The Italian Biotech Industry Facts & Figures. Centro Studi Assobiotec

Transcription

1 The Italian Biotech Industry Facts & Figures

2 Index Introduction Glossary The Italian biotech industry in figures Red biotech Green biotech White biotech The Bioeconomy Supporting innovation Appendix

3 Introduction This document aims to present the key facts and data of the Italian biotech industry, based on their direct assessment by the Assobiotec research department. We specifically focused our analysis on Italian pure biotech companies, as the many start-ups and innovative SMEs that, thanks to the recognized excellence of our academic and industrial scientists and the determination of our entrepreneurs, show the capability to develop the results of basic research into innovative products and technologies, creating shareholder value and qualified job opportunities. Any deviations from the figures relating to the previous years are only due to the reconsideration of the analysis criteria of the data we were able to collect from the questionnaires administered to the companies, from their balance sheets or corporate websites, as well as from a number of interviews to their management. The subsequent reclassification of the comparison sample also allowed us to exclude from the survey those companies that, although formally still active, have actually suspended their research activities for the time being. At this regard, we also highlighted a number of measures to support research, recently adopted by the Italian government. A true change of perspective for the entire national entrepreneurial system that, by making of innovation the key driver of competitiveness, will create the conditions for the Italian biotech industry too, to participate in the bringing about of Bioeconomy as a new model of sustainable growth. The potential of Bioeconomy as well as its current contribution to the Italian growth, in terms of new business and employment opportunities, fully reflect in the Intesa Sanpaolo data, which are also herewith recalled. 3

4 Glossary Red Biotech companies Companies operating in the human health care sector, by using modern biotechnological methods for the development of products for the treatment and prevention of diseases (drugs, new therapeutic approaches, vaccines, diagnostics). Green Biotech companies Companies operating in the agrifood sector, by using modern biotechnological methods for the development of veterinary products, for the production of transgenic plants with applications in the food, chemical, manufacturing and molecular pharming fields, as well as for the development of tests for the detection of ingredients or contaminants in food. White Biotech companies Companies operating in the field of industrial biotechnology, by using modern biotechnological methods for the production and processing of chemical products, materials and fuels from renewable materials, as well as in the field of bioremediation technologies applied to the environment. Multi-business companies Companies operating in at least two of the above mentioned areas of application 4

5 Biotech companies Companies that use at least one modern biological technique, to develop products or services for human and animal treatment, agricultural productivity, renewable resources, industrial production and environmental protection (OECD definition). Pure biotech companies Companies whose core business originates from the use modern biological techniques, to develop products or services for human and animal treatment, agricultural productivity, renewable resources, industrial production and environmental protection (Ernst&Young definition). Italian-owned companies include those biotech companies with Italian capital, mostly pure biotech companies, as well as a number of pharmaceutical companies and CRO (Contract Research Organization). Foreign invested companies consist of all of the Italian subsidiaries of multinational companies, including pure biotech companies. Financial data All figures relating to revenues, investments and number of employees refer the accounting year

6 All figures of the Italian biotech are for Values in thousands of euros /000 Percentages refer to deviations from the previous survey, on homogeneous samples 6

7 the counter-cyclical nature of this industrial sector The number of biotech companies active in Italy, at the end of 2014, is 384. More than half (251) are pure biotech companies; among these, the Italian-owned pure biotech companies (hereinafter, the Italian pure biotech companies) are 225. Total turnover exceeds 7.7 billion euro. Total R&D investment amounts more than 1.5 billion euro, while the number of R&D employees is close to 7,300 units. With an average incidence of R&D investment on turnover of 19% - raising to 31% for the Italian pure biotech companies - the biotech industry is one of the industrial sectors with the highest levels of innovation. 7

8 We have come from years of steady growth and The Italian biotech industry has experienced an extraordinary growth, due to the tremendous impact of these technologies, the renowned excellence of our academic and industrial research, the ability of the Italian companies to translate innovation into valuable products and technologies. Number of biotech companies in Italy 8

9 rank third in Europe in terms of pure biotech companies Source: elaboration on E&Y data 2014 However, many of the Italian pure biotech companies are modestly capitalized due to their limited access to adequate financing 9

10 NUMBER OF SCIENTIFIC PAPERS PER SCIENTIST NUMBER OF QUOTES PER SCIENTIST The productivity of Italian scientists With 1.1% of the world s scientists and 1.5% of global research spending, Italy produced 3.8% of the scientific articles worldwide, obtaining 6% of all citations, thus ranking six times higher than the world average in terms of number of quotes. Source: Scopus and OCSE MSTI 2013/1 10

