Frost & Sullivan

The first nanoparticle drug delivery system reaches the market
On 8th February 2005, the first nanoparticulate drug delivery product, Abraxane for the treatment of breast cancer was launched by Abraxis Oncology, a division of American Pharmaceutical Partners, Inc. The initial announcement in late 2004 saw the company’s share prices rise by 50% and required the Food and Drug Administration (FDA) to create a new class of therapeutic products.

Operating at scales of billionths of a metre, nanoparticulate drug delivery systems involve binding a therapeutic compound to a nanoparticle, or encasing it within a nanoshell. Common materials in development include gold or silicon nanoparticles, with the Abraxane system using a nanoparticulate shell constructed from albumin. A key advantage of nanoshells is that they can be targeted to specific cell populations through conjugation with a monoclonal antibody. When the nanoshell reaches the target site, it is ruptured using a low intensity light source such as a laser, and the therapeutic contents are released. This provides high target specificity, with high potential for treatment of localised neurological disorders and cancer with therapeutic compounds which have side effects in the rest of the body.

The launch of Abraxane is a good indication that nanobiotechnology is finally emerging into a commercially viable sector. The drug forms a new sector in nanoparticulate delivery systems which fits neatly alongside existing nanotherapeutics in the nanoemulsion sector. The market leader in nanoemulsions, Elan Pharmaceuticals Inc., has developed a nano-crystallisation system for milling drug compounds to nanometre scale particles to improve biological uptake into patients. The system had been successfully applied to the Wyeth Pharmaceuticals Inc. Rapamune drug for use in immunosupression during transplant surgery and the Merck & Co., Inc. Emend drug for control of chemotherapy induced nausea and vomiting.

Expanding governmental funding drives the nanobiotechnology market
A significant feature of this industry is the massive amounts of funding which is being supplied to this sector and is driving the nanobiotechnology sector. In the United States, for example, the nanotechnology sector receives funding which is second only to the war on terror. The worldwide investment in nanotechnology research and development in 2004 from both public and private sectors was an estimated $US8.4 billion. An estimated 15% of this was directed at nanobiotechnology applications. With the nanobiotechnology sector only making up around 8% of the nanotechnology industry worldwide in 2004 (Figure 1), funding in nanobiotechnology remains plentiful.

Figure 1: World nanotechnology industry focus in 2004 according to sector. Nanobiotechnology companies represent around 8% of the overall industry.

Drug delivery remains one of the biggest challenges for the pharmaceutical industry. Nearly all therapeutics currently on the market are delivered in a non-specific manner to the whole body, and this results in unintentional side effects. This challenge is of utmost importance in the area of oncology, where treatment involves the selective destruction of tumor cells. This often has non-target effects on surrounding body tissues, resulting in the side effects most commonly observed with chemotherapeutics such as alopecia and nausea.

Future Challenges
As with many emerging and novel sectors, nanobiotechnology will face significant challenges once the novelty factor dies down and the major discoveries and breakthroughs have been made. Although public sector funding is still increasing, it is not being met by input from the private sector, with big pharmaceutical companies reluctant to invest in untried technologies. This requires more action and investment from the pharma-biotech sector, which will most likely take the form of industrial collaboration, consolidation and licensing agreements.

Market development is being slowed down by lack of regulatory case law, manifest over public concern over the potential health and environmental impacts of manufactured nanoparticles. This will improve as new products emerge onto the market and more In the United States especially, this is attracting attention and investigation from governmental organisations, and strong collaborations are being set up with academia, with particular regard to the International Council on Nanotechnology (ICON), established at Rice University’s Center for Biological and Environmental Nanotechnology, which is conducting comprehensive safety studies for the FDA.

If these challenges are overcome, the nanobiotechnology market will develop into a sustainable component of the pharma-biotech industry, and the launch of Abraxane is a good step in the right direction.

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