This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 8/15/2019

Overview
                                Unit: USD millions

2018 DATATOTAL COMPANIESRED BIOTECH COMPANIES
TURNOVER13,66610,112
INVESTMENTS2,4282,148
# COMPANIES641320
Centro Studi Assobiotec, ENEA
Exchange rate EUR 1 = 1.1810 USD (2018)

The importance of the biotech industry to growth and competitiveness in Europe is clear: it is recognized as a Key Enabling Technology (KET) under Horizon 2020 as a means of boosting technological innovation and industrial leadership. Today, the majority of innovative medicines as well as many diagnostic products are developed or manufactured using biotechnology. Globally, biotech medicines represent 20% of commercialized drugs, 40% of authorized drugs and 50% of drugs under development. In Italy there are already 110 biotech drugs available.

In recent years, the biotech industry in Italy has developed due to excellent academic and industrial research as well as the value of the technology and products developed. Italian biotech companies totaled 641 in 2018. The turnover is over $13.6 billion with an increase of 16% between 2014 and 2018, while investments in R&D amounted to $2 billion with about 4,317 employees in biotech research. Biotechnology is among the sectors utilizing the higher level of innovation in Italy.

The red biotech (life sciences) sector in Italy, as in other countries, is the most developed and accounts for the largest number of companies (50%), comprising 320 of the total 641 firms. Pharmaceutical and medical devices biotech firms (74%) are responsible for much of the turnover, with an increased number of projects both in diagnosis and therapies. There are about 100 laboratories (public research centers and university labs), 47 Scientific and Research Hospitals (IRCCS) and around 200 companies. The development of this sector will provide strong opportunities for major U.S. biotech companies looking to partner in order to advance new treatments and product development.

According to the 2018 report by Centro Studi Assobiotec, the Italian biotech industry is a dynamic and innovative sector, particularly in the areas of precision medicine and advanced therapies. However, this industry needs a long-term national strategy with stable and certain rules to develop and remain competitive. Currently, Italy relies on biotech drug imports primarily from the United States, Belgium and Germany.

Leading Sub-Sectors
Italian biotech companies are primarily concentrated in the following areas: oncology, infectious diseases, inflammatory disease, neurological disease and cardiovascular diseases. Recent reemergence of infectious diseases and epidemic outbreaks such as Ebola have oriented investments towards vaccines and new drugs. In fact, the World Health Organization selected an Italian vaccine to fight the Ebola epidemic.

Centro Studi Assobiotec – ENEA Servizio Industria e Associazioni Imprenditoriali
Biopharmaceuticals account for 45% of the projects in the pipeline (discovery phase included), which includes monoclonal antobodies, recombinant proteins and advanced therapies (cellular, genetics and regenerative medicine).

Out of 314 projects, 79 are in the discovery phase, 145 are in the pre-clinical phase and 90 in clinical development:
  • Discovery: 79
  • Pre-clinical: 145
  • Phase I: 35
  • Phase II: 40
  • Phase III: 15
Orphan drugs and advanced therapies represent areas of excellence in the Italian biotech industry. In fact, the Italian academic research sector has the highest number of scientific publications on orphan drugs, while the first ever approved product in advanced therapy in the Western world is a stem cell drug developed by an Italian biotech company.
21 products from Italian biotech companies have received at least one Orphan Drug Designation (ODD), while three products from Italian companies have obtained final market access:
  • Defibrotide (Defitelio®): a life-saving drug for the treatment of the veno-occlusive hepatic disease;
  • Safinamide (Xadago®): a therapy for Parkinsons disease; and
  • Holoclar (Holoclar®): an advanced therapy for patients with corneal burns.
The majority of Italian biotech companies were created as start-ups or spin-offs from academia or industry. These biotech companies are primarily located in scientific parks or incubators (47%), universities or research labs (25%) or are independent (28%). The scientific parks are fundamental network centers for research, enterprise and capital, allowing very small companies to access the necessary resources to grow.

Regionally, Milan is the leading biotech area in Italy, housing approximately 35% of all biotech companies, including Newron and BioXell. Additionally, Lombardy is home to 12 universities, 26 institutes and centers of the National Research Council (CNR), of which 10 are in the biotechnology and health sciences sectors.             
                                                                                            
Small and medium-sized biotech companies in Italy are often the incubators of innovative products for the biopharmaceutical industry. There are a number of U.S. manufacturers of biotech products in the Italian healthcare market: Celgene, Biogen, AbbVie, Amgen, Alexion, Bristol-Myers Squibb, Eli Lilly, and Pfizer maintain wholly-owned subsidiaries in Italy. 