11 The competitiveness of Italian scientists Italian scientists rank third worldwide in terms of number of projects funded by the ERC (36). Although, more than half of them work in a foreign research institution. Source: European Research Council 11

12 Covering all fields of application The percentages below are specific to the subgroup of the Italian pure biotech companies, even if they remain substantially unchanged when calculated on the entire sample. 6% 66% 14% 14% 12

13 to meet a number of key challenges More than half of the Italian biotech companies (277) is active in the Red biotech field, also due to the growing demand for increasingly effective and safe products for the treatment of many diseases of major clinical, epidemiological and social relevance. The companies operating in the Green and in the White biotech segments, and as such responding to the many challenges that modern society is facing in the fields of agriculture, energy and environment, are respectively 95 and 76. As a further evidence of the cross-cutting nature of biotechnology, 58 companies operate in more than one field of application. This is the case of 21 Red biotech companies that develop vaccines for veterinary use, and of 9 companies developing enzymes that find application both in the White and in the Green areas. 13

14 Biotech companies: analysis by size Almost 80% of the Italian biotech companies are micro or small-sized organizations This percentage is even higher for Green and White biotech companies 10% 11% 17% 62% 14

15 Italian pure biotech companies: analysis by size However, among the Italian pure biotech companies, the proportion of micro and smallsized organizations rises to 93%, while that of large-sized organizations falls to 1% 79% 14% 1% 6% 15

16 Geographic distribution Number of companies by Region 16

17 Scientific and Technological Parks (STPs) STPs Incubators 17

18 Biotech companies: analysis by origin The majority (66%) of Italian biotech companies originate from start-ups, academic spin-offs or industrial spin-offs. This percentage increases significantly (84%) by limiting the analysis to the subset of the Italian pure biotech companies 18

19 Italian pure biotech companies: localization Italian pure biotech companies are located within STPs and incubators (47%) Universities or research centres (25%) Independent headquarters (28%) STPs are true poles of aggregation of scientists, entrepreneurs and investors. As such, they allow micro and small-sized biotech companies to access a network of excellence and a wide range of services, which are key in the early stages of their development. STPs Incubators 19

20 Turnover: Italian-owned vs. foreign invested companies The Italian biotech industry totally recorded revenues for 7,726 million euros, with a 4.2% increase on the previous year. The contribution of foreign invested companies amounts to 85%, even though these represent numerically 15% of the sample. 15% 85% Number of companies Revenues 20

21 Italian pure biotech companies: revenues by field of application 76% 24% Italian pure biotech companies revenues exceed 600 million euros, with a percentage contribution of the companies from the Green and the White segments, which is much more significant (28%) compared to that calculated on the entire sample (3.5%). 21

22 R&D investments: Italian-owned vs. foreign invested companies Total R&D investments exceed 1,500 million euros, with a 4.5% increase on the previous year. Remaining unchanged the numerical proportion of the two sub-samples, the higher contribution of the Italian-owned companies is due to the high incidence of the Italian pure biotech companies R&D investments on their revenues or operating costs. 15% 85% Number of companies R&D investments 22

23 Italian pure biotech companies: investments by field of application 78% 22% Italian pure biotech companies revenues amount 200 million euros, with a percentage contribution of the companies from the Green and the White segments, which is much more significant (24%) compared to that calculated on the entire sample (6%). 23

24 R&D employees vs. total employees In line with what we observed with regard to the relationship between R&D investments and revenues, also the numerical incidence of R&D employees on total employees is significantly higher for Italian pure biotech companies, compared to the average of the entire sample. 18% 49% 82% 51% 24

25 R&D employees: educational qualification Biotech companies The Italian biotech industry is one of the industrial sectors with the highest levels of innovation. Actually, more than 80% of its R&D employees has a second level university degree or a PhD 25

26 Financing sources Among the different sources of funding the Italian pure biotech companies draw upon in order to finance their R&D activities, the highest incidence (40% of cases) is that of public financing (Grants), while that of Venture Capital remains relatively modest. 26

27 2014 Venture Capital investment in biotech 2014 VC investment in biotech Global 2014 VC investment in biotech Europe Total capital raised: $ 3,720 million Total capital raised: $ 870 million Source: VentureSource 2014 Although the Venture Capital market is still underdeveloped in our Country, with respect to other European economies, in the last two years Italian pure biotech companies have generated agreements for a total value of over 5 billion euros, compared to an investment of a few hundred millions. 27

