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Biotechnology in Argentina
Knowledge + Innovation to meet global market needs
Photo: courtesy of INTI. National Institute of Industrial Technology
Highlights
>> FACING A GLOBAL OPPORTUNITY
The global biotechnology market has been growing at a strong rate, driven
by constant technological and scientific advances and broadening areas
of application. Mainly concentrated in the U.S., the biotechnology industry
presents attractive opportunities for those countries with the right set of
resources.
May 2009
I. Why Invest in Biotechnology in Argentina?
Photo: courtesy of Bio Sidus labs
II. Industry Structure and Performance
STRUCTURE INDUSTRY SEGMENTS
Diverse and competitive sector. More than 80 A diverse array of products are being produced locally,
firms produce modern biotechnological products locally, covering several areas of biotechnology applications.
covering a wide range of activities: 29% of firms produce Agriculture, food processing, human heath and diagnosis,
inoculants, 23% seeds and plant varieties, 12% animal and animal health are segments in which domestic
health products, 12% food ingredients and 24% human biotechnology presents attractive competitive advantages.
health products. The sector is composed of a mix of global
players and growing domestic companies. Global leaders Agricultural sector. Within agriculture, biotechnology
such as Bayer CropScience, Dow AgroSciences, Nidera, has many applications, including genetic modifications
Monsanto and Pioneer are active in the country, and (GM) of plant varieties, seeds, inoculants, pesticides,
local firms like Bioceres, Biocientífica, Biogénesis-Bagó, fertilizers, vet products and genetic selection for cattle
BioSidus, Cassará, Indear and Wiener Lab are competitive breeding. The worldwide performance of GM crops stands
players in diverse segments. Around 80% of firms are out, increasing its market size 65-fold in 1996-2008 to
domestic small and medium size companies, focused US$7.5 billion. GM crops currently cover an area of 125
almost exclusively on biotechnological activities. million hectares in 25 countries in six continents. These
figures are expected to double in the next ten years.
INDUSTRY BUSINESS PERFORMANCE
Sales and exports. Conservative estimations calculate GM Crop Area by Country
Canada 6%
agricultural sector leads the sales by area of application:
seeds and plant varieties concentrate 41% of total sales, Brazil 13% U.S. 50%
animal health explains 25%, and inoculants add an
additional 8%. The food ingredients sector accounts for
Argentina 17%
15% of sales and human health for the remaining 11%.
Biotechnology exports amount to over US$80 million Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA)
(60% in agro related activities and 24% in human health), Endowed with vast extensions of arable land (32 million
resulting in a biotech trade surplus of over US$50 million. hectares), Argentina embraced, at an early stage, the use
Seeds and plants and human health explain together 72% and generation of genetically modified crops, leading to
of total employment, distributed in almost identical shares. an agricultural revolution that increased both the size of
Private R&D explains over 5% of sales, reaching some the cultivated land and the yields per hectare of its main
US$20 million in total, with the highest ratio seen in human crops. Record-high levels of agricultural production
health (15%). The number of patents presented to the U.S. are reached year after year. Argentina is today a leading
Patent and Trademark Office (USPTO) ant the European country in adopting biotech crops: it has the highest
Patent Office (EPO) by the Argentine biotech sector percentage of arable land planted with GM crops (65%),
amounts to 53 and 12 per year in 2001-2007 respectively. it is the second largest producer of GM crops (21 million
Biotechnology by Segment
Share of total firms, sales, employment and exports Soybean Area and GM Soybean Evolution
100%
11 20.000 10 0
90
6 18.000
In thousand of hectares
80% 1
16.000 80
1 1
14.000 70
60% 1 11
12.000 60
10 0 10.000 50 %
0%
8.000 40
1 6 6.000 30
0%
0 4.000 20
8 8 4 2.000 10
0%
- -
Firms Sales Employment Exports
3
9
7
/0
/0
/0
/0
/0
/0
/0
/0
/9
/9
/9
/0
/0
02
03
04
05
06
07
08
00
96
97
98
99
01
Inoculants Seeds & Plants Animal Health Food Ingredients Human Health
20
20
20
20
20
20
20
20
20
19
19
19
19
.
