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Pediatric Drug Delivery: Technology and Product Opportunities, 2nd Edition

  • ID: 1403511
  • Report
  • 251 Pages
  • MCD Group LLC
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  • Aegis Therapeutics LLC
  • Cambrex Corporation
  • Fertin Pharma
  • Labtec Pharma
  • OctoPlus Inc.
  • SPI Pharma
  • MORE
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.
Note: Product cover images may vary from those shown
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  • Aegis Therapeutics LLC
  • Cambrex Corporation
  • Fertin Pharma
  • Labtec Pharma
  • OctoPlus Inc.
  • SPI Pharma
  • MORE
1. Executive Summary
Market Overview
Drug Delivery Systems for Pediatrics
Formulation Opportunities
Specialty Pediatric Companies
Product Licensing Opportunities

2. Pediatric Market Overview
Market Needs
Therapeutic Needs
Pain Management
Respiratory / Allergy
Attention Deficit Hyperactivity Disorder
Market Size
Key Therapeutic Areas

3. Drug Delivery Systems for Pediatrics
Marketed Products
Dosage Forms
Taste Masking
Orally Disintegrating Dosage Forms
Soft Chewable Delivery Systems
Oral Liquid Delivery Systems
Oral Mucosal Delivery Systems
Transdermal Delivery Systems
Topical Delivery Systems
Nasal Drug Delivery
Pulmonary Delivery Systems
Parenteral and Device Technologies

4. Formulation Opportunities
Oral Reformulation
Taste Masking
Non-invasive Formulations

5. Companies with Pediatric Focus
Adamis Pharmaceuticals Corporation
Aires Pharmaceuticals, Inc
Arbor Pharmaceuticals, Inc
Asklepion Pharmaceuticals, Inc
Centrix Pharmaceutical, Inc
Cornerstone Therapeutics, Inc
Curemark, LLC
FSC Pediatrics, Inc
InfaCare Pharmaceutical Corporation
Lupin Pharmaceuticals, Inc
Madeira Therapeutics
McNeil Pediatrics
Meritage Pharma, Inc
Next Wave Pharmaceuticals, Inc
Pediapharm, Inc
Pernix Therapeutics Holdings, Inc
Reckitt Benckiser Pharmaceutical, Inc
Seaside Therapeutics, Inc
Shionogi Pharma, Inc
Teva Respiratory, LLC
Tiber Laboratories, LLC
Topaz Pharmaceuticals, Inc
TRx Pharma

6. Drug Delivery Technologies for Pediatric Drugs
Buccal Delivery Systems
APTYS Pharmaceuticals
Biodel, Inc
BioDelivery Sciences International
Corium International, Inc
Fertin Pharma
NovaDel Pharma
Orexo AB
Watson, Inc
Oral Delivery Systems
Acino Holding, Ltd
Akina, Inc
Alpex Pharma
Alte Biosciences, Inc
Aprecia Pharmaceuticals Company
Arx, LLC
Banner Pharmacaps
Capricorn Pharma, Inc
Catalent Pharma Solutions
CIMA Labs, Inc
Collegium Pharmaceutical, Inc
Dow Wolff Cellulosics
Egalet A/S
Eurand, Inc
Eurand, Inc
ForTe BV
Grunenthal GmbH
HealthSport, Inc
IntelGenx Corporation
KV Pharmaceutical Company
Labtec Pharma
Losan Pharma GmbH
LTS Lohmann
Meldex International, PLC
NAL Pharmaceuticals, Ltd
Pharmafilm S.r.l
Physica Pharma
SPI Pharma Inc
Tris Pharma
Xel Pharmaceuticals, Inc
Taste Masking Technologies
Balchem Corporation
Cambrex Corporation
Eurand, Inc
ForTe BV
Oralance Pharma
Nasal Technologies
Ikano Therapeutics, Inc
Dermal Delivery Technologies
Altea Therapeutics
Foamix, Ltd
ForTe BV
nanoBioSciences, LLC
Pantec Biosolutions
Quinnova Pharmaceuticals, Inc
TransPharma Medical
Zosano Pharma

