The growing occurrence of pediatric conditions like HIV, cancer, diabetes, and others is boosting the need for treatments specifically designed for children, making pediatric drug development a key focus. At the same time, increased awareness among parents and caregivers about children's health has led to more vigilant and proactive healthcare practices, which in turn is driving the demand for safe and effective medications.
LAS VEGAS , Oct. 10, 2024 /PRNewswire/ -- DelveInsight's Pediatric Drugs Market Insights report provides the current and forecast market analysis, individual leading pediatric drugs companies' market shares, challenges, pediatric drugs market drivers, barriers, trends, and key market pediatric drugs companies in the market.
Key Takeaways from the Pediatric Drugs Market Report
- As per DelveInsight estimates, North America is anticipated to dominate the global pediatric drugs market during the forecast period.
- In the indication segment of the pediatric drugs market, the cancer category had a significant revenue share in the pediatric drug market in 2023.
- Notable pediatric drugs companies such as Novartis AG, Pfizer Inc., Sanofi, Johnson & Johnson Services, Inc., Bayer AG, F. Hoffmann-La Roche Ltd., AstraZeneca, AbbVie, Eli Lilly, Takeda Pharmaceutical Company Limited, Novo Nordisk, Biogen, Teva Pharmaceuticals, Gilead Sciences, Inc., Amgen Inc., Bristol-Myers Squibb, Vertex Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Merck KGaA, and several others, are currently operating in the pediatric drugs market.
- In June 2024, the FDA approved SOFDRA (sofpironium) the first drug for the treatment of primary axillary hyperhidrosis in children 9 years of age and older.
- In April 2024, Novartis's radioligand therapy, LUTATHERA, received FDA approval as the first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors.
- In March 2024, Johnson & Johnson Services, Inc. received U.S. FDA approval for EDURANT® PED (rilpivirine) for certain pediatric patients living with HIV-1.
- In January 2024, DUPIXENT (dupilumab) was approved by the FDA as the first and only treatment for children aged 1 year and older with eosinophilic esophagitis (EOE).
To read more about the latest highlights related to the pediatric drugs market, get a snapshot of the key highlights entailed in the Global Pediatric Drugs Market Report
Pediatric Drugs Overview
Pediatric drugs are medications specifically formulated and dosed for use in children, addressing the unique physiological and developmental needs of this population. Unlike adults, children have distinct pharmacokinetics and pharmacodynamics, meaning the way their bodies absorb, distribute, metabolize, and excrete drugs differs significantly. Pediatric drug development requires careful consideration of these factors to ensure efficacy and safety. Dosing is often weight-based or adjusted for age, and formulations may include liquid, chewable, or dispersible tablets to accommodate the different age groups, from infants to adolescents. This tailored approach helps in minimizing adverse effects and optimizing therapeutic outcomes in young patients.
The development and approval of pediatric drugs are governed by stringent regulations and ethical standards. The Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) in the United States, for example, require pharmaceutical companies to conduct studies in pediatric populations or provide data justifying the use of adult data for pediatric approvals. These laws aim to ensure that children have access to safe and effective medications, encouraging the inclusion of pediatric studies in drug development. Despite these efforts, challenges remain, including the ethical concerns of conducting clinical trials in children, the limited market size for pediatric drugs, and the complexity of developing age-appropriate formulations. Nonetheless, advances in pediatric pharmacology continue to improve the availability and safety of medications for this vulnerable population.
Pediatric Drugs Market Insights
North America dominated the pediatric drugs market in 2023 among all regions. This leading position is driven by several key factors that are increasing the demand for pediatric medications. Firstly, the region has seen a rise in chronic pediatric conditions, including HIV, diabetes, and various cancers, necessitating the ongoing development and implementation of specialized treatments. Secondly, regulatory support from agencies like the FDA has strengthened the approval process and availability of pediatric drugs, ensuring timely access to safe and effective therapies for children. Additionally, the growing approval of new pediatric medications across North America has significantly expanded treatment options and improved healthcare outcomes for young patients. These factors together create a favorable market environment that encourages innovation, investment, and growth in the pediatric drugs sector within the region.
Moreover, the rising number of product approvals in the region significantly strengthens the local market. For instance, in June 2024, the FDA approved FARXIGA (dapagliflozin) in the U.S. for treating pediatric type-2 diabetes. Similarly, in June 2023, Jardiance® (empagliflozin) received FDA approval for treating type 2 diabetes in children aged 10 and older. As more drugs gain regulatory approval, healthcare providers are equipped with a broader selection of treatments specifically designed and tested for pediatric patients. This not only improves the quality of care but also meets previously unmet medical needs in pediatric populations, thereby driving the pediatric drug market in the region.
