NEW YORK, Oct. 23, 2014 /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 SUMMARY1. INDUSTRY OVERVIEW II-1Pediatrics: A Highly Underserved and Undervalued Group II-1Table 1: Global Birth Rate Statistics (2012) by Crude BirthRates per 1000 Population for Key Countries II-2Pediatric Drugs Market - An Abode of Opportunities II-3Recent Pediatric Drug Approvals: 2011-2014 II-3Pediatric Exclusivity Drives Manufacturers' Interest II-5The United States and Europe: Major Markets for Pediatric Drugs II-5Developing Markets to Witness Faster Growth II-5Table 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) (includescorresponding Graph/Chart) II-7Table 4: Developing Regions Lead Children Population Globally(includes corresponding Graph/Chart) II-8Table 5: Asia-Pacific Proportion of Children (0-15 Years AgeGroup) by Select Country: 2013 (includes correspondingGraph/Chart) II-9Table 6: Latin American Proportion of Children (0-15 YearsAge Group) by Country: 2013 (includes correspondingGraph/Chart) II-9Table 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 (0-15Years Age Group) by Country: 2013 (includes correspondingGraph/Chart) II-10Anti-Infectives, and Anti-Allergy/RespiratoryDrugs: LargestSelling Drug Classes II-11Pediatric Vaccines: The Fastest Growing Market Segment II-11Table 9: Global Prevnar 13 Vaccine Sales by Region: 2013 (includes corresponding Graph/Chart) II-12Prescription Hormone Drugs to Drive Pediatric Drugs Growth II-12Table 10: Global Pediatric Drugs Market by Therapeutic Class:Segments Ranked by Growth (includes correspondingGraph/Chart) II-13Clinical Studies and Pipeline Analysis II-13Table 11: Global On-Going Pediatric Drugs Clinical Studies byCountry/Region (includes corresponding Graph/Chart) II-13Table 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-15Potential for Pediatric Drugs Against Obesity-related Conditions II-15Table 13: Top 10 Countries with the Highest Proportion ofOverweight Children (includes corresponding Graph/Chart) II-15Recent Phase III Completed Pediatric Cardiovascular Drugs II-16Lack of Adequate Funding Hinders Pediatric Drug Trials II-16Modeling & Simulation - A Powerful Tool for Pediatric ClinicalStudy Sponsors II-17Pharmacometrics Approaches Gain Traction Among US and EUResearchers II-17Challenges Associated with Adoption of Pharmacometric Approach II-18Guidelines for Conducting Ethically Correct Clinical Trials II-18Controversial Off-Label Drug Usage in the Pediatric HealthcareMarket II-18The US Leads the Pediatric ADHD Drugs Market II-19Non-Stimulant ADHD Drugs Gaining Market II-20Table 14: Global ADHD Non-Stimulant Drugs Market by Type(2014): Percentage Market Share Breakdown of PrescriptionSales for Kapvay, Intuniv, & Strattera (includescorresponding Graph/Chart) II-20Orphan Drugs for Pediatric Use Gain Popularity II-20Pediatric Orphan Drugs in Pipeline as of Year 2013 II-21Need for Higher Focus on Fixed-Dose Combination for PediatricHIV Infections II-22Select Pediatric Antiretroviral Drugs in Pipeline (2014) II-22Pediatric Growth Hormone Drug Market Offers Potential II-24Efforts 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-304. PEDIATRIC VACCINES MARKET II-31Table 15: Number of Reported Cases for Vaccine-PreventableDiseases Globally: 2009-2013 II-31Immunization Coverage II-31Immunization Coverage: 2013, 2012, and 2011 II-32Table 16: Routine Immunization Coverage (2013): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-32Table 17: Routine Immunization Coverage (2012): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-33
Table 18: Routine Immunization Coverage (2011): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-34Market Share of Leading Pediatric Vaccine Manufacturers II-35Table 19: Global Pediatric Vaccines Market by Leading Players(2013): Percentage Market Share Breakdown of Dollar Sales forGlaxoSmithKline, Novartis, Sanofi-Pasteur, Merck, and Others(includes corresponding Graph/Chart) II-35Pediatric Vaccines in Pipeline II-35Pediatric Vaccine Types II-35Hemophilus Influenza Type B Vaccine II-35Available Hib and Combination Vaccines II-36Diphtheria/Tetanus/Pertussis Vaccines (DTaP Vaccines) II-36Available DTaP and Combination Vaccines II-37Table 20: Global DTP3 Immunization Coverage: 2003-2013(includes corresponding Graph/Chart) II-37Table 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 (includescorresponding Graph/Chart) II-47Conjugated and Protein-based Vaccines to Take overPolysaccharide Vaccines for Infectious Diseases II-47List of Infectious Disease Vaccines in the R&D Pipeline (2014) II-48Rising Women Workforce Propels Pediatric Vaccines Growth II-49Table 24: Female Employment-to-Population Ratio (%): 2002,2007 & 2012 (includes corresponding Graph/Chart) II-505. 