Summary

Report Overview
The Global Pediatric Clinical Trials Market reached US$ 14.99 billion in 2023 and is expected to reach US$ 23.54 billion by 2031 growing with a CAGR of 5.8% during the forecast period 2024-2031.
Pediatric clinical trials are research studies designed to evaluate medical treatments' safety, effectiveness, and dosage, including pharmaceuticals and medical devices, specifically for children. These trials are crucial for developing age-appropriate therapies, as children metabolize and react to medications differently than adults.
Pediatric clinical trials are designed and conducted with the unique needs and characteristics of children in mind. While the overall process is similar to adult clinical trials, several key considerations distinguish pediatric studies.
By incorporating specific considerations into their design and execution, these trials aim to generate high-quality evidence on the safety and efficacy of treatments while prioritizing the well-being of child participants and minimizing risks.
Market Dynamics: Drivers
Increasing prevalence of pediatric diseases and technological advancements
The demand for the global pediatric clinical trials market is driven by multiple factors. One of the primary factors is the increasing prevalence of pediatric diseases and technological advancements.
The rising incidence of chronic and infectious diseases among children significantly impacts the pediatric clinical trials market by increasing the demand for effective treatments. Conditions such as type 1 diabetes and childhood cancers have seen a marked increase in prevalence. The prevalence of type 1 diabetes among children and adolescents has seen a significant rise in recent years.
According to the International Diabetes Federation, there were an estimated 1.2 million children and adolescents living with type 1 diabetes as of 2021. The demand for pediatric clinical trials has also surged due to the need for vaccines and treatments for various infectious diseases.
Innovations in pediatric medicine, including developing biomarkers, personalized medicine techniques, and advanced diagnostic instruments, are transforming the landscape of pediatric research and clinical trials. These advancements enable more efficient and focused studies, which are crucial for addressing the unique health needs of children.
Moreover, key players in the industry are more focused on treating pediatric disease, and raising many clinical trials and ongoing R&D activities helps drive this market growth. For instance, in September 2023, Valneva SE and Pfizer Inc. announced encouraging results regarding the immunogenicity and safety of their Lyme disease vaccine candidate, VLA15, specifically for pediatric and adolescent populations when administered as a booster. The findings stem from the VLA15-221 Phase 2 study, which demonstrated a robust anamnestic antibody response across all serotypes in participants aged 5 to 11 years (pediatric) and 12 to 17 years (adolescent), as well as in adults aged 18 to 65, one month following the booster dose given at month 19.
Also, in March 2023, GSK plc announced positive headline results from its Phase III clinical trial assessing the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate. This vaccine was administered in two doses, spaced six months apart, to healthy individuals aged 10 to 25 years. The MenABCWY vaccine integrates the antigen components from GSK's existing meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).
Similarly, in November 2023, Pharming Group N.V. announced that the first patient had been dosed in its Phase III pediatric clinical trial assessing a new formulation of the investigational drug leniolisib. This oral medication is a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor designed for children aged one to six years diagnosed with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency disorder.
Restraints
Factors such as the high cost of clinical studies, regulatory challenges, ethical issues in pediatric research, and the small size of the study population, are expected to hamper the market.
Market Segment Analysis
The global pediatric clinical trials market is segmented based on phase, study design, therapeutic areas, and region.
The oncology segment accounted for approximately 56.1% of the global pediatric clinical trials market share
The oncology segment is expected to hold the largest market share over the forecast period. The rising incidence of pediatric cancers over the past few decades is a significant public health concern that necessitates ongoing research to understand the underlying causes and develop effective treatment protocols tailored specifically to the pediatric population.
Pediatric oncology requires distinct treatment approaches due to the physiological differences between children and adults. These differences influence how cancers develop, progress, and respond to treatment, necessitating specialized strategies for managing childhood cancers.
Moreover, key players in the industry strategies such as partnerships & collaborations, key development such as R&D activities, rising number of clinical trial initiatives in oncology help to drive this market growth. For instance, in May 2024, Cincinnati Children's Hospital initiated the development of an Applied Gene and Cell Therapy Center, aiming to enhance clinical trials for innovative drugs and biological therapeutics targeting children with cancer, blood diseases, and genetic disorders. This initiative comes in response to a significant global health need, as over 300,000 children are diagnosed with cancer each year, and approximately 8 million are born with birth defects.
