May 15, 2008 (Vol. 28, No. 10)

Parenteral Systems Will Give Specialized Oral Delivery Methods a Run for Their Money

The demand for drug delivery systems in the U.S. will increase by over 10% annually to $132 billion in 2012. Growth opportunities will extend to a wide range of compounds and formulations. Oral controlled-release medication will continue to account for the largest share of demand through 2012 due to favorable cost advantages, a wealth of potential new product applications, and significant efficacy benefits over conventional dosage formulations.

Advances in biotechnology and combinatorial chemistry will generate rapid growth opportunities for parenteral and implantable drug delivery systems, especially mAbs, polymer-encapsulated compounds, and drug-eluting stents. In fact, led by mAbs and nanopolymer therapies, parenteral formulations will eventually surpass oral dosages administered via specialized delivery as the largest group of drug delivery systems based on end-use product revenues.

Technical improvements will broaden the market potential of dry-powder and metered-dose inhalation systems by opening up new applications in the administration of asthma and antimigraine medication. Additionally, even-dosing and dose-“dumping” advantages will lead to the increasing use of transdermal patches in the delivery of pain control, hormonal, and cardiovascular agents.

All major multinational pharmaceutical corporations are active in the commercialization of drug delivery systems. In addition, the industry includes about 300 small-to-medium sized drug makers and research firms seeking to develop innovative products or technologies. Based on domestic sales of end-use products, the largest competitors in the field are all major drug-making concerns and include GlaxoSmithKline, Genentech, AstraZeneca, Abbott Laboratories, Wyeth, Eli Lilly, Johnson & Johnson, sanofi-aventis, Amgen, and Pfizer.

Oral Delivery Systems Continue to Be Tweaked

Demand for oral drug delivery systems will expand 7.1% per year to $56.7 billion in 2012. Medicines adapted to controlled-release matrix, diffusion, and reservoir systems will post favorable sales gains, as drug makers seek to gain competitive advantages by introducing new and improved formulations of off-patent pharmaceuticals.

Spurred by ingestion and onset-of-action benefits, orally disintegrating tablets and transmucosal drugs will also generate strong growth opportunities in the delivery of pain-control and other critical-care medication.

Ease-of-administration advantages will promote the widening use of chewable tablet dosages for nutritional, respiratory, and central nervous system agents, especially pediatric preparations. Improved solubility and pharmacokinetic actions will lead to rapid growth both in the number and sales of oral nanoparticle drugs.

Parenteral Preparations to Mature Rapidly

Among all dosage formulations, parenteral preparations will provide the strongest growth opportunities for drug delivery systems with demand expanding over 15% annually through 2012. Ease-of-administration and infection-prevention advantages will boost the market for parenteral drugs and solutions sold in prefilled syringes and premixed IV systems.

Precise targeting advantages in the treatment of cancer and other debilitating diseases will broaden demand for therapeutic mAbs. As of March 2008, there were 21 approved mAbs being sold on the U.S. market. This includes nine anticancer, three antitransplant rejection, and two antiarthritic agents as well as one compound each for allergy-related asthma, blood-clot prevention, macular degeneration, multiple sclerosis, paroxysmal nocturnal hemogolbinuria, plaque psoriasis, and respiratory syncytial virus. Infliximab, one of the antiarthritic therapies, is also indicated for the treatment of Crohn’s disease and psoriasis. Additionally, the anticancer mAb rituximab is also approved for rheumatoid arthritis.

Extended circulation and reduced toxicity benefits will expand the range of indications served by polymer- and liposome-encapsulated drugs, especially in the areas of cancer, neurological, and anti-infective therapies. Advances in materials will broaden the range of injectable medicines adaptable to polymer-protected delivery systems.

In 2007, nine polymer-protected therapies were available in the U.S. Domestic sales of these products ranged from $25 million (pegademase bovine) to nearly $2.4 billion (pegfilgrastim). Seven polymer-protected drug delivery systems on the U.S. market are based on PEGylated technology.

The leading applications for prefilled syringes exist in the packaging of parenteral pharmaceuticals and biologicals that are vulnerable to contamination and are indicated for critical-care and emergency therapy or administered frequently.

Biologicals, which are exposed to an elevated risk of cross contamination when prepared from vials or ampuls, will continue to post the largest share of demand within the prefilled syringe segment—$2.4 billion by 2012. Among specific types of biologicals, vaccines, and blood derivatives will account for the vast majority of usage.

Due largely to the impact of insulin and anticancer drugs, the second largest share of demand was recorded by prefilled syringes. Other widely used medication packaged in prefilled syringes includes narcotic analgesics for alleviating severe pain, thrombolytic agents that treat life-threatening cardiac events, injectable antibiotics for potentially dangerous infections, contaminant-vulnerable immunosuppressive agents for preventing transplant rejection, and psychotherapeutic agents.

Premixed IV solutions are usually packaged in specially designed minibags or small rigid plastic containers. Plastic mini-bags provide a ready-to-use format consisting of an active parenteral drug mixed with an appropriate diluent solution. These containers eliminate the need for admixture preparation and thereby provide significant time, labor, and waste reduction.

Most major parenteral drugs are now available in this format, including virtually all injectable antibiotics as well as the majority of analgesic, anticonvulsant, cardiovascular, psychotherapeutic, and respiratory preparations often administered to surgical, critical care, and emergency patients.

Inhalation, Implantables, and Patches

An increasing incidence of chronic respiratory conditions coupled with the need for safer and more effective therapies will boost growth prospects for inhalation drug delivery systems. Based on widespread use in asthma therapy, dry-powder inhaler formulations will continue to record the largest share of sales. Metered-dose drugs, however, will see slightly faster gains in demand due to ongoing improvements in particle size and propellent safety.

Led by new drug-eluting stents with thinner struts and enhanced safety profiles, implantable drug delivery systems will recapture rapid growth opportunities in cardiovascular medication.

Lastly, advances in electrotransport technologies will broaden applications for transdermal patches, especially in cardiovascular, central nervous system, and hormonal drugs that require continuous dosing.

Bill Martineau is an industry analyst at The Freedonia Group. Web: For more information, contact [email protected]

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