ITALIAN HI-TECH INDUSTRY: THE CASE OF LIFE SCIENCES

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1 ITALIAN HI-TECH INDUSTRY: THE CASE OF LIFE SCIENCES Part Two Executive summary National Interest January 2015 Study conducted by the IMT Institute for Advanced Studies Lucca, the Fondazione CERM, AIFA, and the Centro Studi Farmindustria for Aspen Institute Italia Aspen Institute Italia

2 Executive Summary This study provides a snapshot of the state of health of the life sciences sector in Italy, as well as a comparison of the sector s performance against the main economic and scientific indicators, both before and after the crisis of 2008, with that of the major developed and emerging countries. The picture that emerges points to certain strengths and the resilience of the industry, which remains one of the leaders in Europe for production and export, as well as highlighting continuing difficulties in retaining Italian talent and attracting skilled human capital from abroad. The availability of skilled human capital particularly science graduates at a cost that remains relatively low, together with the high productivity discernible from the performance figures for firms in the sector, constitute competitive advantages that have unquestionably enabled Italy to consolidate existing investments in recent times and to attract foreign capital, thereby affording the country real prospects of assuming a key role as a production base for the European market. Italy s research system boasts levels of scientific output in the pharmaceutical, biomedical and biological fields that are comparable with those of the leading countries in the world, although it also suffers from below-average patent production rates. A growing proportion of inventions by Italian researchers are being patented by foreign multinationals. An examination of industrial trends over the course of the deep and protracted crisis that has hit Italian manufacturing highlights the importance of the life sciences sector. On a global scale, the sector s resilience is attributable to stable demand, the greater average size of its firms, their more pronounced international market presence, and their ability to innovate, with the crisis period witnessing a rise in the number of innovative new drugs launched internationally. On a national scale, what stands out is an ability to increase exports by tapping into growing shares of world demand. This is a key factor for heavily-internationalized sectors in which the localization choices of firms determine performance in terms of production and research, and an aspect that makes the competitiveness of firms, the national innovation system and the country s economy in general a pressing issue. The crisis has contributed to an albeit slight exacerbation of the relative lag with which innovations in the bio-pharmaceutical field may be accessed in Italy, due mainly to fragmentation of the regulatory framework between the state and regions. As part of the study, movements in the localization of patents, publications, inventors and businesses were mapped to geographic precision using mapping tools offered by Google and Yahoo!, enabling the evolution of research clusters and industrial districts to be traced over time. This analysis reveals a tendency towards the progressive marginalization, in Italy, of local scientific and technological research systems a trend which seems attributable to a high level of fragmentation in the national research system, in addition to difficulties in making the public and private research spheres interact with each other, and the growing attractiveness of the foremost global and European research centers Italy is facing new challenges stemming from the intensive processes of integration and convergence that are characterizing advancement in the frontiers of scientific and technological research in a number of areas, including: a) new materials for the reconstruction and regeneration of tissue, for diagnostics and for minimally invasive prostheses; b) simulation and analytical models as the basis for new approaches to tackling the neurological mechanisms characteristic of neurodegenerative disorders, such as Alzheimer s and Parkinson s; c) the development of new Aspen Institute Italia National Interest Italian hi-tech industry: the case of life sciences 2