28 Red biotech Values in thousands of euros /000 Percentages refer to deviations from the previous survey, on homogeneous samples In the case of Italian pure biotech companies, the incidence of R&D investment on their revenues and operating costs reaches on average 33% 28

29 The spearhead segment of the entire sector Health care biotechnology is the spearhead segment in the entire sector, by representing the large majority of companies (72%) and by generating the largest share of revenues (96%) and R&D investments (94%). Red biotech fuels an increasing number of R&D projects addressing diagnosis and therapy, aimed at optimizing the entire pathway of care both from a clinical and economic point of view. Besides more than a hundred laboratories, including public research institutes, universities and research hospitals, the Italian biopharmaceutical chain consists of 200 companies. Of these, 104 are Italian pure biotech companies; for 44 of them we were able to analyse the R&D pipeline. 29

30 Italian pure biotech companies: biopharmaceutical pipeline Project analysis by R&D phase 26 new projects, the last year alone! 30

31 Project analysis by therapeutic area Within the therapeutic areas addressed by Italian pure biotech companies there are several diseases that still constitute some of the major unmet medical needs. 31

32 Project analysis by type and development phase Approximately 45% of the projects (including discovery) are for biopharmaceuticals, which include by definition monoclonal antibodies, recombinant proteins and Advanced Therapy products (Cell therapy, Gene therapy and Regenerative medicine). % biopharmaceuticals at different stages of development Between 2009 and 2015, biopharmaceuticals have gone from 36% to 45% 32

33 Orphan Drugs and Advanced Therapies Nine are the Italian pure biotech companies that have obtained at least one ODD (Orphan Drug Designation). Of the 14 projects, 12 are in clinical development phase; four of them have already reached Phase III. The first Advanced Therapy (AT) product, based on stem cells, approved and registered in the Western world, originates from an Italian pure biotech company. 33

34 The Italian pure biotech companies have already obtained three marketing authorizations *EMA European Medicines Agency, FDA Food and Drug Administration, KFDA Korean Food and Drug Administration 34

35 Defibrotide (Defitelio ), the first drug originating from an Italian pure biotech company to achieve marketing authorization by the European Commission in 2013, is a life-saving drug for the treatment of severe hepatic veno-occlusive disease (VOD). Safinamide (Xadago ), an adjunctive therapy to L-DOPA alone or in combination with other therapies for mid to late-stage Parkinson's disease, received marketing authorization from the European Commission in Holoclar, an Advanced Therapy for the treatment of patients with severe burns of the cornea, is the first ever AT product, based on autologous stem cells, approved and formally registered in the Western world (European Commission ). 35

36 Green biotech Values in thousands of euros /000 Percentages refer to deviations from the previous survey, on homogeneous samples Environmentally friendly solutions alternative to industrial agriculture 36

37 Quality and sustainability of the entire food chain Nowadays, more than ever, growing the agricultural production in a sustainable manner, without increasing cultivated land, preserving biodiversity and reducing water consumption, chemical input and greenhouse emissions becomes a tangible need. The introduction of the new techniques of genetic engineering have drastically changed the perspective of improving the productivity and the quality of a number of plant varieties, fully respecting the sustainability and the quality of the entire food chain. Despite a number of regulatory hurdles, with regard to the application of GMO in agriculture, Italian companies are actively exploiting the potential of biotechnologies in agriculture, by improving the nutritional value of animal and plant productions as well as the sustainability of the Italian food chain. 37

38 White biotech Values in thousands of euros /000 Percentages refer to deviations from the previous survey, on homogeneous samples A driver for sustainable growth 38

39 Retraining traditional industrial processes White biotech makes an increasingly important contribution to the development of a sustainable bio-based economy, by using enzymes and micro-organisms to obtain innovative products in the chemistry, paper, textiles and energy sectors. Industrial biotechnologies could also provide new chances to the chemical industry by allowing easy access to building blocks and materials not easily accessible before, and have a considerable impact in the production of biofuels and biopolymers, by using biomass as an alternative to fossil resources. Italian white biotech companies play a leading role in the transformation of conventional processes with a view to increasing efficiency and sustainability. The Italian industry has opened the largest plant in the world for the production of second-generation bioethanol from agricultural waste, thus defining an entirely new paradigm for the development of Green Chemistry 39

