Overview
The Italian biotech industry is expanding (823 companies with 13,784 employees), with nearly $15 billion in revenue estimated for 2022, a more than 20% increase from 2020. Italian biotech companies were active in the fight against COVID-19, assisting in gene sequencing of the virus, identifying disease-causing receptors, and developing vaccines, antiviral drugs, and new monoclonal antibodies.
The red biotech (life sciences) sector accounts for about half (403) of the companies. With increased research in diagnosis and advanced therapies, pharmaceutical and medical device biotech firms generate 74% of the turnover. There are about 100 public research centers and university labs, 51 scientific and research hospitals (IRCCS), and 244 innovative start-ups. Several U.S. manufacturers, such as Biogen, AbbVie, Amgen, Vertex, Bristol-Myers Squibb, Eli Lilly, and Pfizer maintain subsidiaries in Italy’
Biotechnical advancement provides promising opportunities for U.S. biotech companies looking to develop products and advance new treatments. Italy primarily relies on the United States, Belgium, and Germany for biotech drug imports.
Leading Sub-Sectors
Centro Studi Assobiotec – ENEA Servizio Industria e Associazioni Imprenditoriali
Italian biotech companies primarily represent the following areas of research: oncology and infectious, inflammatory, neurological, and cardiovascular diseases. Recent investments have been directed towards vaccine and drug research.
Biopharmaceuticals, which include monoclonal antibodies, recombinant proteins, and advanced therapies (cellular, genetics and regenerative medicine), account for 45% of the projects in the pipeline (discovery phase included).
Orphan drugs, advanced therapies, and therapeutic solutions for oncology are areas of excellence in the Italian biotech industry. Italy is one of the first countries to introduce advanced therapies to the European market. Twenty companies have developed 45 advanced therapy products that include somatic cellular and gene therapies and regenerative medicine, which are mainly focused on oncology (36%), dermatology (22%), and diseases of the musculoskeletal system (13%). Lombardy, located in northwest Italy, accounts for 43% of the research on therapeutics and 38% of the molecular diagnostics projects. Drug research is concentrated in the northwest (37%) and central Italy (33%), led by the region of Lazio. Central Italy also leads in vaccine development, while Tuscany is a hub for immunology product research.
Requirements
Biopharmaceuticals
All products must be registered with the Italian Ministry of Health’s pharmaceuticals committee, Commissione Unica del Farmaco (CUF). The AIFA (Italian Drug Agency) regulates pharmaceuticals. Market regulations are based on EU Directive 65/65/EEC, 75/318/EEC, and 75/319/EEC. The lengthy drug approval process and drug expenditure ceilings can create challenges for innovative pharmaceutical companies.
Biotech Medical Devices
New EU regulations on medical devices and on in-vitro diagnostic medical devices (MDR) went into effect on May 26, 2021, and May 26, 2022, respectively. Due to delays in approving notified bodies and managing the new regulations, the MDR transition period was extended in March 2023 from May 2024 till the end of 2027 or the end of 2028, depending on the risk class of the device. All medical devices marketed in the EU must bear the CE mark. For more information on regulations, please visit: https://ec.europa.eu/health/md_sector/overview_en. New medical devices must be registered by the Directorate General of Medical Devices and Pharmaceutical Services at the Italian Ministry of Health 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 Ministry of Health.
Clinical trials
Clinical trials for products for human use are regulated by EU Regulation 536/2014. For pharmaceuticals, AIFA is the responsible authority, while the Italian Ministry of Health is responsible for medical devices.
Opportunities
Human Technopole
The Human Technopole (HT) is a cross-disciplinary research institute focused on life sciences, offering research opportunities to both U.S. and Italian companies. With an emphasis on personalized medicine in cancer treatment and neurodegenerative diseases, HT will use genomics, innovative algorithms for data analysis, multi-scale methods in computational life sciences, and advanced technologies for food and diagnostics. The new infrastructure has five research centers and six facilities. Procurement of advanced technologies is ongoing and presents a good opportunity for U.S. companies.
Partnering opportunities
BIO-Europe is an important biannual conference that gathers European and American leaders in emerging companies in biotech, pharma, and finance. The conference will be held November 4-6, 20234 in Stockholm, Sweden.
Resources
Italian Drug Agency (AIFA)
U.S. Commercial Service Italy:
Kira Migliorini, Healthcare Specialist
U.S. Commercial Service, U.S. Embassy Rome
Tel: +39 06 4674 2204
E-mail: kira.migliorini@trade.gov