The pediatric drugs market is estimated to be valued at USD 147.8 Bn in 2024 and is expected to reach USD 333 Bn by 2031, growing at a compound annual growth rate (CAGR) of 12.3% from 2024 to 2031. The market has witnessed steady growth over the past decade attributed to the increasing number of clinical researches focusing on developing drugs exclusively meant for pediatric population.

Market Driver - Increasing Prevalence of Pediatric Diseases

Various studies have found that conditions like HIV, cancer and diabetes which were previously considered adult-onset diseases are now increasingly being diagnosed in pediatric populations as well. For instance, the United Nations Programme on HIV and AIDS (UNAIDS) estimates that around 160,000 children under the age of 15 got newly infected with HIV in 2021 alone. While access to antiretroviral treatment has moderately improved over the years, pediatric HIV infections continue to pose a major public health challenge especially in developing nations with weak healthcare systems.

Similarly, cancer ranks as one of the top ten causes of death among children aged 5-14 years. As per the American Cancer Society, over 15,000 new cancer cases are reported in children under 15 years every year in the United States. However, continued research into newer drugs aimed at improving cure rates and reducing long term side-effects remains an important driver.

Likewise, the incidence of type 1 and type 2 diabetes is rising at an alarming pace among pediatric populations worldwide. Genetic predisposition coupled with lifestyle changes such as unhealthy diets and lack of physical activity has contributed to the growing prevalence of diabetes in children. This presents lucrative opportunities for drug makers in the pediatric therapeutic segment.

Market Driver - Heightened Awareness among Parents about Pediatric Health Issues

With the proliferation of health information across multiple media platforms, parents today are more conscious about children's wellness. Earlier, childhood illnesses may have sometimes been overlooked as a part of growing up. However, greater health education through online resources and doctor consultations have enabled caregivers to understand potential risks and recognize symptoms early. This has positively impacted the demand for pediatric medications.

Further, social media influencers regularly share updates on latest research and treatment protocols. This keeps parents informed and empowers them to advocate for their child's healthcare needs. It also develops trust in pharmaceutical brands that are transparent with product information. Growing participation in online health support communities allow caregivers to exchange advice and experiences. Such virtual platforms complement conventional one-on-one doctor interactions.

In addition, schools and community programs leverage innovative methods to impart age-appropriate knowledge about personal hygiene, nutrition, exercise and illness prevention. Children learn responsibility regarding medication adherence and healthy habits from a young age.

In conclusion, heightened parental vigilance stemming from improved health awareness is a key secondary driver propelling the pediatric drugs market forward. As child health assumes priority, demand for appropriate medication tailored to pediatric use will correspondingly rise.

Market Challenge - Stringent Regulatory Concerns Delaying Drug Availability

The pediatric drugs market faces significant challenges in obtaining regulatory approval for new medications. Regulators rightly impose strict testing requirements on drugs intended for use in children, as their still-developing bodies can respond quite differently than adults. However, meeting all regulatory guidelines can significantly delay drug availability for pediatric patients. Pharmaceutical companies must conduct lengthy clinical trials specifically in pediatric populations, which are more complex and costly than adult trials due to smaller subject pools.

Additionally, ethical concerns around testing new drugs on children slow the approval process. These stringent regulatory hurdles discourage investments in pediatric drug development, leaving many child illnesses without FDA-approved treatment options. The delays in drug approval pose risks to children's health and make the pediatric drugs market less commercially attractive.

Market Opportunity - Growing Awareness About Pediatric Health Issues

One major opportunity for the pediatric drugs market is the rising focus on children's health issues. Advocacy groups are bringing more attention to diseases that uniquely or disproportionately impact youth. They are also highlighting the lack of pediatric-tailored medications available. As awareness grows, political and funding support for pediatric clinical research is increasing. The 21st Century Cures Act provided over $500 million to study off-patent drugs for children.

Non-profit organizations are also dedicating more resources to pediatric drug development. This boost in funding and political will comes amid a changing social landscape where children's well-being is a higher priority. As awareness continues rising, more treatment options should reach pediatric patients, representing an important growth opportunity for companies in this market.

Focus on drug development for rare/orphan diseases: Many big pharmaceutical companies have focused their R&D efforts on developing drugs for rare and orphan diseases that affect the pediatric population. For example, Pfizer invested heavily in developing drugs like Vyndaqel for transthyretin amyloidosis and Spinraza for spinal muscular atrophy - both rare genetic disorders. This strategy of targeting rare diseases has helped companies attain significant market exclusivity through orphan drug designations.

Partnering/licensing deals for new drug candidates: Companies often out-license promising drug candidates in early stages of development to other players who can take them through advanced trials and commercialization. For example, in 2015 Roche partnered with Chiesi Farmaceutici to develop a drug called Orkambi for cystic fibrosis. Such deals help share risks and costs of drug development.

