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European Biopharmaceutical Review

Small but Perfectly Formulated

The total US market for nanomedicines will command strong growth over the long term, rising to over $39 billion in 2011, says William Martineau at Freedonia Group, sustaining a strong upward pace to $82 billion in 2016

Trends in the US pharmaceutical industry will favour the increasing development of nanotechnology drug formulations and delivery systems. The high costs and extensive regulatory requirements involved in commercialising new therapies will prompt proprietary pharmaceutical manufacturers to diversify research and development strategies into product line extensions. Reformulations and drug delivery systems provide a costeffective means to improve the safety, efficacy and convenience of existing medication. In most cases, improved versions of existing medication are subject to less stringent clinical testing standards than new therapies. As a result, the commercialisation timetable is shorter and less costly. More importantly, a multiple source drug adapted to a unique delivery system can sometimes gain new or extended patent protection, providing its developer with significant competitive advantages.

Nanomedicines are pharmaceuticals and biologicals composed of nanoscale active ingredients or adapted to nanoparticle delivery systems. Monoclonal antibodies comprise the principal nanoscale active ingredients now employed in therapeutic applications and 20 such therapies have been approved for use by the FDA. In addition, more than 150 new monoclonal antibody drugs are being tested in US clinical trials. In commercial use, nanoparticle drug delivery agents consist of crystals, liposomes and polymers. Dendrimers, fullerenes, micelles, nanoshells and nanowires are among the nanoparticle drug delivery agents in various stages of development.

MONOCLONAL ANTIBODIES

Discovered in the mid-1970s, monoclonal antibodies meet the definition of nanomaterials, being on average just 20 nanometres in size. They are protein molecules produced through hybridoma technology. A hybridoma is a biological manufacturing factory created by fusing together two cells of different origins. One cell incorporates a gene that stimulates the production of an antibody specific to a single target, such as an antigen or antigen receptor site. The other cell is derived from a mouse and contains an indestructible, continuously dividing tumour. The fused hybridoma produces an unlimited supply of monoclonal antibodies that will respond or react to only one specific stimuli.


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William Martineau is an authority on the health care industry. He has performed in-depth research across biotechnology, pharmaceuticals, medical packaging and related areas, producing titles such as: Pharmaceutical Chemicals, US Pharmaceutical Packaging, World Pharmaceutical Packaging, World Pharmaceuticals I & II, Medical Testing Chemicals, Drug Delivery Systems, and Biotechnology. Prior to joining Freedonia, he was Manager of Market Development at American Sterilizer Company, where he gained experience in health care research and strategic planning. At Invenex Laboratories, he served as Product Manager, responsible for the administration of a line of injectable pharmaceuticals. He also served as Senior Health Care Analyst at Predicasts Inc and Manager of Market Research at Life Technologies Inc (a division of The Dexter Corporation). William holds a BA in Management and an MBA in Marketing and Finance from Kent State University.
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William Martineau
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