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5 Pharmaceutical Innovation: Italian Cutting-Edge Biotech Medicines

5 Pharmaceutical Innovation: Italian Cutting-Edge Biotech Medicines

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M. Fortis and M. Carminati

Out of a total €1.4 billion invested in 2015, companies devoted 700 million to

clinical trials, a fact which makes the pharmaceutical industry the sector which

impacts national R&D the most.

Italy’s share of pharma biotech is increasing steadily. The sector is comprised of

SMEs exclusively dedicated to biotechnologies and pharmaceutical companies

which focus also on biotech. A 2015 report on biotechnologies in the pharmaceutical sector in Italy (Rapporto sulle biotecnologie del settore farmaceutico in

Italia) states that there are 199 companies operating in the sector and 133 are

exclusively dedicated to biotechnology while the other 66 are pharmaceutical

companies that have broadened their scope to include biotechnology. Together they

employ 7000 workers in research, which is equivalent to 7 % of those employed in

R&D in Italy. R&D expenditure is more than half a billion euros with a turnover of

around €7 billion. These figures make biotech pharma one of the primary sectors of

Italian R&D and with a relative intensity in terms of jobs and investments. It is

around 1½ times greater than the medium-high-tech sectors, and around 3½ times

more than the average investment in other Italian manufacturing sectors

(Farmindustria 2015e).

The pharma biotech sector is composed of 33 large companies, 32 medium-size

companies and 134 micro or small companies. The 33 large companies are

essentially pharmaceutical companies which also focus on biotechnology. They

generate 82 % of the income in the biopharmaceutical sector (a little less than

€6 billion in 2013), 66 % of R&D expenditure (€367 million) and employ 56 % of

biotech workers (more than 2000 jobs). The 32 medium-size companies generate

16 % of the overall turnover, 13 % of R&D expenditure, and employ 30 % of

workers in biotech. The 134 micro and small companies in biotech generate the

remaining 2 % of the turnover, 21 % of R&D expenditure and employ 14 % of the

overall workers in the sector.

Overall biopharmaceutical companies represent 26 % of pharmaceutical production and 44 % of R&D activities (Farmindustria 2015e). This is an important

share of the Italian pharmaceutical industry which is experiencing constant growth.

The sector’s organizational model is based on integrating large companies with

small and medium-sized ones. The former are generally able to manage the complete supply chain and can afford greater R&D expenditure due to their size. The

small companies have fewer financial resources. They usually research up to a

specific phase and then sell their scientific discoveries or research services to larger

pharmaceutical or biotech companies which have the skills and means needed to

complete the subsequent research stages to then implement the therapies.

Geographically, Lombardy is the region with the most companies in the pharmaceutical biotech sector (90), followed by Lazio (37) and Tuscany (26). From a

sectoral perspective, as stated in the Rapporto sulle biotecnologie del settore farmaceutico in Italia (Farmindustria 2015e), most companies in biotech pharma

(148) are active in pharmaceutical products which generate 83.8 % of the sector’s

turnover, they absorb 79 % of R&D investments and employ 75.9 % of workers in

R&D. The vaccine sector, with 19 companies and 509 employees, is significant

both in terms of income (€652 million) and R&D investments (€74 million). Next

5 Italy: A New European Pharmaceutical Hub


in importance are drug discovery (the processes linked to obtaining the final product), developing drug delivery technologies (for delivering medicines to a specific

site) and biopharming (production by means of biotechnology using techniques

with active principles of plant origin).


Prospects and Trends

The pharmaceutical industry, the expression of renewed Italian manufacturing, is

today a fundamental specialized “Made in Italy” sector. It is the high tech industry

that has the highest levels of production values, employment, investments and


Italy produces more medicines and vaccines than it consumes. In 2014, production grew by 4.6 % and pharmaceutical exports reached a new historic peak

both in terms of absolute value (€18.6 billion) and as a share of production

(+71 %). After years of negative growth, employment grew by +1 %, especially

thanks to more workers in production (+4 %), and investments increased by +11 %.

