NEW YORK, June 10, 2015 /PRNewswire/ -- 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
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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-2Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3II.
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 HealthcareSpending 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 AgeGroup) by Select Country: 2013 (includes correspondingGraph/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 AgeGroup) by Select Country: 2013 (includes correspondingGraph/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 SelectTherapeutic Area (2012): Number of Drugs Under Developmentfor Cancer, Genetic Diseases, Infectious Diseases,Neurological Diseases, Respiratory Diseases, Skin Disorders,Psychiatric Diseases, Cardiovascular Ailments, Diabetes, GIDiseases, 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 & 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, & 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-25Historical Lack of Focus on Pediatric Drug Development II-25Pediatric Guidelines by Different Regulatory Bodies II-25US Food and Drug Administration (USFDA) II-26Evolution of Regulations for Pediatric Drug Testing II-26New Regulations Incentivize Clinical Trials with PediatricSubjects II-27PREA and BPCA - A Boon for Pharma Companies II-27European Medicines Agency (EMA) II-28EMA Rolls out Regulations for Pediatric Clinical Studies II-28Malaysian Pediatric Association (MPA) II-28Harmonization of Disparate Regional Regulations & Processes -the Next Step II-29International Conference on Harmonisation (ICH) Guidelinesfor 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): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect 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 DistrictsAchieving at Least 80% DTP3 coverage, 2013 (includescorresponding Graph/Chart) II-38Hepatitis A Vaccine II-38Available Hepatitis A and Combination Vaccines II-38Hepatitis B Vaccine II-38Hepatitis B Epidemiology II-39Available Hepatitis B and Combination Vaccines II-39Measles/Mumps/Rubella (MMR) Vaccines II-39Available MMR and Combination Vaccines II-40Rotavirus Vaccines II-40Available Rotavirus Vaccine II-40Polio Vaccines II-40Available Polio and Combination Vaccines II-41Varicella Vaccine II-41Available Varicella Vaccines II-41Pneumococcal Disease Vaccines II-41PCV 13 Replaces PCV 7 II-42Available Pneumococcal Conjugate Vaccine II-42Meningococcal Vaccines II-43Available Meningococcal Polysaccharide and Combination vaccine II-43Combination Vaccines II-44Select Market Trends and Issues II-45Innovations Drive the Infectious Disease Market II-45Hepatitis B Combination Vaccines to Propel Market Growth II-46Table 22: Number of Countries Having Introduced HepBVaccine: 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 R&D Pipeline (2014) II-48
Rising Women Workforce Propels Pediatric Vaccines Growth II-49
Table 24: Female Employment-to-Population Ratio (%): 2002,
2007 & 2012 (includes corresponding Graph/Chart) II-50
5. PEDIATRIC DISEASES - OVERVIEW, STATISTICS & TREATMENT II-51Infective Diseases II-51Recent Phase III Completed Pediatric Drugs for InfectiousDiseases II-51Influenza II-52Treatment II-52Urinary Tract Infection (UTI) II-53Prevalence II-53Treatment II-53Mumps II-53Complications Related to Mumps II-53Prevention of Mumps in children II-54Incidence II-54Candidiasis II-54Fifth Disease II-54Molluscum Contagiosum II-55Roseola II-55Tetanus II-55Whooping Cough II-56Allergy and Respiratory Diseases II-56Recent Phase III Completed Pediatric Drugs for RespiratoryDisorders II-57Prevalence Statistics II-57The US II-57Other Countries II-58Diphtheria II-58Incidence and Mortality Statistics II-58Upper Respiratory Infection (Common Cold) II-58Diagnosis & Treatment II-58Measles II-59Statistics II-59Asthma II-59Prevalence II-60Central Nervous System Disorders II-60Recent Phase III Completed Pediatric Drugs for Neurological/Psychatric Disorders II-60Mental Disorders II-61Prevalence II-61Attention Deficit Hyperactivity Disorder II-61Prevalence II-61Depression II-62Prevalence II-62Epilepsy II-62Epilepsy Treatment II-63Incidence and Prevalence of Epilepsy in the US II-63Hormonal Disorders II-63Diabetes Mellitus II-63Recent Phase III Completed Pediatric Drugs for Diabetes II-64Hypothyroidism II-64Hypothyroidism in Infants and Children II-64Symptoms and Diagnosis II-65Treatment of Hypothyroidism in Children II-65Precocious Puberty II-65Symptoms and Signs II-66Signs of Early Puberty in Girls and Boys II-66Treatment II-66Hypopituitarism II-66Treatment II-67Lymphocytic Thyroiditis II-67Symptoms II-67Treatment II-67Other Diseases II-67Cardiovascular Diseases II-67Hypertension II-67Causes of Hypertension in Children II-68Symptoms of High Blood Pressure II-68Treatment