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Global Pediatric Drugs and Vaccines Market

  • September 2014
  • -
  • Global Industry Analysts
  • -
  • 419 pages

This report analyzes the worldwide markets for Pediatric Drugs and Vaccines in US$ Million by the following Therapeutic Class: Pediatric Vaccines, Pediatric Hormones, Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugs, and Other Pediatric Drugs. The market for 'Pediatric Vaccines' in this report is analyzed by the following Type: Combinations, Hepatitis, MMR, Varicella, Poliovirus, Pneumococcal, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 120 companies including many key and niche players such as -

Actelion Pharmaceuticals Ltd.
Abbott Laboratories
Allergan, Inc.
Amgen, Inc.
AstraZeneca Plc

Table Of Contents

Global Pediatric Drugs and Vaccines Market



I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Pediatrics: A Highly Underserved and Undervalued Group II-1
Table 1: Global Birth Rate Statistics (2012) by Crude Birth
Rates per 1000 Population for Key Countries II-2
Pediatric Drugs Market - An Abode of Opportunities II-3
Recent Pediatric Drug Approvals: 2011-2014 II-3
Pediatric Exclusivity Drives Manufacturers' Interest II-5
The United States and Europe: Major Markets for Pediatric Drugs II-5
Developing Markets to Witness Faster Growth II-5
Table 2: Per-Capita Healthcare Expenditure in Select Regions
(2013) (includes corresponding Graph/Chart) II-6

Table 3: Top 20 Countries with the Highest Healthcare
Spending as a Percentage of GDP (2012) (includes
corresponding Graph/Chart) II-7

Table 4: Developing Regions Lead Children Population Globally
(includes corresponding Graph/Chart) II-8

Table 5: Asia-Pacific Proportion of Children (0-15 Years Age
Group) by Select Country: 2013 (includes corresponding
Graph/Chart) II-9

Table 6: Latin American Proportion of Children (0-15 Years
Age Group) by Country: 2013 (includes corresponding
Graph/Chart) II-9

Table 7: European Proportion of Children (0-15 Years Age
Group) by Select Country: 2013 (includes corresponding
Graph/Chart) II-10

Table 8: The Middle Eastern Proportion of Children (0-15
Years Age Group) by Country: 2013 (includes corresponding
Graph/Chart) II-10
Anti-Infectives, and Anti-Allergy/RespiratoryDrugs: Largest
Selling Drug Classes II-11
Pediatric Vaccines: The Fastest Growing Market Segment II-11
Table 9: Global Prevnar 13 Vaccine Sales by Region: 2013 (
includes corresponding Graph/Chart) II-12
Prescription Hormone Drugs to Drive Pediatric Drugs Growth II-12
Table 10: Global Pediatric Drugs Market by Therapeutic Class:
Segments Ranked by Growth (includes corresponding
Graph/Chart) II-13
Clinical Studies and Pipeline Analysis II-13
Table 11: Global On-Going Pediatric Drugs Clinical Studies by
Country/Region (includes corresponding Graph/Chart) II-13

Table 12: Global Pediatric Drugs Pipeline by Select
Therapeutic Area (2012): Number of Drugs Under Development
for Cancer, Genetic Diseases, Infectious Diseases,
Neurological Diseases, Respiratory Diseases, Skin Disorders,
Psychiatric Diseases, Cardiovascular Ailments, Diabetes, GI
Diseases, Eye Diseases, Arthritis/Musculoskeletal, and Others
(includes corresponding Graph/Chart) II-14