This has inverted the negative trend with double-digit growth figures both in production and research (Farmindustria 2015d). These results were made possible by a

stable regulatory framework in which companies have been able to program their

activities and increase production.

Today, thanks to vibrant domestic firms, and significant pharmaceuticals

investments by foreign companies, Italy has grown to the extent where it can now

legitimately aspire to become a European pharmaceutical hub. At present it is

second in terms of production value in the EU and it has significant international

“clusters”. Italy has important resources like qualified personnel at competitive

prices, cutting-edge factories, world leadership in packaging technologies specific

to the pharmaceutical sector, efficient spinoff sectors, strong clinical trials and

excellent research centers. It also has hospitals that are centers of excellence (for

cancer, rare diseases, genetic therapies, advanced therapies, vaccines, biotechnology, hemoglobin derived therapies, etc.) placing it among those nations with the

highest impact on the scientific community.

All these aspects are particularly important especially when considering how the

pharmaceutical market is being transformed worldwide. The change is in part due to

a growing emerging markets. Demographic growth and improved living conditions

in these countries are accompanied by the need for better healthcare and consequently more pharmaceutical products. Advanced nations, on the other hand are

slowly becoming saturated resulting in sluggish demand, in part also due to the

need for containing costs. The shift in global demand has led to the relocation of

pharmaceutical production around the globe. It has also increased competition

among advanced economies in their pursuit to consolidate existing investments and

attract fresh ones. The analysis provided in this chapter amply describes Italy’s

strategic role in pharmaceuticals and offers evidence to prove it has the necessary

requirements and features for becoming a new European pharmaceutical hub.


M. Fortis and M. Carminati


EFPIA—European Federation of Pharmaceutical Industries and Associations (2016) The

pharmaceutical industry in figures

Eurostat (2016) Statistics database

Farmindustria (2015a) La produzione di valore dell’industria farmaceutica in Italia, Centro Studi


Farmindustria (2015b) Le imprese del farmaco in Italia. Innovazione, occupazione, produzione per

un Paese in salute

Farmindustria (2015c) L’industria del farmaco: innovazione continua. Ricerca, produzione e

occupazione per la crescita del Paese. July

Farmindustria (2015d) Indicatori farmaceutici. July

Farmindustria EY (2015e) Rapporto sulle biotecnologie del settore farmaceutico in Italia

Fondazione Symbola (2015) Le verità sulla competitività italiana. Focus sull’industria


Fortis M (1984) L’apporto del sistema moda-arredo-casa alla bilancia commerciale italiana.

Nomisma, Bologna

Fortis M (1996) Crescita economica e specializzazioni produttive. Sistemi locali e imprese del

made in Italy. Vita e Pensiero, Milan

Fortis M (1998) Il made in Italy. Il Mulino, Bologna

Fortis M, Carminati M (2012) Il contributo delle «4 A» del made in Italy e dei distretti industriali

nella storia dell’export italiano: il caso della meccanica. In: Quadrio Curzio A, Fortis M

(eds) L’industria nei 150 anni dell’unità d’Italia. Paradigmi e protagonisti. Fondazione Edison

series. Il Mulino, Bologna

Istat (2015) Rapporto sulla competitività dei settori produttivi

Istat (2016) Banca dati del commercio con l’estero

ITC—International Trade Centre (2016) Trade map database

Chapter 6

Food & Wine: Quality, Tradition

and Innovation

Marco Fortis and Andrea Sartori

Abstract This chapter evaluates the strengths of some of Italy’s most tangible

resources: agriculture, forestry and fishing. It addresses the misconception that Italy

has inefficient production systems, and provides evidence that its agro-food industry

is resilient and its products are, in fact, in high demand internationally. The fundamental traits of the Italian agro-food industry are described and an in depth

assessment is made of its characteristics and its various specializations. Its foreign

trade performance (specifically long-term and during the most recent economic

crisis) based on the quality of its products is also assessed. The Fortis-Corradini

Index (FCI) is used to identify which products performed best internationally.

