Summary

Pediatric Clinical Trials Market Growth & Trends

The global pediatric clinical trials market size is estimated to reach USD 26.99 billion by 2030, expanding at a CAGR of 5.25% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market is growing on account of the rise in the number of pediatric clinical studies globally. As per the BMC journal, between January 2008 and December 2010, 7,029 pediatric clinical trials were registered. Whereas, between January 2017 and December 2019, the number of registered pediatric clinical trials was 11,738, which certainly reflects a significant surge in the total number of trials across the industry. The treatment options for COVID-19 pediatric patients were limited at the start of the pandemic, owing to which, in May 2020, FDA granted an Emergency Use Authorization (EUA) for Veklury (remdesivir), which could be used for the treatment of COVID-19 in adults and children.

Similarly, Convalescent plasma was also granted an EUA from the FDA for the treatment of children and adults with COVID-19. Such actions by the regulatory agencies are likely to promote the demand for pediatric clinical trials. Furthermore, increasing efforts by several government bodies to support the clinical research pertaining to pediatric diseases has further supported the market growth. For instance, in March 2022, the National Cancer Institute launched the Molecular Characterization Initiative for pediatric tumors. The Initiative is offered through NCI’s Childhood Cancer Data Initiative, which was formed to promote data sharing and collection of new data among researchers who study pediatric oncology.

In addition, the increasing prevalence of pediatric cancer is another significant factor supporting the market as well as the oncology segment’s growth. For instance, as stated by the American Society of Clinical Oncology (ASCO)in February 2022, in the U.S., an estimated 10,470 children are younger than 15 years of age and about 5,480 teens aged 15 to 19 years will be diagnosed with cancer by the end of 2022. The WHO states that diarrhea, malaria, pneumonia, and sepsis are the leading causes of death among children between the age of 1 month and 9 years The high burden of these diseases is contributing to the demand for new treatment opinions. Thus, is likely to have a positive impact on the market growth. Apart from the high burden of infectious diseases, a significant number of children also suffer from diabetes.

For instance, according to the U.S. CDC, over 26.9 million in the U.S. were diagnosed with diabetes in 2018, which included 210,000 children and adolescents younger than age 20—or 25 years. Commercially, COVID19 vaccines were majorly focused on immunizing adults aged 18 years and above, this created a high risk of disease among children below the age of 18 years. The ClinicalTrial.GOV reports that as on 4th May 2022, over 1000 studies were in the active stage for treating and diagnosing COVID-19 for pediatric patients. The burden of COVID-19 among the kids is likely to promote the demand for COVID-19 vaccine trials for pediatrics from 2021.

Pediatric Clinical Trials Market Report Highlights

• The observational segment is expected to witness a considerable growth rate over the forecast period. These studies are done to investigate rare outcomes of the treatment and to detect unusual adverse effects. Such factors are driving the demand for observational studies in pediatrics

• The Phase II segment accounted for the largest share in 2024. Phase II studies consist of a high number of pediatric subjects; moreover, studies in this phase are more complex than that in other phases. Such factors are contributed to the segment's high share

• Based on therapeutic area, the oncology segment accounted for the largest share in 2024, after the others segment, owing to the high burden of cancer among the pediatrics, thus contributing to the demand for clinical studies

• Asia Pacific is projected to witness the fastest CAGR during the forecast years owing to the high population of the region, which contributes to the demand for new treatments

