ITALY Trends and Developments Contributed by: Luca Liistro, Chiomenti
A Sector at a Crossroads The Italian life sciences sector is entering a transfor- mational era, in no small part thanks to global com- petition, regulatory changes and constant M&A activ- ity. Italy remains the world’s sixth-largest exporter of medicines and the third-largest exporter of packaged drugs after Germany and Switzerland. Further, Italy is a country where, in many sectors including healthcare and life sciences, companies are still owned by private shareholders. As a consequence of the latter, there is significant interest from investors willing to support the sectors growth and the development of special projects. The Italian pharmaceutical market: a snapshot According to market data analysts, the Italian pharma- ceutical market continues its steady growth trajectory, with revenues reaching approximately USD60 billion in 2024 and projections suggesting the market will expand to over USD80 billion by 2030. This growth is fuelled by several structural factors, including an aging population that is among the oldest in the world, the increasing burden of diseases and the subsequent need for treatments. Italy’s healthcare system is predominantly publicly funded, with the National Health Service covering the vast majority of the population through general and regional tax revenues. Private health insurance plays a supplementary role, covering a limited portion of the Italian population. This public-centric model creates both opportunities and constraints for pharmaceutical companies, as pricing and reimbursement dynamics remain critical factor of commercial success and effi- ciency. Regulatory reform at the European level The year 2025 marked an important moment for pharmaceutical regulation in Europe, with signifi- cant implications for companies operating in Italy. The European Parliament and Council of the Euro- pean Union (“Council”) reached agreement on the EU Pharmaceutical Package, a comprehensive reform designed to modernise the regulatory framework for medicinal products and strengthen medicine supply security and competitiveness. The reforms include a new framework both for data protection period with
potential extensions, streamlined approval pathways, and enhanced provisions addressing specific sectors. In parallel with the pharmaceutical reforms, the Euro- pean Commission (EC) published its proposed Bio- tech Act in December 2025, aimed at strengthening Europe’s biotechnology sector and accelerating the transition of innovation from research to market. The proposal introduces new funding mechanisms and seeks to incentivise companies to conduct research and production within the EU. For Italian biotech com- panies, which have historically struggled to compete with their counterparts in larger markets, these meas- ures, coupled with tax incentives and the continuing ability of Italian academy to generate innovation, could represent a meaningful opportunity to attract capital and scale operations domestically. The EC has also proposed targeted revisions to the Medical Devices Regulation and the In Vitro Diagnos- tics Regulation, introducing measures intended to simplify compliance while maintaining safety stand- ards. This is coupled with the provisions of the AI Act, which will limit and regulate the recourse to AI-based technology and thus trigger adaptive measures for producers of medical devices that what to distribute products in the EU and in Italy. This regulatory scenario still poses industry concerns surrounding duplicative compliance burdens and should thus incentivise innovative approaches and an increasing role for legal and compliance advisors in the Italian market. The AIFA landscape: pricing, reimbursement and policy debates In Italy, alike it happens in other EU countries, the National Medicines Agency remains the central authority for pharmaceutical governance, managing price negotiations and reimbursement decisions for medicines covered or reimbursed by the National Health Service. In December 2025, the Agenzia Itali- ana Del Farmaco (AIFA) updated its guidelines for Health Technology Assessment dossiers supporting pricing and reimbursement applications, with the new framework set to apply from April 2026.
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