Global trends, future prospects and challenges of Biotechnology in

Pharmaceuticals: Bangladesh perspective

Dr. Md. Moklesur Rahman Sarker
M. Pharm., Ph. D. (Pharma. Science)

Biotechnology in pharmaceuticals is the applied biology that involves the use of living organisms and bioprocesses
in the preparation of life saving medicines.
Infectious diseases are the leading causes of death worldwide and new infectious diseases continue to emerge.
Tremendous progress has been made in biotechnology in developing new vaccines and therapies that dramatically
reduce rates of infection, treat and cure serious illnesses, and save millions of lives. More than 600 new biotech
drugs are in development, including treatments for cancer, HIV/AIDS, Alzheimer's disease, and numerous lifethreatening conditions.
Modern biotechnology can be used to manufacture existing medicines relatively easily and cheaply. Biotechnology
has made landmark breakthroughs in new medical therapies to treat hepatitis B, hepatitis C, cancer,
arthritis, hemophilia, bone fractures, multiple sclerosis, and cardiovascular disorders.
Globally, the pharmaceutical companies have given keen attention to maximize the utilization of biotechnology in
pharmaceutical fields and, hence, they are investing huge capitals for the invention, development, manufacturing
and marketing of biotech drugs. The pharmaceutical companies of Bangladesh are also turning to the biotech
products. Some companies have already introduced some biotech products like human insulin, anticancer drugs, etc.
and some are on the process of launching many other biotech products. Although the journey of Bangladeshi
pharmaceutical companies on the road of biotechnology and biotech products is still at the primary stage, yet its a
positive sign that Bangladeshi companies are trying to cope with global pharmaceutical trend and they have taken
this initiative to mitigate the local demand of biotech products in Bangladesh.

Biotech products for the management of diseases

Drug for Autoimmune diseases and Inflammation

Blood and Lymphatic System products
Anti-cancers drugs
Hormones & Enzymes
Cardiovascular drugs
Drugs act on CNS disorders (e.g., Alzheimer's disease, stroke, Parkinsons disease, schizophrenia)
Drugs act on digestive system (e.g., liver diseases)
Antibiotics and anti-infective drugs (e.g., hepatitis B & C)
Drugs for kidneys and Genito-Urinary system disorders (e.g. urogenital diseases, renal failure)
Drugs for metabolic disorders (e.g. diabetes, obesity)
Drugs act against respiratory & pulmonary diseases (e.g., influenza, asthma)

Biotech pharmaceuticals world scenario

The first genetically engineered products were medicines designed to treat human diseases. For example,
synthetic humanized insulin was developed by joining its gene with a plasmid vector inserted into the
bacterium Escherichia coli. Insulin was previously extracted from the pancreas of abattoir animals (cattle
or pigs). The resulting genetically engineered bacterium enabled the production of vast quantities of
synthetic human insulin at relatively low cost.

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Modern biotechnology makes it possible to produce human growth hormone, clotting

factors for hemophiliacs, fertility drugs, erythropoietin and other drugs. Most drugs today are based on
about 500 molecular targets. Genomic knowledge of the genes involved in diseases, disease pathways, and
drug-response sites are expected to lead to the discovery of thousands more new targets.
At present, global pharmaceutical biotech industries give importance to newer biotech concepts of
recombinant proteins, monoclonal antibodies, gene therapy and transgenic organism among others, rather
than traditional biotechnology that focused on secondary metabolites, antibiotics, steroids, vitamins etc.
Over 370 new biotechnology drug products and vaccines for more than 200 diseases are in different stages
of progress, with the cell cultures being grown under very strict conditions and are regularly maintained in
large stainless steel fermentation vats.
Thousands of biotech companies are engaged in research to produce new biotech molecules to serve the
human needs and are investing billions of dollars for the invention of life-saving crucial medicines, such
as, Anti-AIDS, Anti-cancer drugs, blood products, Genetic products, and other products research that can
alter the genetic code of cells. United States is leading for biotech products along with companies from
other countries including Japan, China, Germany, France, Italy, England, Australia, India etc.

Recent trend and invention techniques of Biotech products

Now a days, safer vaccines can be designed and produced by organisms transformed by means of genetic
engineering. These vaccines will elicit the immune response without the attendant risks of infection. They
will be inexpensive, stable, easy to store, and capable of being engineered to carry several strains of
pathogen at once.
Gene therapy is used for treating, or even curing, genetic and acquired diseases like cancer and AIDS by
using normal genes to supplement or replace defective genes or to bolster a normal function such as
immunity. As of June 2001, more than 500 clinical gene-therapy trials involving about 3,500 patients have
been identified worldwide. These trials focus on various types of cancers. Recently, two children born
with severe combined immunodeficiency disorder were reported to have been cured after being given
genetically engineered cells.
Using pharmacogenomics, new drugs are made based on the proteins, enzymes and RNA molecules that
are associated with specific genes and diseases. These tailor-made drugs promise not only to maximize
therapeutic effects but also to decrease damage to nearby healthy cells.

