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The life sciences present opportunities for developing human welfare activities. Enhanced by inputs from genomic research, biotechnology is a key driver for development in all countries. This report aims at identifying the opportunities for biotechnology in Italy. It introduces Italy as a country, the current situation of biotechnology in Italy and the sectors. In this report also, I have identified a few opportunities for biotechnology in Italy in areas of medicine (stem cell therapy, pharmacogenomics), industrial biotechnology (fine chemicals, olive oil waste and municipal waste management) and other areas such as marine biotechnology and biomining.
ITALY: Location and Economic overview
Italy is strategically located, with the North well placed for entry into the core of the European Union, whereas the Center and South can gradually be regarded as gateways to the promising Balkan economy and also to Northern Africa.
Figure 1. Map Showing Italy's location in the EU.
1.2 Italy's economic overview.
The industrial economy in Italy is highly diversified, divided in to a well-developed industrial north and less-developed agricultural south. Italy's economy is highly motivated by high-quality consumer goods produced by small and medium-sized ventures.
Haven qualified for membership if the Euro group, certain economic reforms have taken place including privatization of ventures previously run by the state. These have resulted in low inflation and interest rates. Exports compensation has also resulted from the competitiveness of the Euro.
2. BIOTECHNOLOGY IN ITALY
2.1 Current situation
Not withstanding a late arrival in the biotechnology development, Italy has a strong international competitive standpoint. Italian biotech companies have tripled in number since 2001, becoming more productive and open to the global market (Assobiotec, 2009).
Since 2005 five Italian biotech companies have been listed on leading stock exchanges. In 2009, total sales amount to over â‚¬5.6 billion (an 18% year-on-year increase), of which 5.3 generated from the sale of innovative products and technologies (Assobiotec, 2009).
2.2 Geographical distribution
The Italian biotech industry is exceedingly condensed in a a small number of locations. Although biotech companies are established in 17 Italian Regions, only few areas account for significant economic numbers.
Lombardy (36% of the total companies), Piedmont (12%), Tuscany (9%), Veneto (8%), Sardinia (7%) and Latium (6%). This division is linked to the existence of assorted skilled players on these territories such as: Italian pharmaceutical companies and foreign multinational subsidiaries, scientific partners (research and clinical centers), finance and professionals (legal, patent and technology transfer offices and consulting companies) and scientific parks, where 24% of the companies are located (Ernst and young, 2010).
There are three major types of biotechnology; Red, Green and White biotechnology. The Italian biotechnology is driven by the red biotech (human health). According to the report, "Biotechnology in Italy" by Ernst and Young 2010, 197 (61%) companies out of the 319 biotechnology companies reported, focused on this field. Green biotechnology (agricultural biotechnology) made up 13% while the white biotechnology (industrial biotechnology) had 7% as shown in figure 2 below.
Figure 2 Biotechnology sectors in Italy. Source: Ernst and Young, 2010
2.3.1 Red Biotech:
This sector includes: Therapeutics, Drug delivery, Tissue engineering, and Molecular diagnostics. Its also includes technologies and services for drug discovery. This sector is certainly the most significant with regards to turnover, employees and R&D investments. 56% of the red biotech companies belong to the pure biotech category whereas the remaining 44% is made up of foreign multinational subsidiaries, Italian pharmaceutical companies and other type of companies (CRO, consortium companies, etc.) (Ernst and Young, 2010).
Table 1 Red biotech data ("red dedicated" and "more core" data companies)
Total biotech turnover
â‚¬ 6.3 billion
Total R&D employees
Total R&D investments
â‚¬ 1.19 billion
Source: Ernst and Young Report on Biotechnologies in Italy - 2010
Figure 3 Biotechnology sectors in Italy. Source: Ernst and Young, 2010
2.3.2 Green Biotech:
The green biotech involves the application of modern biotech processes for the making of transgenic plants for application in the food, material, chemical or fuel sector. It can also be applied in molecular pharming (production of drugs in plants) and in testing for food constituents and existence of contaminants.
In Italy, 55 companies operate in the field of green biotech. 42 out of the 55 are completely dedicated to green biotech while the rest also operate in other fields.
Several biotech crops have been approved for cultivation and consumption by the EU commission. On the other hand, Italy's Ministry of Agriculture remains devotedly opposed to agricultural biotechnology and has maintained a ban on cultivating biotech crops. This appears to be a major set back for the agriculture industry in Italy (Ernst and Young, 2010).
2.3.3 White Biotech:
The industrial white biotech refers to the use of modern biotech methods for the processing and production of chemicals, materials and fuels, including "bioremediation" technologies for the environmental protection (Ernst and Young, 2010). Italy has 26 companies in the field of industrial biotech; 21 of which are totally dedicated to white biotechnology, while 5 also operate in other biotech fields. Most current developments are associated with bioremediation.
2.3.4 R&D and Nanotechnology
The research system in Italy is of high standards in different fields, which can contend with other international research centers. On the other hand the system as a whole is not as perceptive as it could be, due to structural, political and cultural reasons.
