The Italian Biotech Industry
Facts & FiguresASSOBIOTEC

Italian Association for the Developmentof BiotechnologyIndexIntroduction......................................................................................................................................................................................................................2
1. Methodology .......................................................................................................................................................................................................3
2. Executive summary .............................................................................................................................................................................4
3. The Italian biotech industry in figures........................................................................................................ 10
4. R&D activities .............................................................................................................................................................................................. 25
5. Healthcare .......................................................................................................................................................................................................... 36
6. Agriculture and veterinary ................................................................................................................................................ 43
7. Industry and environment ................................................................................................................................................. 45
8. The bioeconomy ..................................................................................................................................................................................... 47
9. Supporting innovation ............................................................................................................................................................... 53
10. Italian biotech companies ................................................................................................................................................. 55

Introduction
The new report on the Italian biotech industry, drafted thanks to the consolidated collaboration between Assobiotec (Italian Association for the Development of Biotechnology, part of Federchimica) and ENEA (National Agency
for New Technologies, Energy and Sustainable Economic Development), offers an update on the current Italianbiotech industry in 2017.
The analysis collects and processes updated information and estimates provided by firms in the sector at the endof 2017, as well as their 2016 financial statements, public data and data from the National Statistical System,
presenting readers with a general picture of the sector which is one of a kind at an international level for its
wealth and thoroughness.
The report focuses on the following main issues: the figures of Italian biotech, a chapter on research and development activities, a snapshot of the ​​healthcare, agriculture and veterinary medicine, industry and environment
sectors, a focus on bioeconomy and measures to support innovation. The data collected within the framework of
the National Statistical Programme will be merged into the statistics on the biotechnology industry edited by theOECD – Organisation for Economic Cooperation and Development, whose methodology is adopted in this study.
On the basis of the estimated data, the biotech firms operating in Italy confirm their status as a highly innovative sector
dedicated to research, with excellences in all the applicative biotechnology sectors. It suffices to think of the Italianleadership in precision medicine and advanced therapies, where three therapies out of the six currently authorised inEurope are the result of Italian research, development and production. It is therefore a dynamic, high-tech sector thatis potentially ready to seize the challenges and opportunities of the biotech sector at an international level.
However, it is also an industrial sector that urgently needs a national strategy in favour of medium-long term
innovation and research composed of measures that are stable over time, in addition to effective, certain andcentralised governance: these measures would allow firms to overcome the limits of their often too-small dimension, in addition to guaranteeing important repercussions for the country in terms of economic and labourdevelopment in support of Italian growth and competitiveness.
Riccardo Palmisano
Assobiotec – Federchimica President
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

2Federico Testa
ENEA President
April 2018

1. Methodology• This analysis was carried out thanks to the collaboration between Centro Studi Assobiotec and the Industry and Business Associations Unit
– Contracts and Partnerships Management Directorate of ENEA.
• Information was collected from questionnaires filled in by the firms,
their available financial statements, other public data and the companies’ websites. Unless otherwise specified, the data on the number ofcompanies refer to 2017, while other economic data refer to 2016 as
the last available data.
The data from the previous years were reprocessed on the basis of the
population’s expansion and the new information available. Particulareffort was dedicated to the extension of the historical series to which
the data refer, as well as to the expansion of the variables considered in
the sector’s analysis; the report also includes a series of data relating
to patents and international trade.
• The definitions adopted and the data processing followed the guidelines developed in relation to the OECD*. These guidelines include thefollowing categories of companies:
– biotech firms: companies that use at least one biotechnological
technique to produce goods or services and/or carry out research anddevelopment in the biotech field;
– dedicated biotech R&D firms: companies that invest at least 75% of
their intra-muros research budget in biotechnology research.

– Healthcare firms: companies operating in the human health sector
using modern biotechnological methods for the research, development
and production of products for the diagnosis, treatment and diseases prevention (drugs, new therapies, vaccines, diagnostic, molecular pharming);– Agriculture and veterinary firms: companies operating in the
agriculture and livestock using modern biotechnological methods toimprove animal and crop production, increase productivity and quality,
improve the characteristics of adaptability to the environment and resistance to pathogens, or develop biological and environmentally-friendly
products for the protection of plants and animals;
– Industry and environment firms: companies using modern biotechnological methods in the industrial field for the retraining of many
conventional production processes, the conversion of renewable biomass into bioproducts and energy, for applications in the food, nutraceutical and cosmeceutical fields, for the development of diagnostics
and environmental remediation systems, or products for the restorationand conservation of artistic heritage;
– Genomics, Proteomics and Enabling Technologies firms (GPET):
companies applying modern biotechnological methods in the field of
the «omics» disciplines (genomics, proteomics, transcriptomics, etc.),
as well as bioinformatics technologies, systems biology, biochips, biosensors and basic research.

• With reference to the sector of application for which each firm mainly
carries out its biotech activities, the firms are classified follows:

*Friedrichs, S. and B. van Beuzekom (2018), “Revised proposal for the revision of the statistical definitions of biotechnology
and nanotechnology”, OECD Science, Technology and Industry Working Papers, 2018/01, OECD Publishing, Paris.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 20183

2. Executive summary

The sector is undergoing
consolidation around the strongest
and most competitive companies…
• The Italian biotech industry has been experiencing a phase of consolidation in recent years.
On the one hand, the number of active companies in the sector is stabilising; on the other
hand, all the main economic indicators are accelerating their growth rate. The snapshot
given by this report therefore suggests that a structural change is taking place, with thesector’s concentrating around the strongest and most competitive companies.
• At the end of 2017, 571 biotech firms were counted in Italy. More than half of these (57%,corresponding to 323 firms) are dedicated biotech R&D firms that devote at least 75% of
their intra-muros R&D investments to biotech research activities.
• The vast majority of Italian biotech firms (76%) are of a micro or small size. Over the last
few years there has been a shrinking trend in the percentage of micro firms on the total;
this contraction is probably linked both to the sector’s consolidation and the continuation of
the negative economic situation.
• The total biotech turnover is over 11.5 billion euros, with an increase of 12% between 2014
and 2016. The number of employees is close to 13,000, registering an increase of 17% in
Italian capital dedicated biotech R&D firms.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®4April 2018

2. Executive summary... with high research intensity• The growth of the number of companies specialised in biotech R&D continues uninterrupted, reaching 57% of the total biotech companies in 2017, thereby confirming the strategic
nature of R&D investments and technological innovation in the sector’s competitive dynamics.
• The total R&D investments* of the firms surveyed amounted to 2.15 billion euros, withinvestments in biotech R&D exceeding 760 million, recording 22% growth between 2014
and 2016.
• The share of micro-small sized dedicated biotech R&D firms is about 89%: 13 percentage
points higher than the total number of biotech companies. This is in line with the division oflabour, which has been consolidated into the research value chain – especially in the healthsector –: large companies seek increasingly specialised and state-of-the-art skills in smaller companies which are closer to the academic field and have higher research intensity.

* Intra-muros plus extra-muros

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 20185

2. Executive summary

Healthcare sector• The picture of Italian biotech firms confirms the primacy, which has already been found inprevious surveys, of companies operating in the biotech sector applied to healthcare: there
are currently 295, representing over half of Italian biotech firms (52%).
• There are 183 dedicated biotech R&D firms, which commit 75% or more of their total
research costs in biotech activities, of which 161 are Italian capital companies.
• The healthcare sector generates a preponderant share of turnover, corresponding to over
8.5 billion (74% of the total) against higher investments (91%) and a higher number of
employees (76%) working in biotech R&D.
• There are 314 projects in the Italian pipeline, of which about 80 are in the discovery phase,
145 have reached the preclinical development and 90 are in clinical development.
• Italian biotech invests in those diseases which still lack adequate therapeutic solutions,such as those in oncology, or diseases of increasing clinical and epidemiological importance such as neurological and degenerative diseases, due to the overall ageing of the
population. Large investments are also directed towards infectious diseases and the development of vaccines.
• Rare diseases and advanced therapy medicinal products are among the sectors of Italianbiotech excellence: on the one hand, Italy’s academic research boasts the largest numberof scientific publications on rare diseases, and on the other hand, out of the six advanced
therapies medicinal products currently authorised for the EU market, three are the resultof Italian R&D.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

6April 2018

2. Executive summary

Agriculture and veterinary
sector• The panorama of firms operating in the agriculture and veterinary sector in Italy is quite
diversified. 50 firms were registered (9% of the total), all characterised by considerable
R&D activities.
• 80% of the total firms can be classified as small or micro businesses.
• The sector’s turnover is close to 900 million euros.
• 2017 saw a significant opening of Italian public research, which is engaging in a vast
and well-focused R&D plan, based on the most advanced biotechnology applied to plant
breeding innovation. This plan represents a turning point which all the research can startfrom, especially in agricultural genetics and varietal improvement. It is placed in a context
of innovation which integrates the progress of life sciences with the parallel perspectivethat precision farming can offer.
• The dedicated biotech R&D firms are all controlled by Italian capital and demonstrate anincrease of more than 50% of investments in biotech R&D compared to the previous two
years.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 20187

2. Executive summary

Bioeconomy and industry
and environment sector• 162 biotech firms operate in the industrial and environmental sector, accounting for 28%
of all firms.
• The sector’s turnover is close to 2 billion euros, registering 16% growth for the Italiancapital dedicated biotech R&D firms compared to 2014 data.
• The application of these techniques can innovate mature sectors such as those of raw
materials, energy production and intermediates while adhering to the principles of environmental, economic and social sustainability that are typical of bioeconomy. This is a complex
concept that includes a multiplicity of sectors whose common basis is input of a renewable
and biological origin, but which can follow different underlying development dynamics conditioned by the peculiarities of each specialisation.
• According to estimates by Intesa Sanpaolo-Assobiotec, bioeconomy in Italy had a production value of 260 billion euros in 2016, corresponding to 8.3% of the total national
economy, experiencing moderate growth in respect to 2015.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®8April 2018

2. Executive summary

GPET• Genomics, Proteomics and Enabling Technologies, or GPET, is an emerging sector that
often works in close synergy with healthcare biotechnology.
• There are 65 Italian firms working in this field, corresponding to 11% of the total biotech
firms in Italy.
• These firms carry out basic research activities, with a particular prevalence in the use of«omics» technologies (genomics, proteomics, transcriptomics, etc.) and in the analysis of
Big Data through bioinformatic approaches.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 20189

3. The Italian biotech industry in figures

The key figures of the Italian biotech sector...
Total firms

Dedicated biotech
R&D firms...