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-827. 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-898. RECENT INDUSTRY ACTIVITY II-90GSK Forms Joint Venture with Biological E to Develop PediatricVaccine II-90Novartis Discontinues JV with Panacea Biotec II-90GSK Inks a Joint Venture with Biological E II-90Nuron Biotech Inks Licensing agreement with Mitsubishi Tanabe II-90DNDi Collaborates with Cipla For Development of 4-in-1Pediatric Drug II-90Merz 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-99Table 25: World Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific, Latin America, and Restof World Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) II-99Table 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-100Table 27: World 15-Year Perspective for Pediatric Drugs andVaccines by Geographic Region - Percentage Share Breakdown ofDollar 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-101Table 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-102Table 29: World Historic Review for Pediatric Vaccines 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-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-104Table 31: World Recent Past, Current & Future Analysis forPediatric Hormones 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-105Table 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-106Table 33: World 15-Year Perspective for Pediatric Hormones 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-107Table 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 MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 2006 through 2012 (includes corresponding Graph/Chart) II-109Table 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-110Table 37: World Recent Past, Current & Future Analysis forPediatric Anti-infective Drugs by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific, Latin America, and Restof World Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) II-111Table 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-112Table 39: World 15-Year Perspective for PediatricAnti-infective 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-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-114Table 41: World Historic Review for Pediatric CNS 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-115Table 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-116Table 43: World Recent Past, Current & Future Analysis forOther Pediatric Drugs by Geographic Region - US, Canada,Japan, Europe, Asia-Pacific, Latin America, and Rest of WorldMarkets Independently Analyzed with Annual Sales in US$Million for Years 2013 through 2020 (includes correspondingGraph/Chart) II-117Table 44: World Historic Review for Other Pediatric Drugs byGeographic Region - US, Canada, Japan, Europe, Asia-Pacific,Latin America, and Rest of World Markets IndependentlyAnalyzed with Annual Sales in US$ Million for Years 2006through 2012 (includes corresponding Graph/Chart) II-118
Table 45: World 15-Year Perspective for Other Pediatric Drugsby Geographic Region - Percentage Share Breakdown of DollarSales for US, Canada, Japan, Europe, Asia-Pacific, LatinAmerica, and Rest of World Markets for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) II-119Table 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-120Table 47: World 15-Year Perspective for Pediatric Vaccines byType - Percentage Share Breakdown of Dollar Sales forCombinations, Hepatitis, MMR, Varicella, Poliovirus,Pneumococcal, and Other Markets for Years 2014 & 2020(includes corresponding Graph/Chart) II-121
