Pediatric Drugs - Market Insights, Competitive Landscape, and Market Forecast - 2030

The Pediatric Drugs market is expected to grow at a steady CAGR forecast till 2030 owing to the increasing prevalence of pediatric diseases, increased awareness among parents and caregivers about pediatric health issues, increased regulatory support, and rise in product approval via regulatory bodies across the globe.

The pediatric drugs market is estimated to grow at a CAGR of 4.79% during the forecast period from 2024 to 2030. The increasing prevalence of pediatric diseases such as HIV, cancer, diabetes, and others drives the demand for specialized treatments tailored for children, making the development of pediatric drugs a priority. Simultaneously, heightened awareness among parents and caregivers about pediatric health issues has led to greater vigilance and proactive healthcare measures, further fueling the demand for effective and safe medications. Additionally, the rise in product approvals via regulatory bodies worldwide, facilitated by supportive policies and expedited review processes, ensures a steady introduction of new and improved pediatric drugs into the market. This combination of factors creates a robust environment for the growth of the pediatric drugs market, ensuring that children have access to the necessary treatments for their health and well-being and further propelling the market growth during the forecast period from 2024 to 2030.

Pediatric Drugs Market Dynamics:

According to the recent data provided by UNICEF (2023), in 2022, out of an estimated 39 million people living with HIV globally, 2.58 million were children aged 0-19. Each day, around 740 children contracted HIV, and about 274 died from AIDS-related causes due to insufficient access to prevention, care, and treatment services.

Additionally, as per the recent data provided by GLOBOCAN (2024), in 2022, the estimated number of new cancer cases for those aged 0 to 19 was 276,000, with projections indicating an increase to 282,000 by 2045.

Furthermore, as per the recent data provided by IDF Diabetes Atlas, In 2021, the estimated cases of Type 1 diabetes among children aged 0-19 were 294.9 thousand in Europe, 229.4 thousand in India, and 244.5 thousand in Southeast Asia.

Thus, as these chronic conditions become more widespread, there is an escalating need for innovative and effective therapeutic options tailored to pediatric patients. This surge in demand drives pharmaceutical companies to intensify their research and development efforts, leading to the introduction of advanced and targeted pediatric formulations thereby boosting the overall market of pediatric drugs.

Additionally, the drug approvals not only highlight the advancements in pediatric pharmacology but also underscore the commitment of regulatory bodies like the FDA to prioritize treatments for severe pediatric conditions. For instance, in April 2024, Day One's OJEMDA™ (tovorafenib) obtained accelerated approval from the US FDA for the treatment of relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), which represents the most prevalent form of brain tumor in children. Thus, these developments instill confidence among healthcare providers and caregivers, leading to increased adoption of newly approved therapies. Consequently, this momentum drives the introduction of more specialized and effective medications for children, ultimately expanding the pediatric drug market and improving health outcomes for young patients.

However, stringent regulatory concerns leading to delays in the availability of medications for children, especially for rare diseases and conditions, and the use of off-labeled drugs in pediatrics due to the lack of approved pediatric formulations may result in slight obstacles to the growth of pediatric drugs.

Pediatric Drugs Market Segment Analysis:

Pediatric Drugs Market by Indication (Respiratory Diseases, Cancer, Neurological Diseases, Genetic Diseases, and Others), Route of Administration (Oral, Parenteral, and Others), Distribution Channels (Hospital & Clinics, Pharmacy, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the indication segment of the pediatric drugs market, the cancer category is estimated to have a significant revenue share in the pediatric drug market in 2023. The cancer indication plays a significant and dominant role in boosting the overall market for pediatric drugs due to several key factors. First, there has been a notable increase in the incidence of childhood cancers globally, necessitating the development of specialized treatments tailored to pediatric patients. These treatments often require precise dosing and formulations to minimize adverse effects and maximize efficacy in young patients. The critical nature of pediatric cancers, such as leukemia, brain tumors, and lymphomas, has prompted intense research and development efforts in the pharmaceutical industry, supported by regulatory incentives for pediatric oncology drug development.