Global Biotech Market Report 2009

With the discovery and introduction of biotech molecules, the pharmaceutical industries in the world are
rapidly rising, changing and expanding. Many changes in sales, market, earnings and R&D have been
observed in the pharmaceutical biotech industries in the year 2009. New trends and reshuffling of top
biotech companies and changes in best selling medicine brands were registered. Many blockbuster drugs
had been registered to be sold by top biotech companies. However, expenditure on R&D registered a
decrease in 2009 but in spite of fall in R&D budget allocations, the number of new drugs approved by
FDA in 2009 increased considerably. More companies were granted licenses as compared to previous
years. There was also an increase in mergers and acquisitions of pharmaceutical biotech companies.
Roche has been recognized as the most efficient R&D Company in 2009.

Pharmaceutical Biotech Market Trends 2010-2025

Many pharmaceutical biotechnology reports forecast a market growth, novel technologies and expansion
into new therapeutic areas during the period 2010-2025. The global pharmaceutical biotech market is
predicted to experience a continual high growth. The pharmaceutical biotech drugs will be manufactured
by all kinds of manufacturers ranging from major pharmaceutical companies to those pharmaceutical
firms that specialize in one or multiple areas. R&D activities have been predicted to grow with some
significant R&D efforts having major impact on the overall biotech market. Introduction of innovative
new treatments will result in further expansion of the pharmaceutical biotech market.

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Recombinant DNA Technology: A Novel technique for Biotech products

Genetic engineering or recombinant DNA technology is a technique where a microorganism is isolated; its
genetic material is cut, manipulated, sealed, again inserted in an organism and allowed to grow in a
suitable environment under controlled conditions to get the desired product. Recombinant DNA
technology has made revolution in the discovery and commercial production of many biotech drugs.
Human insulin: Recombinant DNA technology is used to modify E. coli bacteria to produce
human insulin. Prior to the development of this technique, insulin was extracted from the pancreas glands
of cattle, pigs, and other farm animals. Animal-derived insulin is not indistinguishable from human
insulin, and may therefore produce allergic reactions. The recombinant plasmids were inserted into E.
coli bacteria, which were induced to produce 100,000 molecules of either chain A or chain B human
insulin. The two protein chains were then combined to produce insulin molecules.

Fig. E. coli bacteria, which are frequently

Utilized in production of biotech products

Fig. Insulin crystals

Fig. Growth hormone

Human growth hormone: The human growth hormone was manufactured by extraction from the pituitary
glands of cadavers, as animal growth hormones have no therapeutic value in humans. Production of a
single year's supply of human growth hormone required up to fifty pituitary glands, creating significant
shortages of the hormone. With the development of biotechnology, human growth hormone was produced
by inserting DNA coding for human growth hormone into a plasmid that was implanted in E. coli bacteria.
Thus recombinant DNA technology is used to modify bacteria to produce human growth hormone.
Human Blood Clotting Factors: Prior to the development and FDA approval of a means to produce
human blood clotting factors using recombinant DNA technologies, human blood clotting factors were
produced from donated blood that was inadequately screened for HIV. Thus, HIV infection posed a
significant danger to patients with hemophilia who received human blood clotting factors. The first human
blood-clotting factor to be produced in significant quantities using recombinant DNA technology
was Factor IX, which was produced using transgenic Chinese hamster ovary cells. The Chinese hamster
ovary cells that were stably transfected produced significant quantities of Factor IX, which was shown to
have substantial coagulant properties, though of a lesser degree than Factor IX produced from human
blood. FDA finally approved Factor VIII produced using transgenic Chinese hamster ovary cells in 1992.

Present market size of some biotech products in global market

Antibody products: These are proteins, present in blood or other bodily fluids, which are used by the
immune system for determining and neutralizing bacteria and viruses. At present, the size of antibody
products market is worth more than US$ 3 billion.
Proteins: The market for proteins as biotech products in the global economy were worth US$ 2.3 billion
in 2005, which later rose to reach a value of US$ 2.4 billion for the biotech pharmaceutical sector.

How a biotech drug can be developed and made?