III. MARKET1. THE UNITED STATES III-1A.Market Analysis III-1Major Diseases Afflicting Children in the US III-1Pediatric Drugs Market in the US III-1Market Trends and Issues III-2Pediatric Drugs Witness Supply Shortages III-2Measures Taken to Reduce Supply Shortages III-2Low Enthusiasm for Drug Development Research III-2Lack of New Drugs in Pipeline III-3Manufacturing Challenges III-3New Pediatric Indications for Existing Drugs III-3Pediatric ADHD Drugs Continue to Witness High PrescriptionRate III-4Table 48: The US ADHD Market by Segment (2013): PercentageShare of Total Prescriptions for Adult ADHD and PediatricADHD (includes corresponding Graph/Chart) III-4Rising Incidence of Diabetes Mellitus in North America III-5Table 49: North America Incidence of Type 1 Diabetes inChildren (2012) (includes corresponding Graph/Chart) III-5FDA Approved Antidepressants in Pediatric Patients III-5FDA-Approved Antidepressant Medication by Indication andAge-Group III-5Use of Antidepressant Medications in Pediatric Patients:Treatment Guidelines III-6Pediatric Antidepressant Drugs and Black Box Warnings III-6List of Drugs Mandated by FDA to Carry Black Box Warningon Suicidal Ideation in Adolescents and Children III-7OTC Drugs Market to Maintain Growth Momentum III-7Regulatory Environment III-8Evolution of Regulations for Pediatric Drug Testing III-8New Regulations Incentivize Clinical Trials with PediatricSubjects III-9PREA and BPCA - A Boon for Pharma Companies III-9Pediatric Vaccines Market Witnesses Rapid Growth III-10Anti-Vaccination Trend Restricting the Market III-10Improved Pricing Scenario for Pediatric Vaccines III-10Affordable Care Act Favoring the US Pediatric Drugs Market III-11Child Population & Birth Rates III-11Table 50: Child Birth in the US: Breakdown of Number ofBirths per 1,000 Population for the Years 2003 through2012 (includes corresponding Graph/Chart) III-11Opportunity Indicator III-12Table 51: Number of reported cases for Vaccine-PreventableDiseases 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-21Table 54: The US 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-22Table 55: The US 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-23
2. CANADA III-24A.Market Analysis III-24Opportunity Indicator III-24Table 56: Canadian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-24B.Market Analytics III-25Table 57: Canadian Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-25Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-26Table 59: Canadian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-27
3. JAPAN III-28A.Market Analysis III-28Opportunity Indicator III-28Table 60: Japanese Routine Immunization Coverage(2011-2013): Percentage of Live Births/ NewBorns/Infants/Children Vaccinated III-28B.Market Analytics III-29Table 61: Japanese Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-29Table 62: Japanese 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-30Table 63: Japanese 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-31
4. EUROPE III-32A.Market Analysis III-32Table 64: Proportion of Children in the 0-15 Years Age Groupby Country in Europe (2013) (includes correspondingGraph/Chart) III-32EMA Rolls out Regulations for Pediatric Clinical Studies III-33Market Challenges III-34Cost Considerations III-34Child-Friendly Drug Forms III-34Product Approval III-34B.Market Analytics III-35Table 65: European Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Geographic Region -France, Germany, Italy, UK, Spain, Russia, and Rest ofEuropean Markets Independently Analyzed with Annual Sales inUS$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-35Table 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-36Table 67: European 15-Year Perspective for Pediatric Drugsand Vaccines by Geographic Region - Percentage ShareBreakdown 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-37Table 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-38Table 69: European 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-39Table 70: European 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-40
4a. FRANCE III-41A.Market Analysis III-41Opportunity Indicator III-41Table 71: French Routine Immunization Coverage (2011-2013):Percentage of Live Births/New Borns/Infants/ChildrenVaccinated III-41Product Launches III-41Focus on Select Major Player III-42B.Market Analytics III-43Table 72: French Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-43Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-44Table 74: French 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-45
4b. GERMANY III-46A.Market Analysis III-46Opportunity Indicator III-46Table 75: German Routine Immunization Coverage (2011-2013):Percentage of Live Births/New Borns/Infants/ChildrenVaccinated III-46Select Major Player III-46B.Market Analytics III-47Table 76: German Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-47Table 77: German 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-48Table 78: German 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-49
