Summary

The Pediatric Clinical Trials Market was estimated to grow at a CAGR of 14.5% during the forecast period of 2021-2026. The outbreak of COVID-19 impacted the pediatric clinical trials market. The impact of COVID-19 affects the ability to recruit young patients for new trials and keep the registered patients in line with their study schedules. Many clinical trials are being conducted for COVID-19 vaccines for children, which is expected to significantly boost market development. For instance, in June 2021, Pfizer Inc., announced that it was advancing Phase 2/3 clinical trials for young children in the United States at lower doses than vaccines for adults, for which it had started enrolling children. Additionally, in June 2021, Serum Institute of India (SII) authorities applied for permission for Covovax COVID-19 vaccine from the Drug Controller and General of India (DCGI) to conduct a clinical trial among paediatric population. These developments are expected to boost the market growth.

Factors such as Rising Awareness about Pediatric Medicine, Shifting In-house Clinical Trials to CROs and Increasing Burden of Pediatric Diseases such as Diabetes are expected to boost market growth.

Over the last decade, the pharmaceutical industry has been gradually shifting from in-house clinical research to contract research organization (CRO). According to a report by Tufts University in collaboration with ICON PLC, on CROs’ strategic partnerships, it is estimated that in the year 2020, 70% of all clinical trials had been transferred to CROs across the globe. The role of CROs has become increasingly important as they are more involved in clinical research and are seen more as calculated partners, providing access not only to dedicated expertise but also to patients around the world. Both the FDA and the European Medicines Agency (EMA) have made major changes to their regulations and now need a pediatric component in most clinical studies. The growth of these pediatric trials has also led to the formation of specific pediatric CROs, such as Paidion Research, the first global CRO dedicated exclusively to pediatric health research. Many CROs are consolidating to build up their profiles and strengthen their services. For instance, Synteract acquired Pediatric CRO KinderPharm in November 2018 to further strengthen its pediatric center of development, providing pharmacometric modeling and clinical trial simulation technologies, coupled with juvenile formulation and toxicology services. Such developments in CROs have driven the trend of shifting in-house clinical trials to the CROs.

Key Market Trends

Oncology Segment Sub-segment Therepeutics Segmentation is Expected to Hold a Significant Share Over the Forecast Period

The oncology segment of the market studied is expected to have exponential growth in the forecast period, owing to the increasing prevalence of cancer in the pediatric age group. The most common cancers in children younger than 15 years are leukemia and brain and central nervous system tumors. According to the American Cancer Society, 2021, an estimated 10,500 children in the United States under the age of 15 years will be diagnosed with cancer in the year 2021. It also states that pediatric cancer rates have increased for the past few decades. Furthermore, As per clinicaltrials.gov, in July 2021, there were approximately 3,287 ongoing pediatric clinical trials, for cancer. Rise in the number of these trials is expected to boost market growth.

With the increasing number of pediatric cancer cases worldwide, many hospitals and institutes are focusing on the development of therapeutic drugs for the same, thereby leading to an increased number of pediatric clinical trials across the world. For instance, in November 2020, a first-in-human clinical trial for children with relapsed or refractory neuroblastoma started at the American Family Children's Hospital (AFCH) and was being conducted by researchers at University of Wisconsin School of Medicine and Public Health.Thus, with the increasing focus of major research institutes, along with the need to reduce the number of pediatric cancers, the market studied is expected to grow over the forecast period. Even though there was a minor impact on the cancer clinical trials due to the COVID-19 pandemic in the beginning of 2020, many countries have resumed the trials. In response, in June 2020 St. Jude Children’s Research Hospital, the nurses provided the patients with medical supplies and personal protective equipment, met with the children and provided basic care, and collected blood samples to continue the trials for cancer drugs.

North America is Expected to Account for Largest Market Share in the Global Market

North America is found to hold a significant share for the pediatric clinical trial market and is expected to show a similar trend over the forecast period. The United States is the largest market in the North American region.

The United States is expected to hold a significant share of the market, and it is expected to show a similar trend over the forecast period. According to clinicaltrials.gov, as of June 2021, there were more than 1,265 ongoing pediatric clinical trials in the United States, which represent a large proportion of the global number of pediatric research procedures. The high number of trials and high cost per procedure and patient have largely impacted the market in the United States. The increasing prevalence of diseases in the pediatric population of the country is boosting the research programs to develop specific drugs, increasing the number of clinical trials in the country. For instance, as per the statistics provided by the National Diabetes Statistics Report 2020, an estimate of 187,000 American children and adolescents suffered from Type 1 diabetes in 2018, and this number is estimated to increase in the coming years.

Furthermore, according to the article published on National Institute of Health 2019, 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. Many clinical trials are also currently ongoing in the United States in the field of COVID-19 vaccine for children. For example, in April 2021, Yale University of Medicine started the clinical trial of the COVID-19 vaccine developed by Pfizer and BioNTech in young children and adolescents. Developments like these are expected to boost market growth. Moreover, the presence of major pharmaceutical companies, like Bristol-Myers Squibb Company and Pfizer Inc., and major CROs, like Covance Inc. and ICON PLC, has given the country a cutting edge over the other regions.

Competitive Landscape

The market studied is consolidated, owing to the presence of a few key players in the market with very few other players. Some of the market players include 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. Additionally, the key players have been involved in various startegic alliances such as acquisitions, collaborations along with launch of advanced products to secure the position in the global market. For example, in April 2021, Novartis announced plans to initiate SMART, a Phase 3b clinical study to evaluate the safety and efficacy of Zolgensma (onasemnogene abeparvovec) in young children with spinal muscular atrophy.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 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
5.2.2 Observational Studies
5.3 By Therapeutic Area
5.3.1 Respiratory Diseases
5.3.2 Infectious Diseases
5.3.3 Oncology
5.3.4 Diabetes
5.3.5 Other Therapeutic Areas
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 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
6.1.6 IQVIA
6.1.7 Novartis AG
6.1.8 Pfizer, Inc.
6.1.9 Pharmaceutical Product Development, LLC
6.1.10 Syneos Health Inc.
6.1.11 Paidion Research, Inc.
6.1.12 The Emmes Company, LLC

7 MARKET OPPORTUNITIES AND FUTURE TRENDS