II-68Cancers II-69Brain Tumors II-69Prevalence II-69Leukemia II-69Prevalence II-70Lymphomas II-70Prevalence II-70Retinoblastoma II-71Prevalence II-71Ewing's Sarcoma II-71Symptoms and Treatment II-71Prevalence II-72Wilms' Tumor II-72Stages and Treatment II-73Prevalence & Incidence II-73Children's Rhabdomyosarcoma II-73Symptoms and Signs II-73Treatment II-74Statistics II-74Neuroblastoma II-75Symptoms II-75Treatment II-75Osteogenic Sarcoma II-76Prevalence II-76Symptoms and Treatment II-76Gastrointestinal Disorders II-77Recent Phase III Completed Pediatric Drugs forGastrointestinal Disorders II-77Diarrhea II-77Inflammatory Bowel Disease (IBD) II-77Symptoms II-77Treatment II-78Irritable Bowel Syndrome (IBS) II-78Causes & Symptoms II-78Treatment II-78Pain II-78Pain Control Medicines for Children II-79Statistics II-79Pain Statistics Among the American Children, GeneralPopulation, and Other Adults II-79Malaria II-79Anemia II-80Treatment for Anemia in Children II-80Recent Phase III Completed Pediatric Drugs for GeneticDisorders II-81
6. LIST OF SELECT FDA APPROVED PEDIATRIC DRUGS II-82
7. PRODUCT INTRODUCTIONS/INNOVATIONS II-87Sanofi Pasteur Receives prequalification status for Shan5™ II-87Immune ResponseReceives US FDA Orphan Drug Status for RemuneVaccine II-87Merck's ISEMTRESS Receives FDA Approval II-87Valneva Receives FDA Market Exclusivity for IXIARO® II-87Merck Receives FDA Grant for Production of Live Virus Material II-87Flu Vaccine Receives FDA Approval II-87Sanofi Pasteur Receives EU Approval for Hexyon/HexacimaPediatric Vaccine II-87Novartis Receives FDA Approval for Menveo II-88ROTAVAC Receives Approval II-88MenHibrix Receives Approval II-88GSK Receives EU Approval for Nimenrix II-88Sanofi Pasteur to Launch New Vaccines II-88FDA Approves Omalizumab as Safe Drug for Children II-88ACETO Corporation to unveil generic Cleocin Pediatric Antibiotic II-88GlaxoSmithKline Receives Approval for MenHibrix II-89CHMP Grants Approval for Glaxo's Nimenrix II-89Sanofi 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-91Actelion Pharmaceuticals Ltd (Switzerland) II-91Abbott Laboratories (US) II-91Allergan, Inc. (US) II-92Amgen, Inc. (US) II-92AstraZeneca Plc. (UK) II-92Boehringer Ingelheim GmbH (Germany) II-92Bristol-Myers Squibb Company (US) II-93Crucell N.V. (The Netherlands) II-93Eli Lilly and Company (US) II-93F. Hoffmann-La Roche Ltd (Switzerland) II-94Genentech, Inc. (US) II-94GlaxoSmithKline plc. (UK) II-95InfaCare, Inc. (USA) II-95Merck & Co., Inc. (US) II-95Merck Serono (Switzerland) II-95Novartis AG (Switzerland) II-96Novo Nordisk A/S (Denmark) II-96Pfizer, Inc. (US) II-97Sanofi S.A (formerly Sanofi-Aventis) (France) II-97Shionogi Inc. (US) II-98Shire Pharmaceuticals Group Plc (UK) II-98
10. GLOBAL MARKET PERSPECTIVE II-99
Table 25: World Recent Past, Current & 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 andVaccines by Geographic Region - US, Canada, Japan, Europe,Asia-Pacific, Latin America, and Rest of World MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 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 &
2020 (includes corresponding Graph/Chart) II-101
Table 28: World Recent Past, Current & Future Analysis forPediatric Vaccines by Geographic Region - US, Canada, Japan,Europe, Asia-Pacific, Latin America, and Rest of World MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 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 byGeographic Region - Percentage Share Breakdown of Dollar Salesfor US, Canada, Japan, Europe, Asia-Pacific, Latin America,and Rest of World Markets for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) II-104
Table 31: World Recent Past, Current & 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 byGeographic Region - US, Canada, Japan, Europe, Asia-Pacific,Latin America, and Rest of World Markets IndependentlyAnalyzed with Annual Sales in US$ Million for Years 2006through 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 & 2020
(includes corresponding Graph/Chart) II-107
Table 34: World Recent Past, Current & Future Analysis forPediatric Allergy & Respiratory Drugs by Geographic Region -US, Canada, Japan, Europe, Asia-Pacific, Latin America, andRest of World Markets Independently Analyzed with Annual Salesin US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) II-108
Table 35: World Historic Review for Pediatric Allergy &
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 &Respiratory Drugs by Geographic Region - Percentage ShareBreakdown of Dollar Sales for US, Canada, Japan, Europe,Asia-Pacific, Latin America, and Rest of World Markets forYears 2006, 2014 & 2020 (includes corresponding Graph/Chart) II-110
