Pediatric Clinical Trials Market Size to Hit USD 27.65 Billion by 2033

November 5, 2024 |

1 min read

According to latest report, the global pediatric clinical trials market size is calculated at USD 17.37 billion in 2024 and is projected to hit around USD 27.65 billion by 2033, expanding at a CAGR of 5.3% from 2024 to 2033.

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The global market for pediatric clinical trials is driven by rising research and development investments by pharmaceutical companies leading to the increasing prevalence of infectious and chronic diseases across the pediatrics. There is a sizable product pipeline in the clinical development phase, due to the pediatric population’s unmet healthcare needs.

The pediatric Clinical Trials Market pediatric clinical trials can help to develop the accurate dose of a vaccine or medicine for a child or can focus on the development of a liquid formulation that is easy to swallow. Participation from children in clinical trials helps to develop vaccines and medicines that are effective and safe for children. In addition, the market is also driven by the increasing prevalence of pediatric diseases such as diabetes, outsourcing internal clinical trials to CROs, and rising awareness of pediatric medicines during the forecast period. The increasing prevalence of illness in the pediatric population enhances research efforts and clinical trials to develop specific drugs and drive the pediatric clinical trials market growth.

In addition, the increasingly strict regulations that need pediatric clinical studies for specific treatments and medications, increasing clinical trial operations in developing countries, increasing population of children, and increasing demand for new vaccines and other biologic products to avoid various infectious diseases such as streptococcal pharyngitis, malaria, chickenpox, whooping cough, influenza, rubella, tuberculosis, polio, mumps, and measles are further anticipated to drive the market growth during the forecast period. However, due to various reasons, the high termination rate of pediatric clinical trials may restrain the market growth.

Pediatric Clinical Trials Market Key Takeaways:

• The phase II trials segment dominated the market in 2023 and accounted for the maximum share of more than 32.00% of the global revenue.

• Treatment studies have accounted for the maximum revenue share of the global market of more than 65.00% in 2023

• The oncology therapeutic area segment accounted for the second-largest revenue share of more than 20.0% in the global market in 2023.

• North America dominated the global market in 2023 and accounted for the largest share of 44.0% of the global revenue

• Asia Pacific, on the other hand, is projected to register the fastest CAGR during the forecast period.

Pediatric clinical trials and safety

Pediatric clinical trials are designed and conducted with children in mind. As with clinical research with adults, it begins with a protocol — the detailed plan for the study and schedule of study activities. However, a pediatric study is designed with special considerations for children.

A pediatric clinical trial could help us develop the correct dose of a medicine for a child, or it could focus on development of a liquid formulation that is easier to swallow. Participation from children in clinical trials helps us develop medicines that are safe and effective for children.

Pediatric clinical trials have additional safety guidelines. As with clinical trials with adult participants, the guidelines are governed by regulatory agencies such as the U.S. FDA, and oversight is provided by institutional review boards or independent ethics committees. In addition, the regulatory agencies require pediatric-specific drug development plans that are reviewed and agreed to by the agencies’ own pediatric experts.

Clinical trials explained

The goal of clinical trials is to advance scientific knowledge, but not all clinical trials are created equal. Some are noninvasive and require little involvement from study participants. Others test the effects of new therapies, vaccines and procedures and may call for multiple clinic visits, uncomfortable tests and treatments that produce side effects.

All studies follow an established protocol that outlines what the trial aims to uncover, who is an ideal candidate, which treatments (if any) are being tested and how the results will be assessed. In randomized and controlled clinical trials performed in adults, researchers separate participants into two groups: an experimental group that receives the treatment under investigation and a control group that receives standard treatment or a placebo (water pill).

A randomized, double-blind clinical trial, for example, randomly distributes study participants to receive either the placebo or the experimental treatment. In these trials, neither the patients nor the researchers know who received the treatment and who received the placebo until the study is complete. At the end of the trial, researchers analyze the results to determine whether the new treatment is effective.

Why clinical trials in kids are different

Children are a complicated group to study. Researchers can't lump all children into one bucket—testing a treatment on a 17-year-old is not the same as testing a treatment on an infant. That's just one reason for the seven-year lag time (on average) between an adult approval and a pediatric approval for the same agent—that means adults have access to effective treatments years before they're available to children.