Producing a biotech drug is very complicated and time-consuming process with many years just being
spent in actually identifying the therapeutic protein, the gene sequence, then has to be determined and a
process has to be worked out using biotechnology to produce the molecule. This is then achieved by
transforming the host cell to contain the particular gene of interest and growing the cells in large stainless
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steel tanks. To get the cells to produce the target proteins it must be kept alive and stimulated through
using precise culture conditions, temperature is very often a crucial part. The acidity levels must be
carefully watched for even if they vary a small fraction the cells can easily die, the duration of time the
cells have to be left for will depend on the protein produced and the organism. The proteins are stringently
tested having been isolated from the cultures, and are then formulated into active products. Currently,
culture methods can take several years and due to this there are significant challenges and it is very
expensive right now to manufacture a complex biotech medicine. In-time manufacturing practices are
facing a major global shortage at present. Today, there are only 30 protein-based medicines on the market
with the industries production capacity already being overstretched, with 99 protein based medicines now
being in the late stages of human trials and are expected to hit the market soon the production facilities
which are already struggling will only be stretched even further in the coming years.

Challenges of Biotech drugs

Biotech drugs are used for treating, or even curing, genetic and acquired diseases by using normal genes
to supplement or replace defective genes. But gene therapy faces many obstacles before it can become a
practical approach for treating diseases. The obstacles are gene delivery tools, high costs and limited
knowledge of the functions of genes. Besides, the true development of biotech drugs needs much longer
time (several years) than the conventional drugs, therefore, investment in this sector should be not only for
commercial benefit but also to serve the human being providing new life savings drugs.

Biotechnology status in Indian Pharmaceuticals

Indian biotech made its presence on the world map in 1997 with the introduction of indigenously
developed hepatitis B vaccine. Meanwhile, Indian biotech products explored in multiple arenas including
Bio-Pharmaceuticals and Bio-Nutraceuticals, Vaccines, Monoclonal Antibodies, Recombinant Proteins,
Anti-cancer drugs, Biomedical Components, etc. India is strongly involved with stem cell research and
cell based therapeutics using bone marrow mononuclear cells. The Department of Biotechnology,
Government of India estimates the Indian market for recombinant therapeutics alone at $90 million with
an annual growth rate of 30 percent.
The govt. of India assured the following facilities for the development and strengthens the biotech sector:
Establishment of a single National Biotech Regulatory Authority
Provides efficient and faster clearance of all proposals for biotech products
Exemption of biotechnology segments from licensing requirements
Allows 100 percent foreign direct investment
Increased incentives for commercializing the scientific research
Promoting innovation in small and medium industry
Financial and administrative supports for setting up of biotech parks
Besides, the Department of Biotechnology, Govt. of India, has announced the establishment of Small
Business Innovation Research Initiative. The Indian Government has earmarked funds for soft loans under
the Technology Development Board for biotech sector. Several state governments including the
Government of Andhra Pradesh, Gujarat, Maharashtra and Karnataka have evolved policies encouraging
R&D and investments in biotech areas. The Gujarat Biotech Venture Fund is around $11.1million.

Bangladeshi companies turning to Biotech products

There is no available information on the market of biotech products in Bangladesh. However, the local
demand of biotech drugs in Bangladesh is estimated to be about BDT 600 crore.
Due to the crying need of biotech products for the achievement of self-sufficiency for human medicines,
the pharmaceutical companies of Bangladesh are turning to biotech and high tech products gradually.
Several companies have already introduced anti-cancer, anti-HIV/AIDS drugs, human insulin, and many
other companies are planning to launch biotech and high tech products to keep pace with the worlds
pharma market trend, to fulfill the local demand of biotech products, as well as to export those products to
other countries.

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Anti-cancer drugs: The estimated market of anti-cancer drugs is BDT 300 crore. At present, Beacon,
Beximco, Incepta and Techno Drugs are manufacturing anti-cancer drugs in Bangladesh. Roche
(Bangladesh), sanofi-aventis (Bangladesh), and some other importers market anti-cancer drugs.
Human insulin: The value of human insulin consumption in Bangladesh is estimated as BDT 100 crore.
More than 80% of insulin market is presently held by Novo Nordisk (Denmark) and the rest of the share is
distributed by our local manufacturers and other importers. Recently Square, Incepta, and Popular
Pharmaceuticals have started to manufacture the finished product from imported crystals of human
insulin. In near future, it is expected that our local companies will mostly enjoy the major market share of
insulin and thus will go for shelf-sufficiency of insulin demand in our country.
Vaccines: The estimated market of vaccines in Bangladesh is BDT 100 crore. No company has yet been
involved with vaccine manufacturing in Bangladesh; however, Incepta and Popular Pharma are going to
launch vaccines in their dedicated plants soon. Few other companies like Biopharma, Beacon, and JMI
Pharma are preparing to launch vaccines in near future. At present, Glaxo-SmithKline (GSK), sanofiaventis (Bangladesh) Ltd. and some other importers are marketing vaccines in Bangladesh.
Anti-HIV/AIDS drugs: Beximco Pharmaceuticals Ltd. is the only company in Bangladesh involved with
the manufacturing of anti-HIV/AIDS drugs since the last few years. This giant player in the
pharmaceutical sector of Bangladesh is also preparing to launch many high-tech and biotech life saving
drugs in its highly sophisticated world class manufacturing plant in near future.