4c. ITALY III-50A.Market Analysis III-50Opportunity Indicator III-50Table 79: Italian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-50B.Market Analytics III-51Table 80: Italian Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-51Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-52Table 82: Italian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-53
4d. THE UNITED KINGDOM III-54A.Market Analysis III-54Opportunity Indicator III-54Table 83: The UK Routine Immunization Coverage (2011-2013):Percentage Of Live Births/New Borns/Infants/ChildrenVaccinated III-54Focus on Select Major Players III-54B.Market Analytics III-56Table 84: The UK Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-56Table 85: The UK 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-57Table 86: The UK 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-58
4e. SPAIN III-59A.Market Analysis III-59Opportunity Indicator III-59Table 87: Spanish Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-59B.Market Analytics III-60Table 88: Spanish Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-60Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-61Table 90: Spanish 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-62
4f. RUSSIA III-63A.Market Analysis III-63Opportunity Indicator III-63Table 91: Russian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-63B.Market Analytics III-64Table 92: Russian Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-64Table 93: Russian 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-65Table 94: Russian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-66
4g. REST OF EUROPE III-67A.Market Analysis III-67Opportunity Indicator III-67Table 95: Number of reported cases for Vaccine-PreventableDiseases in Eastern European Region III-67Focus on Select Major Players III-67B.Market Analytics III-71Table 96: Rest of Europe Recent Past, Current & FutureAnalysis for Pediatric Drugs and Vaccines by TherapeuticClass - Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-71Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-72Table 98: Rest of Europe 15-Year Perspective for PediatricDrugs and Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-73
5. ASIA-PACIFIC III-74A.Market Analysis III-74Table 99: Proportion of Children in the 0-15 Years Age Groupby Country in Asia-Pacific (2013) (includes correspondingGraph/Chart) III-74Burgeoning Middle Class Population in Asia Bodes Well forMarket Growth III-74Table 100: World Middle Class Population (2012 & 2030):Percentage Share Breakdown by Region - North America,Europe, Asia-Pacific, Latin America, and Middle East &Africa (includes corresponding Graph/Chart) III-75Vaccines Market in Asia-Pacific III-75Opportunity Indicator III-76Table 101: Number of reported Cases for Vaccine-PreventableDiseases in South-East Asia III-76Table 102: Number of reported cases for Vaccine-PreventableDiseases in West-Pacific Region III-76B.Market Analytics III-77Table 103: Asia-Pacific Recent Past, Current & FutureAnalysis for Pediatric Drugs and Vaccines by GeographicRegion - China, India, and Rest of Asia-Pacific MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 2013 through 2020 (includes corresponding Graph/Chart) III-77Table 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-78Table 105: Asia-Pacific 15-Year Perspective for PediatricDrugs and Vaccines by Geographic Region - Percentage ShareBreakdown of Dollar Sales for China, India, and Rest ofAsia-Pacific Markets for Years 2006, 2014 & 2020 (includescorresponding 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-80Table 107: Asia-Pacific 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-81Table 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-83A.Market Analysis III-83Chinese Market Outlook III-83Opportunity Indicator III-83Table 109: Chinese Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-83Growing Pediatric Market in China III-83
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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 SUMMARY1. INDUSTRY OVERVIEW II-1Pediatrics: A Highly Underserved and Undervalued Group II-1Table 1: Global Birth Rate Statistics (2012) by Crude BirthRates per 1000 Population for Key Countries II-2Pediatric Drugs Market - An Abode of Opportunities II-3Recent Pediatric Drug Approvals: 2011-2014 II-3Pediatric Exclusivity Drives Manufacturers' Interest II-5The United States and Europe: Major Markets for Pediatric Drugs II-5Developing Markets to Witness Faster Growth II-5Table 2: Per-Capita Healthcare Expenditure in Select Regions(2013) (includes corresponding Graph/Chart) II-6
