Contant of the page - Back to top
Opportunities
The main business opportunities in the Italian biotech industry lie in the Red Biotech segment, (i.e. R&D), and primarily in the areas of top specialisation and prestige of Italian research such as Biomedicine, Oncology, Diagnostics, and Neuroscience.
Prospective investment typologies include:
- Spin-off by research or company
- Multifunction R&D centres
- Research Partnership between foreign company and R&D Italian centres
- Research Partnership between foreign company and Italian company
- Venture Capital Funding.
The small and flexible structure of Italian companies encourages B2B–B2R technological partnering in the Red Biotech segment. Furthermore the opportunity, for Italian small enterprises with turnover below 10 million euro to increase research activities thanks to Venture Capital funds, provides relevant perspectives for development.
Italy offers plenty of scope for opportunities in the field of Clinical Trials. In recent years changes to regulatory procedures, now compliant with European rules, have decentralised decision-making to special Ethics Committees.
In May 2009, Assobiotec (Italian Association for Biotechnology Development), AIFA (National Medicines Agency) and the ISS (National institute of Public Health, Istituto Superiore di Sanità) signed the agreement aimed at fostering early-phase clinical trials for new drugs in Italy.
Thanks to the Agreement, timing for evaluation of Clinical Trial applications was reduced from 100 days in 2005 to 45 days in 2009.
Such a major result, combined with the presence of an extensive network of over 170 competent centres (including hospitals, IRCCS institutes and universities), led to a drastic reduction in terms of market costs and timing, thus making Italy one of the most appealing locations for carrying out clinical trials.
Clinical Trials per Year
| Year | CT | % |
|---|---|---|
| 2000 | 562 | 8.3 |
| 2001 | 610 | 9.0 |
| 2002 | 571 | 8.0 |
| 2003 | 579 | 8.0 |
| 2004 | 623 | 9.0 |
| 2005 | 663 | 11.0 |
| 2006 | 777 | 11.0 |
| 2007 | 791 | 11.0 |
| 2008 | 869 | 12.0 |
| 2009 | 742 | 10,1 |
| Total | 6,787 | 100,0 |
(Source: National Medicines Agency- AIFA 2010)
Total clinical trials performed in the 2000-2009 period amounted to 6,787. Primarily concentrated on Phase II and Phase III, clinical trials are routinely conducted in Italy compliantly with the internationally recognised clinical protocol and quality control standards.
In 2009 Phase III studies, for the first time, are below 40% whilst Phase I and Phase II trials are still growing: in the last year they reached combined 43.5% of the total. In 2004 -2009, 159 Phase I studies were entered into OsSC (3.6% of total clinical trials). They are mainly multicentre and international and sponsored by pharmaceuticals companies. Nearly 26% of them (41) are first in human trials.
Chart 1
Oncology is the most investigated therapeutic branch (29.4%), followed by Cardiology/Vascular Diseases (9.6%), Neurology (8.9%) and Immunology and Infectious Diseases (8.4%).
Top 5 Clinical Trials by Therapeutic branch
Total CTs: 4,465 - of which 4,444 (99.5%) with specified therapeutic branch
| Therapeutic branch | CT | % |
|---|---|---|
| Oncology | 1,314 | 29,4 |
| Cardiology/Vascular Diseases | 428 | 9,6 |
| Neurology | 396 | 8,9 |
| Immunology and infectious Diseases | 376 | 8.4 |
| Gastroenterology | 231 | 5,2 |
(Source: National Medicines Agency – AIFA 2010)
Pharmaceutical companies are the prime players in the area of Clinical Trials. Over 350 businesses are responsible for testing primarily on Antineoplastic and Immunomodulatory Medicines, drugs for nervous system treatment, and Antimicrobials. The first 26 out of 360 pharmaceutical companies sponsor 66% of clinical trials.
Top 10 Clinical Trials for Profit Sponsors
(Source: National Medicines Agency – AIFA 2010)
Among several important no-profit organisations carrying out Clinical Trials, Gemelli University Hospital of Rome, Suor Orsola Malpighi Hospital of Bologna, San Raffaele Hospital of Milan, S. Giovanni Battista University Hospital of Turin, and the European Institute of Oncology (IRCCS) of Milan are all leaders in the field.
Top 5 Clinical Trial for No-Profit Sponsors
