Alfasigma, an international pharmaceutical company founded in Italy, is a leading company in contract manufacturing, able to provide an integrated and exhaustive service covering all aspects of this activity, and to be a unique partner in outsourcing activities for the manufacturing of nearly all pharmaceutical forms, in the volumes required, for outside bodies.

High qualitative standards and the utmost reliability are always ensured, thanks to the know-how obtained in many years’ experience, the use of innovative technologies and a modern plant, which has been recently enlarged and further developed.

Alfasigma is one of Italy’s leading pharmaceutical companies with a strong international positioning and the commitment to delivering innovative healthcare solutions. The Group has a worldwide presence operating in over 100 countries worldwide with approximately 4,000 employees dedicated to research, development, production, and distribution. The company has a strong focus in the gastro-intestinal therapeutic area and worldwide has products also in vascular, metabolic areas and in nutraceuticals and medical foods. 

Alfasigma’s mission is to improve people’s health and quality of life by offering caregivers and healthcare personnel therapeutic solutions according to the highest standards of quality and safety.

In this Q&A with Rocco Paracchini, the director of Alfasigma’s CDMO business unit, we explore the dynamic trends shaping Italy’s CDMO sector. In addition, Rocco shares his insights on the rapid growth and innovative capabilities that distinguish Alfasigma in this competitive landscape.

Contract Pharma: How would you characterize the state of Italy’s pharmaceutical sector?

Rocco Paracchini: Italy’s pharma sector is one of the most important and attractive markets within the EU, and one of the top five in terms of revenue. It has a rich history of pharmaceutical research and development, and is home to several renowned universities, research centers and pharmaceutical companies—a combination that helps drive scientific advancements.

Unfortunately, the Italian Regulatory Environment is also known for its complex approval processes and difficult-to-navigate pricing regulations. Recent organizational changes at The Italian Medicines Agency – AIFA, have not yet been able to provide the long-awaited improvements in approval times and pricing for drugs.

However, pharmaceutical companies based in Italy are globally recognized for their high-quality production facilities, and represent a European excellence center, since they are able produce a wide range of drugs, including generics and specialty medicines. All things considered, the main players are evolving to cope with recent trends and challenges, and Alfasigma stands out among them.

CP: What are the current trends driving growth in the Italian CDMO market?

Rocco: On average, the CDMO industry is projected to grow at a high-end single digit rate for the next 5 years, with different rates depending on the dosage form. It’s no secret that the European marketing authorization (MA) holders are realizing how important it is to have a reliable, flexible and conveniently located manufacturing source of finished dosage forms (FDF). Among European CDMOs, the Italian players are well equipped to serve the different needs of the market. Italy is still the top country for pharmaceutical manufacturing production, both in terms of volume and in terms of value, confirming its importance within the EU and beyond.

CP: In terms of value, how much is the Italian CDMO market worth and what is the forecast for the next several years?

Rocco: In 2023 the Italian CDMO market registered €2.3 billion, equivalent to 22.8% of the European total, confirming its European leadership in the EU CDMO space. The general expectation is that the growth will continue at 6-7% CAGR for the next 3-5 years. Investments made by multinational drugmakers can vary significantly depending on the type of product involved. A clear sign of this tendency was Novo Nordisk’s move to acquire Catalent—one of most relevant sites in Anagni, Italy—earlier in 2024. That was a milestone for the entire CDMO industry.

CP: What makes Italy a unique market and appealing location for pharmaceutical investment?

Rocco: Italy has a tradition of drug manufacturing, favored by a very active entrepreneurial base. Nowadays, Italy can count on a significant number of relevant players of different sizes and skillsets, including equipment, API/excipients, FDF and, more recently, nutraceutical products.

CP: What are some of the key challenges facing Italian CDMOs, and how are companies like Alfasigma addressing them?

Rocco: I expect Italian CDMOs will have to continue to grapple with challenges in supply chain instability driven by war, transportation disruptions, and increasing energy costs, as well as inventory reduction and market demand volatility, while safeguarding their relationship with pharma customers. At Alfasigma we intend to establish a customer-centric approach, making sure that our partners and eventually patients around the world can count on us to fulfill their medical needs.

CP: How has the demand for biopharmaceuticals and specialty medicines influenced Italy’s CDMO sector?

Rocco: Demand for biopharmaceuticals and specialty medicines has significantly impacted the contract development and manufacturing organization (CDMO) sector globally, and Italy is no exception. As demand for biopharmaceuticals increased, the CDMO business model emerged, and CDMOs were entrusted with developing and manufacturing production processes for pharmaceutical companies. Italy’s CDMO sector has evolved alongside the biopharmaceutical industry, playing a critical role in meeting the demand for innovative medicine.



CP: Are there any recent regulatory changes in Italy and/or the EU that are having an impact on the CDMO industry?

Rocco: There are at least two major regulatory changes impacting the industry. First, GMP Annex 1—the European Union’s guidelines for good manufacturing practices (GMP) for sterile medicinal products for human and veterinary use—became effective in August 2023. These guidelines are still affecting organizations operating in sterile manufacturing that decided to ensure continuity of supply while adhering to the new principles.

Second, the mandatory application of Serialization by EU FMD (Falsified Medicine Directive) as of February 2025 will require full traceability of the pharmaceutical product (prescription only) through a central EU coding system, while eliminating the optical sticker (the so called “Bollino”), which has been an Italian Ministry of Health (MoH) prerogative.

CP: What are the key components of Alfasigma’s strategy for growth in the CDMO market over the next five years?

Rocco: At Alfasigma CDMO we intend to use the excellent reputation the business unit has earned over the past few years as a springboard from which to invest in enhancing our capacity and capabilities in different directions, areas where we anticipate our core competencies will make the difference for our partners and customers. Specifically, we intend to expand our R&D capabilities and manufacturing technologies across all our sites in Italy and the U.S.

CP: How does Alfasigma plan to leverage new technologies and innovation to enhance its CDMO capabilities and services?

Rocco: Alfasigma aims to establish its position as European CDMO by investing both structurally and organizationally. We have just started our journey to become one of the leading EU-based CDMOs, yet one that remains affiliated with an important pharmaceutical group.

CP: What future developments or trends do you foresee in the Italian CDMO market over the next five to ten years?

Rocco: There is a general expectation that artificial intelligence (AI) and digitalization will shape future trends in drug development, and more broadly the way the medical community prescribes medicine. Cell and gene therapies have been very successful to this point in addressing a number of unmet medical needs, but the cost of these therapies and their market viability have put their progress on a rocky road.

More and more often, the increasingly common terminology of personalized medicine intersects with the urgent need of rare disease therapies (so-called orphan drugs), which in turn are not necessarily of interest for the major pharma companies. All in all, CDMOs need to stay on top of the trends and try to be forward-looking, interpreting market signals and proactively engaging their key customers to share the risks and benefits of decisions that will have to be made, sooner or later.

Learn more about Alfasigma >>>>>