"Principal investigators for pediatric trials provide focused care and attention to kids in these trials simply because children's bodies and minds are still developing," says Dr. David Ziring, associate director of the Pediatric Inflammatory Bowel Disease Program at Cedars-Sinai.

So, while clinical trials for children are run in a similar manner as those for adults, there are a few key caveats:

Informed consent: Depending on the age of the child, both the participating child and the child's parent need to consent to participate in the study. Older children and teenagers complete a separate informed consent. "We need to know they're willing to participate in the trial," Dr. Ziring says.
Children's trials come last: Studies that are randomized and controlled set out to identify effective treatments for a particular condition. These trials occur only after preliminary research shows the agent is safe and effective in the lab, then in animals and finally in adults. "Kids are always the last to get tested with a new treatment," says Dr. Dralyuk. "By the time researchers begin trials for children, we know the intervention is safe and effective in adults."
Placebo use: Clinical trials for children generally don't include placebos. "If there's evidence that a treatment works well in adults, it's not ethical to expose a child to a placebo and withhold a treatment that could improve their condition," says Dr. Ziring.

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Pediatric Clinical Trials Market Segment Insights

By phase type

The phase ll trials segment dominated the market share in 2023 and also accounted for the largest market share. To investigate the efficacy and safety of the intervention, phase ll trials are conducted on children. Phase ll studies include a higher number of pediatric subjects. As compared to other phases, studies in this phase are more complex. Basically, medicinal product testing in pediatrics is delayed until the trials reach phase lll, which studies the adverse effects, acceptability, and efficacy further contributes to the segment growth. For instance, in May 2024, eClinicalMedicine enrolled 26 children with hypochondroplasia and launched a phase 2, single-arm, open-label trial at a single center in the USA. To establish a baseline annualized growth velocity, the trial consists of a 6-month observation period followed by a 12-month intervention period during which vosoritide is administered daily via subcutaneous injection at a dose of 15 μg/kg/day.

By study design types

The treatment studies segment accounted for the largest market share in 2023. The majority of treatment pediatric trials had no masking, randomized, small-scale, and single-site. In the child group, medicines used to treat adults may not impact in the same way that they impact adults and children's bodies are still developing so children need treatment studies specifically for them. For instance, in May 2024, Cincinnati Children's began work on a Cell Therapy Center and Applied Gene, which will allow the health system to increase clinical trials of biological therapeutics and innovative drugs for patients with genetic diseases, blood diseases, and cancer. In addition, more than 300,000 children are diagnosed with cancer every year, and an estimated 8 million are born with a birth defect across the globe.

By therapeutic area type

The global market has been further segmented into inflammation, respiratory diseases, oncology, and infectious diseases, on the basis of therapeutic areas. The oncology therapeutic area segment accounted for the second-highest market share in 2023. Across the world, cancer is one of the major causes of death. It is expected that cancer patients across children below the age of 19 are expected to reach 291000 by 2040.

By regional insights

North America dominated the pediatric clinical trials market in 2023. The increasing number of public organizations, increasing CROs conducting pediatric trials in the region, and increasing presence of a significant number of pharmaceutical companies. For instance, in March 2022, it was reported that to treat children with autism in the country, researchers in the region are focusing on advances in neuroscience. For instance, the recent NIH investment in pediatric research accounts for 4 billion. Such initiatives are further driving the market growth in the region.

U.S. Pediatric Clinical Trials Market Trends

The U.S. controls the global pediatric clinical trial industry, due to its ever-changing regulatory environment and sophisticated research infrastructure. Government incentives and grants motivate investments in pediatric clinical research and pediatric medication. The U.S. is expected to command a significant percent of the share in the region. In addition, disease foundations and patient advocacy organizations significantly transform the industry of pediatric pharmaceutical trials in the U.S. during the forecast period.

Asia Pacific is expected to grow fastest during the forecast period.

On account of rapidly growing pediatric patient population, low study costs, and regulatory compliance, the region has become a hotspot for conducting clinical trials. In addition, the increasing rapid child population and increasing prevalence of pediatric diseases are expected to drive the growth of the pediatric clinical trials market in the region. China, India, Japan, and South Korea are the major countries in the market growth.

