Abstract
With the mapping of the human genome and the concomitant explosion of
proteomics, a steady stream of biopharmaceuticals have been
launched--recombinant therapeutic proteins, monoclonal antibody-based products
used for therapeutic or in vivo diagnostic purposes, and nucleic acid-based
products. As the rate of regulatory approval for biopharmaceuticals increases,
the number of products reaching the market will impose unprecedented demands
on the industry's biomanufacturing capacity. Whether or not this will create a
biomanufacturing bottleneck is a hotly debated issue in the industry. One
issue that is not debatable, though, is the high cost of manufacturing
biopharmaceuticals. While biopharmaceuticals produced in bacterial or
mammalian cell culture bioreactor facilities have proven to be very effective
therapeutic agents, they are also among the most expensive drugs produced, and
there is doubt that the current pricing models are sustainable regardless of
these agents' efficacy.
One way to address these concerns is through transgenics, which makes use of
animals and plants to manufacture biopharmaceuticals. Mammalian, avian, and
plant platforms for biomanufacturing can dramatically decrease costs of
production, facilities and, scale-up. In the research realm, many scientists
believe that the transgenic mouse and other transgenic species will help lead
researchers to a biomedical revolution over the next decade.
This report provides a comprehensive analysis of the current status of the
subsector of the biotechnology industry focused on animal and plant
transgenics for biopharmaceutical production and research. The transgenic
species and technologies involved in the production of human
biopharmaceuticals are detailed, including an in-depth discussion of
individual products currently in research and clinical trials. The report
concentrates on the use of whole transgenic animals and plants as an
alternative biomanufacturing method as opposed to traditional methods of
microbial fermentation or mammalian cell culture.
The information for this report was gathered using both primary and secondary
research including comprehensive research of secondary sources such as company
literature, databases, investment reports, and medical and business journals.
Kalorama Information conducted interviews with key industry officials,
consultants, scientists developing transgenic technology, and other
individuals at university and private laboratories involved in transgenic
research. These sources were the primary basis for information specifically
relating to trends affecting the science of transgenics, and calculating the
future revenues of this nascent biotechnology sector. Specific interviews with
transgenic organizations company representatives included marketing directors,
division managers, and product representatives.
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