Additionally, the backing from various regulatory bodies fosters trust and helps pediatricians make well-informed treatment decisions, encouraging the early adoption of newly approved drugs and ensuring compliance with FDA guidelines. For example, as of May 2024, the FDA began publishing a monthly column titled "FDA Updates" in AAP News, the American Academy of Pediatrics' monthly magazine. This column offers insights from FDA experts on pediatric health, covering newly approved pediatric medical products, critical safety warnings, and updates on the agency's initiatives in pediatric product development. These efforts help inform healthcare providers, pediatricians, and caregivers about new FDA-approved pediatric medications, safety updates, and advancements in pediatric product development, thereby boosting the pediatric drug market in the region.
Consequently, these factors are anticipated to drive the growth of the pediatric drug market in the region.
To know more about why North America is leading the market growth in the pediatric drugs market, get a snapshot of the Pediatric Drugs Market Outlook
Pediatric Drugs Market Dynamics
The pediatric drugs market is an essential segment of the pharmaceutical industry, characterized by unique dynamics that differentiate it from the broader market. A key driver of growth in this market is the increasing global pediatric population, which necessitates the development of safe and effective medications specifically designed for children. Furthermore, rising awareness about pediatric diseases, coupled with better access to healthcare services in emerging markets, is fueling the demand for pediatric drugs. Governments and international health organizations are also emphasizing the importance of pediatric care, leading to supportive policies and funding for research and development in this area.
Regulatory challenges, however, are a significant aspect of the pediatric drug market. Developing medications for children requires navigating stringent regulatory frameworks, as pediatric patients are more vulnerable to adverse drug reactions than adults. This necessitates rigorous clinical trials and extensive safety testing, which can be time-consuming and costly. The regulatory landscape is also complicated by the need for age-appropriate formulations, such as liquid forms or chewable tablets, which further adds to the development costs and complexity.
Another notable trend in the pediatric drugs market is the increasing focus on rare pediatric diseases and orphan drugs. With advancements in biotechnology, pharmaceutical companies are now more equipped to develop targeted therapies for rare conditions that primarily affect children. These orphan drugs, often granted special regulatory incentives, are becoming a significant revenue stream for companies operating in this space. However, the high cost of these drugs and the small patient populations they serve present ongoing challenges in ensuring access and affordability.
In addition, there is growing interest in pediatric vaccines, driven by the need to address preventable diseases in children. The COVID-19 pandemic has underscored the importance of immunization, leading to heightened investments in vaccine research and development. Companies are now focusing on developing combination vaccines that protect against multiple diseases, as well as novel vaccine delivery systems that are more suitable for children.
Overall, the pediatric drugs market is poised for continued growth, driven by demographic trends, regulatory support, and advances in medical research. However, the market also faces challenges related to drug development costs, regulatory hurdles, and the need to balance innovation with affordability and access. As pharmaceutical companies continue to navigate these complexities, the pediatric segment is likely to remain a critical area of focus within the broader healthcare landscape.
Get a sneak peek at the pediatric drugs market dynamics @ Pediatric Drugs Market Dynamics Analysis
Report Metrics | Details |
Coverage | Global |
Study Period | 2021-2030 |
Pediatric Drugs Market CAGR | ~5% |
Key Pediatric Drugs Companies | Novartis AG, Pfizer Inc., Sanofi, Johnson & Johnson Services, Inc., Bayer AG, F. Hoffmann-La Roche Ltd., AstraZeneca, AbbVie, Eli Lilly, Takeda Pharmaceutical Company Limited, Novo Nordisk, Biogen, Teva Pharmaceuticals, Gilead Sciences, Inc., Amgen Inc., Bristol-Myers Squibb, Vertex Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Merck KGaA, among others |
Pediatric Drugs Market Assessment
- Pediatric Drugs Market Segmentation
- Pediatric Drugs Market Segmentation By Indication: Respiratory Diseases, Cancer, Neurological Diseases, Genetic Diseases, and Others
- Pediatric Drugs Market Segmentation By Route of Administration: Oral, Parenteral, and Others
- Pediatric Drugs Market Segmentation By Distribution Channel: Hospitals & Clinics, Pharmacy, and Others
- Pediatric Drugs Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
- Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View
Which MedTech key players in the pediatric drugs market are set to emerge as the trendsetter explore @ Pediatric Drugs Companies
Table of Contents
1 | Pediatric Drugs Market Report Introduction |
2 | Pediatric Drugs Market Executive Summary |
3 | Competitive Landscape |
4 | Regulatory Analysis |
5 | Pediatric Drugs Market Key Factors Analysis |
6 | Pediatric Drugs Market Porter's Five Forces Analysis |
7 | Pediatric Drugs Market Layout |
8 | Pediatric Drugs Market Company and Product Profiles |
9 | KOL Views |
10 | Project Approach |
11 | About DelveInsight |
12 | Disclaimer & Contact Us |
Interested in knowing the pediatric drugs market by 2030? Click to get a snapshot of the Pediatric Drugs Market Trends
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