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Table 3: Top 20 Countries with the Highest HealthcareSpending as a Percentage of GDP (2012) (includescorresponding Graph/Chart) II-7Table 4: Developing Regions Lead Children Population Globally(includes corresponding Graph/Chart) II-8Table 5: Asia-Pacific Proportion of Children (0-15 Years AgeGroup) by Select Country: 2013 (includes correspondingGraph/Chart) II-9Table 6: Latin American Proportion of Children (0-15 YearsAge Group) by Country: 2013 (includes correspondingGraph/Chart) II-9Table 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 (0-15Years Age Group) by Country: 2013 (includes correspondingGraph/Chart) II-10Anti-Infectives, and Anti-Allergy/RespiratoryDrugs: LargestSelling Drug Classes II-11Pediatric Vaccines: The Fastest Growing Market Segment II-11Table 9: Global Prevnar 13 Vaccine Sales by Region: 2013 (includes corresponding Graph/Chart) II-12Prescription Hormone Drugs to Drive Pediatric Drugs Growth II-12Table 10: Global Pediatric Drugs Market by Therapeutic Class:Segments Ranked by Growth (includes correspondingGraph/Chart) II-13Clinical Studies and Pipeline Analysis II-13Table 11: Global On-Going Pediatric Drugs Clinical Studies byCountry/Region (includes corresponding Graph/Chart) II-13Table 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-15Potential for Pediatric Drugs Against Obesity-related Conditions II-15Table 13: Top 10 Countries with the Highest Proportion ofOverweight Children (includes corresponding Graph/Chart) II-15Recent Phase III Completed Pediatric Cardiovascular Drugs II-16Lack of Adequate Funding Hinders Pediatric Drug Trials II-16Modeling & Simulation - A Powerful Tool for Pediatric ClinicalStudy Sponsors II-17Pharmacometrics Approaches Gain Traction Among US and EUResearchers II-17Challenges Associated with Adoption of Pharmacometric Approach II-18Guidelines for Conducting Ethically Correct Clinical Trials II-18Controversial Off-Label Drug Usage in the Pediatric HealthcareMarket II-18The US Leads the Pediatric ADHD Drugs Market II-19Non-Stimulant ADHD Drugs Gaining Market II-20Table 14: Global ADHD Non-Stimulant Drugs Market by Type(2014): Percentage Market Share Breakdown of PrescriptionSales for Kapvay, Intuniv, & Strattera (includescorresponding Graph/Chart) II-20Orphan Drugs for Pediatric Use Gain Popularity II-20Pediatric Orphan Drugs in Pipeline as of Year 2013 II-21Need for Higher Focus on Fixed-Dose Combination for PediatricHIV Infections II-22Select Pediatric Antiretroviral Drugs in Pipeline (2014) II-22Pediatric Growth Hormone Drug Market Offers Potential II-24Efforts 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-304. PEDIATRIC VACCINES MARKET II-31Table 15: Number of Reported Cases for Vaccine-PreventableDiseases Globally: 2009-2013 II-31Immunization Coverage II-31Immunization Coverage: 2013, 2012, and 2011 II-32Table 16: Routine Immunization Coverage (2013): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-32Table 17: Routine Immunization Coverage (2012): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-33
Table 18: Routine Immunization Coverage (2011): Percentageof Live Births/New Borns/Infants/ Children Vaccinated bySelect Region II-34Market Share of Leading Pediatric Vaccine Manufacturers II-35Table 19: Global Pediatric Vaccines Market by Leading Players(2013): Percentage Market Share Breakdown of Dollar Sales forGlaxoSmithKline, Novartis, Sanofi-Pasteur, Merck, and Others(includes corresponding Graph/Chart) II-35Pediatric Vaccines in Pipeline II-35Pediatric Vaccine Types II-35Hemophilus Influenza Type B Vaccine II-35Available Hib and Combination Vaccines II-36Diphtheria/Tetanus/Pertussis Vaccines (DTaP Vaccines) II-36Available DTaP and Combination Vaccines II-37Table 20: Global DTP3 Immunization Coverage: 2003-2013(includes corresponding Graph/Chart) II-37Table 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 (includescorresponding Graph/Chart) II-47Conjugated and Protein-based Vaccines to Take overPolysaccharide Vaccines for Infectious Diseases II-47List of Infectious Disease Vaccines in the R&D Pipeline (2014) II-48Rising Women Workforce Propels Pediatric Vaccines Growth II-49Table 24: Female Employment-to-Population Ratio (%): 2002,2007 & 2012 (includes corresponding Graph/Chart) II-505. 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-827. 