Finally, the beverage industry is examined, especially wine, one of Italy’s proudest

symbols of excellence, to illustrate overall quality as well as record levels reached.



Italians… pizza chefs? Well, not only. Delicious food and wine are characteristic of

Italian culture and cuisine, but “Made in Italy” means much more. Italian food and

beverages are deeply rooted in traditions which vary immensely by region. They

constitute a unique Italian heritage renown and appreciated around the world. Their

undisputed quality places Italian products at world vertexes for variety and excel-

M. Fortis (&)

Department of International Economics, Institutions and Development,

Università Cattolica del Sacro Cuore, Milan, Italy

e-mail: marco.fortis@edison.it

A. Sartori

Fondazione Edison, Milan, Italy

e-mail: andrea.sartori@unicatt.it

© Springer International Publishing Switzerland 2016

M. Fortis (ed.), The Pillars of the Italian Economy,

DOI 10.1007/978-3-319-40186-7_6



M. Fortis and A. Sartori

lence. It is no coincidence that Italy has the most EU certified products.1 In fact,

more than one out of four certified products are Italian.

At the root of its reputation—based on an articulated gastronomic culture,

extremely high quality ingredients and a rich biodiversity2 of raw materials—are

Made in Italy food and beverage industries, especially wines.

The extent of the impact of the “Food and wine” sector, visible in myriad ways,

can be seen through its exports. Italy has done extraordinarily well and is among the

most competitive nations in the world. Prestigious food products, mainly wines,

generate substantial trade balances that bolster exports even further. In addition,

Italian industrial production processes are more innovative and environmentally

sustainable than generally imagined. The focus on environmentally sustainable food

was the central theme of the World Fair “EXPO Milano 2015”3 entitled Feeding the


The European Union has developed three schemes of geographical indications and traditional

specialties to promote and protect the names of quality products and foodstuffs, which must

comply with the criteria listed in EU Regulation (1151/2012) in order to be eligible. The adopted

schemes are:

• Protected Designation of Origin—PDO: agricultural products and foodstuffs which are produced, processed and prepared in a given geographical area using recognized know-how;

• Protected Geographical Indication—PGI: agricultural products and foodstuffs closely linked

to the geographical area. At least one of the stages of production, processing, or preparation

must take place in the area;

• Traditional Speciality Guaranteed—TSG: highlights the traditional character of the product, in

either its composition or means of production.

In concrete terms, the EU product quality schemes relate to agricultural products and foodstuffs, wines, spirits and aromatized wines, which producers or producer groups have registered in

compliance with the EU Regulation. The purpose of the regulation is to encourage the diversification of agricultural production, to protect the misuse of a product’s name, to prevent counterfeiting and to assist consumers by providing comparable information of a product’s specific


For further information see European Commission (2016).


According to a recent survey, the biodiversity of the Italian fauna and flora comprises around

7000 types of flora and 58,000 types of animals. Italy has 504 registered varieties of vines and 533

registered varieties of olives, while France has 278 registered varieties of vines and Spain has only

70 registered varieties of olives (Coldiretti 2015).


More than 20 million people visited the Milan EXPO (2015) and more than 150 countries and

international organizations were represented. Approximately 5000 events were organized during

the 184 days of the fair. The Milan Charter, listing the principles and main objectives of fundamental issues like nutrition, environmental sustainability, and human rights, was signed by heads

of State, representatives of civil society and international organizations, along with famous people

and ordinary citizens: it was subsequently presented to the United Nations (EXPO 2015).

6 Food & Wine: Quality, Tradition and Innovation


Planet. Energy for Life. Its objective was to increase awareness and give precedence to essential issues such as sustainable development and food safety.4


Agriculture, Forestry and Fishing: Value Added

and Innovation

Italy generates extremely high value added thanks to agriculture, forestry and

fishing. These sectors rival those of countries like France and are much larger than

big EU economies including Germany and Spain. Furthermore, the implementation

of the new European accounting system (“ESA 2010”) provides fresh data which

depicts a very different scenario and reconfigures the power relations among the

various leading EU nations (Fortis and Carminati 2015).