40 The Bioeconomy Europe combines the potential applications of biotechnologies, with a model of smart, sustainable and inclusive growth based on the use of renewable bio-resources, supporting economic recovery and generating new qualified job opportunities. The development of the Bioeconomy is a priority objective of the European policies, on which to focus resources and investment to support research, training, and the growth of new markets. Within the several reports on the major challenges of the European economy, with a specific focus on the aspects of environmental sustainability, Intesa Sanpaolo, in collaboration with Assobiotec and the nova-institut, has recently drawn up a study to measure the potential of the Bioeconomy in our Country, and what Italy can express in terms of competitiveness in the various areas identified by the Commission (agriculture, fisheries, food, wood and paper industry, Green Chemistry). 40

41 The impact of Bioeconomy on production Values in millions of euros / Source: Intesa Sanpaolo Research Department 2014 In terms of production, Bioeconomy in Italy worth about 240 billion euro, equal to 7.6% of the total value of national production 41

42 The impact of Bioeconomy on employment Values in thousands of units Source: Intesa Sanpaolo Research Department 2014 In terms of employment, Bioeconomy in Italy provides work for more than 1.5 million people, equal to 6.9% of employed people 42

43 The impact of Bioeconomy on exports Values in millions of euros / Source: Intesa Sanpaolo Research Department 2014 The value of Italian exports generated by the sectors belonging to Bioeconomy amounts to about 44 billion euros, representing almost 12% of total exports 43

44 Thinking of an ecosystem for innovation In the last few years, the Italian government has implemented a number of rulings aimed at making of innovation the key to the competitiveness of our industrial system. Among the measure which were adopted: the recognizing of the status of innovative start-up; the introducing of a tax credit on R&D costs and investments; the adoption of a system of preferential taxation on intellectual property incomes (Patent Box); the recognizing of the status of innovative SME. The administrative simplifications and the tax benefits pursuant to those measures will boost the competitiveness of the Italian biotech companies, particularly by facilitating their access to adequate funding. 44

45 Do you know what my favourite renewable fuel is? An ecosystem for innovation Thomas L. Friedman 45

46 Appendix: companies with R&D activities in Italy A. Costantino & C. AAA Advanced Accelerator Application AAT Advanced Analytical Technologies AB Analitica AbbVie Abiel Accelera Acraf ACS Dobfar Actelion Pharmaceuticals Italia Active Cells Actygea Adienne AEP Polymers Agrifutur Agritest Agroils Technologies Agrolabo Alexion Pharma Italy Alfa Intes Industria Terapeutica Splendore Alga&Zyme Alga Mundi Algain Energy AlgaRes Alicebiosources Allergopharma Also Biotech Altergon Italia Ambrosia Lab Amgen Anallergo Ananas Nanotech Apavadis Biotechnologies Aptalis Pharma Aptuit Apuliabiotech Archimede R&D Ardis Areta International Arterra Bioscience Astrazeneca Avantea Axxam Bayer BBA Biotech BCS Biotech Beta Renewables BGT Italia BiCT Bio Fab Research Bio Genetix Bio Soil Expert Bio3 Research Bioaesis Bioagro Biocell Center Biochemtex Biodermol Biodigitalvalley Bioecopest BIOerg Biofer Biofordrug Biogen Idec Italia Biogenera Bioindustria LIM Bioindustry Park Silvano Fumero Bio-ker Bioman Biomarin Europe Biomat Biomedical Research Biomedical Tissues Biomerieux Italia Bionat Italia Bionucleon Bio-on Bioops Biopaint Biopharma Biopox Biorep Biosearch Ambiente 46

47 Biosistema Biosphere BioSpire Biosynth Biotec Sys Biotecgen Bioteck Bioteknet Biouniversa Bluegreen Biotech BMR Genomics Boehringer Ingelheim Italia Bristol Myers Squibb BSA Ambiente BSP Pharmaceuticals BTM Biological Tools for Mediterranean Agricolture Byflow C4T Colosseum Combinatorial Chemestry Center for Technology C5-6 Italy Cage Chemicals CBM CCS Aosta Ceinge Biotechnologies Avanzate Celgene CellDynamics Chemi Chiesi Farmaceutici CHORiSiS Chrono Benessere Clonit Cogep Congenia Cosma CPC Biotech Creabilis Therapeutics CRS4 Bioinformatica Cryolab Cutech Cyanagen DAC Dalton Biotecnologie Derming DI.V.A.L. Dia-chem Dia.pro Diagnostic Bioprobes Diasorin Diatech Pharmacogenetics Diatheva Diesse Diagnostica Senese Diesse Ricerche Dna Analytica Dompé Biotech Ecobioservices and Researches Ecoil Eco-Sistemi Ecotechsystems Elab Eli Lilly Italia Ephoran - Multi Imaging Solutions Epi-C Epigen Therapeutics Epinova Biotech Epitech Eridania-Sadam Erydel Espikem Etna Biotech Eudendron Euroclone Eurosen Eurospital - Laboratorio R&S Eurovix Euticals Evolution Technology Laboratories Exenia Group Exosomics Siena Experteam Explora Biotech Externautics Fase 1 Fatro FEM2-Ambiente Finceramica Faenza Flamma FlowMetric Europe Fly Life Food Research innovation Fotosintetica & Microbiologica Franvax G&life Galatea Biotech Galileo Research Geltis Biotech Gemiblab Genedia Genenta Science Genespin Geneticlab Genomix4life Genomnia Genovax Gentium Gentoxchem 47