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Market Definitions
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. GVR’s Internal Database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Market Formulation & Validation
1.6. Model Details
1.6.1. Commodity Flow Analysis
1.6.2. Bottom-up Approach
1.7. List of Secondary Sources
1.8. List of Abbreviations
1.9. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Pediatric Clinical Trials Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Growth in the Number of Pediatric Clinical Trials
3.2.1.2. Rising Investment in R&D by the Pharmaceutical Companies
3.2.1.3. High Burden of Chronic and Infectious Diseases among Children
3.2.2. Market Restraint Analysis
3.2.2.1. Rising Costs of Clinical Trials
3.2.2.2. Complex Regulatory Landscape
3.3. Market Analysis Tools
3.3.1. Porter’s Five Forces Analysis
3.3.2. PESTEL Analysis
3.3.3. COVID-19 Impact Analysis
Chapter 4. Pediatric Clinical Trials Market: Phase Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Pediatric Clinical Trials Market; Phase Movement Analysis
4.3. Global Pediatric Clinical Trials Size & Trend Analysis, by Phase, 2018 to 2030 (USD Million)
4.4. Phase I
4.4.1. Phase I market estimates and forecasts 2018 to 2030 (USD Million)
4.5. Phase II
4.5.1. Phase II market estimates and forecasts 2018 to 2030 (USD Million)
4.6. Phase III
4.6.1. Phase III market estimates and forecasts 2018 to 2030 (USD Million)
4.7. Phase IV
4.7.1. Phase IV market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 5. Pediatric Clinical Trials Market: Study Design Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Global Pediatric Clinical Trials Market; Study Design Movement Analysis
5.3. Global Pediatric Clinical Trials Size & Trend Analysis, by Study Design, 2018 to 2030 (USD Million)
5.4. Treatment Studies
5.4.1. Interventional studies market estimates and forecasts 2018 to 2030 (USD Million)
5.5. Observational Studies
5.5.1. Observational studies market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 6. Pediatric Clinical Trials Market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Global Pediatric Clinical Trials Market; Indication Movement Analysis
6.3. Global Pediatric Clinical Trials Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
6.4. Infectious Diseases
6.4.1. Infectious diseases market estimates and forecasts 2018 to 2030 (USD Million)
6.5. Oncology
6.5.1. Oncology market estimates and forecasts 2018 to 2030 (USD Million)
6.6. Autoimmune/inflammation
6.6.1. Autoimmune/inflammation market estimates and forecasts 2018 to 2030 (USD Million)
6.7. Respiratory Disorders
6.7.1. Respiratory disorders market estimates and forecasts 2018 to 2030 (USD Million)
6.8. Mental Health Disorders
6.8.1. Mental Health Disorders market estimates and forecasts 2018 to 2030 (USD Million)
6.9. Others
6.9.1. Others market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 7. Pediatric Clinical Trials Market: Regional Estimates & Trend Analysis
7.1. Regional Market Share Analysis, 2024 & 2030
7.2. Regional Market Dashboard
7.3. North America
7.3.1. North America Market Estimates and Forecasts 2018 to 2030 (USD Million)
7.3.2. U.S.
7.3.2.1. Key country dynamics
7.3.2.2. Competitive scenario
7.3.2.3. Regulatory framework
7.3.2.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
7.3.3. Canada
7.3.3.1. Key country dynamics
7.3.3.2. Competitive scenario
7.3.3.3. Regulatory framework
7.3.3.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
7.3.4. Mexico
7.3.4.1. Key country dynamics
7.3.4.2. Competitive scenario
7.3.4.3. Regulatory framework
7.3.4.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
7.4. Europe
7.4.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
7.4.2. UK
7.4.2.1. Key country dynamics
7.4.2.2. Competitive scenario
7.4.2.3. Regulatory framework
7.4.2.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
7.4.3. Germany
7.4.3.1. Key country dynamics
7.4.3.2. Competitive scenario
7.4.3.3. Regulatory framework
7.4.3.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
7.4.4. France
7.4.4.1. Key country dynamics
7.4.4.2. Competitive scenario
7.4.4.3. Regulatory framework
7.4.4.4. France market estimates and forecasts 2018 to 2030 (USD Million)
7.4.5. Italy
7.4.5.1. Key country dynamics
7.4.5.2. Competitive scenario
7.4.5.3. Regulatory framework
7.4.5.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
7.4.6. Spain
7.4.6.1. Key country dynamics
7.4.6.2. Competitive scenario
7.4.6.3. Regulatory framework
7.4.6.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
