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02-Mar-2021

Pediatric Clinical Trials Market to Reach Highest Growth Line at 9.0% CAGR till 2023 – by GlaxoSmithKline plc., Sanofi S.A., Novartis AG, Johnson & Johnson, Merck, etc

Global Pediatric Clinical Trials Market – Insights

Pediatric clinical trials are focused on evaluating the efficacy of drugs that are used in for the treatment of various diseases in pediatric patients.

The global pediatric clinical trials market size was valued at US$ 12,571.7 million in 2020, and is expected to exhibit a CAGR of 9.0% over the forecast period (2020 – 2027).

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Figure 1. Global Pediatric Clinical Trials Market Share (%), by Clinical Phase, 2020

Global Pediatric Clinical Trials Market: Drivers

Increasing number of drugs under clinical trial is expected to propel growth of the global pediatric clinical trials market. For instance, according to Pharmaceutical Research and Manufacturers’ Association (PHRMA)’s 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.

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Moreover, increasing approval and launch of novel pediatric drugs is expected to propel growth of the market. For instance, in August 2018, Biocodex received the 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 the U.S. FDA approval for Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

Increasing demand for new vaccines and other biologic products is also expected to boost growth of the market. For instance, 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.

Global Pediatric Clinical Trials Market: Restraints 

However, several pediatric clinical trials are terminated due to several reasons such as patient accrual, behavioral problem, and trial conduct issues such as inaccurate dosing, difficulty in formulation, informative termination, drug toxicity during trials, and regulatory issues. According to the 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. Such scenario is expected to hinder growth of the global pediatric clinical trials market.

Figure 2. Global Pediatric Clinical Trials Market Value (US$ Mn), by Region, 2020

Global Pediatric Clinical Trials Market: Regional Analysis

North America is expected to account for the largest market share in the global pediatric clinical trials market over the forecast period. This is attributed to increasing incidence of chronic diseases in pediatric population and increasing number of clinical trials conducted in the U.S. Infants, children, and adolescents are at high risk of various diseases such as cancer, diabetes, diarrhea, encephalitis, polio, epilepsy, chronic obstructive pulmonary disease, (COPD), and asthma. For instance, 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.

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Global Pediatric Clinical Trials Market: Competitive Landscape

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

Table of Contents

  1. Research Objectives and Assumptions
    • 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. (2019)
    • List Of Pediatric Trials Registered In Europe (2015-2019)
    • Overview Of Pediatric Trials Network (PTN) And List Of Trials Registered Under PTN
  4. Global Subcutaneous Drug Delivery Market, Impact of COVID-19 Pandemic
    • Post COVID-19 Impact
    • Initiatives Taken To Conduct Ongoing Clinical Trials
    • Clinical Trial Analysis
  5. Global Subcutaneous Drug Delivery Market, By Clinical Trial Phase, 2016-2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
    • Segment Trends
      • Pre-clinical
        • Introduction
        • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
      • Phase I
        • Introduction
        • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
      • Phase II
        • Introduction
        • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
      • Phase III
        • Introduction
        • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
  6. Global Subcutaneous Drug Delivery Market, By Study Design, 2016–2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
      • Segment Trends
        • Interventional Study
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
            • Randomized Trials
              • Introduction
              • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
            • Non-randomized Trials
              • Introduction
              • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
            • Crossover Trials
              • Introduction
              • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
        • Observational Study
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2016–2027, (US$ Mn)
  7. Global Pediatric Clinical Trials Market, By Medical Condition, 2020 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017– 2027
      • Segment Trends
        • Neuropsychiatric Conditions
          • Introduction
          • Market Size and Forecast, and Y-o-Y Growth, 2020 – 2027, (US$ Mn)
        • Infectious Diseases
        • Maternal and Perinatal Conditions
        • Respiratory Diseases
        • Cardiovascular Diseases
        • Cancer
        • Digestive Diseases
        • Diabetes
        • Nutritional Deficiencies
        • Others
  8. Global Subcutaneous Drug Delivery Market, By Region, 2016–2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, By Country, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, For Countries, 2017–2027
    • North America
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country, 2016–2027 (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country, 2016–2027 (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country, 2016–2027 (US$ Mn)
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country, 2016–2027 (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country, 2016–2027 (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Introduction
      • Market Size and Forecast, By Clinical Trial Phase, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Study Design, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Medical Condition, 2016–2027 (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2016–2027 (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  9. Competitive Landscape
    • Company Profiles
      • Syneos Health Inc.*
        • Company Overview
        • Clinical Trial Phase Portfolio
        • Financial Overview
        • 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.
      • Takeda Pharmaceutical Company Limited
      • Vertex Pharmaceuticals Inc.
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Last Updated: 02-Mar-2021