...of which, Italian capital
dedicated biotech R&D firms

Number of firms*

571

323

296

Biotech turnover**11,535,929

4,583,022

1,124,316

Total R&D investment**

2,148,985

549,843

300,474

Total biotech R&D
investment**

764,367

491,607

270,039

Biotech employees**

12,781

5,879

4,087

Biotech R&D employees**

3,790

2,875

1,868
*Last available data, 2017

Values in thousands of euros €/000• At the end of 2017, there were 571 biotech firms in Italy.
• The total biotech turnover is over 11.5 billion euros, with an increase of
12% between 2014 and 2016.
• The number of employees is close to 13,000, registering an increase of
17% in Italian capital dedicated biotech R&D firms.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

10**Last available data, 2016

• The total R&D investment*** of the firms amounted to 2.15 billion euros,with investments in biotech R&D exceeding 760 million, recording 22%
growth between 2014 and 2016.
*** Intra-muros plus extra-muros

April 2018

3. The Italian biotech industry in figures...reflect a sector undergoing a phase of consolidation
Number of biotech firms in Italy
700
600
500

452

478

506

535

549

562

576

582

583

571

2012

2013

2014

2015

2016

2017*

400
300
200
100

2008

2009

2010

2011

• In the last 4 years, the number of Italian biotech companies hasremained stable. Such demographic dynamics, to which the long standing negative situation of our economy is no stranger, is mainly due
to the progressive increase of the number of companies which are nolonger in business, parallel to a number of new born companies which
are now active in the biotech field.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

* Provisional data

• The demographic trend recorded is a further confirmation of how prolonged negative economic phases often tend to jeopardise the most innovative, and therefore riskier, business initiatives instead of stimulating
them; so, these initiatives require special attention in times of crisis.

April 201811

3. The Italian biotech industry in figures... which believes in R&D
R&D Intensity
40%
34.3%

35%
30%

26.5%

24.0%

25%

Intra-muros and extra-muros R&D
investments on overall turnover
Intra-muros and extra-muros biotech
R&D investments on biotech turnoverR&D employees on total employees

20%
13.6%

15%

14.0%
10.7%

10%

6.6%

5%

7.0%

2.5%

0%
Italian biotech industry

Dedicated biotech
R&D firms

Italian capital dedicatedbiotech R&D firms• More than half of the active firms (57%, corresponding
to 323 firms) dedicate at least 75% of their intra-muros and extra-muros R&D investments to biotech research activities. Of these, 296 have Italian capital, anumber that grew by 16% from 2014 to 2016.
• As far as the Italian capital dedicated biotech R&D
firms are concerned, the average incidence of total
R&D investments on turnover is 24%**, exceeding
the 40% for more than 63% of these firms. The
activity of the large part of these companies is

exclusively R&D, not including productive processes, if not occasionally.
• The intensity of intra-muros and extra-muros investments and the number of employees dedicated toresearch and innovation are greater in the Italian capital dedicated biotech R&D firms. Since the latter are
mainly micro or small firms, they are more focused on
research operations than production and sales.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

12**Intra-muros and extra-muros biotech R&D investments/Biotech turnover

April 2018

3. The Italian biotech industry in figures... and is increasingly specialised
Growth dynamics of biotech firms(index number 2014=100)

Dedicated biotech firms*
Dedicated biotech R&D firms
Total firms

108
107
106
105
104
103
102
101
100

2014

2015

2016

*Defined as firms that dedicate at least 75% of theirproduction of goods and services, or research anddevelopment, to biotechnologies

The intensity of research and innovation in the sector is confirmed at a high level andinvestments in biotech R&D are experiencing sustained growth. This is reflected in an
increase in the share of companies specialising in biotechnology, and even more so in thosespecialising in biotech R&D.
More and more companies among those surveyed tend to concentrate their business on
biotech products and/or services, trying to seize the strong growth opportunities that thesemarkets envisage compared to the more traditional ones. Competitiveness is predominantly
technological in these markets, therefore investment in research and development and theinnovation capacity of individual companies are fundamental assets.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201813

3. The Italian biotech industry in figures

Firms active in all sectors ofapplication…
Analysis by field of application
28%

11%

52%

9%

Healthcare
Industry and environment
Agriculture and veterinary
GPET

The picture of Italian biotech companies confirms the primacy of firms operating in the biotech sector applied to healthcare, which represent over half of Italian biotech firms (52%). These firms are followed by those focused on industry and environment, which represent 28% of
the total. A portion of the total is also reserved for firms active in Genomics, Proteomics andEnabling Technologies – GPET (11%) and the agriculture and veterinary biotech sector (9%).

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

14

April 2018

3. The Italian biotech industry in figures... moving towards a moresustainable future, guided by astrong spirit of innovation•
Developing diagnostic systems and innovative therapies which lead to a series ofimportant repercussions in many therapeutic, diagnostic, nanobiotechnology and cosmetic
fields. More than half of the Italian biotech companies (295) are active in the healthcare
sector, presenting innovative solutions in the medical and pharmaceutical fields.
• Improving agricultural production, generating bioactive substances whose presence is limited in nature (biopharming), increasing production without enlarging the cultivation surface
area, reducing water consumption and the effects of pests and plant diseases, protecting
animal health. There are 50 companies active in the agriculture and veterinary biotech
sector.
• Offering tools to optimise the transformation of biomass into eco-sustainable bioproducts
and third-generation biofuels, or to improve the yield and environmental sustainability of
traditional production processes. There are 161 biotechnology firms active in industrial andenvironmental sectors.
• Carrying out basic research activities, being a powerful accelerator for all the other applicative fields of biotechnology. From genes to proteins up to bioinformatics technologies
and biochips, there are 65 firms working in the field of Genomics, Proteomics and Enabling
Technologies - GPET, with a particular prevalence in the use of «omics» technologies and in
the analysis of Big Data through bioinformatic approaches.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201815

3. The Italian biotech industry in figures

Biotech firms:
analysis by size10%•
76% of Italian biotech firms are micro or
small-sized organizations.
• In the four years considered in the analysis,
there is a shrinking trend in the percentage of
micro-firms on the total.
•This contraction is probably linked both tothe consolidation of the sector and to thecontinuation of the negative economic situation.

Micro: 1-9 employees
Small: 10-49 employees
Medium: 50-249 employees
Big: 250+ employees

14%

Micro
Small
Medium
Big

19%

2014

2015

2016

2017

Micro

60%

59%

58%

57%

Small

17%

18%

18%

19%

Medium

13%

13%

14%

14%

Big

10%

10%

10%

10%

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

16

57%

April 2018

3. The Italian biotech industry in figures

Dedicated biotech R&D firms:
analysis by size
• Of the total number of dedicated biotech R&D firms, the percentage of those which aremicro or small-sized is nearly 90%.
• The reduction in the percentage of micro-sized firms is particularly marked in the agriculture and veterinary sector and GPET sector, for which there has been a contraction in thenumber of firms of this size respectively of 15% and approximately 14%.

Distribution of micro-firms by sector
Healthcare
Agriculture andveterinary

Micro: 1-9 employees
Small: 10-49 employees
Medium: 50-249 employees
Big: 250+ employees

Micro
Small

Industry andenvironment
GPET

Medium
Big

90%

2%
9%

85%

69%

20%

80%
75%
70%
65%
60%

2014

2015

2016

2017

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201817

3. The Italian biotech industry in figures
Biotech firms: geographic
distribution of registered offices

Analysis by geographic distribution
Firms
Registeredoffices 2016

Local units
2016

Numero%Numero%Contribution
Contribution
toLocal research
intra-muros to biotech
units 2016
biotech R&D turnover
investments
Numero%Lombardy
LatiumEmilia-Romagna
Piedmont
VenetoTuscanyCampania
Friuli-Venezia Giulia
SicilyApuliaTrentino-Alto Adige
Sardinia
MarcheLiguria
UmbriaAbruzzo
Molise

162
58
57
52
47
42
34
30
17
15
14
14
12
8
5
5
5

28%
10%
10%
9%
8%
7%
6%
5%
3%
3%
2%
2%
2%
1%
1%
1%
1%

235
82
88
75
64
67
44
33
24
23
16
18
18
12
7
8
6

28%
10%
11%
9%
8%
8%
5%
4%
3%
3%
2%
2%
2%
1%
1%
1%
1%

182
59
65
61
47
56
42
35
21
21
14
17
13
10
7
5
5

27%
9%
10%
9%
7%
8%
6%
5%
3%
3%
2%
3%
2%
1%
1%
1%
1%

23%
17%
6%
11%
3%
22%
5%
7%
1%
1%
1%
0%
0%
0%
0%
1%
0%

32%
21%
10%
4%
3%
16%
2%
0%
0%
4%
1%
5%
1%
0%
0%
0%
0%

Other Regions

6

1%

10

1%

7

1%

1%

0%

Total

583 100%

830 100% 667

100%

100%

100%

RegionENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

18

> 12%
9% - 11.9%
6% - 8.9%
2% - 5.9%< 2%

April 2018

3. The Italian biotech industry in figures
Biotech firms:
geographic distributionof local units

Biotech firms: geographic
distribution of local
research units

> 12%

> 12%

9% - 11.9%

9% - 11.9%

6% - 8.9%

6% - 8.9%

2% - 5.9%

2% - 5.9%

< 2%

< 2%

• With 28% of firms and local units in its territory, 23% of investments and • 
Lombardy is followed by Latium and Emilia-Romagna for number
32% of turnover, Lombardy is confirmed as the first region for presence,of firms, in particular for registered offices and production sites, andEmilia-Romagna and Piedmont for the number of offices where researchcommitment and results in biotech. It has therefore maintained theleadership role for national biotech.
activities are carried out.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

April 201819

3. The Italian biotech industry in figures
Biotech turnover:geographic
distribution

Intra-muros biotech
R&D investments:
geographic distribution
30% and more
16% - 29.9%
5% - 15.9%
1%-4.9%< 1%• Looking at investments in R&D, Tuscany ranks second for biotech
Lombardy, and followed by Tuscany.
investments, preceded by Lombardy and followed by Lazio. About two • The contribution to turnover is greater than the contribution to national
thirds of investments in biotech research are concentrated in the three
investments in six regions: Emilia-Romagna, Latium, Lombardy, Marche,
regions of Lombardy, Tuscany and Latium, true leading areas for Italian
Apulia and Sardinia.
research.
• The three regions with the highest average investment in relation to the•Considering the turnover, Latium is in second place preceded bynumber of production sites are Basilicata, Friuli Venezia Giulia and Tuscany.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

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April 2018

3. The Italian biotech industry in figures

Biotech turnover analysis

Total companies: breakdown of
turnover by field of application
17%• Considering the total number of firms, those active in thehealthcare sector generate almost three quarters of the total
biotech turnover.
• 68% of the biotech turnover is generated by foreign-owned
firms, which represent only 13% of the firms surveyed.
• While foreign-based firms make most of their turnover in the​​human health sector, the Italian capital firms make most of their
turnover in the sector dedicated to industry and environment.