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-898. RECENT INDUSTRY ACTIVITY II-90GSK Forms Joint Venture with Biological E to Develop PediatricVaccine II-90Novartis Discontinues JV with Panacea Biotec II-90GSK Inks a Joint Venture with Biological E II-90Nuron Biotech Inks Licensing agreement with Mitsubishi Tanabe II-90DNDi Collaborates with Cipla For Development of 4-in-1Pediatric Drug II-90Merz 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-99Table 25: World Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific, Latin America, and Restof World Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) II-99Table 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-100Table 27: World 15-Year Perspective for Pediatric Drugs andVaccines by Geographic Region - Percentage Share Breakdown ofDollar 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-101Table 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-102Table 29: World Historic Review for Pediatric Vaccines 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-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-104Table 31: World Recent Past, Current & Future Analysis forPediatric Hormones 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-105Table 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-106Table 33: World 15-Year Perspective for Pediatric Hormones 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-107Table 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 MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 2006 through 2012 (includes corresponding Graph/Chart) II-109Table 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-110Table 37: World Recent Past, Current & Future Analysis forPediatric Anti-infective Drugs by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific, Latin America, and Restof World Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) II-111Table 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-112Table 39: World 15-Year Perspective for PediatricAnti-infective 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-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-114Table 41: World Historic Review for Pediatric CNS 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-115Table 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-116Table 43: World Recent Past, Current & Future Analysis forOther Pediatric Drugs by Geographic Region - US, Canada,Japan, Europe, Asia-Pacific, Latin America, and Rest of WorldMarkets Independently Analyzed with Annual Sales in US$Million for Years 2013 through 2020 (includes correspondingGraph/Chart) II-117Table 44: World Historic Review for Other Pediatric Drugs byGeographic Region - US, Canada, Japan, Europe, Asia-Pacific,Latin America, and Rest of World Markets IndependentlyAnalyzed with Annual Sales in US$ Million for Years 2006through 2012 (includes corresponding Graph/Chart) II-118
Table 45: World 15-Year Perspective for Other Pediatric Drugsby Geographic Region - Percentage Share Breakdown of DollarSales for US, Canada, Japan, Europe, Asia-Pacific, LatinAmerica, and Rest of World Markets for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) II-119Table 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-120Table 47: World 15-Year Perspective for Pediatric Vaccines byType - Percentage Share Breakdown of Dollar Sales forCombinations, Hepatitis, MMR, Varicella, Poliovirus,Pneumococcal, and Other Markets for Years 2014 & 2020(includes corresponding Graph/Chart) II-121
III. MARKET1. THE UNITED STATES III-1A.Market Analysis III-1Major Diseases Afflicting Children in the US III-1Pediatric Drugs Market in the US III-1Market Trends and Issues III-2Pediatric Drugs Witness Supply Shortages III-2Measures Taken to Reduce Supply Shortages III-2Low Enthusiasm for Drug Development Research III-2Lack of New Drugs in Pipeline III-3Manufacturing Challenges III-3New Pediatric Indications for Existing Drugs III-3Pediatric ADHD Drugs Continue to Witness High PrescriptionRate III-4Table 48: The US ADHD Market by Segment (2013): PercentageShare of Total Prescriptions for Adult ADHD and PediatricADHD (includes corresponding Graph/Chart) III-4Rising Incidence of Diabetes Mellitus in North America III-5Table 49: North America Incidence of Type 1 Diabetes inChildren (2012) (includes corresponding Graph/Chart) III-5FDA Approved Antidepressants in Pediatric Patients III-5FDA-Approved Antidepressant Medication by Indication andAge-Group III-5Use of Antidepressant Medications in Pediatric Patients:Treatment Guidelines III-6Pediatric