Moreover, from a cultural perspective, the nanobiotechnological field researchers initiate significant challenges as a result of their great cultural disparity and multidisciplinarity. As a result of this, Italy is creating a new generation of researchers who will be able to exploit the opportunities offered by this multidisciplinarity. Italy is doing this with the nano-medicine PhD program, organized by the new European Center of Nanomedicine (CEN), recently promoted and financed by the Lombardy Region.
3. Opportunities for biotechnology in Italy
The opportunities for biotechnology identified in this report cover the areas of medical and pharmaceutical biotechnology, industrial biotechnology, agriculture, marine biotechnology and nanobiotechnology.
3.1 Medical and pharmaceutical biotechnology.
The Italian biotech industry is driven by the medical sector, but not with standing there are still opportunities in areas of pharmacogenomics, pharmaceutical products, genetic testing, gene and stem cell therapy.
Pharmacogenomics involves the study of an individual's genetic make-up and how they affect/influence the individual's response to drugs: including disposition, safety and permissibility, and effectiveness. It is aimed at the ability to produce drug that adapt to each person's genetic makeup. This is still a new field and offers a great potential in treatment of genetic disorders like Alzheimer's disease, cancers and diabetes.
The benefits of pharmacogenomics include; development of tailor-made medicines, more accurate methods of determining appropriate drug dosages and metabolism, and improvements of the drug discovery and approval process.
Table 2. Benefits of pharmacogenomics
Development of tailor-made medicines.
Using pharmacogenomics, pharmaceutical companies can create drugs based on the proteins, enzymes and RNA molecules that are associated with specific genes and diseases. This also promise to decrease harm to nearby healthy cells.
Accurate determination of drug dosages.
Knowing a patient's genetics will enable doctors to determine how well his/ her body can process and metabolize a medicine. This will maximize the value of the medicine and decrease the likelihood of overdose.
Easier discovery of potential therapies using genome targets.
Genes have been associated with numerous diseases and disorders. With modern biotechnology, these genes can be used as targets for the development of effective new therapies, which could significantly shorten the drug discovery process.
Safer vaccines can be designed and produced by organisms transformed by means of genetic engineering. These vaccines will elicit the immune response without the attendant risks of infection. They will be inexpensive, stable, easy to store, and capable of being engineered to carry several strains of pathogen at once.
Despite the strong therapeutic pipeline of the Italian biotech, there are still opportunities to further develop pharmaceutical products, such as edible vaccines.
Stem cell therapy has been an issue of debate in Italy, based on religious reasons, regarding the source of the cells used. However, the Vatican has currently decided to sponsor the use of adult stem cells for the treatment of intestinal disease. This involves a US$2.7m donation to the International Intestinal Stem Cell Consortium, which serves as a joint platform for researchers from for Stem Cell Biology and Regenerative Medicine at the University of Maryland, the University of Salerno, the Bambino Gesù Childrens' Hospital in Rome and the Istituto Superiore di Sanita (EBSIN, 2010).
Opportunities for biotechnology in Italy, in areas of stem cell and GM crops, are minimal. This is as a result of political, cultural and religious beliefs. The production of GM crops is currently banned by the Italian Ministry of Agriculture limiting the opportunities for biotechnology in agriculture.
Nanobiotechnology is another promising field of biotechnology, with potential applications in fields such as: food farming, environment, cosmetics and medicine. Italy's strong research force, with the presence of research parks coupled with government funds and European Technology Platform on Nanomedicine (ETPN), offers a great opportunity for developments in nanobiotechnology.
3.3 Industrial `biotechnology
Recent issues, such as oil prices and growing concerns about environmental pollution and global warming, are turning escalating attention to industrial biotechnology, with regards to possible benefits relating energy and environment. The availability of advanced modern biotechnology tools, such as high throughput screening, metabolic engineering, metagenomics and synthetic biology, combined with genome sequence information for a growing number of organisms, are supporting development of better or new applications of industrial biotechnology (Zika et al, 2007). The main targets of research activities are identification of new biocatalysts or microorganisms for production processes and optimization of enzymes and production strains for certain tasks, including development of new biocatalytic pathways in microorganisms (Zika et al, 2007).
Fine chemicals are the largest segment within Italy's industrial biotech sector, with chemical production reaching â‚¬55 billion in 2006 with exports worth â‚¬21 billion (Barmore, 2010). One of the key fields for biocatalysis is in production of fine chemicals, including pharmaceutical compounds. The high selectivity of enzymes aids production of these compounds, which is otherwise difficult to achieve due to the highly complex functional groups within the molecule (Pollard and Woodley, 2007). There is an opportunity for metabolic pathway engineering for production not only of different complex compounds (e.g. alklaloide) but also of compounds that would otherwise be inaccessible because the organisms cannot be cultured (e.g. the cytotoxic substance patellamide) (Zika et al, 2007). There is also an opportunity in biotechnological production of small molecule drug precursors.
