKING A PIP SUBMISSION
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
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
Table 21 : TOP 10 COUNTRIES RANKED BY STUDY PARTICIPATION AND PATIENT ENROLLMENT FOR STUDIES ON VACCINES 2007-2010
Table 22 : PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013
Table 23 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013
Table 24 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS BY REGION, 2013
Table 25 : GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR RESPIRATORY CONDITIONS, 2013
Table 26 : PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES THROUGH PEDIATRIC REGULATORY PATHWAYS, 2013
Table 27 : GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS, 2013
Table 28 : GLOBAL SALES OF ANTI-INFECTIVE PEDIATRIC DRUGS APPROVED BY REGION, 2013
Table 29 : GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR INFECTIOUS DISEASES, 2013
Table 30 : PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013
Table 31 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS, 2013
Table 32 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR CNS CONDITIONS BY REGION, 2013
Table 33 : GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF CNS CONDITIONS, 2013
Table 34 : LEADING PEDIATRIC AND ADOLESCENT VACCINES WORLDWIDE, 2013
Table 35 : GLOBAL SALES OF VACCINES BY AGE/INDICATION, 2013
Table 36 : GLOBAL SALES OF PEDIATRIC VACCINES BY REGION, 2013
Table 37 : GLOBAL SALES OF TOP FIVE PEDIATRIC/ADOLESCENT VACCINES, 2013
Table 38 : LEADING PEDIATRIC ANTIDIABETIC THERAPIES, 2013
Table 39 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY ROUTE, 2013
Table 40 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR THE TREATMENT OF DIABETES BY REGION, 2013
Table 41 : GLOBAL SALES OF TOP FIVE PEDIATRIC ANTIDIABETIC DRUGS, 2013
Table 42 : APPROVED PEDIATRIC ORPHAN DRUGS IN THE U.S., 2006-2009
Table 43 : PEDIATRIC (CATEGORY 1) DISEASES WITH MOST DESIGNATIONS
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
Table 46 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS BY REGION, 2013
Table 47 : GLOBAL SALES OF TOP FIVE PEDIATRIC DRUGS APPROVED IN ORPHAN CONDITIONS, 2013
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
Table 50 : GLOBAL SALES OF TOP FIVE PEDIATRIC ONCOLOGY DRUGS, 2013
Table 51 : GLOBAL SALES OF PEDIATRIC DRUGS APPROVED FOR OTHER CONDITIONS, BY REGION, 2013
Table 52 : GLOBAL SALES OF PEDIATRIC DRUGS BY THERAPY AREA, THROUGH 2019
Table 53 : U.S. SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019
Table 54 : EUROPEAN SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019
Table 55 : JAPANESE SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019
Table 56 : REST OF WORLD SALES OF PEDIATRIC DRUGS BY THERAPEUTIC AREA, THROUGH 2019

List of Figures

Summary Figure : GLOBAL PEDIATRIC MARKET, 2013-2019
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
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
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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