Biotechnology-
Future
This text has been
adapted from the speech 'Key areas of the future knowledge-based
bio-economy and the need for a policy agenda' presented by Dirk
Carrez, EuropaBio's Public Policy Director.
Introduction
EuropaBio is the European Association of Bioindustries. We have
around 85 corporate member companies, and - as we are in Europe - 25
national member associations. Via these national associations we
represent around 1,800 small and medium-sized biotech companies. Our
member companies are active in all areas of biotech: red, white and
green. EuropaBio represents the interests of the industry towards
the European institutions so that legislation encourages and enables
biotechnology companies in Europe to innovate and provide for our
society’s unmet needs.
I was asked to talk about the future of the bioeconomy. But does
that mean that the bioeconomy does not exist today? Sometimes we
have the impression that the bioeconomy is something that we still
have to create. When we at EuropaBio discuss this issue with Members
of the European Parliament, authorities, Commission officials, and
even some journalists, they often ask us: ‘you are talking about
biotechnology and the bioeconomy, but where is it? We don’t see it.’
And in fact it’s true: biofuel is a fuel, bioplastics are plastics,
a biomedicine is a medicine. Biotechnology is a technology, not just
a single product. We call it “The invisible revolution”. So we
always have to explain to non-experts or non-scientists what the
bioeconomy really is. Before starting my presentation, I will show
you a very short video about the bioeconomy today. The video was
made by EuropaBio to show people what the impact of biotechnology on
our society is today. This video can be downloaded from our website
www.europabio.org.
The bioeconomy tomorrow – Healthcare
Let us
start with healthcare or red biotech. Today healthcare biotech
accounts for about one-fifth of all drugs on the market, and this is
still increasing. We have around 160 approved medicines, vaccines
and genetic tests on the market. Fifty per cent of all new drugs in
development are developed via biotechnology: around 360 products
targeting approximately 200 diseases. This will lead to more
personalized and more efficient medication. Biotechnology will also
offer new and more efficient ‘therapeutic weapons’, is improving
product safety, and makes large-scale production possible. In fact,
healthcare biotechnology helps us to move from disease treatment,
via a better and efficient cure with improvements in diagnosis and
detection, towards prevention through the application of genetics,
genomics and proteomics.
Within EuropaBio - after analysis prepared with the help of a number
of our member companies - we see four main areas in the future of
healthcare biotech:
- The first area is the development of new innovative treatments,
via new medicines and vaccines. In the area of medicines, this will
mainly be proteins that help the body to fight all kinds of
infections, and new biotech medicines to treat diseases such as
anaemia, cystic fibrosis and different forms of cancer.
Biotech vaccines are becoming more and more important. Where
conventional vaccines use weakened or dead forms of a virus, a
biotechnology produced vaccine consists only of the antigen, not the
actual virus and cannot transmit the virus itself. Research is
ongoing for vaccines to combat influenza, AIDS, herpes viruses, and
cholera.
- A second important area in the field of healthcare biotech is the
area of diagnostics. Here we will see some improvements in the more
classic diagnostics, e.g. for the screening of HIV and hepatitis.
But we are moving more and more towards genetic testing. Today,
worldwide close to 1,000 human diseases can be identified by genetic
testing. The difficulty is that we don’t have a cure for each of
these diseases, so here we have a ethical problem. But we should not
forget that this kind of genetic testing can also help people to
better assess their risk of developing a certain disease, including
cancer, or help them to counterbalance health risks by adjustments
in their lifestyle. Importantly, due to this kind of genetic
testing, we can develop more targeted, patient-specific
prescriptions in order to increase the chance of successful
treatment.
- We call the third area “unmet medical needs”. In this area, cells
and tissues will play an important role in orthopaedics, in skin
repair and in new cell-based cancer immunotherapy. And as people are
living longer, new cell-based therapies to treat neurodegenerative
diseases such as Parkinson’s disease or Alzheimer’s disease will be
essential.
“Gene therapy”, where we use the genes themselves as drugs to
correct certain genetic disorders or where a missing gene can be
replaced, will become crucial. This research is ongoing and over the
long term we think that this will offer exciting new possibilities.
- The last important area is the “tailor-made medicines”, where
pharmocogenetics will offer new ways to match medicine doses and
medical treatments to individual groups of patients, increasing both
the safety and efficacy of treatments by diminishing the trial and
error for patients trying to find the optimal dose and treatment.
Over the longer term, we expect also to see results from proteomics,
a science which studies the physiological functions of proteins and
their effects on diseases, and of recombinant DNA and cell cultures
to produce missing or defective proteins.
For EuropaBio and its member companies, these are the key areas for
the future bioeconomy, and more specifically for the healthcare
area.
The bioeconomy tomorrow - Agri-food
So
what about the green biotech or the agri-food sector in the future?
If we look to the Crop Breeding Technology Timeline, we see that
cultivation of crops started dozens of years ago, and that new crop
improvement technologies such as hybridisation and mutagenesis were
introduced at the beginning of the last century. The recombinant DNA
technology started more than twenty years ago, and especially with
the new knowledge from genomics and bioinformatics, this evolution
will move even faster in this area. The new plant biotechnology will
focus on the input traits as well as on the output traits:
- Input traits are, for instance, disease resistances against
viruses, bacteria, and fungi. Research is ongoing and products are
already on the market. The main genetically optimised crops that are
cultivated today are insect resistant and herbicide tolerant plants,
but we expect soon new cold, heat or drought tolerant crops to be
developed via modern biotechnology. Crops that use nutrients more
efficiently, that grow more uniformly, or with shorter time to
harvest will probably be the result of future research.
- In the area of output traits, more and more research is being done
on changing nutritional composition, for instance more starch for
industrial crops, or oil for biodiesel production. High energy crops
for biofuel production, or plants with more fibres for industrial
production are also in the pipeline.
So where today we have started to cultivate mainly the first
generation of GM crops, focusing on agronomic traits and beneficial
mainly for farmers and the environment, the second generation of
genetically optimised crops will focus more on quality traits,
having a benefit for consumers and human or animal health. Over the
longer term, we will develop third generation crops, where plants
will be used as factories to produce fibres, antibiotics or even
pharmaceuticals. We expect this to happen over the next 10 to 15
years.
Industrial biotechnology and the bio-based economy
What
is industrial or white biotechnology? It is in fact the application
of biotechnology for the processing and production of chemicals,
materials and fuels. It is very diverse and has an impact on
different industrial sectors, including chemicals, pharma, food and
feed, pulp and paper, textiles and energy, materials and plastics.
It often uses biomass or biorenewables, and converts this via
bioprocesses into all kinds of bioproducts such as polymers,
enzymes, biofuels, chemicals or pharmaceuticals. White biotechnology
is the basis of the new bio-based economy. The “classical or
conventional” economy is based on fossil energy or non-renewable
feedstock transformed via mainly chemical processes into a number of
products, producing CO2 and waste which is incinerated or used as
landfill. The “bio-based economy” is using biomass as renewable
feedstock, which is converted via mainly bioprocesses into
bioproducts. The by-products can be used by another company as input
or feedstock for another production process. The CO2 that is
produced is taken up via photosynthesis into new biomass.
There are many examples of bio-based products already on the market.
They include pulp and paper, biopolymer fibres for construction and
household applications (e.g.wall boards and carpeting),
biodegradable plastics, biofuels (bioethanol and biodiesel),
lubricants and industrial enzymes, such as those used in detergents
and in the paper and food processing industries. These bio-based
products are already made from agricultural and forestry feedstocks
that provide a sustainable resource for manufacture.
Biotechnological processes also form the basis for the manufacture
of some antibiotics, vitamins, amino acids and other fine chemicals.
White biotechnology will continue to make inroads in some sectors
for economic reasons. However, in many cases the main driver for
change will be the reduced environmental footprint of biological
processes. Of course, the processes themselves still have to be
efficient and economic, but often both cost and environmental
benefits come together.
A few years ago, the OECD published a report on biotechnology and
sustainability, analysing 21 case studies across a range of sectors.
These studies confirmed that biotechnology can reduce both costs and
the environmental footprint of industrial processes. Some cases
showed a reduction of 10-50% in capital and operating costs, while
in others water and energy use decreased by 10-80% and the use of
non-aqueous solvents was drastically reduced or eliminated. The
achievement of such environmental benefits at the same time as
reducing costs is a clear win-win situation, and there will be many
other opportunities as technologies continue to develop and be
applied. The Öko-Institute in Germany, together with EuropaBio and
other partners, has also collected a number of case studies in a
report published in 2003. They came to the same conclusions. Today,
many of our member companies make LCA studies measuring the
environmental impacts of their production process and the
sustainability of their products.
This is today, but what does the future hold for industrial
biotechnology? We think that the integrated diversified biorefinery
- an integrated cluster of industries, using a variety of different
technologies to produce chemicals, pulp and paper, biofuels, food
ingredients and power from biomass raw materials - is a key element
in the future biobased economy. These integrated biorefineries, like
conventional, fossil-fuel refineries and chemical complexes, can
produce a wide range of commodities and specialty end-products. The
difference is that, rather than starting from fossil oil, the raw
material is coming from agricultural resources such as crops (which
can be grown and harvested every year) and trees. The current
renewable feedstocks are typically wood, starch and sugar, but in
the future, more complex by-products such as straw and even
agricultural residues and households waste – could be converted into
a wide range of end products.
Especially in the chemical sector we will see an important impact of
industrial biotechnology. Fermentation and bioprocesses are already
commonly used in the fine chemicals sector, to produce, for example,
vitamins, pharmaceutical intermediates and flavours. Recent reports
predict annual growth rates of nearly 5% for fermentation products
(compared to 2-3% for overall chemical production) in the coming
years. McKinsey & Company predicts that by 2010, bio-based products
will account for 10 percent of sales within the chemical industry,
accounting for 125 billion EUR in value. Already, in 2005, products
made from biobased feedstocks or through fermentation or enzymatic
conversion account for 7 percent of sales and 77 billion EUR in
value within the chemical sector, and different studies agree that
these products will play an increasingly significant role in the
chemical and other manufacturing industries in the future. An
important area will be biofuels, such as bioethanol or biodiesel.
Today, the global biofuels market consists of approximately 85%
bioethanol and 15% biodiesel. Bioethanol is produced and consumed
mainly in Brazil and North America. On the other hand, Europe is the
world leader in biodiesel production and this fuel represents about
3/4 of the European biofuels market. By 2010, it is estimated that
global biodiesel production will be three times that of
2005, while the global biofuel ethanol production in 2010 is
expected to be close to double the output in 2005. Probably the vast
majority, if not all, of this increased production will employ first
generation technology, and agricultural crops will continue to
account for the bulk of raw material used by the sector, while
second generation technologies (e.g. cellulosic ethanol and
biomass-to-liquid biodiesel) will enter mainstream commercial
production after 2010. The third generation will be a kind of
integrated biorefining complexes.
It will be possible in the future to develop a bio-based economy.
Today we can make a lot of chemical building blocks from petroleum,
and from these building blocks all kinds of intermediates and
finished products or consumer goods can be made. In the future we
will be able to produce such building blocks and similar consumer
goods from all kinds of biomass, and normally in a more efficient
and sustainable way. These are the key areas in the field of white
biotechnology.
Do we still need political support to develop
the future biobased economy?
The
commercial success of bioproducts and processes depends on
scientific, technological and environmental innovation and on a
supportive regulatory framework. Nevertheless, Europe is currently
well placed to develop good products for the market, building on its
established strengths:
-
Europe has a solid chemical, pulp and paper, woodworking and
biotechnology industry infrastructure;
-
Europe is the world leader in key industrial biotechnologies
such as enzyme technologies, and both small- and large-scale
fermentation. The key enzyme-business players are heavily
concentrated in Europe;
-
Europe is very strong in the development and production of
biobased specialities (such as food ingredients,
pharmaceuticals, and fine chemicals);
-
Renewable raw materials are available in Europe, but competition
is increasing;
-
Europe has an education system that performs to a high standard
and provides an extremely highly skilled workforce.
So why
do we still need political support? We need this to lower the risk:
a company that starts to invest in research can succeed or fail, so
there is a big risk for start ups. If you succeed, you must protect
your invention, there are some IP risks because you don’t know
exactly what your competitor has done. Then you have to find the
finances to develop your process or product, so you have some
financing risks. Of course, if you want to commercialise a new
product or a process, you have some regulatory risks. And, finally,
you have to bring the product to the market at a competitive price,
so you have a marketing risk. But in this value chain, the risk goes
down as the value goes up.
Unfortunately – and especially in Europe - there are additional
political risks. If this “risk” is at the beginning of your process,
it can be avoided. For instance, if a specific regulation will make
it very difficult to commercialise a product, you often don’t even
start the research for that product.
In Europe we sometimes have “political risks” at the end of the
value chain. The European approval system for GMOs is a good
example: even if the independent European Food and Safety Agency (EFSA)
gives positive advice based on pure and independent science, it is
still a political decision to approve a new GMO for
commercialisation. Another example: it sometimes takes years before
European Directives are implemented in Members States, and sometimes
Member States do not implement these directives correctly, so your
product cannot immediately be commercialised. These political risks
at the end of the innovation value chain clearly increase the risk
and lower the value for a company. But if in Europe we can turn
these political risks into political support, with a long-term
vision, lower the risk and increase the value, companies and
entrepreneurs will invest more and faster.
That is why EuropaBio has developed a policy agenda to build a
biobased economy. To establish a sustainable and knowledge-based
bioeconomy in Europe, efforts are needed:
-
To
establish a coherent European Policy Agenda for Industrial
Biotechnology and the Knowledge-based Bioeconomy (KBBE),
-
To
stimulate and support innovation in plant science and industrial
biotechnology,
-
To
promote production and the use of bio-based products and
processes,
-
To
create awareness amongst all stakeholders, and
-
To
improve investment in KBBE-related SMEs
First,
why do we need a coherent policy agenda for the bio-based economy?
The Commission has taken up industrial biotechnology as an important
technology. It has been incorporated into many European policies,
the most important being research and innovation, sustainable
development, climate change and energy, biofuels and finally the
European biotechnology strategy itself. There is a biofuels
technology platform, there are biofuels directives, a biomass action
plan and a European biofuels strategy. DG Agriculture is working on
the reform of the sugar regime – and industrial sugar is important
for biotech fermentation processes. DG Environment has also taken up
industrial biotechnologies into the environmental technologies
action plan, and so on. However every DG is developing its own
strategy in quite an independent way and there are dangers
associated with this. For example, biomass must be used to produce
biofuels. The target for biofuels to replace classic fuel for
transport has previously been set at 5.75% by 2010. Calculations
show that when using the available technologies, around 20% of the
land available in Europe is needed to achieve this target. The
Commission recently announced that by 2020, 10% of transport fuels
should be biofuels. This means we need even more biomass than
previously estimated. We need to seriously think about how we are
going to achieve this. This requires effective and coherent
strategic research. We cannot afford to have the effectiveness
reduced via fragmentation of delivery. Other DGs, along with
industries, are also interested in the production of chemicals and
plastics from biomass. This is another biotechnological strategy
working toward sustainability that also requires coordination. What
we need is an independent overview to ensure we are developing a
coherent policy to achieve these targets, otherwise competitive
biomass could become deadlocked. For example, if demand of biomass
is high then the price will be high and the competitiveness of the
industry will be affected. This is a danger. The aim of a
Knowledge-Based Bio-Economy is to achieve a sustainable technology
in a sustainable industry which is good for the environment while
still being economically competitive. What EuropaBio proposes is to
nominate a “Knowledge-Based Bio-Economy Co-coordinator” to oversee
the coordination of the policies and to develop a real roadmap
toward the Knowledge-Based Bio-Economy at both the European and
Member State level. This is the real hurdle to overcome - having
coordination, a coherent policy and a strategic roadmap toward a
bio-based economy.
The second topic is innovation. When politicians talk about
innovation they often talk about research funding. In the area of
industrial biotech we are very happy to see that the Commission has
developed technology platforms as a tool to develop the content of
FP7 – the largest of Europe’s research programmes run by the EU
Commission. EuropaBio is coordinating the industrial biotechnology
section of the Technology Platform on Sustainable Chemistry (SusChem)
and is also a major stakeholder in the Biofuels and Plants for the
Future Technology Platforms. The aim of these technology platforms
was to develop the Strategic Research Agendas that we need in Europe
for the next ten to fifteen years to develop this technology. The
Commission is now really looking to these research agendas to
develop the content of the next FP7 programme. This is very positive
and FP7 has allocated funds to KBBE. A lot of Member States are
starting up programmes in the area of industrial biotechnology and
there is an EC funded network called ERA-NET which brings together
the various budgets in the area of white biotechnology from Research
Councils around the Member States. However, to develop a competitive
knowledge-based industry in Europe, you have to transform the
knowledge that is created by research into new products and
processes that can be commercialised. This will brings new money
that can be reinvested in research. This requires going one step
further than only research funding. Today more than 20,000 new
patents are added every year in the area of bioproducts and
bioprocesses. But this knowledge is not always transformed into new
products. To help transform this knowledge into new products there
is a real need for demonstration projects and research oriented
pilot plants. If industry together with academia, Member States and
the Commission, in public-private partnerships, can invest in this
type of pilot plants then they can test whether a certain process
can be scaled up. If it can be shown that this process works on a
larger scale, then industrial partners can have the confidence to
start making the huge investments needed to create these production
plants. I am confident that the development in Europe of the KBBE
will occur through the already positive support of DG Research and
the European Investment Bank, both of whom have expressed initial
interest in developing such demonstration projects.
The third topic: how can we stimulate and promote the use of
bio-based products and processes. Sometimes they are more expensive
so we need to explain the benefits and provide some incentives to
promote the use and purchase of bio-based products in the market. To
do this we can provide, both at the European and Member State level,
some market incentives to stimulate the commercialisation of
bio-based products. For instance public procurement rules could be
very helpful. This has been developed in France and is working well.
Temporary pricing measures and tax breaks can help to introduce a
product onto the market until critical volume and commercial
viability is reached. The whole area of biofuels is a good example
of this. Biofuels are more expensive than classic fuels. Member
States are allowed to give tax exemptions to assist in the
introduction phase. Another example is the labelling of bioplastics
showing that they are biodegradable or bio-based. This can be used
in retail at point of sale. We can also stimulate bioprocesses in
industry by developing a cheaper and faster approval system for
sustainable products and processes. To date if an industry develops
a new process or product which is more environmentally friendly than
the conventional process or product, it still has to be registered.
This can be both time consuming and expensive. By developing a
faster and less expensive regulatory system or even preferential
treatment for environmentally friendly products, entry into the
market could be fast tracked. This would help to develop new market
incentives to overcome the hurdle of high investments. Bearing in
mind the Kyoto protocol, if a technology / product can illustrate a
reduction in CO2 emissions, then industry could be incented to
invest in it.
Fourth: we have to create awareness amongst stakeholders. Many
people are aware of biotechnology because of the GMO debate or
because of the healthcare applications – such as vaccines - and the
stem cell research debate. Industrial biotechnology is a little
different. Applications cover a wide range of industrial sectors
from detergents to fuel to vitamins to textiles making it a bit more
invisible. Creating awareness among stakeholders, politicians,
industry, academia, consumers, farmers and of course investors is
vital.
Finally, how can we improve investments in SMEs, especially in
industrial biotech related SMEs. There are a lot of smaller
companies in industrial biotechnology providing what we call
platform technologies to develop or produce certain biochemicals or
pharmaceutical ingredients. These SMEs collaborate with the larger
chemical companies to develop new chemicals via biotechnological
processes. For example, they have developed and patented a certain
screening process which is used as a service for the larger
companies. This is vital in the development of industrial
biotechnology and Europe’s aim to develop, for example, fossil fuel
replacements. It is difficult to raise venture capital in Europe for
all SMEs. But the big problem in the area of industrial
biotechnology is raising awareness amongst investors. They know red
and green biotech but not white biotech. The activities of many of
these SMEs are different and so they need a different funding
mechanism. We are quite happy to see that some private European
venture capital companies have seen that and are developing a
different type of funding – more project orientated than product
orientated. And to assist this we must continue to raise awareness
amongst private venture capitalists.
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