2. MARKET TRENDS AND ISSUES II-15
Potential for Pediatric Drugs Against Obesity-related Conditions II-15
Table 13: Top 10 Countries with the Highest Proportion of
Overweight Children (includes corresponding Graph/Chart) II-15
Recent Phase III Completed Pediatric Cardiovascular Drugs II-16
Lack of Adequate Funding Hinders Pediatric Drug Trials II-16
Modeling and Simulation - A Powerful Tool for Pediatric Clinical
Study Sponsors II-17
Pharmacometrics Approaches Gain Traction Among US and EU
Researchers II-17
Challenges Associated with Adoption of Pharmacometric Approach II-18
Guidelines for Conducting Ethically Correct Clinical Trials II-18
Controversial Off-Label Drug Usage in the Pediatric Healthcare
Market II-18
The US Leads the Pediatric ADHD Drugs Market II-19
Non-Stimulant ADHD Drugs Gaining Market II-20
Table 14: Global ADHD Non-Stimulant Drugs Market by Type
(2014): Percentage Market Share Breakdown of Prescription
Sales for Kapvay, Intuniv, and Strattera (includes
corresponding Graph/Chart) II-20
Orphan Drugs for Pediatric Use Gain Popularity II-20
Pediatric Orphan Drugs in Pipeline as of Year 2013 II-21
Need for Higher Focus on Fixed-Dose Combination for Pediatric
HIV Infections II-22
Select Pediatric Antiretroviral Drugs in Pipeline (2014) II-22
Pediatric Growth Hormone Drug Market Offers Potential II-24
Efforts to Ease Drug Use in Children Continues II-24

3. REGULATORY ENVIRONMENT II-25
Historical Lack of Focus on Pediatric Drug Development II-25
Pediatric Guidelines by Different Regulatory Bodies II-25
US Food and Drug Administration (USFDA) II-26
Evolution of Regulations for Pediatric Drug Testing II-26
New Regulations Incentivize Clinical Trials with Pediatric
Subjects II-27
PREA and BPCA - A Boon for Pharma Companies II-27
European Medicines Agency (EMA) II-28
EMA Rolls out Regulations for Pediatric Clinical Studies II-28
Malaysian Pediatric Association (MPA) II-28
Harmonization of Disparate Regional Regulations and Processes -
the Next Step II-29
International Conference on Harmonisation (ICH) Guidelines
for Pediatric Formulations II-30

4. PEDIATRIC VACCINES MARKET II-31
Table 15: Number of Reported Cases for Vaccine-Preventable
Diseases Globally: 2009-2013 II-31
Immunization Coverage II-31
Immunization Coverage: 2013, 2012, and 2011 II-32
Table 16: Routine Immunization Coverage (2013): Percentage
of Live Births/New Borns/Infants/ Children Vaccinated by
Select Region II-32

Table 17: Routine Immunization Coverage (2012): Percentage
of Live Births/New Borns/Infants/ Children Vaccinated by
Select Region II-33

Table 18: Routine Immunization Coverage (2011): Percentage
of Live Births/New Borns/Infants/ Children Vaccinated by
Select Region II-34
Market Share of Leading Pediatric Vaccine Manufacturers II-35
Table 19: Global Pediatric Vaccines Market by Leading Players
(2013): Percentage Market Share Breakdown of Dollar Sales for
GlaxoSmithKline, Novartis, Sanofi-Pasteur, Merck, and Others
(includes corresponding Graph/Chart) II-35
Pediatric Vaccines in Pipeline II-35
Pediatric Vaccine Types II-35
Hemophilus Influenza Type B Vaccine II-35
Available Hib and Combination Vaccines II-36
Diphtheria/Tetanus/Pertussis Vaccines (DTaP Vaccines) II-36
Available DTaP and Combination Vaccines II-37
Table 20: Global DTP3 Immunization Coverage: 2003-2013
(includes corresponding Graph/Chart) II-37

