Pediatric Clinical Trials Market, by Clinical Trial Phase (Pre-clinical, Phase I, Phase II, and Phase III), by Study Design (Interventional, [Randomized Trial, Non-randomized Trial, Crossover Trial], and Observational), by Medical Condition (Neuropsychiatric Conditions, Infectious Diseases, Maternal and Perinatal Conditions, Respiratory Diseases, Cardiovascular Diseases, Cancer, Digestive Diseases, Diabetes, Nutritional Deficiencies, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : Feb 2019 |
  • Pages : 277 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Pediatric Clinical Trials Market – Easy Administration of Medications

Pediatric clinical trials play a major role in modern healthcare, as pediatric clinical trials are the only criteria to launch new drugs in market for various indications that affect pediatric population and therefore pharmaceutical and biotechnological industries have been gradually shifting from in-house clinical research to contract research organization (CRO).

The global pediatric clinical trials market size was valued at US$ 9,885.7 million in 2017, and is expected to exhibit a CAGR of 8.8% over the forecast period (2018 – 2026).

Figure 1. Global Pediatric Clinical Trials Market Value (US$ Mn), by Region, 2017

Pediatric Clinical Trials  | Coherent Market Insights

                                                       Source: Coherent Market Insights Analysis (2018)

Robust product pipeline, increasing approval of new pediatric drugs and high outsourcing for drug are factors driving growth of the market 

Increasing number of drugs under clinical stage of development in order to cater to unmet medical needs for pediatric patient population is expected to boost the market growth. According to Pharmaceutical Research and Manufacturers’ Association (PHRMA) data in 2018, over 1,300 industry-sponsored pediatric clinical trials are underway across a variety of therapeutic areas, including diseases where there is significant unmet need such infectious diseases, neurologic conditions, genetic disorders, and several forms of cancer. Furthermore, robust product pipeline and increasing approval of new pediatric drugs is expected to boost the market growth. For instance, in August 2018, Biocodex received U.S. FDA approval for Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome. Similarly, in October 2018, Regeneron Pharmaceuticals received U.S. FDA approval for Dupixent (dupilumab) for the treatment of moderate-to-severe asthma.

Moreover, in December 2018, Stemline Therapeutics, received U.S. FDA approval for Elzonris (tagraxofusp-erzs) for the treatment of blastic plasmacytoid dendritic cell neoplasm in adults and pediatrics. In June 2018, GW Pharmaceuticals received U.S. FDA approval for Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

However, high termination percentage of pediatric clinical trials due to several reasons is expected to hinder growth of the pediatric clinical trials market. Pediatric trials have high percentage of failure due to reasons such as patient accrual. Other issues include, behavioral problem and trial conduct issues such as inaccurate dosing, difficulty in formulation, and informative termination along with regulatory issues and drug toxicity during clinical trials. According to U.S. FDA, around 25 - 40% of pediatric trials fail to establish safety, efficacy, and result in a labeled indication for pediatric use, which results in their termination.

Figure 2. Global Pediatric Clinical Trials Market Share (%), by Study Design, 2018 and 2026

Pediatric Clinical Trials  | Coherent Market Insights

                                                                  Source: Coherent Market Insights Analysis (2018)

Increasing prevalence of chronic diseases in pediatric population in North America is expected to bolster the market growth

North America is expected to hold dominant position in the global pediatric clinical trials market, owing to high prevalence of chronic diseases in pediatric population and increasing number of clinical trials conducted in the U.S. Pediatric population is one of the most vulnerable groups to various diseases such as polio, epilepsy, encephalitis, asthma, chronic obstructive pulmonary disease, (COPD) and other respiratory diseases. Other diseases also include, cancer, diabetes, diarrhea, leukemia, anemia, chronic kidney disease, and other rare diseases that result in substantial disease burden worldwide. Increasing demand for new vaccines and other biologic products to tackle various infectious diseases such as measles, mumps, polio, tuberculosis, rubella, influenza, whooping cough, chickenpox, malaria, and streptococcal pharyngitis is also expected to boost the market growth. According to the World Health Organization (WHO) 2018, around 86% of infants are vaccinated against 26 diseases worldwide. However, around 19.5 million children are unvaccinated leading to death of 2-3 million children annually. Innovative approaches such as micro-needle vaccine can be utilized after due trial for safety and efficacy.

Similarly, according to the Centers for Disease Control and Prevention (CDC) factsheet in 2018, around 470,000 children had active epilepsy in the U.S., accounting for around 0.6% of children aged 0-17 years.

Key Players

Major players operating in the global pediatric clinical trials market include, Syneos Health Inc., IQVIA Holdings, Inc., Charles River Laboratories International Inc., Covance Inc., ICON plc., Pharmaceutical Product Development, LLC, Genentech (F. Hoffmann-La Roche AG), Pfizer, Inc., Bristol - Myers Squibb, GlaxoSmithKline plc., Sanofi S.A., Novartis AG, Johnson & Johnson, Merck & Co., Inc., Shire plc., and Vertex Pharmaceuticals Inc.

Clinical trials are the gold standard and must for generating evidence-based data and knowledge in medicine. Clinical trials conducted on children (between age group of 0 to 18) for research and development of drugs or formation of new drugs are called as pediatric clinical trials. Pharmaceuticals and biotechnological industries and government regulatory bodies are collectively focused on improving research and development for pediatrics population. A new law in the U.S. and Europe was passed as pediatric regulation 2007 that required new adult drugs to be tested for use in children. This in turn is expected to lead to increasing number of pediatric clinical trials in the U.S. and worldwide.

