Monday, January 28, 2013

Biologic Therapeutic Drugs markets and technologies

The focus of the pharmaceutical industry has changed significantly in the past 60 years.  Historically, the focuses of research and products were on small-molecule drugs. Advances in biochemistry, immunology, and biotechnology, however, have broadened our understanding of the mechanisms that operate within the body and what happens when these mechanisms go out of control.  There are significant molecular differences between small molecules, therapeutic proteins, monoclonal antibodies (mAbs) and vaccines.  Due to convenience, which drives patient compliance, what is the benefit afforded by an orally administered drug?  One of the most profound industry-shaping characteristics is the orally available nature of small molecules versus the injectable nature of most biologics.  However, it is the advent of attractive drug targets, the ability to create an oral form of large molecule drugs, and the improvement in manufacturing capabilities that will advance large molecules.
Antibiotics were developed out of the need to battle infection on the battlefield in the late 1930s and early 1940s. .  Medicinal chemists developed techniques for synthesizing drugs to reduce dependence on natural plant and animal sources.  By the 1970s, the products ofthe pharmaceutical industry consisted to a great extent of molecules created in the laboratory either by chemical synthesis or fermentation. These were small molecules, relative to the size of naturally occurring substances such as insulin.
Because small molecules are typically orally available, they can be prescribed by a primary-care physician and self-administered at home. This means that predominantly small-molecule-focused drug companies need large sales forces to address the large number of primary-care physicians, with obvious consequences for structure and costs.  Further, because small molecules can be synthesized by high-throughput chemical processes or large-volume fermentation, the cost of goods of these products is likely to be exceedingly low.
By contrast, biologics (also termed biopharmaceuticals) are generally administered intravenously and, therefore, require assistance from medical personnel, with a few obvious exceptions – for example, self-administered insulin.  Biopharma drug sales forces tend to be focused on the hospital sector and can be considerably smaller in size.
Concurrently, biologic therapies can be far more expensive to manufacture and require longer processing times. As a result, the margins for biologics are often much lower. In many cases, however, pricing has been matched with the investment required to research, develop, and manufacture these large-molecule products.
Biopharmaceuticals have experienced shifts in interest from both patient care providers and manufacturers. Due to the dearth of small-molecule targets that are druggable with a safe product, more and more pharmaceutical companies are looking to large-molecule drugs to bolster their pipelines. 
The above is an extract from the BCC Research report, Biologic Therapeutic Drugs: Technologiesand Global Markets (BIO079B). To download the complimentary first chapter, please click above.

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