Total companies: breakdown of turnover between
Italian capital and foreign invested firms
100%
90%
80%

8%
1%

74%

Italian capital dedicated biotech R&D
firms: breakdown of the turnover by
field of application
4%

32%

1%

43%

52%

70%
60%
50%
40%
30%
20%

68%

Italian capital firms
Foreign invested firms

10%
0%

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

Healthcare

Industry andenvironment

Agriculture
and veterinary

GPET

April 201821

3. The Italian biotech industry in figures

Export turnover• There are 214 exporting biotech firms, on the base of ISTAT data on
foreign trade, equal to 37% of the total in 2016.
• At the end of 2016, biotech firm exports amounted to 11.3 billion
euros, while the biotech product exports by biotech firms amounted to
834 million euros, equal to 7.4% of these firms’ total exports.
• Biotech product exports are driving the foreign competitiveness offirms in the sector: in fact, they are up by almost 11% compared
to 2014, in an open contrast to the entire export volume of biotech
firms, which also includes non-biotech products, where a significant
decrease was recorded (–15%).
• The figure for biotech products (+11%) confirms its absolutely positive
trend, also when compared to the growth of total national exports (+ 4%).

2014

2015

2016

Total Italian firm exports

378,553,915

390,833,847

394,443,779

Biotech firm exports

13,277,230

11,408,756

11,285,058

Biotech firm exports vs. total Italy exports

3.5%

2.9%

2.9%

Biotech product exports by biotech firms

752,531808,278

833,454

Biotech product exports vs. total biotech firm exports

5.7%

7.1%

7.4%

Values in thousands of euros €/000
Source: elaboration on ISTAT data, 2014-2016
Note: The export data are collected on the basis of the combined nomenclature, a classification that follows a product criterion, not a technological one. Consequently, the analysis of export flows is subject to potential
bias due to the fact that both biotech and non-biotech products can be included within a given commodity code. Furthermore, the data only refers to product exchanges and does not consider service flows. [See OECD, A
Framework for Biotechnology Statistics, 2005].

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

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April 2018

3. The Italian biotech industry in figures

Export: comparison with Italian industry
Percentage of exporting firms by industry sector• As already highlighted, biotech firms are characterised for their high projection on foreign markets(38% of exporting firms in 2015). The percentageof exporting firms has tended to increase over thelast few years, and is on average more than one anda half times that of the manufacturing sector (with
23% of exporting firms in 2015) and more than seven times that relating to Italian industry as a whole,which substantially stops at just under 5%.
• Among the most active biotech sectors in terms ofexports, the agriculture and veterinary sector mustbe highlighted, where more than one in two firms is
an exporter.
• At the same time, there is also an increase in theexport vocation in the field of biotech productions.
All the firms in the sector compete with this trend,
but in this case as well, the firms in the agriculture
and veterinary sector show much more accentuatedaverage growth.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

38%

40%
35%
30%
25%
20%
15%
10%
5%
0%

Italian industry
total
Manufacturing

23%

Biotech5%

2015

Number of exporting
biotech firms vs.
total biotech firms

Number of biotech firms
exporting biotech
products vs. total
biotech firms

Healthcare

38%

11%

Agriculture and veterinary

53%

13%

Industry and environment

36%

10%

GPET

19%

4%

2016

April 201823

3. The Italian biotech industry in figures

Export: analysis by regional intensity

30% and more
15% - 29.9%
10% - 14.9%
5% - 9.9%< 5%
no export

Geographic distributionof total exports
by biotech firms

Geographic distributionof biotech product exports
by biotech firms• The distribution of biotech exports is strongly polarised around four regionsin Italy (Lombardy, Piedmont, Tuscany and Latium), which represent morethan 90% of the total, even if with variable contributions over time.
• Of note are the significant increase in the percentage relating to Piedmont,

which started at 7.6% in 2014 to reach 18% in 2016 and, in parallel, thedecrease in the percentage relating to Tuscany, which from almost 40%
in 2014 fell to below 25% in 2016, contributing to counterbalance theweight of the overall export of biotech products among the major regions.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®24

April 2018

4. R&D activities

Research is the growthengine of any economic
system• According to a report from the European Commission*– those EU Countries that have invested in innovation, knowledge andgrowth of business skills, could better overcome the crisis;– adequate investments in research and technological innovation arebehind the higher levels of productivity of the leading European
economies.
• This is why Italy too needs to support research, and biotechnology
research in particular.
• 
Not by chance, the European Union has included biotechnologies
among the Key Enabling Technologies, based on their potential impact
and retrain on a broad number of industrial sectors.

*Source: The drivers of Total Factor Productivity in catching-up economies - DG ECFIN 2014

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201825

4. R&D activities

R&D investment
Total firms

Dedicated biotech
R&D firms...

... of which, Italian capital
dedicated biotech R&D firms

Total intra-muros R&D investment

1,579,916

427,248

221,720

Intra-muros biotech R&D investment

506,892

421,165

216,394

Total extra-muros R&D investment

569,069

122,595

78,755Extra-muros biotech R&D investment

257,475

70,44253,644

Total R&D investment

2,148,985

549,843

300,474

Total biotech R&D investment

764,367

491,607

270,039

Values in thousands of euros €/000 - Investments 2016
• Considering total companies, the share of biotech R&D investment
amount to 35% of total R&D investments; this figure rises to 90%
when only considering the Italian capital dedicated biotech R&D firms.
• The amount of biotech R&D expenditure is around 764 million euros, up
22% compared to 2014.
• 34% of the total biotech investments are for financing research activities
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®26

carried out in outsourcing (extra-muros biotech investments), while
67% of the research activities are carried out within the companies(intra-muros biotech investments).
• The dedicated biotech R&D firms invest just over 491 million euros,
using 64% of all the resources invested in biotech by the entire sector.

April 2018

4. R&D activities

R&D investment by field of application
Healthcare

Industry and environment Agriculture and veterinary

GPET

Total firms

Dedicatedbiotech R&D
firms

Total firms

Dedicatedbiotech R&D
firms

Total firms

Dedicatedbiotech R&D
firms

Total firms

Dedicatedbiotech R&D
firms

Total intra-muros
R&D investment

1,321,717

390,875

182,016

24,79349,834

5,533

26,350

6,047

Intra-muros biotech
R&D investment

445,073

386,613

40,391

23,041

11,705

5,519

9,722

5,993

Total extra-muros
R&D investment

486,178

109,294

66,593

12,232

15,453

661

845

409

Extra-muros biotech
R&D investment

253,010

68,817

2,035

900

2,053

547

376

178

Total R&D
Investment

1,807,895

500,169

248,609

37,02565,286

6,194

27,195

6,456

Total biotech
R&D investment

698,083

455,430

42,42723,941

13,759

6,066

10,098

6,171

Values in thousands of euros €/000 - Investments 2016
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201827

4. R&D activities

Sources of financing
Analysis of the financing sources by kind
80%
70%

72%

60%
60%
38%

40%
30%

22%

20%

6%

10%
0%
Selffinancing

Public andprivate capital
grants

Debt

Venturecapital /Private equity

3%
Strategic
alliances

3%0%

Friends & Family Convertible
Financing
debt

0%

0%

0%

IPO

Post IPOPIPE (Private
Investment in
Public Equity)

Total firms: analysis of the financing sources used in 2016 (data obtained from the answers provided to the questionnaire)• Self-financing is always the predominant form of financing for biotech
firms: in 2016, almost three quarters of them (72%) self-financed.
Almost 40% of the firms analysed had access to public or private
grants, and 22% resorted to debt capital.
• The Italian equity market is weak: only 6% of the firms surveyed wereable to access venture capital funds.
• Government funding is still an essential source of funding available
for companies, especially in the early stages of development.
• T he firms do not resort to more sophisticated financing instruments.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®28

The small amount of revenue from strategic alliance agreements indicates the lack of maturity of the Technology Transfer and the valorization systems of Italian research.
• Italian biotech firms have not yet taken advantage of the opportunities offered by the recent introduction of the individual savings plans
known as PIR (Piani individuali di Risparmio), which are financing
instruments that can be useful for introducing liquidity into the firms,
stimulating the development of the stock market: less than 5% of thefirms are interested in a possible stock exchange listing.
April 2018

4. R&D activities

Venture Capital investments• Although biotech is the second largest sector in Italy for the number of investments inhigh-tech firms*, the number of transactions and the total amount of investments are still
too far from those of the main European economies.
• 71% of the biotech transactions detected in Italy involved start-ups, while the remaining
29% represents firms in expansion. The average investment amount is significantly lower
than in other sectors.

Total biotech and medical investments
2 500

350
2,272
300

2 000

1,819

250

Number of firms
receiving investments
Amountof investments

1 500

200
150

1 000

100
500
50
0

444
0
FranceGermany

Italy* Source: AIFI, 2018
Only data relating to AIFI members
were collected

Values in millions of euros € / 000,000
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201829

4. R&D activities

Biotech patent analysis• Italy plays an important role in the international framework thanks to
the quality of its science and scientists focusing on Life Sciences: thebibliometric indices prove that Italy is the first country in the world interms of number of citations and number of publications per researcher*.
Italy also boasts a strong specialisation in the field of rare diseases andorphan drugs and is the first in the world for the number of scientificpublications on the subject**.
• It is useful to combine these data which testify the excellent researchcarried out in Italy with an analysis of Italian biotech patents, which canprovide further information on the innovative activity in this sector.

