Pediatric Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Pediatric Clinical Trials market is segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Study Design (Treatment Studies and Observational Studies), Therapeutic Area (Respiratory Diseases, Infectious Diseases, Oncology, Diabetes, and Other Therapeutic Areas) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 14.5 %

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Market Overview

The Pediatric Clinical Trials Market was estimated to grow at a CAGR of 14.5% during the forecast period. 

The outbreak of COVID-19 impacted the pediatric clinical trials market. The impact of COVID-19 affected the ability to recruit young patients for new trials and keep the registered patients in line with their study schedules. Many clinical trials were being conducted for COVID-19 vaccines for children, which is expected to significantly boost market development. For instance, in September 2021, Pfizer and BioNTech announced positive topline results from pivotal trial of COVID-19 Vaccine in Children 5 to 11 Years and submitted the data to the Food and Drug Administration, European Medicines Agency and other regulatory agencies around the world. The companies introduced positive findings from a Phase 2/3 clinical trial in April 2022 that examined the immunogenicity, safety, and efficacy of a 10-g booster dosage (third dose) of the Pfizer-BioNTech COVID-19 vaccine in healthy children between the ages of 5 and 11. These findings support the idea that a third dosage of the vaccination is likely to help pediatric age group retain high levels of viral protection.

Additionally, in June 2021, Serum Institute of India (SII) authorities applied for the Covovax COVID-19 vaccine from the Drug Controller and General of India (DCGI) to conduct a clinical trial among the pediatric population. These developments by key market players are expected to boost market growth.

In addition, rising awareness about pediatric medicine, shifting in-house clinical trials to CROs, and the increasing burden of pediatric diseases such as diabetes are actively affecting the growth of the studied market.

Over the last decade, the pharmaceutical industry has been gradually shifting from in-house clinical research to contract research organization (CRO). For instance, the article titled 'The Growing Role of CROs in Clinical Trials' published in PPD (Part of Thermo Fisher Scientific) in April 2022, stated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs). It also stated that venture capitalists increased investments into the biotech sector by 60% in January 2021 compared to a year prior. The shifting of in-house clinical trials to CROs is projected to augment the market growth during the forecast period.

Also, according to a report by Tufts University in collaboration with ICON PLC, on CROs’ strategic partnerships, it was estimated that in 2020, 70% of all clinical trials had been transferred to CROs across the globe. The role of CROs has become increasingly important as they are more involved in clinical research and are seen more as calculated partners, providing access not only to dedicated expertise but also to patients around the world. The growth of the pediatric trials has also led to the formation of specific pediatric CROs, such as Paidion Research, the first global CRO dedicated exclusively to pediatric health research. Such developments in CROs have driven the trend of shifting in-house clinical trials to the CROs and ultimately boost the studied market growth.

The increasing involvement of companies in clinical trails and funding by the government worldwide to develop noval therapies is expected to boost the market. For instance, in May 2022, the Australian Government’s Medical Research Future Fund (MRFF) funded USD 21.6 million to the researchers for developing a treatment for juvenile idiopathic arthritis and other musculoskeletal disorders. Also, in March 2021, the company Moderna Inc. announced the first participants dosed in Phase 2/3 study of the COVID-19 Vaccine candidates in the pediatric population. The surge in trials and funding by the government are anticipated to augment the market growth.

Therefore, owing to the aforementioned factors the studied market is anticipated to witness growth over the analysis period. however, ethical issues in pediatric research and small size of study population are likely to impede market growth.

Scope of the Report

As per the scope of the report, clinical trials conducted on children, for the research and development of new drugs, are called pediatric clinical trials. The Pediatric Clinical Trials market is segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Study Design (Treatment Studies and Observational Studies), Therapeutic Area (Respiratory Diseases, Infectious Diseases, Oncology, Diabetes, and Other Therapeutic Areas) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Phase
Phase I
Phase II
Phase III
Phase IV
By Study Design
Treatment Studies
Observational Studies
By Therapeutic Area
Respiratory Diseases
Infectious Diseases
Other Therapeutic Areas
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East and Africa
South Africa
Rest of Middle East and Africa
South America
Rest of South America

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Key Market Trends

Oncology Segment is Expected to Witness Growth Over the Forecast Period

The oncology segment of the market studied is expected to have exponential growth in the forecast period, owing to the increasing prevalence of cancer in the pediatric age group. The most common cancers in children younger than 15 years are leukemia and brain and central nervous system tumors.

According to the American Cancer Society, Cancer Facts and Figures 2022 report, an estimated 10,470 children (aged 0 to 14 years) is likely to be diagnosed with cancer and 1,050 children is predicted to die from the disease in 2022 in America. It also states that pediatric cancer rates have increased over the past few decades. Furthermore, As per, in September 2022, there were approximately 3,368 ongoing pediatric clinical trials, for cancer. The surge in the number of these trials is expected to boost the segment's growth.

