Pediatric Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase II, IV), By Study Design (Treatment, Observational Studies), By Therapeutic Areas (Mental Health Disorders, Oncology), And Segment Forecasts, 2022 - 2030

Report Overview

The global pediatric clinical trials market size was valued at USD 14.5 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 5.1% during the forecast period. The global market has noticed critical growth on account of the rising R&D investments by pharmaceutical companies owing to the high burden of chronic and infectious diseases among the pediatrics. The COVID-19 pandemic has contributed significantly to the demand for pediatric clinical trials, owing to the growing demand for vaccines to curb the spread of the infection. For instance, In March 2021, the biotechnology company Moderna Inc. reported that it is recruiting patients aged between 6 -12 years for clinical trials of mRNA-1273 COVID-19 vaccines.

Such factors are likely to have a positive impact on the market. Rising awareness among the parents for pediatric clinical trials for treating serious infections and chronic diseases, and a significant number of CROs conducting pediatric trials are also driving the market. Autism is one of the common disorders in children. As per the CDC, 1 in 44 children in the U.S. had autism in 2018. The high burden of autism among kinds is likely to drive the demand for autism clinical trials and thus is anticipated to promote market growth. Public organizations globally are providing funding to develop better treatment for the pediatric population.

For instance, in May 2022, the Australian Government’s Medical Research Future Fund (MRFF) funded USD 1.8 million to the researchers for developing a treatment for juvenile idiopathic arthritis. Such actions are further promoting the pediatric clinical trial market. Recruitment and patient retention are one of the major challenges for pediatric clinical research. However, in recent years there has been a gradual adoption of decentralized trials for easing the pediatric trials. For instance, in June 2021, a global organization, Clinical Oncology Group (COG) conducted clinical research for children and adolescents partnered with Signify Heath, a platform used for conducting decentralized trials.

This partnership was intended to conduct clinical trials for children suffering from leukemia. Such partnerships are likely to increase the adoption of decentralized trials and are expected to pediatric clinical trials faster. During the pandemic, pediatric clinical trials were halted to reduce the spread of the virus. This affected the recruitment of young patients for new trials. Such incidences are expected to have a negative impact on market growth. However, owing to the urgent need for advanced therapeutics many clinical trials were resumed. For instance, in August 2020, a biotech company, Cerecor Inc. resumed the Phase 1b clinical study of CERC-002 for treating severe pediatric-onset Crohn’s disease. Resuming clinical studies owing to the growing demand for innovative treatments has enhanced the market growth.

Phase Insights

On the basis of phase, the global market has been further sub-segmented into phases I, II, III, and IV pediatric clinical trials. The phase II trials segment dominated the market in 2021 and accounted for the maximum share of more than 32.00% of the global revenue. Phase II trials are conducted on children to investigate the safety and efficacy of the intervention. Phase II studies consist of a high number of pediatric subjects; moreover, studies in this phase are more complex than those in other phases. Generally, medicinal product testing in children is deferred until the trials reach phase III, which examines the efficacy, acceptability, and adverse effects.

Although the purpose of the deferral is to safeguard children from undue injury, it also implies that children’s access to potentially valuable treatments would be delayed. The phase IV segment is expected to register the fastest growth rate of more than 5.00% during the forecast period. Phase IV post-marketing trials are infrequently conducted in children. However, the Food and Drug Administration (FDA) Pediatric Research Equity Act (PREA) requires pediatric trials of marketed medicines.

Study Design Insights

On the basis of study design, the global market has been further categorized into treatment studies and observational studies. Treatment studies have accounted for the maximum revenue share of the global market of more than 65.00% in 2021. According to Clinicaltrials.gov, from 2000 to 2019, a total of 53,060 pediatric trials were registered, with 36,136 (68.1%) including treatment studies. However, the majority of treatment pediatric trials were single site (61.4%), small-scale (58.9%), randomized (66.0%), and had no masking (56.9%), there were fewer drug trials conducted throughout time.

