Italy Biosimilars Market Overview, 2030

Italy's biosimilars industry is experiencing significant growth, driven by a combination of regulatory support, cost-saving imperatives, and increasing demand for affordable biologic therapies. The Italian Medicines Agency (AIFA) plays a pivotal role in this expansion by implementing policies that encourage the adoption of biosimilars, thereby promoting competition and reducing healthcare expenditures. The national procurement framework, established under Law 232/2016, allows physicians to choose among the top three lowest-priced biosimilars in public tenders, fostering a competitive environment that benefits both the healthcare system and patients. This supportive regulatory landscape has led to high biosimilar utilization rates in Italy. For instance, biosimilars account for 100% of rituximab and bevacizumab usage, and over 98% for trastuzumab and filgrastim. Such widespread adoption underscores the confidence of healthcare providers in biosimilar efficacy and safety, as well as the effectiveness of policies aimed at integrating biosimilars into clinical practice. Italy’s regional tendering system incentivizes the uptake of biosimilars by favouring competitive pricing, which accelerates market penetration. The increased manufacturing capacity domestically and collaborations between Italian firms and multinational pharmaceutical companies also contribute to market expansion by ensuring a steady supply of high-quality biosimilar products. The government’s continued efforts to streamline regulatory pathways and foster confidence among prescribers and patients have resulted in increasing physician willingness to prescribe biosimilars, further supporting steady demand growth. Another important aspect of market growth is the expansion of biosimilars into therapeutic areas beyond oncology, such as autoimmune diseases and hematologic disorders, where biologics have become standard treatment options. This diversification of indications opens up new opportunities for biosimilar manufacturers.

According to the research report, “Italy Biosimilars Market Overview, 2030” published by Bonafide Research, the Italy Biosimilars market is projected to reach USD 2.89 Billion by 2030. This growth is fueled by the increasing demand for cost-effective biologic alternatives and the expiration of patents for several original biologic drugs. Key players in this sector include Celltrion, Sandoz, Mylan, Roche, and Amgen, who are leveraging Italy's favorable manufacturing environment to meet both domestic and international demand. The variability in biosimilar adoption across different regions in Italy highlights the need for continued education and harmonization of practices to ensure equitable access to biosimilar therapies nationwide. Additionally, while biosimilars are not automatically substitutable at the pharmacy level, ongoing efforts to streamline regulatory procedures and enhance transparency are expected to further bolster their integration into the healthcare system. High production costs associated with biologics have posed concerns about the sustainability of health care systems globally, with biosimilars being presented as cost-effective alternatives priced at about 20% to 30% less than reference agents. Increased utilization of biosimilars could reduce biologic prices even more. Tender systems, which Italy uses, allow for greater biosimilar utilization and price reductions by allowing biosimilars and reference products to compete on pricing in hopes of being granted a contract with the region’s public health plan. The present study compared dosing unit quantity and financial expenditure between originator and biosimilar products in an Italian health care facility serving around 1.1 million people, aiming to identify cost-saving opportunities.

In Italy, the growth of the biosimilars industry is notably influenced by regional dynamics, with several key cities and regions emerging as pivotal hubs for biosimilar adoption, manufacturing, and research. Cities such as Milan, Rome, Bologna, and Naples play crucial roles in this landscape due to their established pharmaceutical infrastructure, presence of healthcare institutions, and active participation in clinical research. Milan, as Italy’s financial and industrial powerhouse, stands out as a major center for pharmaceutical companies and biotech firms. It hosts numerous multinational corporations and contract manufacturing organizations (CMOs) that focus on biosimilar development and production. The city benefits from advanced research facilities and a robust network of hospitals and universities, fostering innovation and facilitating clinical trials essential for biosimilar approval and market penetration. Milan’s strategic position allows it to be a hub not only for manufacturing but also for distribution across Italy and to international markets. Rome, the political and administrative capital, is influential in shaping healthcare policy and regulation. The presence of national regulatory bodies such as the Italian Medicines Agency (AIFA) and the Ministry of Health enables close coordination between industry stakeholders and policymakers, which accelerates biosimilar approval processes and adoption initiatives. Additionally, Rome’s large healthcare network serves a significant patient population, where early adoption and clinical use of biosimilars are increasingly supported by policy incentives and educational campaigns. Bologna and other northern Italian cities like Turin and Genoa contribute to the biosimilars sector through their strong industrial bases and academic institutions. Bologna, in particular, benefits from collaborations between universities and pharmaceutical companies that drive research and development activities. The region’s focus on biotechnological innovation supports the production of high-quality biosimilars and helps attract investments. Southern cities such as Naples are gradually catching up, with increasing awareness and infrastructure improvements aimed at closing the regional adoption gap. Efforts to harmonize biosimilar prescribing practices across regions are ongoing, with targeted programs to enhance physician and patient confidence, which is critical for market growth in less developed areas.