Source: Bisang, Gutman, Lavarello, Sztulwark and Diaz (2006) Source: CONABIA and SAGPYA Total soybean area GM soybean/ Total soybean
hectares; 17% of world GM area) and enjoys top-notch DNA technology, including human erythropoietin, human
productivity in soy, corn and their derivatives. Some interferons, colony-stimulating factors and human growth
companies also produce bioinsecticides and pulse crop hormone. These products are already sold in Asia, the
inoculants, while others use seedling micropropagation Middle East and Latin America. Argentina is, along
and vegetable tissue culturing technologies. with the U.S., Australia, Korea and New Zealand, one of
the few countries in the world with the technology of
Food Processing. Argentina counts with a large and pharmaceutical diary. It is also one of nine countries with
highly competitive food and beverage industry, with capacity to clone animals successfully. BioSidus is one
total sales of US$53 billion (31% of total manufacturing of the sector’s leaders. In the field of diagnosis, there are
production sales) and exports of US$21 billion (30% of products and developments using recombinant protein
total manufacturing production exports). Significant and monoclonal antibodies to detect infectious diseases,
applications of biotechnology are being developed such as Chagas’ Disease, Cholera, Hepatitis B and C,
and implemented in this field. Biotechnology in food and HIV. There is also capacity for molecular oncology,
processing is focused on the production of high-fructose leukocyte differentiation antigens, genetic predisposition to
corn syrup and its intermediate product glucose syrup. hereditary diseases, and filiations and personal identity.
Five companies stand out in this segment. While three
of them are domestically-owned (Alimentaria San Luis, Sales of Domestic Pharmaceutical Production
Arcor and Georgalos), the other two have been acquired by (in US$ million)
2.500
Exports
global food companies (Industrias de Maíz and Refinerías
Internal market
2.000
de Maíz). Two leaders in the dairy sector (SanCor and
1.500
La Serenísima-Danone) have recently launched their
probiotic milk lines by incorporating Lactobacillus and 1.000
-
of national and multinational companies present in
2002 2003 2004 2005 2006 2007 2008
Argentina. A salient case in the area of animal vaccines
Source: Center of Studies for Production (CEP)
CASE STUDY
Bio Sidus: translating scientific breakthroughs into products for a better quality of life
BioSidus, under the guidance of the pharmaceutical to ensure the perpetuity of the transgenic lineage.
firm Sidus, has become a leading organization in Human growth hormone obtained from the milk
the biotechnological field, thanks to the efficient of these transgenic cows has already been tested
integration of both enterprise and technology. for bioequivalence against the bacterial-derived
By the end of the 1970s, the managing staff of reference product and is about to start efficiency
“Instituto Sidus”, conscious of the central role clinical trials. The production of recombinant human
of modern biotechnologies, decided to enter proteins in the milk of transgenic cows is expected
in the biotechnological research field. In 1980, to be a highly efficient and cost-effective method
Sidus’ Area of Biotechnology was created, compared to more traditional manufacturing
under Sidus’ entrepreneurial support and the techniques, with the yield from only a small number
scientific concurrence of an important group of of transgenic cows meeting market demand for
professionals from the University of Buenos Aires. many medical applications. Additionally, BioSidus has
The goals successfully achieved in technological developed lineages of transgenic cows to produce
and manufacturing developments led Sidus in bovine growth hormone for veterinary use. However,
1983 to create BioSidus as an organically individual the most ambitious target in this technological
enterprise, which by 1990 had rolled out its first platform is the development of transgenic cattle for
biogeneric product: erythropoietin. Almost 20 years human insulin precursor. To this day, eight cloned
later, BioSidus commercializes locally and abroad transgenic cows were born which will be induced to
seven recombinant proteins for use in human health: lactation in the coming months to assess presence
erythropoietin, interferon alfa 2a and 2b, interferon of human insulin precursor in their milk. As from this
beta 1a, filgrastim, lenograstim and somatropin. milk, the human insulin precursor will be purified to
Additionally, BioSidus counts with a pipeline of homogeneity and submitted to an enzymatic cleavage
multiple biosimilar candidates in different stages of to recover biopharmaceutical degree human insulin.
development. Lead products in the pipeline include This will be of special significance because it will allow
PTH 1-34, interferon beta 1b and streptokinase. large quantities of product at an affordable cost to
meet the increasing demand of insulin to treat the
Over 75% of BioSidus revenues come from exports growing population of diabetes patients.
to almost 30 countries in Latin America, Middle East,
Eastern Europe and Asia Pacific (including India, Ongoing projects also include gene therapy targeting
Thailand and Lebanon) holding a significant market angiogenesis of ischemic heart tissue. BioSidus has
share in these territories. Furthermore, the company is developed and produced pharmaceutical grade
filing for regulatory approval to distribute its products naked plasmid DNA codifying for the human protein
in 10 additional countries through partnerships with vascular endothelial growth factor and has assessed
local pharmaceutical firms. Its recently launched through preclinical testing in laboratory animals
product, Interferon beta 1a, is rapidly gaining market that its injection into the cardiac muscle resulted in
presence in different countries. increased growth of new blood vessels as well as in
muscle regeneration. These findings led to conduction
In addition, the company is taking steps to prepare of Phase I clinical studies currently underway with
for its eventual commercialization in developed promising results. Phase II clinical trials are set to start
countries. To achieve this goal, BioSidus is in the in 2009.
process of upgrading its manufacturing processes
and refurbishing a new facility in line with U.S. FDA In collaboration with the Argentine Dirección Nacional
and EMEA regulatory standards. To accomplish this, del Antártico, research has been conducted aimed
BioSidus has entered into a strategic association with at the isolation and characterization of certain
an U.S. based firm to distribute its current product microorganisms from the Antarctic territory that
portfolio in the U.S.. are particularly adapted to extreme temperature.