Future of biotech drugs in Bangladesh

In future, many Bangladeshi companies may show interest to manufacture biotech finished products
mainly by importing the basic raw materials as they are doing for the manufacturing of pharmaceutical
finished products. Very little or no company would show interest, at least in near future, for the real
advancement of biotech drugs in Bangladesh. Yes, the local manufacturing of those products will reduce
the present high cost of many of biotech products that are presently being imported. Therefore, the price
of most of the widely used biotech products would be within the buying capacity of our people in near
future. Actually, the possibility of basic development of biotech molecules/products through research
would be practically next to impossible for the private sector without active support from the govt.
considering its high technology, expenses, time consumption, investment return, etc. Alternatively,
foreign investment in this segment or tie-up with foreign Biotech companies would make it happen.

Recommendations
1. Currently, the application of biotechnology for the development and production of biotech drugs is at
the preliminary stage in Bangladesh. Lack of infrastructure and shortage of funds and no support from
the govt. are hindering the initiative and progress in biotechnological research. Besides, entrepreneurs
in our country lack interest and, usually, they have more interest in the import of technology to get
quick
returns.
Initiative
and
investment
are
lacking
in
this
sector.
Bangladesh needs a clear policy; institutional development for true research and funding from the
govt. and entrepreneurs for the application of biotechnology for pharmaceuticals. The investors should
invest in this sector for long-term basis for the real development of biotech pharmaceuticals.
2. Almost all living things contain compounds, which are therapeutic to us, and a great deal of the
medicines which are available today are made from plants. For example, a certain type of fungus is
found to produce a novel antioxidant enzyme that sucks up free radicals that are known to encourage
the growth of tumors. Marine biotechnologists found that organisms containing certain compounds
have the ability to destroy tumors, could prevent inflammation, help to relive pain and were able to kill
microorganisms. Thus, by using our natural sources and sufficient scientists from Pharmaceutical,
Biological and Microbiological background with minimum remuneration, we can start
biotechnological research activities for the invention of new biotech molecules.
3. India has established Genome Valley and Biotech Park for the dedicated research, development and
manufacturing of biotech products. Bangladesh govt. also should take an effective initiative to set up a
dedicated park for biotech products like API Park that is going to be started in this country soon. In
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fact, without the direct financial involvement, administrative support, research facilities sponsored by
the Govt. of Bangladesh, no true research for biotech pharmaceuticals would be feasible.
4. The Indian government provides a number of benefits to biopharma companies like instant customs
clearance, plug and play facilities for lab work, access to R&D fund, waiver of stamp duty and
registration charges on land/building transfer in the first instance, IPR and patent facilitating cell to
ensure data protection and facilitate patenting process, normal sales tax of one percent, single window
clearance, provision of rebate based on the employment opportunity created. Besides, there is also a
capital subsidy of 25 percent of the total project cost is offered to those companies that are setting up
biotech related infrastructure. Other countries like USA, UK, France, Germany, Australia, Japan, and
China also offer such kinds of supports. Likewise, our govt. should offer such kinds of support.
5. International Center for Diarrhoeal Diseases and Research in Bangladesh (ICDDRB), Bangladesh
Council for Scientific and Industrial Research (BCSIR), Center for Advanced Research in Sciences,
and Department of Biotechnology and Genetic Engineering of Dhaka University, Pharmacy and
Microbiology departments of different universities in Bangladesh can be utilized for conducting
various research projects for the development of biotech molecules. Different leading pharmaceutical
companies can offer research project to pursue research for the development of new and worlds
existing biotech products that will surely enhance the development of biotech sector in Bangladesh.

Conclusion
Still, Bangladesh is importing a lot of anti-cancer, anti-diabetic drugs, vaccines, blood products, and other
high tech and life-saving drugs to meet the present demand for our country people. Many of these biotech
drugs are coming from India, Switzerland, France, etc. In this context, our leading pharmaceutical
companies should take vigorous steps for research, introduction and manufacturing of biotech products as
much as possible, at least to reduce the import dependency of those products. The govt. should encourage
and ensure the financial, administrative, and all kinds of support for the introduction and real development
biotech drugs in Bangladesh.
[Note: References are available on request]
(The writer is Sr. Lecturer, Dept. of Pharmacy, Daffodil International University and can be reached at
E-mail: dr.mokles@daffodilvarsity.edu.bd)

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