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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