48 Genzyme Gexnano Gilead Sciences Italia Gio.Eco Giotto Biotech GlaxoSmithKline Glyconova Gnosis Go Diagnostic Grape Green Lab Harrison Clinical Research Italia HMGBiotech Holostem Terapie Avanzate Hygeia Lab IGA Technology Services IMMAGINA Biotechnology In4Tech Inbios Indena Integrated Systems Engineering Intermune IOM Ricerca IPAD International Plant Analysis and Diagnostics Ipsen IRB Istituto di Ricerche Biotecnologiche IRBM Science Park Isagro ISB Ion Source & Biotechnologies Istituto Biochimico Italiano Giovanni Lorenzini Istituto di Ricerche Biomediche Antoine Marxer Italfarmaco Janssen-Cilag JV Bio Kedrion Kemotech Kither Biotech KOS Genetic Kron Morelli Ktedogen Laboratori Turval Italia Laboratorio Genoma Life Line Lab Lipinutragen Lofarma Lundbeck Pharmaceuticals Italy Magis Farmaceutici Mater Biotech Matrica Mavi Sud Med & Food CQS Medestea Research & Production Mediapharma Mediteknology Menarini Biotech Merck Serono Merial Italia Meristema Merz Pharma Italia Micro4You Microbion Microbiotec Microgenomics Micron Research Service Microspore Mindseeds Laboratories Mipharm MoLiRom Molecular Links Rome MolMed Molteni Therapeutics MRIT Lab MSD Italia MyBasol Mybatec Naicons Nano4Bio Nanomaterials Nanomed Labs Nanomed3D Nanosurfaces Nanovector Narvalus NatiMab Therapeutics Naxopharma Nealys Need Pharmaceuticals Nerviano Medical Scienses NeuHeart NeuroVisual Science Technology NEST Neuro-Zone Newron Pharmaceuticals Next Genomics NEXThERA Biosciences NGB Genetics Nicox Research Institute Nobil Bio Ricerche NoToPharm 48

49 Novamont Novartis Farma Novartis Vaccines and Diagnostics NTI Natural Technologies Italia Nurex Nutrigene Officina Biotecnologica Oncoxx Biotech Ophera Parco Scientifico della Sicilia Parco Tecnologico Padano Personal Genomics Pfizer Italia Pharma Go Pharmadiagen Philogen Phytoengineering Italia Pianeta Pincell Plantechno Plasmore Prigen Primm Probiotical Procos Pharmaceutics Proge Farm Pharmaceutical Prolabin & Tefam Promis Biotech Proteotech Proxenia ProXentia Raresplice RE.D.D. Research for Drug Development Recordati Reithera ReMembrane Research & Innovation Resindion Reverdia Rigenerand Roche Rotalactis Rottapharm Biotech RTC Research Toxicology Centre S.A.F.AN. Bioinformatics Sacace Biotechnologies Sacco Salentec Sanofi Sanofi Pasteur MSD Sclavo Diagnostics International Serge Genomics Società di SERvizi GEnetici Servier Italia Setlance Shire Italia Sifi Sigea Sigma-Tau Silicon Biosystems Sirius-Biotech SiTec Consulting Skin Squared Smile Biotech Soft Materials & Technoogies Spider Biotech Sprin Stallergenes Stemgen Synbiotec Synchimia Syntec Takeda Italia Takis Target Heart Biotec Technogenetics Tecna Lab Tectronik Tes Pharma Teva Italia Thetis Tib-Molbiol Toma Advanced Biomedical Assays TOR Tissue and Organ Replacements Toscana Biomarkers Transactiva Trustech TTFactor Tydockpharma UB-Care UCB Pharma UFPeptides UN.E.CO. Veolia Environment Versalis Vet Spin Vetogene Virostatics Vismederi VivaBioCell Wetware Concepts Xeptagen Ylichron 49

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