3 techniques and materials for cellular regeneration; and d) the development and use of new imaging techniques. In this convergence of scientific and technological trajectories formerly considered far-removed from each other, possibilities for successful business ventures arise at the interface of fields such as biomedicine, pharmaceutics, biotechnology, new materials, and information technology. Italian start-ups may have opportunities for breaking into these areas, with excellent results even on a small scale. In contrast, the public research system is laboring under greater difficulties, with a seeming inability to implement innovative organizational models that would facilitate the establishment of multidisciplinary laboratories and would bring educational syllabuses up-to-speed to take account of and, where possible, enable a leading role to be played in the expansion of the frontiers of scientific and technological research. Notable at a global level has been the inexorable rise of the Boston, Bay Area and San Diego clusters, where all the research activities of multinational pharmaceutical companies and the major university and hospital research centers are concentrated. In terms of the sector s growth prospects and industrial policy, certain areas for action emerged which could enable the potential of life sciences to be fully tapped, including with a view to increasing the competitiveness of Italy both in the research sphere and in hi-tech and scientific research-based sectors. The sector is already, for that matter, kick-starting a recovery trajectory, in some ways anticipating a trend that will hopefully encompass the entire Italian economy. The research world of the past has undergone significant changes. Biopharmaceutical research today is characterized by a strong level of competitiveness, and it is no longer just the size of the individual firm that matters, but also the quality and level of specialization of the sector and of the relevant institutional framework. In this new competitive scenario, the current patent system is totally obsolete: there is a need to move away from an approach that focuses primarily on patent protection towards one based on protection of shared innovation. One important field with scope for further development is that of hospital research, especially in the area of clinical studies. In this context, specialized operators such as Contract Research Organizations (CROs), together with a growing number of start-ups, are stepping up their activities in Italy, in the process enhancing the skills of leading hospital facilities in the conduct of clinical trials. Against this backdrop, which confirms the attractiveness of Italian facilities, it is important to ensure that the country is able to play a growing role in Europe in the conduct also of Phase I clinical trials. A second priority area arises from the need to strengthen the main Italian innovation clusters in Rome and Milan, by increasing their centrality to the national research system. Greater consolidation into poles of research is a necessary precondition for attracting and retaining investment and skilled human capital, thereby regaining a role in global division-of-innovativelabor networks. Crucial in this regard will be the ability to provide a strong boost to the internationalization of the recruitment of young researchers and students, as well as to the innovation of research and teaching organizational models, which are still exceedingly polarized along traditional educational lines according to relatively self-contained disciplinary strands. There is a need to increase the capacity to conduct applied research by facilitating the patenting of inventions developed in the public sector, including through the strengthening of collaboration with the private sector. The interviews conducted during the study showed a growing propensity on the part of Italian firms in the biotech, pharmaceutical and biomedical sectors to collaborate with university research centers in Italy and abroad. Many of these collaborative ventures are accomplished through confidentiality undertakings, material transfer agreements or the forging of Aspen Institute Italia National Interest Italian hi-tech industry: the case of life sciences 3

4 partnerships on behalf of third parties. The development of intellectual property is left almost entirely to private-sector operators, while the patent committees of Italian universities emerge as poorly equipped to fulfill their role, often lacking the necessary expertise. The intellectual property stemming from the outcomes of Italian research is frequently capitalized on by third parties, often outside the country. Lately, some Italian universities have been developing an entrepreneurial vision for the management of intellectual property that facilitates collaboration, although sometimes this can create competitive tensions with firms over licenses and royalties. On another front, it also comes down to promoting conditions that facilitate access to risk capital and credit for hi-tech startups. Notwithstanding the significant progress made in this regard, the international crisis has produced a scenario characterized by asymmetries between national innovation systems which must be taken into account. Finally, in order to increase the country s competitiveness, it is essential to strengthen national regulatory bodies, equipping them with adequate resources and personnel to streamline authorization processes, thereby improving procedures and avoiding duplication and the fragmentation of powers across various levels of jurisdiction. Some of the main empirical findings of the study can be summarized as follows: * In Italy, the pharmaceutical and medtech industries have increased their contribution to the economy in terms of value-added (up from 5% to 6% of manufacturing industry from 2008 to 2013), and even more so in terms of exports (up from 5% to 7%). * The life sciences sector is characterized by a significantly higher-than-average level of productivity, while the pharmaceutical industry is the leading manufacturing sector. Investments are also above average levels, contributing to the productivity result as well as to an excellent quality-to-cost ratio for human resources. * European Commission data puts life sciences among the top rankings for long-term industrial growth. The European Union, as a whole, has the world s largest manufacturing output, while Germany, Italy, the United Kingdom and France together persistently account for more than half of European value-added. * For every euro spent in the pharmaceutical sector in Italy, the impact on the economy of the country is almost double. In particular, for every employee in the pharmaceutical industry, at least one other person finds employment in allied industries. The multiplier effect of the Italian pharmaceutical sector is higher than the average for European countries and than for the United States, confirming the country has a stronger manufacturing bent than its other major international competitors. * In terms of research, the pharmaceutical and medtech industries have greater links with external centers of excellence than other sectors, as shown by the degree of openness of firms to extramural R&D, which is 55% higher than the average for manufacturing. In particular, the pharmaceutical sector is the leading industry in this regard, recording a 25% growth in spend on outsourced R&D between 2008 and 2012, in line with trends seen in the major European countries. * In Italy, life sciences is the sector which attracts the most foreign investment. Despite the sector being increasingly integrated into the global economy, much of its value-added is still created and retained within national borders. In Germany, the sector accounts for 86% of Aspen Institute Italia National Interest Italian hi-tech industry: the case of life sciences 4

