Could you briefly introduce Federchimica Assobiotec?

Assobiotec is the Industry Trade Association for the development of biotechnology in Italy. It represents approximately 120 companies, as well as science and technology parks operating in healthcare and bioeconomy, including agriculture, industry and environment.

Established in 1986 as a part of Federchimica, Assobiotec is also a founding member of EuropaBio, the European Association for Bioindustries, and of ICBA (the International Council of Biotechnology Associations). In Italy, through Federchimica, it is a founding member of ALISEI (Italian National Cluster of Life Sciences) and SPRING (Italian National Cluster of Green Chemistry). Assobiotec actively participates to the work of Blue Growth cluster and CLAN (the Italian National AgriFood Cluster).

Could you highlight some recent developments for the association?

Biotechnology is ever more important in different fields of application. During the pandemic, biotech provided answers and solutions in all the phases of the crisis management, from sequencing the virus genome to molecular diagnostic tests, vaccines, and monoclonal antibodies. Assobiotec carries out ambitious projects to push industrial policy in favor of biotechnology innovation, and our role has been constantly evolving. Due to the heterogeneous nature of our associated companies, we focus on many areas of innovation and advocacy, such as orphan drugs, advanced therapies, diagnostics, clinical trials, access to innovation, manufacturing, fiscal rules, incentives to innovate, new breeding techniques, circular economy and others.

The health biotech industry is a growing one in Italy. What characterizes this sector?

Italy has an excellent academic and research tradition, with a labor cost lower than many other European countries. The sector is particularly dynamic and truly motivated to innovate and grow, but we pay the price for huge juridical, fiscal and regulatory obstacles. The result is the very small average size of the Italian biotech enterprises, 90% of these being SMEs. The post pandemic PNRR and the Next Generation EU funds could be an unrepeatable opportunity to remove obstacles and to exploit the potential of the Italian biotech sector.

The BioINItaly Report 2020 – realized by Federchimica Assobiotec with ENEA – counts 344 enterprises in the health sector (49% of the total number of biotech enterprises in Italy) with over 9 billion euros revenues value (75% of the total revenues value). The health sectors also collects the majority (91%) of R&D investments and the highest employment rate (75%) for Italian biotech R&D.

The startup ecosystem is extremely fertile: between 2017 and 2019 more than 50 new innovative startups have been recorded in biotechnologies. Unfortunately, many valuable ideas and projects often struggle to reach the stabilization phase.

What are the key therapies that biopharma companies look at? How has the pandemic influenced their focus/operations?

Italian biotech massively invests in unmet medical needs including therapeutic solutions for oncology, infectious diseases and neurology. A special mention is also deserved for diagnostics.

The contribution of national biotechnologies in the collective mobilization for the fight against the SARSCoV-2 has seen and is still seeing an important role into gene sequencing of the virus, identification of the receptor responsible for the disease, diagnostics, but also in the development of vaccines, antiviral drugs, and monoclonal antibodies. Italian biotech companies are also at the forefront of this global battle.

Italy has the first global plant for the production of biobutanol in Veneto. How will the development of this biorefinery help Italy’s bioeconomy?

Integrated biorefineries are present throughout Italy, with cumulative investments reaching one billion euros. Circular bio-economy is a new paradigm that generates wealth within the limits of the planet's resources and, in the vision of the European Green New Deal, inevitably it will be a pillar of post-pandemic recovery and resilience. Nevertheless, for this to happen, not only strategies but action plans are needed for translating the enormous potential into innovative and sustainable industrial applications, from the North to South in Italy.

How do you see investment appetite in biopharma?

At the end of 2019, 25 financing transactions  for a total of approximately 152 million euros were recorded in Italy. The record places our country as recipient of 5% of European investments and 1% of global investments. The average cut for investment in biotech, which stands at around 6 million euros, is underpowered compared to the European average (20 million euros) and despite some significant placements, national numbers remain too low.

However, the government has recently made different regulatory interventions in the right direction, such as eliminating tax for 3-year exits in innovative startups; for companies carrying out R&D activity for innovative drugs, there is a tax credit of 20% for costs incurred between 1 June 2021 to 31 December 2030; this is extended to foreign companies carrying out R&D activity in Italy, increasing the cap from 4 to 20 million euros per year for each beneficiary.

Furthermore, the Enea Biomed Tech Foundation is now re-shaped with a strong focus on biotechnology and innovation.

These are all actions that we believe can give concrete help to the development of our startups and SMEs.

What is your broader assessment for Italy as a biotech hub? What is your outlook for the future?

We are optimistic about the future. Italy has the fundamentals: good research with peaks of excellence and entrepreneurial skills. If the country begins to believe in itself and to move accordingly, Italy will soon be able to cross the gap that today divides us from the main economies in this sector. Biotech demonstrated its extraordinary value in coping with the pandemic and today it is the key to sustainably re-start the economy.