Industries of the New Era
Biotechnologies shape the development of humankind in the 21st century
Biotechnologies shape the development of humankind
in the 21st century
According to international experts, the global sales of pharmaceutical products are estimated at about $700 billion. The global pharmaceutical market expands by almost 6% every year. The pharmaceutical markets of developing countries are expanding even faster. In the next five years they are expected to grow by 13-16% and make significant inroads into the global pharmaceutical market. For example, by 2013 the pharmaceutical market of China will account for one fifth of the global pharmaceutical market growth. Biology has made significant advances over recent years penetrating into a multitude of industries, while biotechnologies have become one of the key instruments of the global sci-tech progress. The UN ex-
the major objective of Belarus’ economic policy till 2020 is to enhance the competitiveness of the national economy and its export potential via a drastic upgrade and development of new products in the manufacturing industry, construction, agricultural industry, transport, communications and other industries using cutting-edge technologies. this fully pertains to the pharmaceutical industry and biotechnologies – the industries of the 21st century which are based on business-oriented research infrastructure.
perts believe biological technologies will shape the development of humankind across all walks of life in the 21st century.
Biotechnological companies are among the most technology intensive enterprises, therefore, they are concentrated in technologically advanced countries like the U.S. (almost half of the total global production), Germany, Japan, Canada, France and the UK. The global market of biotechnological products is currently estimated at $400 billion per year. In the years to come, the global output is likely to grow by 7-8% every year. The market will be dominated by industrial microbiology, DNA technologies, creation of diagnostic preparations for agriculture and medicine.
In the last decade the U.S. and the European Union have been providing significant sup- port for biotechnologies. They have developed a legal framework to commercialize biotechnological products and invested heavily in fundamental research, biopharmaceuticals, bioenergy, agricultural biotechnologies, etc.
The U.S. is the industry leader accounting for 73% of the global profits generated by the industry, with Europe holding 20%, Canada 4% and Asia 3%.
The European Union, in turn, has developed a long-term strategy with a pronounced environmental focus. The project is backed by over 50 billion allocated in 2008-2013. In recent years biotechnology-based enterprises have been on the rise in China, India, Brazil, Japan and other countries. There is a reason behind it. The pharmaceutical industry and biotechnologies are among the most lucrative industries, third only to oil and gas industry and banking.
To Reach the Top
Over 85% of domestic pharmaceuticals are produced by companies that were part of Belbiopharm Concern not long ago. They include ten pharmaceuti-
cal companies and two research firms. In 2009 the Belarusian pharmaceutical market was estimated at $615.4 million (in selling prices), up by 3% in monetary terms and 1.6% in physical volume. The pharmaceutical industry accounts for less than 1% of Belarus’ industrial output. The efforts of Belbiopharm Concern to raise foreign investments and establish advanced pharmaceutical companies met with little success (only $7.3 million worth of foreign investments was raised in 2006-2010, all of them in 2010).
The concern was supposed to promote the pharmaceutical and microbiological industries. However, little has been done to upgrade microbiological companies. Today, Belarus has virtually no effective microbiological enterprises. They have been either shut down, like the Obol Feed Supplement Plant, or became part of other companies, like the Novopolotsk Protein and Vitamin Concentrates Plant, or their production facilities got so antiquated that they could not produce competitive products like the Enzim company. Given the focus on the development of the pharmaceutical industry, some changes took place in the structure of personnel. Today the enterprises of the former concern have almost no specialists capable of solving strategic problems facing the biotechnology industry. Belarus used to make a wide range of biotechnology products (protein feed additives, enzymes, feed amino acids, vitamins) in the 1970-80s for the needs of the Soviet Union, while now it is dependent on imports of these products. Annually, $300 million is spent to buy biotech products abroad.
Belarus imports biological products of animal origin, herb- al preparations, biological plant protection products, feeds, feed additives, preservatives, preserved feed, veterinary drugs, bacterial products for the dairy industry.
Therefore, the key task is not only to reduce the dependence of the economy on imports, but to start the production of competitive products with a high export value.
This task which the government set before scientists is not simple. We need to deal with scientific and technological stagnation in the pharmaceutical and biotechnology industry, to catch up with the world-class pharmaceutical and biotechnology companies, to implement mechanisms for sustainable innovation development of these sectors, to promote the development of clusters of modern pharmaceutical and biotechnology industry, to
create a modern R&D infrastructure to develop and manufacture:
– a wide range of drugs on the basis of chemical synthesis from plant and animal materials, bio-medicines, drugs based on protein-peptide substances, vaccines, including recombinant vaccines, stem cells, and also targeted drug delivery systems;
– enzyme preparations for industry and agriculture, plant protection agents, preparations to improve soil fertility, functional food products, food and feed additives, probiotic preparations for the food and agricultural purposes, preparations for protecting the environment from man-made pollution and bioremediation, clean bio-fuel from renewable raw materials, etc.