Table 37: World Recent Past, Current & 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-infectiveDrugs by Geographic Region - US, Canada, Japan, Europe,Asia-Pacific, Latin America, and Rest of World MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 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 & 2020 (includes corresponding Graph/Chart) II-113
Table 40: World Recent Past, Current & Future Analysis forPediatric CNS Drugs by Geographic Region - US, Canada, Japan,Europe, Asia-Pacific, Latin America, and Rest of World MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 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 byGeographic Region - Percentage Share Breakdown of Dollar Salesfor US, Canada, Japan, Europe, Asia-Pacific, Latin America,and Rest of World Markets for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) II-116
Table 43: World Recent Past, Current & 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 byGeographic Region - US, Canada, Japan, Europe, Asia-Pacific,Latin America, and Rest of World Markets IndependentlyAnalyzed with Annual Sales in US$ Million for Years 2006through 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 & 2020
(includes corresponding Graph/Chart) II-119
Table 46: World Recent Past, Current & Future Analysis forPediatric Vaccines by Type - Combinations, Hepatitis, MMR,Varicella, Poliovirus, Pneumococcal, and Other MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 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 & 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 & 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/ NewBorns/Infants/Children Vaccinated III-12Immunization Program III-13Recommended Immunization Schedule for Persons Aged 0through 18 Years - United States, 2014 III-13Catch-Up Immunization Schedule for Persons Aged 4 Monthsthrough 18 Years Who Start Late or Who are More than 1Month Behind —United States, 2014 III-14Product Launches/Approvals III-15Strategic Corporate Developments III-17Focus on Select Major Players III-17B.Market Analytics III-21Table 53: The US Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-21
Table 54: The US Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 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 & Future Analysis
for Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy &
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 andVaccines by Therapeutic Class - Pediatric Vaccines,Pediatric Hormones, Allergy & Respiratory Drugs,Anti-infective Drugs, CNS Drugs and Other Pediatric DrugsMarket Independently Analyzed with Annual Sales in US$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-26
Table 59: Canadian 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy & Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 & 2020 (includes corresponding Graph/Chart) III-27
3. JAPAN III-28A.Market Analysis III-28Opportunity Indicator III-28Table 60: Japanese Routine Immunization Coverage(2011-2013): Percentage of Live Births/ NewBorns/Infants/Children Vaccinated III-28B.Market Analytics III-29Table 61: Japanese Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-29
Table 62: Japanese Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 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 & 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 andVaccines by Geographic Region - France, Germany, Italy, UK,Spain, Russia, and Rest of European Markets IndependentlyAnalyzed with Annual Sales in US$ Million for Years 2006through 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 & 2020 (includes corresponding Graph/Chart) III-37
Table 68: European Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-38
Table 69: European Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 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 & Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy &
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 andVaccines by Therapeutic Class - Pediatric Vaccines,Pediatric Hormones, Allergy & Respiratory Drugs,Anti-infective Drugs, CNS Drugs and Other Pediatric DrugsMarket Independently Analyzed with Annual Sales in US$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-44
Table 74: French 15-Year Perspective for Pediatric Drugs and
Vaccines by Therapeutic Class - Percentage Share Breakdown
of Dollar Sales for Pediatric Vaccines, Pediatric Hormones,
Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugs
and Other Pediatric Drugs Market for Years 2006, 2014 & 2020
(includes corresponding Graph/Chart) III-45
4b. GERMANY III-46A.Market Analysis III-46Opportunity Indicator III-46Table 75: German Routine Immunization Coverage (2011-2013):Percentage of Live Births/New Borns/Infants/ChildrenVaccinated III-46Select Major Player III-46B.Market Analytics III-47Table 76: German Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-47
Table 77: German Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 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 & Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy &
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 andVaccines by Therapeutic Class - Pediatric Vaccines,Pediatric Hormones, Allergy & Respiratory Drugs,Anti-infective Drugs, CNS Drugs and Other Pediatric DrugsMarket Independently Analyzed with Annual Sales in US$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-52
Table 82: Italian 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy & Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 & 2020 (includes corresponding Graph/Chart) III-53
4d. THE UNITED KINGDOM III-54A.Market Analysis III-54Opportunity Indicator III-54Table 83: The UK Routine Immunization Coverage (2011-2013):Percentage Of Live Births/New Borns/Infants/ChildrenVaccinated III-54Focus on Select Major Players III-54B.Market Analytics III-56Table 84: The UK Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-56
Table 85: The UK Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 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 & Future Analysis for
Pediatric Drugs and Vaccines by Therapeutic Class -
Pediatric Vaccines, Pediatric Hormones, Allergy &
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 andVaccines by Therapeutic Class - Pediatric Vaccines,Pediatric Hormones, Allergy & Respiratory Drugs,Anti-infective Drugs, CNS Drugs and Other Pediatric DrugsMarket Independently Analyzed with Annual Sales in US$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-61
Table 90: Spanish 15-Year Perspective for Pediatric Drugs
and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy & Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 & 2020 (includes corresponding Graph/Chart) III-62
4f. RUSSIA III-63A.Market Analysis III-63Opportunity Indicator III-63Table 91: Russian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-63B.Market Analytics III-64Table 92: Russian Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-64
Table 93: Russian Historic Review for Pediatric Drugs and
Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 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 & Future
Analysis for Pediatric Drugs and Vaccines by Therapeutic
Class - Pediatric Vaccines, Pediatric Hormones, Allergy &
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 Drugsand Vaccines by Therapeutic Class - Pediatric Vaccines,Pediatric Hormones, Allergy & Respiratory Drugs,Anti-infective Drugs, CNS Drugs and Other Pediatric DrugsMarket Independently Analyzed with Annual Sales in US$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-72
Table 98: Rest of Europe 15-Year Perspective for Pediatric
Drugs and Vaccines by Therapeutic Class - Percentage Share
Breakdown of Dollar Sales for Pediatric Vaccines, Pediatric
Hormones, Allergy & Respiratory Drugs, Anti-infective Drugs,
CNS Drugs and Other Pediatric Drugs Market for Years 2006,
2014 & 2020 (includes corresponding Graph/Chart) III-73
5. ASIA-PACIFIC III-74A.Market Analysis III-74Table 99: Proportion of Children in the 0-15 Years Age Groupby Country in Asia-Pacific (2013) (includes correspondingGraph/Chart) III-74Burgeoning Middle Class Population in Asia Bodes Well forMarket Growth III-74Table 100: World Middle Class Population (2012 & 2030):Percentage Share Breakdown by Region - North America,Europe, Asia-Pacific, Latin America, and Middle East &Africa (includes corresponding Graph/Chart) III-75Vaccines Market in Asia-Pacific III-75Opportunity Indicator III-76Table 101: Number of reported Cases for Vaccine-PreventableDiseases in South-East Asia III-76
Table 102: Number of reported cases for Vaccine-Preventable
Diseases in West-Pacific Region III-76
B.Market Analytics III-77
Table 103: Asia-Pacific Recent Past, Current & Future
Analysis for Pediatric Drugs and Vaccines by Geographic
Region - China, India, and Rest of Asia-Pacific Markets
Independently Analyzed with Annual Sales in US$ Million for
Years 2013 through 2020 (includes corresponding Graph/Chart) III-77
Table 104: Asia-Pacific Historic Review for Pediatric Drugsand Vaccines by Geographic Region - China, India, and Restof Asia-Pacific Markets Independently Analyzed with AnnualSales in US$ Million for Years 2006 through 2012 (includescorresponding 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 & 2020 (includes
corresponding Graph/Chart) III-79
Table 106: Asia-Pacific Recent Past, Current & FutureAnalysis for Pediatric Drugs and Vaccines by TherapeuticClass - Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-80
Table 107: Asia-Pacific Historic Review for Pediatric Drugs
and Vaccines by Therapeutic Class - Pediatric Vaccines,
Pediatric Hormones, Allergy & 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 PediatricDrugs and Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 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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