Pediatric Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design (Treatment Studies, Observational Studies), By Therapeutic Areas (Infectious Diseases, Oncology, Autoimmune/Inflammatory Diseases, Respiratory Disorders, Mental Health Disorders, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global pediatric clinical trials market size was valued at USD 15.87 billion in 2023 and it is projected to reach at USD 25.13 billion by 2032, increasing at a CAGR of 6.2% from 2024 to 2032.

For a variety of indications that affect children, paediatric clinical trials are the only criteria for releasing new drugs onto the market. As a result, pharmaceutical and biotechnological industries have been shifting away from in-house clinical research and toward contracts with contract research organisations (CRO).

Due to unmet medical requirements in the paediatric population, there is a large product pipeline in the clinical stage of development. In the near future, the pharmaceutical industry will benefit greatly from a strong pipeline of new drugs being developed. A growing awareness about pediatric medicine, a shift away from conducting clinical trials in-house and toward contract research organisations (CROs), and an increasing burden of pediatric diseases like diabetes are the primary factors driving the expansion of the market for paediatric clinical trials. It is anticipated that the market for pediatric clinical trials would demonstrate consistent growth over the course of the next years due to the expanding significance of pediatric medicine.

Market Dynamics

Global pediatric clinical trials market drivers

A growing need for novel vaccines and other biologics

Growth in the market is likely to be driven by increasing demand for novel vaccines and other biologic products to treat infectious illnesses including measles and mumps as well as tuberculosis and rubella. Around 86% of newborns get immunized against 26 illnesses, according to the World Health Organization (WHO), while 19.5 million children remain unvaccinated, resulting in the mortality of 2-4 million children per year.

Around 0.6% of children aged 0-17 years in the United States are believed to have current epilepsy, according to a data sheet from the Centers for Disease Control and Prevention (CDC). The Diabetes Atlas 2017 published by the International Diabetes Federation (IDF) estimates that 463 million people worldwide will have diabetes by 2019. One million people under the age of 20 (children and adolescents) have type 1 diabetes.

Pediatric cancer cases are rising at an alarming rate

Increasingly, medical facilities and research institutions around the world are focusing on the development of therapeutic medications for pediatric cancer, which has resulted in an increase in pediatric clinical trials. If you look at a February 2022 report from the American Society of Clinical Oncology (ASCO), it estimates that by the end of 2022, an estimated 10,470 children under the age of 15 will be diagnosed with cancer in the United States. According to the World Health Organization, the most common causes of death in children aged one month to nine years are as follows: diarrhea, malaria, pneumonia, and sepsis. The increased prevalence of these disorders has fueled the quest for innovative therapeutic options. As a result, the market's growth is projected to be boosted.

There is a large number of children who have diabetes in addition to the large number of children who have infectious diseases. The US Centers for Disease Control and Prevention (CDC) reports that 210,000 children and adolescents under the age of 25 were diagnosed with diabetes in 2018. To put it another way, the market researched is predicted to develop over time because of the growing attention from major research institutes and the need to eliminate pediatric cancers.

Global pediatric clinical trials market restraints

Pediatric clinical trials have a significant failure rate

On the other hand, a high percentage of pediatric clinical studies being terminated for a variety of reasons is anticipated to be a barrier to the market expansion of pediatric clinical trials. A large percentage of pediatric clinical studies are unsuccessful for a variety of reasons, including a shortage of patients. Other challenges include behavioral problems and trial conduct issues during clinical studies. These issues include erroneous dosing, difficulty in formulation, and informative termination. Regulatory issues and drug toxicity are also issues that arise during clinical trials. According to the data provided by the Food and Drug Administration (FDA) of the United States, somewhere between 25 and 40 percent of pediatric trials are terminated because they are unable to prove that the treatment is safe and effective for children and do not produce a labelled indication for the treatment's use in children.

Global pediatric clinical trials market opportunities

Growing spending in pediatric clinical trials research and development                                                     

Investors in the market are concentrating their efforts on pediatric trials using innovative compounds that are currently being developed for research and development. Pediatric patients have crucial unmet medical needs, and the market's major companies are focusing on developing new and improved products in order to meet those demands, in addition, a healthy medicinal development pipeline helped fuel the market's expansion. As of 2018, more than 1,300 industry-sponsored pediatric clinical trials were taking place in a wide range of treatment areas, including diseases with large unmet needs such infectious diseases, neurologic problems and genetic abnormalities, as well as various forms of cancer. Key market players are also focusing on acquisition tactics to acquire access to new items and extend their product offerings in promising areas. These will lead to lucrative opportunities during the forecast period.

Regional Analysis

The Global Pediatric Clinical Trials Market is segmented by geography into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

In 2021, the market in North America was the most lucrative and held the highest share, accounting for 45% of the total income generated worldwide. This is because the region is home to a sizeable population of pharmaceutical businesses as well as CROs that are actively engaged in the conduct of paediatric trials. In addition to this, public groups are also carrying out active measures in order to assist paediatric research. For example, the National Institutes of Health (NIH) is contributing $4 billion to paediatric research at the moment. These kinds of activities are contributing even more to the expansion of the market in this region.