5 domestic value-added, while in Italy it is around 72%. In the medium to long term, the role of the BRIC countries and the rest of the world as a source of intermediate inputs will increase. Italy remains one of the leading pharmaceuticals producers in Europe, with productivity growth in line with that of its major European partners. * As regards the clinical testing of drugs in Italy, figures in the latest report from AIFA show a fall in the total number of trials, due to a reduction in clinical studies conducted by public agencies. However, an increase was noted in Phase I trials, which for the first time topped 10%, resulting in an overall increase in so-called early-phase testing, which amounted to 45% of the total number of trials given the go-ahead. Italy s share of clinical trials in the European Union was 17.2%, in line with previous years. * The clinical phase is also pivotal for medtech manufacturers, over half of whom invest in preor post-marketing studies. Clinical studies are becoming increasingly important, rising from 21% of total R&D spend in 2010 to 34% in 2013, posting an increase in value of over 30%. * In the course of the study, the names of inventors were drawn from 2.4 million patents registered with the European Patent Office. Observing changes of address for inventors between two consecutive patents, 20,000 cases were identified of inventors in the life sciences field who had moved. The analysis reveals that the countries at the center of the mobility network in Europe are Switzerland and Germany, with the former showing a net influx of talent from abroad. Italy, in contrast, recorded a net exodus. * In Italy, there is a higher percentage of inventor rather than institutional patent holders. This differential has been increasing over time, due in the main to the progressive reduction in the proportion of patents awarded to Italian firms. The number of inventions of Italian researchers affiliated with foreign multinationals is on the rise. * The scientific and patenting output of Italy in the field of life sciences was analyzed, with the data for scientific publications sourced from SCImago and Pubmed, while on the patenting front, triadic patents (filed in Europe, the United States and Japan) were considered as a gauge of inventions of global significance. Among the more developed countries, Italy has a high scientific publication output which is showing modest growth, especially in the pharmaceutical field. Also observable is the rapid rise of China into the ranks of the countries with the highest number of publications. Italy is among the countries most specialized in biomedical and pharmaceutical research, although its rating on the relative specialization index (proportion of publications in the field of life sciences to total national scientific publication output) is in decline, especially in the fields of biochemistry and biotechnology. * In terms of the total number of citations garnered by scientific works, Italy s relative position has remained essentially unchanged. In the biomedical field, the value of scientific publications, measured by the number of citations, is high and growing. However, the degree of internationalization of Italian research in the field of life sciences is still limited. In particular, it is notable that there has been a fairly small increase in the number of international publications in the pharmaceutical and biomedical fields. Aspen Institute Italia National Interest Italian hi-tech industry: the case of life sciences 5

6 * When patent production is considered, Italy s position emerges as notably weaker. The country s ranking has worsened in all areas of research during the crisis, and, in particular, in the more patent-intensive fields (biotechnology and pharmaceuticals). There continues to be difficulty in turning the potential of basic research into innovation (patents-to-publications ratio) a difficulty which has grown progressively worse over the course of the crisis, with a negative impact, in the medium to long term, on the ability to generate industrial value. * The main Italian research clusters in the field of life sciences occupy relatively low positions in the world ranking. The top three clusters for total Impact Factor of scientific publications (source: Pubmed) are Rome (in 258 th place), Pisa (in 344 th place) and Milan (in 347 th place). If only the number of publications is considered, then Rome and Milan are placed 122 nd and 125 th respectively. The average level of research produced in the main Italian clusters reflects the difficulty of attracting talent from abroad and retaining the best Italian researchers. * Overall, Italy s research clusters still lag too far behind in the global division-of-innovativelabor network. An analysis of the content of scientific publications reveals that Italian research centers do not always work on issues that are at the cutting-edge of biomedical research, from which fact stems the reduced average impact of Italian scientific output. Aspen Institute Italia National Interest Italian hi-tech industry: the case of life sciences 6

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