Triadic biotech patent families by inventor’s countryof residence and first priority date - worldwide percentage
shares
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%

1996 - 1998
1999 - 2001
2002 - 2004
2005 - 20072008 - 20132011 - 2013

United States• The international panorama shows how most of the global biotech
patent shares are concentrated in few macro-geographical areas. Aftera prolonged growing trend in the worldwide share of patents, Europe
has seen a slight decrease over the latter period. A step backwards thathas benefited more the United States than the new emerging countries.
This points out how the competition for the technological leadershipin the biotech sector still involves the United States and Europe as its
main players, hence its relevance for the competitiveness of advanced
countries.
* Source: The European House-Ambrosetti, 2017**Source: Scopus

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®30

European Union (28)

Japan

China

Source: elaboration of OECD Patent Statistics data, April 2018.
Note: To compile patent statistics aimed at reflecting the inventiveness of the local laboratories and labour force of a given
country it is recommended to use the inventor’s country of residence.
Furthermore, «the priority date is the first date of filing of a patent application, anywhere in the world, to protect an invention
and therefore can be considered as the closest to the invention date».
Lastly, in an international comparison, «patent indicators constructed on the basis of information from a single patent officeshow certain weaknesses. The “home advantage” bias is one, since, proportionate to their inventive activity, domestic
applicants tend to file more patents in their home country or region than non-resident applicants. Patent families are a way
of working out patent indicators that are comparable across countries. A patent family comprises all patents or applications
protecting the same invention. A particular type of family is the triadic patent family. According to the OECD definition, a
triadic patent family is a set of patent applications filed at the EPO and at the JPO and granted by the USPTO, sharing one
or more priority applications. The restriction to the USPTO grants instead of applications is due to the non-publication of
applications by the USPTO until 2001, which rendered statistics based entirely on applications impossible. Patents includedin the family are typically of higher value, as patentees only take on the additional costs and delays of extending protection toother countries if they deem it worthwhile». [Cf. the OECD Patent Statistics Manual, 2009].

April 2018

4. R&D activities• In the period considered, the worldwide annual number of new applications for biotech patents sharply decreases after 2002. This decline is largely due to the consequences of the completion of the Human Genome Projectin 2003*, which raised the level of scientific knowledge and triggered a public debate on genetic engineering,leading to a lessening of inventions considered patentable. On the one hand, national and international regulations have been steered in a more restrictive direction; on the other hand, some Patent Offices have considered
many human gene product inventions no longer patentable due to a lack of the novelty requirement.

New biotech patent applications** - index number (2002=100)
Germany
FranceUnited Kingdom
United States
Italy

120
110
100
90

**Data for patent familiesof any size (all inventions),by inventor’s country ofresidence and by firstpriority date.

80
70
60

2015

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

2000

1999

1998

1997

40

1996

50

Source: elaboration of orbit.com data - extraction April 2018

• Within this sectoral trajectory, whilst taking account of the different total number of applications, Italy shows aless negative trend than some of the main players of the biotech sector.
*OECD Biotechnology Statistics, 2009; Mueller H et al. Pharm Pat Anal. 4(5):349-50, 2015

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201831

4. R&D activities
Biotech patent applications filed at the EPO (European Patent Office), byinventor’s country of residence and first priority date - worldwide percentage
shares12%

1996 - 1998
1999 - 2001

10%

2002 - 2004
2005 - 2007

8%2008 - 20132011 - 2013

6%
4%
2%
0%
Germany

FranceUnitedKingdom

Netherlands

Denmark

Spain

Italy

Belgium

Source: elaboration of OECD Patent Statistics data, April 2018.

Focusing on European countries, it is possible to highlight a steady growth in the worldwide percentage shareof Italy’s biotech patent applications filed at the EPO (European Patent Office) up to 2010. This share rises from
1.4% in the three-year period 1996-1998 to 1.7% in the last three-year period for which the data is available,
after peaking over 2% in the three-year period 2008-2010.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®32

April 2018

4. R&D activities
Number of applications for Italian biotech patents*
400

Total Italian biotech patents

350

Biotech patents of italian biotech firms

300• Focusing the analysis on the most recent years, there
is an absolute decline in the number of new Italianbiotech patents broadly in line with international
sectoral trends.
• On average, the share of Italian biotech patents
generated by firms remains constant at around30%, while the remaining 70% is generated by otherplayers including primarily the public and university
research system.

250
200
150
100
50
0
2008

2009

• Among the main patent authorities where Italian biotech patent applications
are filed, the UIBM (Italian Patent and Trademark Office) and the EPO (European
Patent Office) are the most used competent offices, with a growth in the share of
initial filing applications from 36% to 46% for the UIBM, and from 20% to 26%
for the EPO between 2008 and 2016.
• The first filing strategy has certainly been affected by the signing of an agreement between the UIBM and the EPO which calls for the EPO’s drafting of aprior art search accompanied by a written opinion for all patent applications forindustrial inventions filed in Italy from 1st July 2008 which do not claim any priority. Obtaining such an authoritative technical opinion on the patentability of an
invention facilitates, at a lower cost, the decisions on the international extensionof patent protection.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

2010

2011

2012

2013

2014

2015

2016**

Patent authorities where the initial filing applications
were submitted for Italian biotech patents in 2016**
4.58%
6.54%
16.34%

46.41%
UIBM(Italian PTO)
EPO
USPTO

26.14%

OthersPCT* Data for patent families of any size (all inventions), by inventor’s country of residence and by first priority date.
** Provisional data
Source: elaboration of orbit.com data - extraction April 2018

April 201833

4. R&D activities

Number of documents of Italian biotech patentfamilies published in the various
national Offices

This graph, representing the number of documents published in thevarious national Offices, provides information on the main international markets for the Italian actors of the biotech sector, as the national
filings are a good indicator of the markets that need to be protected.
Over two thirds of all the extensions are concentrated in nine patentauthorities and one third of the total are published at the EPO (European Patent Office), the USPTO (United States Patent and Trademarks Office) and the CIPO (Canadian Intellectual Property Office),
confirming the strategic role for the biotech sector of the European
and North American markets.

GREENL(DENM
ALASKA (USA)CANADA

UNITED STATES OF AMERICAMEXICOAZORES(PORTUGALTHE BAHAMAS

CUBA
HAITI
JAMAICA

More than 1000
601 - 1000
301 - 600
101 - 300
1 - 1000più del 20%

DOMINICAN
REPUBLIC

PUERTORICO (USA)SAINT KITTS AND NEVISBELIZEGUATEMALAMONSERRATGUADALOUPEDOMINICAHONDURASV

MARTINIQUE

EL SALVADORSAINT VICENTNICARAGUABARBADOS

TRINIDAD AND TOBAGOSAN JOSE

VENEZUELAPANAMAGUYANASURINAME

COLOMBIAFRENCHGUANAECUADORBRAZILPERU

BOLIVIAPARAGUAY

tra il 10% e il 20%
Source: elaboration of orbit.com data - extraction April 2018

tra il 5% e il 10%

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

tra l’1% e il 5%
April 2018

CHILE
URUGUAY
ARGENTINAFALKLANDISLANDS (UK)34

tra lo 0,5% e l’1%

SOUTH
GEORGIA (U4. R&D activities

LAND
MARK)

SVALBARD(NORWAY)ICELANDFINLANDNORWAYESTONIALATVIA
LITHUIANIADANIMARCA
IRELAND

UNITED NETHERLAND
KINGDOM

BELARUSPOLANDGERMANYBELGIUMSLOVAKIAFRENCH

LIECHTENSTEIN

MOLDOVA

AUSTRIAHUNGARYSWITZERLANDSLOVENIAROMANIA

CROATIABOSNIAAND
HERZEGOBINASERBIASPAIN

BULGARIA
AR

MACEDONIA

ITALY

MEN

ALBANIAIA

AZERBAIJANTURKMENISTANTURKEYGREECE

SYRIA

MALTA
CYPRUSTUNISSIAMADEIRA ISLANDS(PORTUGAL)

NORTH
KOREA

UZBEKISTANMONTENEGROPORTUGAL

MOROCCO

IRAN

IRAQ

LEBANON

CAPE
VERDE

PAKISTANKUWAIT

LIBYA

MALI

NIGER

CHAD

SENEGALGUINEA-BISAUGUINEA

LIBERIA

COTE GHANA
D’IVOIRE

SAUDI
ARABIAERITHEA

SUDAN

QATAR

BANGLADESH
UNITED
ARAB
EMIRATES

INDIA

OMAN

CAMEROONUGANDAKENYA

EQUATORIALGUINEA

GABON
CONGO

DEMOCRATIC
REPUBLIC
OF THE CONGOPHILIPPINES

SRI
LANKA

SOMALIA

MALASIAINDONESIASEYCHELLESCABINDA(PROVINCE)GUAM

VIETNAMCAMBODIAADAM
AND NICOBARISLANDS (INDIA)ETHIOPIACENTRAL
AFRICANREPUBLICBIOKO (EQUATORIALGUINEA)

SAO
TOME

LAOS

THAILANDDJIBOUTINIGERIA

MYANMAR(BURMA)

YEMEN

BENIN

TOGO

SIERRA LEONE

BURKINAFASO

NEPAL
BHUTANEGYPTWESTERN
SHARAHTHE GAMBIAJAPANISRAEL

ALGERIA

MAURITANIA

SOUTH
KOREA

CHINA
KASHMIR

AFGHANISTANJORDANCANARY ISLANDS(SPAIN)MONGOLIAKAZAKHSTANUKRAINECZECHREPUBLICLUXEMBOURG

L)

UK)

RUSSIASWEDENFAROE
ISLANDSTANZANIAPAPUANEWGUINEASOLOMON
ISLANDSCOMOROSANGOLAZAMBIA

MALAWIZIMBAWE

NAMIBIA

MAYOTTE(FRANCE)VANUATU

MOZAMBIQUE

FIJI

MADAGASCAR

MAURITUS
REUNION

BOTSWANANEW CALEDONIA(FRANCE)

AUSTRALIASWAZILAND

SOUTH
AFRICALESOTHOKERGUELENISLAND (FRANCE)HEARD ISLAND(AUSTRALIA)NEW
ZELAND35

5. Healthcare

A snapshot of firms involved in thehealthcare sector
Total firms

Dedicated biotech
R&D firms...