Furthermore, advancements in understanding the molecular and genetic basis of pediatric cancers have led to the development of targeted therapies and immunotherapies, which have shown promising results in clinical trials. The success of these therapies encouraged further investment in pediatric oncology, driving innovation and expanding the pipeline of new drugs. Additionally, the advocacy efforts of patient groups and healthcare professionals have raised awareness about the unique needs of pediatric cancer patients, leading to improved access to specialized care and treatments.

Moreover, regulatory initiatives such as the US FDA's Pediatric Oncology Drug Initiative (PODI) and the European Medicines Agency's (EMA) Pediatric Investigation Plans (PIPs) have played a crucial role in facilitating the approval and availability of new drugs for childhood cancers. These initiatives provide incentives for drug developers to conduct clinical trials in pediatric populations and obtain regulatory approval for pediatric indications. For instance, in December 2023, Eflornithine Hydrochloride was approved to reduce the risk of relapse in both adult and pediatric patients with high-risk neuroblastoma. Bosutinib Monohydrate received approval in September 2023 for the treatment of chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in patients aged 1 year and older. Dabrafenib Mesylate, approved in March 2023, is indicated for the treatment of pediatric patients aged 1 year and older with low-grade glioma (LGG) harboring a BRAF V600E mutation requiring systemic therapy. Trametinib Dimethyl Sulfoxide, also approved in March 2023, is indicated for pediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

Overall, cancer indication in pediatrics acts as a dominating factor in boosting the pediatric drug market by driving innovation, expanding treatment options, improving outcomes, and ensuring that children with cancer receive the best possible care. This focus on pediatric oncology not only benefits patients and their families but also contributes to the advancement of medical science and the growth of the pharmaceutical industry.

North America is expected to dominate the overall pediatric drugs market:

North America is expected to account for the highest proportion of the pediatric drugs market in 2023, out of all regions. This leadership position is driven by several key factors contributing to the increased demand and adoption of pediatric medications. Firstly, the region has witnessed a rise in chronic pediatric diseases, such as HIV, diabetes, and various cancers, which necessitate continuous development and deployment of specialized treatments. Secondly, regulatory support from bodies like the FDA has bolstered the approval and availability of pediatric drugs, facilitating timely access to safe and effective therapies for young patients. Moreover, the increased approval of new pediatric drugs across North America has played a crucial role in expanding treatment options and improving healthcare outcomes for children. These factors collectively contribute to a conducive market environment that supports innovation, investment, and growth within the pediatric drugs sector across the region.

According to the recent data provided by GLOBOCAN, in 2022, the estimated number of new cases of cancer among individuals aged 0 to 19 was 17.4 thousand, with projections indicating an increase to 16.9 thousand by 2045. Additionally, in Canada alone, there were 1.5 thousand new cases of cancer in the same age group in 2022, with expectations of rising to 1.59 thousand by 2045.

Furthermore, as per the recent data provided by IDF Diabetes Atlas, In 2021, the estimated cases of Type 1 diabetes in North America among children aged 0-19 were 192.5 thousand, and in Canada was 19.8 thousand.

In response to these increased health challenges, pharmaceutical companies are investing in research and development to develop new pediatric drugs and improve existing treatments. Advances in molecular and genetic understanding of pediatric cancers, for instance, have led to the development of targeted therapies and immunotherapies, which offer more effective treatment options with reduced side effects. Similarly, innovations in diabetes management, including new insulin formulations and technologies, are transforming care for young patients.

Additionally, the increase in product approval in the region further bolsters the market in the region. For instance, in June 2024, FARXIGA (dapagliflozin) was approved in the U.S. by the FDA for the treatment of pediatric type-2 diabetes. Additionally, in June 2023, the U.S. FDA approved Jardiance® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older. Thus, as more drugs receive regulatory approval, healthcare providers gain access to a wider range of treatments that are specifically formulated and tested for pediatric patients. This not only enhances the quality of care but also addresses unmet medical needs in pediatric populations thereby boosting the market of pediatric drugs across the region.