It is predicted that the United States will continue to hold a large portion of the market throughout the projection period. There were more than 1,265 ongoing paediatric clinical trials in the United States as of June 2021, which represents a considerable part of the global number of paediatric research processes, according to clinicaltrials.gov. The U.S. market has been significantly impacted by the vast number of studies and high per-procedure and-patient costs. Clinical trials in the country are increasing as a result of a growing number of children being diagnosed with illnesses that could be treated with certain pharmaceuticals. According to the National Diabetes Statistics Report 2020, around 187,000 American children and adolescents have Type 1 diabetes in 2018, and this figure is expected to rise in the coming years.

On the other side, it is anticipated that Asia Pacific would record the highest CAGR throughout the course of the forecast period. The Asia-Pacific area has quickly become a centre for the conduct of clinical trials as a result of the simplicity with which regulatory compliance may be achieved, the low costs of studies, and the constantly expanding paediatric patient population. In addition, supportive activities that promote paediatric research in the region are driving growth in the regional market. This is a direct result of the high prevalence of paediatric disorders in the region. According to a report published by UNESCO in March 2022, for instance, experts in China are concentrating on creating advancements in neuroscience in order to better treat autistic children in the country.

Segmental Analysis

The Global Pediatric Clinical Trials Market is divided into different segments according to the Phase, Study Design, Therapeutic Areas, and Region (Geography).

By Phase, the Global Pediatric Clinical Trials Market is segmented into Phase I, Phase II, Phase III, and Phase IV. In 2021, the phase II trials market segment held the largest market share, contributing more than 35% of worldwide revenue. Children are used in phase II trials to examine the intervention's safety and effectiveness. Pediatric participants make up a large portion of phase II trials, which are also more difficult than phase I studies. Children are typically not tested for medicinal products until phase III of the trials, which looks at the efficacy, acceptability, and side effects.

Although the deferral is meant to protect children from unwarranted harm, it also suggests that children's access to potentially beneficial treatments would be postponed. During the projected period, the phase IV segment is anticipated to increase at the quickest rate, exceeding 5.00%. Rarely are pediatric phase IV post-marketing trials carried out. Pediatric studies for marketed medications are necessary, nonetheless, according the FDA's Pediatric Research Equity Act (PREA).

By Study Design, the Global Pediatric Clinical Trials Market is segmented into Treatment Studies and Observational Studies. More than 67% of the global market's revenue in 2021 was attributable to treatment studies. Clinicaltrials.gov reports that a total of 53,060 pediatric trials were registered between 2000 and 2019; of those, 36,136 (68.1%) included therapy studies. However, there were fewer pharmacological studies carried out throughout time, and the majority of pediatric therapy trials were single site (61.4%), small-scale (58.9%), randomized (66.0%), and had no masking (56.9%).

Drug studies were the most prevalent observational trial category (40%) while behavioral treatment trials climbed from 13 to 21%. The majority of funding for pediatric therapy studies comes from institutions (80%), industry (20%), the National Institutes of Health (NIH) (2%), and U.S. federal agencies (0.5%). The industry-funded trials, whether single-site or multi-site, were also finished more frequently and had a stronger treatment emphasis. On the other hand, behavioral and "other" intervention treatments predominated in NIH- and other-funded trials.

By Therapeutic Areas, the Global Pediatric Clinical Trials Market is segmented into Infectious Diseases, Oncology, Autoimmune/Inflammatory Diseases, Respiratory Disorders, Mental Health Disorders, and Others. In terms of revenue share, the oncology therapeutic area sector ranked second globally in 2021 with a share of more than 20%. One of the leading causes of death in the globe is cancer. By 2040, it is predicted that 291,000 children under the age of 19 would have been diagnosed with cancer. The NCI's Young Cancer Data Initiative, which was introduced in 2019 to encourage data sharing and the gathering of fresh data among researchers who study childhood cancers, offers the Molecular Characterization Initiative.

The purpose of this government initiative is to provide researchers with data on pediatric cancer. It's a form of covert assistance that will accelerate the sector's expansion. Over the projected period, the category for mental health disorders is anticipated to develop at the fastest rate. One of the main causes of the significant demand for pediatric clinical trials for mental health disorders is the high frequency of CNS-related conditions in children, such as autism hyperactivity, migraine, seizures, and others. It is anticipated that financing for CNS-related clinical investigations from various public organizations would help this market segment grow even further.

By Region or Geography, the Global Pediatric Clinical Trials Market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2021, North America held a lion's share of the global market, contributing 45% of global sales. This is because there are several pharmaceutical companies and CROs operating in the area and conducting pediatric studies. On the other side, Asia Pacific is anticipated to see the quickest CAGR during the projection period. Due to its simple regulatory compliance requirements, affordable research costs, and fast expanding pediatric patient population, the Asia Pacific area has emerged as a hub for clinical trial operations.

Recent Developments

• March 2022 - As the first of numerous significant enhancements to its leading life science customer engagement platform, IQVIA had announced the launch of OCE+. With the addition of IQVIA's Next Best recommendation engine to its Orchestrated Customer Engagement (OCE) platform, OCE+ provides enhanced HCP experiences, higher efficiency, and increased ROI for healthcare professionals (HCPs).
• March 2022 - Pfizer started Phase 2/3 research in March 2022 for PAXLOVID pills, which are intended to treat COVID-19 in young patients. Within three days of the onset of symptoms, PAXLOVID decreased the probability of hospitalisation or mortality from any cause by 89% and 88%, respectively (within five days of appearance of symptoms).