Table 21: Developing Countries With % of Districts
Achieving at Least 80% DTP3 coverage, 2013 (includes
corresponding Graph/Chart) II-38
Hepatitis A Vaccine II-38
Available Hepatitis A and Combination Vaccines II-38
Hepatitis B Vaccine II-38
Hepatitis B Epidemiology II-39
Available Hepatitis B and Combination Vaccines II-39
Measles/Mumps/Rubella (MMR) Vaccines II-39
Available MMR and Combination Vaccines II-40
Rotavirus Vaccines II-40
Available Rotavirus Vaccine II-40
Polio Vaccines II-40
Available Polio and Combination Vaccines II-41
Varicella Vaccine II-41
Available Varicella Vaccines II-41
Pneumococcal Disease Vaccines II-41
PCV 13 Replaces PCV 7 II-42
Available Pneumococcal Conjugate Vaccine II-42
Meningococcal Vaccines II-43
Available Meningococcal Polysaccharide and Combination vaccine II-43
Combination Vaccines II-44
Select Market Trends and Issues II-45
Innovations Drive the Infectious Disease Market II-45
Hepatitis B Combination Vaccines to Propel Market Growth II-46
Table 22: Number of Countries Having Introduced HepB
Vaccine: 2003-2013 (includes corresponding Graph/Chart) II-46

Table 23: Global Infant HepB3 Coverage: 2003-2013 (includes
corresponding Graph/Chart) II-47
Conjugated and Protein-based Vaccines to Take over
Polysaccharide Vaccines for Infectious Diseases II-47
List of Infectious Disease Vaccines in the RandD Pipeline (2014) II-48
Rising Women Workforce Propels Pediatric Vaccines Growth II-49
Table 24: Female Employment-to-Population Ratio (%): 2002,
2007 and 2012 (includes corresponding Graph/Chart) II-50

5. PEDIATRIC DISEASES - OVERVIEW, STATISTICS and TREATMENT II-51
Infective Diseases II-51
Recent Phase III Completed Pediatric Drugs for Infectious
Diseases II-51
Influenza II-52
Treatment II-52
Urinary Tract Infection (UTI) II-53
Prevalence II-53
Treatment II-53
Mumps II-53
Complications Related to Mumps II-53
Prevention of Mumps in children II-54
Incidence II-54
Candidiasis II-54
Fifth Disease II-54
Molluscum Contagiosum II-55
Roseola II-55
Tetanus II-55
Whooping Cough II-56
Allergy and Respiratory Diseases II-56
Recent Phase III Completed Pediatric Drugs for Respiratory
Disorders II-57
Prevalence Statistics II-57
The US II-57
Other Countries II-58
Diphtheria II-58
Incidence and Mortality Statistics II-58
Upper Respiratory Infection (Common Cold) II-58
Diagnosis and Treatment II-58
Measles II-59
Statistics II-59
Asthma II-59
Prevalence II-60
Central Nervous System Disorders II-60
Recent Phase III Completed Pediatric Drugs for Neurological/
Psychatric Disorders II-60
Mental Disorders II-61
Prevalence II-61
Attention Deficit Hyperactivity Disorder II-61
Prevalence II-61
Depression II-62
Prevalence II-62
Epilepsy II-62
Epilepsy Treatment II-63
Incidence and Prevalence of Epilepsy in the US II-63
Hormonal Disorders II-63
Diabetes Mellitus II-63
Recent Phase III Completed Pediatric Drugs for Diabetes II-64
Hypothyroidism II-64
Hypothyroidism in Infants and Children II-64
Symptoms and Diagnosis II-65
Treatment of Hypothyroidism in Children II-65
Precocious Puberty II-65
Symptoms and Signs II-66
Signs of Early Puberty in Girls and Boys II-66
Treatment II-66
Hypopituitarism II-66
Treatment II-67
Lymphocytic Thyroiditis II-67
Symptoms II-67
Treatment II-67
Other Diseases II-67
Cardiovascular Diseases II-67
Hypertension II-67
Causes of Hypertension in Children II-68
Symptoms of High Blood Pressure II-68
Treatment II-68
Cancers II-69
Brain Tumors II-69
Prevalence II-69
Leukemia II-69
Prevalence II-70
Lymphomas II-70
Prevalence II-70
Retinoblastoma II-71
Prevalence II-71
Ewing's Sarcoma II-71
Symptoms and Treatment II-71
Prevalence II-72
Wilms' Tumor II-72
Stages and Treatment II-73
Prevalence and Incidence II-73
Children's Rhabdomyosarcoma II-73
Symptoms and Signs II-73
Treatment II-74
Statistics II-74
Neuroblastoma II-75
Symptoms II-75
Treatment II-75
Osteogenic Sarcoma II-76
Prevalence II-76
Symptoms and Treatment II-76
Gastrointestinal Disorders II-77
Recent Phase III Completed Pediatric Drugs for
Gastrointestinal Disorders II-77
Diarrhea II-77
Inflammatory Bowel Disease (IBD) II-77
Symptoms II-77
Treatment II-78
Irritable Bowel Syndrome (IBS) II-78
Causes and Symptoms II-78
Treatment II-78
Pain II-78
Pain Control Medicines for Children II-79
Statistics II-79
Pain Statistics Among the American Children, General
Population, and Other Adults II-79
Malaria II-79
Anemia II-80
Treatment for Anemia in Children II-80
Recent Phase III Completed Pediatric Drugs for Genetic
Disorders II-81

