Pediatric Clinical Trials Market Size Worth US$ 31.77 Billion by 2033, with a 5.5% CAGR Growth, Report by DataM Intelligence

AUSTIN, Texas and TOKYO, Sept. 15, 2025 /PRNewswire/ -- According to DataM Intelligence, the global pediatric clinical trials market size reached US$ 19.74 Billion in 2024 from US$ 18.79 Billion in 2023 and is expected to reach US$ 31.77 Billion by 2033, growing at a CAGR of 5.5% during the forecast period 2025-2033. 

The pediatric clinical trials market is transforming child healthcare with therapies tailored for infants, children, and adolescents. Growing awareness of pediatric-specific needs has led to age-appropriate formulations and safety protocols. Regulatory measures like the EU Paediatric Regulation, PREA, and the RACE for Children Act mandate pediatric inclusion in drug development, boosting trial activity in oncology, infectious diseases, and rare genetic disorders.

Nirsevimab (Beyfortus) is a breakthrough monoclonal antibody approved to prevent Respiratory Syncytial Virus (RSV) in infants and young children, providing protection throughout the RSV season with a single injection. Clinical trials demonstrated a 70-75% reduction in RSV-related hospitalizations among preterm and term infants. Beyfortus exemplifies how pediatric trials are delivering life-saving therapies. 

Key market players support these trials with comprehensive services, while innovations like decentralized trials and digital monitoring enhance patient access and data quality. Collaborative efforts across hospitals, CROs, and research institutions drive efficiency and accelerate development of targeted pediatric treatments.

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Indication type The oncology segment is dominating the pediatric clinical trials market with a 32.21% share in 2024

The oncology segment commands leadership in the pediatric clinical trials market. This concentration is driven by the rising incidence. For instance, according to the National Cancer Institute, it is estimated that, in 2024, a total of 14,910 children and adolescents ages 0 to 19 will be diagnosed with cancer and 1,590 will die of the disease in the United States. Among children (ages 0 to 14 years), it is estimated that 9,620 will be diagnosed with cancer and 1,040 will die of the disease, spurring investment in age-specific therapies.

Regulatory frameworks like the U.S. RACE for Children Act mandate evaluation of molecularly-targeted oncology drugs in children, accelerating trial pipelines. Moreover, pediatric oncology trials are frequently at the forefront of innovation, incorporating CAR-T therapies, immunotherapy, and novel targeted agents that require specialized pediatric protocols and FDA-reviewed Pediatric Study Plans. Pediatric oncology leads clinical trials due to a high disease burden, regulatory support, innovation-driven therapies, and strong backing from large hospital and research networks.

North America is expected to dominate the global pediatric clinical trials market with a 42.37% in 2024

North America dominates the global pediatric clinical trials market, driven by a robust regulatory framework, a high concentration of leading pharmaceutical companies and research institutions, and substantial public and private funding. Support from the NIH fuels extensive research on rare diseases, neurology, and autoimmune conditions. 

The US has enacted pediatric laws like PREA and BPCA to mandate and incentivize pediatric drug studies. The recent RACE for Children Act has expanded pediatric oncology trials by requiring evaluation of targeted cancer drugs in children. Leading children's hospitals such as Texas Children's and MD Anderson provide exceptional access to these trials. The US also led rapid pediatric COVID-19 vaccine evaluations and the approval of Beyfortus for infant RSV protection. Additionally, it has pioneered decentralized clinical trials with digital approaches to improve pediatric participation and retention.

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The Asia Pacific region is the fastest-growing region in the global pediatric clinical trials market, with a CAGR of 6.1% in 2024

The Asia-Pacific region is rapidly emerging as the fastest-growing market for pediatric clinical trials due to regulatory modernization, large patient populations, and increased healthcare investments. Countries like Japan, India, and China have streamlined ethical reviews, fast-track approvals, and decentralized trial guidelines that reduce trial setup times, attracting multinational sponsors. India offers cost advantages, vast treatment-naïve populations, and partnerships with organizations like Gavi to increase vaccination rates. 

The growth is further supported by regional CROs and global service providers such as WuXi AppTec and Novotech enhancing trial recruitment and data capabilities. The region is also a key hub for innovative pediatric products, including next-gen vaccines and novel gene therapies, backed by government funding and private R&D collaborations.

Europe Pediatric Clinical Trials Market Poised for Significant Growth

Europe's pediatric clinical trials market benefits from strong regulations like the EU Paediatric Regulation, which mandates Paediatric Investigation Plans (PIPs) for all new drugs. The ICH E11(R1) guidance supports rigorous, age-appropriate study designs across member states, fostering multicountry trials and reliable data. 

Collaborative initiatives such as Horizon 2020 and the European Network of Paediatric Research (Enpr-EMA) streamline recruitment and protocols. EMA's focus on oncology and rare disease trials aligns with global efforts like the US RACE for Children Act. Combined with efficient consent procedures, public-private funding, and multicenter cooperation, Europe remains a leading hub for pediatric clinical research and innovation.

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Key Pediatric Clinical Trials Companies

Major companies working towards the market's growth include ICON plc, Pfizer Inc., Syneos Health, Thermo Fisher Scientific Inc., Medpace, Bristol-Myers Squibb Company, IQVIA Inc., Parexel International Corporation, and Charles River Laboratories, among others.

Recent Developments:

l   In June 2025, Bavarian Nordic commenced a Phase III trial of its chikungunya vaccine, CHIKV VLP, targeting the paediatric population aged two to 11 years old. This marks the first study of the single-dose, virus-like particle (VLP) for children. Under the brand name Vimkunya, the vaccine is currently available for individuals aged 12 years and above in the EU, the US, and the UK.

l   In April 2025, Opus Genetics, Inc. announced one-month clinical data from the first pediatric patient treated with its investigational gene therapy, OPGx-LCA5, in a Phase 1/2 open-label trial for LCA5-related inherited retinal disease (IRD). The new data builds upon previously reported positive results from adult patients treated in the same study.

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