In addition, we need to create the now missing system of logistics of pharmaceutical and biotechnology industry, to make domestic and imported medicines available to the population and public healthcare, to improve the regulatory framework governing intellectual property in general and turnover, certification and licensing of pharmaceutical and biotechnology products in particular, to upgrade the system of secondary and higher education and personnel training for these sectors, to bring the system of registration, quality control and turnover of pharmaceutical and biotechnology products in line with international standards, to ensure international accreditation and certification of new pharmaceuticals and biotechnology and to advance to at least top 70 global pharmaceutical manufacturers by 2015.
We are expected to produce pharmaceutical and biotechnology products worth at least $1.2 billion by 2015 and to make sure that Belarusian medicines will account for 50% of the domestic market by 2015. In the next five years we need to continuously upgrade 20 production lines so that we could export around $200 million worth of pharmaceuticals a year.
Belbiopharm Concern has failed to expand the research sector. Cooperation between the concern and research institutions of other departmental affiliation was not efficient, either. Given everything mentioned above, the President issued a decree to reorganize Belbiopharm Concern and to create the Pharmaceutical Industry Department at the Healthcare Ministry. Biotechnology research will be handled by the research production corporation Biotech being set up at the National Academy of Sciences.
Areas of Focus
The sector will focus on the three main areas:
– pharmaceutical industry, i.e. production of drugs, including medicinal substances and formulas, with an emphasis on production of comparatively cheap generics (drugs that were developed and patented in other countries), as well as new domestically-developed medicines;
– biotechnology industry, i.e. production of high-tech medicines based on chimeric proteins and monoclonal antibodies (using cell technologies and chimeric bodies), and highly purified ferments for medicine, agriculture, food and light industries; production of chimeric proteins with useful properties (lactoferrin, filgrastim, erythropoietin), therapeutic monoclonal antibodies and their fragments; development and application of genome biotechnologies in medicine, sports, agriculture, and environmental protection;
– microbiology industry, i.e. development and manufacturing of products of microbiologic synthesis (pharmaceutical substances, ferment preparations, probiotics, biological decontaminants, bio preservatives, fodder and food additives, bacterial concentrates for food industry, plant-protecting agents, microbial fertilizers, agents for bioremediation, biofuel, etc.).
The main priority of reforms in the pharmaceutical and biotechnology industry is to ensure medical, food, energy and environmental safety of the country by developing and producing a wide range of pharmaceutical and biotechnology goods, fostering research in biotechnology and raising its competitiveness.
To set up an adequate industrial infrastructure for the development of the biotechnology industry, it is necessary to reconstruct existing microbiology
production facilities and build new ones. New companies and production facilities established under the government program “Innovative Biotechnologies” for 2010-2012 and up to 2015 can be used as a good example of such facilities. Much needs to be done to upgrade and convert biotechnology companies that used to be part of Belbiopharm Concern.
In order to raise the bar for the sci-tech biotechnology projects and boost production of scienceintensive products, it is necessary to launch production of goods based on the latest achievements in biotechnology, gene engineering, immunology, and molecular genetics.
It is also necessary to ensure close cooperation between research and production companies, including private firms, when implementing joint projects under government programs.
With a view to implementing government policy in the pharmaceutical and biotechnol- ogy industry and making it more competitive, it is necessary to set up a departmental system of professional training in these areas, organize regular training and retraining courses in order to keep the personnel updated on the new developments in this industry as well as to improve logistics of universities and update curricula with a focus on improving training of highly qualified personnel.
The majority of the existing biotechnological companies are loss-making. Therefore, it is dif- ficult for them to raise additional loans. In this context, upgrade projects need a lot of private investments at the early stages of their implementation in order to refocus loss-making companies on production of profitable goods. There is also an urgent need to form a market infrastructure promoting business initiative and competitiveness in the biotechnology industry.
Large commercialization projects should be implemented us- ing public-private partnership and involving international corporations.
The most important investment projects in the pharmaceutical industry will be funded from the state budget, by national pharmaceutical companies and with the help of bank loans. Joint ventures with foreign companies using the latest technologies and foreign investments will play an important role in the development of the national pharmaceutical sector.
In pursuance of the presidential order, the Economy Ministry has been developing a Biograd Techno Park concept to promote pharmaceutical and biotechnology industry. Belarus has already gained some experience in operating institutions of this kind. Therefore, the park is expected to become a powerful tool for everyone involved in the development of new technologies and medicines to reach their goals.
As part of the government program “Innovative Biotechnologies” for 2010-2012 and until 2015, the ZhodinoagroPlemelita breeding company has introduced cutting-edge technologies to increase the yielding capacity of animals. Pictured is junior research associate Yuri Kirikovich at the mobile laboratory for transplanting embryos
Belmedpreparaty is Belarus’ leading pharmaceutical
Novopolotsk Plant of Protein and Vitamin Concentrates is Belarus’ only producer of microbiological protein for animals – a natural feed supplement included in the government import substitution program