Furthermore, the support from various regulatory bodies enhances trust and helps pediatricians make informed decisions about treatment options, encouraging early adoption of newly approved drugs, and promoting compliance with FDA guidelines. For instance, as per the latest update of May 2024, The FDA published a monthly column in AAP News, the American Academy of Pediatrics' (AAP) monthly news magazine, titled "FDA Updates." This column provided insights from FDA experts on issues related to pediatric health, including new pediatric medical products approved by the FDA, important safety warnings, and updates on the agency's initiatives and progress in pediatric product development. Thus, these initiatives can serve as a platform to inform healthcare providers, pediatricians, and caregivers about new FDA-approved pediatric medications, safety updates, and the progress in pediatric product development thereby escalating the market of pediatric drugs across the region.

Thus, the above-mentioned factors are expected to escalate the market of pediatric drugs in the region.

Pediatric Drugs Market Key Players:

Some of the key market players operating in the Pediatric Drugs market include 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 others.

Recent Developmental Activities 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).
• In June 2023, the US FDA approved Jardiance® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older.
• In February 2023, ViiV Healthcare received European Union marketing authorization for Triumeq, the first dispersible single-tablet regimen containing dolutegravir. It is a once-daily treatment for children living with HIV in Europe.

Key takeaways from the pediatric drugs market report study:

• Market size analysis for current pediatric drugs size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the pediatric drugs market.
• Various opportunities available for the other competitors in the pediatric drugs market space.
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current pediatric drugs market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for pediatric drug market growth in the coming future?

Target audience who can be benefited from this pediatric drugs market report study:

• Pediatric drugs providers
• Research organizations and consulting companies
• Pediatric drugs related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in pediatric drugs
• Various end-users who want to know more about the pediatric drugs market and the latest technological developments in the pediatric drugs market.

Frequently Asked Questions for the Pediatric Drugs Market:

1. What are pediatric drugs?

Pediatric drugs are medications specifically formulated and approved for use in children and adolescents under the age of 18. These drugs are essential for treating a wide range of medical conditions that affect young patients, including infections, chronic diseases, and rare disorders. Pediatric drugs undergo rigorous testing and evaluation to ensure they are safe, effective, and appropriate for children, whose bodies metabolize and respond to medications differently than adults.

2. What is the market for pediatric drugs?

The pediatric drugs market is estimated to grow at a CAGR of 4.79% during the forecast period from 2024 to 2030.

3. What are the drivers for the pediatric drug market?

The increasing prevalence of pediatric diseases such as HIV, cancer, diabetes, and others drives the demand for specialized treatments tailored for children, making the development of pediatric drugs a priority. Simultaneously, heightened awareness among parents and caregivers about pediatric health issues has led to greater vigilance and proactive healthcare measures, further fueling the demand for effective and safe medications. Additionally, the rise in product approvals via regulatory bodies worldwide, facilitated by supportive policies and expedited review processes, ensures a steady introduction of new and improved pediatric drugs into the market. Additionally, the support from regulatory bodies in the form of expedited review processes and incentives for developing pediatric drugs boosts the market. This combination of factors creates a robust environment for the growth of the pediatric drugs market, ensuring that children have access to the necessary treatments for their health and well-being and further propelling the market growth during the forecast period from 2024 to 2030.

4. Who are the key players operating in the pediatric drugs market?

Some of the key market players operating in the Pediatric Drugs are 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 others.

5. Which region has the highest share in the pediatric drugs market?

North America is expected to account for the highest proportion of the pediatric drugs market in 2023, out of all regions. This leadership position is driven by several key factors contributing to the increased demand and adoption of pediatric medications. Firstly, the region has witnessed a rise in chronic pediatric diseases, such as asthma, diabetes, and various cancers, which necessitate continuous development and deployment of specialized treatments. Secondly, regulatory support from bodies like the FDA has bolstered the approval and availability of pediatric drugs, facilitating timely access to safe and effective therapies for young patients. Moreover, the increased approval of new pediatric drugs across North America has played a crucial role in expanding treatment options and improving healthcare outcomes for children. These factors collectively contribute to a conducive market environment that supports innovation, investment, and growth within the pediatric drugs sector across the region.


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