...of which, Italiancapital dedicatedbiotech R&D firms

Number of firms*

295

183

161

Biotech turnover**8,583,049

4,362,434

940,447

Total R&D investment**

1,807,895

500,169

261,506

Total Biotech R&D investment**

698,083

455,429

243,012Biotech employees**

8,513

4,853

3,122

Biotech R&D employees**

2,877

2,369

1,397

Values in thousands of euros €/000• Investments in biotech R&D have increased by 22% and biotech turnover has increased by 10% compared
to 2014.
• The incidence of research investments on turnover, or on operating costs, for the Italian capital dedicated*Last available data, 2017**Last available data, 2016
biotech R&D firms is on average 26%.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®36

April 2018

5. Healthcare

Advances in science drive thetransformation of the healthcare world• Genomics, Big Data, «chemical surgery» to mend genetic material, nanobiotechnologies,
theranostics, machine learning, 3D modelling, smart pills: today biotech firms have newtools for responding to the population’s growing health demand. In this context, today thetherapeutic process benefits from more and more timely diagnoses, therapies designed
for individual patients thanks to precision medicine and therapeutic response monitoring.
Added to this is the remarkable progress in terms of prevention, thanks for example to thepossibility of diagnose diseases on a genotypic basis and the identification of a genetic
predisposition to a disease in presence of certain susceptibility genes.
• At the end of 2017, 295 firms were working on all stages of the therapeutic process in thehealthcare sector, representing the majority of national biotech firms (52%). There are 183
dedicated biotech R&D firms which commit 75% or more of their total research costs tobiotech activities, of which 161 with Italian capital.
• The healthcare sector generates a preponderant share of turnover (74%) against higher
investments (91%) and a higher number of biotech R&D employees (76%).
• The increase in R&D investments recorded in Italy is in line with what is occurring at a global level, where a recovery in investments has been recorded in the pharmaceutical sector.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201837

5. Healthcare

Therapeutics: focus on the Italian pipeline• The data collected from 84 firms with Italian capital*, through firm websites and responses to questionnaires,
about products being developed showed a total of 314 projects, including about 80 in the discovery phase.
• Of the remaining 235, 145 are projects in preclinical development and 90 in clinical development (15% inPhase I, 17% in Phase II and 6% in Phase III).
• Added to these projects are 7 more projects and products that are the result of Italian R&D carried forward byfirms that have become foreign-owned over time (due to acquisitions or moving the firm’s registered office).
• Compared to the previous analysis, 28 products have left the Italian pipeline because the 11 firms they originated from are no longer present in Italy, having ceased their business or having been the subject of acquisitions.

Number of projects
Discovery

79

Preclinical145

Phase I

35

Phase II

40

Phase III

15

Total

314

Product analysis by development phase
6%

62%

17%

Preclinical
Phase I
Phase II
Phase III* Only firms with Italian capital were considered. The number of products should therefore be considered partial
compared to the total biotech products entirely developed in Italy.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

38

15%

April 2018

5. Healthcare

Therapeutic areas of strategic interest• Italian biotech invests in those diseases which still lack adequate
therapeutic solutions, such as those in oncology or autoimmune
diseases, or those of increasing clinical and epidemiological importancesuch as neurological and degenerative diseases, also in relation to thegeneral ageing of the population.
•
Large investments are also directed towards work on infectious

diseases and the development of vaccines.
• It should be noted that, compared to the previous survey of 2016, thearea relating to dermatology has risen three positions, from eighth tofifth, tripling the products in clinical development, and the area relating
to inflammation and autoimmune diseases has gained a position,
reaching fourth place for order of development.

Product analysis by therapeutic area and phase of development
Respiratory diseases
Gastrointestinal
diseases
Metabolic, hepatic andendocrine diseases
Cardiovascular diseases
and haemotology

In recent years Italian research has provided
therapies that have been able to restore
sight, treatments capable of guaranteeing
a new life perspective for “bubble children”(affected by ADA-SCID) and treatments thathave made it possible to intervene whentransplants are rejected. The first therapy
tested on a “butterfly child” suffering fromepidermolysis bullosa is Italian.

Preclinical
Phase I

Musculoskeletal diseases

Phase II

Dermatology

Phase III

Inflammatory andautoimmune diseases
Neurology
Infectious diseases
Oncology
0

20

40

60

80

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

100

120
April 201839

5. Healthcare

The growing share of biopharmaceuticals• For the first time, well over half (56%) of new therapeutic products are concerned with the development of active
principles classified as biopharmaceuticals: monoclonal antibodies, recombinant proteins, vaccines and products
Advanced Therapy Medicinal Products (ATMPs). The projects’ analysis also includes research on new active principles of chemical synthesis – such as small molecules and peptides – developed thanks to biotech methods.
• The number of vaccines has risen from 5% to 11%: it has more than doubled compared to the previous survey of2016. In addition to these, 2 DNA vaccines that actually fall into the category of gene therapies (a cancer vaccine
for B-cell lymphoma and a prophylactic one for Lupus Erythematosus).
• The oncological application of monoclonal antibodies and recombinant proteins is predominant: of all the monoclonal
antibodies being studied (60 products), 47 (78%) have an application in oncology; out of the 45 recombinant proteins
being studied, an impressive 31 (69%) are used for the treatment of tumours. It should be noted that the number ofrecombinant proteins has risen from 9% in the previous survey to 14%.
3%

Product analysis by type
Small molecules
Monoclonal antibodies
Recombinant proteins

3%
Gene therapy
Natural Products

5%6%

PeptidesCell therapy
Regenerative medicine

Vaccines

Other

11%

19%

14%
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

40

23%

3%

14%
April 2018

5. Healthcare

Orphan drugs and Advanced Therapy Medicinal Products• The rare disease and ATMPs sector are among the areas of excellence
the preclinical phase and 8 in clinical trials. To these are added 3 otherof Italian research: on the one hand, Italy’s academic research boasts
products in Phase III, which have been developing as transplant prothe largest number of scientific publications on rare disease, and on theducts according to the Italian transplant legislation, concerning tissues
other hand, out of the six ATMPs currently authorised for the EU market,
for regenerative medicine starting from the donation of amniotic cells,
three are the result of Italian R&D.
dermis and other human tissues. One third of these products are applied• 14 Italian biotech firms have obtained the Orphan Drug Designation
within oncology, followed by the musculoskeletal (19%) and dermatolo(ODD) for 21 products. An impressive 10 of these are dedicated to thegical (17%) areas.
treatment of rare oncological diseases, 4 to rare neurological diseases • The most used technologies in gene therapy include the use of oligonucleotides* (30%) and platforms for the preparation of viral vectors for the corand 4 others to rare dermatological diseases.
rection of genetic defects at the origin of the pathologies in question (13%).
• In the area of ​​ATMPs, there are a total 36 projects, of which 22 inOrphan Drug Designation Number of projects

Cell therapy

Gene therapy Regenerative medicine Total

EMA

8Discovery

1

5

0

6

FDA

2

Preclinical

5

9

8

22

EMA + FDA

11

Phase I

0

4

0

4

Phase II

4

0

0

4

Total

10

18

8

36

Total

21

*All oligonucleotides with a DNA or RNA base are included in the count, while PNA-basedoligonucleotides (peptidonucleic acid) are excluded, even if they are used for similar
purposes, as they are considered within the category of peptides based on their chemicalphysical characteristics.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201841

5. Healthcare

Diagnostics• With the advent of molecular diagnostics, including the set of molecular biology techniques for the analysis of
nucleic acids, proteins and metabolites, new identification, quantification and predictive methods have beendeveloped that identify and analyse the disease and its causes in an accurate, rapid and timely manner.
• Molecular diagnostics makes it possible to maintain the highest-quality care levels thanks to tools that not only
allow the correlation of a diagnosis with therapeutic schemes reflecting the patient’s characteristics, but also tomonitor its effectiveness in a constant manner. An advantage for the patient, therefore, but also for the entire
economic system, thanks to the optimisation of the use of resources and the rationalisation of public health costs.
• There are 189 Italian firms active in this sector with at least one research project, i.e. 64% of those in the entire
healthcare biotech sector. Of these, the vast majority is micro-sized (64%), located in Lombardy and focusedon projects relating to cancer.
• The need to monitor the progression of diseases by means of a method with good sensitivity, high reproducibility and low invasiveness has led to the recent development of so-called “liquid biopsy” that make it possible
to study circulating tumour DNA (ctDNA) through a simple blood sample. Liquid biopsy is the frontier of in-vitro
diagnostic research: they can be used to analyse a spectrum of mutations associated with cancer – biomarkers–, which are useful for diagnosis and the development of personalised therapies, but also for the segmentationof the population eligible for a given treatment or for monitoring relapses. The information acquired thanks to
ctDNA analysis made it possible to create the first cancer drug in the United States to treat tumours identified
by biomarkers and not by their localisation. Moreover, the drug’s approval is associated with the approval of its
relative companion diagnostic for this indication. Precisely because of their importance not only from a medical
point of view, but also for the optimisation of public health spending, regulatory bodies are streamlining theauthorisation procedures for oncological profiling tests, for example for the early detection of the type of drug
to use according to the specific mutation present in the patient.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

42

April 2018

6. Agriculture and veterinary

A snapshot of the firms in the agriculture
and veterinary sector
Total firms

Dedicated biotech R&D
firms...

...of which, Italian capital
dedicated biotech R&D firms

Number of firms*

50

24

24

Biotech turnover**892,552

33,31633,316

Total R&D investment**

65,286

6,194

6,194

Total Biotech R&D investment**

13,759

6,066

6,066

Biotech employees**

1,134

141

141

Biotech R&D employees**

180

99

99

Values in thousands of euros €/000• The sector’s turnover is close to 900 million euros.
• 36% of the total firms are not only involved in agriculture, but also inveterinary medicine and the improvement of animal production, while
the remaining 64% are focused on agriculture and the development of
products to improve yields.

