REPORT HIGHLIGHTS
- The current worldwide market for therapeutics from transgenic sources is
zero, but is expected to exceed $1 billion in 2008 and reach $18.6 billion
in 2013.
- By 2008, between eight and 10 transgenically produced human therapeutics
are expected to be on the market. By 2013, there should be at least 30
products on the market or substantially more.
- If regulatory guidelines for the production of generic drugs using
transgenic systems are developed, the number of product approvals could be
two or three times the projection for 2013.
- The manufacture of biopharmaceuticals in animal and plant transgenic
systems represents a revolution in the production of human therapeutics.
This is expected to generate products for as little as 1/1000th the cost of
current methods.
INTRODUCTION
Recent advances in genomics and gene discovery have led to the identification
of new biopharmaceuticals. As more genes are identified and proteins
characterized, more biopharmaceutical targets will become available for drug
discovery. As more protein products are developed to treat diseases, there is
growing concern about the ability of the pharmaceutical industry to meet
production demands.
This important BCC report provides insight into new
technologies for producing drugs, biologics, cells, tissues and organs from
transgenic animals and for producing biopharmaceuticals from transgenic plants.
The primary products in development for human medicine using so-called
biopharming or molecular pharming are protein-based drugs, including antibodies
and vaccines.
The introduction of transgenic biopharmaceutical production
technologies and transgenically produced human therapeutics will revolutionize
the healthcare market in two ways. The first will be a significant reduction in
the pricing of existing pharmaceuticals, which can be produced transgenically
for as little as 1/1000th the cost of a product manufactured using mammalian
cell culture systems. The second advantage of transgenic production is markedly
higher profits for companies producing biopharmaceuticals using transgenic
technology.
Transgenic animals already are in use for in vivo testing of drugs
and vaccines designed for humans. Transgenic animals also are being used for the
production of pharmaceuticals, in particular protein-based drugs, including
antibodies that have yet to enter the marketplace.
SCOPE OF STUDY
The report contains:
- discussion of the transgenic species and technologies involved in the
production of human therapeutics
- in-depth discussion of individual products currently in development
- estimates of current markets for proteinbased products with forecasts
through 2013
- discussion of the impact of transgenically produced protein drugs and
vaccines on the marketplace as well as the regulatory environment
- profiles of companies focusing solely on the development of these products
as well as companies that are including such products in a diverse product
pipeline.
METHODOLOGY
The base year for this study is 2003. Market figures are based on revenues at
the manufacturers' level and are projected at 2003-dollar value (i.e., inflation
is not computed into the projection figures).
INFORMATION SOURCES
Data to prepare this study was derived from information obtained from
interviews with management at transgenic products and services companies as well
as with personnel working at pharmaceutical, biotech and contract manufacturing
companies, and government agency spokespersons. Key information from business
literature was used to obtain expert opinion on commercial potential and market
sizes from industry professionals.
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