Antidepressant Drugs and Black Box Warnings III-6List of Drugs Mandated by FDA to Carry Black Box Warningon Suicidal Ideation in Adolescents and Children III-7OTC Drugs Market to Maintain Growth Momentum III-7Regulatory Environment III-8Evolution of Regulations for Pediatric Drug Testing III-8New Regulations Incentivize Clinical Trials with PediatricSubjects III-9PREA and BPCA - A Boon for Pharma Companies III-9Pediatric Vaccines Market Witnesses Rapid Growth III-10Anti-Vaccination Trend Restricting the Market III-10Improved Pricing Scenario for Pediatric Vaccines III-10Affordable Care Act Favoring the US Pediatric Drugs Market III-11Child Population & Birth Rates III-11Table 50: Child Birth in the US: Breakdown of Number ofBirths per 1,000 Population for the Years 2003 through2012 (includes corresponding Graph/Chart) III-11Opportunity Indicator III-12Table 51: Number of reported cases for Vaccine-PreventableDiseases 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-21Table 54: The US 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-22Table 55: The US 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-23
2. CANADA III-24A.Market Analysis III-24Opportunity Indicator III-24Table 56: Canadian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-24B.Market Analytics III-25Table 57: Canadian Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-25Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-26Table 59: Canadian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-27
3. JAPAN III-28A.Market Analysis III-28Opportunity Indicator III-28Table 60: Japanese Routine Immunization Coverage(2011-2013): Percentage of Live Births/ NewBorns/Infants/Children Vaccinated III-28B.Market Analytics III-29Table 61: Japanese Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-29Table 62: Japanese 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-30Table 63: Japanese 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-31
4. EUROPE III-32A.Market Analysis III-32Table 64: Proportion of Children in the 0-15 Years Age Groupby Country in Europe (2013) (includes correspondingGraph/Chart) III-32EMA Rolls out Regulations for Pediatric Clinical Studies III-33Market Challenges III-34Cost Considerations III-34Child-Friendly Drug Forms III-34Product Approval III-34B.Market Analytics III-35Table 65: European Recent Past, Current & Future Analysisfor Pediatric Drugs and Vaccines by Geographic Region -France, Germany, Italy, UK, Spain, Russia, and Rest ofEuropean Markets Independently Analyzed with Annual Sales inUS$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-35Table 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-36Table 67: European 15-Year Perspective for Pediatric Drugsand Vaccines by Geographic Region - Percentage ShareBreakdown 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-37Table 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-38Table 69: European 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-39Table 70: European 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-40
4a. FRANCE III-41A.Market Analysis III-41Opportunity Indicator III-41Table 71: French Routine Immunization Coverage (2011-2013):Percentage of Live Births/New Borns/Infants/ChildrenVaccinated III-41Product Launches III-41Focus on Select Major Player III-42B.Market Analytics III-43Table 72: French Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-43Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-44Table 74: French 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-45
4b. GERMANY III-46A.Market Analysis III-46Opportunity Indicator III-46Table 75: German Routine Immunization Coverage (2011-2013):Percentage of Live Births/New Borns/Infants/ChildrenVaccinated III-46Select Major Player III-46B.Market Analytics III-47Table 76: German Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-47Table 77: German 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-48Table 78: German 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-49
4c. ITALY III-50A.Market Analysis III-50Opportunity Indicator III-50Table 79: Italian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-50B.Market Analytics III-51Table 80: Italian Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-51Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-52Table 82: Italian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-53