• All the dedicated biotech R&D firms have Italian capital. This explains
the recorded increase of more than 50% (exactly 53%) of the investments in biotech R&D compared to the previous survey.
• The incidence of research investments on turnover, or on operating costs,
for the Italian capital dedicated biotech R&D firms is on average 18%.
*Last available data, 2017

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec ®

**Last available data, 2016

April 201843

6. Agriculture and veterinaryAgri-food chain, the challenge of innovation
based on sustainability• The panorama of firms operating in the agriculture and veterinary sector
in Italy is quite diversified; it is difficult to identify a decidedly prevalent
activity in the 50 firms surveyed, which are all however characterised byconsiderable research and development. 80% of them can be classified
as small or micro-firms.
• The types of activities these firms focus on can be summarised asfollows:
– Molecular diagnostics and characterisation
– Research and development using molecular biology techniques,
mainly as a service activity
– Production of biological plant protection products, biostimulants andbiofertilisers– Experimentation of plant varieties and biomaterials in the field
– Genetic improvement (breeding) of plant varieties
– Advanced veterinary therapies• These firms’ shared mission lies in the use of more or less advanced
molecular biology techniques for the progress and innovation of sustainable agriculture, with particular attention to the needs of Italian
agriculture, although some firms are actually the Italian branches oflarge international groups.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®44• 2017 saw a significant new perspective for the Italian public research,which is engaging in a vast and well-focused research and development
plan based on the most advanced biotechnologies applied to plant
breeding innovation. This plan represents a turning point which all the
research can start from, especially in agricultural genetics and varietal
improvement. It is placed in a context of innovation which integrates
the progress of life sciences with the parallel perspective that precision
farming can offer.
• Support for research on genetic editing can also offer an important
contribution to preserve the typical plant varieties of the Italian agriculturalenvironment and to study their genomes in detail. Italian research alreadyexcels in this context: the results obtained thus far are a valid premise for
exploiting the most of what the frontiers of new genetics promise.
• The cooperation between the scientific and political-decisional levelthat has recently emerged in Italy can be the right tool for facing thechallenges of the future with effective interventions and solutions for
agriculture which are simultaneously sustainable and productive. This
opening not only leads Italian agriculture to expect increased operational
capacity as regards the most advanced research, but also a concrete
economic impact on the entire agri-food sector.

April 2018

7. Industry and environment

A snapshot of firms involved in the industrial
and environmental sector
Total firms

Dedicated biotech
R&D firms...

...of which Italian capital
dedicated biotech R&D firms

Number of firms*

161

76

73

Biotech turnover**1,988,943

151,009

115,538

Total R&D investment**

248,609

37,025

26,419Total Biotech R&D investment**

42,42723,941

14,890

Biotech employees**

2,640

605

556

Biotech R&D employees**

489

254

222

Values in thousands of euros €/000• The sector’s turnover is close to 2 billion euros, registering 16% growth
for the Italian capital dedicated biotech R&D firms.
• Investments in biotech R&D are about a fifth of total R&D investments,
with an increase of 44% compared to the previous two-year period.
• The incidence of research investments on turnover, or on operating costs,
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®for the Italian capital dedicated biotech R&D firms is on average 13%.
• Among the Italian capital firms, about 52% of the biotech turnoveris totalized by the sector dedicated to industry and environment,
highlighting it as one of the Italian biotech industry’s competitive
strengths.
* Last available data, 2017 ** Last available data, 2016
April 201845

7. Industry and environment

Industrial biotechnologies, growthengine for sustainable development• Industrial biotechnology use cells – yeasts, moulds, bacteria, plants – and enzymes togive life to bio-based products such as bioplastics, biological building materials, organic
pharmaceuticals, cosmetic products and biofuels, to name only a few. The conscious andconsolidated use of the wealth nature offers by an industry capable of transforming natural
products and processes into solutions for the market is not a novelty. It suffices to mention
that the first enzyme specially designed for the detergent industry was placed on the market as early as 1988.
• Thanks to industrial biotech, today it is possible to have products with high added value andgreater efficiency in terms of cost and environmental sustainability; they are often easily
biodegradable solutions which require less consumption of water and fossil fuels and create
less waste during their production cycle. The fields of application of industrial biotech are
numerous: from biotransformations through enzymatic catalysis for the redevelopment oftraditional industrial processes, to the preparation of chemical compounds by fermentation;from the production of bioplastics to bioremediation and environmental diagnostics, frombioenergy production to the restoration and conservation of artistic heritage, up to thedesign of new fabrics for the clothing industry.
• The application of these techniques can make it possible to innovate mature sectors suchas those of raw materials, energy production and intermediates while adhering to the principles of environmental, economic and social sustainability that are typical of bioeconomy.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

46

April 2018

8. The bioeconomy

Production of goods and energy
from renewable natural resources

The integrated ecosystemof the Italian bioeconomy

Sustainableagriculture
and forestry
sectorSustainable andcompetitive agri-foodsector, for a healthyand safe diet

EU Level

Living water
resources andmarine bioeconomy

Biobasedindustries

Regional Level• The bioeconomy, of which industrial biotechnologies are the real engine, is an economy thatuses biological resources from both the land and the sea as input for energy, industrial, foodand feed production. The definition of bioeconomy includes the sectors of agriculture, food,fishing, forestry, the wood and paper industry and that of bio-based industries.
• For example, the biowaste from the agri-food industry contains a high potential in itself, tothe point that the European Union has set itself the goal of deriving the production of 2% ofrenewable energy from this source.

National Level

INDUSTRYCIVIL SOCIETYRESEARCH

INSTITUTIONS• The topic of reusing waste and by-products is central to the industrial sectors that traditionally use biological resources as their main source of supply (forest, starch, sugar, biofuels/
bioenergy, biotechnology sectors) and in others for which biomass is among the raw materials used (chemical, plastics and consumer goods).

ITALIAN BIOECONOMY STRATEGY
Integration between sectors, systems, actors and institutions
Source: National bioeconomy strategy.
BIT - Bioeconomy in Italy. A unique opportunity for reconnecting the environment,
economy and society, 2017.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201847

8. The bioeconomy

Italy towards a leading rolein the Euro-Mediterranean scenario• Italy boasts some of the world’s leading industrial players operating in the context of thebioeconomy, but also first-level research with real academic excellence as well as a highly
innovative biotech start-up and SME system.
• The first biorefineries in the world for the production of biobased chemicals are Italian, whichhave allowed the industrial revamping of abandoned production facilities and the creationof new jobs.
• The Italian bioeconomy model is based on the development of local areas, in a logic of territorial regeneration. There is a system of national technological clusters supporting this modelwith three active entities: SPRING – Italian Cluster of Green Chemistry; CL.AN. – National
Technology Agrifood Cluster, and BIG – Blue Italian Growth Cluster (marine and maritime
sector). These three entities act as resource catalysts to coordinate and strengthen the link
between the research world and the business world.
• Italy is decisively aiming at a leading role in the Euro-Mediterranean bioeconomy scenario
with a very challenging objective, as indicated in the National bioeconomy strategy: passing
from 251 billion euros in turnover and 1.7 million employees – as estimated in an analysis
by the Intesa Sanpaolo Research Department in reference to 2014 – to 300 billion euros andover 2 million employed by 2030.
• According to estimates by Intesa Sanpaolo-Assobiotec, bioeconomy in Italy produced a value
equal to 260 billion euros of production in 2016, corresponding to 8.3% of the total national
economy experiencing moderate growth.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

48

April 2018

8. The bioeconomy

The National bioeconomy strategy
presented in April 2017
• In April 2017 the National bioeconomy strategy was presented thanks to the teamwork
involving many subjects1: it is part of the implementation process of the National Smart
Specialisation Strategy (National S3) to ensure the reconciliation of economic growth withenvironmental sustainability.
• The strategy emphasises the importance of research and innovation to increase productivity, product quality and sustainability in every sector that makes up the bioeconomy.
• The interconnection of the various sectors is necessary in order to encourage the development of this meta-sector, in particular between those in the agri-food chain and thechemical and energetic valorisation of lignocellulosic and residual biomasses. In Italy there
are three million hectares of land which are no longer cultivated: vast agricultural areasthat can be regenerated today to produce indigenous and/or industrial biomass to feed
Italy’s biorefineries; there are 15 million tons/year of by-products and waste from the foodindustry, a rich availability of woody biomass guaranteed by over 13 million hectares offorest, which is generally used very little; non-food biomass (algal and posidonia but also
microorganisms) generated by the country’s seas that can be enhanced from a chemicaland energy perspective.
• As explained by the Bioeconomy Investment Summit held in Helsinki in December 2017, amajor boost in civil society awareness, education and training is envisaged: it is not merely
a question of integrating biological knowledge into traditional industry, as the transition also
takes place at the social level.

“The strategy aims to offera shared vision of economic,
social and environmental
opportunities and challenges
related to the implementationof an Italian bioeconomy rooted
in the territory. It is also an
important opportunity for Italy tostrengthen its role in promoting
sustainable growth in Europe
and the Mediterranean basin”.2

1. M inistry of Economic Development, Ministry of Agriculture, Food and Forestry Policies, Ministry of Education, University and Research, Ministry of the Environment andProtection of Land and Sea, Conference of Regions and Autonomous Provinces, Agency for Territorial Cohesion, National Technological Clusters SPRING and CL.AN.
2. BIT - Bioeconomy in Italy. A unique opportunity for reconnecting the environment, economy and society, 2017.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201849

8. The bioeconomy

Bioeconomy in Italy
Production value in 2016, net of the water cycle
Italy

Millions of euros

Agriculture, forestry and fishing
Food, beverages, tobacco industry
Textiles from natural fibres and tanning
Timber industry
Paper industry
Biobased chemicals
Biobased pharmaceutical products
Biofuels
BioenergyManagement and recovery of biodegradable waste

56,003
132,801
17,153
13,15623,098
3,037
5,107
350
2,237
7,366

Bioeconomy Total

260,308

Bioeconomy weight on the total economy

Values ​​expressed in millions of euros €/000,000

8.3 %Source: Intesa Sanpaolo elaboration of various sources

Bioeconomy is a complex concept that includes a multiplicity of sectors whose common basis is the renewable
and biological origin of their inputs, but which can follow different underlying development dynamics conditionedby the peculiarities of each specialisation.
In terms of production, the Bioeconomy in Italy is worth 260 billion euros, corresponding to 8.3% of the national
total experiencing moderate growth.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®50

April 2018

8. The bioeconomy

Bioeconomy in Europe in 2016
The European Bioeconomy in 2016, net of the water cycle
350
260.3

250
163.2

288.7

Contribution to the total good
production (%)

Contribution to the total
economy (%)

330.7

300

200

Weight of the bioeconomy on the economy, 2016 (% values)

40

34.1

30

183.1

29.0

26.3
20.8

20

150
100

16.8

10

50

4.0

0

5.9

7.5

Germany

France

8.3

8.8

Italy

Spain

0
United Kingdom

Spain

Italy

FranceGermany

United Kingdom

Values in billions of euros €/000,000,000

Note: The data relating to the % weight on the total production of goods is calculated using the bioeconomy value net of
the waste component.