Hot Enzymes from extremophilic microorganisms (extremozymes) are anticipated to play an important role in industrial biotechnology due to their exceptional stability at high or low temperatures, high pressure, high salt concentrations (Shah and Gupta, 2007). Italy has a number of hot geothermal spot, and these can serve as sources for isolation of these extremophilic microorganisms.
Currently more than 35 000 enzyme reactions are known (Straathof, 2002). Adding the vast number of microorganisms that cannot be isolated with current culturing techniques, it is estimated that only 1% of bacteria can be cultured (Tringe and Rubin, 2005). These are likely sources of as yet unknown enzymes, hereby providing a potentially large pool of enzymes for industrial purposes. Access to 'unculturable' microorganisms can be opened up by metagenomics. Italy has a 7600 km coastline (CIA world factbook, 2010). This offers an opportunity for marine biotechnology, creating a platform for isolation of more useful enzymes for different applications, especially in medicine and food processing.
3.3.1 Olives (Cultivation and Waste management)
Statistics shows that Italy is the second highest producer of olive oil in the world, with about 603,000 tons in 2007 (Chandra, M. and Sathiavelu, S. 2009) as shown in tables 3 and 4 and figure 4 below. Italy is also the highest consumer of olive (figure 5). This suggests a high production of olive waste.
Different types of olive oil production can be linked with several environmental harms like soil erosion, exhaustion of water resources and pollution through overuse of agrochemicals (EC,DGA). Biotechnology can be applied in the cultivation of these olive trees, by genetically modifying them to yield more and be pest resistance. This reduces the dependency on agrochemicals.
Table 3. Worldwide statistics of Olive oil production
Worldwide olive oil production
460 million gallons
Worldwide olive oil consumption
486 million gallons
Average annual world olive oil consumption over the last 30 years
1,465,000 metric tons
30% - 190 million trees
Largest producers worldwide
Spain, Italy, Greece, Portugal, Tunisia, Turkey, Syria
Source: Chandra, M. and Sathiavelu, S. 2009.
Table 4. Trend of Olive oil production from the years 2000 to 2007 (in 1000 tonnes)
Source: Chandra, M. and Sathiavelu, S. 2009.
Figure 4 Main olive oil producing countries.
Source: Chandra, M. and Sathiavelu, S. 2009
Figure 5. World olive oil consuming countries.
Source: Chandra, M. and Sathiavelu, S. 2009
Nevertheless, there are major issues associated with olive oil waste disposal. These include water and environmental pollutions; odorous emissions. As a consequence of water pollution control legislation in Italy, olive mill wastewaters have to undergo treatment before released into the environment (Azbar et al, 2004)
In view of the high cost of treatment plants and considering the possible socio-economic troubles that may start off from olive oil pollution, there is a need to effectively and economically manage olive oil waste.
Because of the high organic content of olive oil mill wastewaters, anaerobic treatment processes with biogas production can be considered, using anaerobic organisms. Anaerobic treatment has a number of advantages, such as low sludge generation, methane gas production, less energy requirement for operation, and easy restart after several months of shutdown before seasonal production (Azbar et al, 2004).
Recently, there have been several attempts for anaerobic digestion of olive mill wastewater after physical, chemical, and biological pretreatments or after dilution and chemical adjustment (pH correction and nutrient addition) (Azbar et al, 2004).
Several compounds antibacterial agents in olive fruit appear significantly in olive oil wastewater. Although these compounds are discarded as wastes, they can be extracted biotechnologically and used as raw material in the industry. A report by Mulinacci et al 2001, illustrates the presence of 1500-4000 mg Lâˆ’1 polyphenols in the wastewaters from olive oil mills in Italy. These can be used for antioxidants production.
Olive oil mills generate gas emissions resulting in significant odor complaints. Uncovered storage lagoons and olive cakes with high moisture content are sources of odor nuisance, especially during warm and dry summer season. These odours result from the presence of volatile organic acids and other low-boiling organic substances. This can be reduced, by using biofilters in the processes.
3.3.2 Municipal waste management
Another issue in Italy is municipal waste management (CIA world factbook, 2010). Biotechnology has a great opportunity in this area, in removal of organic solid. Treatment of waste with bacteria (aerobic or anaerobic) prior to release breaks down excess nutrients into nitrogen gas and carbon dioxide and trace elements, which can be captured and used in other applications.
Nevertheless, biotechnology can also be applied in this area to production of biofuels.
Italy's natural resources include; coal, mercury, zinc, potash, marble, barite, asbestos, pumice, fluorspar, feldspar, sulphide minerals, natural gas and crude oil reserves.
This offers opportunities for biominig using organisms such as thermophilic sulfide-oxidizing archaea to extract metals from sulphide minerals.
Olive oil waste disposal is a serious issue, not just in Italy but also for the entire olive oil producers. There is great potential for application of biotechnology in minimizing these issues. Also, considering the available natural resources of Italy and the steady growth of the research force, Italy has opportunities for biotechnology beyond the few identified in this report. Much more opportunities may arise from metagenomics and nanobiotechnology.