A novel species has been isolated and identified
With significant investments in R&D, BioSidus activities - Bizionia argentinensis, and its full genome has been
include the development of expression systems to sequenced. In this sense, BioSidus is once again a
produce, formulate and clinically test recombinant pioneer in genomics in Argentina since this is the
proteins for human health. The company’s R&D efforts first national experience of integral sequencing of
focused on innovative transgenic biopharmaceutical a microorganism genome. The genome is currently
manufacturing merit special mention. BioSidus has under analysis seeking for genes that encode for
built up a pharmaceutical dairy comprised of a herd enzymes active at cold temperature. There is a great
of 33 cloned transgenic cattle, including twelve cows potential for industrial applications of these “cold
producing biopharmaceutical grade recombinant enzymes” in the food, textile and laundry industries,
human growth hormone in their milk and seven bulls among others.
III. Foundation for Success
LOCAL SKILLS AND TALENT financed courses for more than 2,400 students from
Qualified human resources. Developing Argentina, Brazil, Uruguay and Paraguay
biotechnology requires highly qualified human resources.
Argentina is the country with the highest number of
researchers per active person in Latin America (3.4/1,000 RESEARCH AND DEVELOPMENT
active) and has internationally renowned scientific Research institutes. Research institutes from
skills and a pioneering spirit. In natural sciences, this universities and companies carry out R&D activities in
tradition is evidenced by three Nobel Prizes awardees (B. a wide range of disciplines and specialties in Argentina.
Houssay, L. Leloir and C. Milstein). In total, over 59.000 Almost 70 of these centers (41 companies and 27 research
researchers and scholars undertake research activities groups) are focused on agricultural issues and 37 are
both in the public and private sectors. These talents are dedicated to biosciences. Specifically, 28 are devoted
also growing thanks to the Program RAICES, a strategic to biotechnology research, including public centers,
project from the Ministry of Science and Technology university centers and private foundations.
that promotes and facilitates the return of Argentine
distinguished researchers working abroad. In the last few Regional hubs and business incubators. A recent
years more than 600 professionals have been relocated in trend has been the emergence and consolidation
local research institutions. of technological hubs and business incubators in
different knowledge-intensive fields. A highlight within
Specialized research and training. Today, 1,350 agricultural research is the Rosario biotechnological
researchers and technicians undertake scientific hub in the province of Santa Fe. Comprised of several
research in biosciences. Specifically, 241 scientists and institutions mainly devoted to vegetal biotechnology,
101 technicians are involved in biotechnological research the hub brings together more than 400 professionals,
lines. More than 30 universities and higher education constituting the main biotechnological pole in Latin
institutions offer undergraduate and graduate careers America. The Argentine-Spanish Center for Plant
in biotechnology. Scientific researchers continue their Genomics (CEBIGEVE) and the National Institute for
education through doctoral and postdoctoral scholarships Agro-biotechnology (INDEAR) are two of its members.
sponsored by CONICET. Additionally, courses for CEBIGEVE is an R&D center resulting from the scientific
researchers coming from the public and private cooperation between Spain and Argentina. INDEAR, in
sector are offered at the Argentine-Brazilian School of turn, results from the partnership between the private
Biotechnology (EABBIO). From 1987 to 2003, EABBIO firms Bioceres and BioSidus and the CONICET.
Photo: courtesy of Biogénsesis Bagó
Photo: courtesy of Roemmers labs
20,000
through the “Por qué Biotecnología” (Why
15,000
Biotechnology?) program.
10,000
8
7
/0
/0
/0
/0
/0
/0
/9
/9
/9
/0
/0
00
02
03
04
05
06
07
96
97
98
99
01
20
20
20
20
20
20
20
20
19
19
19
19
Source: Argentine Association of Seed Traders (ASA) and Secretariat of Agriculture, Livestock, fishing and Food (SAGPYA). educational levels.
IV. Policy Initiatives
Photo: courtesy of INTI. National Institute of Industrial Technology
Venture capital. Government is increasingly involved Fund for Scientific and Technological Research
(FONCYT): Supports research projects targeted
in the promotion and development of venture capital at generating new scientific and technological
funds for technology-based companies in Argentina. knowledge. Promotion and financing instruments are
The Ministry of Science and Technology has put in place awarded, in all cases, through public bids. The FONCyT
has sponsored an important number of projects in the
the Program CREARCIT to encourage the growth and
area of biotechnology between 2003 and 2008, for
creation of innovative firms in all technological fields over US$37 million.
through venture capital investment.