Source: Intesa Sanpaolo elaboration on Eurostat data

Source: Intesa Sanpaolo elaboration of Eurostat Data

Germany stands out in absolute terms for production value, even if the weight that the bioeconomy has on the
total German economy is less than that observed in other countries (5.9%). In relative terms, the weight thatthe bioeconomy has on the Spanish economy stands out most, equal to 8.8% (29% only on the production of
goods) despite an absolute value of 183.1 billion euros. With its production value of 260 billion euros , Italy is inthird place after Germany and France; instead by bioeconomy weight on the total economy of 8.3%, it is second
after Spain.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201851

8. The bioeconomy

Composition of bioeconomy in Europe
Value of the production in 2016 by sector
United Kingdom**

Spain

Italy

FranceGermany

Agriculture, forestry and fishing*
Food, beverages, tobacco industry
Textiles from natural fibres and tanning
Timber industry
Paper industry
Biobased chemicals
Biobased pharmaceutical products
Biofuels
BioenergyManagement and recovery of biodegradable waste

23.8%
54.4%
0.7%
6.1%
8.2%
1.3%
1.1%
0.0%
1.2%
3.3%

28.2%
56.4%
1.2%
3.2%
6.4%
1.4%
1.4%
0.2%
0.2%
1.4%

21.5%
51.0%
6.6%
5.1%
8.9%
1.2%
2.0%
0.1%
0.9%
2.8%

28.8%
55.2%
0.6%
3.8%
5.7%
1.2%
2.5%
0.0%
0.3%
1.9%

15.5%
55.5%
0.7%
7.3%
11.1%
2.0%
2.7%
0.4%
1.3%
3.5%

Bioeconomy

100.0%

100.0%

100.0%

100.0%

100.0%

Total Bioeconomy (millions of euros)

163,193

183,107260,308

288,685

330,673

Bioeconomy weight on the total

4.0%

8.8%

8.3%

7.5%

5.9%

Water cycle (millions of euros)

19,1398,250

10,026

13,961

21,728

Total Bioeconomy and Water Cycle

182,332

191,357

270,334

302,646

352,401

Bioeconomy and water cycle weight on total economy

4.5%

9.2%

8.6%

7.8%

6.3%

Values in million of euros €/000,000 - Source: Intesa Sanpaolo elaboration on Eurostat data
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®52* Source: National Accounts**year 2015

April 2018

9. Supporting innovation

The results of public support for
R&D activities• In 2016, around 50% of firms benefited from at least one form of public support for their
R&D activities, 51% of which came from local administrations.

Share of beneficiary firms by type of contribution
Regional and local government
administration

21%

Central government administration

17%

European Union and othersupranational administration
Other

Share of beneficiary firms by type of tax measure
R&D tax credit

28%

IP Box5%

IRES deductions

4%

24%

Super-amortisation

19%

2%

Other

7%

• With regard to tax benefits, the R&D tax credit measure remains the most important tax
benefit for companies. To date, more than a quarter of the firms in the biotech sector havealready taken advantage of the measure, and this number is growing over time. The need tostabilise this measure in the near future by making it permanent is therefore quite clear.
• The recourse to super-amortisation and other measures has doubled, which mainly include
the reductions related to hiring highly qualified personnel.
ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®April 201853

9. Supporting innovation

A look at what has been donein recent years
Numerous steps have been taken forward in recent years: policymakers are generally paying
increasing attention to the sector; the ambition to put Research and Innovation at the centre
of a strategic vision is spreading out.
Various aids have been fundamental in this path: the recognition of the status of innovative
start-ups and innovative SMEs, the adoption of a preferential taxation regime on income from
intellectual property (Patent Box), initiatives for the financing of new firms in Life Sciences,tax credit mechanism on R&D costs and investments and the introduction of the individual
savings plans, known as PIR (Piani Individuali di Risparmio). These important measures thenled to the adoption of the National Plan «Impresa 4.0» in 2017, with which all the effective
measures were upgraded and addressed in a 4.0 logic and new measures were envisaged inorder to fully respond to the emerging needs.
Within this scenario, the following measures must also not be forgotten: the National Research Plan, the Smart Specialisation Strategy, the presentation of the National Bioeconomy
Strategy in April 2017 and the resources allocated to a three-year plan to relaunch genetic
improvement in agriculture.
An indication of this virtuous path is Italy’s ranking in second place for the rate of adoption ofentrepreneurship incentive measures, according to the European Digital Forum Crowdsourcing
Network, 2016.

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®54April 2018

10. Italian Biotech Companies• 3 C.I. srl• 4F Biotech srl• 4Lab Diagnostics srl• A&A Fratelli Parodi spa• A. Costantino & C. spa• AAT Advanced Analytical
Technologies srl• AB Analitica srl• Abbvie srl• Abich srl• Abiel srl• Aboca spa• Accelera srl• Acqua & Sole srl• Acque del Chiampo spa• ACS Dobfar spa• Active Cells srl• Actygea srl• Aczon srl• Adienne srl• Advanced Accelerator
Applications Italy srl• Advanced Molecular andBiological Computation AMBC srl• Advent srl• AEP Polymers srl• Aethia srl• Agri New Tech srl• Agrifutur srl• Agritest srl• Agroalimentare Sud spa• Agrobiotech soc. coop.
• Agroils Technologies spa• Agrolabo spa• Alexion Pharma Italy srl• Alfasigma spa• Alga&Zyme Factory srl• Algain Energy srl• AlgaRes srl• Allergan spa• Allergopharma spa• Alltox srl• Alphagenics Biotech srl• Also Biotech srl• Altergon Italia srl• Ambiotec sas• Ambrosialab srl• Amgen srl• Amiko srl• Anallergo srl• Ananas Nanotech srl• Angelini ACRAF spa• Anika Therapeutics srl• Apotech Peptidi & Cosmesi srl• Apta Regenerative Technologies
ART srl• Aptenia srl• Aptuit srl• Apulia Biotech scrl
• Archimede R&D srl• Ardis srl• Areta International srl• Arterra Bioscience srl• Asoltech srl• Astrazeneca spa• Autifony srl• Avantea srl• Axxam spa

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®• BASF Italia srl• Baxalta Italy srl• Baxter spa• Bayer Cropscience srl• Bayer spa• BBA Biotech srl• Be Biotech srl• Bio Fab Research srl• Bio Soil Expert srl• Bio Tools srl• Bioaesis srl• Bioagro srl• Biobanca Biogem srl• Biocell Center spa• Biochemtex spa• Bict srl• Biodermol Ambiente srl• Biodiagene srl• Biodiversa srl• Bioecopest srl• BIOerg srl• Biofarmitalia spa• Biofer spa• Biofordrug srl• Biogas Italia BTS srl• Biogen Italia srl• Biogenera spa• Bio-Ker srl• Biological Tools for
Mediterranean Agricolture
BTM srl• Bioman srl• Biomedical Research srl• Biomedical Tissues srl• Biomerieux Italia spa• Biomolecular Research
Genomics srl• Bionat Italia srl• Bio-on srl• Biopharma srl• Bioplantec srl• Biopolife srl• BioPox srl• Biorep srl• Bioridis srl• Biorigen srl• Bioscience Genomics srl• Biosearch Ambiente srl• Biosearch srl• Biosensing Technologies srl• Biosensor srl• Bioside srl• Biosphere srl• Biosynth srl• Biotec Fermenti srl• Biotec Sys BTS srl• Biotecgen srl• Bioteck srl• Biotecnologie BT srl• Biotecnologie Innovative per
Ricerca e Diagnostica - BIRD srl• Biotecnomed scarl• BioTekNet scpa
• Biouniversa srl• Biovalene srl• Bio-Ve-Oil Olimpo srl• Blast Research srl• Boehringer Ingelheim Italia spa• Bracco Imaging spa• Braindtech srl• BRD Lab srls
• Bristol-Myers Squibb srl• BSA Ambiente srl• BSL Cosmetics srl• BSP Pharmaceuticals srl• Byflow srl• C. Sandroni & C. srl• C4T scarl• C5-6 Italy srl• Cage Chemicals srl• Campus Regi Biologia
CAREBIOS srl• Capua Bioservices spa• Caresilk srls
• CCS Aosta srl• Ceinge Biotecnologie Avanzate
scrl• Celgene srl• CellDynamics srl• Cellply srl• Centro Ricerche Applicate ARC srl• Centro Sperimentale del Latte srl• Cereal Docks spa• Charybdis Vaccines srl• Chemi spa• Chemical Center srl• Chemicare srl• Chiesi Farmaceutici spa• Chrono Benessere srl• Clonit srl• Clover Therapeutics srl• Colorobbia Italia spa
April 201855

10. Italian Biotech Companies• Congenia srl• Consorzio Interdisciplinaredi Studi Biomolecolari ed
Applicazioni Industriali scrl
• Consorzio Interuniversitario di
Ricerca in Chimica dei Metalli
nei Sistemi Biologici• Consorzio Italiano Biogas e
Gassificazione• Consorzio per il Centro di
Biomedicina Molecolare scrl
• Controllo Genetico Piante/Cibi
COGEP srl• Cooperativa di Ricerca e Studi
per la Pesca l’Acquacoltura el’Ambiente CYPRAEA• Cooperativa Produttori Bieticoli
COPROB sca• Corion Biotech srl• CPC Biotech srl• Crabion srl• CRC Biotek srl• Croda Italiana spa• Crucell Italy srl• CryoLab srl• Cutech srl• Cyanagen srl• Daimar srl• Dalton Biotecnologie srl• Danone spa• Demethra Biotech srl• Detoxizymes srl• Dia-Chem srl• Diadem srl• Diagnostic Bioprobes Dia.Pro srl• Diamante srl• DiaSorin spa• Diatech Pharmacogenetics srl• Diatech srl• Diatheva srl• Dicofarm spa• Diesse Diagnostica Senese spa• Dival Toscana srl• DNA Analytica srl• Dompe’ Farmaceutici spa• Dott. Dino Paladin - CRS• Dow Agrosciences Italia srl• Dow Italia spa• Ebios Futura srl• Ecobioservices and Researches srl• Eco-Sistemi srl• Ecotechsystems srl• Edgelab srl• Eggplant srl• Elettra - Sincrotrone Trieste scpa
• Eli Lilly Italia spa• Elitechgroup spa• Eltek spa• Enbiotech srl• Engenome srl• ENI spa
• Enrico Giotti spa• Enthera srl• Ephood srl• Ephoran Multi Imaging Solutions
srl• Epi C srl• Epigen Therapeutics srl