China Pediatric Clinical Trials Market Trends

The rapidly growing population that is reduced regulatory procedures and naive to treatment contributed to the market growth in China. Due to the growing acceptance of precision medicines, the landscape of pediatric clinical trials is changing in China. Furthermore, growing awareness of pediatric health and rising technological breakthroughs accelerate the demand for pediatric patient trials in China.

Pediatric Clinical Trials Market Company Insights

Some of the major players in the market for pediatric clinical trials such as Pfizer Inc., QPS Holdings, LabCorp Drug Development, Premier Research, PPD Inc., Medpace, Inc., Syneos Health, ICON plc, and others. Partnerships, collaborations, acquisitions, and trial initialization among others are the major strategies adopted by major market players.

• For instance, in June 2024, a global leader in innovative and comprehensive laboratory services, Labcorp announced the launch of a suite of central laboratory solutions, Labcorp Global Trial Connect. The aim behind this launch was to increase the speed of clinical trials where the heart of clinical research is conducted.

Related Report

Clinical Trials Market ; The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.

Clinical Trials Support Services Market ; The global clinical trials support services market size was exhibited at USD 21.80 billion in 2023 and is projected to hit around USD 45.73 billion by 2033, growing at a CAGR of 7.69% during the forecast period 2024 to 2033.

Immuno-oncology Clinical Trials Market ; The global immuno-oncology clinical trials market size was exhibited at USD 8.30 billion in 2023 and is projected to hit around USD 35.37 billion by 2033, growing at a CAGR of 15.6% during the forecast period 2024 to 2033.

Virtual Clinical Trials Market; The global virtual clinical trials market size was exhibited at USD 8.85 billion in 2023 and is projected to hit around USD 15.70 billion by 2033, growing at a CAGR of 5.9% during the forecast period 2024 to 2033.

Artificial Intelligence (AI) in Clinical Trials Market ; The global AI in clinical trials market size was valued at USD 1.58 billion in 2023 and is anticipated to reach around USD 20.16 billion by 2033, growing at a CAGR of 29% from 2024 to 2033.

AI-based Clinical Trials Solution Provider Market ; The global AI-based clinical trials solution provider market size was exhibited at USD 2.60 billion in 2023 and is projected to hit around USD 19.16 billion by 2033, growing at a CAGR of 22.11% during the forecast period 2024 to 2033.

Biologics Market ; The global biologics market size was estimated at USD 511.04 billion in 2023 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period from 2024 to 2033.

Oncology Clinical Trials Market ; The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.

Cell And Gene Therapy Clinical Trials Market ; The global cell and gene therapy clinical trials market size reached USD 11.62 billion in 2023 and is projected to hit around USD 47.40 billion by 2033, expanding at a CAGR of 15.09% during the forecast period from 2024 to 2033.

U.S. Clinical Trials Supply And Logistics Market; The U.S. clinical trials Supply and logistics market size was estimated at USD 1.90 billion in 2023 and is projected to hit around USD 3.95 billion by 2033, growing at a CAGR of 7.6% during the forecast period from 2024 to 2033.

U.S. Clinical Trials Market; The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.

Europe Clinical Trials Market ; The Europe clinical trials market size was exhibited at USD 22.25 billion in 2024 and is projected to hit around USD 43.00 billion by 2034, growing at a CAGR of 6.81% during the forecast period 2024 to 2034.

Some of the prominent players in the 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 Recent Developments

• In September 2024, the leader in at-home EEG and computational neurodiagnostics, Beacon Biosignals Inc. Announced the launch of the Home EEG Application and Dreem Feasibility In Research Study, HEADFIRST. The aim behind this launch was to explore the usability of home-based EEG recordings in pediatric patients with neurotypical controls and neurodevelopmental disorders.

• In August 2024, Researchers at the UCLA Health Jonsson Comprehensive Cancer Center are launching a first-of-its-kind clinical trial to evaluate the effectiveness and safety of a cancer vaccine targeting H3 G34-mutant diffuse hemispheric glioma, to combat one of the most lethal forms of pediatric brain cancer. This is a highly aggressive brain tumor that is typically found in young adults and adolescents.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2023 to 2033. For this study, Nova one advisor, Inc. has segmented the pediatric clinical trials market

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