Also, in May 2024, Seattle Children's Hospital is set to launch the first clinical trial in the United States using chimeric antigen receptor (CAR) T-cell therapy to treat pediatric patients with systemic lupus erythematosus (SLE), a common form of lupus. This pioneering trial, named Reversing Autoimmunity through Cell Therapy (REACT-01), is scheduled to begin this summer and has received authorization from the U.S. Food and Drug Administration (FDA).
Similarly, in April 2023, Seattle Children's Hospital announced the launch of a groundbreaking clinical trial that utilizes a novel approach to combat pediatric brain and spinal cord tumors. The trial, known as BrainChild-04, employs a unique chimeric antigen receptor (CAR) T-cell therapy that simultaneously targets four different antigens expressed by these cancers.
Market Geographical Analysis
North America accounted for approximately 46.8% of the global pediatric clinical trials market share
North America region is expected to hold the largest market share over the forecast period owing to the high incidence of pediatric diseases is driving the market growth in the region. Pediatric cancers, while relatively rare compared to adult cancers, are a significant health concern due to their impact on children. Despite their lower incidence, childhood cancers represent one of the leading causes of disease-related mortality in children. According to the American Cancer Society, approximately 10,470 children aged 0 to 14 were expected to be diagnosed with cancer in 2022 in the United States.
Moreover, a growing number of clinical trials and the United States has a well-established regulatory framework that encourages and supports pediatric clinical trials. Initiatives like the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) mandate that pharmaceutical companies assess the safety and efficacy of new drugs in pediatric populations.
According to clinicaltrials.gov, as of September 2022, there were more than 1,644 ongoing pediatric clinical trials in the United States, which represent a significant portion of global pediatric research efforts.
In addition, a major number of key player's presence, significant investment in R&D, presence of leading research institutions, collaboration & partnerships, and technological advancements would propel this market growth in the region. For instance, in New York, in April 2024, Pfizer Inc. announced promising top-line immunogenicity and safety data from its ongoing pivotal Phase 3 clinical trial, known as MONeT (RSV Immunization Study for Adults at Higher Risk of Severe Illness). This trial is evaluating the efficacy of a single dose of the vaccine ABRYSVO in adults aged 18 to 59 who are at increased risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
Similarly, in February 2023, Syneos Health announced the establishment of a Decentralized Clinical Trial (DCT) Site Network aimed at facilitating the adoption of DCTs and ensuring high-quality delivery of these trials along with digital health technology solutions. This new DCT Site Network complements the company's existing Site Advocacy Group and aims to bring clinical trials closer to patients. Initially launched in the U.S. and Canada, the network will encompass various therapeutic areas, including Internal and General Medicine, Family Practice, Neurology, Endocrinology, Pediatrics, Psychiatry, Dermatology, Cardiology, Obstetrics and Gynecology, Ophthalmology, and Respiratory.
Market Segmentation
By Phase
Phase I
Phase II
Phase III
Phase IV
By Study Design
Treatment Studies
Observational Studies
Prospective Cohort
Case-Control Study
Cohort Study
Cross-Sectional Study
Ecological Study
By Therapeutic Areas
Oncology
Autoimmune or Inflammatory Diseases
Respiratory Diseases
Infectious Diseases
Mental Health Disorders
Others
By Region
North America
U.S.
Canada
Mexico
Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
South America
Brazil
Argentina
The rest of South America
Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
Middle East and Africa
Market Competitive Landscape
The major global players in the pediatric clinical trials market include Pfizer Inc., ICON plc, GSK plc, Syneos Health, Bristol-Myers Squibb Company, IQVIA Inc., Thermo Fisher Scientific Inc. (PPD Inc.), Novartis AG, The Emmes Company, LLC, and Medpace among others.