6. LIST OF SELECT FDA APPROVED PEDIATRIC DRUGS II-82

7. PRODUCT INTRODUCTIONS/INNOVATIONS II-87
Sanofi Pasteur Receives prequalification status for Shan5â„¢ II-87
Immune ResponseReceives US FDA Orphan Drug Status for Remune
Vaccine II-87
Merck's ISEMTRESS Receives FDA Approval II-87
Valneva Receives FDA Market Exclusivity for IXIARO® II-87
Merck Receives FDA Grant for Production of Live Virus Material II-87
Flu Vaccine Receives FDA Approval II-87
Sanofi Pasteur Receives EU Approval for Hexyon/Hexacima
Pediatric Vaccine II-87
Novartis Receives FDA Approval for Menveo II-88
ROTAVAC Receives Approval II-88
MenHibrix Receives Approval II-88
GSK Receives EU Approval for Nimenrix II-88
Sanofi Pasteur to Launch New Vaccines II-88
FDA Approves Omalizumab as Safe Drug for Children II-88
ACETO Corporation to unveil generic Cleocin Pediatric Antibiotic II-88
GlaxoSmithKline Receives Approval for MenHibrix II-89
CHMP Grants Approval for Glaxo's Nimenrix II-89
Sanofi Receives EMA Approval for Hexaxim II-89

8. RECENT INDUSTRY ACTIVITY II-90
GSK Forms Joint Venture with Biological E to Develop Pediatric
Vaccine II-90
Novartis Discontinues JV with Panacea Biotec II-90
GSK Inks a Joint Venture with Biological E II-90
Nuron Biotech Inks Licensing agreement with Mitsubishi Tanabe II-90
DNDi Collaborates with Cipla For Development of 4-in-1
Pediatric Drug II-90
Merz Acquires CUVPOSA Oral Solution II-90

9. FOCUS ON SELECT GLOBAL PLAYERS II-91
Actelion Pharmaceuticals Ltd (Switzerland) II-91
Abbott Laboratories (US) II-91
Allergan, Inc. (US) II-92
Amgen, Inc. (US) II-92
AstraZeneca Plc. (UK) II-92
Boehringer Ingelheim GmbH (Germany) II-92
Bristol-Myers Squibb Company (US) II-93
Crucell N.V. (The Netherlands) II-93
Eli Lilly and Company (US) II-93
F. Hoffmann-La Roche Ltd (Switzerland) II-94
Genentech, Inc. (US) II-94
GlaxoSmithKline plc. (UK) II-95
InfaCare, Inc. (USA) II-95
Merck and Co., Inc. (US) II-95
Merck Serono (Switzerland) II-95
Novartis AG (Switzerland) II-96
Novo Nordisk A/S (Denmark) II-96
Pfizer, Inc. (US) II-97
Sanofi S.A (formerly Sanofi-Aventis) (France) II-97
Shionogi Inc. (US) II-98
Shire Pharmaceuticals Group Plc (UK) II-98

