Russia through the prism of the world biopharmaceutical market

Biotechnology
Journal
isting biotechnologies, including production of mAbs or
recombinant proteins. Soviet genetic engineering has developed
almost synchronously with that of the USA, Japan
and the EU [18], and as early as in 1984 successful synthesis
of human proinsulin gene was reported by the Shemyakin-Ovchinnikov
Institute of Bioorganic Chemistry
(IBCH) [19]. Pilot production of rIFN-α based on domestically
engineered producer Pseudomonas sp. VG-84 and
developed by VNII Genetika, IBCH and the Institute of Virology
“Vector” was launched in the middle of 80s in
Novosibirsk region [20], and already by the end of 80s, domestic
rIFN-α was successfully tested in volunteers
[21–23].
The All-Union Collection of Industrial Microorganisms
(VKPM) possessed a number of highly efficient strains,
that could produce major amino acids, enzymes, antigens,
antibiotics, vitamins, etc. This formed the basis for
construction of novel super-producers for various recombinant
proteins. The National Center for Safety of Biologically
Active Substances (Moscow region) has provided
necessary biological trials for new pharmaceuticals. A developed
network of universities, fundamental and applied
research institutes, and project and design bureaus
throughout the country has performed all the necessary
stages of biopharmaceutical implementation, including
R&D, laboratory and clinical trials, education and training
of personnel, equipment projection, etc. More than 80% of
equipment for the biotech industry was built by domestic
manufacturers (http://www.biorosinfo.ru). The managing
functions were performed by the Ministry of High School
Education, Ministry of Medical and Microbiological Industry,
Ministry of Healthcare, Ministry of Chemical Machine
Building, Academy of Sciences and Academy of
Medical Sciences.
However, as a result of the structural disintegration
that took place in 1992–1998, the overall biopharmaceutical
production has reduced fourfold. The vast majority of
domestic manufacturers traditionally focused on minor
production increases or on reproduction of existing technologies
to substitute imported counterparts. Efforts to
implement new advanced technologies were minimal.
Russian plants had obsolete equipment, and a relatively
low technological level and did not correspond to the international
GMP standards. In addition, they had no experience
of aggressive marketing, unlike Western companies.
Since the State support collapsed in 1991 and in the
absence of models and mechanisms of venture capital
funding of biotechnological projects, Russian manufacturers
were no longer able to maintain connections with
the product developers from specialized research institutes,
who had previously visited factories on a regular
basis to supervise and improve the manufacturing
process. As a consequence, by the end of 90s, most of do-
mestic pharmbiotech products were superseded by corresponding
products of western competitors in the Russian
market.
4 © 2007 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim
BTJ 07/07 | TD | DOI 10.1002/biot.200700091
Biotechnol. J. 2007, 2
In 2003, products of medicinal biotechnology constituted
>70% of the Russian biotech market. However, the
list of manufactured products was significantly shorter
than that of the world biopharmaceuticals. As a result of
insufficient governmental support for the basic research
in the past 15 years, the national biotech industry primarily
manufactured generics, with high-tech products accounting
for only 10% of the total production. Still, antibiotics,
vitamins, enzymes, immunology products, preparations
derived from human donor blood, and a few genetically
engineered products are manufactured by domestic
companies. The domestic biopharmaceutical market was
supplied only at the 51.3% level in 2003, of which 11.3%
were locally manufactured (http://www.biorosinfo.ru).
This demonstrates a potential for growth for the Russian
pharmbiotech market.
The list of immunological products in 2004 included
up to 500 products■check■ manufactured by more than
40 domestic companies (39 different vaccines, 17 anatoxins,
23 allergens, 24 bacteriophages, 123 immunodiagnostic
kits and 48 immunoglobulins) with total sales of
nearly $ 1.8 billion [24]. The largest domestic manufacturers
of immunological products have been Federal State
Unitary Enterprise “Microgen”, private companies “Biomed”,
“Combiotech”, “Diagnostic systems”, and others.
In 2003, 14 state pharmaceutical plants located throughout
Russia merged to create the state holding “Microgen”
with the personnel of ~8000 employees, including
~200 PhD scientists. The total sales of the holding were
$ 160 million in 2005. The list of products manufactured
by Microgen includes more than 400 items. One of the
most important products, flu vaccine “Grippol” contains
highly purified surface antigens hemagglutinin and
neuraminidase of flu viruses type A and type B conjugated
with water-soluble immunomodulator polyoxidonium.
Since 1997 more than 50 million people have been vaccinated
by Grippol (http://www.microgen.ru).
In a related field, up to 200 immunological products
were introduced for veterinary needs. High-quality vaccines
and diagnostic kits against avian influenza, anthrax,
cattle tuberculosis, epizootic aphthae and other
diseases potentially dangerous for humans were manufactured
by the research institute VNII of Animal Protection
(Yuryevets, Vladimir region), Veterinary Institute
(Khasan), Chumakov Institute of Poliomyelitis and Viral
Encephalitis and others [24].
In vitro diagnostic kits constitute one of the rapidly
growing segments of Russian biotech market, with annual
sales of ~$ 100 million in 2003 and annual growths of
~10% in subsequent years. Most of them are represented
by various enzyme immunoassay and DNA diagnostic
kits, which are manufactured by more than 40 small and
medium-size domestic companies covering near 30% of
national demand. The remaining 70% is imported
(http://www.biorosinfo.ru). Leading research institutes
(Engelhard Institute of Molecular Biology, Institute of
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