The major factors for the growth of the pediatric clinical trials market include the rising awareness about pediatric medicine, shifting in-house clinical trials to CROs, and increasing burden of pediatric diseases, such as diabetes.
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, the 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. As time progressed, even big companies began outsourcing their work. Thus, the competitive landscape in the field of CROs has increased rapidly. An increasing number of CROs were added to the list, globally, providing reliable and effective offerings to companies. Due to the increase in the number of CROs, pharmaceutical companies started increasing their research practices. In the past few years, organizations, such as IQVIA, PAREXEL, PPD, and others, have gained the confidence of big pharmaceutical companies and are performing well. Pediatric clinical trials have also gained importance as a result of this shift, as companies can now conduct more clinical trials (including pediatrics that was left out before, owing to uncertain returns and lack of resources).
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 the increasing importance of pediatric medicine, the market for pediatric clinical trials is expected to record steady growth.
Scope of the Report
As per the scope of the report, clinical trials conducted on children, for the R&D of new drugs, are called pediatric clinical trials. Due to the increasing awareness about pediatric medicine, the need to effectively tackle diseases in children, FDA supporting pediatric clinical trial research, and others, the global pediatric clinical trials market is growing. There are various factors that are restraining the market, which include the lack of infrastructure for pediatric clinical trials and ethical issues.
Key Market Trends
Phase ll Segment under Phase-wise Segmentation is expected to hold the Largest Market Share during the Forecast Period
Phase II is the step after Phase l for any biopharmaceutical company to proceed where clinical efficacy or biological activity (‘proof of concept’ studies) and optimum dose to show biological activity with minimal side-effects (‘definite dose-finding’ studies) are performed in 100-300 patients with the specific disease. The time period is several months to two years in most scenarios. The success rate in this phase drops down sharply, and as per the US FDA, the successful trials moving forward are around 33%. As per the clinicaltrials.gov, nearly 5,849 studies are currently in process 2019 with active study undergoing
Owing to high uncertainty and the complex procedure of data collection, analysis, and representation as per government protocols, the pharmaceutical companies generally outsource the clinical trials to the clinical research organizations (CROs) with expertise in various protocols/guidelines laid down by governments across the globe. The rising number of collaborations of companies with hospital chains and CROs with a focus on niche therapeutic segments act as the major driving factors for the success and approval of candidates in this phase. The emerging markets are a rising source of CROs and diversified patient pool for the growth of success rate in phase II. Thus, owing to all the above-mentioned factors, the market is expected to witness high growth over the forecast period.
North America is expected to account for the Largest Market Share in the Global Market
North America is found to hold a significant share for the pediatric clinical trials market and is expected to show a similar trend over the forecast period. The pediatric clinical trials scenario in the United States has been fluctuating since 2005. The number of clinical trials conducted on the pediatric population in the United States has been increasing since 2005-2009.
However, from 2009-2011, almost an equal number of pediatric clinical trials were performed in the United States. According to the ClinicalTrials.gov, in 2019, more than 3,363 pediatric research procedures were conducted in the United States, which represented a large proportion of the overall global count of pediatric research procedures. The high number of trials and high cost per procedure and patient have largely contributed to the market in the United States. This has made the US pediatric clinical trials market the largest in the world. The population of children in the United States is more than a quarter of the total population, but the pediatric clinical trials performed are ten times lesser than the non-pediatric ones. This is mainly because of ethical issues related to pediatric research and the complexity involved. Another major factor restraining the market is the relatively small target population for the end product.
The market studied is consolidated, owing to the presence of a few key players in the market. Some of the market players are Bristol – Myers Squibb, Charles River Laboratories International Inc., Covance Inc., ICON plc, IQVIA, Novartis AG, Pfizer, Inc., Pharmaceutical Product Development, LLC, and Syneos Health Inc.
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1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Awareness about Pediatric Medicine
4.2.2 Shifting In-house Clinical Trials to CROs
4.2.3 Increasing Burden of Pediatric Diseases, such as Diabetes
4.3 Market Restraints
4.3.1 Ethical Issues in Pediatric Research
4.3.2 Small Size of Study Population
4.4 Porter’s Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Phase
5.1.1 Phase I
5.1.2 Phase II
5.1.3 Phase III
5.1.4 Phase IV
5.2 By Study Design
5.2.1 Treatment Studies
126.96.36.199 Randomized Control Trial
188.8.131.52 Adaptive Clinical Trial
184.108.40.206 Non-randomized Control Trial
5.2.2 Observational Studies
220.127.116.11 Cohort Study
18.104.22.168 Case-Control Study
22.214.171.124 Cross-Sectional Study
126.96.36.199 Ecological Study
5.3.1 North America
188.8.131.52 Rest of Europe
184.108.40.206 South Korea
220.127.116.11 Rest of Asia-Pacific
5.3.4 Middle East & Africa
18.104.22.168 South Africa
22.214.171.124 Rest of Middle East & Africa
5.3.5 South America
126.96.36.199 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Bristol-Myers Squibb Company
6.1.2 Charles River Laboratories International Inc.
6.1.3 Covance Inc.
6.1.4 GlaxoSmithKline plc
6.1.5 ICON plc
6.1.7 Novartis AG
6.1.8 Pfizer, Inc.
6.1.9 Pharmaceutical Product Development, LLC
6.1.10 Syneos Health Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
By Study Design
Randomized Control Trial
Adaptive Clinical Trial
Non-randomized Control Trial
Rest of Europe
Rest of Asia-Pacific
Middle East & Africa
Rest of Middle East & Africa
Rest of South America