Argentine Technology Fund (FONTAR): Supports
projects targeted at improving the private sector
productivity on the basis of technological innovation.
SCIENTIFIC PROMOTION There are various financing instruments granted
Funds for R&D. The national government has through public bids or permanent window. The
implemented several programs and instruments that FONTAR has approved biotechnological projects for
over US$15 million in 2003-2006.
promote and facilitate basic research and technological
10
REGULATORY FRAMEWORK Promoting and protecting health. The National
Environmental and health safety. In Argentina, Administration of Drugs, Foods and Medical Technology
GMOs are evaluated before these products are marketed. (ANMAT) promotes and protects human health by
Since 1992, 400 field trials for different transformation assuring the quality and efficacy of medical products,
events have been assessed and authorized. The food and domestic-use products, medical and diagnosis
evaluation process includes three steps. First, the devices. Since 1992, the Ministry of Health is in charge of
National Advisory Committee for Agricultural providing authorization for release to the market.
Biotechnology (CONABIA) evaluates the likely impact
on the agricultural ecosystem, comparing potential Intellectual Property Rights. As a signatory of the
environmental consequences with those of conventional Trade-Related Aspects of Intellectual Property Rights
plants, initially through experimental release and then agreement (TRIPS), Argentina provides an effective
more extensive release into the environment. Second, patent protection system, including pharmaceutical
the National Service of Agricultural and Food Health products. The National Institute of Industrial Property
and Quality (SENASA) conducts a food safety evaluation. (INPI) made significant progress in reducing its patent
Third, the National Direction for Agricultural Food backlog, including the implementation of fast-track
Markets (DNMA) makes an evaluation of potential procedures and a one-time opportunity in 2005 for
commercial impact by analyzing the status of the GM companies to prioritize their patent applications before
product under study in the destination markets in terms INPI. FONTAR offers subsidies to SMEs to apply for
of whether the product has been approved or not and, as patents both locally and abroad.
a result, whether the addition of a GM crop to Argentina’s
exports might represent a potential barrier to access
these markets. To date, 10 GM crop varieties have been
authorized for sale.
11
V. Main Challenges
12
Photo: courtesy of INTI. National Institute of Industrial Technology
SOURCES: The trends, data and figures included on Global Status of Biotech/GM Crops, 2008 / The information provided through this brochure
in this material were elaborated by ProsperAr Ministry of Science and Technology (MINCYT) / does not in any way constitute legal or
based on information provided by: Argentine National Institute of Statistics and Census (INDEC) professional advice. ProsperAr (Agencia Nacional
Association of Seed Traders / Argentine Forum on / National Observatory for Science Technology de Desarrollo de Inversiones) reserves the right
Biotechnology (FAB) / BiotecSur / Bisang, Campi and Innovation, Strategic Plan, 2005 / OECD, to revise, amend, alter or delete the information
and Cesa, “Biotecnología y desarrollo”, CEPAL, Biotechnology Statistics, 2006 / Sánchez, provided herein at any time and in no way be
2009 / Bisang, Gutman, Lavarello, Sztulwark and Rozemberg, Butler and Rufo, “The emergence held responsible or liable in respect of any such
Diaz (comp.) “Biotecnología y desarrollo. Un of new successful export activities in Argentina: revisions, amendments, alterations or deletions.
modelo para armar”, UNGS-Prometeo, Buenos self-discovery, knowledge niches, or barriers to
Aires, 2006 / Center of Studies for Production riches?”, IDB, 2008 / Secretariat of Agriculture, Cover photo: courtesy of Roemmers labs.
(CEP) / Ernst & Young, Beyond Borders: Global Livestock, fishing and Food (SAGPYA).
Biotechnology Report 2009 / ISAAA Report
13
Argentina at a glance
Country profile
Political division 23 autonomous provinces and the Autonomous City of Buenos Aires
Source: ProsperAr based on data provided by the Argentine National Institute of Statistics and Census, the Central Bank’s Market Expectations Survey (REM), the International Monetary Fund and the United Nations
Conference on Trade and Development (as of April 30, 2009).
14
ProsperAr is Argentina’s National Investment Development Agency
Our mission is to develop direct foreign and domestic investment to contribute
to Argentina’s competitiveness and sustainable development.
>> Provide timely and relevant information on business sectors and geographical
locations in Argentina.
>> Help identify investment and innovation opportunities in strategic sectors.
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business in Argentina.
>> Assist in building partnerships between foreign investors and local companies.
15
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BIOTECHNOLOGY in Argentina
can benefit you, please contact us:
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