4d. THE UNITED KINGDOM III-54A.Market Analysis III-54Opportunity Indicator III-54Table 83: The UK Routine Immunization Coverage (2011-2013):Percentage Of Live Births/New Borns/Infants/ChildrenVaccinated III-54Focus on Select Major Players III-54B.Market Analytics III-56Table 84: The UK Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-56Table 85: The UK 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-57Table 86: The UK 15-Year Perspective for Pediatric Drugs andVaccines by Therapeutic Class - Percentage Share Breakdownof Dollar Sales for Pediatric Vaccines, Pediatric Hormones,Allergy & Respiratory Drugs, Anti-infective Drugs, CNS Drugsand Other Pediatric Drugs Market for Years 2006, 2014 & 2020(includes corresponding Graph/Chart) III-58
4e. SPAIN III-59A.Market Analysis III-59Opportunity Indicator III-59Table 87: Spanish Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-59B.Market Analytics III-60Table 88: Spanish Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-60Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-61Table 90: Spanish 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-62
4f. RUSSIA III-63A.Market Analysis III-63Opportunity Indicator III-63Table 91: Russian Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-63B.Market Analytics III-64Table 92: Russian Recent Past, Current & Future Analysis forPediatric Drugs and Vaccines by Therapeutic Class -Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-64Table 93: Russian 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-65Table 94: Russian 15-Year Perspective for Pediatric Drugsand Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-66
4g. REST OF EUROPE III-67A.Market Analysis III-67Opportunity Indicator III-67Table 95: Number of reported cases for Vaccine-PreventableDiseases in Eastern European Region III-67Focus on Select Major Players III-67B.Market Analytics III-71Table 96: Rest of Europe Recent Past, Current & FutureAnalysis for Pediatric Drugs and Vaccines by TherapeuticClass - Pediatric Vaccines, Pediatric Hormones, Allergy &Respiratory Drugs, Anti-infective Drugs, CNS Drugs and OtherPediatric Drugs Market Independently Analyzed with AnnualSales in US$ Million for Years 2013 through 2020 (includescorresponding Graph/Chart) III-71Table 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$Million for Years 2006 through 2012 (includes correspondingGraph/Chart) III-72Table 98: Rest of Europe 15-Year Perspective for PediatricDrugs and Vaccines by Therapeutic Class - Percentage ShareBreakdown of Dollar Sales for Pediatric Vaccines, PediatricHormones, Allergy & Respiratory Drugs, Anti-infective Drugs,CNS Drugs and Other Pediatric Drugs Market for Years 2006,2014 & 2020 (includes corresponding Graph/Chart) III-73
5. ASIA-PACIFIC III-74A.Market Analysis III-74Table 99: Proportion of Children in the 0-15 Years Age Groupby Country in Asia-Pacific (2013) (includes correspondingGraph/Chart) III-74Burgeoning Middle Class Population in Asia Bodes Well forMarket Growth III-74Table 100: World Middle Class Population (2012 & 2030):Percentage Share Breakdown by Region - North America,Europe, Asia-Pacific, Latin America, and Middle East &Africa (includes corresponding Graph/Chart) III-75Vaccines Market in Asia-Pacific III-75Opportunity Indicator III-76Table 101: Number of reported Cases for Vaccine-PreventableDiseases in South-East Asia III-76Table 102: Number of reported cases for Vaccine-PreventableDiseases in West-Pacific Region III-76B.Market Analytics III-77Table 103: Asia-Pacific Recent Past, Current & FutureAnalysis for Pediatric Drugs and Vaccines by GeographicRegion - China, India, and Rest of Asia-Pacific MarketsIndependently Analyzed with Annual Sales in US$ Million forYears 2013 through 2020 (includes corresponding Graph/Chart) III-77Table 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-78Table 105: Asia-Pacific 15-Year Perspective for PediatricDrugs and Vaccines by Geographic Region - Percentage ShareBreakdown of Dollar Sales for China, India, and Rest ofAsia-Pacific Markets for Years 2006, 2014 & 2020 (includescorresponding 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-80Table 107: Asia-Pacific 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-81Table 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-83A.Market Analysis III-83Chinese Market Outlook III-83Opportunity Indicator III-83Table 109: Chinese Routine Immunization Coverage(2011-2013): Percentage of Live Births/NewBorns/Infants/Children Vaccinated III-83Growing Pediatric Market in China III-83
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