Key Developments
In July 2024, GSK launched a new multichannel campaign titled 'Ab India Banega 7-Star,' which emphasizes to parents that the future of India lies in their hands. The campaign encourages them to protect their children's future through seven essential vaccinations against 14 diseases, including chickenpox, hepatitis A, hepatitis B, meningitis, measles, mumps, rubella, pneumonia, influenza, diphtheria, tetanus, pertussis, HiB infection, and polio.
In February 2024, Innovative Trials announced a new initiative aimed at enhancing patient retention in pediatric clinical studies, called the Retention Patch Program. This program, launched in partnership with the Oliver Patch Project, is designed to engage children and young people under 18 throughout their clinical trial experiences.
In October 2023, Neurocrine Biosciences, Inc. announced positive top-line results from its Phase 3 CAHtalyst Pediatric Study, which evaluates the efficacy, safety, and tolerability of crinecerfont in children and adolescents diagnosed with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
Why Purchase the Report?
To visualize the global pediatric clinical trials market segmentation based on phase, study design, therapeutic areas, and region and understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of the pediatric clinical trials market with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping is available in Excel consisting of key products of all the major players.
The global pediatric clinical trials market report would provide approximately 62 tables, 55 figures, and 184 pages.
Target Audience 2024
Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Phase
3.2. Snippet by Study Design
3.3. Snippet by Therapeutic Areas
3.4. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increasing Prevalence of Pediatric Diseases and Technological Advancements
4.1.1.2. XX
4.1.2. Restraints
4.1.2.1. High Cost of Clinical Studies
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter’s Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
6. By Phase
6.1. Introduction
6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
6.1.2. Market Attractiveness Index, By Phase
6.2. Phase I *
6.2.1. Introduction
6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Phase II
6.4. Phase III
6.5. Phase IV
7. By Study Design
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
7.1.2. Market Attractiveness Index, By Study Design
7.2. Treatment Studies*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Observational Studies
7.3.1. Prospective Cohort
7.3.2. Case-Control Study
7.3.3. Cohort Study
7.3.4. Cross-Sectional Study
7.3.5. Ecological Study
8. By Therapeutic Areas
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
8.1.2. Market Attractiveness Index, By Therapeutic Areas
8.2. Oncology *
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Autoimmune or Inflammatory Diseases
8.4. Respiratory Diseases
8.5. Infectious Diseases
8.6. Mental Health Disorders
8.7. Others
9. By Region
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
9.1.2. Market Attractiveness Index, By Region
9.2. North America
9.2.1. Introduction
9.2.2. Key Region-Specific Dynamics
9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
9.2.6.1. U.S.
9.2.6.2. Canada
9.2.6.3. Mexico
9.3. Europe
9.3.1. Introduction
9.3.2. Key Region-Specific Dynamics
9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
9.3.6.1. Germany
9.3.6.2. U.K.
9.3.6.3. France
9.3.6.4. Spain
9.3.6.5. Italy
9.3.6.6. Rest of Europe
9.4. South America
9.4.1. Introduction
9.4.2. Key Region-Specific Dynamics
9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
9.4.6.1. Brazil
9.4.6.2. Argentina
9.4.6.3. Rest of South America
9.5. Asia-Pacific
9.5.1. Introduction
9.5.2. Key Region-Specific Dynamics
9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
9.5.6.1. China
9.5.6.2. India
9.5.6.3. Japan
9.5.6.4. South Korea
9.5.6.5. Rest of Asia-Pacific
9.6. Middle East and Africa
9.6.1. Introduction
9.6.2. Key Region-Specific Dynamics
9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic Areas
10. Competitive Landscape
10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis
11. Company Profiles
11.1. Pfizer Inc*
11.1.1. Company Overview
11.1.2. Product Portfolio and Description
11.1.3. Financial Overview
11.1.4. Key Developments
11.2. ICON plc
11.3. GSK plc
11.4. Syneos Health
11.5. Bristol-Myers Squibb Company
11.6. IQVIA Inc.
11.7. Thermo Fisher Scientific Inc. (PPD Inc.)
11.8. Novartis AG
11.9. The Emmes Company, LLC
11.10. Medpace (*LIST NOT EXHAUSTIVE)
12. Appendix
12.1. About Us and Services
12.2. Contact Us