10. GLOBAL MARKET PERSPECTIVE II-99
Table 25: World Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-99

Table 26: World Historic Review for Pediatric Drugs and
Vaccines by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2006 through 2012 (includes corresponding Graph/Chart) II-100

Table 27: World 15-Year Perspective for Pediatric Drugs and
Vaccines by Geographic Region - Percentage Share Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific,
Latin America, and Rest of World Markets for Years 2006, 2014 and
2020 (includes corresponding Graph/Chart) II-101

Table 28: World Recent Past, Current and Future Analysis for
Pediatric Vaccines by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) II-102

Table 29: World Historic Review for Pediatric Vaccines by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America, and Rest of World Markets Independently
Analyzed with Annual Sales in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) II-103

Table 30: World 15-Year Perspective for Pediatric Vaccines by
Geographic Region - Percentage Share Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific, Latin America,
and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-104

Table 31: World Recent Past, Current and Future Analysis for
Pediatric Hormones by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) II-105

Table 32: World Historic Review for Pediatric Hormones by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America, and Rest of World Markets Independently
Analyzed with Annual Sales in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) II-106

Table 33: World 15-Year Perspective for Pediatric Hormones by
Geographic Region - Percentage Share Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific, Latin America,
and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-107

Table 34: World Recent Past, Current and Future Analysis for
Pediatric Allergy and Respiratory Drugs by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific, Latin America, and
Rest of World Markets Independently Analyzed with Annual Sales
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-108

Table 35: World Historic Review for Pediatric Allergy and
Respiratory Drugs by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2006 through 2012 (includes corresponding Graph/Chart) II-109

Table 36: World 15-Year Perspective for Pediatric Allergy and
Respiratory Drugs by Geographic Region - Percentage Share
Breakdown of Dollar Sales for US, Canada, Japan, Europe,
Asia-Pacific, Latin America, and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-110

Table 37: World Recent Past, Current and Future Analysis for
Pediatric Anti-infective Drugs by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-111

Table 38: World Historic Review for Pediatric Anti-infective
Drugs by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2006 through 2012 (includes corresponding Graph/Chart) II-112

Table 39: World 15-Year Perspective for Pediatric
Anti-infective Drugs by Geographic Region - Percentage Share
Breakdown of Dollar Sales for US, Canada, Japan, Europe,
Asia-Pacific, Latin America, and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-113

Table 40: World Recent Past, Current and Future Analysis for
Pediatric CNS Drugs by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific, Latin America, and Rest of World Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) II-114

Table 41: World Historic Review for Pediatric CNS Drugs by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America, and Rest of World Markets Independently
Analyzed with Annual Sales in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) II-115

Table 42: World 15-Year Perspective for Pediatric CNS Drugs by
Geographic Region - Percentage Share Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific, Latin America,
and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-116

Table 43: World Recent Past, Current and Future Analysis for
Other Pediatric Drugs by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, Latin America, and Rest of World
Markets Independently Analyzed with Annual Sales in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-117

Table 44: World Historic Review for Other Pediatric Drugs by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America, and Rest of World Markets Independently
Analyzed with Annual Sales in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) II-118

Table 45: World 15-Year Perspective for Other Pediatric Drugs
by Geographic Region - Percentage Share Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific, Latin
America, and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-119

Table 46: World Recent Past, Current and Future Analysis for
Pediatric Vaccines by Type - Combinations, Hepatitis, MMR,
Varicella, Poliovirus, Pneumococcal, and Other Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) II-120

Table 47: World 15-Year Perspective for Pediatric Vaccines by
Type - Percentage Share Breakdown of Dollar Sales for
Combinations, Hepatitis, MMR, Varicella, Poliovirus,
Pneumococcal, and Other Markets for Years 2014 and 2020
(includes corresponding Graph/Chart) II-121


