Impact Analysis of Covid-19 The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters. Request Sample

Pediatric clinical trials play a major role in modern healthcare, as pediatric clinical trials are the only criteria to launch new drugs in the market for various indications that affect pediatric population and therefore, pharmaceutical and biotechnological industries have been gradually shifting from in-house clinical research to contract research organization (CRO).

There is significant product pipeline under clinical stage of development due to unmet medical needs for pediatric patient population. Robust drug development pipeline offer lucrative growth opportunities for the market in the near future. According to Pharmaceutical Research and Manufacturers Association (PHRMA) data in 2018. Moreover, in 2020, there are over 1,300 industry-sponsored pediatric clinical trials underway across a variety of therapeutic areas, including diseases where there is significant unmet need for treatment of infectious diseases, neurologic conditions, genetic disorders, and several forms of cancer.

The global pediatric clinical trials market size is estimated to be 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).

Figure 1. Global Pediatric Clinical Trials Market Share (%), by Clinical Phase, 2020

Increasing demand for new vaccines and other biologic products to treat various infectious diseases such as measles, mumps, polio, tuberculosis, rubella, influenza, whooping cough, chickenpox, malaria, and streptococcal pharyngitis is expected to drive the market growth. According to the World Health Organization (WHO) 2018, globally, around 86% of infants are vaccinated against 26 diseases, however, 19.5 million children are unvaccinated leading to death of 2-3 million children annually. According to the Centers for Disease Control and Prevention (CDC) factsheet in 2018, around 470,000 children had active epilepsy in the U.S., which is estimated to be around 0.6% of children aged 0-17 years.

According to the International Diabetes Federation’s (IDF) Diabetes Atlas 2017, around 463 million patients were suffering from diabetes worldwide in 2019. Of this, one million people (children and adolescents below 20 years of age) were suffering from type 1 diabetes.

Furthermore, rapidly rising children population is expected to propel demand for pediatric drug. Children represents 40% of world’s population, according to UN Population Prospect report in 2017. In 2016, there were around 74 million children younger than 18 years old in the U.S., accounting for 23% of the total population. The number of children in the country has grown since 1980, when there were 64 million children and is projected to continue to increase to 80 million in 2050, according to the U.S. Census Organization.

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 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.

Pediatric Clinical Trials Market Report Coverage Report Coverage Details Base Year: 2019 Market Size in 2019: US$ 12,571.7 Mn Historical Data for: 2016 to 2019 Forecast Period: 2020 to 2027 Forecast Period 2020 to 2027 CAGR: 9.0% 2027 Value Projection: US$ 22,993.0 Mn Geographies covered: North America: U.S. and Canada

U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America

Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe

Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific

China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC, Israel, and Rest of the Middle East

GCC, Israel, and Rest of the Middle East Africa: South Africa, North Africa, and Central Africa Segments covered: By Clinical Trial Phase: Pre-clinical, Phase I, Phase II, Phase III.

Pre-clinical, Phase I, Phase II, Phase III. By Study Design: Interventional: Randomized Trial, Non-randomized Trial, Crossover Trial. Observational

By Medical Condition: Neuropsychiatric Conditions, Infectious Diseases, Maternal and Perinatal Conditions, Respiratory Diseases, Cardiovascular Diseases, Cancer, Digestive Diseases, Diabetes, Nutritional Deficiencies, Others. Companies covered: 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., Takeda Pharmaceutical Company Limited, and Vertex Pharmaceuticals Inc Growth Drivers: Strong product pipeline, approval of new pediatric drugs, and increasing outsourcing for drug development by clients

Commercial tie-ups and acquisitions by key players

Innovation in clinical research and implementation of advanced technology

Increasing incidence of chronic diseases among the pediatric population Restraints & Challenges: Difficulty in conducting clinical trials for pediatric population

High termination rate of pediatric clinical trials due to various reasons

Global Pediatric Clinical Trials Market – Impact of Coronavirus (Covid-19) Pandemic

Following the outbreak of COVID-19 in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization has declared it a public health emergency. According to the World Health Organization’s report, the manifestation of the coronavirus (COVID-19) has resulted in more than 14 million infected individuals worldwide as of 24 July 2020.

Furthermore, according to the Centers for Disease Control and Prevention, as of April 2, 2020, around 2,572 (1.7%) cases of COVID-19 were registered in patients younger than 18 years in the U.S.

Therefore, market players and research institutes are focusing on research and development activities by initiating clinical trials of drugs for the treatment of COVID-19 in children.

For instance, Gilead Sciences initiated phase 2/3 clinical trials in June 2020, to evaluate the safety, efficacy, tolerability, and pharmacokinetics of Remdesivir, an antiviral drug, in pediatric patients with coronavirus disease 2019 (COVID-19). The trial is estimated to be completed by December 2020.

Similarly, the University of Calgary initiated an observational study on March 18, 2020 to determine the clinical characteristics and outcomes of children potentially infected by COVID-19. The study is estimated to be completed by March 17, 2022.

Furthermore, research institutes are conducting observational studies to understand the impact of COVID-19 in various hospital departments.

For instance, the South Egypt Cancer Institute initiated an observational study on May 15, 2020 to determine the effect of the COVID-19 pandemic on effect on patients in the pediatric cancer care divisions in Egypt and the UAE. The study is estimated to be completed by May 15, 2021.

Figure 2. Global Pediatric Clinical Trials Market Value (US$ Mn), by Region, 2020





Increasing focus of CROs in the North America region on strategic mergers and acquisitions to expand the number of pediatric trials in the region is expected to drive the market growth in this region. For instance, in November 2018, Syneteract, a contract research organization based in North Carolina, acquired a niche CRO KinderPharm, focused on rare disease pediatric trials, in order to expand the pediatric trials footprint of Syneteract. In April 2018, KinderPharm LLC and Worldwide Clinical Trials formed a strategic alliance to develop the first single center of excellence for pediatric drug development and clinical research.

Followed by North America, Europe pediatric clinical trials market is expected to show significant growth during the forecast period, owing to increasing focus of organizations to facilitate pediatric drug development process. For instance, in May 2018, the members of the Collaborative Network for European Clinical Trials for Children/conect4children initiative, which include specialists from the University of Liverpool, Alder Hey Children’s NHS Foundation Trust (AHCNFT), and Liverpool Women’s NHS Foundation (LWNFT), announced a collaborative pediatric network to facilitate the development of novel drugs and therapies for the European pediatric population.

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., Takeda Pharmaceutical Company Limited, and Vertex Pharmaceuticals Inc.