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

56• Epinova Biotech srl• Epitech Group spa• Eridania Italia spa• Erydel spa• Espikem srl• Etna Biotech srl• Eudendron srl• Eugenomics srl• Euroclone spa• Eurocoating spa• Eurofins Genoma Group srl• Eurospital spa• Eurovix spa• Euticals spa• Ever srl• Evolution Technology
Laboratories srl• Evvivax srl• Exenia Group srl• Exosomics Siena spa• Experteam srl• Explora srl• Exprivia spa• Fabbrica Italiana Sintetici FIS spa• Farma ID srl• Fastest srl• Fastissues srl• Fatro spa• Fem2 - Ambiente srl• Ferrania Technologies spa• Ferring spa• Fertirev srl• Fic Htmd srl• Fides Pharma srl• Fidia Farmaceutici spa• Fin-Ceramica Faenza spa• Flora Conservation Società
Semplice Agricola• Flowmetric Europe srl• Fly Life srl• Fotosintetica & Microbiologica srl• Franvax srl• Fresenius Medical Care Italia spa• G&Life spa• Galascreen srl• Galatea Bio Tech srl• Galileo Research srl• Geltis srl• Genechron srl• Genedia srl• Genefast srl• Genenta Science srl• Generon srl• Genesis Bioscience srl• Genespin srl• Geneticlab srl• Genomix4Life srl• Genomnia srl• Genovax srl• Genprobio srl• Gentium spa• Gentoxchem srl• Gentras snc• Gexnano srl• GFBiochemicals Italy spa• Gilead Sciences srl• Giotto Biotech srl• Glaxosmithkline spa• Glaxosmithkline Vaccines srl• Glures srl• Gnosis Bioresearch srl• Gnosis spa• Graphene Nanotechnologies
Hub srl• Green Service srl• Greenbone Ortho srl• Greentech srl• Gruppo Ricerche Avanzate Per
l’Enologia GRAPE srl• GSK Vaccines Institute for Global
Health srl• Hera spa• HMGBiotech srl• Holostem srl• Hospira Italia srl• HPF Nutraceutics srl• Hygeia Lab srl• IGA Technology Services srl• Immagina Biotechnology srl• ImmunePharma srl• Immures srl• In3Diagnostic srl• In4Tech srl• Inbios srl• Incyte Biosciences Italy srl• Indena spa• Industria Meridionale Alcolici srl• Industriale Chimica srl• Inkidia srl• Innoven srl• Integrated Systems EngineeringsrlApril 2018

10. Italian Biotech Companies• Intercept Italia srl• IOM Ricerca srl• Ion Source & Biotechnologies
ISB - srl
• Ipsen spa• IRBM Science Park spa• Isagro spa• Istituto Biochimico Italiano
Giovanni Lorenzini spa• Istituto di Ricerche Biomediche
Antoine Marxer RBM spa• Istituto Ricerche Applicate IRA srl• iSweetch srl• Italfarmaco spa• Italia Biogenomic Technology
BGT srl• Italian Bio Products IBP spa• Izo srl
• Janssen Cilag spa• Kayser Italia srl• Kedrion spa• Kemira Italy spa• Kemotech srl• Kialab srl• Kither Biotech srl• Kos Genetic srl• Kron Morelli srl• Kronosdna srl• Ktedogen srl• Labor srl• Laboratori Biomicron srl• Laboratori Turval Italia srl• Laboratorio Analisi Veterinarie
LAV srl• Laboratorio Di Micro E Submicro
Tecnologie Abilitanti Dell’Emilia
Romagna - Mist E-R scrl
• Lamberti spa• Lati Industria Termoplastici spa• Lay Line Genomics spa• Lazzeri Società Agricola a r.l.
• LB Lyopharm - Laboratorio
Biontologia srl• Lead Discovery Siena srl• LEBSC srl• Lesaffre Italia spa• Lgv1 srl• Lifegene sas• LifeLineLab srl• Liosintex srl• Lipinutragen srl• Lofarma spa• Lundbeck Pharmaceuticals
Italy spa
• Magis Lab srl• Mater Biotech spa• Materias srl• Matrica spa• Mavi Sud srl• Mediapharma srl• Medical Research Institute
MRITLab srl• Mediteknology srl• Mediterranea Biotecnologie srl• Menarini Biotech srl• Menarini Ricerche spa• Menarini Silicon Biosystem spa• Merck Serono spa

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

• Merial Italia spa• Meristema srl societa’ agricola• Metagenics Italia srl• Micro Biological Survey MBS srl• Micro4you srl• Microbiol snc• Microbion srl• Microbiotec srl• Microgem srl• Microgenomics srl• Micromilk srl• Micron Research Service srl• Microspore spa• Microtech srl• Mindseeds Laboratories srl• ML Biotech Italia srl• Mogu srl• Molecular Biotechnology srl• Molipharma srl• Molirom srl• Molmed - Molecular Medicine
spa• Molteni Therapeutics srl• Monsanto Agricoltura Italia spa• Monteresearch srl• MSD Italia srl• MSD Vaccines spa• Mybatec srl• Naicons srl• Nanofaber srl• Nanomed3d srl• Nanoshare srl• Nanosilical Devices srl• Nanovector srl• Natimab Therapeutics srl• Natural Technologies Italia srl• Navhetec srl• Naxospharma srl• NCR Biochemical spa• Nealys srl• Need Pharma srl• Neotron spa• Nerviano Medical Sciences srl• Neuheart srl• Neuro Visual Science Technology
srl• Neuro-Zone srl• Newron Pharmaceuticals spa• Newronika srl• Next Genomics srl• Nextage srl• Nextgen srl• NGB Genetics srl• Nib Biotech srl• Nice srl• Nicox Research Institute srl• No Self srl• Nobil Bio Ricerche srl• Norgine Italia srl• Nouscom srl• Novaetech srl• Novagenit srl• Novaicos srls
• Novamont spa• Novartis Farma spa• Novo Nordisk spa• Noxamet srl• Nurex srl• Nutraceutica srl• Nutrigene srl• NuvoVec srl• Olon spa• Oncoxx Biotech srl• Ophera srl• Orphan Europe Italy srl• Oxi.Gen Lab srl• Pentares Biopharma srl• Personal Genomics srl• Petropark srl• Pfizer Italia srl• Pharma Life srl• Pharmadiagen srl• Philogen spa• Phytoremedial srl• PinCell srl• Pioneer Hi-Bred Italia Servizi
Agronomici srl• Plasfer srls
• Plasmore srl• Pomona Ricerca srl• Prigen srl• Primm srl• Prindex srl• Probiotic CGB srl• Probiotical spa• Proge Farm srl• Promis Biotech srl• Proteotech srl• Proxenia srl• ProXentia srl• Ptc Therapeutics Italy srl• Raresplice srl
April 201857

10. Italian Biotech Companies• Recordati Industria Chimica e
Farmaceutica spa• Reithera srl• Remembrane srl• Repros srl• Research & Innovation srl• Research Toxicology Centre spa• Resindion srl• Ricerche Sperimentali Montale srl• Rigenerand srl• Roche spa• Roelmi HPC srl• Roquette Italia spa• Rottapharm Biotech spa• Sacace Biotecnologies srl• Sacchetto spa• Sacco srl• SAFAN Bioinformatics sas• Safood srl• Salentec srl• Sandoz Industrial Products spa• Sanofi spa• Sclavo Diagnostics International srl• Sea Marconi Technologies sas• Sedicidodici srl• Seno Seed srls
• Sentinel CH spa• Serge Genomics srl• SetLance srl• Shire Italia spa• Shoreline Societa’ Cooperativa• Sienna Biopharmaceuticals srl• Sigea srl• Silk Biomaterials srl• S-in Soluzioni Informatiche Srl• Sirius-Biotech srl• Smile Biotech srl• Società Industria Farmaceutica
Italiana SIFI spa• Società Italiana Sementi spa• Società Metropolitana Acque
Torino spa• Società Prodotti Antibiotici spa• Società Produttori Sementi spa• Sooft Italia spa• Spaceland Italia srl• Spike Renewables srl• Stallergenes Italia srl• Stemgen spa• STMicroelectronics srl• Synbiotec srl• Syngenta Italia spa• Syntech srl• Takeda Italia spa• Takis srl• Technogenetics srl• Tecna srl• Tecnobios Procreazione srl• Tectronik srl• Telea Biotech srl• Tensive srl• Teracell srl• Tes Pharma srl• Tethis spa• Thankstem srl• Tib Molbiol srl• Tissue and Organ Replacements
TOR srl

ENEA - Industry and Business Association Unit • Centro Studi Assobiotec®

58• Tissuegraft srl• Tissuelab spa• Toma Advanced Biomedical
Assays spa• Transactiva srl• Trustech srl• Tydock Pharma srl• UB-Care srl• UCB Pharma spa• Ufpeptides srl• Ulisse Biomed srl• UNECO Srl• Unilab sas• Unistrains srl• University of Pittsburgh Medical
Center Italy srl• Ustem srl• Valagro spa• Vaxxit srl• Vaxynethic srl• Veneziana Energia Risorse
Idriche Territorio Ambiente
Servizi - VERITAS spa• Vera Salus Ricerca srl• Versalis spa• Vetogene srl• Vetspin srl• Vevy Europe spa• Villani spa• Virostatics srl• Vismederi Research srl• Vismederi srl• Vitroscreen srl• VivaBioCell spa• Wellmicro srl• Wetware Concepts srl• Xeda Italia srl• Xeptagen spa• Yenetics srl• Ylichron srl• Zoetis Manufacturing Italia srl

Companies tracked by internet analysis

April 2018

credits
Assobiotec - Federchimica
Rita Fucci
Elisabetta Molteni
Leonardo Vingiani
ENEA
Gaetano Coletta
Oscar Amerighi
Daniela Palma
Marco Casagni

Graphic design and creation: Studio ABC Zone (MI)Photo: Shutterstock
Printed by: La Compagnia della Stampa Srl

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