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Major Diseases Afflicting Children in the US III-1
Pediatric Drugs Market in the US III-1
Market Trends and Issues III-2
Pediatric Drugs Witness Supply Shortages III-2
Measures Taken to Reduce Supply Shortages III-2
Low Enthusiasm for Drug Development Research III-2
Lack of New Drugs in Pipeline III-3
Manufacturing Challenges III-3
New Pediatric Indications for Existing Drugs III-3
Pediatric ADHD Drugs Continue to Witness High Prescription
Rate III-4
Table 48: The US ADHD Market by Segment (2013): Percentage
Share of Total Prescriptions for Adult ADHD and Pediatric
ADHD (includes corresponding Graph/Chart) III-4
Rising Incidence of Diabetes Mellitus in North America III-5
Table 49: North America Incidence of Type 1 Diabetes in
Children (2012) (includes corresponding Graph/Chart) III-5
FDA Approved Antidepressants in Pediatric Patients III-5
FDA-Approved Antidepressant Medication by Indication and
Age-Group III-5
Use of Antidepressant Medications in Pediatric Patients:
Treatment Guidelines III-6
Pediatric Antidepressant Drugs and Black Box Warnings III-6
List of Drugs Mandated by FDA to Carry Black Box Warning
on Suicidal Ideation in Adolescents and Children III-7
OTC Drugs Market to Maintain Growth Momentum III-7
Regulatory Environment III-8
Evolution of Regulations for Pediatric Drug Testing III-8
New Regulations Incentivize Clinical Trials with Pediatric
Subjects III-9
PREA and BPCA - A Boon for Pharma Companies III-9
Pediatric Vaccines Market Witnesses Rapid Growth III-10
Anti-Vaccination Trend Restricting the Market III-10
Improved Pricing Scenario for Pediatric Vaccines III-10
Affordable Care Act Favoring the US Pediatric Drugs Market III-11
Child Population and Birth Rates III-11
Table 50: Child Birth in the US: Breakdown of Number of
Births per 1,000 Population for the Years 2003 through
2012 (includes corresponding Graph/Chart) III-11
Opportunity Indicator III-12
Table 51: Number of reported cases for Vaccine-Preventable
Diseases in American Regions III-12

Table 52: Routine Immunization Coverage in the US
(2011-2013): Percentage of Live Births/ New
Borns/Infants/Children Vaccinated III-12
Immunization Program III-13
Recommended Immunization Schedule for Persons Aged 0
through 18 Years - United States, 2014 III-13
Catch-Up Immunization Schedule for Persons Aged 4 Months
through 18 Years Who Start Late or Who are More than 1
Month Behind —United States, 2014 III-14
Product Launches/Approvals III-15
Strategic Corporate Developments III-17
Focus on Select Major Players III-17
B.Market Analytics III-21
Table 53: The US Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-21

Table 54: The US Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-22

Table 55: The US 15-Year Perspective for Pediatric Drugs and
Vaccines by Therapeutic Class - Percentage Share Breakdown
of Dollar Sales for Pediatric Vaccines, Pediatric Hormones,
Allergy and Respiratory Drugs, Anti-infective Drugs, CNS Drugs
and Other Pediatric Drugs Market for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-23

2. CANADA III-24
A.Market Analysis III-24
Opportunity Indicator III-24
Table 56: Canadian Routine Immunization Coverage
(2011-2013): Percentage of Live Births/New
Borns/Infants/Children Vaccinated III-24
B.Market Analytics III-25
Table 57: Canadian Recent Past, Current and Future Analysis
for Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-25

Table 58: Canadian Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-26

Table 59: Canadian 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-27

3. JAPAN III-28
A.Market Analysis III-28
Opportunity Indicator III-28
Table 60: Japanese Routine Immunization Coverage
(2011-2013): Percentage of Live Births/ New
Borns/Infants/Children Vaccinated III-28
B.Market Analytics III-29
Table 61: Japanese Recent Past, Current and Future Analysis
for Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-29