With the increasing number of pediatric cancer cases worldwide, many hospitals and institutes are focusing on developing therapeutic drugs for the same, thereby leading to an increased number of pediatric clinical trials worldwide. For instance, in November 2020, a first-in-human clinical trial for children with relapsed or refractory neuroblastoma started at the American Family Children's Hospital (AFCH) and was being conducted by researchers at University of Wisconsin School of Medicine and Public Health.

Moreover, in June 2020, the Leukemia and Lymphoma Society (LLS) collaborated with the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) to launch precision medicine clinical trials for children with acute leukemia. These collaborations are projected to boost the segment growth.

Clinical trials

North America is Expected to Dominate the Pediatric Clinical Trials Market Over The Forecast Period

North America is found to hold a significant share of the pediatric clinical trial market and is expected to show a similar trend over the forecast period.

According to, as of September 2022, there were more than 1,644 ongoing pediatric clinical trials in the United States, which represent a large proportion of the global number of pediatric research procedures. The high number of trials and high cost per procedure and patient have primarily impacted the market in the United States.

The increasing prevalence of diseases in the pediatric population of the country is boosting the research programs to develop specific drugs. For instance, According to the International Diabetes Federation Diabetes Atlas Tenth edition, December 2021 update, more than 1.2 million children and adolescents (0-19 years) were living with type 1 diabetes in 2021.

Many clinical trials were commenced in the United States in the field of COVID-19 vaccines for children. For instance, in April 2021, Yale University of Medicine started the clinical trial of the COVID-19 vaccine developed by Pfizer and BioNTech in young children and adolescents. Developments like these are expected to boost market growth.

Additionally, the key players have been involved in various startegic alliances such as acquisitions, collaborations along with launch of advanced products to secure the position in the global market. For instance, in April 2021, Novartis initiated SMART, a Phase 3b clinical study to evaluate the safety and efficacy of Zolgensma (onasemnogene abeparvovec) in young children with spinal muscular atrophy. These developments are projected to augment the market growth in the region

Therefore, owing to the above-mentioned factors, the growth of the studied market is anticipated in the North America Region.

Pediatric Clinical Trials Market - Growth Rate by Region

Competitive Landscape

The pediatric clinical trials market is consolidated, owing to the presence of a few key players in the market with very few other players. Some of the market players include Bristol - Myers Squibb, Charles River Laboratories International Inc., Covance Inc., ICON plc, IQVIA, Novartis AG, Pfizer, Inc., Pharmaceutical Product Development, LLC, and Syneos Health Inc. 

Recent Developments

  • In August 2022, Pfizer announced positive top-line results from its pivotal United States Phase 3 study in infants which evaluated its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine for the pediatric population.
  • In July 2022, Sanofi's Phase 3 trial showed positive results in children 1 to 11 years of age with eosinophilic esophagitis (EoE). There are no approved treatments for children with EoE under 12 years of age.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Awareness about Pediatric Medicine

      2. 4.2.2 Shifting In-house Clinical Trials to CROs

      3. 4.2.3 Increasing Burden of Pediatric Diseases, such as Diabetes

    3. 4.3 Market Restraints

      1. 4.3.1 Ethical Issues in Pediatric Research

      2. 4.3.2 Small Size of Study Population

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Phase

      1. 5.1.1 Phase I

      2. 5.1.2 Phase II

      3. 5.1.3 Phase III

      4. 5.1.4 Phase IV

    2. 5.2 By Study Design

      1. 5.2.1 Treatment Studies

      2. 5.2.2 Observational Studies

    3. 5.3 By Therapeutic Area

      1. 5.3.1 Respiratory Diseases

      2. 5.3.2 Infectious Diseases

      3. 5.3.3 Oncology

      4. 5.3.4 Diabetes

      5. 5.3.5 Other Therapeutic Areas

    4. 5.4 Geography

      1. 5.4.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Bristol-Myers Squibb Company

      2. 6.1.2 Charles River Laboratories International Inc.

      3. 6.1.3 Covance Inc.

      4. 6.1.4 GlaxoSmithKline plc

      5. 6.1.5 ICON plc

      6. 6.1.6 IQVIA

      7. 6.1.7 Novartis AG

      8. 6.1.8 Pfizer, Inc.

      9. 6.1.9 Pharmaceutical Product Development, LLC

      10. 6.1.10 Syneos Health Inc.

      11. 6.1.11 Paidion Research, Inc.

      12. 6.1.12 The Emmes Company, LLC

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global Pediatric Clinical Trials Market market is studied from 2019 - 2027.

The Global Pediatric Clinical Trials Market is growing at a CAGR of 14.5% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Bristol-Myers Squibb Company, Covance Inc., IQVIA, Pharmaceutical Product Development, LLC, Syneos Health Inc. are the major companies operating in Global Pediatric Clinical Trials Market.

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