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Proteomics
Proteomics – the identity, function and interaction of proteins
in living organisms – is not new, but it is now experiencing significant
growth. Proteins are responsible for cellular structure and function
including signalling and growth, and are therefore the targets of
most drug discovery efforts. For example, comparison of protein
profiles from normal and diseased cells or tissues can provide valuable
information for potential therapeutic intervention.
In contrast to genomics, the ‘industrialisation’ of proteomics
is in its infancy. Unlike DNA, proteins cannot be amplified to aid
detection and analysis. Also, in contrast to the 35,000 to 45,000
human genes, there may be up to two million different types of proteins,
and these have complex differences in their 3-D structure which
affect their function. One of the current major technologies for
protein identification is two-dimensional protein gel separation,
which can be followed with mass spectrometry detection for analysis
of many different proteins within complex samples.
Technologies such as microarrays for high throughput parallel analysis
of proteins are only just starting to emerge, but are considerably
more complex than their DNA counterparts. Proteomics will utilise
not one, but many different types of technologies. These are likely
to include fluorescent and chemiluminescent analysis for identification
and characterisation, mass spectrometry for protein analysis, as
well as chromatography for high-resolution separation and characterisation.
The estimated total market for proteomics may exceed £1.5 billion
($2.2 billion) by 2005, driven by the development of high throughout
technologies. Market requirements to achieve this include increased
throughput, sensitivity and accuracy, achieved through technologies
for labelling, separation, detection, characterisation and sophisticated
analysis software. Currently the major suppliers of proteomics systems
include Amersham Biosciences, Applied Biosystems, Bio-Rad and Micromass
(a division of Waters).
Genomics
The market value of genomics – systems for research into genes –
is approximately £700 million ($1 billion) with annual growth in
the order of 20 per cent. However, the market is composed of three
sub-segments, sequencing, gene expression and genetic variation,
that are growing at different rates.
The race to complete the first draft of the human genome has driven
the uptake of high throughput sequencing systems in both public
sector genome centres and privately funded genome companies. In
this segment of the sequencing market, Amersham Biosciences and
Applied Biosystems are the market leaders. Growth in this segment
will not continue at the same rate as in the previous two years,
but work will continue to validate the human genome sequence, explore
genetic variation and analyse the genetic make-up of other species.
These centres will continue to demand technologies to increase throughput,
manage reduced sample volumes, and speed up front-end sample preparation.
In the medium to low throughput sequencing market there are over
10,000 sequencers in place worldwide, based on slab gel electrophoresis
or the more recent capillary technology. In 2001, the Canadian company
Visible Genetics Inc became the first to be granted FDA validation
for sequence-based testing for HIV. This paves the way for a new
approach to molecular diagnostic in vitro testing in clinical
laboratories.
Gene expression analysis is predominantly performed using microarray
platforms and represents a market of approximately £275 million
($400 million), growing at over 30 per cent per year. Affymetrix
is the major supplier of prearrayed chips, with many others including
Agilent, Amersham Biosciences and Motorola active in the market
with a range of flexible solutions and formats for end-users. Microarray
technology is now in the mainstream research market with products
including spotters, scanners, fluorescent kits, software and genetic
chips pre-formatted with genetic content.
Analysis of single nucleotide polymorphisms (SNPs) should facilitate
a better understanding of individual susceptibility to disease and
response to drug treatment. Customer requirements for higher throughput
technologies at significantly reduced cost per test have meant that
growth has been slower than originally projected. However, this
emerging market could grow to be over £240 million ($350 million)
by 2005. Companies within this segment include Amersham Biosciences,
Orchid BioSciences, Sequenom and Third Wave.
Bioassays
Researchers use bioassays to measure and quantify the biological
processes involved in cellular activities, metabolism and disease.
Bioassays
are involved at almost every stage of the preclinical drug discovery
and development process – a progressive narrowing-down of possibilities
until only one compound remains. Validation of target molecules,
primary screening of possible drug candidates, secondary screening
to select lead candidates and finally, testing of the lead candidates
to validate their metabolic/toxicological properties are among the
hurdles that must be passed before a potential drug candidate can
move into clinical trials.
One of the largest bottlenecks has traditionally been in the primary
drug screening area. With the advances in genomics and proteomics
increasing the number of potential drug targets and the availability
of large combinatorial
libraries of between 100,000 and 1,000,000 chemical compounds,
there has been a growing demand for high throughput technology to
screen for potential new drugs. There are now systems available
in the market for primary screening of 250,000-750,000 compounds
per day, and these have gone far towards eliminating the bottleneck.
The heart of the current high throughput primary screening process
consists of assays and detection instrumentation. The market will
continue to grow, driven by technology advances such as miniaturisation
to decrease assay costs.
The success of high throughput primary screening technologies has
shifted the bottlenecks in bioassays to other areas of the drug
discovery and development process. At the same time, the need for
pharmaceutical companies to eliminate candidates with adverse metabolic
effects at an earlier stage, thus reducing overall failure rate
and costs, is driving applications such as target validation and
metabolism/toxicology studies. As a result, there is an emerging
market for ‘high information’ secondary-screening formats. This
is starting to stimulate the growth in assay systems for cellular
and sub-cellular analysis within the pharmaceutical industry. The
market leaders in primary and secondary screening instruments are
Amersham Biosciences, Cellomics, Molecular Devices and Perkin Elmer.
Total pharmaceutical company expenditure on a wide range of high
throughput drug screening products, technologies and services remains
over £1 billion ($1.5 billion) per year. Outsourcing to contract
service providers is becoming increasingly attractive to big pharmaceutical
companies. Companies including Amersham Biosciences provide enabling
products to both service providers and pharmaceutical companies.
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