Global Pediatric Clinical Trials Market – Insights
Pediatric clinical trials are focused on evaluating the efficacy of drugs that are used in for the treatment of various diseases in pediatric patients.
The global pediatric clinical trials market size was valued at US$ 12,571.7 million in 2020, and is expected to exhibit a CAGR of 9.0% over the forecast period (2020 – 2027).
Global Pediatric Clinical Trials Market: Drivers
Increasing number of drugs under clinical trial is expected to propel growth of the global pediatric clinical trials market. For instance, according to Pharmaceutical Research and Manufacturers’ Association (PHRMA)’s data in 2018, over 1,300 industry-sponsored pediatric clinical trials are underway across a variety of therapeutic areas, including diseases where there is significant unmet need such infectious diseases, neurologic conditions, genetic disorders, and several forms of cancer.
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Moreover, increasing approval and launch of novel pediatric drugs is expected to propel growth of the market. For instance, in August 2018, Biocodex received the U.S. FDA approval for Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome. Similarly, in October 2018, Regeneron Pharmaceuticals received U.S. FDA approval for Dupixent (dupilumab) for the treatment of moderate-to-severe asthma. Moreover, in December 2018, Stemline Therapeutics, received U.S. FDA approval for Elzonris (tagraxofusp-erzs) for the treatment of blastic plasmacytoid dendritic cell neoplasm in adults and pediatrics. In June 2018, GW Pharmaceuticals received the U.S. FDA approval for Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
Increasing demand for new vaccines and other biologic products is also expected to boost growth of the market. For instance, according to the World Health Organization (WHO) 2018, around 86% of infants are vaccinated against 26 diseases worldwide. However, around 19.5 million children are unvaccinated leading to death of 2-3 million children, annually.
Global Pediatric Clinical Trials Market: Restraints
However, several pediatric clinical trials are terminated due to several reasons such as patient accrual, behavioral problem, and trial conduct issues such as inaccurate dosing, difficulty in formulation, informative termination, drug toxicity during trials, and regulatory issues. According to the U.S. FDA, around 25 – 40% of pediatric trials fail to establish safety, efficacy, and result in a labeled indication for pediatric use, which results in their termination. Such scenario is expected to hinder growth of the global pediatric clinical trials market.
Global Pediatric Clinical Trials Market: Regional Analysis
North America is expected to account for the largest market share in the global pediatric clinical trials market over the forecast period. This is attributed to increasing incidence of chronic diseases in pediatric population and increasing number of clinical trials conducted in the U.S. Infants, children, and adolescents are at high risk of various diseases such as cancer, diabetes, diarrhea, encephalitis, polio, epilepsy, chronic obstructive pulmonary disease, (COPD), and asthma. For instance, according to the Centers for Disease Control and Prevention (CDC) factsheet in 2018, around 470,000 children had active epilepsy in the U.S., accounting for around 0.6% of children aged 0-17 years.
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Key Takeaways of the Pediatric Clinical Trials Market:
The global pediatric clinical trials market is expected to exhibit a CAGR of 8.8% over the forecast period, attributed to robust product pipeline and increasing regulatory approval of new pediatric drugs
Among clinical trial phase, pre-clinical segment held a dominant position in the pediatric clinical trials market in 2018, attributed to safety and efficacy concerns about new molecules or drugs, as every new molecule must go through pre-clinical study
Among study design, randomized trial segment held a dominant position in the pediatric clinical trials market in 2018, as randomized trial study design eliminates the chance of biasness in clinical trials and is considered as the most favorable study design
Among medical condition, neuropsychiatric conditions segment held a dominant position in the pediatric clinical trials market in 2018, attributed to increasing number of mental disorders in children and adolescents. Mental disorders mainly affect children below age of 14 years.
Global Pediatric Clinical Trials Market: Competitive Landscape
Key players operating in the global pediatric clinical trials market include, Charles River Laboratories International Inc., Syneos Health Inc., IQVIA Holdings, Inc., Pharmaceutical Product Development, LLC, Genentech (F. Hoffmann-La Roche AG), Covance Inc., ICON plc., Pfizer, Inc., Bristol – Myers Squibb, GlaxoSmithKline plc., Sanofi S.A., Novartis AG, Johnson & Johnson, Merck & Co., Inc., Shire plc., and Vertex Pharmaceuticals Inc.
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