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Pediatric Clinical Trials Global Market Report 2025
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Pediatric clinical trials serve as critical investigations into the efficacy, safety, and appropriate dosage of pharmaceuticals, medical devices, and therapies specifically tailored for children. Developing age-appropriate treatments and procedures is paramount in refining and identifying the most effective medical interventions available for pediatric patients.

These trials typically encompass several distinct phases Phase I, Phase II, Phase III, and Phase IV. Phase I trials primarily concentrate on establishing the safety profile and determining the appropriate dosage range of new medications, typically involving 20-100 healthy volunteers. Diverse study designs, such as treatment and observational studies, are employed across various therapeutic areas. These encompass infectious diseases, oncology, autoimmune or inflammatory diseases, respiratory disorders, mental health disorders, among other medical domains, enabling comprehensive exploration and assessment of treatments for pediatric patients.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The pediatric clinical trials market research report is one of a series of new reports from The Business Research Company that provides pediatric clinical trials market statistics, including pediatric clinical trials industry global market size, regional shares, competitors with a pediatric clinical trials market share, detailed pediatric clinical trials market segments, market trends and opportunities, and any further data you may need to thrive in the pediatric clinical trials industry. This pediatric clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pediatric clinical trials market size has grown strongly in recent years. It will grow from $17.41 billion in 2024 to $18.38 billion in 2025 at a compound annual growth rate (CAGR) of 5.6%. The growth in the historic period can be attributed to regulatory incentives, unmet medical needs, advancements in pediatric medicine, global public health initiatives, ethical imperatives, pediatric vaccination programs.

The pediatric clinical trials market size is expected to see strong growth in the next few years. It will grow to $24.64 billion in 2029 at a compound annual growth rate (CAGR) of 7.6%. The growth in the forecast period can be attributed to integration of real-world evidence, pediatric biomarker discovery, expanded access programs, pediatric infectious disease research, pediatric cardiology advancements. Major trends in the forecast period include patient-centric trial design, adoption of adaptive trial designs, digital health technologies, global collaboration and consortia, pediatric oncology advancements.

The forecast of 7.6% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. research initiatives by increasing costs for electronic patient-reported outcome (ePRO) platforms and wearable monitoring devices imported from the UK and Finland, potentially slowing trial enrollment and raising developmental expenses. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The rise in pediatric cancer cases is expected to drive the pediatric clinical trials market forward. Pediatric cancers, though rare, exhibit unique growth patterns distinct from adult tumors, necessitating specialized research and treatments. Pediatric clinical trials play a pivotal role in advancing prognosis and treatment methods. According to the American Cancer Society's estimates in January 2023, approximately 9,910 children in the US under 15 will be diagnosed with cancer, with about 1,040 expected deaths in 2023. Consequently, increased healthcare spending fuels the growth of the pediatric clinical trials market.

The burgeoning demand for outsourcing services is set to propel the pediatric clinical trials market's expansion. As preclinical research grows in complexity, pharmaceutical and biotech companies increasingly seek specialized skills beyond their in-house capabilities. Outsourcing services aid in crafting safe, ethical, and scientifically robust pediatric clinical trial protocols. A survey by BioPlan Associates Inc. in April 2023 revealed that around 84.6% of biomanufacturers outsource analytical testing, while 74.5% seek toxicity testing outsourcing, highlighting the surging reliance on outsourcing in pediatric clinical trials, driving market growth.

Product innovation stands out as a pivotal trend reshaping the pediatric clinical trial market. Companies within this sector are investing in innovative products to maintain their market standing. An instance is The Leukemia & Lymphoma Society's launch of the Pediatric Acute Leukemia (PedAL) Master Clinical Trial in June 2022. This groundbreaking trial is tailored to pediatric acute leukemia, leveraging individual tumor biology to match children with the most promising treatments, emphasizing innovation in pediatric cancer research.

