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The completion of the draft sequence of the human genome in 2000
has been hailed as one of the greatest achievements of mankind.
This offers the hope of personalised medicine, more effective therapeutics
and genetic tests that may help to predict and prevent the major
diseases.
The seeds of this discovery and of the ‘genomics revolution’ were
sown back in the 1950s with the identification of the structure
of DNA (the double helix). Rapid developments in the new discipline
of molecular biology in the 1970s and beyond paved the way for understanding
how the genetic blueprint directs the activities of individual cells
via RNA and proteins. Today, using commercially available chemical
and biological reagents, instruments and integrated technologies,
researchers across the world in academic, government-funded and
commercial laboratories are probing the basic mechanisms underlying
disease and identifying novel targets for development of new drugs.
Genomics has generated a plethora of potential new targets for
pharmaceutical companies to exploit, and a key bottleneck is now
the validation of the most important targets. For pharmaceutical
companies, it is essential that they develop drugs more quickly
and at lower cost, and limit the possibility of failure in the later
stages of development. Since the 1980s, the biotech revolution has
also developed industrialised techniques from the research laboratory
into the manufacturing environment, providing a new generation of
pure, safe and cost-effective biopharmaceuticals.
As researchers now probe the function of genes, significant investment
is being focused towards ‘proteomics’ in order to understand the
structure, roles and interactions of proteins, which are at the
heart of cellular function. Proteins are much more complex than
DNA, not only due to the different composition of the amino
acid ‘building blocks,’ but also as a result of their three-dimensional
structures and biochemical modifications.
The more scientists learn, the more the interactive relationships
between proteins, genes, predisposition to disease, differing responsiveness
to drugs and drug development seem to blur the distinctions between
these fields. Techniques such as bioinformatics cross these boundaries
and support the integration and analysis of vast amounts of complex
information. At the beginning of the 21st century, life science
research is becoming increasingly multi-disciplinary. It remains
vital for understanding the mechanisms of disease, and is pointing
the way to increasingly targeted therapeutics for our global society.
 
Market overview
The life science customer segments served by Amersham Biosciences
include research and development groups within academic and clinical
research laboratories, pharmaceutical companies, biotech companies
and contract service providers, as well as biopharmaceutical manufacturing
groups. Historically, researchers have typically carried out many
different procedures with small numbers of each particular test;
in recent years, however, there has been a move towards larger teams
carrying out a high volume of single applications (eg. high throughput
sequencing or drug screening).
The market for providing reagents, kits and multi-purpose instruments
is fragmented with many different global and local suppliers. However,
there is a trend towards fully validated, integrated systems that
combine hardware, software and consumables, dedicated towards these
single applications. The closer links between upstream and downstream
processes and the need to share and analyse related data are also
driving demand for information products and systems. These offer
significant opportunities for companies that can offer technological
platforms for protein studies and drug screening as well as genomics.
Global recessionary pressure in 2001 and the resulting effect on
the equity markets have impacted many biotechnology companies, particularly
with respect to their capital spending.However, total worldwide
pharmaceutical/biotech R&D spend increased by approximately nine
per cent to £43 billion ($63 billion) in 2001, with 18 per cent
growth in the USA, and academic/government spending is strong.
Spending on gene-related drug research by the top 18 pharmaceutical
companies in the world has been estimated to rise from approximately
£1.7 billion ($2.5 billion) in 2000, corresponding to five per cent
of their R&D spend, to over £8.6 billion ($12.6 billion) by 2010,
or 24 per cent of their R&D spend.1
2001 saw increasing competitor consolidation in the market, supporting
the trend of a move towards a smaller number of larger companies
that have a strong market franchise and intellectual property position.
In addition, new competitors such as Agilent and Motorola became
more active in the market, although others such as Corning and Incyte
exited from the genomics tools supply segment. The bursting of the
‘dot com’ bubble has affected most of the new companies that entered
the life science market to compete at the level of the supply chain
(e-commerce). However, the provision of electronic information pre-
and post-sale (e-service) continues to be important in this market.
Despite the availability of far more potential targets than previously,
pharmaceutical companies are still well short of the number of drugs
they need to launch per year to meet their financial targets. The
recognition of the bottlenecks in the process is driving the uptake
of new screening technologies that provide increasing amounts of
information to select winners at an earlier stage in the drug development
process.
Laboratory workflow systems, which integrate information from platforms,
sample and reagent logistics, enable production research by handling
data from sample to end result. Companies beginning to compete in
this market include Amersham Biosciences, Applied Biosystems, Cimmaron
and Informax.
1 Source: Parexel’s Pharmaceutical R&D Statistical
Handbook, 2001
Separations
Bioprocess
The number of biopharmaceutical candidates in clinical trials and
gaining regulatory approval has increased every year for the past
decade, leading to a rapid rise in the total number of marketed
drugs. There are now almost 100 such biopharmaceuticals from companies
such as Amgen, Eli Lilly, Johnson & Johnson and NovoNordisk. The
production of these drugs requires chromatographic separations media
and systems as a key stage in purification. The market for these
bioprocess products is worth approximately £300 million ($440 million)
and is growing at around 15 per cent per year, driven by the increasing
number of licensed biomedicines.
The increased quantities needed for particular drugs (eg. monoclonal
antibodies and insulin) are also a strong driver. Companies in this
segment include Amersham Biosciences, Dyax/Biotage, Merck KgaA,
Millipore and TosohBiosep.
Biotechnology drug candidates in clinical trials comprise a wide
range of compounds including monoclonal antibodies, DNA-based gene
therapies, growth factors, interferon and vaccines. The growth rates
in this area are expected to be maintained or to rise in the future
as an increasing number of novel proteins, peptides and anti-sense
drugs are brought to market as therapeutic products. There are
currently more than 450 biopharmaceuticals in phase I, II and III
clinical trials in the USA. This market growth for bioprocess products
will be underpinned by the increasing propensity of pharmaceutical
companies to look for manufacturing technologies that further improve
overall production economy, and by the increasing desire for self-sufficiency
in some of these products in developing countries.
Laboratory separations
Chromatography
is one of the core technologies used in protein analysis, and growth
in this market is being fuelled by the overall market expansion
in proteomics. Laboratory chromatography techniques are also used
in method development and scale-up for biopharmaceutical
manufacturing. Companies in this segment, valued at approximately
£310 million ($450 million) with anticipated low double-digit growth,
include Amersham Biosciences, Bio-Rad and Millipore.
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