7.4.7. Denmark
7.4.7.1. Key country dynamics
7.4.7.2. Competitive scenario
7.4.7.3. Regulatory framework
7.4.7.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
7.4.8. Sweden
7.4.8.1. Key country dynamics
7.4.8.2. Competitive scenario
7.4.8.3. Regulatory framework
7.4.8.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
7.4.9. Norway
7.4.9.1. Key country dynamics
7.4.9.2. Competitive scenario
7.4.9.3. Regulatory framework
7.4.9.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)
7.5. Asia Pacific
7.5.1. Asia Pacific Market Estimates and Forecasts 2018 to 2030 (USD Million)
7.5.2. Japan
7.5.2.1. Key country dynamics
7.5.2.2. Competitive scenario
7.5.2.3. Regulatory framework
7.5.2.4. Japan market estimates and forecasts 2018 to 2030 (USD Million)
7.5.3. China
7.5.3.1. Key country dynamics
7.5.3.2. Competitive scenario
7.5.3.3. Regulatory framework
7.5.3.4. China market estimates and forecasts 2018 to 2030 (USD Million)
7.5.4. India
7.5.4.1. Key country dynamics
7.5.4.2. Competitive scenario
7.5.4.3. Regulatory framework
7.5.4.4. India market estimates and forecasts 2018 to 2030 (USD Million)
7.5.5. Australia
7.5.5.1. Key country dynamics
7.5.5.2. Competitive scenario
7.5.5.3. Regulatory framework
7.5.5.4. Australia market estimates and forecasts 2018 to 2030 (USD Million)
7.5.6. South Korea
7.5.6.1. Key country dynamics
7.5.6.2. Competitive scenario
7.5.6.3. Regulatory framework
7.5.6.4. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
7.5.7. Thailand
7.5.7.1. Key country dynamics
7.5.7.2. Competitive scenario
7.5.7.3. Regulatory framework
7.5.7.4. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
7.6. Latin America
7.6.1. Latin America Market Estimates and Forecasts 2018 to 2030 (USD Million)
7.6.2. Brazil
7.6.2.1. Key country dynamics
7.6.2.2. Competitive scenario
7.6.2.3. Regulatory framework
7.6.2.4. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
7.6.3. Argentina
7.6.3.1. Key country dynamics
7.6.3.2. Competitive scenario
7.6.3.3. Regulatory framework
7.6.3.4. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
7.7. MEA
7.7.1. MEA Market Estimates and Forecasts 2018 to 2030 (USD Million)
7.7.2. South Africa
7.7.2.1. Key country dynamics
7.7.2.2. Competitive scenario
7.7.2.3. Regulatory framework
7.7.2.4. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
7.7.3. Saudi Arabia
7.7.3.1. Key country dynamics
7.7.3.2. Competitive scenario
7.7.3.3. Regulatory framework
7.7.3.4. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
7.7.4. UAE
7.7.4.1. Key country dynamics
7.7.4.2. Competitive scenario
7.7.4.3. Regulatory framework
7.7.4.4. UAE market estimates and forecasts 2018 to 2030 (USD Million)
7.7.5. Kuwait
7.7.5.1. Key country dynamics
7.7.5.2. Competitive scenario
7.7.5.3. Regulatory framework
7.7.5.4. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 8. Competitive Landscape
8.1. Company Categorization
8.2. Company Market Position Analysis, 2024
8.3. Company Profiles
8.3.1. ICON plc
8.3.1.1. Company overview
8.3.1.2. Financial performance
8.3.1.3. Service benchmarking
8.3.1.4. Strategic initiatives
8.3.2. Syneos Health
8.3.2.1. Company overview
8.3.2.2. Financial performance
8.3.2.3. Service benchmarking
8.3.2.4. Strategic initiatives
8.3.3. Medpace
8.3.3.1. Company overview
8.3.3.2. Financial performance
8.3.3.3. Service benchmarking
8.3.3.4. Strategic initiatives
8.3.4. Thermo Fisher Scientific Inc.
8.3.4.1. Company overview
8.3.4.2. Financial performance
8.3.4.3. Service benchmarking
8.3.4.4. Strategic initiatives
8.3.5. Premier Research
8.3.5.1. Company overview
8.3.5.2. Financial performance
8.3.5.3. Service benchmarking
8.3.5.4. Strategic initiatives
8.3.6. ICON plc
8.3.6.1. Company overview
8.3.6.2. Financial performance
8.3.6.3. Service benchmarking
8.3.6.4. Strategic initiatives
8.3.7. Laboratory Corporation of America
8.3.7.1. Company overview
8.3.7.2. Financial performance
8.3.7.3. Service benchmarking
8.3.7.4. Strategic initiatives
8.3.8. QPS Holdings.
8.3.8.1. Company overview
8.3.8.2. Financial performance
8.3.8.3. Service benchmarking
8.3.8.4. Strategic initiatives
8.3.9. Pfizer Inc.
8.3.9.1. Company overview
8.3.9.2. Financial performance
8.3.9.3. Service benchmarking
8.3.9.4. Strategic initiatives
8.3.10. The Emmes Company, LLC
8.3.10.1. Company overview
8.3.10.2. Financial performance
8.3.10.3. Service benchmarking
8.3.10.4. Strategic initiatives
8.3.11. IQVIA Inc.
8.3.11.1. Company overview
8.3.11.2. Financial performance
8.3.11.3. Service benchmarking
8.3.11.4. Strategic initiatives