Invest in Spain Business Opportunity Personalised Medicine

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  • 1. Business OpportunityPersonalised Medicine 2009 update
  • 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 Medicine2009 Update Page 2 of 9
  • 3. CONTENTS1. IDENTIFICATION OF THE BUSINESS........................................... 42. 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 _____________________ 73. REASONS THAT FAVOUR THE DEVELOPMENT OF THISINITIATIVE .................................................................................... 84. RELEVANT LINKS ........................................................................ 9Business Opportunity: Personalised Medicine2009 Update Page 3 of 9
  • 4. 1. IDENTIFICATION OF THE BUSINESSRecent advances in the extraction of information from the human genome arehelping to close the gap between the diagnosis of an illness and its prevention andtreatment. The current healthcare value chain is based on four events during apatient’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 personalisedmedicine. Thanks to new technology in genomics now in development, thisapproach will considerably improve the prevention and treatment of a particularaffliction. Healthcare providers will be able to apply this type of personalisedmedicine to specific patients that will be segmented according to their geneticprofiles. Each group of patients responds differently to a particular type oftreatment and this creates an opportunity for new tools that can characterise agenetic sub-population and for the development of preventive methods andtherapies that target a specific patient type.The model will expand to include early segments in the value chain, such asinformation on genetic predisposition to a certain disease, stratifying patientpopulations. Advances like these will open the door to monitoring andprevention of the diseases in question. In addition, diagnosis that is more accuratewill make it possible to select treatment from a series of options and to monitor theprocess, obtaining better results in healing patients with safer methods andhealthcare that will generally costs less1.Various technologies are emerging from the work on molecular biology, which arepositioning pharmacogenomics as the basis of personalised medicine. Theintegration of genetic information with pharmacology allows us to identify the long-term risks of drug use, to select appropriate treatment and the correspondingdosage, 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, 2006Business Opportunity: Personalised Medicine2009 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 profileis determined, it is possible to identify new biomarkers and build new biochips to obtain information onthe development of more effective and more targeted therapy. The process entails a constant flow ofinformation between patient and doctor2.2 BioSerentia.Business Opportunity: Personalised Medicine2009 Update Page 5 of 9
  • 6. 2. MARKET TRENDS2.1 The global marketThese new developments are currently gaining strength in the healthcare sectorand therefore we are not yet able to quantify the market value of personalisedmedicine. Consequently, we mention below some of the trends that reflect thepotential of this attractive collaborative activity, which is directly linked totranslational 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 playersAs with the rest of the global market, personalised medicine in Spain is in the earlystage of development. Possibly there are many biomarkers to be discovered andthis could take many years to complete. However it receives solid backing in Spainfrom private and public research groups that are already working on advancesin 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 2006Business Opportunity: Personalised Medicine2009 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-operationGiven the integrated nature of personalised medicine we need organisations thatcan provide and promote the collaboration framework needed to bringparticipants in this innovative area together. In this respect Spain offers solid anddynamic networks that can facilitate co-operation and strategies for the creationof a unique capability in translational personalised medicine in the global market.4 Asebio Report 2007, corporate websites.Business Opportunity: Personalised Medicine2009 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 INITIATIVEThe Spanish National R&D Plan for 2008-2011 makes healthcare one of itsstrategic actions. This action is divided into key lines that support the developmentof personalised medicine in Spain, including molecular and cellular technologiesapplicable to healthcare, translational research, pharmaceutical researchand the development of new pharmaceutical technologies. The main goal ofthe Spanish government is to encourage innovation, increasing public and privateinvestment in healthcare R&D by local and foreign business.In order to co-ordinate these initiatives the Carlos III Health Institute has preparedan information system on aid and subsidies. This enables research centres andcompanies to apply in a clear and efficient manner for support from the Spanishgovernment. In biotechnology alone, including the healthcare area, governmentinvestment in 2006 exceeded €1 billion.Thanks to this incentive, important multidisciplinary projects are being carried outat domestic, European and global levels with a high participation of Spanishcompanies and research centres.Business Opportunity: Personalised Medicine2009 Update Page 8 of 9
  • 9. Furthermore in its research and development centres Spain has an excellentcritical mass of researchers, working at an international level in genomics andproteomics, and in the development of new drugs. This talent pool complementsSpain’s competitive advantage in terms of the cost-benefit ratio associated withthe use of these resources.Moreover, if the number of research projects has grown, so has the importance ofthe applications for personalised medicine arising from the use of these newtechnologies in Spain. The three areas that are acquiring greatest relevance aremolecular diagnosis, pharmacogenetics and drug development. These are alldirectly 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.esBusiness Opportunity: Personalised Medicine2009 Update Page 9 of 9