Requirements
Biopharmaceuticals

The main regulatory authority in Italy is the Ministry of Health. All products must be registered with the Ministry of Health’s pharmaceuticals committee, Commissione Unica del Farmaco (CUF). The regulatory body for pharmaceuticals is the AIFA (Italian Drug Agency). Market regulation is based on EU Directive 65/65/EEC, 75/318/EEC and 75/319/EEC. Despite the fact that the Italian has not implemented new measures impacting drug makers since 2014, issues such as the lengthy drug approval process and drug expenditures ceilings creates challenges for innovative pharmaceutical companies in the market.

Biotech Medical Devices
In April 2017, the European Commission adopted two new Regulations on medical devices which entered into force in May 2017. These replace the existing three Directives: Active Implantable Medical Devices Directive (90/385/EEC), Medical Devices Directive (93/42/EEC) and In Vitro Diagnostic Medical Device Directive (98/79/EEC). The new rules will only apply after a transitional period: regulation on medical devices will go into effect in spring 2020 and regulations on in vitro diagnostic medical devices in 2022.  All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law.  Please find more information on these regulations here: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_it

The designated competent authority for medical devices in Italy is the Directorate General of Medical Devices and Pharmaceutical Services at the Ministry of Health. New-to-market medical devices must be registered and have a unique identification number in the National Health System directory (Repertorio). We recommend that U.S. companies designate a third party in Italy to register their products with the Minister of Health.

Clinical trials
In Italy, clinical trials are regulated by the new EU Regulation 536/2014 concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The new Regulation substitutes the EU Directive 2001/20/EC. The regulation will ensure that the rules for conducting clinical trials are identical throughout the EU. More information is available at https://ec.europa.eu/health/human-use/clinical-trials/regulation_en.

For pharmaceuticals, the responsible authority is AIFA, while for medical devices the Italian Ministry of Health is the main point of contact.

Opportunities
Human Technopole

At the closure of the 2015 Milan Expo, Italy launched a project for building a new national cross-disciplinary research institute focused on life sciences, called Human Technopole (HT), offering strong opportunities for both U.S. and Italian companies.  Its mission is to contribute to the development of personalized medicine in the treatment of cancer and neurodegenerative diseases. To this end the HT will use genomics, innovative algorithms for data analysis, multiscale methods in computational life sciences and advanced technologies for food and diagnostics. The new groundbreaking infrastructure will include seven research centers and four facilities. Three existing buildings –- Palazzo Italia, US6 and Cardo NO -- will be refurbished and two new buildings will be built. In February 2018, the coordinating committee appointed Scottish scientist Iain Mattaj as the HT Director General. To find more information visit https://htechnopole.it/en.

Government Incentives
In recent years the Italian government has adopted a number of incentives to support innovation to foster economic growth:
  • recognition of the status of “innovative” start-ups;
  • introduction of a tax credit on research;
  • preferential tax policy on revenue generated by intellectual property rights;
  • and recognition of the status of “innovative” SMEs

Venture capitals and business angels
Furthermore, a number of initiatives to finance new enterprises in Life Sciences have been recently launched, such as the venture capital fund Panakès (www.panakes.it) with 120 million euro dedicated to biomedical technologies and medical devices, the fund Principia III Health (www.principiasgr.it) with 206 million euro and the association of business angels, Italian Angels for Biotech – IAB (www.italianab.it), created by a group of entrepreneurs, managers and scientists to support ideas and talents in this sector.

Partnering opportunities
The major partnering event in Europe for U.S. companies is BIO-Europe, the largest conference serving the global biotechnology industry. It annually attracts leading dealmakers from biotech, pharma and finance along with the emerging companies. The conference features around 3,500 attendees and 19,200 one-to-one meetings. Upcoming conference in Hamburg, Germany November 11-13, 2019 (http://www.ebdgroup.com/).

The key Italian event to boost business, partnering and networking opportunities is “Meet in Italy for Life Sciences”, which will take place in Trieste on October 16-18, 2019. The last edition featured 300 participants and 1,400 one-to-one meetings: https://meetinitalylifesciences.eu.

Web Resources
MINISTERO DELLA SALUTE (Ministry of Health)
www.salute.gov.it

AIFA (Italian Drug Agency)
www.aifa.it

ASSOBIOTEC (Italian Association of Biotechnology)
www.assobiotec.it

CLUSTER ALISEI (Advanced Life Sciences in Italy)
Association to promote and enhance innovation
www.clusteralisei.it

FARMINDUSTRIA (Italian Trade Association for Pharmaceuticals)
www.farmindustria.it

CONFINDUSTRIA DISPOSITIVI MEDICI (Italian Trade Association for Medical Devices)
www.confindustriadm.it

U.S. Commercial Service Contact:
Kira Migliorini, Healthcare Technologies Specialist
U.S. Commercial Service, U.S. Embassy Rome
Tel: +39 064674 2204
E-mail: Kira.Migliorini@trade.gov

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.