Focus on combination/fixed dose formulations: Players develop FDCs or combination formulations that can treat multiple symptoms/comorbidities with a single drug. An example is Trisulfam which is a fixed-dose combo of 3 drugs used to manage epilepsy in children. This improves compliance over separate pills.

Geographic expansion into emerging markets: As developing nations get more access to healthcare, companies look to register existing drugs and conduct local clinical trials.

Insights, By Indication: Rising Pediatric Cancer Cases Drive Growth in the Cancer Segment

In terms of indication, cancer contributes the highest share owning to rising number of pediatric cancer cases globally. Pediatric cancer refers to cancers occurring between birth and 19 years of age. Each year, over 15,000 children and adolescents in the United States are diagnosed with cancer.

According to the American Cancer Society, cancer is the second leading cause of death in children aged 1 to 14 years. Leukemia, brain and central nervous system tumors, lymphomas, and sarcomas are the most common types of pediatric cancers.

Development and success of new targeted therapies and immunotherapy drugs are improving survival rates in pediatric cancer patients. However, successful treatment requires timely diagnosis and access to appropriate drugs. Hence, demand for targeted drugs and immunotherapy drugs indicated for various cancers remain strong in the pediatric drugs market.

Insights, By Route of Administration: Convenience Drives Preference for Oral Route of Administration

In terms of route of administration, the segment – oral administration contributes the highest due to convenience and ease-of-use. Pediatric patients often find oral medicines more acceptable and convenient compared to intravenous or injectable drugs. Liquid oral formulations and flavored chewable medicines are particularly popular among children and infants.

Moreover, oral drugs allow for self-administration and home-based care, minimizing hospital visits and resulting costs. This higher convenience and flexibility associated with oral drugs is a key factor driving their increased uptake over parenteral drugs in pediatric care. Continued R&D into novel taste-masking and sustained release technologies will further support growth of orally administered pediatric drugs.

Insights, By Distribution Channel: Improving Role of Hospitals and Clinics in Pediatric Care

In terms of distribution channel, hospitals & clinics contribute the highest share to the owing to growing role of these healthcare settings in pediatric care. For serious and chronic pediatric health conditions like cancer, neurological disorders and genetic diseases, specialized treatments are often needed. This drives hospital-led administration of pediatric drugs.

Moreover, hospitals offer multi-disciplinary care, complex dosing requirements, available emergency response, and coordination with other specialist departments. They also provide pediatric-focused clinical trials for new drug developments. The growth in number of pediatric ambulatory care centers and specialty children's hospitals augurs well for expanded distribution of pediatric medicines via the hospital segment. Their advantages in managing high-risk pediatric cases will continue supporting higher share over retail pharmacy channels.

• Regulatory bodies like the FDA continue to prioritize pediatric drug approvals, as seen with new formulations for pediatric cancers, diabetes, and other chronic conditions.
• Advances in molecular and genetic understanding of pediatric diseases are driving the development of new therapies.
• As per UNICEF (2023), 2.58 million children aged 0-19 are living with HIV globally.
• GLOBOCAN (2024) estimates 276,000 new pediatric cancer cases in 2022, projected to increase to 282,000 by 2045.
• In 2021, Type 1 diabetes cases in children were 294.9K in Europe, 229.4K in India, and 244.5K in Southeast Asia.

The major 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., and Merck KGaA.

• In June 2024, FDA approved Sofdra (sofpironium) for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in both adults and children aged 9 years and older. Sofdra is a topical anticholinergic gel that works by inhibiting sweat production at the sweat glands. It is the first new chemical entity approved in the U.S. for this condition, providing a novel treatment option for those suffering from excessive sweating​.
• In April 2024, the FDA approved Novartis' Lutathera (lutetium Lu 177 dotatate) for the treatment of pediatric patients aged 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including tumors in the foregut, midgut, and hindgut.
• In March 2024, Johnson & Johnson received FDA approval for EDURANT® PED (rilpivirine) for the treatment of pediatric patients with HIV-1. This approval is specifically for treatment-naïve children aged at least 2 years, weighing between 14 kg and 25 kg, in combination with other antiretroviral therapies. The approval is based on clinical trials that showed the efficacy of rilpivirine in suppressing HIV in pediatric patients​.
• In January 2024, Dupixent (dupilumab) has been approved by the U.S. FDA for treating eosinophilic esophagitis (EoE) in children aged 1 year and older. This approval made Dupixent the first and only FDA-approved treatment for children in this age group suffering from EoE. The approval was based on the successful outcomes of the Phase 3 EoE KIDS trial, which demonstrated that a significant portion of children treated with Dupixent achieved histological remission of the disease.

• By Indication
  • Cancer
    • Leukemia
    • Brain Tumors
    • Lymphomas
  • Respiratory Diseases
  • Neurological Diseases
  • Genetic Diseases
  • Others
• By Route of Administration
  • Oral
  • Parenteral
  • Others
• By Distribution Channel
  • Hospitals & Clinics
  • Pharmacy
  • Others