Table 62: Japanese Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-30

Table 63: Japanese 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-31

4. EUROPE III-32
A.Market Analysis III-32
Table 64: Proportion of Children in the 0-15 Years Age Group
by Country in Europe (2013) (includes corresponding
Graph/Chart) III-32
EMA Rolls out Regulations for Pediatric Clinical Studies III-33
Market Challenges III-34
Cost Considerations III-34
Child-Friendly Drug Forms III-34
Product Approval III-34
B.Market Analytics III-35
Table 65: European Recent Past, Current and Future Analysis
for Pediatric Drugs and Vaccines by Geographic Region -
France, Germany, Italy, UK, Spain, Russia, and Rest of
European Markets Independently Analyzed with Annual Sales in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-35

Table 66: European Historic Review for Pediatric Drugs and
Vaccines by Geographic Region - France, Germany, Italy, UK,
Spain, Russia, and Rest of European Markets Independently
Analyzed with Annual Sales in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-36

Table 67: European 15-Year Perspective for Pediatric Drugs
and Vaccines by Geographic Region - Percentage Share
Breakdown of Dollar Sales for France, Germany, Italy, UK,
Spain, Russia, and Rest of European Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-37

Table 68: European Recent Past, Current and Future Analysis
for Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-38

Table 69: European Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-39

Table 70: European 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-40

4a. FRANCE III-41
A.Market Analysis III-41
Opportunity Indicator III-41
Table 71: French Routine Immunization Coverage (2011-2013):
Percentage of Live Births/New Borns/Infants/Children
Vaccinated III-41
Product Launches III-41
Focus on Select Major Player III-42
B.Market Analytics III-43
Table 72: French Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-43

Table 73: French Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-44

Table 74: French 15-Year Perspective for Pediatric Drugs and
Vaccines by Therapeutic Class - Percentage Share Breakdown
of Dollar Sales for Pediatric Vaccines, Pediatric Hormones,
Allergy and Respiratory Drugs, Anti-infective Drugs, CNS Drugs
and Other Pediatric Drugs Market for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-45

4b. GERMANY III-46
A.Market Analysis III-46
Opportunity Indicator III-46
Table 75: German Routine Immunization Coverage (2011-2013):
Percentage of Live Births/New Borns/Infants/Children
Vaccinated III-46
Select Major Player III-46
B.Market Analytics III-47
Table 76: German Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-47

Table 77: German Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-48

Table 78: German 15-Year Perspective for Pediatric Drugs and
Vaccines by Therapeutic Class - Percentage Share Breakdown
of Dollar Sales for Pediatric Vaccines, Pediatric Hormones,
Allergy and Respiratory Drugs, Anti-infective Drugs, CNS Drugs
and Other Pediatric Drugs Market for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-49

4c. ITALY III-50
A.Market Analysis III-50
Opportunity Indicator III-50
Table 79: Italian Routine Immunization Coverage
(2011-2013): Percentage of Live Births/New
Borns/Infants/Children Vaccinated III-50
B.Market Analytics III-51
Table 80: Italian Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-51

Table 81: Italian Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-52

Table 82: Italian 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-53

4d. THE UNITED KINGDOM III-54
A.Market Analysis III-54
Opportunity Indicator III-54
Table 83: The UK Routine Immunization Coverage (2011-2013):
Percentage Of Live Births/New Borns/Infants/Children
Vaccinated III-54
Focus on Select Major Players III-54
B.Market Analytics III-56
Table 84: The UK Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-56

Table 85: The UK Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-57

Table 86: The UK 15-Year Perspective for Pediatric Drugs and
Vaccines by Therapeutic Class - Percentage Share Breakdown
of Dollar Sales for Pediatric Vaccines, Pediatric Hormones,
Allergy and Respiratory Drugs, Anti-infective Drugs, CNS Drugs
and Other Pediatric Drugs Market for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-58

