Clinical trials that are conducted on children for the R&D of new drugs are called pediatric clinical trials. The global pediatric clinical trials market is expected to register a CAGR of 14.5% during the forecast period of 2018–2023.
Shift of In-House Clinical Trials to CRO’s
Over the last decade, the pharmaceutical industry has been gradually shifting from in-house clinical research to contract research organization (CRO). Until the end of the 20th century, a majority of pharmaceutical companies structured out and executed clinical trials on their own, in their premises. Only small companies with fewer resources, in terms of money, manpower, and minutes outsourced their clinical research work to CROs.
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Major Players: QUINTILES TRANSNATIONAL INC., PAREXEL INTERNATIONAL, PHARMACEUTICAL PRODUCT DEVELOPMENT LLC, COVANCE INC., CHARLES RIVERS LABORATORIES INC., PFIZER INC. and CENTERWATCH, among others.
Owing to the spread of clinical research from the United States and Europe to most parts of the world, the numbers of clinical research started increasing at a rapid rate. This gave rise to various problems for pharmaceutical companies, as they now had to conduct more trials in less time, in addition to other resources. To manage the workload, even the big companies started outsourcing their work to CROs. The advantage of not only curtailing the extra work but also the cost for R&D, proved to be a motivating factor for pharmaceutical companies for outsourcing. As a result, an increasing number of CROs were established in the recent past, which are working-hand-in-hand with the companies, to hasten the research and shorten the drug launch period. The ease of outsourcing clinical trials is boosting the practice of pediatric clinical trials and thereby, the market for the same. In the coming years, with increasing importance for pediatric medicine, the market for pediatric clinical trials is expected to record steady growth.
Increasing awareness about pediatric medicine, the need to effectively tackle diseases in children, FDA support for pediatric clinical trials research, and the increasing burden of pediatric diseases, such as diabetes, are some of the other factors contributing to the growth of the market.
Ethical Issues in Pediatric Research
The pediatric clinical trials involve a wide age group, ranging from preterm neonates to post-pubertal adolescents. This heterogeneous age group makes the ethical requirements complex. The major challenge is the lack of understanding of the ethical practices by children. It was observed that of 71% of the reported adverse drug reactions, only 2% of the trials involved safety monitoring committees. This resulted in the stringent requirement of an independent safety monitoring board, with pediatric expertise. Another major challenge for pediatric clinical trials is the ethical issues related to payment for participation.
Additionally, the relative rarity of pediatric diseases, the small size of study population, and lack of infrastructure in developing countries are also restraining the pediatric clinical trials market.
United States to have the Highest Share
The global pediatric clinical trials market is segmented by phase study, design, and geography. By geography it is segmented into North America, Europe, Asia-Pacific, the Middle East & Africa, and South America.
The pediatric clinical trials scenario in the United States has always been fluctuating since 2005. The number of clinical trials conducted on the pediatric population in the United States has been on a high from 2005-2009. However, from 2009-2011, almost an equal number of pediatric clinical trials were performed in the United States. After 2011, there was an exponential increase in pediatric research in the country. According to the clinicaltrials.gov, in 2013, more than 290 pediatric research procedures were conducted in the United States, which represented a large proportion of the global number of pediatric research procedures, more than 35% if quantified. The high number of trials and high cost per procedure and patient have largely contributed to the market in the United States.
Key Developments in the Market
• February 2018 – PPD and Acurian introduced an innovative patient concierge service for clinical trials, which provides personalized support for patients and enhances retention for clients.
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This post was originally published on Chief Analyst