In 2015, Italy ranked first in Europe for value added, which was €33.1 billion

(Fig. 6.1). It has consistently ranked among the top spots for added value in

agriculture, forestry, and fishing for at least fifteen years.5 This rather constant,

positive trend has been accentuated even more in recent years. From 2009 to 2015

value added increased overall by 17.9 %. Moreover, from 2014 to 2015 it grew by

5.6 %.

These data highlight the constant decline of French agriculture, heavily subsidized by the European Union. They also depict the unfolding of increasing added

value in Italian agriculture and forestry.

Istat figures (Istat 2015a) show that the added value generated, in 2014, was

2.2 % of nominal GDP. The positive result was even greater when taking into

consideration that the sum of the agriculture sector and the food industry—the

so-called agro-food sector—represent 4 % of Italian added value and 6 % of total

production. Furthermore, over the past fifteen years, Italian agriculture has significantly evolved in virtue of processes which have noticeably changed production, at

Fondazione Edison organized a “Cycle of Conferences on Innovation, Institutions and Economy

during Expo 2015”. Amartya Sen, Nobel Laureate in Economics, held the first conference with a

Lecture on “Famines and food security: sustainability and crises”. Other prestigious economists

who provided important contributions are: Michael Landesmann on “Convergence, divergence and

the problems of external imbalances in the European economy”; Jackie Krafft on “Anything new

on governance and growth of firms in a context of innovation and eco-innovation? Issues and

results”; Joel Mokyr on “Is technological change a thing of the past?”; Paul Allan David on “The

economics of stabilizing the global climate and sustaining the world's food supplies—while there's

still time”; and Bina Agarwal on “Institutions, property, and gender inequality”. The closing

Lecture was held by Fabiola Gianotti, Director-General of CERN, on “Fundamental research and

much more: CERN's example” (Fondazione Edison 2015).


Italy’s added value was the highest in Europe from 2003–2009 (with the exception of 2007 when

Italy was slightly surpassed by France). In the three-year period which followed, from 2010 to

2012, Italy ranked second. In 2013, Italy once again surpassed France becoming first in Europe

and generated €33.6 billion. In 2014 it shared first place (notwithstanding the decrease) along with

France earning €31.3 billion. Finally, in 2015, it returned to a solid first place with €33.1 billion.



M. Fortis and A. Sartori


















billion (current prices)































Fig. 6.1 Added value (at current prices) of agriculture, forestry and fishing (2000–2015). Source

Compiled by Fondazione Edison using data from Eurostat (Eurostat 2016)

the structural level (company reorganizations) and at the production level (product

substitution). Basically, Italian agriculture tends to internalize some stages of the

production process in order to maintain part of the value added of support activities

and farm diversification activities.6 Istat calculations show that the support activities

which surround agricultural production in 2014 were 12.9 %, when secondary

activities were added (8.6 %) it increased to 21.5 %.

It is therefore obvious that Italy is a European leader thanks to its ability to

produce wealth and its innovative capacity. Furthermore, the primary sector, with

its agro-food production, represents one of the most important productive sectors.

Overall, it is worth more than €260 billion (MIPAAF 2016). These are indications

that the sector represents a concrete heritage for Italy and that potential is continually emerging, specifically in favor of the Italian agro-food sector.


Farm diversification activities are increasing. Agro-tourism is on the rise again as well as sustainable agriculture and direct sales linked to an increased use of renewable energy. Moreover,

there is increasing demand for activities linked to multifunctional farms, renewable energies

(photovoltaic and biomass), school farms, recreational activities, sustainable agriculture, direct

sales, production of feedstuffs, reconverting parks and gardens, agro-tourism and various processing activities.

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