4e. SPAIN III-59
A.Market Analysis III-59
Opportunity Indicator III-59
Table 87: Spanish Routine Immunization Coverage
(2011-2013): Percentage of Live Births/New
Borns/Infants/Children Vaccinated III-59
B.Market Analytics III-60
Table 88: Spanish Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-60

Table 89: Spanish Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-61

Table 90: Spanish 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-62

4f. RUSSIA III-63
A.Market Analysis III-63
Opportunity Indicator III-63
Table 91: Russian Routine Immunization Coverage
(2011-2013): Percentage of Live Births/New
Borns/Infants/Children Vaccinated III-63
B.Market Analytics III-64
Table 92: Russian Recent Past, Current and Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-64

Table 93: Russian Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-65

Table 94: Russian 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-66

4g. REST OF EUROPE III-67
A.Market Analysis III-67
Opportunity Indicator III-67
Table 95: Number of reported cases for Vaccine-Preventable
Diseases in Eastern European Region III-67
Focus on Select Major Players III-67
B.Market Analytics III-71
Table 96: Rest of Europe Recent Past, Current and Future
Analysis for Pediatric Drugs and Vaccines by Therapeutic
Class - Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-71

Table 97: Rest of Europe Historic Review for Pediatric Drugs
and Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-72

Table 98: Rest of Europe 15-Year Perspective for Pediatric
Drugs and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-73

5. ASIA-PACIFIC III-74
A.Market Analysis III-74
Table 99: Proportion of Children in the 0-15 Years Age Group
by Country in Asia-Pacific (2013) (includes corresponding
Graph/Chart) III-74
Burgeoning Middle Class Population in Asia Bodes Well for
Market Growth III-74
Table 100: World Middle Class Population (2012 and 2030):
Percentage Share Breakdown by Region - North America,
Europe, Asia-Pacific, Latin America, and Middle East and
Africa (includes corresponding Graph/Chart) III-75
Vaccines Market in Asia-Pacific III-75
Opportunity Indicator III-76
Table 101: Number of reported Cases for Vaccine-Preventable
Diseases in South-East Asia III-76

Table 102: Number of reported cases for Vaccine-Preventable
Diseases in West-Pacific Region III-76
B.Market Analytics III-77
Table 103: Asia-Pacific Recent Past, Current and Future
Analysis for Pediatric Drugs and Vaccines by Geographic
Region - China, India, and Rest of Asia-Pacific Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) III-77

Table 104: Asia-Pacific Historic Review for Pediatric Drugs
and Vaccines by Geographic Region - China, India, and Rest
of Asia-Pacific Markets Independently Analyzed with Annual
Sales in US$ Million for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-78

Table 105: Asia-Pacific 15-Year Perspective for Pediatric
Drugs and Vaccines by Geographic Region - Percentage Share
Breakdown of Dollar Sales for China, India, and Rest of
Asia-Pacific Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-79

Table 106: Asia-Pacific Recent Past, Current and Future
Analysis for Pediatric Drugs and Vaccines by Therapeutic
Class - Pediatric Vaccines, Pediatric Hormones, Allergy and
Respiratory Drugs, Anti-infective Drugs, CNS Drugs and Other
Pediatric Drugs Market Independently Analyzed with Annual
Sales in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-80

Table 107: Asia-Pacific Historic Review for Pediatric Drugs
and Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy and Respiratory Drugs,
Anti-infective Drugs, CNS Drugs and Other Pediatric Drugs
Market Independently Analyzed with Annual Sales in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-81

Table 108: Asia-Pacific 15-Year Perspective for Pediatric
Drugs and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy and Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-82

5a. CHINA III-83
A.Market Analysis III-83
Chinese Market Outlook III-83
Opportunity Indicator III-83
Table 109: Chinese Routine Immunization Coverage
(2011-2013): Percentage of Live Births/New
Borns/Infants/Children Vaccinated III-83
Growing Pediatric Market in China III-83

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