Press release
Pediatric Clinical Trials Market Key Findings with Worldwide Top Companies Syneos Health, IQVIA Holdings, Charles River Laboratories International , Covance, ICON
Global Pediatric Clinical Trials Market, by Clinical Trial Phase (Pre-clinical, Phase I, Phase II, and Phase III), by Study Design (Interventional, [Randomized Trial, Non-randomized Trial, Crossover Trial], and Observational), by Medical Condition (Neuropsychiatric Conditions, Infectious Diseases, Maternal and Perinatal Conditions, Respiratory Diseases, Cardiovascular Diseases, Cancer, Digestive Diseases, Diabetes, Nutritional Deficiencies, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) was valued at US$ 9,885.7 million in 2017, and is projected to exhibit a CAGR of 8.8% over the forecast period (2018 – 2026), as highlighted in a new report published by Coherent Market Insights.Increasing approval of new pediatric drugs to augment the market growth
Key players in the market are focused on launching novel pediatric drugs in order to cater to unmet needs of pediatric patients. This in turn is expected to boost the market growth. Moreover, robust product pipeline is also expected to boost the market growth. For instance, in December 2018, Merck and Company received U.S. Food and Drugs Administration (FDA) approval for Vaxelis for indication of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type B. This is expected to help the company to increase its product portfolio in the pediatric segment.
Similarly, in December 2018, Servier Laboratories received approval for Asparlas (calaspargase pegol-mknl), an asparagine specific enzyme for the treatment of acute lymphoblastic leukemia in pediatrics and young adults. This is expected to help the company to increase its product portfolio in pediatric therapy segment. According to the International Diabetes Federation’s (IDF) Diabetes Atlas 2017, around 425 million patients were suffering from diabetes worldwide in 2017, of which one million people (children and adolescents below 20 years of age) were suffering from type 1 diabetes, with around 150,000 new cases reported, annually.
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Increasing number of drugs under clinical stage of development in order to cater to unmet medical needs for pediatric patient population is expected to boost the market growth. According to Pharmaceutical Research and Manufacturers’ Association (PHRMA) 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. Furthermore, robust product pipeline and increasing approval of new pediatric drugs is expected to boost the market growth. For instance, in August 2018, Biocodex received 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 U.S. FDA approval for Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
However, high termination percentage of pediatric clinical trials due to several reasons is expected to hinder growth of the pediatric clinical trials market. Pediatric trials have high percentage of failure due to reasons such as patient accrual. Other issues include, behavioral problem and trial conduct issues such as inaccurate dosing, difficulty in formulation, and informative termination along with regulatory issues and drug toxicity during clinical trials. According to 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.
Other diseases also include, cancer, diabetes, diarrhea, leukemia, anemia, chronic kidney disease, and other rare diseases that result in substantial disease burden worldwide. Increasing demand for new vaccines and other biologic products to tackle various infectious diseases such as measles, mumps, polio, tuberculosis, rubella, influenza, whooping cough, chickenpox, malaria, and streptococcal pharyngitis is also expected to boost the market growth. 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. Innovative approaches such as micro-needle vaccine can be utilized after due trial for safety and efficacy.
Similarly, 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.
Key Players
Major players operating in the global pediatric clinical trials market include, Syneos Health Inc., IQVIA Holdings, Inc., Charles River Laboratories International Inc., Covance Inc., ICON plc., Pharmaceutical Product Development, LLC, Genentech (F. Hoffmann-La Roche AG), 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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Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.
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