Erythropoietin (EPO) biosimilars are experiencing a high compound annual growth rate (CAGR) in Italy's biosimilars industry, driven by several interrelated factors that enhance both clinical and economic outcomes. A significant catalyst for this growth is the increasing prevalence of anemia associated with chronic kidney disease (CKD) and cancer treatments. As the Italian population ages, the incidence of CKD rises, leading to a higher demand for erythropoiesis-stimulating agents (ESAs) like EPO to manage anemia in these patients. Similarly, cancer therapies often induce anemia, further elevating the need for effective treatments. EPO biosimilars provide a cost-effective alternative to originator biologics, making them an attractive option for healthcare systems aiming to manage these conditions economically. The Italian Medicines Agency (AIFA) has implemented policies that encourage the use of biosimilars, including EPO biosimilars, to promote cost savings within the National Health Service. These policies have led to high utilization rates of EPO biosimilars, with reports indicating that in 2022, approximately 98.8% of EPO prescriptions were for biosimilars. Such widespread adoption underscores the confidence in the safety and efficacy of these biosimilars among healthcare providers and patients. Furthermore, the expiration of patents for original EPO products has paved the way for the introduction of biosimilars, fostering competition and driving down prices. This market dynamics shift not only makes EPO therapies more affordable but also increases their accessibility to a broader patient population.

The biosimilars segment targeting chronic and autoimmune disorders in Italy is experiencing a high compound annual growth rate (CAGR) due to multiple converging factors that reflect both medical need and evolving healthcare strategies. Italy faces a substantial burden of chronic autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, and multiple sclerosis, which require long-term biologic treatments to manage symptoms and improve patients’ quality of life. Biologic therapies have revolutionized the management of these conditions but are often prohibitively expensive, creating a pressing demand for more affordable alternatives. Biosimilars have emerged as cost-effective substitutes that maintain comparable safety and efficacy profiles to their originator biologics, thus providing an attractive solution for both healthcare providers and patients. Italy’s healthcare system, through its national and regional policies, strongly promotes biosimilar adoption by integrating reimbursement incentives and educational initiatives that increase physician confidence in prescribing these products. Additionally, the expiration of patents on major biologics used in autoimmune disease treatment has opened the market for biosimilar competition, driving prices down and accelerating uptake. Patient advocacy and awareness campaigns have further contributed to acceptance and trust in biosimilars. Technological advancements in manufacturing and regulatory harmonization have also enabled faster development and approval of biosimilars in this category.

The Contract Research and Manufacturing Services (CRAMS) segment within Italy’s biosimilars industry is experiencing a high compound annual growth rate (CAGR) due to several key factors that align with broader trends in pharmaceutical outsourcing and biosimilar development. As biosimilars become increasingly important in reducing healthcare costs and expanding patient access to biologic therapies, pharmaceutical companies are under growing pressure to accelerate development timelines while maintaining stringent quality and regulatory standards. Many firms, especially small and mid-sized biotech companies, lack the in-house capabilities or resources to manage the complex manufacturing and research processes required for biosimilar production. This has driven a rising demand for specialized contract research organizations (CROs) and contract manufacturing organizations (CMOs) that offer end-to-end solutions, from cell line development and clinical trial support to large-scale commercial manufacturing. Italy’s well-established pharmaceutical infrastructure, skilled workforce, and strategic location within Europe make it an attractive hub for these outsourced services. Additionally, favorable government policies, investment incentives, and collaborations between Italian companies and global pharmaceutical players have strengthened the CRAMS sector. The ability of contract service providers to offer cost-effective, scalable, and compliant manufacturing processes also helps biosimilar developers mitigate risks and reduce capital expenditures.