Regardless of external challenges, the Italian pharmaceutical industry is clearly equipped for success, in terms of physical capital, expertise, and culture.
There is a “Made in Italy” element in pharmaceuticals which is just as significant as it is in cars for Ferrari, or in leather for Gucci
To start with, Italy already has a reputation for quality and workmanship upheld today by luxury automotive and fashion brands, which can be traced to the country’s centuries of experience producing wines, olive oil, and leather of the finest quality. AIFA’s Luca Pani affirms that “there is a “Made in Italy” element in pharmaceuticals which is just as significant as it is in cars for Ferrari, or in leather for Gucci.
We are incredibly good at using numerically controlled machines, such as those used in pharmaceuticals, and there is a very strong SME network in the country. The quality of the drugs these companies make is outstanding, accurate up to 99% and passing every external test.” Recipharm Italy’s CEO Giorgio Bruno concurs, going so far as to say that, “the Italian stamp is important for our success and our reputation at the international level.”
Signalling the quality and technical sophistication of Italian pharmaceutical manufacturing is the presence of several multinational facilities producing highly innovative drugs for the global market. Georg Schroeckenfuchs, Novartis country president, illustrates this fact by saying that “in the cardio-metabolic therapeutic area we have a standout product in Entresto, which has attained great success in treating chronic heart failure.
Interestingly our worldwide production of this particular product is carried out here in Italy and demonstrates our local competitiveness in manufacturing vis-à-vis other Novartis manufacturing sites worldwide.” Novartis’ generics division Sandoz also has facility in Roverto, which had “an export budget of USD 113 million in 2015,” and, according to Sandoz managing director Manlio Florenzano, is “dedicated to to the production of API (Acid Clavulanic, Acid Mycophenolate and Tiamulina).” Moreover, Florenzano reiterates that “as part of our long-term strategy we continue to upgrade and modernize our facilities: in 2015-2016 alone, EUR 5 (USD 5.5) million was invested in technological innovation to ensure the highest standards of quality.”
Other big-pharma and big-biotech players with significant manufacturing presences in Italy include GSK with two facilities, Pfizer with four following the integration with Hospira, a Lilly facility which produces a third of the company’s global insulin supply, and Boehringer Ingelheim. Boehringer Ingelheim president Anna Maria Porrini explains that the company’s manufacturing presence in Italy is through subsidiary “Bidachem SPA, which manufactures APIs and plays an important role in the provision of our innovative drugs. It is considered a strategic production site by the Boehringer Ingelheim group and as such we invested EUR 70 (USD 90) million back into the plant in the past five years, and continue to invest around EUR 10 (USD 11.2) million each year in order to keep the facility up to date.”
AbbVie’s Italian manufacturing plays a similar role within that organization, as general manager Fabrizio Greco notes, “the Campoverde manufacturing site has been chosen as the global production site for one of the three active ingredients in our revolutionary treatment to eradicate Hepatitis C. The AbbVie interferon-free therapy against hepatitis C is an important research milestone that can improve the lives of 160 million patients worldwide.
All these elements position our manufacturing site as one of the highest performing and most competitive in the AbbVie manufacturing landscape.” Similarly, Baxalta country managing director Fabio Andreola explains that “our plant in Rieti is a state-of-the-art plasma fractionation plant that has been expanded significantly over the last few years, supplying other Baxalta worldwide with plasma, to process into branded plasma-derivatives. In terms of technology, this site is quite advanced even within the context of Baxalta’s innovative global manufacturing network.”
[Italians] place a great emphasis on flexibility. This is why Italian CDMOs in general have a great reputation around the world. We are very flexible in catering to the needs of our customers
Italy is also home to an assortment of internationally competitive CDMOs that work closely with these leading multinationals. Aldo Braca’s BSP is one, as, from the time he founded the organization, “our key objective was to be a CDMO which specializes in a particular segment… we wanted to carve out a specific segment of the market for ourselves.”
Citing the global pharmaceutical industry’s shift from cardiovascular products toward oncology in the last decade, Braca explains that BSP offer their clients “a strong value proposition … because we solve one of the major challenges of the conjugation process,” within their highly specialized oncology facility at, so specialized that outside engineering groups are not allowed within the facility, as according to Braca “we consider our plant to be intellectual property.” The focus for the CDMO is currently on the construction of two new immunotherapy plants that they aim to have operational by 2019.
Leading global CDMOs including Patheon, Catalent, Famar, and Latina all have at least one facility in the country, while Sweden based Recipharm now operates four facilities in Italy following their acquisitions of the Corvette Group and Mitim in October 2014 and February 2016 respectively. Recipharm‘s Bruno explains that what his clients look for in a CDMO “partner is quality, efficiency, capacity and reliability.
The price is important of course but it is not the most crucial factor. Flexibility is key because clients routinely face market fluctuations and they expect us to be able to act and react accordingly.” Italians, he says, “place a great emphasis on flexibility. This is why Italian CDMOs in general have a great reputation around the world. We are very flexible in catering to the needs of our customers.” Between reputation, expertise, and hard work Recipharm Italy is clearly doing something right, as Bruno admits that “at the moment, we operate with full capacity in all plants that belong to the Recipharm umbrella in Italy – from Biologici to Mitim.”