Major players in pediatric clinical trials prioritize collaborations and partnerships to deliver dependable services. Strategic partnerships, characterized by structured affiliations between commercial entities, are pivotal in fostering reliability in service provision. Strados Labs' collaboration with Ann & Robert H. Lurie Children's Hospital in September 2023 exemplifies this approach. Their clinical trial involves the RESP Biosensor, a wearable device employing acoustic sensors to monitor lung sounds for asthma symptoms. The trial aims to assess the RESP Biosensor's effectiveness in accurately detecting and monitoring asthma exacerbations in children, showcasing partnerships' role in advancing pediatric healthcare technology.

In March 2024, PCM Trials, a U.S.-based provider of mobile research nurse visits for decentralized clinical trials, acquired EmVenio Research for an undisclosed amount. This acquisition enables PCM Trials to adopt a more patient-centric and decentralized approach to clinical trials, enhancing participant recruitment and retention, especially among underrepresented minorities. EmVenio is a U.S.-based company focused on improving access to pediatric clinical trials, particularly for diverse and underserved populations.

Major companies operating in the pediatric clinical trials market include Medpac Inc., Pharmaceutical Product Development Inc., ICON plc, Syneos Health Inc., QPS Holdings LLC, Pfizer Inc., IQVIA Inc., Premier Research, Labcorp - Laboratory Corporation of America Holdings, The Emmes Company LLC, Synteract Inc., Charles River Laboratories International Inc., Covance Inc., Bristol-Myers Squibb Company, GlaxoSmithKline plc, BioNTech SE, Moderna Inc., Parexel International Corporation, PRA Health Sciences, Wuxi AppTec, Merck & Co. Inc., AstraZeneca plc, Sanofi S.A., Johnson & Johnson, Eli Lilly and Company, Takeda Pharmaceutical Company Limited, C.H. Boehringer Sohn AG & Co. KG, AbbVie Inc., Teva Pharmaceutical Industries Ltd., Oracle Health sciences

North America was the largest region in the pediatric clinical trials market in 2024. The regions covered in the pediatric clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

The countries covered in the pediatric clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain

The pediatric clinical trials market includes revenues earned by entities through clinical research services, consulting, outsourcing services, and medical communications. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Pediatric Clinical Trials Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on pediatric clinical trials market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for pediatric clinical trials ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pediatric clinical trials market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Pediatric Clinical Trials Market Characteristics

3. Pediatric Clinical Trials Market Trends And Strategies

4. Pediatric Clinical Trials Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Pediatric Clinical Trials Growth Analysis And Strategic Analysis Framework

6. Pediatric Clinical Trials Market Segmentation

7. Pediatric Clinical Trials Market Regional And Country Analysis

8. Asia-Pacific Pediatric Clinical Trials Market

9. China Pediatric Clinical Trials Market

10. India Pediatric Clinical Trials Market

11. Japan Pediatric Clinical Trials Market

12. Australia Pediatric Clinical Trials Market

13. Indonesia Pediatric Clinical Trials Market

14. South Korea Pediatric Clinical Trials Market

15. Western Europe Pediatric Clinical Trials Market

16. UK Pediatric Clinical Trials Market

17. Germany Pediatric Clinical Trials Market

18. France Pediatric Clinical Trials Market

19. Italy Pediatric Clinical Trials Market

20. Spain Pediatric Clinical Trials Market

21. Eastern Europe Pediatric Clinical Trials Market

22. Russia Pediatric Clinical Trials Market

23. North America Pediatric Clinical Trials Market

24. USA Pediatric Clinical Trials Market

25. Canada Pediatric Clinical Trials Market

26. South America Pediatric Clinical Trials Market

27. Brazil Pediatric Clinical Trials Market

28. Middle East Pediatric Clinical Trials Market

29. Africa Pediatric Clinical Trials Market

30. Pediatric Clinical Trials Market Competitive Landscape And Company Profiles

31. Pediatric Clinical Trials Market Other Major And Innovative Companies

32. Global Pediatric Clinical Trials Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Pediatric Clinical Trials Market

34. Recent Developments In The Pediatric Clinical Trials Market

35. Pediatric Clinical Trials Market High Potential Countries, Segments and Strategies

36. Appendix

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