Italy - Country Commercial Guide
Biotechnology

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-10-29

Overview

The Italian biotech industry is expanding. In 2019, a total of 696 companies with 4,526 employees generated revenue of $14.5 billion, an increase of 16% increase from 2014.

In 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.   

The red biotech (life sciences) sector accounts for the largest number of companies (49.4%), representing 344 of the 696 firms. With increased research in diagnosis and advanced therapies, pharmaceutical and medical devices biotech firms generate 74% of the turnover. There are about 100 public research centers and university labs, 47 Scientific and Research Hospitals (IRCCS), and around 200 biotech companies, most of which were founded as start-ups or spin-offs. Several U.S. manufacturers, such as Celgene, Biogen, AbbVie, Amgen, Alexion, Bristol-Myers Squibb, Eli Lilly, and Pfizer maintain subsidiaries in Italy.

      Unit: USD millions

2019 DATA

TOTAL COMPANIES

RED BIOTECH COMPANIES

TURNOVER

14,597

10,947

INVESTMENTS

2,739

293

# COMPANIES

696

344


Exchange rate 1 USD = EUR 0.82 (2021)Centro Studi Assobiotec, ENEA

Biotechnical advancement provides promising opportunities for U.S. biotech companies looking for product development and to advance new treatments.

Italy primarily relies on the U.S., Belgium, and Germany for biotech drug imports. Due to COVID-19, about 40% of biotech companies operating in Italy reported a reduction in business and research due to a decrease in clients, newfound logistical problems, and the cash crisis.

Leading Sub-Sectors

Italian biotech companies primarily represent the following areas of research: oncology, infectious diseases, inflammatory disease, neurological diseases, and cardiovascular diseases. Recently, investments have been directed towards vaccine and drug research.

Chart - Analysis by Product Type
Chart - Analysis of Product Type

Centro Studi Assobiotec – ENEA Servizio Industria e Associazioni Imprenditoriali

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). Out of 375 projects, 131 are in the discovery phase, 171 are in the pre-clinical phase, and 73 in clinical development (Phase I: 33, Phase II: 28, Phase III: 12).

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 into 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 expenditures ceilings can create challenges for innovative pharmaceutical companies.

Biotech Medical Devices

On May 26, 2021, new EU regulations on medical devices went into effect, while regulations on in vitro diagnostic medical devices will go into effect on May 26, 2022.

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 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 the new EU Regulation 536/2014. More information: https://ec.europa.eu/health/human-use/clinical-trials/regulation_en 

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 new 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 represents a good opportunity for U.S. companies. For more information, visit:  https://htechnopole.it/en   

Partnering opportunities

BIO-Europe is an important annual conference that gathers European and American leaders in emerging companies in biotech, pharma, and finance. The virtual conference will be held on October 25-28, 2022 (https://www.ebdgroup.com/).

Additionally, “Meet in Italy for Life Sciences” https://meetinitalylifesciences.eu/ is an annual event, with Genoa hosting the 2021 meeting September 29 - October 1. The event is designed to promote networking and boost businesses. 

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

https://www.trade.gov/italy