7. Product Licensing Opportunities
Albuterol Dry Powder Inhaler
Allergy Chewing Gum
Atopic Dermatitis Treatment
AtopiclairTM Cream
CRO-PED for Pediatric Diarrhea
Children's Dietary Supplement
Ciprofloxacin Otic Solution
Cough/Cold Pediatric Formulations
Decongestant Cream Stick
Decongestant Patch
Fever Cooling Patch
Foam-Based Dermatology Products
Foam-Based Products for Infants
GastroGard-R for Rotavirus
HedrinTM for the Treatment of Head Lice
Human Growth Hormone Nasal Spray
Insect Repellent Patch
Insecticide-Free Head Lice Treatment
Liposomal Amikacin Formulation
Long-acting Somatropin Injection
Moisturizing Cream for Dermatitis
Nasal Somatropin Formulation
NeoCeramTM Skin Barrier Emulsion
Novel Head Lice Formulation
Once-weekly Injectable Somatropin
Oral Film Formulation of Prednisolone
Oral Rotavirus Thin Film Product
Orally Disintegrating Acetaminophen Formulations
Orally Disintegrating Allergy Products
Pediatric Pain Formulations
Peptide for Chronic Middle Ear Infections
Sinlice, Pediculicide Treatment
Site-Specific Otitis Media Treatment
Sustained Release Somatropin Injection
Teething Gel for Babies
Zinc Oxide Spray


Table 1: Pediatric Age Related Subgroups
Table 2: Antihypertensives Granted Pediatric Exclusivity
Table 3: Cholesterol Drugs Granted Pediatric Exclusivity
Table 4: Diabetes Products Used in Pediatrics
Table 5: Pain Medications Granted Pediatric Exclusivity
Table 6: Emerging Technologies for Antibiotics
Table 7: Leading Respiratory/Allergy Products for Pediatrics
Table 8: ADHD Medications for Pediatrics
Table 9: Drugs Approved for Epilepsy
Table 10: Sales of 25 Drugs Commonly Prescribed to Pediatrics
Table 11: Sales of Leading Pediatric-Focused Products, 2009
Table 12: Sales of Leading ADHD Drugs, 2009
Table 13: Sales of Leading Prescription Allergy Drugs, 2009
Table 14: Sales of Leading Asthma Drugs, 2009
Table 15: Pediatric Oral Antibiotic Market
Table 16: DDS Products Approved for Pediatric Use
Table 17: OTC DDS Products for Pediatrics
Table 18: Key Players in Taste Masking
Table 19: ODT Technology Summary
Table 20: Key Players in ODT Market
Table 21: Oral Film Technology Summary
Table 22: Key Players in Oral Film Market
Table 23: ODD Pipeline Products for Pediatrics
Table 24: Advantages of Chewable Dosage Forms
Table 25: Soft Chewable Delivery Systems
Table 26: Liquid Drug Delivery Technologies
Table 27: Liquid Pediatric Products in Development
Table 28: Key Players in Buccal Delivery
Table 29: Transdermal Pediatric Products
Table 30: Transdermal Pipeline for Pediatrics
Table 31: Topical Pediatric Pipeline
Table 32: Nasal Pipeline Products Applicable to Pediatrics
Table 33: Pulmonary Pipeline for Pediatrics
Table 34: Parenteral DDS Pediatric Pipeline
Table 35: Pediatric Drug Candidates for Oral Reformulation
Table 36: Taste Masking Development Opportunities
Table 37: Non-invasive Reformulation Opportunities
Table 38: Arbor Product Pipeline
Table 39: Asklepion Pipeline
Table 40: Pediatric Products of Centrix
Table 41: Therapeutic Targets of Centrix
Table 42: Cornerstone Products Prescribed to Pediatrics
Table 43: Madeira Product Pipeline
Table 44: McNeil's Pediatric Product Developments
Table 45: NextWave Pipeline Products
Table 46: Pediapharm Pipeline
Table 47: Marketed Products by Reckitt Benckiser
Table 48: Pediatric Products Marketed by Shionogi
Table 49: Shionogi Pediatric Pipeline
Table 50: NonSpil OTC Products
Table 51: Rx Products Marketed by Taro
Table 52: Teva's Key Products for Pediatrics
Table 53: Tiber Laboratories Product Portfolio
Table 54: VIAdel Pipeline
Table 55: NovaDel Pipeline
Table 56: Orexo's Sublingual Pipeline
Table 57: Alpex Pipeline
Table 58: Marketed Zydis Products
Table 59: Catalent Product Pipeline
Table 60: Products Developed by CIMA
Table 61: Ethypharm's ODT Products
Table 62: Eurand's ODT Products
Table 63: HealthSport Products
Table 64: Labtec Products
Table 65: LTS Wafer Systems
Table 66: Meldex DDS Pipeline
Table 67: MonosolRx Pipeline
Table 68: Malt-o-Fast Comparative Data
Table 69: Tris Product Pipeline
Table 70: Products Containing Microcaps Technology
Table 71: NODS® Pipeline
Table 72: OptiNose Pipeline
Table 73: PassPortTM Product Pipeline
Table 74: ViaDerm Pipeline
Table 75: Foamix Pipeline Products