In terms of observational trial categories, drug studies were the most common (36.9%), while behavioral treatment trials increased from 12.6 to 20.4%. The treatment studies for pediatric trials are mostly funded by Institutions (78.8%), industry (19.1%), NIH (National Institute of Health) (1.6%) & U.S. federal agencies (0.5%). In addition, the industry-funded trials were completed more frequently and were more focused on treatment, whether they were single-site or multi-site trials. NIH-funded and other-funded trials, on the other hand, had a larger proportion of behavioral and "other" intervention trials.

Therapeutic Areas Insights

On the basis of therapeutic areas, the global market has been further segmented into infectious diseases, oncology, autoimmune/inflammation, respiratory disorders, mental health disorders, and others. The oncology therapeutic area segment accounted for the second-largest revenue share of more than 17.7% in the global market in 2021. Cancer is one of the major causes of death worldwide. It is estimated that cancer cases among children below the age of 19 years are likely to reach 291,000 by 2040. The Molecular Characterization Initiative is offered through NCI’s Childhood Cancer Data Initiative, which was launched in 2019 to promote data sharing and collection of new data among researchers who study childhood cancers.

The government has launched this to collect data on pediatric cancer for researchers. It’s a kind of indirect support that will boost the segment’s growth. The mental health disorders segment is expected to rise with the fastest growth rate over the forecast period. The high prevalence of CNS-related issues, such as autism hyperactivity, migraine, seizures, and others, in children, is one of the key reasons for the high demand for pediatric clinical trials for mental health disorders. The funding for CNS-related clinical studies from various public organizations is expected to further support the growth of this segment.

Regional Insights

On the basis of geographies, the market has been further divided into North America, Asia Pacific, Latin America, Europe, Middle East & Africa. North America dominated the global market in 2021 and accounted for the largest share of 44.0% of the global revenue. This is due to the presence of a significant number of pharmaceutical companies and CROs conducting pediatric trials in the region. Apart from this, public organizations are also undertaking active initiatives to support pediatric research. For instance, the current NIH funding for pediatric research accounts for USD 4 billion. Such initiatives are further contributing to the market growth in this region.

Asia Pacific, on the other hand, is projected to register the fastest CAGR during the forecast period. The Asia Pacific region has become a hotspot for conducting clinical trials on account of the ease of regulatory compliance, low study costs, and rapidly growing pediatric patient population. Moreover, supportive initiatives promoting pediatric research in the region, owing to the high prevalence of pediatric diseases, are driving the regional market. For instance, UNESCO, in March 2022, reported that researchers in China are focusing on making advances in neuroscience to treat children with autism in the country.

Key Companies & Market Share Insights

Trial initialization, acquisitions, and partnerships among others were the key strategies adopted by market players. For instance, in March 2022, Pfizer initiated a Phase 2/3 study for PAXLOVID tablets, specifically designed to treat COVID-19 in pediatric patients. In November 2018, a U.S.-based CRO, Synteract, acquired KinderPharm, a CRO focused on developing advanced therapies for pediatrics. This acquisition was intended to strengthen Synteract’s research activities in pediatric trials. Some of the prominent players in the global pediatric clinical trials market include:

• ICON plc

• Syneos Health

• Medpace, Inc.

• PPD Inc.

• Premier Research

• LabCorp Drug Development

• QPS Holdings.

• Pfizer Inc.

• The Emmes Company, LLC

• IQVIA Inc.

Pediatric Clinical Trials Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global pediatric clinical trials market report on the basis of phase, study design, therapeutic areas, and region:

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Study Design Outlook (Revenue, USD Million, 2018 - 2030)

  • Treatment Studies

  • Observational Studies

• Therapeutic Areas Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Diseases

  • Oncology

  • Autoimmune/Inflammatory Diseases

  • Respiratory Disorders

  • Mental Health Disorders

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE