2. SUMMARY OF THIS OPPORTUNITY
Personalised medicine in Spain affords an opportunity for foreign companies,
mainly for the following reasons:
Spain already has advanced private and public centres that are developing new
technology in diagnosis, biomarker search, microarray development,
gene suppression and the development of personalised therapies. As a
result of this Spain offers foreign companies a range of products that can
complement their technology or a chance to acquire candidates that reinforce
their current portfolios.
Spain has high-level scientific talent with training at international level and
an excellent cost-benefit ratio. Apart from benefiting from the reduced cost of
staff, companies that invest in Spain will obtain highly successful results,
comparable with any other area of innovation.
In 2010 alone the global diagnostics industry linked directly to the initial stages
of the value chain for personalised medicine expects to invoice €30 billion.
Spain will not avoid the impact on the healthcare market and is currently
developing various technologies to capitalise on the advances in disease
prevention and to use the results to treat disease with new personalised
techniques.
In fact Spain offers a fecund environment for personalised medicine owing to its
integrated healthcare system, which is highly accessible. Foreign firms have
access to an extensive biomedical research and practice network
including numerous hospitals where they can obtained genetic samples and
carry out clinical trials on new drugs and therapies.
At institutional level, the present Spanish R&D Plan for 2008-2011 includes
molecular technology and pharmaceutical and translational research as priorities
in the healthcare area. This plan contains multiple government aid packages to
boost technological innovation in Spain and these are available to foreign as
well as local firms.
Business Opportunity: Personalised Medicine
2009 Update Page 2 of 9
3. CONTENTS
1. IDENTIFICATION OF THE BUSINESS........................................... 4
2. MARKET TRENDS ........................................................................ 6
2.1 The global market____________________________________ 6
2.2 The Spanish market and its prominent players _____________ 6
2.3 Institutions that foster co-operation _____________________ 7
3. REASONS THAT FAVOUR THE DEVELOPMENT OF THIS
INITIATIVE .................................................................................... 8
4. RELEVANT LINKS ........................................................................ 9
Business Opportunity: Personalised Medicine
2009 Update Page 3 of 9
4. 1. IDENTIFICATION OF THE BUSINESS
Recent advances in the extraction of information from the human genome are
helping to close the gap between the diagnosis of an illness and its prevention and
treatment. The current healthcare value chain is based on four events during a
patient’s illness and treatment: onset of illness, diagnosis based on symptoms,
treatment and recovery (and in some cases, monitoring).
However the healthcare model of the future will be based on personalised
medicine. Thanks to new technology in genomics now in development, this
approach will considerably improve the prevention and treatment of a particular
affliction. Healthcare providers will be able to apply this type of personalised
medicine to specific patients that will be segmented according to their genetic
profiles. Each group of patients responds differently to a particular type of
treatment and this creates an opportunity for new tools that can characterise a
genetic sub-population and for the development of preventive methods and
therapies that target a specific patient type.
The model will expand to include early segments in the value chain, such as
information on genetic predisposition to a certain disease, stratifying patient
populations. Advances like these will open the door to monitoring and
prevention of the diseases in question. In addition, diagnosis that is more accurate
will make it possible to select treatment from a series of options and to monitor the
process, obtaining better results in healing patients with safer methods and
healthcare that will generally costs less1.
Various technologies are emerging from the work on molecular biology, which are
positioning pharmacogenomics as the basis of personalised medicine. The
integration of genetic information with pharmacology allows us to identify the long-
term risks of drug use, to select appropriate treatment and the corresponding
dosage, and to reduce the secondary effects of such medication.
These technologies include the following applications:
Genetic biomarkers: the key tools for designing personalised medicine.
These genetic sequences will be used to distinguish the different patient
types and to monitor their predisposition to certain diseases as well as for
treatment during illness and post-treatment tracking. Biomarkers are the
starting point for the creation of diagnostics, for the construction of biochips
(DNA microarrays) and the quest for new therapeutic targets in disease
treatment.
1
Innovations in Diagnostics. Business Insights, 2006
Business Opportunity: Personalised Medicine
2009 Update Page 4 of 9
5. Biochips: are DNA microarrays with hundreds of genetic biomarkers
indicating an individual’s genotype and her or his classification by
subpopulation. They will allow us to determine the specific genetic profile
and corresponding treatment, and will lead to the creation of medication
that is more appropriate or therapy in each case.
Gene suppression (RNAi): this mechanism controls genic expression by
means of a complementary RNA messenger, impeding the transduction of
the associated protein. Thanks to genetic information obtained from specific
patients, we can design RNAi that targets genetic sequences that are unique
to a given population, leading to treatment that is more effective.
Figure 1: the relationship between different personalised medicine technologies. Once the genetic profile
is determined, it is possible to identify new biomarkers and build new biochips to obtain information on
the development of more effective and more targeted therapy. The process entails a constant flow of
information between patient and doctor2.
2
BioSerentia.
Business Opportunity: Personalised Medicine
2009 Update Page 5 of 9
6. 2. MARKET TRENDS
2.1 The global market
These new developments are currently gaining strength in the healthcare sector
and therefore we are not yet able to quantify the market value of personalised
medicine. Consequently, we mention below some of the trends that reflect the
potential of this attractive collaborative activity, which is directly linked to
translational medicine.
Personalised medicine is closely related to the buoyant global diagnosis market,
which is expected to reach €30 billion in 2010.
There is a strong trend towards predictive medicine as an innovative area of
technology and this will boost sales over the next ten years.
It reflects a paradigm shift away from medicine as treatment to medicine as
disease prevention.
Big pharmaceutical companies are adjusting their corporate strategies in an
effort to become the global leaders in personalised medicine. This development
will position small and mid-size biotech companies as attractive commercial
partners in the joint development and licensing of products for the sector.
Pharmaceutical and biomedical companies see new opportunities in recycling
old forms of medication that had been discarded after testing on the wrong
population groups and that can now be modified thanks to newly available
genetic information3.
2.2 The Spanish market and its prominent players
As with the rest of the global market, personalised medicine in Spain is in the early
stage of development. Possibly there are many biomarkers to be discovered and
this could take many years to complete. However it receives solid backing in Spain
from private and public research groups that are already working on advances
in personalised medicine:
Sylentis (a Spanish company in the Zeltia Group) has been working on new
therapeutic targets via the use of RNAi molecules for five years. Sylentis can
be seen as a partnership opportunity. It could be a receiver of stratified
information on patient populations or a developer of customised gene-
silencing molecules for other companies with personalised medicine projects.
3
The Case for Personalized Medicine, PMC 2006
Business Opportunity: Personalised Medicine
2009 Update Page 6 of 9
7. CIC bioGUNE (a co-operative research centre) has a new research area that
specialises in gene suppression. Its gene-suppression platform is developing
RNA interference libraries using a robotized system to handle a large number
of samples.
Apart from the above there are important research centres all over Spain
that are working in the RNAi area. They include the Centro Superior de
Investigaciones Científicas, Centro de Regulación Genómica, Parque
Científico de Barcelona, Centro Nacional de Investigaciones
Oncológicas and the Instituto de Investigaciones Biomédicas Alberto
Sols. These centres and the Spanish university laboratories offer excellent
opportunities for in-licensing of possible therapeutic targets. They can also
provide a solid support structure in terms of capacity and scientific
knowledge for foreign firms in Spain.
Gendiag carries out research and development of DNA microarrays. It has
projects in several areas including oncology, cardiovascular disease,
digestion and drug metabolism. The latter is now one of the most advanced
areas in Spain and elsewhere in the world. This is due to the great
importance attached to the varying response of different patients to drugs
and their metabolism.
NeoCodex is another company that makes Spain attractive as an
investment target for personalised medicine. Its R&D is focused on the
search and validation of genetic biomarkers through mass studies of the
human genome. It has created the biggest bank of DNA samples in Spain
with help from the extensive network of hospitals available at domestic level.
These hospitals complete the value chain for the application of personalised
medicine, from start to finish of the patient’s healthcare cycle. Neocodex’s
genotyping capacity can handle up to 300 million SNPs (biomarkers) per
year, making it a source of opportunities for other companies in the sector.
Finally, we can mention a number of companies that have been set up
recently to enter the personalised medicine market. They include Ferrer
Incode (microchips for diagnosis and prediction of cancer) and Pharmakine
(pharmacogenomic outsourcing)4.
2.3 Institutions that foster co-operation
Given the integrated nature of personalised medicine we need organisations that
can provide and promote the collaboration framework needed to bring
participants in this innovative area together. In this respect Spain offers solid and
dynamic networks that can facilitate co-operation and strategies for the creation
of a unique capability in translational personalised medicine in the global market.
4
Asebio Report 2007, corporate websites.
Business Opportunity: Personalised Medicine
2009 Update Page 7 of 9
8. The Carlos III Health Institute manages a special network for co-
operative cancer research. This co-ordinates research groups from
universities, research centres and innovative foundations that are working
on collaborative projects. It is a further example of the opportunity that
Spain offers foreign investors. In this case a foreign company could form
co-operative alliances with advanced technology centres (the National
Oncological Research Centre is a key member of the network). This way a
company can complement its R&D projects or obtain licences for advanced
studies or marketing of medication made in Spain.
RedRespira is another collaboration network sponsored by the Carlos III
Health Institute. It studies the diagnostic and therapeutic implications in
respiratory illnesses. One of its functions is to encourage translational
research in this area by 65 research groups and more than 500
researchers in eight autonomous communities. Some 18 university
hospitals help to complete the healthcare value chain in which discoveries
and new drugs and therapies can be tested on patients.
Spain has 21 collaboration networks like the ones mentioned above as
well as eight on-line biomedical research centres. Together they make
up an extensive community in which universities, institutes of technology,
hospitals and other research centres are working on the future
development of personalised medicine.
3. REASONS THAT FAVOUR THE DEVELOPMENT OF THIS INITIATIVE
The Spanish National R&D Plan for 2008-2011 makes healthcare one of its
strategic actions. This action is divided into key lines that support the development
of personalised medicine in Spain, including molecular and cellular technologies
applicable to healthcare, translational research, pharmaceutical research
and the development of new pharmaceutical technologies. The main goal of
the Spanish government is to encourage innovation, increasing public and private
investment in healthcare R&D by local and foreign business.
In order to co-ordinate these initiatives the Carlos III Health Institute has prepared
an information system on aid and subsidies. This enables research centres and
companies to apply in a clear and efficient manner for support from the Spanish
government. In biotechnology alone, including the healthcare area, government
investment in 2006 exceeded €1 billion.
Thanks to this incentive, important multidisciplinary projects are being carried out
at domestic, European and global levels with a high participation of Spanish
companies and research centres.
Business Opportunity: Personalised Medicine
2009 Update Page 8 of 9
9. Furthermore in its research and development centres Spain has an excellent
critical mass of researchers, working at an international level in genomics and
proteomics, and in the development of new drugs. This talent pool complements
Spain’s competitive advantage in terms of the cost-benefit ratio associated with
the use of these resources.
Moreover, if the number of research projects has grown, so has the importance of
the applications for personalised medicine arising from the use of these new
technologies in Spain. The three areas that are acquiring greatest relevance are
molecular diagnosis, pharmacogenetics and drug development. These are all
directly connected to the value chain of personalised medicine.
Figure 2: the future healthcare model, personalised medicine (modified, from Business Insights).
4. RELEVANT LINKS
The Spanish R&D plan 2008-2011 (in Spanish): www.plannacionalidi.es
The Carlos III Health Institute: www.isciii.es
On-line biomedical research centres:
www.isciii.es/htdocs/redes/centrosciber.jsp
Co-operative healthcare research networks: www.retics.net
Ministry of Health and Social Policy: www.msc.es
Business Opportunity: Personalised Medicine
2009 Update Page 9 of 9
