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Pediatric Drug Delivery: Technology and Product Opportunities, 2nd Edition
MCD Group LLC, Oct 2010, Pages: 251
This 250+ page report provides a comprehensive overview of the pediatric drug delivery market and includes relevant market data, key players, pharmaceutical product information, drug delivery technology profiles, and partnering opportunities.
This industry report was written to stimulate development and marketing partnerships in the pharmaceutical industry that will ultimately result in products that better serve the needs of pediatric patients. It is well known that there are an inadequate number of pharmaceutical products available and/or approved for use in pediatric patients. This report identifies the key therapeutic segments within the pediatric market along with relevant market data for pediatric-focused products. In addition, the report reviews the companies actively developing or marketing pediatric products and delivery technologies that can be used to develop appropriate dosage forms for pediatrics. Finally, this report provides specific, actionable information related to partnering opportunities in the pediatric drug delivery space.
Market Overview
Pediatric patients are treated for a variety of conditions, although they seek medical treatment most often for coughs, colds, fever, allergies, bacterial and fungal infections, and respiratory conditions such as asthma and bronchitis. There is also a growing number of pediatric patients being diagnosed and treated for conditions more often associated with adults. For instance, an increasing number of children are being diagnosed with high blood pressure, high cholesterol levels, pre-diabetes and diabetes. While there are numerous medications on the market to treat the various conditions afflicting pediatrics, a large percentage of these drugs are not available in child-friendly dosage forms. In addition, it is estimated that approximately 70% of the medications on the market today have not been tested for use in pediatric patients, although they are routinely prescribed to them. There are clearly unmet needs in the pediatric segment concerning appropriate dosage forms which are proven to be safe and effective in pediatric patients.
MCD Group estimates that the US prescription market for pediatric products is worth in excess of $14 billion. This is a conservative estimate, but a realistic one that is based on concrete sales data for pediatric-focused products as well as pharmaceutical formulations prescribed commonly to the pediatric patient population. Prescription products for asthma and attention deficit hyperactivity disorder (ADHD) generate the most significant revenues in the pediatric market. The leading products include GSK's Advair®, AstraZeneca's Pulmicort Respules®, and Shire's Adderall XR®. Several recent product launches in the pediatric segment are expected to contribute significant revenues over the next five years; these products include Shire's Daytrana® and Vyvanse® products for ADHD, Alcon's Patanase® nasal spray for allergies, and Nycomed's Alvesco® inhaler for asthma. Given the number of new pediatric-focused formulations expected to enter the market within the next 3-5 years, MCD Group estimates that the US prescription pediatric market could grow to $20 billion by 2015.
Drug Delivery Systems for Pediatrics
It is well known that it can be tricky and somewhat difficult to administer medications to pediatric patients of all ages. One of the primary obstacles is administering an accurate, age or weight-appropriate dose in a manner that is acceptable to the child. Bitter or unpleasant taste is an obvious challenge, as is the type of dosage form, as it must be easy to administer without undesirable side effects.
The drug delivery industry offers a full array of innovative dosage forms that are suitable for pediatric patients. Examples of such dosage forms include orally disintegrating tablets and films, soft chewables, taste-masked solutions and suspensions, dry powder syrups/sachets, transdermal patches, and needle-free devices. Unfortunately, the delivery needs of pediatric patients have been widely ignored for many years despite the availability of child-friendly delivery systems. However, over the past five years there has been a resurgence in the number of companies developing and testing new products for pediatrics, in part due to the Best Pharmaceuticals Act for Children passed in 2002 as well as a growing awareness of unmet needs in the pediatric segment by both industry and healthcare providers.
This report profiles more than 75 drug delivery technologies suitable for pediatric patients. The principle platforms covered include oral, buccal, nasal, dermal, and taste masking technologies. These delivery systems are broadly applicable to pediatric pharmaceuticals for both local and systemic delivery. Pulmonary delivery technologies are not individually profiled in this report due to the large number of developers, and the fact that a majority of development projects are limited to local delivery applications. In the future, we predict that there will be more applications of pulmonary delivery for various pediatric illnesses.
- Overview of Delivery Technologies Profiled
- Type of Delivery Systems Total Sample Companies
- Oral Delivery Systems 52 Aprecia, Capricorn, Egalet, IntelGenX
- Buccal Delivery Systems 9 Aptys, Biodel, NovaDel, Orexo
- Dermal Delivery Systems 9 Altea, Foamix, Quinnova, Zosano
- Taste Masking Technologies 6 Cambrex, ForTe
- Nasal Delivery Systems 2 Ikano, OptiNose
Formulation Opportunities
With a growing number of children being treated for new indications, such as high cholesterol and hypertension, it is imperative that safe and effective formulations be made available for this patient sub-group. Furthermore, these new formulations must be available in dose-appropriate, child-friendly dosage forms. Examples of some of the indications where suitable pediatric formulations are needed include HIV infection, ADHD, pain, hypercholesterolemia, and hypertension.
In addition to developing child-friendly formulations of certain existing drugs, a need also exists for developing improved oral taste masked products that are longer acting. In the pediatric segment there are a sufficient number of oral solutions for pain, fever, cough, and allergies, but these products require dosing multiple times per day and sometimes in the middle of the night or during the school day. Sustained release technologies should be employed to address this unmet need in the pediatric space. Tris Pharma is a company actively engaged in this area, with nearly 20 oral SR liquids in its pipeline, many of which have applicability to pediatric patients.
Finally, injectable medications are painful, uncomfortable and ultimately very undesirable for pediatric patients. In some cases injection is the only available (and sometimes feasible) administration route, but there is a clear need for non-invasive delivery products for certain indications. Multiple companies are working in this area, developing unique, non-invasive formulations for vaccines, growth hormone delivery, and diabetes. Examples of these new product developments include a transdermal influenza vaccine by Intercell, a nasal somatropin formulation by Critical Pharmaceuticals, and a microneedle patch formulation of somatropin by TransPharma Medical.
Specialty Pediatric Companies
Of the hundreds of companies developing and/or marketing pharmaceutical products, only 24 have been identified as having a specific interest or focus on pediatric indications. These companies are primarily specialty pharmaceutical companies developing or in-licensing pediatric-focused products for eventual marketing in the US. Several of these companies have established pediatric sales forces, but many are still in the growing stages and are eager to form partnerships in the pediatric segment. This report profiles these companies and discusses specific product developments and partnering needs. Some of the companies featured in this report include Arbor Pharmaceuticals, Madeira Therapeutics, Curemark, and Pediapharm, Inc.
Product Licensing Opportunities
The final section of this report features more than 35 partnership opportunities in the pediatric pharmaceutical market. Several different types of opportunities are presented including co-development, marketing, and licensing agreements for both Rx and OTC products for such indications as head lice, dermatitis, allergies, ear infections, and growth disorders. All development stages are covered, ranging from preclinical to registration.
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