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

Demand for Novel Delivery Systems Rising

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

  • 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: www.freedoniagroup.com. For more information, contact pr@freedoniagroup.com

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