Market Dynamics

Robust product pipeline, increasing approval of new pediatric drugs and high outsourcing for drug development are major factors driving pediatric clinical trials market growth. According to Pharmaceutical Research and Manufacturers’ Association (PHRMA) data in 2018, over 1,300 industry-sponsored pediatric clinical trials are underway across a variety of therapeutic areas, including diseases where there is significant unmet need such as infectious diseases, neurologic conditions, genetic disorders, and several forms of cancer. Similarly, 5 pediatric drugs received U.S. FDA approvals in 2018 and 4 and 7 in 2017 and 2015, respectively.

Moreover, introduction of new approaches in clinical research and implementation of advanced technology is expected to boost the market growth. Adoption of data analytics and machine learning platforms is expected to help in better management of the data generated during trials, which can play key role in faster drug development. For instance, in 2015, Quintiles announced the addition of advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution.

Key features of the study:

  • This report provides in-depth analysis of the pediatric clinical trials market, provides market size (US$ million) and Compound Annual Growth Rate (CAGR %) for the forecast period (2018 – 2026), considering 2017 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by key players
  • It profiles key players in the global pediatric clinical trials market based on the following parameters–company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include, Syneos Health Inc., IQVIA Holdings, Inc., Charles River Laboratories International Inc., Covance Inc., ICON plc., Pharmaceutical Product Development, LLC, Genentech (F. Hoffmann-La Roche AG), Pfizer, Inc., Bristol - Myers Squibb, GlaxoSmithKline plc., Sanofi S.A., Novartis AG, Johnson & Johnson, Merck & Co., Inc., Shire plc., and Vertex Pharmaceuticals Inc.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global pediatric clinical trials market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the pediatric clinical trials market

Detailed Segmentation:

  • Global Pediatric Clinical Trials Market, By Clinical Trial Phase:
    • Pre-clinical
    • Phase I
    • Phase II
    • Phase III
  • Global Pediatric Clinical Trials Market, By Study Design:
    • Interventional
      • Randomized Trial
      • Non-randomized Trial
      • Crossover Trial
    • Observational
  • Global Pediatric Clinical Trials Market, By Medical Condition:
    • Neuropsychiatric Conditions
    • Infectious Diseases
    • Maternal and Perinatal Conditions
    • Respiratory Diseases
    • Cardiovascular Diseases
    • Cancer
    • Digestive Diseases
    • Diabetes
    • Nutritional Deficiencies
    • Others
  • Global Pediatric Clinical Trials Market, By Region:
    • North America
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Clinical Trial Phase:
        • Pre-clinical
        • Phase I
        • Phase II
        • Phase III
      • By Study Design:
        • Interventional
          • Randomized Trial
          • Non-randomized Trial
          • Crossover Trial
        • Observational
      • By Medical Condition:
        • Neuropsychiatric Conditions
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Syneos Health Inc. *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • IQVIA Holdings, Inc.
    • Charles River Laboratories International Inc.
    • Covance Inc.
    • ICON plc.
    • Pharmaceutical Product Development, LLC.
    • Genentech (F. Hoffmann-La Roche AG).
    • Pfizer, Inc.
    • Bristol - Myers Squibb.
    • GlaxoSmithKline plc.
    • Sanofi S.A.
    • Novartis AG
    • Johnson & Johnson
    •  Merck & Co., Inc.
    • Shire plc.
    • Vertex Pharmaceuticals Inc.

 “*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Clinical Trial Phase
      • Market Snippet, By Study Design
      • Market Snippet, By Medical Condition
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Impact Analysis
      • Market Opportunities
    • Collaborators For Pediatric Trial Network Studies
    • Incentives To Promote Pediatric Trial
    • Regulatory Scenario
    • Total Number Of Trials In the U.S. and Europe
    • List Of Pediatric Trials Registered In The U.S. (2018)
    • List Of Pediatric Trials Registered In Europe (2015-2018)
    • Overview Of Pediatric Trials Network (PTN) And List Of Trials Registered Under PTN
  4. Global Pediatric Clinical Trials Market, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017– 2026
      • Segment Trends
    • Phase-I
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Phase-II
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Phase-III
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
  5. Global Pediatric Clinical Trials Market, By Study Design, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017– 2026
      • Segment Trends
    • Interventional
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
        • Randomized Trial
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
        • Non-randomized Trial
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
        • Cross-over Trial
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
        • Observational
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
  6. Global Pediatric Clinical Trials Market, By Medical Condition, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017– 2026
      • Segment Trends
    • Infectious Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Maternal and Perinatal Conditions
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Respiratory Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Cardiovascular Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Digestive Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Diabetes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Nutritional Deficiencies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
  7. Global Pediatric Clinical Trials Market, By Region, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • Germany
        • U.K.
        • France        
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of APAC
    • Middle East
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Clinical Trial Phase, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Study Design, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2018 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Syneos Health Inc.*
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • IQVIA Holdings, Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Charles River Laboratories International Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Covance Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • ICON plc
        •  Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Pharmaceutical Product Development, LLC
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Genentech (F. Hoffmann-La Roche AG)
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Pfizer, Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Bristol - Myers Squibb
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • GlaxoSmithKline plc
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Sanofi S.A.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Novartis AG
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Johnson & Johnson
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Merck & Co., Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Shire plc
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Vertex Pharmaceuticals Inc.
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 38 market data tables and 34 figures on "Pediatric Clinical Trials Market - Global forecast to 2026”.

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