Pediatric Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The Pediatric Clinical Trials market is segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Study Design, and Geography

Market Snapshot

Study Period:

2018 - 2026

Base Year:


Fastest Growing Market:

Asia Pacific

Largest Market:

North America


14.5 %

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Market Overview

The major factors for the growth of the pediatric clinical trial market include the rising awareness about pediatric medicine, shifting in-house clinical trials to CROs, and increasing the burden of pediatric diseases, such as diabetes.

Over the last decade, the pharmaceutical industry has been gradually shifting from in-house clinical research to contract research organization (CRO). Until the end of the 20th century, the majority of pharmaceutical companies structured out and executed clinical trials on their own, in their premises. Only small companies with fewer resources (in terms of money, manpower, and minutes) outsourced their clinical research work to CROs. As time progressed, even big companies began outsourcing their work. Thus, the competitive landscape in the field of CROs has increased rapidly. An increasing number of CROs were added to the list, globally, providing reliable and effective offerings to companies. Due to the increase in the number of CROs, pharmaceutical companies started increasing their research practices. In the past few years, organizations, such as IQVIA, PAREXEL, PPD, and others, have gained the confidence of big pharmaceutical companies and are performing well. Pediatric clinical trials have also gained importance as a result of this shift, as companies can now conduct more clinical trials (including pediatrics that was left out before, owing to uncertain returns and lack of resources). The ease of outsourcing clinical trials is boosting the practice of pediatric clinical trials, and thereby, the market for the same.

Scope of the Report

As per the scope of the report, clinical trials conducted on children, for the R&D of new drugs, are called pediatric clinical trials. Due to the increasing awareness about pediatric medicine, the need to effectively tackle diseases in children, FDA supporting pediatric clinical trial research, and others, the global pediatric clinical trials market is growing. There are various factors that are restraining the market, which include the lack of infrastructure for pediatric clinical trials and ethical issues.

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 & Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

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Key Market Trends

Phase ll Segment under Phase-wise Segmentation is Expected to Hold Largest Market Share Over the Forecast Period

Phase II is the step after Phase l for any biopharmaceutical company to proceed where clinical efficacy or biological activity ('proof of concept' studies) and optimum dose to show biological activity with minimal side-effects (‘definite dose-finding’ studies) are performed in 100-300 patients with the specific disease. The time period is several months to two years in most scenarios. The success rate in this phase drops down sharply, and as per the US FDA, the successful trials moving forward are around 33%. As per the, nearly 5,849 studies are currently in process 2019 with active study undergoing. The rising number of collaborations of companies with hospital chains and CROs with a focus on niche therapeutic segments act as the major driving factors for the success and approval of candidates in this phase. The emerging markets are a rising source of CROs and diversified patient pool for the growth of success rate in phase II. Thus, owing to all the above-mentioned factors, the market is expected to witness high growth over the forecast period.

Clinical trials

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North America is Expected to Account for Largest Market Share in the Global Market

North America is found to hold a significant share for the pediatric clinical trial market and is expected to show a similar trend over the forecast period. According to the, in 2019, more than 3,363 pediatric research procedures were conducted in the United States, which represented a large proportion of the overall global count of pediatric research procedures. The high number of trials and high cost per procedure and patient have largely contributed to the market in the United States. This has made the United States pediatric clinical trials market the largest in the world. The population of children in the United States is more than a quarter of the total population, but the pediatric clinical trials performed are ten times lesser than the non-pediatric ones. This is mainly because of ethical issues related to pediatric research and the complexity involved. Another major factor restraining the market is the relatively small target population for the end product.

Pediatric Clinical Trials Market - Growth Rate by Region

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Competitive Landscape

The market studied is consolidated, owing to the presence of a few key players in the market. Some of the market players are 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.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 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


    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 & Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & 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.

    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 Pediatric Clinical Trials Market market is studied from 2018 - 2026.

The 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 2020.

  • Bristol-Myers Squibb Company
  • Covance Inc.
  • Pharmaceutical Product Development, LLC
  • Syneos Health Inc.

Are the major companies operating in Pediatric Clinical Trials Market.

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