The data highlighted by the BioInItaly Report 2011, by Assobiotec and Ernst & Young, in cooperation with Farmindustria and the Italian Institute for Foreign Trade, are very exciting. In fact, despite the international economic situation, the Italian biotech industry showed a growing trend in 2010. At the end of the year, 375 Italian companies were identified as being engaged in research and development activities; of these, 221 fall under the definition of “pure biotech” companies as outlined by the Ernst & Young Center for international studies in biotechnology. Out of the 375 identified companies, 246 operate in the human health sector and of these, 185 on an exclusive basis. The dedicated companies operating in the “green biotech” field are 49, those in the “white biotech” 21, those in the GPET (Genomics, Proteomics, and Enabling Technologies) 41, while 79 companies have activities in more than one application field (“multi-core”). The size of companies remains a peculiar feature of this sector, with 75% of companies falling under the “micro” (less than 10 employees) and “small” (less than 50 employees) categories. The economic and financial analysis shows that the overall turnover for the biotech sector in Italy is € 7.4 billion, with an increase of 6% as compared to last year. The pharmaceutical companies account for 84% of the total, of which 16% are pure biotech companies. With regard to R&D investments, it is estimated that biotech companies made an overall investment of about € 1.76 billion. The analysis of the Italian biotech pipeline shows 237 products for therapeutic use, of which 82 in the preclinical phase, 30 in Phase I, 67 in Phase II and 58 in Phase III. The research activities of Italian-capital companies have contributed 32 products, most of which are still in the pre-clinical phase or in the initial phases of clinical development, while 79 products, most of which in a late-stage phase, are in the portfolio of foreign-capital companies. With 64 products in pre-clinical phase and 60 in clinical development phase, of which 21 in Phase I, 26 in Phase II and 13 in Phase III, pure biotech companies are an authentic promise for the whole sector. Although no product has been marketed yet, it is clear that these companies are rapidly filling a time gap which is exclusively due to the fact that most of them are relatively young, if we consider the period of time (10 -12 years) necessary to complete the development of a new molecule today.
The high level of excellence achieved by our pure biotech companies is also demonstrated by the significant increase (+10%) in the number of Orphan Drug Designations obtained by European and U.S. regulatory authorities in the field of Rare Diseases, and by their dynamism in the field of Advanced Therapies where, among a total of 19 projects being clinically developed, 2 protocols of cell therapy have already reached Phase III.
This development is a strong index of the Italian biotech industry's capacity of innovation, which even in an international context characterised by a little growth of investments and doubtful forecasts, has shown itself able to forge ahead, and confidently project itself towards the future.
Therefore, the research commitment is growing and in this scenario agreements between Italian companies and international partners are multiplying.
Another key factor is the excellent academic & research background present in Italy, with a strong commitment towards education and training of biotech scientists & technicians: for instance, although our country ranks 13th in terms of R&D investments in proportion to GDP (1.2%), Italian research ranks among the best in terms of quality, with a trend indicating steady growth.
In fact, Italy is one of the top three countries worldwide in the number of publications per researcher, and among the first ten countries in terms of citations per scientific article, showing a great capability of improving the research value through patents- Italy ranks third in Europe for patents per 1000 researchers.
Specifically, the growth of the emerging life sciences industry in recent years has been accelerated by the Government’s commitment to develop the biotech sector. For instance, foreign investors are greeted with a variety of incentives and there are no restrictions on foreign ownership. Moreover several regional authorities, too, are actively involved in promoting biotech, through funding technology transfer agencies, incubators and seed funds.
Italy is now an attractive and competitive place for entrepreneurs and investors in the biotech field. With a strong portfolio of potentialities, the country is pursuing its own path towards a level of maturity that will certainly generate further innovation and economic growth, thus reinforcing the country’s role as an international player.
For more information about the biotech sector, it is possible to download the report “Biotechnology in Italy-Report 2011” at the “Biotech In Italy” section.