Figure 1: US Prescription Pediatric Market, 2009
Note: Product cover images may vary from those shown
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4 of 3
- "Acino Holding Inc.
- Adamis Pharmaceuticals Corporation
- Aegis Therapeutics LLC
- Aires Pharmaceuticals, Inc.
- Akina Inc.
- Alpex Pharma
- Altea Therapeutics
- Alte Biosciences
- Altus Pharmaceuticals Inc.
- APR Applied Pharma Research
- Aprecia Pharmaceuticals Company
- APTYS Pharmaceuticals
- Arbor Pharmaceuticals, Inc.
- Aridis Pharmaceuticals
- Arx, LLC
- Asklepion Pharmaceuticals, Inc.
- Balchem Corporation
- Banner Pharmacaps
- Biodel Inc.
- Biodelivery Sciences International
- BTG International
- Cambrex Corporation
- Capricorn Pharma, Inc.
- Catalent Pharma Solutions
- Centrix Pharmaceutical, Inc.
- Ceragenix Pharmaceuticals Inc.
- CIMA Labs, Inc.
- Collegium Pharmaceutical
- Corium International
- Cornerstone Therapeutics, Inc.
- Critical Pharmaceuticals Limited
- Curemark, LLC
- Dow Wolff Cellulosics
- Egalet A/S
- Ethypharm
- Eurand
- Ferndale Laboratories
- Fertin Pharma
- Flamel Technologies
- Foamix Ltd.
- ForTe BV
- FSC Pediatrics, Inc.
- Grunenthal GmbH
- Healthsport, Inc.
- Ikano Therapeutics
- Immuron Limited
- InfaCare Pharmaceutical Corporation
- InteGenx Corporation
- Intercell
- KV Pharmaceutical Company
- Labtec Pharma
- Lavipharm
- Losan Pharma GmbH
- LTS Lohmann
- Lupin Pharmaceuticals, Inc.
- Madeira Therapeutics
- Manhattan Pharmaceuticals, Inc.
- McNeil Pediatrics
- Meldex International
- Meritage Pharma, Inc.
- Monosol Rx
- NAL Pharmaceuticals Ltd.
- nanoBiosciences, LLC
- Napo Pharmaceuticals, Inc.
- NextWave Pharmaceuticals, Inc.
- NovaDel Pharma
- OctoPlus Inc.
- OptiNose
- Oralance Pharma
- Orexo AB
- Pantec Biosolutions
- ParaPRO, LLC
- Pediapharm, Inc.
- Pharmafilm s.r.l.
- Piedmont Pharmaceuticals LLC
- Physica Pharma
- Quinnova Pharmaceuticals, Inc.
- Reckitt Benckiser Pharmaceutical, Inc.
- Respirics, Inc.
- Salvat Biotech LLC
- Seaside Therapeutics, Inc.
- Shionogi Pharma, Inc.
- Sinclair Pharmaceuticals Ltd.
- SPI Pharma
- TaroPharma
- Teva Respiratory, LLC
- Tiber Laboratories, LLC
- Topaz Pharmaceuticals, Inc.
- Transave, Inc.
- Transpharma Medical
- Tris Pharma
- TRx Pharma
- Uluru, Inc.
- Watson, Inc.
- Xel Pharmaceuticals
- Zosano Pharma
Note: Product cover images may vary from those shown